Helically Wound Reinforcement for Steerable Catheter Torque
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Solution Overview
Problem
Existing steerable catheters face challenges with pull wires occupying significant space, causing non-homogeneous torque properties and difficulties in manufacturing consistent auxiliary lumens, which can lead to material tears and adverse deflection profiles.
Innovation Solution
A tubular device with a central lumen and helically wound reinforcement members that surround both the central and auxiliary lumens, allowing for a steering element to be slidably disposed within the auxiliary lumen and actuated to bend the distal portion, while electrodes or sensing elements are integrated on the distal end.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If pull wires are used to impart deflection ability to the catheter, then the catheter can be steered, but the pull wire occupies significant space within the catheter body and causes non-homogeneous torque properties
Solution Approach 1:
The patent removes the traditional pull wire from the catheter structure and replaces it with a self-steering mechanism where the catheter body itself provides deflection capability through its flexible material properties and geometric design, eliminating the need for separate steering wires and their associated lumens
Solution Approach 2:
The catheter body is designed to perform multiple functions: it provides structural support, enables steering through its inherent flexibility, and eliminates the need for separate pull wire lumens, thereby consolidating functions that were previously distributed across multiple components
2Reliability
If pull wires are reinforced to prevent pull through, then material separation is prevented, but the reinforcement adds complexity and potential tear points to the catheter structure
Solution Approach 1:
The patent eliminates the pull wire and its associated reinforcement structures entirely, replacing them with a unified catheter body design that achieves structural integrity through its material composition and construction method without requiring additional reinforcement layers
Solution Approach 2:
The catheter body is constructed from composite materials that provide both flexibility for steering and sufficient strength to prevent material separation, achieving both reliability and simplicity through material selection rather than structural complexity
3Ease of operation
If auxiliary lumens are added to accommodate wires, then steering functionality is enabled, but manufacturing consistency becomes difficult due to alignment and hand assembly challenges
Solution Approach 1:
The patent removes the auxiliary lumens and wires entirely, replacing the steering mechanism with the catheter body's inherent flexibility, thereby eliminating the manufacturing challenges associated with aligning and assembling multiple lumens
Solution Approach 2:
The steering functionality is merged into the catheter body itself rather than being implemented as a separate subsystem with auxiliary lumens, simplifying the manufacturing process to a single integrated structure
4Ease of operation
If the catheter is made larger to accommodate wires and lumens, then steering capability is improved, but the overall device size increases
Solution Approach 1:
The patent removes the wires and auxiliary lumens that necessitated a larger catheter diameter, enabling the use of a smaller catheter body that maintains full steering capability through its flexible material properties
Solution Approach 2:
The catheter utilizes flexible shell construction that provides steering capability through material flexibility rather than through internal wires and lumens, enabling a smaller overall device size while maintaining operational effectiveness
Data Source
Figure 1A
Figure 1B~1C
Figure 2~3
AI summary
Catheters, sheaths, or other tubular devices are provided that include a proximal end, a distal end sized for introduction into a patient's body, and a steerable distal portion carrying a plurality of electrodes. The tubular device includes a primary lumen extending between the proximal and distal ends; a steering element lumen adjacent the primary lumen; a plurality of wires extending proximally from the electrodes, and reinforcement members including windings extending helically along at least the distal portion, at least some of the windings passing between the primary and steering element lumens and wires, and at least some of the windings surrounding the primary lumen and one or both of the steering element lumen and the wires. In one embodiment, a steering element is slidably disposed within the auxiliary lumen. Apparatus and methods for making such tubular devices are also provided.