Vagus Nerve Stimulation Swallow Detection Override

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Solution Overview

Problem

Vagus nerve stimulation therapies for conditions like heart failure and hypertension can cause adverse events such as dysphagia, laryngismus, and aspiration due to the disruption of swallowing mechanics and laryngeal muscle coordination, necessitating a solution to manage these side effects while maintaining therapeutic efficacy.

Innovation Solution

Implementing a system that detects swallow events and other physiological events to temporarily override or adjust the programmed neural stimulation schedule, using sensors like EMG, pressure sensors, and accelerometers to prevent aspiration and manage dysphagia, laryngismus, and pharyngitis by suspending or modifying the stimulation during such events.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If vagus nerve stimulation is delivered according to a programmed schedule, then therapeutic efficacy for heart failure and hypertension is improved, but adverse events such as dysphagia, laryngismus, and aspiration occur due to disruption of swallowing mechanics

Engineering Contradiction:

Improvetherapeutic efficacyVSAvoiddysphagia, laryngismus, aspiration

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system performs preliminary detection of swallow events, laryngeal spasms, and other adverse physiological events before delivering neural stimulation. By detecting these events in advance (or concurrently), the system can prevent stimulation during critical swallowing phases, thereby avoiding aspiration and dysphagia while maintaining therapeutic efficacy during safe periods

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The stimulation delivery schedule is made dynamic rather than fixed. The system continuously monitors physiological events and adjusts the stimulation timing in real-time, overriding the programmed schedule when adverse events are detected. This dynamic adaptation allows the system to maintain therapeutic benefits while avoiding harmful interactions with swallowing mechanics

Inventive Principle:

Principle #15Dynamics

2Ease of operation

If neural stimulation is continuously delivered to maintain therapeutic benefits, then patient comfort deteriorates due to side effects, but reducing stimulation frequency improves comfort while potentially reducing therapeutic efficacy

Engineering Contradiction:

Improvepatient comfortVSAvoidtherapeutic efficacy

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The system uses periodic stimulation bursts rather than continuous delivery, synchronized with the detection of safe physiological windows. By delivering stimulation in periodic bursts only when no adverse events are detected, the system maintains therapeutic efficacy while improving patient comfort by avoiding stimulation during swallowing and other sensitive periods

Inventive Principle:

Principle #19Periodic action

Data Source

PatentUS9155894B2Systems and methods for avoiding aspiration during autonomic modulation therapy

Publication Date: 2015.10.13 CARDIAC PACEMAKERS INC

AI summary

Some embodiments provide a method comprising delivering neural stimulation for a neural stimulation therapy according to a programmed schedule, detecting a swallow event, and responding to the detected swallow event by overriding the programmed schedule.