Neuromodulation System Using Stored Relationships for Patient-Specific Stimulation

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Solution Overview

Problem

Current neurostimulation systems lack the ability to customize stimulation configurations effectively for individual patients, leading to reduced efficacy and increased side effects due to predetermined settings at manufacturing, rather than patient-specific needs.

Innovation Solution

A system and method that utilize a programming control circuit, storage device, and user interface to program neurostimulation through electrodes, using neuromodulation relationships to determine optimal waveform and electrode configurations based on specific neural targets, allowing for customization and real-time adjustments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If predetermined stimulation configurations are used at manufacturing, then device complexity is reduced and ease of manufacture is improved, but adaptability to individual patient needs deteriorates and efficacy is reduced

Engineering Contradiction:
Improveease of manufactureVSAvoidadaptability
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The system pre-calculates and stores multiple stimulation configurations and their corresponding neural targets in a database during manufacturing. This preliminary action allows the device to provide customized therapy without requiring complex real-time calculations, thus maintaining ease of manufacture while enabling high adaptability to individual patient needs.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system enables dynamic adjustment of stimulation parameters (amplitude, pulse width, frequency, electrode configuration) based on patient-specific anatomical and physiological data. By allowing flexible parameter changes, the system achieves high adaptability while maintaining a relatively simple device architecture through standardized hardware design.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If customized stimulation configurations are implemented for each patient, then efficacy and reduction of side effects are improved, but device complexity and programming difficulty increase

Engineering Contradiction:
ImproveefficacyVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system introduces an external programming device as an intermediary that handles complex configuration tasks. The implantable neurostimulator maintains simple hardware, while the external device performs sophisticated calculations, stores configurations in a database, and communicates programming instructions to the implantable device, thus achieving high efficacy without significantly increasing implantable device complexity.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system creates standardized configuration templates and parameter sets that can be copied and adapted for different patients. Instead of requiring unique complex programming for each patient, clinicians can select from pre-defined templates and modify parameters as needed, reducing programming complexity while maintaining customized efficacy.

Inventive Principle:
Principle #26Copying

3Reliability

If sophisticated neurostimulation configurations are generated, then therapy efficacy is improved, but programming time and loss of time increase

Engineering Contradiction:
ImproveefficacyVSAvoidprogramming time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system pre-calculates optimal stimulation configurations and stores them in a database during manufacturing or initial setup. When a patient requires therapy, the system quickly retrieves and applies pre-configured parameters based on patient-specific data, dramatically reducing programming time while maintaining sophisticated, effective stimulation configurations.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system enables automatic configuration selection and parameter optimization with minimal clinician intervention. By implementing automated algorithms that can independently select appropriate stimulation parameters based on stored patient data and pre-configured protocols, the system reduces the time clinicians spend on manual programming while ensuring effective therapy delivery.

Inventive Principle:
Principle #25Self-service

Data Source

PatentEP3648832B1System for selecting stimulation configuration and target for neuromodulation
Publication Date: 2021.11.24 BOSTON SCI NEUROMODULATION CORP
  • EP3648832B1 patent drawingFigure 1~2
  • EP3648832B1 patent drawingFigure 3~4
  • EP3648832B1 patent drawingFigure 5

AI summary

An example of a system for delivering neurostimulation may include a programming control circuit, a storage device, and a user interface. The programming control circuit may be configured to program a stimulation device for delivering the neurostimulation according to a stimulation configuration specified by a waveform parameter set and an electrode parameter set. The storage device may be configured to store one or more neuromodulation relationships each relating one or more candidate stimulation configurations to one or more neural targets each specified by a target parameter set The user interface may include modulation control circuitry configured to determine the stimulation configuration for programming the stimulation device using a stored neuromodulation relationship. The modulation control circuitry may be configured to obtain two parameter sets of the waveform parameter set, the electrode parameter set, and the target parameter set and to determine the other parameter set.