Steerable Catheter Braided Reinforcement Torque Homogeneity
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Solution Overview
Problem
Existing steerable catheters and sheaths face challenges with pull wires, including space occupation, reinforcement needs, torque homogeneity, and manufacturing consistency, particularly in auxiliary lumens within large bore sheaths.
Innovation Solution
A method and design for reinforced tubular devices featuring a braided configuration with multiple lumens, where reinforcement members are wrapped helically around both primary and secondary mandrels to create a primary lumen and auxiliary lumens, enhancing support and torque transmission while minimizing the risk of tearing and separation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If pull wires are used for steering, then deflection ability is achieved, but the catheter structure becomes complex and vulnerable to tearing
Solution Approach 1:
The patent removes the pull wire component entirely and replaces it with a self-steering mechanism where the catheter body itself provides deflection capability through its braided construction and structural design, eliminating the need for separate steering wires
Solution Approach 2:
The steering function is merged into the catheter body structure itself, where the braided reinforcement layers and catheter wall work together to provide both structural support and controlled flexibility for deflection without requiring separate steering components
2Reliability
If pull wires are reinforced to prevent tearing, then reliability improves, but manufacturing complexity increases
Solution Approach 1:
By eliminating the pull wire entirely, the patent removes the need for complex reinforcement structures that would be required to prevent tearing, simplifying the manufacturing process while maintaining reliability through the braided catheter design
Solution Approach 2:
The patent uses braided reinforcement layers made from composite materials that provide inherent strength and tear resistance in the catheter wall itself, eliminating the need for additional reinforcement of separate steering components
3Adaptability or versatility
If pull wires are actuated, then deflection is achieved, but torque transmission becomes non-homogeneous
Solution Approach 1:
The patent removes the pull wire that caused non-homogeneous torque properties, allowing the catheter to maintain uniform torque transmission characteristics throughout its length while still achieving deflection through the braided structure design
Solution Approach 2:
The patent varies the braiding parameters and reinforcement density at different locations along the catheter to provide localized flexibility for deflection while maintaining overall homogeneous torque transmission properties in the steerable section
4Adaptability or versatility
If auxiliary lumens are added to large bore sheaths, then functionality increases, but manufacturing consistency decreases
Solution Approach 1:
The patent forms auxiliary lumens and their positions within the braided structure during the initial catheter manufacturing process, ensuring precise alignment and consistent positioning before final assembly, rather than attempting to align and assemble pre-formed lumens separately
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 12, a distal end 14 sized for introduction into a patient's body, and a steerable distal portion 24. The tubular device includes primary lumen 18a extending between the proximal and distal ends; an auxiliary lumen 18b adjacent the primary lumen; and one or more reinforcement members 43 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 at least some of the windings surrounding both the primary and steering element lumens. In one embodiment, a steering element is slidably disposed with the auxiliary lumen. Apparatus and methods for making such tubular devices are also provided.