Neural Inhibition for Chronic Cardiac Dysfunction Prevention
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Solution Overview
Problem
Current treatments for acute myocardial infarction (AMI) fail to adequately prevent the formation of chronic proarrhythmic cardiac and stellate substrates, leading to increased risk of ventricular arrhythmias and sudden cardiac death, particularly during the subacute and chronic phases, due to inadequate suppression of sympathetic tone and remodeling of the cardiac and autonomic nervous systems.
Innovation Solution
A method involving the delivery of a neural inhibiting therapy to the extracardiac sympathetic nervous system, using electrical therapeutic signals to inhibit neural activity in nerves associated with the stellate ganglion and paravertebral chain, which can be initiated within 40 days of an MI event, continued for a desired period, and then discontinued to allow neural activity to resume, using implantable or percutaneously placed electrodes under image guidance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pharmaceutical therapies are used to reduce infarct size and prevent SCD, then survival may be improved, but adequate titration during the subacute phase is difficult resulting in inadequate therapy
Solution Approach 1:
The patent replaces pharmaceutical therapy with an electrical stimulation system that delivers precise, controllable neural inhibition signals to the stellate ganglion. This electrical system provides reliable and reproducible dosing without the titration difficulties of medications, allowing precise control of sympathetic tone suppression during the critical subacute phase.
Solution Approach 2:
The system allows dynamic adjustment of stimulation parameters (amplitude, pulse width, frequency, duty cycle) to optimize sympathetic inhibition efficacy. This parameter control enables adequate therapy delivery during the subacute phase without the titration limitations of pharmaceutical approaches.
2Reliability
If ICD is used for primary or secondary prevention of SCD, then SCD can be prevented by cardioverting during arrhythmic events, but the device does not help treat the underlying disease state and is not recommended until the chronic timeframe when remodeling has already occurred
Solution Approach 1:
The neural inhibition system is deployed during the subacute phase (before 40 days post-MI) to prevent the formation of proarrhythmic substrates and reverse remodeling before it occurs. This preliminary action addresses the underlying disease state before chronic remodeling sets in, rather than waiting until an ICD would be indicated.
Solution Approach 2:
The system applies preliminary anti-action by suppressing sympathetic tone and preventing maladaptive remodeling processes before they can establish chronic proarrhythmic substrates. This prevents the development of the very conditions that would later require ICD therapy.
3Reliability
If neural remodeling of the autonomic system occurs during the subacute phase, then sympathetic overactivity accelerates heart failure and arrhythmias, but current treatments fail to adequately suppress sympathetic tone
Solution Approach 1:
The system extracts and isolates the sympathetic nervous system output by delivering targeted electrical inhibition specifically to the stellate ganglion. This selective neural inhibition removes the harmful sympathetic overactivity that drives maladaptive remodeling without affecting other physiological systems.
Solution Approach 2:
The electrical stimulation system acts as an intermediary between the brain's autonomic control and the cardiac tissue, blocking the transmission of harmful sympathetic signals through the stellate ganglion while allowing continued monitoring and adjustment of therapy.
4Ease of operation
If wearable ICDs are used as less invasive defibrillator devices, then surgery is avoided and cost is reduced, but these devices do nothing to slow the progression of remodeling that puts patients at risk for long-term mortality
Solution Approach 1:
The patent merges the benefits of less invasive wearable device delivery with the therapeutic capability to actively prevent remodeling. The system combines percutaneous or wearable implementation with neural inhibition therapy that addresses both accessibility and disease modification.
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
This approach reduces sympathetic tone, prevents the formation of proarrhythmic substrates, improves cardiac stability, and decreases the risk of ventricular arrhythmias and sudden cardiac death by promoting reverse remodeling of the cardiac tissue, thereby improving long-term cardiac outcomes.
Implementation Method 1
delivering an electrical therapeutic signal to the nerve sufficient to substantially prevent neural activity of the nerve from occurring
Data Source
AI summary
A method to prevent formation of unfavorable sequelae includes initiating delivering a neural inhibiting therapy to a nerve associated with an extracardiac sympathetic nervous system of a patient within 40 days of an onset of symptoms associated with acute coronary syndrome. The neural inhibiting therapy includes delivering an electrical therapeutic signal to the nerve sufficient to substantially prevent neural activity of the nerve from occurring. The method also includes continuing delivery of the neural inhibiting therapy to the nerve associated with the extracardiac sympathetic nervous system for a desired treatment period and discontinuing delivery of the neural inhibiting therapy to the nerve after the desired treatment period and enabling neural activity of the nerve to resume.