Deflectable Catheter with Fluoroelastomer and ePTFE Composite

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Solution Overview

Problem

Conventional catheters lack the necessary flexibility and precision to navigate complex vascular pathways effectively, often resulting in high friction surfaces that can lead to material and device failure during interventional procedures.

Innovation Solution

A deflectable catheter made from a combination of fluoroelastomer and expanded polytetrafluoroethylene (ePTFE) materials, which provides a low coefficient of friction and elasticity, allowing for precise articulation into complex curves and maintaining stability within the anatomy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional catheter materials are used, then the catheter structure is simple and easy to manufacture, but the friction surface is high leading to material and device failure

Engineering Contradiction:

Improvedevice failure riskVSAvoidfriction surface

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The catheter shaft is constructed from a composite material comprising fluoroelastomer and expanded polytetrafluoroethylene (ePTFE). This composite structure combines the elasticity and flexibility of fluoroelastomer with the low friction properties of ePTFE, achieving both reduced friction and improved reliability simultaneously without material failure

Inventive Principle:

Principle #40Composite materials

2Adaptability or versatility

If the catheter is made more flexible to navigate tortuous vessels, then navigation capability improves, but torque resistance and structural stability deteriorate

Engineering Contradiction:

Improvenavigation capabilityVSAvoidtorque resistance

Core Design Contradiction:

Adaptability or versatilityVSStrength

Solution Approach 1:

The catheter employs varying durometer materials along its length, with the distal portion being softer (20-40 Shore A) for flexibility and navigation, while the proximal portion is harder (30-50 Shore A) for torque resistance and stability. This local differentiation allows the catheter to navigate tortuous vessels while maintaining structural integrity and torque control

Inventive Principle:

Principle #3Local quality

3Measurement precision

If the catheter shaft is made stiffer to maintain stability at target location, then positioning accuracy improves, but the ability to navigate complex pathways deteriorates

Engineering Contradiction:

Improvepositioning accuracyVSAvoidnavigation through tortuous vessels

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

The catheter shaft is divided into multiple sections with different stiffness properties. The distal section (10-30 cm from tip) has lower durometer (20-40 Shore A) for navigating complex pathways, while proximal sections have higher durometer (30-50 Shore A) for maintaining stability and positioning accuracy at the target location, achieving both navigation capability and positioning precision

Inventive Principle:

Principle #1Segmentation

4Object-affected harmful factors

If low friction material is used, then the coefficient of friction decreases improving device performance, but the material loses elasticity and toughness

Engineering Contradiction:

Improvecoefficient of frictionVSAvoidelasticity and toughness

Core Design Contradiction:

Object-affected harmful factorsVSStrength

Solution Approach 1:

The composite structure combines ePTFE (providing low friction with coefficient of 0.04-0.08) as the outer layer with fluoroelastomer (providing elasticity and toughness) as the inner layer. This composite material simultaneously achieves low friction surface properties while maintaining the elastic and tough characteristics needed for catheter flexibility and recovery

Inventive Principle:

Principle #40Composite materials

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The fluoroelastomer and ePTFE composite material enhances the catheter's flexibility, toughness, and torque resistance, reducing the risk of material failure and improving the precision and effectiveness of procedures such as delivering implantable devices and therapeutic agents.

Implementation Method 1

The fluoroelastomer and ePTFE composite material can have a low coefficient of friction and low modulus of elasticity

Methodology Applied

Scientific EffectFriction: Friction

Implementation Method 2

The deflectable catheters and hemostasis valves can be made at least partially, if not entirely, from a fluoroelastomer and expanded polytetrafluoroethylene (ePTFE) combination

Methodology Applied

Scientific EffectElasticity: Elasticity

Data Source

PatentUS20240050702A1Deflectable catheter with compound curve articulation and materials for the same

Publication Date: 2024.02.15 QMAX

AI summary

Deflectable catheters, hemostasis valves, and materials for the same are disclosed. The deflectable catheters and hemostasis valves can be made at least partially, if not entirely, from a fluoroelastomer and ePTFE combination. A deflectable region of the catheters can be articulated to form simple and/or complex curves.