Hypoglossal Nerve Cuff Stimulation Synchronized to Breathing
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Solution Overview
Problem
Existing neurostimulation systems for treating obstructive sleep apnea (OSA) fail to synchronize tongue muscle stimulation with the respiratory cycle and often require additional surgery and expertise to implant nerve cuff electrodes at the hypoglossal nerve trunk, leading to inefficiencies and increased risk.
Innovation Solution
An implantable neurostimulator with integrated sensing circuitry and control circuitry synchronizes electrical pulse trains with respiratory cycles, using a nerve cuff electrode with multiple electrode contacts to selectively stimulate hypoglossal nerve fascicles, reducing surgical time and complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If nerve cuff electrode is implanted at the HGN trunk with multiple electrode contacts, then the stimulation can be delivered to multiple nerve fascicles, but it is difficult to selectively stimulate only the target tongue protrusor muscle fascicles without recruiting other non-targeted fascicles
Solution Approach 1:
The HGN trunk is segmented into multiple fascicles, each innervating different muscles. The nerve cuff electrode is designed with multiple independently controllable electrode contacts that can selectively stimulate specific fascicles. This segmentation allows the system to target only the tongue protrusor muscle fascicles while avoiding recruitment of fascicles innervating other muscles, thus resolving the contradiction between versatility and selectivity.
Solution Approach 2:
Different electrode contacts on the nerve cuff are positioned to contact specific fascicles at different locations along the HGN trunk. By applying stimulation locally at specific contact points, the system can selectively activate target fascicles while leaving non-targeted fascicles unaffected. This local quality approach enables precise control over which muscle groups are activated.
2Device complexity
If stimulation is delivered without synchronization to the respiratory cycle, then the treatment is simpler to implement, but the tongue protraction does not occur when most needed during inspiration
Solution Approach 1:
The system incorporates sensors that detect respiratory cycle phase and provide feedback to the stimulation control circuitry. Based on this feedback, the system automatically synchronizes stimulation delivery to occur during the inspiratory phase when tongue protraction is most needed. This feedback mechanism ensures reliable timing of tongue protraction while maintaining automated operation that does not increase operational complexity for the user.
Solution Approach 2:
The system performs preliminary detection of the respiratory cycle phase before delivering stimulation. By anticipating the inspiratory phase through continuous monitoring, the system prepares to deliver stimulation at the optimal moment, ensuring tongue protraction occurs precisely when needed during inspiration rather than randomly or continuously.
3Manufacturing precision
If nerve cuff electrode is implanted at the distal branch of HGN, then specific tongue protrusor muscle fascicles can be targeted, but additional surgery time and expertise are required
Solution Approach 1:
The nerve cuff electrode is designed with multiple electrode contacts that can potentially stimulate multiple fascicles. This preliminary design capability allows the system to achieve precise targeting of specific fascicles even when implanted at the more accessible proximal HGN trunk location, eliminating the need for complex distal branch dissection while maintaining the ability to selectively stimulate target muscles.
Solution Approach 2:
The nerve cuff electrode with multiple electrode contacts is designed to be universally applicable at the HGN trunk location. It can selectively stimulate different fascicles depending on which electrode contacts are activated, providing the same targeting capability as distal branch implantation but with simpler surgical access. This multi-functional design resolves the contradiction between precision and surgical complexity.
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 system effectively stimulates hypoglossal nerve fascicles in synchronization with respiratory cycles, minimizing surgery time and risk while improving treatment efficacy for OSA.
Implementation Method 1
The sensing circuitry comprises at least one sensor integrated directly to or within the case. The at least one sensor is configured for sensing physiological artifacts that are caused by respiration.
Implementation Method 2
The stimulation circuitry is configured for generating an electrical pulse train... causing the stimulation circuitry to deliver the electrical pulse train to at least one electrode contact
Data Source
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AI summary
An electrode lead comprises an electrically insulative cuff body and at least three axially aligned electrode contacts circumferentially disposed along the inner surface of the cuff body when in the furled state. The electrode contacts may be circumferentially disposed around a nerve, and an electrical pulse train may be delivered to the electrode contacts thereby stimulating the nerve to treat obstructive sleep apnea. The electrical pulse train may be one that pre-conditions peripherally located nerve fascicles to not be stimulated, while stimulating centrally located nerve fascicles. A feedback mechanism can be used to titrate electrode contacts and electrical pulse train to the patient. A sensor that is affixed to the case of a neurostimulator can be used to measure physiological artifacts of respiration, and a motion detector can be used to sense tapping of the neurostimulator to toggle the neurostimulator between an ON position and an OFF position.