Extravascular Neuromodulation for Heart Failure Treatment
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Solution Overview
Problem
Current treatments for end-stage heart failure, such as inotropic agents, increase myocardial oxygen consumption and pose risks of myocardial ischemia and arrhythmias, necessitating a therapeutic approach that enhances cardiac output without elevating heart rate or oxygen demand.
Innovation Solution
Electrical neuromodulation at extravascular sites within the chest cavity, specifically targeting both sympathetic and parasympathetic cardiac nerves to balance autonomic control, using a minimally invasive delivery method and a closed-loop neuromodulation system that adjusts stimulation parameters based on real-time cardiovascular feedback.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If inotropic agents are used to increase myocardial contractility and cardiac output, then cardiac output is improved, but heart rate increases and myocardial oxygen consumption increases
Solution Approach 1:
The patent segments the autonomic nervous system control into separate sympathetic and parasympathetic pathways, allowing independent modulation of each. By placing electrodes at the cardiac plexus, the invention can selectively stimulate sympathetic nerves for contractility while simultaneously stimulating parasympathetic nerves to control heart rate, thereby decoupling the traditional coupled response of inotropic agents.
Solution Approach 2:
The patent applies local quality by targeting specific anatomical locations (cardiac plexus, pericardial transverse sinus) with electrodes that have different stimulation characteristics. The first electrode array targets sympathetic nerves while the second targets parasympathetic nerves, allowing region-specific autonomic modulation to achieve selective contractility enhancement without excessive tachycardia.
2Productivity
If inotropic agents are used to increase myocardial contractility, then cardiac output is improved, but the risk of myocardial ischemia and arrhythmias increases
Solution Approach 1:
The patent implements closed-loop feedback control where the neuromodulation system continuously monitors cardiac parameters (heart rate, blood pressure, cardiac output) and automatically adjusts the stimulation parameters of the electrode arrays. This real-time feedback allows the system to optimize contractility enhancement while preventing excessive heart rate increases that would cause ischemia and arrhythmias.
Solution Approach 2:
The patent changes the physiological parameters of cardiac function by modulating autonomic nerve activity rather than directly stimulating the myocardium. By adjusting the balance of sympathetic and parasympathetic tone through electrical stimulation at the cardiac plexus, the system achieves inotropic effects without the harmful side effects of direct myocardial stimulation, such as ischemia and arrhythmias.
3Productivity
If electrical stimulation is applied at extravascular sites to modulate autonomic cardiac nerves, then ventricular contractility is increased, but the complexity of the delivery system increases
Solution Approach 1:
The patent makes the electrode arrays multi-functional by designing them to serve both as stimulation electrodes and as sensing electrodes for feedback control. The same electrode arrays that deliver autonomic modulation also monitor cardiac parameters, eliminating the need for separate sensing leads and simplifying the overall system architecture while maintaining advanced closed-loop control capabilities.
Data Source
AI summary
Treatment of heart failure in a patient by electrically modulating both the sympathetic and parasympathetic autonomic cardiac nerve fibers that innervate the patient's heart at an extravascular site in the pericardial space of the heart. The extravascular site is any suitable single location inside the chest cavity that carries both sympathetic and parasympathetic cardiac nerves such as the cardiac plexus or the pericardial transverse sinus or any two separate extravascular sites with one site carrying predominantly sympathetic cardiac nerves and the other site carrying predominantly parasympathetic cardiac nerves for electrically modulating the balance of autonomic cardiac nerve control. Physiologic inputs from a neuromodulation system's own sensors or from separate implanted or external cardiovascular hemodynamic sensor systems can be used for closed loop control over the balance of sympathetic and parasympathetic cardiac autonomic effects on the patient's cardiac function in real time response to chronic and transient physiologic needs.