Autonomic Feedback for Spinal Cord Stimulation Dosing

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Solution Overview

Problem

Current spinal cord stimulation (SCS) systems lack effective tools for managing dosing, relying heavily on patient discretion and limited sensing capabilities, which can lead to overregulation or under-regulation of therapy.

Innovation Solution

An implantable medical device system that includes a lead for spinal column placement, sensing circuitry to monitor autonomic function metrics, and control circuitry to adjust stimulation parameters based on sensed data, thereby reducing the risk of overregulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If patient discretion is used to manage SCS dosing with a remote control, then ease of operation is improved, but reliability of dosing management deteriorates due to lack of objective feedback

Engineering Contradiction:

Improvepatient controlVSAvoiddosing management

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The system implements closed-loop feedback by continuously monitoring autonomic function metrics (heart rate, blood pressure, respiration) and using this information to automatically adjust stimulation dosing. This objective physiological feedback replaces subjective patient discretion, improving dosing reliability while maintaining ease of operation through automated control.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The system enables self-service dosing management by allowing the implanted device to automatically adjust stimulation parameters based on real-time autonomic function monitoring. The system serves itself by autonomously titrating dosing without requiring patient intervention, thereby improving reliability while maintaining ease of operation.

Inventive Principle:

Principle #25Self-service

2Device complexity

If limited sensing capabilities are used for SCS monitoring, then device complexity is reduced, but measurement precision deteriorates insufficiently for effective dosing management

Engineering Contradiction:

Improvesensing capabilityVSAvoidautonomic function monitoring

Core Design Contradiction:

Device complexityVSMeasurement precision

Solution Approach 1:

The system applies multi-functionality by using the existing pulse generator and lead infrastructure to perform both stimulation delivery and autonomic function monitoring. By repurposing available hardware components for dual functions, the system achieves precise multi-parameter monitoring without proportionally increasing device complexity.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS20250152944A1Systems and methods to titrate SCS dosing through autonomic measures

Publication Date: 2025.05.15 BOSTON SCI NEUROMODULATION CORP

AI summary

Methods and systems for delivering a therapy and observing one or more metrics of autonomic function. Spinal cord stimulation may be initiated, and patient response monitored using one or more metrics of autonomic function, including heart rate, heart rate variability, or other markers. Therapy intensity may be increased or decreased, or therapy may be changed to use a different program, or therapy may be ceased, depending on changes in the observed metrics of autonomic function.