Nerve Cuff Electrode Assembly for Swelling-Tolerant Neurostimulation

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Solution Overview

Problem

Existing electrode implementations for neurostimulation, such as those used in obstructive sleep apnea therapy, often cause acute and chronic injuries to nerves due to swelling and undesirable tissue responses like fibrotic growth, making it challenging to effectively stimulate target nerves without causing harm.

Innovation Solution

The development of an electrode assembly with a cuff body that wraps around the nerve, featuring a compliant design with a smooth outer surface and embedded electrode elements, allowing for safe and effective nerve stimulation by accommodating nerve swelling and minimizing tissue irritation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing electrode implementations are used for neurostimulation, then nerve stimulation can be achieved, but acute and chronic nerve injuries occur due to swelling and fibrotic growth

Engineering Contradiction:

Improvenerve stimulation effectivenessVSAvoidnerve injuries and fibrotic growth

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The electrode assembly employs a flexible cuff body made of soft, compliant material that forms a hollow cylinder wrapping around the nerve. This flexible shell structure accommodates nerve swelling and movement without causing mechanical injury, while the thin film construction allows effective electrical contact for stimulation while minimizing tissue irritation and fibrosis.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The cuff body acts as an intermediary between the electrode elements and the nerve. It provides a protective interface that distributes electrical stimuli evenly across the nerve surface while physically isolating the electrode from direct contact with nerve tissue, thereby preventing acute and chronic injuries and fibrotic growth.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If electrode elements are embedded within the cylinder wall, then effective nerve stimulation is achieved, but the structure becomes more complex

Engineering Contradiction:

Improvestimulation effectivenessVSAvoidelectrode assembly structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The electrode elements are merged with the cylinder wall structure, where the electrodes are embedded within the wall thickness rather than being separate components. This integration combines the structural support function of the cylinder wall with the electrical stimulation function, reducing the number of discrete parts while maintaining effective nerve stimulation capability.

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS12478786B1Electrode devices and methods for neurostimulation treatment

Publication Date: 2025.11.25 RESTORA MEDICAL INC

AI summary

At least some embodiments of the present disclosure are directed to systems and methods for sleep disordered breathing (e.g., obstructive sleep apnea) therapy. An electrode assembly includes a cuff body to wrap around a nerve. The cuff body includes an inner layer to form a hollowed cylinder shape, and an outer layer to overlap at least a part of the inner layer and cover a closeable opening of the inner layer. Electrode elements are at least partially embedded within the inner layer and spaced apart from each other along a longitudinal direction. The electrode elements each include an arcuate portion facing a lumen of the inner layer. The electrode assembly has a cross-sectional shape that is substantially circular.