Hydrophobic EFEP Catheter Barrier Layer Design

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Solution Overview

Problem

Catheter shafts made from polar polymeric materials tend to absorb water when exposed to aqueous environments, leading to mechanical softening and compromised performance during medical procedures due to the lack of chemical compatibility with non-polar fluoropolymers like PTFE, which are inert and difficult to integrate without inconvenient surface treatments.

Innovation Solution

The use of a terminally-functionalized ethylene-perfluoroethylenepropylene (EFEP) copolymer as a hydrophobic barrier layer, covalently bonded to reactive polar polymers, provides a hydrophobic barrier that prevents water absorption and maintains mechanical integrity by forming a stable, chemically compatible interface with the catheter shaft's layers, even in the presence of metallic braids.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If polar polymeric materials are used for catheter shafts, then ease of manufacture and bonding is improved, but water absorption increases leading to mechanical softening and performance compromise

Engineering Contradiction:
Improvebonding capabilityVSAvoidmechanical strength
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The catheter shaft is constructed as a multi-layer composite structure with an inner polar polymeric layer (e.g., polyamide, polyurethane, polyester) providing ease of manufacture and bonding, and an outer non-polar fluoropolymer layer (e.g., PTFE, FEP, EFEP) providing water resistance. This composite structure combines the advantages of both material types while mitigating their individual disadvantages.

Inventive Principle:
Principle #40Composite materials

2Object-affected harmful factors

If non-polar fluoropolymers like PTFE are used, then water absorption is reduced, but chemical compatibility and bonding difficulty worsen

Engineering Contradiction:
Improvewater absorptionVSAvoidbonding difficulty
Core Design Contradiction:
Object-affected harmful factorsVSEase of manufacture

Solution Approach 1:

The catheter shaft is constructed as a multi-layer composite structure with an inner polar polymeric layer (e.g., polyamide, polyurethane, polyester) providing ease of manufacture and bonding, and an outer non-polar fluoropolymer layer (e.g., PTFE, FEP, EFEP) providing water resistance. This composite structure combines the advantages of both material types while mitigating their individual disadvantages.

Inventive Principle:
Principle #40Composite materials

3Ease of manufacture

If polar polymeric materials are used, then bonding ease is improved, but mechanical softening upon water exposure increases

Engineering Contradiction:
Improvebonding easeVSAvoidmechanical strength
Core Design Contradiction:
Ease of manufactureVSStrength

Solution Approach 1:

The catheter shaft is constructed as a multi-layer composite structure with an inner polar polymeric layer (e.g., polyamide, polyurethane, polyester) providing ease of manufacture and bonding, and an outer non-polar fluoropolymer layer (e.g., PTFE, FEP, EFEP) providing water resistance. This composite structure combines the advantages of both material types while mitigating their individual disadvantages.

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 hydrophobic barrier layer effectively prevents water absorption, maintaining the mechanical strength and stiffness of the catheter shaft, reducing the risk of delamination and ensuring consistent performance and maneuverability during prolonged exposure to aqueous environments.

Implementation Method 1

a hydrophobic barrier layer, such as a layer comprising a terminally-functionalized ethylene-perfluoroethylenepropylene (EFEP) copolymer

Methodology Applied
Scientific EffectHydrophobicity: Hydrophobe

Implementation Method 2

covalently bonded to reactive polar polymers, provides a hydrophobic barrier that prevents water absorption and maintains mechanical integrity

Methodology Applied
Scientific EffectCovalent bonding: Chemical Bonding

Data Source

PatentEP2627391B2Hydrophobic catheter and composition
Publication Date: 2021.11.24 ST JUDE MEDICAL ATRIAL FIBRILLATION DIVISION INC
  • EP2627391B2 patent drawingFigure 1
  • EP2627391B2 patent drawingFigure 2
  • EP2627391B2 patent drawingFigure 3

AI summary

In various embodiments, a surgical catheter 10 is provided. The catheter 10 may comprise one or more hydrophobic barrier layers made from an ethylene-perfluoroethylenepropylene ("EFEP") copolymer. Additionally, the catheter 10 may comprise another polymer layer made from a reactive polar polymer. In at least one embodiment, the reactive polar polymer may be a modified- poly(ether block amide) ("PEBA") copolymer, such as an amine-terminated PEBA. Moreover, in various embodiments, a composition is provided that may comprise a reactive polar polymer bonded to an EFEP copolymer.