Closed-Loop Nasal Nerve Stimulation for Headache Pain Relief

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Solution Overview

Problem

Current treatments for headache pain, including migraines and cluster headaches, often have short-lived effects and vary significantly in effectiveness among individuals, with invasive methods being reserved for refractory cases and non-invasive methods offering limited long-term relief.

Innovation Solution

A closed-loop therapy delivery system that includes an electrode device for stimulating the dorsal nasal nerve structure, with sensors to monitor physiological parameters such as tearing, tissue impedance, and electrically evoked signals, and a controller to automatically adjust stimulation parameters to optimize pain relief, using non-paresthesia stimulation therapies like burst and high-frequency signals.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If non-invasive treatments (medications, biofeedback, acupuncture) are used to treat headache pain, then patient comfort is maintained and invasiveness is reduced, but the duration of pain relief is short-lived and effectiveness varies significantly between individuals

Engineering Contradiction:
Improvepatient comfortVSAvoidduration of pain relief
Core Design Contradiction:
Ease of operationVSDuration of action of moving object

Solution Approach 1:

The system employs a closed-loop feedback mechanism where sensors continuously monitor physiological parameters (tear production, nasal congestion, skin conductance) and transmit this data to a controller. The controller automatically adjusts stimulation parameters based on real-time feedback, ensuring sustained pain relief while maintaining patient comfort. This feedback loop prevents the short-lived effect problem by dynamically adapting to the patient's changing physiological state.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system transitions from static, fixed-parameter stimulation to dynamic, adaptive stimulation. The controller continuously modifies stimulation intensity, frequency, and duration based on real-time sensor feedback, allowing the therapy to adapt to the patient's evolving pain state. This dynamic adjustment ensures sustained effectiveness without requiring invasive interventions.

Inventive Principle:
Principle #15Dynamics

2Duration of action of moving object

If invasive treatments (nerve blocks, surgical interventions) are used to treat headache pain, then duration of pain relief is extended, but device complexity and procedural risk increase

Engineering Contradiction:
Improveduration of pain reliefVSAvoidcomplexity of treatment procedure
Core Design Contradiction:
Duration of action of moving objectVSDevice complexity

Solution Approach 1:

The system uses an intermediary approach by stimulating the sphenopalatine ganglion through the nasal cavity using a minimally invasive electrode device. This mediates between non-invasive and fully invasive approaches, providing extended pain relief duration through targeted neural stimulation without requiring surgical nerve transection or ganglion resection. The device delivers controlled electrical stimulation through the nasal mucosa, achieving sustained relief with reduced complexity and risk.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system replaces mechanical surgical interventions (nerve transection, ganglion resection) with electrical neural stimulation. Instead of physically altering or removing neural structures through surgery, the system uses controlled electrical fields to modulate pain signals. This substitution achieves extended pain relief duration while dramatically reducing procedural complexity, risk, and recovery time.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Ease of operation

If traditional medications are used to treat headache pain, then ease of administration is maintained, but the duration of action is short and pain recurs at similar or increased intensity

Engineering Contradiction:
Improveease of administrationVSAvoidduration of pain relief
Core Design Contradiction:
Ease of operationVSDuration of action of moving object

Solution Approach 1:

The system provides continuous pain relief through sustained neural stimulation, replacing the intermittent action of medications. The controller continuously delivers adaptive stimulation based on real-time feedback, ensuring uninterrupted pain suppression. This continuous action prevents pain recurrence that occurs with medication wear-off, while maintaining ease of administration through automated closed-loop control.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The closed-loop feedback system continuously monitors physiological indicators of pain and automatically adjusts stimulation parameters to maintain effective pain suppression. This feedback mechanism ensures sustained duration of action by detecting early signs of pain recurrence and increasing stimulation intensity accordingly, preventing the pain rebound effect seen with traditional medications.

Inventive Principle:
Principle #23Feedback

4Duration of action of moving object

If high-intensity stimulation is applied to achieve sustained pain relief, then duration of action is extended, but energy consumption increases and patient comfort decreases

Engineering Contradiction:
Improveduration of pain reliefVSAvoidenergy consumption
Core Design Contradiction:
Duration of action of moving objectVSUse of energy by moving object

Solution Approach 1:

The system uses dynamic parameter adjustment to optimize the balance between duration of pain relief and energy consumption. The controller continuously adapts stimulation intensity, frequency, and pulse width based on real-time feedback from physiological sensors. This dynamic optimization delivers sustained pain relief at the minimum effective energy level, avoiding excessive energy consumption while maintaining extended duration of action.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system achieves sustained pain relief through intelligent parameter modulation rather than constant high-intensity stimulation. The controller varies stimulation parameters (intensity, frequency, duration) based on the patient's physiological state and pain level, delivering effective therapy at optimized energy levels. This parameter adaptation extends pain relief duration while minimizing energy consumption and maintaining patient comfort.

Inventive Principle:
Principle #35Parameter changes

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 system provides sustained and personalized pain relief by dynamically adjusting stimulation parameters based on real-time feedback, minimizing energy consumption and maintaining patient comfort while effectively suppressing pain signals transmitted through A-delta and C-fibers.

Implementation Method 1

delivering a stimulation signal via the electrode device to the dorsal nasal structure

Methodology Applied
Scientific EffectElectrical stimulation: Electrical Impedance Tomography

Implementation Method 2

sensing a physiological parameter associated with the headache pain. The physiological parameter is tearing, impedance of tissue surrounding the dorsal nasal structure, an electrically evoked signal

Methodology Applied
Scientific EffectImpedance measurement: Electrical Impedance Tomography

Data Source

PatentUS20240001123A1Systems and methods for improving headache pain
Publication Date: 2024.01.04 REALEVE LLC
  • US20240001123A1 patent drawing
  • US20240001123A1 patent drawing
  • US20240001123A1 patent drawing

AI summary

Methods and systems for improving headache pain by using feedback mechanisms are provided.