Closed-Loop Spinal Cord Stimulation for Evoked Response Avoidance

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Solution Overview

Problem

Conventional sub-perception Spinal Cord Stimulation (SCS) therapies face prolonged wash-in time, high power consumption, and complex optimization processes, with existing systems struggling to effectively and efficiently detect and maintain small evoked neural activities below detection thresholds.

Innovation Solution

A closed-loop control system for electrostimulation that adjusts stimulation parameters in response to detected evoked neural activities, using a feedback mechanism to maintain these activities at or below a specified threshold, thereby optimizing power usage and therapeutic efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional sub-perception SCS uses higher-frequency pulses to achieve paresthesia-free effect, then analgesia effect is achieved, but power consumption increases and battery life shortens

Engineering Contradiction:

Improveanalgesia effectVSAvoidpower consumption

Core Design Contradiction:

ReliabilityVSUse of energy by moving object

Solution Approach 1:

The system dynamically adjusts stimulation parameters including frequency, amplitude, and pulse width based on real-time feedback from evoked neural activity detection. This allows the system to maintain effective analgesia while optimizing power consumption by reducing stimulation intensity when sufficient pain relief is achieved without paresthesia.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The closed-loop system continuously detects evoked neural activities and uses this feedback to adjust stimulation parameters. This feedback mechanism enables the system to maintain minimal effective stimulation levels, avoiding excessive power consumption while ensuring reliable analgesia effect.

Inventive Principle:

Principle #23Feedback

2Reliability

If conventional sub-perception SCS uses higher-frequency pulses, then paresthesia-free analgesia is achieved, but wash-in time is prolonged

Engineering Contradiction:

Improveanalgesia effectVSAvoidwash-in time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The system performs preliminary detection of evoked neural activities before full therapy activation. This preliminary action allows the system to pre-optimize stimulation parameters and establish effective therapy settings before formal treatment begins, reducing the wash-in period.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

Real-time feedback from evoked neural activity detection during the initial phase allows rapid adjustment of stimulation parameters to achieve effective analgesia faster, significantly reducing wash-in time from hours/days to minutes.

Inventive Principle:

Principle #23Feedback

3Reliability

If conventional sub-perception SCS is used, then pain relief is achieved, but therapy optimization becomes complex and onerous

Engineering Contradiction:

Improvepain reliefVSAvoidtherapy optimization process

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The system performs self-optimization by automatically detecting evoked neural activities and adjusting stimulation parameters without requiring extensive manual programming or clinician intervention. This self-service capability simplifies the therapy optimization process while maintaining effective pain relief.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The closed-loop feedback system automatically monitors evoked neural activities and adjusts stimulation parameters in real-time, eliminating the need for complex manual optimization procedures and reducing the burden on clinicians and patients.

Inventive Principle:

Principle #23Feedback

4Use of energy by moving object

If the system detects small evoked neural activities below detection thresholds, then power consumption can be reduced, but detection precision is challenging

Engineering Contradiction:

Improvepower consumptionVSAvoidevoked neural activity detection

Core Design Contradiction:

Use of energy by moving objectVSMeasurement precision

Solution Approach 1:

The system uses feedback from evoked neural activity detection to adjust stimulation parameters, creating a closed-loop control that maintains stimulation at minimal effective levels, thereby reducing power consumption while ensuring therapeutic efficacy.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The system changes detection parameters such as averaging window size, filtering settings, and threshold levels to optimize detection of small evoked neural activities. These parameter adjustments enhance measurement precision for detecting sub-threshold neural responses.

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS20260041916A1Closed loop stimulation based on response avoidance

Publication Date: 2026.02.12 BOSTON SCI NEUROMODULATION CORP

AI summary

Systems and methods for closed-loop control of electrostimulation while avoiding, or maintaining a substantially low level of, evoked neural activity are disclosed. A system comprises an electrostimulator to deliver a stimulation pulse train, a sensing circuit to sense evoked responses to respective pulses in the pulse train, and a controller to detect an evoked neural activity from an averaged evoked response by averaging evoked responses to respective pulses. The averaging operation can be controlled by a noise level of the averaged evoked response, or by a count of epochs (pulses) being used for averaging. Responsive to the evoked neural activity satisfying a detection criterion, the controller recursively adjusts stimulation parameters until the detection criterion is no longer satisfied. The electrostimulator delivers electrostimulation according to the recursively adjusted stimulation parameters.