His-Bundle ICD for Low-Energy Pain-Free Defibrillation

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Current implantable cardioverter defibrillators (ICDs) use high-energy shocks for ventricular fibrillation, causing tissue damage, pain, and increased morbidity and mortality, with limited effectiveness in terminating ventricular fibrillation and requiring frequent battery replacements.

Innovation Solution

An ICD system that includes a power source, controller, and electrode coupled to the His-bundle of the heart, delivering pulsed defibrillation signals based on detected ventricular fibrillation characteristics to terminate arrhythmias using low-energy pacing pulses, thereby reducing tissue damage and improving treatment efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If high-energy shocks (25-35 J) are used to terminate ventricular fibrillation, then defibrillation effectiveness is improved, but tissue damage increases leading to increased morbidity and mortality

Engineering Contradiction:

Improvedefibrillation effectivenessVSAvoidtissue damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The defibrillation shock is divided into multiple sequential pulses (typically 3-5 pulses) delivered at specific intervals. Each pulse is of lower energy than a single conventional shock, but the cumulative effect achieves defibrillation while distributing tissue exposure over time, reducing peak current density and associated tissue damage.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Multiple pulses are delivered periodically with specific inter-pulse intervals (e.g., 10-20 milliseconds between pulses). This periodic delivery allows tissue recovery between pulses and targets refractory periods of cardiac cells, achieving defibrillation through temporal patterning rather than single high-energy delivery.

Inventive Principle:

Principle #19Periodic action

2Reliability

If high-energy shocks are delivered to terminate ventricular fibrillation, then arrhythmia termination is achieved, but patient pain and mental distress increase

Engineering Contradiction:

Improvearrhythmia terminationVSAvoidpatient pain

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The single high-energy shock is segmented into multiple lower-energy pulses. Each individual pulse is below the pain threshold, but the sequence of pulses collectively terminates the arrhythmia, eliminating or reducing patient pain while maintaining therapeutic effectiveness.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Instead of delivering a single shock at maximum energy, the system delivers multiple pulses at partial energy levels. The cumulative effect of these partial actions achieves the therapeutic goal while keeping each individual stimulus below the pain threshold.

Inventive Principle:

Principle #16Partial or excessive action

3Reliability

If high-energy shocks are used for defibrillation, then ventricular fibrillation is terminated, but battery life decreases requiring frequent device replacement

Engineering Contradiction:

Improvedefibrillation capabilityVSAvoidbattery life

Core Design Contradiction:

ReliabilityVSDuration of action of moving object

Solution Approach 1:

The total energy requirement for defibrillation is segmented across multiple pulses. While the cumulative energy may be similar to or slightly higher than a single shock, the use of lower peak power requirements and more efficient capacitor discharge patterns improves overall energy utilization and extends battery life.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The defibrillation waveform parameters are changed from a single high-voltage, high-current pulse to multiple lower-voltage pulses with specific timing. This parameter transformation optimizes energy delivery efficiency and reduces total energy consumption while maintaining defibrillation effectiveness.

Inventive Principle:

Principle #35Parameter changes

4Reliability

If high current density is used surrounding shocking electrodes, then defibrillation shock effectiveness is improved, but electroporation occurs leading to conduction disturbances and tissue necrosis

Engineering Contradiction:

Improvedefibrillation shock effectivenessVSAvoidelectroporation and tissue necrosis

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The high current density is segmented across multiple pulses with sufficient inter-pulse intervals. This allows tissue to recover between pulses and prevents cumulative electroporation damage while maintaining the necessary current density for each individual pulse to effectively terminate fibrillation.

Inventive Principle:

Principle #1Segmentation

Data Source

PatentUS10765875B2Implantable cardiac devices and methods for delivering low energy, pain-free defibrillation signals for ventricular arrhythmias

Publication Date: 2020.09.08 UNIV OF UTAH RES FOUND

AI summary

An implantable cardioverter defibrillator (ICD) and methods of detection and treatment of dangerous and life-threatening heart rhythms by delivering real-time, customized low-energy pacing pulses to specific anatomy in the heart. The ICD includes a power source, a controller, powered by the power source, including an electronic processor, a memory, and a signal generator. The ICD also includes a lead coupled to the controller and an electrode that is in electrical communication with a His-bundle of a patient's heart. The ICD detects a ventricular arrhythmia of the patient's heart using the controller, and is configured to provide a pulsed defibrillation signal to the electrode to terminate the ventricular arrhythmia.