Extra Cardiac Defibrillation Lead Positioning in Vena Cava

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Solution Overview

Problem

The high failure rate of endocardial defibrillation leads and the increased energy requirements of subcutaneous ICDs pose challenges in patient safety and surgical complexity, while traditional implantable defibrillators face issues with mechanical stresses and energy efficiency.

Innovation Solution

An extra cardiac implantable cardioverter defibrillator system with a metal case and a defibrillation lead that includes a connector and a defibrillation coil electrode positioned in the inferior vena cava, avoiding physical contact with heart tissue and using external electrodes to maintain an electric field vector for efficient defibrillation, simplifying the surgical procedure and reducing energy requirements.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If endocardial defibrillation leads are used, then defibrillation function is provided, but mechanical stresses cause high failure rates

Engineering Contradiction:
Improvelead reliabilityVSAvoidmechanical stress resistance
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent extracts the defibrillation lead from the heart chambers (endocardial position) and relocates it to the venous system (superior vena cava or right atrium appendage). This removes the lead from the high mechanical stress environment of the heart chambers while maintaining defibrillation functionality through external cardiac shock delivery.

Inventive Principle:
Principle #2Taking out (Extraction)

2Reliability

If subcutaneous ICD configuration is used, then leads are excluded from heart chambers, but energy requirements double

Engineering Contradiction:
Improvepatient safetyVSAvoiddefibrillation energy
Core Design Contradiction:
ReliabilityVSUse of energy by moving object

Solution Approach 1:

The patent positions the defibrillation lead in specific locations within the venous system (superior vena cava or right atrium appendage) to optimize the electric field vector for defibrillation. This localized positioning allows for more efficient energy delivery compared to subcutaneous ICD, reducing the energy requirement from twice that of standard ICD to approximately 20-40% higher than standard ICD.

Inventive Principle:
Principle #3Local quality

3Reliability

If defibrillation lead is placed in inferior vena cava, then mechanical failure rates reduce, but new surgical approach is required

Engineering Contradiction:
Improvedevice longevityVSAvoidsurgical procedure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent utilizes the venous system, which is already a common access route for cardiac electrophysiology procedures, to deliver the defibrillation lead to the inferior vena cava. This approach leverages existing surgical expertise and pathways, making the procedure more universally applicable and less complex than completely new surgical approaches.

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

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 reduces mechanical failure rates, lowers energy needs, and simplifies the implantation process, extending device longevity and reducing risks associated with traditional ICDs, while maintaining familiar implantation procedures and using standard components for cost-effectiveness.

Implementation Method 1

using external electrodes to maintain an electric field vector for efficient defibrillation

Methodology Applied
Scientific EffectElectric Field: Electric Field

Data Source

PatentUS11357996B2System and method for extra cardiac defibrillation
Publication Date: 2022.06.14 SORIN CRM
  • US11357996B2 patent drawing
  • US11357996B2 patent drawing
  • US11357996B2 patent drawing

AI summary

A system and method for extra cardiac defibrillation is disclosed. In a particular embodiment, an extra cardiac implantable cardioverter defibrillator system includes an implantable defibrillator having a metal case and a defibrillation lead. The defibrillation lead has a connector at its proximal end for coupling to the implantable defibrillator and a first defibrillation coil electrode at a distal portion of the lead. The first defibrillation electrode configured to be disposed in an inferior vena cava.