Percutaneous Stimulation Lead Delivery for Precise Hypoglossal Placement
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Solution Overview
Problem
Existing treatments for obstructive sleep apnea, such as electrical stimulation of the hypoglossal nerve, face challenges in accurately delivering and positioning stimulation leads to effectively maintain upper airway patency during breathing.
Innovation Solution
A percutaneous delivery system for implantable stimulation leads, utilizing a site locator tool and lead introduction tools, to precisely position the stimulation electrode near the hypoglossal nerve, synchronized with respiratory patterns to stimulate the nerve and maintain airway patency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a stimulation lead is delivered percutaneously to treat obstructive sleep apnea, then the ease of operation and patient comfort are improved, but the manufacturing precision and placement accuracy become more difficult to achieve
Solution Approach 1:
The patent employs an introducer device as an intermediary tool that facilitates percutaneous delivery of the stimulation lead. The introducer includes a needle portion for percutaneous insertion and a lead introducer portion that guides the stimulation lead into the target location. This intermediary device enables minimally invasive delivery while maintaining precise electrode placement through its structured design and guiding features.
Solution Approach 2:
The patent implements preliminary actions by first creating a percutaneous access path using the introducer needle, then sequentially delivering the stimulation lead through the established pathway. The introducer device is positioned and secured before lead delivery, ensuring the correct anatomical pathway is established in advance. This preliminary positioning and securing of the introducer prevents lead migration and ensures accurate final electrode placement.
2Reliability
If the stimulation lead is positioned to stimulate the hypoglossal nerve, then the effectiveness of treating sleep apnea is improved, but the risk of damaging surrounding structures increases
Solution Approach 1:
The patent applies local quality by designing the electrode array with specific spacing and configuration to target only the hypoglossal nerve while avoiding surrounding structures. The electrodes are arranged to provide localized stimulation precisely at the nerve location, with insulation on portions of the lead to prevent unintended stimulation of adjacent tissues. This localized electrode design ensures effective nerve stimulation while minimizing risk to surrounding anatomical structures.
3Adaptability or versatility
If the electrode array is configured with multiple electrodes at different spacings, then the adaptability to different nerve locations is improved, but the device complexity increases
Solution Approach 1:
The patent implements segmentation by dividing the electrode array into multiple discrete electrodes with different spacing configurations. The array includes first and second electrodes with a first spacing, and third and fourth electrodes with a second spacing. This segmented design allows selection of appropriate electrode pairs based on the specific anatomical location and nerve configuration, providing adaptability without requiring a completely different device for each scenario.
Data Source
AI summary
Systems and methods are described and illustrated for percutaneously implanting a stimulation lead for treating sleep-related disordered breathing.