Hypoglossal Nerve Cuff Electrode Structure to Reduce Delamination
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Solution Overview
Problem
Nerve cuffs used for stimulating the hypoglossal nerve to treat obstructive sleep apnea are prone to delamination due to inadequate bonding between conductive and non-conductive layers, and lack flexibility, which can lead to inefficiencies and potential damage to the nerve.
Innovation Solution
The nerve cuffs are designed with a cuff body having multiple electrically conductive members spaced in the width direction, with openings and straps to enhance adhesion and flexibility, and a lead body with conductors connecting these contacts to an implantable pulse generator, allowing for adjustable sizing and reduced delamination risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional nerve cuffs with laminated conductive and non-conductive layers are used, then electrical stimulation function is achieved, but delamination occurs due to inadequate bonding
Solution Approach 1:
The conductive layer is segmented into multiple discrete conductive members (first and second conductive members) rather than a continuous layer. This segmentation reduces the total bonding surface area between layers, thereby reducing the cumulative bonding defects and delamination risk while maintaining effective electrical stimulation capability through the distributed conductive elements.
Solution Approach 2:
The patent applies different properties to different parts of the nerve cuff structure. The conductive members are strategically positioned and sized (first conductive member wider than second) to optimize local electrical stimulation effectiveness, while the non-conductive layer provides localized mechanical support and insulation where needed. This local optimization allows the structure to achieve reliable bonding in critical areas without requiring uniform bonding across the entire surface.
2Strength
If rigid nerve cuff structures are used, then structural stability is achieved, but flexibility is reduced causing potential nerve damage
Solution Approach 1:
The nerve cuff employs a non-conductive layer that functions as a flexible shell encompassing the conductive members. This flexible shell structure provides the necessary structural stability to maintain the cuff's form and protect the nerve, while simultaneously allowing sufficient flexibility to conform to the nerve's contours and accommodate physiological movements without causing damage. The thin film nature of the non-conductive layer ensures flexibility while maintaining structural integrity.
3Ease of manufacture
If fixed-size nerve cuffs are manufactured, then manufacturing simplicity is achieved, but adaptability to varying nerve sizes is reduced
Solution Approach 1:
The nerve cuff design incorporates adjustable sizing capability through the configuration and spacing of the conductive members within the non-conductive layer. The cuff can be adjusted to accommodate varying nerve diameters by modifying the expansion or contraction of the flexible non-conductive shell, while the relative positions and dimensions of the conductive members are maintained to preserve electrical stimulation functionality across different sizes.
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 improved nerve cuffs provide enhanced flexibility and reduced delamination, ensuring stable nerve stimulation and better compatibility with varying nerve sizes, thereby improving treatment efficacy for obstructive sleep apnea.
Implementation Method 1
first and second relatively wide electrically conductive members 112, 120, 120a, 120b, 120c, 120d, 120e located between the first and second layers 116, 118 of the cuff body
Implementation Method 2
The present inventors have determined that certain electrically conductive materials with otherwise desirable properties (e.g., platinum-iridium) do not bond well with the adhesive (e.g., silicone adhesive) that is used to bond non-conductive layers
Data Source
AI summary
An electrode that includes an elongate lead body and a nerve cuff. The nerve cuff may include a biologically compatible, elastic, electrically insulative cuff body configured to be circumferentially disposed around a nerve, first and second relatively wide electrically conductive contacts carried by the cuff body that are spaced from one another in the length direction and that extend in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape, and a plurality of relatively narrow electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction and are located between the first and second relatively wide electrically conductive contacts.