Internal Thoracic Vein Lead Implantation for Lower Defibrillation Energy

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Solution Overview

Problem

Existing implantable defibrillators face challenges such as higher energy requirements, larger pulse generators, and limited utility of bradycardia and anti-tachycardia pacing due to subcutaneous implantation, necessitating alternative implant techniques and locations.

Innovation Solution

Implanting leads in the internal thoracic vein (ITV) via intercostal access, utilizing screening criteria and methods like ultrasound or fluoroscopy to determine patient suitability, and employing tunneling techniques for lead placement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If subcutaneous defibrillators are used, then lead failure issues are avoided, but pulse generators become larger and higher energy is required

Engineering Contradiction:
Improvelead reliabilityVSAvoidpulse generator size
Core Design Contradiction:
ReliabilityVSVolume of stationary object

Solution Approach 1:

The internal thoracic vein serves as an intermediary pathway between the subcutaneous space and the heart. The lead travels through this vascular route, allowing the electrode to contact the heart while the pulse generator remains subcutaneous, thus avoiding lead failure from cardiac motion while reducing the energy requirements compared to purely subcutaneous systems.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If subcutaneous defibrillators are used, then lead failure issues are avoided, but pacing utility is limited and patient comfort deteriorates

Engineering Contradiction:
Improvelead reliabilityVSAvoidpacing utility
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The internal thoracic vein provides a pathway that allows the lead to reach cardiac structures for effective pacing while maintaining the benefits of subcutaneous generator placement. This intermediary vascular route enables both reliable lead positioning and effective pacing function.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If transvenous leads are used, then surgical risks are reduced, but lead failure remains significant due to flexing at heart attachment

Engineering Contradiction:
Improvesurgical riskVSAvoidlead reliability
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The internal thoracic vein acts as a protective intermediary channel for the lead. By routing the lead through this vein rather than having it directly attached to the heart surface, the lead is shielded from the mechanical stress of cardiac motion while still achieving cardiac therapy delivery.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Power

If epicardial patch electrodes are used, then defibrillation therapy can be delivered, but surgical risks increase and device reliability decreases

Engineering Contradiction:
Improvedefibrillation capabilityVSAvoidsurgical risk
Core Design Contradiction:
PowerVSObject-affected harmful factors

Solution Approach 1:

The internal thoracic vein provides a less invasive intermediary access route compared to thoracotomy for epicardial electrode placement. The lead can be delivered through this vascular pathway to achieve defibrillation capability with reduced surgical intervention.

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

Facilitates lower defibrillation thresholds, allowing for smaller pulse generators and viable pacing, with increased safety and predictability, while avoiding lead failure and infection risks.

Implementation Method 1

at least one of the rib spacing, ITV location, and ITV diameter is determined using an ultrasound transducer

Methodology Applied
Scientific EffectUltrasound: Ultrasound

Data Source

PatentUS12458798B2Implanting a lead in the internal thoracic vasculature
Publication Date: 2025.11.04 CARDIAC PACEMAKERS INC
  • US12458798B2 patent drawing
  • US12458798B2 patent drawing
  • US12458798B2 patent drawing

AI summary

Methods for implanting leads in the internal thoracic vein (ITV) of a patient may include first screening the patient to determine if various screening criteria are met. The screening criteria may include rib spacing, ITV location, and ITV diameter. When a predetermined parameter of at least one of the screening criteria is met, the implantation of one or more leads extending into the ITV and to a pulse generator are completed.