Stapedius Muscle Electrode with Helical Coil Fixation
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Solution Overview
Problem
Existing stapedius muscle electrodes are traumatic, require drilled holes in bone, and have inadequate fixation, making them difficult to implant and remove without causing damage.
Innovation Solution
A bipolar stapedius muscle electrode configuration with two flexible, elastic, electrically conductive oblong elements that coil around the tendon and muscle belly, allowing secure fastening without bone drilling, using the tendon as a guide for insertion and featuring atraumatic removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing stapedius muscle electrodes are used to detect action currents, then the electrode can pick up electrical signals from the muscle, but the electrode causes traumatization and requires drilled holes in bone for fixation
Solution Approach 1:
The electrode is divided into multiple segments: a flexible shaft portion that can be guided through soft tissue, a radiopaque marker for positioning, and a coil portion that engages with the stapedius muscle. This segmentation allows the electrode to be inserted through the tympanic cavity without bone drilling while achieving reliable muscle fixation through the coil mechanism.
Solution Approach 2:
The flexible shaft portion acts as an intermediary element that bridges the gap between the external insertion point and the internal muscle target. It allows the electrode to navigate through soft tissue structures (tympanic cavity, sternomandibular ligament) to reach the stapedius muscle without requiring direct bone penetration, thereby avoiding bone damage while maintaining fixation reliability.
2Reliability
If the electrode is made rigid to ensure stable contact with the muscle, then the electrode can reliably detect action currents, but the electrode becomes difficult to insert and remove without causing damage
Solution Approach 1:
The electrode transitions from a rigid structure to a dynamic, flexible configuration. The flexible shaft portion allows the electrode to adapt to the contours of the tympanic cavity and sternomandibular ligament during insertion, while the coil portion provides flexible engagement with the stapedius muscle. This dynamic design enables easy insertion and removal without causing tissue damage, while maintaining stable muscle contact for reliable signal detection.
Solution Approach 2:
The electrode employs flexible structural elements including a flexible shaft portion and a coil portion that can deform to match the anatomy of the insertion path and target muscle. This flexibility allows the electrode to navigate through soft tissue structures without causing trauma during insertion, and facilitates easy removal, while still providing stable contact with the stapedius muscle for reliable action current detection.
3Ease of manufacture
If the electrode uses a simple structure for easy manufacturing, then the electrode can be produced cost-effectively, but the electrode fails to provide secure fixation on the muscle
Solution Approach 1:
The electrode is segmented into functionally distinct portions: a flexible shaft portion for navigation, a radiopaque marker for positioning, and a coil portion for muscle engagement. This segmentation allows each portion to be optimized for its specific function while maintaining overall manufacturing simplicity. The coil portion, in particular, provides secure muscle fixation through its helical structure that can be formed in a single manufacturing step.
Solution Approach 2:
The coil portion of the electrode utilizes a helical curvature that provides secure engagement with the stapedius muscle. This curved, spiral structure allows the electrode to wrap around or engage with the muscle tissue, providing reliable fixation without requiring complex manufacturing processes. The curvature is achieved through standard coil-forming techniques, maintaining ease of manufacture while ensuring secure muscle attachment.
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 electrode achieves secure fixation with minimal traumatization, prevents pressure necrosis, and ensures reliable contact with the muscle tissue for detecting action currents, facilitating easy insertion and removal.
Implementation Method 1
Each of the two oblong elements is pre-shaped as coiled along its entire length or along a part of its length... the coiled parts can be moved guided in the direction toward the stapedius muscle and at least partially screwed into the area of the muscle belly adjoining the tendon and/or pushed onto this area
Implementation Method 2
the electrode having two biocompatible, flexible, elastic, electrically conductive oblong elements... for detecting the action currents generated upon a contraction of the stapedius muscle
Data Source
AI summary
The invention relates to a stapedius muscle electrode array for detecting the action elements generated when a human stapedius muscle is contracted. Said array comprises an electrode (2, 2′, 2″) that is adapted for bipolar discharge and is to be attached to a human stapedius muscle. The electrode has two flexible, elastic, electrically conducting elongate elements (2a, 2b), each of which has a distal (4a, 4b) and a proximal end (17a, 17b) and is helically preshaped along at least some of the length thereof to the distal end (4a, 4b) thereof in such a way that the distal end (4a, 4b) and a section of the respective elongate element (2a, 2b) which adjoins the distal end (4a, 4b) can be placed at least in part around the tendon (7) extending between the stapedius muscle and the stapes while the helical part can be guided along the tendon (7), can be moved in the direction of the stapedius muscle, and can be at least partly twisted into and/or slid onto the region of the muscle belly (6) adjoining the tendon (7). The two elongate elements (2a, 2b) are electrically insulated from one another, and the helical parts (3) thereof are intertwined in such a way as to run around a common centerline (11), allowing the helical parts (3) to be jointly placed around the tendon (7), be guided along the tendon (7), and be brought in contact with the stapedius muscle.