TENS Device Sleep-Wake Detection

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Solution Overview

Problem

Conventional Transcutaneous Electrical Nerve Stimulation (TENS) devices cannot safely operate during sleep due to the risk of electrode peeling, which increases current density and can cause painful stimulation or thermal burns, and they lack automated means to adjust stimulation intensity based on the user's sleep-wake state for optimal pain relief.

Innovation Solution

A TENS device with an integrated accelerometer that monitors body orientation and movement to determine the user's sleep-wake state, adjusting stimulation parameters such as intensity and duration to ensure safe and effective pain relief during both wake and sleep periods.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If TENS devices operate during sleep, then pain relief benefits are improved, but the risk of electrode peeling and thermal burns increases

Engineering Contradiction:
Improvepain relief effectivenessVSAvoidelectrode peeling and thermal burn risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The TENS device dynamically adjusts stimulation intensity based on detected sleep-wake state. During wake periods, higher intensities provide effective pain relief. During sleep periods, the system automatically reduces intensity to minimize electrode peeling risk and thermal burn hazards while maintaining therapeutic benefit.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system incorporates sensors that continuously monitor physiological parameters (such as skin impedance, body movement, or EEG signals) to detect sleep-wake transitions. This feedback enables real-time adjustment of stimulation parameters, ensuring safe operation during sleep while maintaining effective pain relief during wakefulness.

Inventive Principle:
Principle #23Feedback

2Reliability

If stimulation intensity is increased for optimal pain relief, then therapeutic effectiveness is improved, but sleep quality is disturbed

Engineering Contradiction:
Improvepain relief effectivenessVSAvoidsleep quality interference
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device implements dynamic intensity modulation based on detected sleep-wake state. During wake periods, the system delivers higher stimulation intensities optimized for pain relief. Upon detecting sleep onset, the system automatically reduces intensity to a lower level that maintains pain suppression without disturbing sleep architecture or causing awakenings.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes key stimulation parameters (intensity, pulse width, frequency) based on the user's physiological state. The controller adjusts these parameters in real-time according to sleep-wake detection, transitioning from wake-optimized parameters during daytime to sleep-optimized parameters during nighttime to balance therapeutic effectiveness with sleep quality preservation.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If automated sleep-wake detection is added to TENS devices, then safety and effectiveness are improved, but device complexity increases

Engineering Contradiction:
Improvesafe and effective operationVSAvoiddevice structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system introduces intermediary components (sensors for sleep-wake detection, microcontroller for state determination, and control algorithms for parameter adjustment) that mediate between the user's physiological state and the stimulation delivery. These intermediaries enable automated adaptation without requiring complex user interaction or manual monitoring.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The TENS device performs self-adjustment of stimulation parameters based on its own sensing capabilities. The integrated sensors continuously monitor the user's state, and the embedded controller automatically modifies stimulation settings without external intervention, enabling the device to serve itself in optimizing therapy delivery while maintaining simplicity for the user.

Inventive Principle:
Principle #25Self-service

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 provides safe and effective pain relief during sleep by reducing stimulation intensity when the user is asleep, preventing interference with sleep quality and minimizing the risk of electrode peeling, thus enhancing the therapeutic benefits of TENS therapy.

Implementation Method 1

A TENS device with an integrated accelerometer that monitors body orientation and movement to determine the user's sleep-wake state

Methodology Applied
Scientific EffectAccelerometer: Accelerometer

Implementation Method 2

Electrical stimulation is typically delivered to the user through electrodes, with the electrical stimulation being in the form of low intensity (typically less than 100 mA), short duration (typically 50-400 μsec) pulses at frequencies typically between about 10 and 200 Hz

Methodology Applied
Scientific EffectElectrical stimulation: Electrical Impedance Tomography

Implementation Method 3

The electrodes typically utilize hydrogels to create a stable low-impedance electrode-skin interface to facilitate the delivery of electrical current to the user

Methodology Applied
Scientific EffectHydrogel: Hydrogel

Data Source

PatentUS11247052B2Transcutaneous electrical nerve stimulator with automatic detection of user sleep-wake state
Publication Date: 2022.02.15 NEUROMETRIX INC
  • US11247052B2 patent drawing
  • US11247052B2 patent drawing
  • US11247052B2 patent drawing

AI summary

Apparatus for transcutaneous electrical nerve stimulation in a user, the apparatus comprising:a housing;stimulation means for electrically stimulating at least one nerve;an electrode releasably mounted to the housing and connectable to the stimulation means for electrical stimulation of the at least one nerve;monitoring means for monitoring the user's body orientation and movement;analysis means for analyzing said orientation and movement; andcontrol means for controlling the output of the stimulation means in response to said analysis of said orientation and movement.