Medical Implantable Lead Insulation Wear Reduction

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Solution Overview

Problem

Cardiac leads fail due to insulation abrasion caused by the design of hollow lead cables, leading to wear and breakage at tight bends and turns, with prior attempts to improve insulation composition or thickness not fully addressing the issue without compromising flexibility.

Innovation Solution

An intermediate fibrous layer of biocompatible, shaped metal flattened ribbon filaments is introduced between the conductive cable and insulation, providing a smooth, cushioning, and lubricating layer to reduce wear and abrasion, formed from materials like tantalum and fabricated through specific processes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If insulation thickness is increased to reduce wear and prevent lead failure, then reliability is improved, but flexibility deteriorates

Engineering Contradiction:
Improveinsulation wear resistanceVSAvoidlead flexibility
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

A soft intermediate layer is introduced between the hollow lead cable and the insulation layer. This intermediate layer acts as a mediator that absorbs mechanical stress and prevents direct abrasion between the cable and insulation, allowing the insulation to be thinner while maintaining wear resistance and preventing lead failure.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If the lead cable is made more robust to prevent insulation breakage, then reliability is improved, but flexibility deteriorates

Engineering Contradiction:
Improveinsulation integrityVSAvoidlead flexibility
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The soft intermediate layer is placed beforehand between the lead cable and insulation layer to cushion and absorb mechanical stresses before they can cause insulation breakage. This prevents stress concentration at bending points and tight turns, maintaining insulation integrity without requiring a thicker or more robust cable structure.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Reliability

If insulation composition is improved to resist abrasion, then reliability is improved, but manufacturing complexity increases

Engineering Contradiction:
Improveabrasion resistanceVSAvoidinsulation composition complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

Instead of complicating the insulation composition to achieve abrasion resistance, a simple soft intermediate layer is introduced as an intermediary. This layer takes on the abrasion-resistant function, allowing the insulation layer to remain simple in composition while still achieving reliable wear protection.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 fibrous layer significantly reduces insulation wear and lead failure, maintaining flexibility and preventing stress on surrounding body parts, thus enhancing the durability and reliability of cardiac leads.

Implementation Method 1

The fibrous layer which preferably is in the form of a braided fibrous material of shaped metal flattened filaments provides a smooth and cushioning layer and a lubricity which reduces insulation wear

Methodology Applied
Scientific EffectLubrication: Lubrication

Data Source

PatentUS9031671B2Medical implantable lead and manufacture thereof
Publication Date: 2015.05.12 COMPOSITE MATERIALS TECH INC
  • US9031671B2 patent drawing
  • US9031671B2 patent drawing
  • US9031671B2 patent drawing

AI summary

A medical implantable lead comprising a core formed of a bare conductive wire formed from a biocompatible, corrosion-resistant conductive material, loosely wrapped in a fibrous material formed of shaped flattened ribbon filaments of a valve metal, and surrounded by a biocompatible insulation material.