Neuromodulation Device with L-Shaped Channel for Nerve Protection
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Solution Overview
Problem
Current neuromodulation devices face challenges in effectively treating pelvic floor dysfunctions due to their inability to selectively stimulate specific pelvic floor muscles, leading to non-specific stimulation and unwanted side effects. Additionally, traditional electrode implantation methods often damage small and fragile autonomic nerves, especially those near blood vessels or internal organs.
Innovation Solution
A neuromodulation device with a unique L-shaped longitudinal channel that allows for a slide-in-lock mechanism, minimizing nerve manipulation and damage. The device includes a chamber for receiving a nerve, at least one electrode for stimulation, and a channel that is 5-50% smaller than the nerve diameter, facilitating easy implantation and reducing nerve stretching.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional electrode implantation methods (suturing and medical grade epoxy) are used to secure cuff electrodes to small and fragile nerves, then the electrode can be securely attached, but nerve damage occurs due to excessive manipulation
Solution Approach 1:
A flexible polymer tube is introduced as an intermediary carrier that guides and protects the electrode during implantation. The tube allows the electrode to be delivered to the nerve target with minimal manipulation, and the electrode is then secured within the tube using a novel fixation mechanism that does not require sutures or epoxy, thereby preventing nerve damage while ensuring secure attachment
Solution Approach 2:
The traditional mechanical securement methods (suturing and epoxy) are replaced with a novel fixation mechanism that utilizes the flexible polymer tube structure itself to hold the electrode in place. This substitution eliminates the need for invasive securing techniques that cause nerve damage, while maintaining reliable electrode attachment through the tube's inherent mechanical properties
2Adaptability or versatility
If traditional cuff electrodes are used for autonomic nerve stimulation, then the electrode can interface with the nerve, but the fragile nerve anatomy is damaged during implantation
Solution Approach 1:
The electrode is encased in a flexible polymer tube that conforms to the fragile nerve anatomy. This flexible shell protects the nerve during implantation by allowing gentle positioning and securing, while maintaining the electrode's ability to interface with the nerve through the tube's flexible structure. The thin-walled polymer tube provides sufficient mechanical protection without compromising electrical contact
3Productivity
If volume conductance stimulation method is used for pelvic floor muscle stimulation, then electrical stimulation can be applied, but selective stimulation of targeted muscles is not possible leading to unwanted side effects
Solution Approach 1:
The electrode array is designed with spatially distributed electrodes that can be independently controlled. Each electrode or electrode group can be stimulated selectively to target specific pelvic floor muscles, allowing precise local control of stimulation. This local quality approach replaces the non-selective volume conductance method, enabling targeted muscle stimulation without causing unwanted effects in adjacent areas
4Productivity
If intravaginal and anal plug electrodes are used for pelvic floor stimulation, then stimulation can be applied, but patients experience pain, discomfort or mucosal injury
Solution Approach 1:
The flexible polymer tube serves as a protective intermediary that delivers the electrode to the nerve target while shielding the surrounding tissue. This tube-based approach eliminates the need for direct intravaginal or anal plug electrodes that cause mucosal injury, while maintaining stimulation capability through the tube's flexible structure that can be positioned precisely without causing discomfort
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 device enables facile and rapid implantation with reduced nerve manipulation, effectively preventing nerve damage. It allows for selective stimulation of specific pelvic floor muscles, reducing unwanted side effects and improving treatment efficacy for conditions like urinary incontinence and overactive bladder.
Implementation Method 1
a channel defined by two walls, wherein the channel comprises an average width that is 5-50% smaller than an average diameter of the chamber
Data Source
AI summary
In one aspect, a neuromodulation device is described herein. In some embodiments, a neuromodulation device comprises a chamber operable to receive a nerve, at least one electrode disposed in the chamber, and a channel defined by two walls. In some embodiments, the channel of the device is in fluid communication with an interior of the chamber and an external surface of the device. In another aspect, methods of neuromodulation are described herein. In some embodiments, methods described herein can use one or more neuromodulation devices described herein.