Substernal Pacing Lead for Extravascular ICD

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Solution Overview

Problem

Subcutaneous ICD systems require high energy for defibrillation, leading to larger device sizes, reduced patient comfort, and increased costs, while lacking the capability to deliver anti-tachycardia pacing without causing discomfort to the patient.

Innovation Solution

An implantable cardiac defibrillation system with a substernal pacing lead that includes a defibrillation lead and a pacing lead, where the pacing lead is implanted partially along the patient's sternum to deliver pacing pulses and defibrillation shocks, allowing for the provision of both therapies without direct attachment to the heart.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If subcutaneous ICD systems are used to avoid direct heart attachment, then surgical risks are reduced, but device size increases and patient comfort decreases

Engineering Contradiction:

Improvesurgical risk reductionVSAvoiddevice size

Core Design Contradiction:

ReliabilityVSVolume of stationary object

Solution Approach 1:

The system separates defibrillation and pacing functions into two distinct leads: a subcutaneous defibrillation lead and a substernal pacing lead. This segmentation allows each lead to be optimized for its specific function, enabling the pacing lead to be smaller while the defibrillation lead handles the high-energy shocks.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The substernal pacing lead acts as an intermediary by being positioned between the subcutaneous space and direct heart contact. It delivers pacing pulses through the sternum to the heart without requiring transvenous access, reducing surgical risks while maintaining effective pacing capability.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If subcutaneous ICD systems are used, then lead attachment risks are reduced, but energy requirements for defibrillation increase

Engineering Contradiction:

Improvelead attachment safetyVSAvoiddefibrillation energy

Core Design Contradiction:

ReliabilityVSUse of energy by moving object

Solution Approach 1:

By separating defibrillation and pacing functions into different leads, the system can optimize the defibrillation lead's electrode configuration and positioning to achieve effective shocks with lower energy requirements, while the pacing lead handles low-energy pacing functions.

Inventive Principle:

Principle #1Segmentation

3Reliability

If conventional subcutaneous ICD systems are used, then defibrillation capability is maintained, but anti-tachycardia pacing capability is lost or causes extreme discomfort

Engineering Contradiction:

Improvedefibrillation functionVSAvoidpacing therapy capability

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The system divides cardiac therapy into two specialized leads: the subcutaneous defibrillation lead for high-energy shocks and the substernal pacing lead for low-energy pacing. This segmentation enables effective anti-tachycardia pacing without the discomfort associated with conventional subcutaneous pacing.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The substernal pacing lead delivers pacing pulses with sufficient energy to effectively capture the heart and terminate tachyarrhythmias, providing more than the minimal required action for reliable anti-tachycardia pacing without causing patient discomfort.

Inventive Principle:

Principle #16Partial or excessive action

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

Enables effective defibrillation with reduced energy requirements, improving device size and patient comfort, and allows for painless anti-tachycardia pacing, enhancing the system's therapeutic capabilities.

Implementation Method 1

a pacing lead that includes a distal portion having one or more electrodes and a proximal portion coupled to the ICD, the distal portion of the pacing lead being implanted at least partially along a posterior side of a sternum of the patient and configured to deliver pacing pulses to the heart of the patient

Methodology Applied

Scientific EffectElectrical conduction: Conduction (electrical)

Implementation Method 2

a defibrillation lead having a proximal portion coupled to the ICD and a distal portion having a defibrillation electrode configured to deliver a defibrillation shock to a heart of the patient

Methodology Applied

Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentUS20240123218A1Implantable cardioverter-defibrillator (ICD) system including substernal pacing lead

Publication Date: 2024.04.18 MEDTRONIC INC

AI summary

An implantable cardiac defibrillator (ICD) system includes an ICD implanted subcutaneously in a patient, a defibrillation lead having a proximal portion coupled to the ICD and a distal portion having a defibrillation electrode configured to deliver a defibrillation or cardioversion shock to a heart of the patient, and a pacing lead that includes a distal portion having one or more electrodes and a proximal portion coupled to the ICD. The distal portion of the pacing lead is implanted at least partially along a posterior side of a sternum of the patient within the anterior mediastinum. The ICD is configured to provide pacing pulses to the heart of the patient via the pacing lead and provide defibrillation shocks to the patient via the defibrillation lead. As such, the implantable cardiac system provides pacing from the substernal space for an extravascular ICD system.