EMG Clinician Programmer for Implantable Lead Positioning

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Solution Overview

Problem

Current neurostimulation systems face challenges in accurately positioning and configuring implantable leads due to variability in nerve tissue structures and electrical properties among patients, leading to inconsistent treatment outcomes, frequent adjustments, and patient discomfort.

Innovation Solution

An integrated electromyography (EMG) clinician programmer is used to standardize the placement and programming of implantable leads, providing objective and quantitative means for verifying activation of motor responses and automating electrode threshold determinations, thereby improving lead placement accuracy and reducing procedural time.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional neurostimulation lead placement methods are used, then the procedure can be performed with simple equipment, but lead placement accuracy is poor and treatment outcomes are inconsistent

Engineering Contradiction:
Improvelead placement accuracyVSAvoidequipment complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent introduces an EMG clinician programmer as an intermediary device that mediates between the neurostimulation system and the clinician. This device provides automated threshold determination and lead placement guidance, improving measurement precision while managing complexity through a dedicated intermediary tool rather than requiring complex integration into existing simple systems.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces manual, mechanical lead placement methods with an automated EMG-based system. The EMG clinician programmer automatically determines threshold values and provides feedback for precise lead positioning, substituting mechanical trial-and-error placement with electronically-guided precision placement.

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

2Productivity

If manual electrode threshold determination is used, then the equipment remains simple, but procedural time is excessive and patient discomfort increases

Engineering Contradiction:
Improveprocedural efficiencyVSAvoidprogramming equipment complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The EMG clinician programmer performs automated threshold determination, allowing the system to self-determine optimal stimulation parameters without requiring extensive manual adjustment by the clinician. The device automatically sweeps through thresholds and identifies activation points, enabling the equipment to service itself in the parameter determination process.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent implements automated parameter sweeping and threshold determination, where the EMG clinician programmer systematically changes stimulation parameters to identify threshold values. This automated parameter exploration improves productivity by eliminating manual parameter adjustment while the device manages the complexity of parameter space exploration.

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If frequent stimulation protocol adjustments are made to accommodate patient variability, then treatment can be adapted to individual patients, but the number of office visits and patient discomfort increase

Engineering Contradiction:
Improvetreatment customizationVSAvoidnumber of office visits
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

Solution Approach 1:

The EMG clinician programmer performs preliminary threshold determination and lead placement optimization during the initial implantation procedure. By establishing accurate threshold values and optimal lead positioning upfront, the system reduces the need for subsequent adjustments and office visits, while still maintaining adaptability to individual patient anatomy and response.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements EMG-based feedback during lead placement and threshold determination. The system provides real-time feedback on lead positioning quality and stimulation threshold values, allowing the clinician to optimize treatment parameters in a single procedure. This feedback mechanism enables treatment customization without requiring multiple iterative adjustments across separate office visits.

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 EMG clinician programmer enhances the precision and consistency of neurostimulation treatment by allowing for more accurate lead placement and programming, reducing patient discomfort and the need for repeated adjustments, and improving the overall effectiveness of neurostimulation therapy.

Implementation Method 1

an integrated electromyography (EMG) clinician programmer which is coupled to the implantable lead and to at least one EMG sensing electrode

Methodology Applied
Scientific EffectElectromyography:

Implementation Method 2

delivering test stimulations at a same stimulation amplitude level for a same period of time sequentially to each of the four electrodes of the implantable lead

Methodology Applied
Scientific EffectElectrical stimulation: Electric Field

Data Source

PatentUS20230158306A1Electromyographic Lead Positioning and Stimulation Titration in a Nerve Stimulation System for Treatment of Overactive Bladder
Publication Date: 2023.05.25 AXONICS INC
  • US20230158306A1 patent drawing
  • US20230158306A1 patent drawing
  • US20230158306A1 patent drawing

AI summary

The present invention provides improved methods for positioning of an implantable lead in a patient with an integrated EMG and stimulation clinician programmer. The integrated clinician programmer is coupled to the implantable lead, wherein the implantable lead comprises at least four electrodes, and to at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient. The method comprises delivering a test stimulation at a stimulation amplitude level from the integrated clinician programmer to a nerve tissue of the patient with a principal electrode of the implantable lead. Test stimulations are delivered at a same stimulation amplitude level for a same period of time sequentially to each of the four electrodes of the implantable lead. A stimulation-induced EMG motor response is recorded with the integrated clinician programmer for each test stimulation on each electrode of the implantable lead via the at least one pair of EMG sensing electrodes so as to facilitate initial positioning of the implantable lead at a target stimulation region.