Self-Expanding Electrode Cuff for Hypoglossal Nerve Stimulation

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Solution Overview

Problem

Existing electrode cuffs for stimulating the hypoglossal nerve face challenges such as nerve irritation, swelling, and fibrosis, leading to reduced effectiveness and patient discomfort due to improper positioning and restricted blood supply, especially during the initial post-implantation period.

Innovation Solution

An expandable electrode cuff design with flange members that can adjust from a fully engaged to fully open position to accommodate nerve size changes, ensuring secure positioning and preventing nerve constriction, utilizing a self-expanding mechanism to maintain contact and accommodate swelling without restricting blood flow.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the electrode cuff is placed in close proximity to the hypoglossal nerve, then stimulation effectiveness is improved, but nerve irritation occurs due to normal motion of the chin and neck

Engineering Contradiction:

Improvestimulation effectivenessVSAvoidnerve irritation

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The electrode cuff incorporates a self-expanding mechanism with flange members that can dynamically adjust between engaged and open positions. This dynamic structure allows the cuff to adapt to nerve movement while maintaining effective contact, resolving the contradiction between close proximity for stimulation effectiveness and avoidance of irritation from normal motion.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The cuff's expandable design changes the physical parameters of contact pressure and positioning. By adjusting the expansion state, the system can optimize the balance between maintaining effective neural contact and reducing mechanical irritation during physiological movements.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If the electrode cuff is placed in close proximity to the hypoglossal nerve, then stimulation effectiveness is improved, but connective tissue buildup occurs between the nerve and electrode, reducing stimulation effectiveness

Engineering Contradiction:

Improvestimulation effectivenessVSAvoidconnective tissue buildup

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The self-expanding cuff maintains optimal contact pressure through its dynamic structure, preventing the nerve from adhering to the electrode. The flange members can adjust to maintain spacing that prevents connective tissue formation while ensuring effective stimulation, addressing the stability issue of connective tissue buildup.

Inventive Principle:

Principle #15Dynamics

3Stability of the object's composition

If the electrode cuff is tightly fitted around the hypoglossal nerve, then positioning stability is improved, but nerve swelling causes constriction and potential strangulation

Engineering Contradiction:

Improvepositioning stabilityVSAvoidnerve constriction

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The expandable cuff design with movable flange members provides dynamic adjustment capability. When nerve swelling occurs, the flange members can transition from engaged to open positions, increasing the internal volume and relieving constriction while maintaining positioning stability through the overall cuff structure.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The self-expanding mechanism is designed to accommodate anticipated nerve swelling by providing expandable capacity. The flange members are positioned to allow expansion before critical constriction occurs, cushioning against the harmful effects of nerve swelling.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

4Object-affected harmful factors

If the electrode cuff is made expandable to accommodate nerve swelling, then nerve constriction is prevented, but device complexity increases

Engineering Contradiction:

Improvenerve constrictionVSAvoidcuff structure

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The cuff is segmented into flange members that can independently move between engaged and open positions. This segmentation allows the expansion function to be achieved through simple, discrete components rather than a complex continuous mechanism, reducing overall device complexity while maintaining the ability to accommodate nerve swelling.

Inventive Principle:

Principle #1Segmentation

Data Source

PatentEP2310083B1Self expanding electrode cuff

Publication Date: 2015.10.21 MEDTRONIC INC

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AI summary

An expandable electrode cuff of an implantable stimulation system that includes a base member, a first flange member extending from a proximal end along a first side wall of the base member to a first distal end, and a second flange member extending from a proximal end along a second side wall of the base member to a second distal end. The first flange member extends over both a top wall of the base member and the second flange member, and the second flange member extends over the top wall to form a lumen. The electrode cuff is capable of being advanced between a first position corresponding to both flange members extending over the top wall, a second position corresponding to the first flange member not extending over the top wall and the second flange member extending over the top wall, and a third position corresponding to both of the flange members not extending over the top wall.