Patient-Customized Cochlear Electrode Arrays for Anatomical Fit
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Solution Overview
Problem
Current cochlear implant technologies face challenges in achieving optimal electrode array placement due to the large variations in individual cochlear anatomy, leading to suboptimal hearing outcomes, as existing methods rely on generic designs rather than patient-specific approaches, and precise imaging of intra-cochlear structures is difficult with current technologies.
Innovation Solution
A method for designing a patient-customized electrode array by segmenting cochlear structures in pre-operative CT images using shape models, defining a 3D curve, and transforming it into the patient's anatomy to determine the optimal electrode placement, ensuring accurate registration and insertion depth, curvature matching, and curvature characterization of electrodes to match the patient's anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If generic electrode array designs are used, then device complexity is reduced and ease of manufacture is improved, but manufacturing precision and adaptability to patient-specific anatomy deteriorate
Solution Approach 1:
The patent performs preliminary actions by acquiring patient-specific cochlear anatomy data through imaging (CT or MRI) before electrode array manufacturing. Shape models are constructed from this data, and electrode arrays are customized based on these pre-acquired anatomical specifications, ensuring precise fit while maintaining manufacturing feasibility through standardized customization protocols.
Solution Approach 2:
The patent applies parameter changes by modifying electrode array geometry parameters (curvature, length, diameter) based on patient-specific cochlear shape model parameters. The customization process adjusts these physical parameters to match the individual patient's cochlear anatomy, achieving precise placement while using standardized manufacturing processes that accommodate parameter variations.
2Adaptability or versatility
If patient-specific electrode arrays are designed, then adaptability to individual cochlear anatomy is improved, but device complexity and manufacturing difficulty increase
Solution Approach 1:
The patent manages design complexity through parameter changes by systematically adjusting electrode array geometry parameters based on patient-specific measurements. Rather than creating entirely custom designs, the approach modifies key parameters (curvature radius, length, diameter) within standardized array families, balancing adaptability with manageable design complexity.
Solution Approach 2:
The patent applies local quality by customizing specific portions of the electrode array that correspond to patient-specific anatomical variations, while maintaining standardized sections where anatomy is relatively uniform. This selective customization reduces overall design complexity while preserving adaptability where it is most needed.
3Ease of operation
If standard insertion depths are used, then ease of operation is improved, but measurement precision and placement accuracy deteriorate due to anatomical variations
Solution Approach 1:
The patent applies parameter changes by determining patient-specific insertion depth parameters based on the shape model analysis of individual cochlear anatomy. The system calculates optimal insertion depths that account for variations in cochlear length, curvature, and scala tympani dimensions, providing precise depth guidance while maintaining ease of surgical operation through clear quantitative targets.
4Device complexity
If generic array placement methods are used, then device complexity is reduced, but hearing outcomes deteriorate due to suboptimal positioning and channel interaction artifacts
Solution Approach 1:
The patent performs preliminary actions by constructing detailed shape models of patient-specific cochlear anatomy and simulating electrode array placement before actual surgery. This pre-operative planning identifies optimal trajectories and positioning that minimize channel interaction artifacts and maximize perimodiolar positioning, improving hearing outcomes while providing clear surgical guidance that manages complexity.
Solution Approach 2:
The patent applies feedback by using the shape model analysis to provide real-time guidance during electrode array insertion. The system compares actual placement against the pre-planned optimal position derived from patient-specific anatomy, allowing adjustments to achieve target positioning and minimize channel interaction, thereby improving reliability of hearing outcomes.
Data Source
AI summary
A patient-customized electrode array (EA) includes a plurality of electrodes, {Ei}, assembled in a pre-curved form, wherein the curvature of the EA at the i-th electrode Ei is characterized with a curvature that matches the curvature of the i-th point Pi of a structure curve in the cochlea of a patient where the i-th electrode Ei is to be placed, wherein i=1, 2, 3, . . . N, N is an integer greater than zero.