EMG-Guided Electrode Placement for Pelvic Floor Stimulation

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Solution Overview

Problem

Current electrical stimulation systems for treating pelvic floor disorders face challenges in accurately placing electrodes to deliver targeted therapy while minimizing side effects, often requiring extensive fluoroscopy and prolonged procedure times.

Innovation Solution

The system employs electromyographic (EMG) response-guided electrode placement, using stimulation circuitry to deliver electrical stimulation at varying levels at multiple positions, sensing EMG responses, and scoring positions for chronic implantation based on threshold responses to ensure effective targeting and minimize unintended stimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If fluoroscopy is used to guide electrode placement, then placement accuracy is improved, but procedure time increases and radiation exposure increases

Engineering Contradiction:

Improveelectrode placement accuracyVSAvoidprocedure time

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The patent replaces fluoroscopy (radiation-based imaging system) with EMG-guided navigation (physiological response-based system). The EMG system uses electrical stimulation and sensing to provide real-time feedback on nerve proximity and electrode positioning, eliminating the need for continuous fluoroscopic imaging while maintaining placement accuracy.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent implements a feedback mechanism where EMG signals are continuously monitored during electrode advancement. When the electrode approaches the target nerve, characteristic EMG responses are detected, providing real-time feedback to guide precise positioning without requiring fluoroscopic visualization.

Inventive Principle:

Principle #23Feedback

2Measurement precision

If fluoroscopy is used to guide electrode placement, then placement accuracy is improved, but radiation exposure increases

Engineering Contradiction:

Improveelectrode placement accuracyVSAvoidradiation exposure

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent substitutes fluoroscopy (ionizing radiation-based system) with EMG-guided navigation (electrophysiological system). This replacement eliminates radiation exposure entirely while maintaining the ability to achieve accurate electrode placement through physiological signal detection.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent converts the potentially harmful radiation-based fluoroscopy into a beneficial radiation-free alternative. By using EMG signals that are naturally produced by the nervous system in response to electrical stimulation, the system achieves accurate guidance without any harmful radiation exposure to the patient.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

3Reliability

If multiple positions are tested to ensure accurate targeting, then therapy efficacy is improved, but procedure time increases

Engineering Contradiction:

Improvetherapy efficacyVSAvoidprocedure time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent uses real-time EMG feedback to rapidly assess multiple electrode positions. As the electrode is advanced or repositioned, EMG responses are continuously monitored, allowing the operator to quickly identify the optimal position without manually testing each position extensively. The feedback mechanism accelerates the position-testing process.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The patent performs preliminary EMG assessments during the implantation procedure itself, rather than requiring separate pre-operative planning or post-implantation adjustments. The EMG-guided system allows for real-time optimization of electrode positioning, combining the benefits of multiple position testing with efficient procedure execution.

Inventive Principle:

Principle #10Preliminary action

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

This approach reduces fluoroscopy usage, decreases procedure time, and enhances the accuracy of electrode placement, leading to improved therapy efficacy and patient quality of life by ensuring targeted stimulation with minimal side effects.

Implementation Method 1

The sensing circuitry may be configured to sense electromyographic (EMG) responses from the patient to the electrical stimulation

Methodology Applied

Scientific EffectElectromyographic response:

Data Source

PatentUS12090321B2Lead placement for nerve stimulation

Publication Date: 2024.09.17 MEDTRONIC INC

AI summary

Example systems for positioning an implantable electrode may include a stimulation circuitry, a sensing circuitry, and processing circuitry. The stimulation circuitry may generate electrical stimulation deliverable to a patient. The sensing circuitry may sense electromyographic (EMG) responses. The processing circuitry may control the stimulation circuitry to deliver the electrical stimulation at a plurality of different stimulation metric levels at each of a plurality of different positions. The processing circuitry may sense, via the sensing circuitry, electromyographic (EMG) responses to the electrical stimulation. The processing circuitry may score one or more of the different positions for chronic implantation of at least one implantable electrode. The scoring may be based on a stimulation metric level greater than a predetermined metric threshold sufficient to evoke at least some of the sensed EMG responses, and a level of the at least some of the sensed EMG responses.