Keyed Steerable Catheter Nested Design
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Solution Overview
Problem
Steerable catheters with existing pull wire mechanisms face manufacturing complexities and variability issues, limiting their effectiveness in navigating complex anatomical paths and increasing manufacturing costs due to the need for additional lumens and components, which can compromise reliability and flexibility.
Innovation Solution
The use of nested catheters with a keyed configuration, featuring an outer sheath with a spline and an inner sheath with a keyway, allows for multi-planar steering without additional components, providing mechanical strength and uniform structural features, while preventing air or fluid leakage and enhancing operational reliability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If pull wire mechanisms are used for catheter steering, then steering capability is achieved, but manufacturing complexity increases due to dedicated lumens and additional components
Solution Approach 1:
The patent combines the steering function with the structural support function by integrating the pull wire mechanism into the existing catheter wall structure. The pull wires are embedded within the catheter body rather than requiring separate dedicated lumens, merging multiple functions into a unified structure that reduces manufacturing complexity while maintaining steering capability.
Solution Approach 2:
The catheter structure is designed to serve multiple functions: the wall structure provides both structural support and houses the steering mechanism. The same catheter body that provides mechanical strength also contains the pull wires for steering, eliminating the need for separate dedicated lumens and reducing overall device complexity.
2Ease of operation
If pull wire mechanisms with dedicated lumens are used, then steering is enabled, but manufacturing costs increase due to additional space requirements and tolerance maintenance
Solution Approach 1:
The patent merges the steering mechanism with the catheter wall structure, eliminating the need for separate dedicated lumens. The pull wires are integrated into the existing catheter body, which reduces manufacturing costs by eliminating additional molding operations, reducing tolerance stack-up, and minimizing material usage while maintaining full steering functionality.
3Ease of manufacture
If single-plane pull wire deflection is used, then manufacturing is simpler, but effectiveness in reaching treatment sites is limited
Solution Approach 1:
The patent transitions from single-plane to multi-planar steering by incorporating multiple pull wires arranged in different orientations within the catheter body. This allows the catheter tip to deflect in multiple planes (radial and axial directions), enabling navigation through complex anatomical paths while maintaining manufacturing simplicity through the integrated wall structure design.
4Measurement precision
If additional components are added for steering, then steering precision improves, but reliability decreases due to more potential failure points
Solution Approach 1:
The patent merges the steering mechanism with the existing catheter structure, eliminating the need for additional separate components. The pull wires are integrated into the catheter wall, reducing the number of potential failure points while maintaining steering precision. This integration reduces reliability concerns associated with additional components such as separate lumens, connectors, and mounting structures.
Data Source
AI summary
Disclosed herein are devices, systems, and methods relating to steerable catheters. A steerable catheter includes a first actuation line, an inner catheter, and an outer catheter. The inner catheter has an inner catheter proximal end, an inner catheter distal end, an inner catheter outer surface defining a keyway that is longitudinally-extending, and an inner catheter inner surface defining an inner catheter lumen. The outer catheter has an outer catheter proximal end, an outer catheter distal end, an outer catheter outer surface, and an outer catheter inner surface defining an outer catheter lumen and a spline that is longitudinally-extending and that projects radially inward into the outer catheter lumen. The outer catheter lumen is operable to receive the inner catheter with the spline of the outer catheter operable to key with the keyway of the inner catheter. The spline defines a spline lumen operable to receive the first actuation line.