Smart Mouthpiece for Cardiac Autonomic Neuropathy Testing

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Solution Overview

Problem

Current biomedical equipment for cardiac autonomic neuropathy tests requires expertise to ensure correct execution, especially due to environmental variations like altitude, which can affect test results, limiting its use to trained personnel and complicating the evaluation process.

Innovation Solution

A 'smart' mouthpiece connected to a base unit that measures breath pressure and trend, informs patients or nurses about correct test execution, and adjusts for environmental pressure differences, allowing autonomous and correct test performance without specialized expertise.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a physician or specialized nursing staff performs the test to ensure correct execution, then the reliability of test results is improved, but the ease of operation deteriorates as only trained personnel can use the equipment

Engineering Contradiction:
Improvetest execution correctnessVSAvoiduser accessibility
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The mouthpiece incorporates feedback mechanisms that provide real-time information to the patient about test execution quality. The system monitors breath pressure and trend, compares them against expected patterns, and provides immediate feedback to guide the patient toward correct test performance, enabling untrained users to achieve reliable results

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system enables patients to perform and monitor their own tests autonomously. The mouthpiece provides self-service functionality by automatically detecting test quality issues and guiding patients to correct their performance without requiring external supervision by trained personnel

Inventive Principle:
Principle #25Self-service

2Measurement precision

If the equipment monitors multiple parameters (heartbeat, respiration, intrathoracic pressure, orthostatism) to evaluate test correctness, then the measurement precision is improved, but the device complexity increases

Engineering Contradiction:
Improvetest evaluation accuracyVSAvoidsystem configuration
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The mouthpiece serves as an intermediary device that consolidates multiple measurement functions. It integrates breath pressure monitoring, breath trend detection, and environmental pressure sensing into a single auxiliary component that interfaces with the base unit, simplifying the overall system architecture while maintaining comprehensive monitoring capabilities

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent combines multiple sensing functions (breath pressure measurement, breath trend detection, environmental pressure sensing) into a single integrated mouthpiece assembly. This merging of functions reduces the number of separate components and simplifies the system configuration while maintaining the ability to evaluate multiple test parameters

Inventive Principle:
Principle #5Merging (Combining)

3Adaptability or versatility

If the equipment adjusts for environmental pressure variations to maintain accurate results, then the adaptability is improved, but the device complexity increases due to additional sensors and processing

Engineering Contradiction:
Improveenvironmental condition compensationVSAvoidpressure sensing system
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The environmental pressure sensor is localized within the mouthpiece assembly, specifically positioned to measure ambient pressure at the point of patient interaction. This local measurement approach allows the system to compensate for environmental variations without requiring multiple sensors throughout the equipment, maintaining simplicity while achieving adaptability

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

Enables accurate and simplified execution of cardiac autonomic neuropathy tests by patients or less qualified personnel, unaffected by environmental pressures, with automatic data transmission and feedback, ensuring reliable results without increased costs or maintenance.

Implementation Method 1

a 'smart' mouthpiece connected to a base unit that measures breath pressure and trend

Methodology Applied
Scientific EffectPressure measurement:

Implementation Method 2

The mouthpiece (3) comprises also an atmospheric pressure sensor (9), connected to said processing electronic board (8) for the evaluation of the correctness of the test execution depending also on the atmospheric pressure that is present locally

Methodology Applied
Scientific EffectAtmospheric pressure sensing:

Data Source

PatentUS11793410B2Auxiliary component for an equipment for cardiac autonomic neuropathy test and equipment that includes such a component
Publication Date: 2023.10.24 METEDA SRL
  • US11793410B2 patent drawing

AI summary

Equipment for carrying out cardiac autonomic neuropathy tests includes a base unit to which a mouthpiece is connected, forming an autonomous system for measuring the pressure and/or the pattern of breath, provided with a series of LEDs aimed at informing a patient, who is undergoing the test, about correctness or incorrectness of a test execution. The mouthpiece is provided with a flow sensor, aimed at measuring a patient's pattern of breath, and a pressure sensor. The mouthpiece includes also an atmospheric pressure sensor aimed at measuring the environmental pressure. The equipment includes also a sensor, aimed at measuring the heartbeat, applied by simple contact to the patient's wrist area, and an orthostatic measuring device aimed at measuring any change of the patient's position. Data can be introduced or analysed and the type of exam to do can be selected. Results of the tests can be stored in a memory.