Vagus Nerve Stimulation Device with Bounded Titration
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Solution Overview
Problem
Current treatments for chronic cardiac dysfunction, such as congestive heart failure, are palliative and do not effectively restore autonomic balance between the sympathetic and parasympathetic nervous systems, leading to limited therapeutic options and potential side effects.
Innovation Solution
An implantable device providing bi-directional electrical stimulation of the cervical vagus nerve using a pulse generator and helical electrodes, with an integrated leadless heart rate sensor to autonomously titrate therapy and restore autonomic balance through continuous alternating cycles of stimulation and inhibition.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If medication is prescribed to manage chronic cardiac dysfunction, then cardiac function is temporarily improved, but side effects occur and continued efficacy is not assured
Solution Approach 1:
The patent replaces the pharmacological chemical system with an electrical stimulation system. Instead of using medications that chemically interact with the body to manage cardiac dysfunction, the invention uses electrical pulses delivered via vagus nerve stimulation to directly modulate autonomic nervous system activity, thereby improving cardiac function without the metabolic side effects of drugs.
Solution Approach 2:
The patent introduces the vagus nerve as an intermediary between the external stimulator and the heart. Electrical stimulation is delivered to the vagus nerve, which then mediates the transmission of signals to modulate sympathetic and parasympathetic outflow to the heart, providing a controlled mechanism to improve cardiac function without direct drug-heart interaction.
2Productivity
If drug therapy is re-titrated following crisis, then temporary recovery is achieved, but patient survival is not assured
Solution Approach 1:
The patent implements preliminary titration of stimulation parameters during the initial implantation and programming phase. The device is pre-configured with titration protocols that gradually adjust stimulation intensity and duration to achieve optimal therapeutic effect before clinical deployment, preventing the need for repeated crisis-driven adjustments and ensuring immediate effectiveness.
Solution Approach 2:
The patent incorporates feedback mechanisms where the device monitors physiological responses and automatically adjusts stimulation parameters to maintain optimal therapeutic effect. This closed-loop control ensures continuous effectiveness without requiring repeated manual re-titration following crises, thereby improving patient survival while minimizing time loss.
3Adaptability or versatility
If CRT is used to treat systolic dysfunction, then ventricular synchrony is restored, but it is not indicated for patients with preserved ejection fraction
Solution Approach 1:
The patent creates a universal therapy that can treat both systolic dysfunction and preserved ejection fraction conditions through vagus nerve stimulation. Unlike CRT which is specifically designed for mechanical dyssynchrony, the vagus nerve stimulation approach modulates autonomic nervous system outflow to the heart, providing a mechanism that is effective across multiple cardiac dysfunction etiologies including both reduced and preserved ejection fraction.
Solution Approach 2:
The patent changes the therapeutic parameter from mechanical electrical pacing (CRT) to neurophysiological electrical stimulation (VNS). By targeting the vagus nerve instead of directly pacing the ventricles, the therapy mechanism changes from restoring mechanical synchrony to modulating autonomic tone, thereby expanding applicability to patients with preserved ejection fraction who do not exhibit mechanical dyssynchrony.
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
The device effectively decreases heart rate, increases heart rate variability, reduces cardiac workload, and improves left ventricular function, while providing long-term benefits of decreased cytokine production, increased baroreflex sensitivity, and anti-inflammatory effects.
Implementation Method 1
delivering multi-chamber stimulation and shock therapy
Implementation Method 2
cathodic induction of action potentials
Implementation Method 3
integrated leadless heart rate sensor configured to sense the patient's heart rate
Implementation Method 4
pair of helical electrodes configured to conform to an outer diameter of a cervical vagus nerve sheath
Data Source
Figure 1
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AI summary
An implantable device (11) for providing electrical stimulation of cervical vagus nerves (15. 16, 61) for treatment of chronic cardiac dysfunction with bounded titration is provided. A stimulation therapy lead (13) includes helical electrodes (14) configured to conform to an outer diameter of a cervical vagus nerve sheath, and a set of connector pins (28) electrically connected to the helical electrodes (14). A neurostimulator (12) includes an electrical receptacle (25) into which the connector pins (28) are securely and electrically coupled. The neurostimulator (12) includes a pulse generator configured to therapeutically stimulate the vagus nerve (15, 16, 61) through the helical electrodes (14) in alternating cycles of stimuli application and stimuli inhibition (90) that are tuned to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by triggering bi-directional action potentials. The neurostimulator (12) includes an integrated leadless heart rate sensor (31) configured to sense heart rate and alter the triggering in response to the sensed heart rate falling outside a predetermined range.