Patient-Specific Neurostimulation Optimization Using Baseline and Implant Data

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Solution Overview

Problem

Existing medical devices for electrical nerve stimulation, such as those used for urinary incontinence, face challenges in determining optimal therapy settings due to patient variability and the need for customized treatment, leading to inefficiencies and increased power consumption.

Innovation Solution

A system and method for determining personalized neurostimulation therapy settings using patient-specific and population-informed information, integrating data from implantable and external devices with cloud computing to optimize stimulation program settings over time.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional trial-and-error method is used to determine stimulation settings, then therapeutic effectiveness may be achieved, but time consumption and number of office visits increase

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidtime to find therapeutic settings
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system performs preliminary actions by collecting patient-specific information (demographics, medical history, anatomy) and population-informed information (aggregate data from similar patients) before actual therapy delivery. This pre-processing of data enables the algorithm to generate optimized stimulation settings in advance, eliminating the need for multiple trial-and-error office visits and significantly reducing the time to achieve therapeutic effectiveness.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system creates a digital model or copy of the patient's physiological characteristics by processing their specific information and population data. This digital twin allows the optimization algorithm to simulate and determine effective stimulation settings virtually before applying them to the actual patient, thereby reducing the need for repeated physical adjustments during office visits.

Inventive Principle:
Principle #26Copying

2Adaptability or versatility

If customized stimulation settings are determined through multiple office visits, then patient-specific therapy is achieved, but device complexity and resource requirements increase

Engineering Contradiction:
Improvepatient-specific customizationVSAvoidsystem complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The system enables self-service by implementing an automated optimization algorithm that processes patient information and population data to determine personalized stimulation settings without requiring extensive manual intervention from healthcare providers. The algorithm autonomously analyzes the data, generates optimized settings, and can be implemented through a processor in the medical device itself, reducing the need for complex external programming systems and multiple adjustment visits.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system achieves patient-specific customization by dynamically changing stimulation parameters (amplitude, pulse width, frequency, electrode configuration) based on the optimization algorithm's analysis of patient-specific and population data. Rather than requiring a complex system to manually adjust each parameter through multiple visits, the algorithm simultaneously optimizes all parameters based on processed information, simplifying the overall system architecture while maintaining high adaptability.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If continuous stimulation is provided, then therapeutic effect is maintained, but power consumption increases

Engineering Contradiction:
Improvetherapeutic effect maintenanceVSAvoidpower consumption
Core Design Contradiction:
ReliabilityVSUse of energy by moving object

Solution Approach 1:

The optimization algorithm determines optimized stimulation settings that can be delivered in periodic or intermittent fashion rather than continuous stimulation. By analyzing patient-specific response patterns and population data, the system identifies optimal timing and duration for stimulation episodes, maintaining therapeutic effectiveness while reducing overall power consumption of the implantable device.

Inventive Principle:
Principle #19Periodic action

Data Source

PatentEP4135834B1Patient specific optimization algorithm
Publication Date: 2025.07.09 MEDTRONIC INC
  • EP4135834B1 patent drawingFigure 1
  • EP4135834B1 patent drawingFigure 2A
  • EP4135834B1 patent drawingFigure 2B

AI summary

A system may receive first information relating to a patient captured during a baseline period that is prior to the patient receiving stimulation. The system may receive second information relating to the patient captured during an initial therapy assignment. The second information may include testing data generated by delivering stimulation during an implant procedure. The system may determine initial stimulation program settings based on the first information, the second information and population-informed information. The population-informed information may be related to other patients. The system may cause, during a training period, delivery of therapy based on the initial stimulation program settings.