Sacral Neuromodulation Electrode Design for Selective Nerve Activation
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Solution Overview
Problem
Current sacral nerve stimulation (SNS) treatments for overactive bladder lack a comprehensive understanding of underlying mechanisms, leading to a trial-and-error approach in programming and limited efficacy due to dynamic range limitations between symptom inhibition and stimulation-evoked side effects.
Innovation Solution
A computational model incorporating three-dimensional pelvic anatomy and detailed nerve geometry is used to analyze nerve responses to stimulation, optimizing electrode geometries and stimulation parameters for selective and effective sacral neuromodulation, including novel lead designs and positioning methods to enhance treatment efficacy and reduce side effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional trial-and-error programming is used for SNS, then device complexity is reduced, but treatment efficacy and selectivity are limited
Solution Approach 1:
The patent applies preliminary action by pre-computing three-dimensional models of pelvic anatomy and nerve geometry before clinical implantation. These models allow prediction of optimal electrode positions and stimulation parameters in advance, eliminating trial-and-error programming and improving treatment efficacy from the outset.
Solution Approach 2:
The patent creates computational copies (three-dimensional models) of the patient's actual anatomy and nerve structures. These virtual models can be manipulated and tested without physical intervention, allowing optimization of stimulation parameters and electrode positioning before actual implantation, thereby improving reliability without increasing operational complexity.
2Reliability
If stimulation parameters are increased to improve symptom inhibition, then treatment efficacy is improved, but stimulation-evoked side effects increase
Solution Approach 1:
The patent applies local quality by using three-dimensional models to identify specific regions of the sacral nerve that produce therapeutic effects versus those that produce side effects. By targeting stimulation to specific local regions through optimized electrode positioning and parameter selection, the treatment achieves symptom inhibition while avoiding harmful side effects.
Solution Approach 2:
The patent replaces the mechanical trial-and-error adjustment of stimulation parameters with computational modeling and simulation. The three-dimensional models predict optimal parameters before implantation, substituting empirical mechanical adjustment with theoretical computation, thereby achieving effective symptom inhibition without the need to increase stimulation intensity to the point of causing side effects.
3Measurement precision
If dynamic range is expanded to increase selectivity, then treatment precision is improved, but device complexity increases
Solution Approach 1:
The patent performs preliminary computational modeling and simulation before clinical implantation to determine optimal electrode positions and stimulation parameters. This advance planning expands the dynamic range and improves neural activation selectivity without requiring complex real-time adjustments during device operation, as the optimization is completed in advance using three-dimensional models.
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 approach increases the selectivity and efficacy of sacral neuromodulation, expanding the dynamic range of neural activation, improving treatment outcomes for conditions like overactive bladder while minimizing side effects and extending device lifetime.
Implementation Method 1
stimulating a sacral nerve in the subject with an electrode according to a set of stimulation parameters
Data Source
AI summary
A method of treating or preventing at least one symptom associated with a disease or condition in a subject in need thereof. The method comprising: stimulating a sacral nerve in the subject with an electrode according to a set of stimulation parameters; wherein the set of stimulation parameters is based on a three-dimensional model. The three-dimensional model includes a pelvic organs model, a sacral nerve model, and an electrode model. Electrode designs for stimulating a sacral nerve in a subject in need thereof.