Dual-Laminate Coated Braid Catheter for Kink Resistance

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Solution Overview

Problem

Existing catheters face issues with kinking and electrical shorts due to insufficient flexibility and durability of braid wire assemblies, which fail after a limited number of articulations, hindering their effectiveness in navigating tortuous vasculature and delivering electrical energy.

Innovation Solution

A catheter shaft with a braid assembly coated with a dual-laminate coating, comprising a flexible non-electrically-conductive polymer and a thermoplastic bonding adhesive, which enhances insulation and flexibility, allowing the braid wires to serve as conductive elements and withstand multiple articulations without tearing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing insulative coatings are used on braid wires, then electrical insulation is provided, but the coatings are too stiff and tear after only 10-12 articulations

Engineering Contradiction:
Improvedurability of insulative coatingVSAvoidflexibility of insulative coating
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent applies a dual-laminate coating system consisting of an inner flexible insulative layer (e.g., polyurethane with Shore A 50-70 durometer) and an outer bonding layer (e.g., polyamide with Shore D 40-50 durometer). This composite structure combines the flexibility needed for repeated articulations with the bonding strength required for durability, resolving the contradiction between coating flexibility and durability.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent specifies precise durometer ranges for the coating materials (Shore A 50-70 for the inner layer, Shore D 40-50 for the outer layer) to optimize both flexibility and durability. By controlling these physical parameters, the coating can withstand more than 50 articulations without tearing while maintaining electrical insulation properties.

Inventive Principle:
Principle #35Parameter changes

2Shape

If metallic wire braiding is added to provide flexibility and kink resistance, then catheter flexibility is improved, but device complexity and manufacturing difficulty increase

Engineering Contradiction:
Improvecatheter flexibilityVSAvoidbraid assembly complexity
Core Design Contradiction:
ShapeVSDevice complexity

Solution Approach 1:

The patent combines the structural support function and electrical insulation function into a single integrated braid assembly with dual-laminate coated wires. The coated braid members provide both mechanical flexibility/kink resistance and electrical insulation, eliminating the need for separate insulation layers and reducing overall device complexity.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The braid assembly serves multiple functions simultaneously: providing structural support for catheter flexibility, preventing kinking, and providing electrical insulation for the conductive elements. This multi-functionality reduces the number of separate components needed in the catheter construction.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Device complexity

If braid wires are used as electrical wires without insulation, then device complexity is reduced, but electrical shorts occur due to contact between adjacent braid wires

Engineering Contradiction:
Improveinsulation structure complexityVSAvoidelectrical insulation reliability
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The dual-laminate coating system provides reliable electrical insulation while maintaining flexibility. The inner flexible insulative layer (polyurethane, Shore A 50-70) prevents electrical contact between adjacent braid wires, while the outer bonding layer (polyamide, Shore D 40-50) ensures durable attachment, achieving both insulation reliability and flexibility.

Inventive Principle:
Principle #40Composite materials

4Volume of moving object

If the catheter shaft is made thinner to increase usable inner diameter, then productivity and energy delivery efficiency are improved, but structural integrity and kink resistance deteriorate

Engineering Contradiction:
Improveusable inner diameterVSAvoidstructural integrity
Core Design Contradiction:
Volume of moving objectVSStrength

Solution Approach 1:

The dual-laminate coating on the braid members provides enhanced structural integrity and kink resistance even in thinner catheter shafts. The combination of flexible insulative material and bonding layer creates a durable composite structure that maintains strength while allowing for reduced overall catheter diameter.

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 solution provides catheters with improved flexibility and durability, enabling them to withstand a higher number of articulations without electrical shorts, reducing thickness, and increasing the usable inner diameter while maintaining effective energy delivery.

Implementation Method 1

The second coating is made of a thermoplastic bonding adhesive that bonds to the outer layer

Methodology Applied
Scientific EffectThermal bonding: Melting

Data Source

PatentUS10682177B2Medical device having laminate-coated braid assembly
Publication Date: 2020.06.16 ST JUDE MEDICAL ATRIAL FIBRILLATION DIVISION INC
  • US10682177B2 patent drawing
  • US10682177B2 patent drawing
  • US10682177B2 patent drawing

AI summary

A catheter includes a braid assembly having a dual-laminate coating. The braid assembly includes a plurality of braid members interwoven to provide for interstices between the braid members, each braid member having an electrically conductive element, a flexible non-electrically-conductive polymer coating that insulates the electrically conductive element and a thermoplastic bonding adhesive coating. The braid assembly is formed between an inner polymer layer and an outer polymer layer. One or more of the braid members may be coupled to an energy delivery element.