Auricular Neurostimulation for Menstrual Bleeding Reduction

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Solution Overview

Problem

Women's health conditions such as premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), dysmenorrhea, vasomotor symptoms (VMS), preeclampsia, postural orthostatic tachycardia syndrome (POTS), polycystic ovary syndrome (PCOS), endometriosis, adenomyosis, and abnormal uterine bleeding have been neglected due to historical exclusion of women in medical research, leading to inadequate treatment options.

Innovation Solution

Non-invasive auricular neurostimulation therapy targeting vagal and trigeminal neural fibers to modulate the autonomic nervous system, increasing serotonin, norepinephrine, and endorphin release, altering the parasympathetic/sympathetic ratio, and stimulating uterine vasodilation to treat these conditions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If women are excluded from medical research to simplify study design, then research complexity is reduced, but treatment effectiveness for women's health conditions deteriorates

Engineering Contradiction:
Improveresearch design complexityVSAvoidtreatment effectiveness
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The patent segments the approach to women's health research by creating dedicated protocols that account for hormonal cycle phases, separating female health research from generic medical research while maintaining rigorous scientific standards. This allows for sex-specific treatment optimization without compromising overall research quality.

Inventive Principle:
Principle #1Segmentation

2Manufacturing precision

If hormonal cycle variability is accounted for in research, then treatment precision for women is improved, but research complexity and cost increase

Engineering Contradiction:
Improvetreatment precisionVSAvoidresearch protocol complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent implements periodic action by structuring research protocols around the menstrual cycle phases (follicular, ovulatory, luteal, menstrual), conducting assessments and interventions at regular intervals that align with hormonal fluctuations. This periodic approach captures temporal variability while maintaining systematic research design.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The patent applies parameter changes by adjusting research protocols to account for varying hormonal states, modifying measurement parameters, intervention timing, and assessment frequencies based on the participant's current cycle phase. This allows precise treatment optimization without requiring entirely separate research frameworks.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If neurostimulation therapy parameters are optimized for each menstrual phase, then symptom relief is improved, but treatment complexity increases

Engineering Contradiction:
Improvesymptom relief effectivenessVSAvoidtreatment protocol complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent implements dynamics by making neurostimulation therapy parameters adaptive rather than static, adjusting stimulation intensity, frequency, and duration based on the patient's current menstrual phase and symptom severity. This dynamic adjustment optimizes effectiveness while using automated protocols to minimize manual complexity.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent applies feedback mechanisms where treatment parameters are continuously adjusted based on patient-reported symptoms and physiological measurements taken at each cycle phase. This closed-loop system optimizes symptom relief while using algorithmic decision-making to simplify the overall treatment management.

Inventive Principle:
Principle #23Feedback

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 therapy effectively reduces symptoms by improving hormonal balance, increasing blood flow, and modulating autonomic function, providing relief for a range of women's health issues.

Implementation Method 1

the electrodes are positioned in the ear and used to deliver electrical stimulation to treat the woman's health condition

Methodology Applied
Scientific EffectElectrical stimulation: Electrical Impedance Tomography

Data Source

PatentUS12582820B2Neurostimulation therapy for treating uterine bleeding
Publication Date: 2026.03.24 SPARK BIOMEDICAL INC
  • US12582820B2 patent drawing
  • US12582820B2 patent drawing
  • US12582820B2 patent drawing

AI summary

In an illustrative embodiment, methods and systems for treating uterine bleeding include applying, at least every other day in which a subject exhibits or is expected to exhibit menstrual bleeding, neurostimulation therapy in one or more sessions, each session having a duration of at least five minutes, the neurostimulation therapy including applying electrical neurostimulation or mechanical neurostimulation to directly and/or indirectly activate one or more neural targets, the one or more neural targets including a trigeminal cervical complex and/or vagal efferent fibers. The neurostimulation therapy may be configured to enhance platelet function of the subject, thereby reducing a total volume of blood loss over a course of the menstrual bleeding.