Cochlear Implant Electrode Array Cover Assembly for Tip Curling Prevention
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Solution Overview
Problem
Conventional packaging methods for cochlear implant electrode arrays are inadequate, leading to premature tip curling and potential trauma during insertion due to unconstrained rotation and translation, and exposure to saline can affect embedded drugs or shape memory elements.
Innovation Solution
The use of an electrode array cover assembly with a resilient insert and apertured cover to maintain the array in a straightened state and create a fluidic seal, preventing liquid exposure to areas other than the contacts during testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If the electrode array is packaged in a conventional hollow cylindrical tube, then the array can be stored and transported, but the array becomes unconstrained in rotation and translation at the tip end, leading to premature tip curling
Solution Approach 1:
The packaging system is segmented into multiple functional components: a constraint mechanism with radial fins that engage the tapered flexible body, a seal assembly with O-ring, and a protective housing. This segmentation allows each component to perform its specific function - the fins provide rotational and translational constraint, the O-ring provides sealing, and the housing provides protection - thereby preventing tip curling while maintaining packaging feasibility
Solution Approach 2:
A constraint mechanism acts as an intermediary between the electrode array and the packaging environment. The radial fins of the constraint mechanism engage with the tapered flexible body of the array, providing the necessary mechanical constraint to prevent rotation and translation that would cause tip curling, while allowing the array to be properly positioned and secured within the packaging
2Productivity
If the electrode array is exposed to saline for functional testing, then testing can be performed, but the saline exposure can affect embedded drugs or shape memory elements
Solution Approach 1:
The sensitive components (embedded drugs and shape memory elements) are effectively extracted from the saline environment through the use of a protective barrier. The packaging system allows the electrode contacts to be exposed to saline for testing while the flexible body containing the drugs and shape memory elements remains protected, separating the testing function from the protected components
Solution Approach 2:
The packaging system implements local quality by providing selective exposure - only the electrode contacts are exposed to saline for functional testing, while the flexible body containing the drugs and shape memory elements remains protected. This localized approach allows testing to proceed without compromising the integrity of the sensitive embedded components
3Adaptability or versatility
If the flexible body is tapered from base to tip, then the array can conform to the cochlea shape, but the array becomes unconstrained at the tip end leading to rotation and translation
Solution Approach 1:
The constraint mechanism is activated in advance during packaging and storage to prevent tip curling. The radial fins are positioned to engage the tapered flexible body before insertion, maintaining the array in a controlled state. During insertion, the constraint mechanism is released or disengaged, allowing the array to conform to the cochlea while preventing unwanted rotation and translation
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
Prevents premature curling and maintains the electrode array in a straightened state, allowing for effective saline exposure for testing while protecting the shape memory element and drugs from moisture, thereby enhancing the insertion process and device integrity.
Implementation Method 1
a resilient insert compressed between the inner surface of the electrode array cover and the outer surface of the electrode array
Implementation Method 2
a fluidic seal is formed between the array body and the apertured portion of the wall
Data Source
AI summary
An apparatus in accordance with at least one of the present inventions comprises a cochlear implant including an electrode array with an array body that defines an outer surface and a plurality of electrically conductive contacts on the array body, and an electrode array cover assembly including an electrode array cover including a wall, defining an inner surface and an outer surface, and a plurality of spaced cover apertures that extend through an apertured portion of the wall from the inner surface to the outer surface and that are at least substantially aligned with the electrically conductive contacts, and means, at least partially within the electrode array cover, for holding the array body straight and against the inner surface of the apertured portion of the wall in such a manner that a fluidic seal is formed between the array body and the apertured portion of the wall.