Bilateral Hypoglossal Electrode Assembly for Single-Incision Implantation

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Solution Overview

Problem

Existing treatments for sleep disordered breathing, such as obstructive sleep apnea, are inadequate in selectively stimulating discrete nerves like the hypoglossal nerves to effectively manage the condition.

Innovation Solution

Implantable stimulation electrode assemblies are designed to deliver selective stimulation energy to bilateral nerves, such as the left and right hypoglossal nerves, through a single incision, with a flexible support body that conforms to patient anatomy and maintains nerve contact, allowing for targeted therapy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If existing treatments are used for sleep disordered breathing, then treatment is provided, but selective stimulation of discrete nerves like hypoglossal nerves is inadequate

Engineering Contradiction:

Improveselective stimulation precisionVSAvoidtreatment effectiveness

Core Design Contradiction:

Measurement precisionVSReliability

Solution Approach 1:

The electrode assembly is divided into multiple discrete electrodes (first electrode, second electrode, third electrode, fourth electrode) arranged in a specific pattern. Each electrode can be selectively activated to stimulate specific nerves, allowing precise targeting of hypoglossal nerves while avoiding stimulation of other structures. This segmentation enables selective nerve stimulation for effective sleep apnea treatment.

Inventive Principle:

Principle #1Segmentation

2Ease of manufacture

If a single incision is used for implantation, then ease of surgery is improved, but delivering selective stimulation to bilateral nerves becomes more challenging

Engineering Contradiction:

Improvesurgical implantation easeVSAvoidselective nerve stimulation capability

Core Design Contradiction:

Ease of manufactureVSEase of operation

Solution Approach 1:

The electrode assembly utilizes a three-dimensional arrangement of electrodes extending in multiple directions from a single implantation site. The electrodes are configured to reach bilateral hypoglossal nerves through spatial distribution, allowing selective stimulation of nerves on both sides of the airway while accessing the target through a single incision. This dimensional approach resolves the conflict between surgical simplicity and selective stimulation capability.

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

3Adaptability or versatility

If a flexible support body is used to conform to patient anatomy, then adaptability is improved, but structural complexity increases

Engineering Contradiction:

Improveanatomical conformationVSAvoidsupport body structure

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The electrode assembly incorporates a flexible support body that can conform to the contours of the patient's airway and surrounding tissues. This flexible structure allows the electrodes to maintain optimal contact with the hypoglossal nerves while adapting to individual anatomical variations. The flexibility is achieved through materials and design that permit bending and shaping without compromising electrode functionality or structural integrity.

Inventive Principle:

Principle #30Flexible shells and thin films

Data Source

PatentEP4103265B1Stimulation electrode assemblies and systems for treating sleep disordered breathing

Publication Date: 2025.12.24 INSPIRE MEDICAL SYSTEMS INC

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AI summary

Simulation electrode assemblies for applying bilateral stimulation, for example stimulating both the left and right hypoglossal nerves of a patient in the treatment of sleep disordered breathing. In some methods, a stimulation electrode assembly is inserted through an incision at a side of the patient and implanted at a location extending across the patient's mid-line.