Cochlear Implant ECAP-Based Programming System

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Solution Overview

Problem

Current cochlear implant programming methods are time-consuming and subjective, particularly challenging for pediatric patients due to their inability to communicate effectively, leading to inconsistent results and prolonged mapping sessions.

Innovation Solution

An implantable electrical stimulation system with an electrode array, sensor, and processing circuitry that applies electrical stimuli and measures evoked compound action potentials (ECAPs) to determine parameters for all electrode contacts, reducing the need for extensive behavior measurements and enabling faster, more accurate programming.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If behavior measurement methods are used to program cochlear implant electrodes, then subjective feedback can be obtained for M/C/T levels, but the programming time becomes excessively long (20-30 minutes per electrode)

Engineering Contradiction:
ImproveM/C/T level measurement accuracyVSAvoidprogramming session duration
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent replaces the mechanical/behavioral measurement system with an electrical measurement system. Specifically, it uses electrically evoked compound action potential (ECAP) measurements to objectively determine electrode parameters, substituting the subjective behavioral feedback method with an automated electrical physiological response measurement that provides both accuracy and speed.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system enables self-service programming by using the patient's own physiological responses (ECAP measurements) to automatically determine the appropriate M/C/T levels for each electrode. This eliminates the need for extensive clinician-guided behavioral testing, allowing the system to program itself based on objective electrical measurements of the patient's neural responses.

Inventive Principle:
Principle #25Self-service

2Measurement precision

If ECAP measurement is used to supplement subjective response, then objective data can be obtained, but the correlation with M/C/T levels becomes inconsistent and unreliable

Engineering Contradiction:
Improveobjective measurement capabilityVSAvoidECAP threshold correlation consistency
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent changes the measurement parameters and methodology for ECAP acquisition and analysis. It employs specific stimulation protocols, multiple measurement levels, and advanced signal processing techniques to extract reliable M/C/T level correlations from ECAP data. By optimizing these parameters, the system achieves consistent and reliable correlation between ECAP thresholds and perceptual levels.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The system implements feedback mechanisms where ECAP measurement results are continuously refined and correlated with behavioral responses. The measured ECAP data feeds into an algorithm that adjusts and optimizes the correlation model, creating a closed-loop system that improves reliability through iterative refinement of the ECAP-M/C/T level relationship.

Inventive Principle:
Principle #23Feedback

3Measurement precision

If conventional behavior measurement is used for pediatric CI users, then M/C/T levels can be determined, but the process becomes extremely difficult due to communication limitations and inability to sit still

Engineering Contradiction:
ImproveM/C/T level determinationVSAvoidprogramming difficulty for pediatric patients
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent replaces the behavioral measurement mechanism with an electrical physiological measurement mechanism that does not require patient communication or cooperation. ECAP measurements capture objective neural responses directly through electrical stimulation and recording, eliminating the need for behavioral feedback that pediatric patients cannot provide reliably.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system performs self-programming by automatically measuring ECAP responses and determining M/C/T levels without requiring patient participation beyond passive stimulation. The system serves itself by using the patient's inherent physiological responses to program the implant, making the process as easy as applying the stimulation and recording the automatic neural response.

Inventive Principle:
Principle #25Self-service

4Adaptability or versatility

If multiple electrodes are programmed using behavior measurements, then comprehensive mapping can be achieved, but the overall mapping session time extends to 1.5-2 hours

Engineering Contradiction:
Improvecomprehensive electrode mapping coverageVSAvoidtotal mapping session duration
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

Solution Approach 1:

The patent segments the programming process into efficient stages: first acquiring ECAP measurements for all electrodes, then using automated algorithms to compute M/C/T levels for each electrode based on these measurements. This segmentation allows comprehensive mapping of multiple electrodes to be completed rapidly through parallel measurement and automated computation rather than sequential behavioral testing.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system maintains continuous useful action by automatically processing ECAP measurements and computing electrode parameters without interruption. The automated computation of M/C/T levels from ECAP data allows the programming process to flow continuously across multiple electrodes, eliminating the repeated start-stop nature of behavioral measurements and achieving comprehensive mapping in compressed time.

Inventive Principle:
Principle #20Continuity of useful action

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

This system significantly reduces the time required for cochlear implant mapping by automatically computing parameters for all electrode contacts, improving accuracy and efficiency, especially for pediatric patients, and allowing for remote programming.

Implementation Method 1

The sensor may be configured for sensing and determining a measured evoked compound action potential (ECAP) of the at least one stimulating electrode contact

Methodology Applied
Scientific EffectEvoked compound action potential (ECAP):

Data Source

PatentUS20240009455A1Implantable electrical stimulation (IES) system and a method thereof
Publication Date: 2024.01.11 CHOI CHARLES TAK MING
  • US20240009455A1 patent drawing
  • US20240009455A1 patent drawing
  • US20240009455A1 patent drawing

AI summary

An implantable electrical stimulation (IES) system and a method thereof, is disclosed. The implantable electrical stimulation (IES) system may comprise an implantable electrode array having a plurality of electrode contacts, an electrical stimulus means, a sensor and a processing circuitry. The electrical stimulus means may be configured for applying the electrical stimulus to at least one stimulating electrode contact of the implantable electrode array. The sensor may be configured for sensing and determining a measured ECAP of the at least one stimulating electrode to generate data for determining a plurality of parameters for the at least one stimulating electrode of the implantable electrode array. The processing circuitry may be configured for processing the measured ECAP and plurality of parameters of the at least one stimulating electrode of the implantable electrode array to compute the corresponding parameters for the remaining electrode contacts of the implantable electrode array.