Catheter Construction with Gradual Durometer Transitions for Torque Stability
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Solution Overview
Problem
Conventional catheter designs face challenges in navigating tortuous anatomy due to abrupt changes in structural properties, leading to torque instability, poor navigation, and mechanical compromise between stiffness and flexibility, which affects torque transmission and vessel trauma.
Innovation Solution
The catheter construction incorporates a composite polymeric layer with customizable material sections, allowing for gradual or abrupt transitions in structural properties, ensuring optimal performance by combining materials with different durometers and orientations to match anatomical demands.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the catheter uses abrupt transitions between different polymer durometers to provide varying structural characteristics, then the catheter can be designed to navigate tortuous anatomy with different stiffness requirements, but the abrupt changes cause torque instability and poor navigation performance
Solution Approach 1:
The patent applies parameter changes by transitioning from abrupt durometer changes to gradual transitions. Specifically, the distal tip region uses a first durometer polymer while the proximal region uses a second durometer polymer with progressively increasing stiffness, creating a gradient rather than a step change. This gradual parameter transition maintains adaptability to different anatomical regions while ensuring torque stability throughout the catheter shaft.
Solution Approach 2:
The patent employs composite materials by combining multiple polymer materials with different durometers in a single catheter structure. The catheter includes a distal tip section with softer polymer material and a proximal shaft section with progressively stiffer polymer materials, creating a composite structure that optimizes both navigation capability and torque transmission without abrupt transitions.
2Strength
If the catheter uses stiffer polymer materials in the proximal end to enable pushing and manipulation, then the catheter can be manipulated through tortuous anatomy, but the distal end becomes insufficiently flexible to pass through loops and smaller blood vessels
Solution Approach 1:
The patent applies local quality by assigning different durometer characteristics to different regions of the catheter. The distal tip uses softer polymer material for flexibility and navigation through tortuous anatomy, while the proximal shaft uses progressively stiffer polymer materials for manipulation and pushing. This spatial variation in material properties allows each region to optimize its function locally.
Solution Approach 2:
The patent uses parameter changes to create a durometer gradient along the catheter length. The polymer durometer transitions gradually from soft at the distal tip to stiff at the proximal end, allowing the catheter to maintain flexibility where needed for navigation while providing structural support where needed for manipulation, eliminating the need for abrupt material changes.
3Ease of manufacture
If the catheter uses a single uniform polymer material throughout, then the manufacturing is simple, but the catheter cannot meet the varying structural requirements of different anatomical regions
Solution Approach 1:
The patent applies segmentation by dividing the catheter into distinct functional regions with different material properties. The catheter is segmented into a distal tip region with softer polymer and a proximal shaft region with stiffer polymer, allowing each segment to be optimized for its specific function while maintaining overall structural integrity.
Solution Approach 2:
The patent uses composite materials to create a catheter with varying durometer properties along its length. By combining multiple polymer materials with different stiffness characteristics in a single integrated structure, the catheter can adapt to varying anatomical requirements while maintaining manufacturing feasibility through controlled material transitions.
Data Source
AI summary
Polymeric tubing, for use with catheters or other medical devices, where the polymeric tubing can have regions of customized properties including, but not limited to, durometer, torque control, flexibility, axial strength, stiffness, etc. One variation of the device allows for transitions between regions to be configured such that there can be gradual or customized transitions between various regions such that the structural characteristics differential between the regions are selectively designed. Additional variations include outer layers having a plurality of material sections extending in a spiral direction along the axial length to form a continuous wall of the outer layer. In certain variations, the structural characteristic differential is minimized or eliminated as compared to conventional catheters.