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
Engineering 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
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.
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.
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
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.
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.
3Reliability
If sophisticated neurostimulation configurations are generated, then therapy efficacy is improved, but programming time and loss of time increase
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.
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.
Data Source
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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.