Cranial Nerve Stimulation for Depression During Sleep

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Solution Overview

Problem

Efficacy of depression treatment therapies is difficult to quantify, and existing methods do not effectively utilize sleep cycle information to adjust cranial nerve stimulation for improved treatment outcomes during sleep.

Innovation Solution

An implantable medical device (IMD) monitors sleep cycle information to adjust cranial nerve stimulation parameters, such as vagus nerve or trigeminal nerve stimulation, based on sleep stage transitions and REM sleep duration to enhance serotonin production and alleviate depressive states.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If cranial nerve stimulation is applied to treat depression, then depressive symptoms may be reduced, but the efficacy of the treatment is difficult to quantify

Engineering Contradiction:
Improvetreatment efficacyVSAvoidefficacy quantification
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The system monitors sleep cycle information and uses it to adjust stimulation parameters in real-time, creating a closed-loop feedback system. The IMD determines sleep stage transitions and adjusts cranial nerve stimulation accordingly, allowing the treatment to adapt to the patient's physiological state and improving both reliability and measurability of efficacy

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent changes stimulation parameters (amplitude, pulse width, frequency) based on detected sleep stages. By dynamically adjusting these parameters according to sleep cycle information, the system optimizes treatment delivery and creates measurable outcomes through parameter modulation

Inventive Principle:
Principle #35Parameter changes

2Reliability

If fixed cranial nerve stimulation parameters are used, then device operation is simple, but treatment efficacy is reduced due to inability to adapt to sleep stage transitions

Engineering Contradiction:
Improvetreatment efficacyVSAvoidparameter adjustment mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The IMD autonomously monitors sleep cycles and automatically adjusts stimulation parameters without requiring external intervention. The device self-regulates by detecting sleep stage transitions and modifying cranial nerve stimulation accordingly, eliminating the need for manual programming while maintaining adaptive efficacy

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system transitions from static fixed parameters to dynamic adaptive parameters that change in response to physiological conditions. The stimulation parameters are continuously adjusted based on real-time sleep stage detection, making the treatment adaptable to the patient's changing neurological state

Inventive Principle:
Principle #15Dynamics

3Productivity

If cranial nerve stimulation parameters are adjusted based on sleep cycle information, then treatment efficacy is improved, but device complexity increases

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidsleep monitoring and parameter adjustment system
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The IMD performs multiple functions: it monitors sleep cycles, determines sleep stages, adjusts stimulation parameters, and delivers cranial nerve stimulation. By combining these functions in a single integrated device, the system achieves high treatment effectiveness without requiring multiple separate components, thereby limiting the increase in complexity

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentEP3134166B1Cranial nerve stimulation to treat depression during sleep
Publication Date: 2020.06.24 LIVANOVA PLC
  • EP3134166B1 patent drawingFigure 1
  • EP3134166B1 patent drawingFigure 2A~2B
  • EP3134166B1 patent drawingFigure 3

AI summary

A method includes determining sleep cycle information related to a sleep cycle of a patient based on body parameter data. The method also includes adjusting a cranial nerve stimulation parameter based on the sleep cycle information. The method further includes applying a cranial nerve stimulation therapy to treat depression based on the adjusted cranial nerve stimulation parameter.