Non-Invasive Ear Stimulation for Bleeding Control

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Solution Overview

Problem

Current methods for stimulating the vagus nerve to regulate inflammation and bleeding are invasive, carry risks of side effects, or lack specificity, and existing non-invasive methods may be ineffective or require surgery.

Innovation Solution

Development of non-invasive devices and systems that mechanically stimulate the vagus nerve, specifically targeting the inflammatory reflex through the ear, using actuators and drivers to apply controlled mechanical stimulation within specific frequency and duration parameters, reducing proinflammatory cytokines and bleeding time without invasive procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If invasive methods are used to stimulate the vagus nerve, then the effectiveness of regulating inflammation and bleeding is improved, but the risk of side effects and invasiveness increases

Engineering Contradiction:

Improveeffectiveness of regulating inflammation and bleedingVSAvoidrisk of side effects and invasiveness

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces invasive electrical or mechanical stimulation systems with a non-invasive acoustic stimulation system. The acoustic wave generator produces sound waves that can penetrate tissue to stimulate the vagus nerve without requiring surgical implantation of electrodes or mechanical devices, thereby eliminating the harmful effects of invasiveness while maintaining therapeutic effectiveness

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces acoustic waves as an intermediary medium to transmit stimulation energy to the vagus nerve. Instead of direct electrical or mechanical contact with the nerve, acoustic waves serve as a mediator that can penetrate through skin and tissue to activate the vagus nerve, reducing direct harm to the body while achieving the desired physiological modulation

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If non-invasive methods are used to stimulate the vagus nerve, then the safety and ease of operation are improved, but the effectiveness may be reduced or require surgery

Engineering Contradiction:

Improvesafety and non-invasive natureVSAvoideffectiveness of treatment

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent employs periodic acoustic stimulation delivered in controlled cycles to the vagus nerve. The acoustic wave generator delivers stimulation in repeated intervals, which enhances the reliability of vagus nerve activation and the subsequent anti-inflammatory and hemostatic effects, ensuring consistent therapeutic outcomes without requiring surgical intervention

Inventive Principle:

Principle #19Periodic action

Solution Approach 2:

The patent utilizes specific acoustic parameters (frequency, intensity, duration) that have been optimized to effectively stimulate the vagus nerve. By carefully controlling these parameters, the system achieves reliable therapeutic effects through non-invasive means, overcoming the limitation that non-invasive methods typically produce weaker stimulation

Inventive Principle:

Principle #35Parameter changes

3Object-affected harmful factors

If existing non-invasive methods are used, then invasiveness is reduced, but the specificity and effectiveness are compromised

Engineering Contradiction:

ImproveinvasivenessVSAvoidspecificity of vagus nerve targeting

Core Design Contradiction:

Object-affected harmful factorsVSMeasurement precision

Solution Approach 1:

The patent focuses acoustic stimulation on specific anatomical locations where the vagus nerve is accessible near the surface, such as the neck or ear regions. By concentrating the acoustic energy on these localized areas, the system achieves high specificity for vagus nerve stimulation while maintaining non-invasive operation, avoiding diffuse or non-specific effects

Inventive Principle:

Principle #3Local quality

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 non-invasive stimulation effectively reduces bleeding time and inflammation by inhibiting the inflammatory reflex, with significant reductions in proinflammatory cytokines and minimal impact on cardiac measures, offering a safer and more specific treatment option compared to existing methods.

Implementation Method 1

mechanically stimulating a subject's vagus nerve, specifically through the ear

Methodology Applied

Scientific EffectMechanical stimulation: Mechanical Force

Data Source

PatentUS10912712B2Treatment of bleeding by non-invasive stimulation

Publication Date: 2021.02.09 THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH

AI summary

Devices, systems and methods for stimulating (e.g., noninvasively) a subject's inflammatory reflex are provided to reduce bleed time. The method may include the step of non-invasively stimulating the inflammatory reflex (e.g., the vagus nerve, the splenic nerve, the hepatic nerve, the facial nerve, and the trigeminal nerve) of a subject, such as by mechanical stimulation, in a manner which significantly reduces bleed time in the subject. Devices for non-invasively stimulating the inflammatory reflex may include a movable tip or actuator that is controlled to mechanically stimulate the ear. The devices may be hand-held or wearable, and may stimulate the cymba conchae region of the subject's ear.