Implantable Device eCAP Threshold Search for Remote Programming

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Solution Overview

Problem

Current remote programming methods for implantable medical devices, such as spinal cord stimulation, often result in uncomfortable sensations for patients due to inaccurate titration of stimulation parameters, and rely on patient feedback or pre-defined settings, which can be limiting and prone to errors.

Innovation Solution

A method involving an evoked compound action potential (eCAP) threshold search to determine a coupling factor between electrodes and neural tissue, allowing for the generation of personalized stimulation parameters that minimize discomfort and avoid pre-defined parameter limitations, using test stimulation pulses and remote data connections for iterative adjustments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If remote programming is performed using pre-defined settings or patient feedback, then the programming can be done remotely without travel requirements, but the stimulation parameters may be inaccurate leading to uncomfortable sensations

Engineering Contradiction:

Improveremote programming capabilityVSAvoidstimulation parameter accuracy

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent implements a closed-loop feedback system where eCAP signals are continuously monitored during remote programming. The system automatically adjusts stimulation parameters based on the detected eCAP threshold, ensuring accurate titration without requiring patient feedback or travel to clinical facilities. This resolves the contradiction by providing both remote operation capability and precise parameter measurement through objective physiological feedback.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The system performs self-adjustment of stimulation parameters by automatically detecting eCAP thresholds and calculating appropriate stimulation levels. The implantable device autonomously titrates parameters based on real-time eCAP monitoring, eliminating the need for patient feedback or clinician intervention during remote programming sessions while maintaining high precision.

Inventive Principle:

Principle #25Self-service

2Adaptability or versatility

If patient feedback is used for parameter adjustment, then personalized therapy can be achieved, but the process becomes time-consuming and requires patient cognitive participation

Engineering Contradiction:

Improvepersonalized therapyVSAvoidprogramming time

Core Design Contradiction:

Adaptability or versatilityVSLoss of time

Solution Approach 1:

The patent replaces the subjective patient feedback mechanism with an objective eCAP detection system. The implantable device automatically measures eCAP signals to determine stimulation thresholds and calculates personalized parameters without requiring patient cognitive participation or time-consuming feedback loops. This achieves both personalized therapy and time efficiency by substituting mechanical/physiological measurement for subjective patient reporting.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If stimulation parameters are increased to overcome neural habituation or lead migration, then therapy effectiveness may be maintained, but uncomfortable sensations and side effects increase

Engineering Contradiction:

Improvetherapy effectivenessVSAvoiduncomfortable sensations

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent uses eCAP threshold detection to dynamically adjust stimulation parameters based on actual neural coupling conditions. By continuously monitoring eCAP signals, the system identifies the minimum effective stimulation level required to achieve therapeutic effect, avoiding unnecessary parameter increases that would cause discomfort. This resolves the contradiction by maintaining therapy effectiveness through precise parameter optimization rather than brute-force parameter increases.

Inventive Principle:

Principle #35Parameter changes

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 approach enables safe, rapid, and accurate remote programming of implantable medical devices, reducing the risk of uncomfortable sensations and improving therapy outcomes by leveraging direct physiological feedback and patient-specific parameter adjustments.

Implementation Method 1

performing, by means of the implantable medical device, an evoked compound action potential (eCAP) threshold search by stimulating the neural tissue with test stimulation pulses

Methodology Applied

Scientific EffectEvoked compound action potential (eCAP):

Data Source

PatentUS11806538B2Method for programming an implantable medical device and system for configuring stimulation parameters of an implantable medical device

Publication Date: 2023.11.07 BIOTRONIK SE & CO KG

AI summary

A method programs an implantable medical device to configure the implantable medical device for stimulating neural tissue by at least one electrode. The method includes: performing, by the implantable medical device, an evoked compound action potential (eCAP) threshold search by stimulating the neural tissue with test stimulation pulses; determining, based on the eCAP threshold search, an eCAP threshold amplitude and a coupling factor that is indicative of a coupling between the at least one electrode and the neural tissue; and generating a first set of stimulation parameters containing at least a stimulation amplitude that is determined in dependence on the eCAP threshold amplitude and the coupling factor.