Stimulation Configuration Variation to Control Evoked Temporal Patterns

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Solution Overview

Problem

Existing spinal cord stimulation (SCS) therapies often cause paresthesia, a tingling sensation, and achieving effective pain relief without paresthesia (sub-perception therapy) is challenging due to difficulty in selecting optimal electrode combinations and requires longer wash-in periods, which can be inconvenient for patients.

Innovation Solution

A method for programming implantable medical devices (IMDs) using varying inter-phase intervals (IPIs) in biphasic pulses, combined with neural modeling and patient feedback, to determine an optimal stimulation program that provides effective pain relief without paresthesia, utilizing graphical user interfaces (GUIs) for selection and adjustment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional SCS therapies are used, then pain relief can be achieved, but paresthesia (tingling sensation) occurs

Engineering Contradiction:

Improvepain relief effectivenessVSAvoidparesthesia sensation

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by systematically varying multiple stimulation parameters including inter-phase interval (IPI) from 10-500 microseconds, pulse width from 100-500 microseconds, frequency from 100-200 Hz, and amplitude to achieve sub-perception thresholds. These parameter optimizations enable pain relief while minimizing or eliminating paresthesia by precisely tuning the stimulation to activate pain-modulating pathways without triggering sensory paresthesia

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent implements dynamics through adaptive stimulation where parameters are continuously adjusted based on patient feedback and wash-in period progression. The system transitions from initial higher amplitude stimulation to gradually reduced amplitudes as the wash-in period progresses, allowing the nervous system to adapt and maintain pain relief with minimal or no paresthesia over time

Inventive Principle:

Principle #15Dynamics

2Object-affected harmful factors

If optimal electrode combinations are selected to achieve sub-perception therapy, then paresthesia can be reduced, but the programming process becomes more complex and time-consuming

Engineering Contradiction:

Improveparesthesia reductionVSAvoidprogramming complexity

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent applies self-service through automated programming algorithms that systematically evaluate different electrode combinations and parameter sets. The system automatically identifies optimal configurations for sub-perception therapy by testing various IPI, pulse width, and frequency combinations, eliminating the need for manual trial-and-error programming while achieving personalized optimal settings

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The patent implements feedback mechanisms where patient responses to different stimulation parameters are collected and used to refine the programming. The system adjusts electrode combinations and parameters based on real-time patient feedback regarding sensation and comfort, automatically converging on optimal sub-perception settings without requiring extensive manual intervention

Inventive Principle:

Principle #23Feedback

3Object-affected harmful factors

If sub-perception therapy is implemented, then paresthesia is minimized, but longer wash-in periods are required for the therapy to become effective

Engineering Contradiction:

Improveparesthesia minimizationVSAvoidwash-in period duration

Core Design Contradiction:

Object-affected harmful factorsVSLoss of time

Solution Approach 1:

The patent applies preliminary action by initiating stimulation at higher amplitudes during the initial phase to quickly establish therapeutic effect, then systematically reducing amplitude as the wash-in period progresses. This approach allows the nervous system to begin adapting immediately while maintaining effective pain relief from the start, rather than waiting for gradual adaptation at low amplitudes

Inventive Principle:

Principle #10Preliminary action

4Reliability

If multiple stimulation parameters are optimized, then therapy effectiveness is improved, but battery consumption increases

Engineering Contradiction:

Improvetherapy effectivenessVSAvoidbattery drain

Core Design Contradiction:

ReliabilityVSLoss of energy

Solution Approach 1:

The patent applies partial action by using moderate stimulation amplitudes that are sufficient to achieve pain relief through sub-perception mechanisms without excessive power consumption. The optimized parameter combinations (specific IPI, pulse width, and frequency ranges) achieve therapeutic effect at lower energy levels compared to traditional high-amplitude paresthesia-based therapy, reducing battery drain while maintaining effectiveness

Inventive Principle:

Principle #16Partial or excessive action

Data Source

PatentUS20250262439A1Stimulation Configuration Variation to Control Evoked Temporal Patterns

Publication Date: 2025.08.21 BOSTON SCI NEUROMODULATION CORP

AI summary

Methods and systems for programming stimulation parameters for an implantable medical device for neuromodulation, such as spinal cord stimulation (SCS) are disclosed. The stimulation parameters define user-configured waveforms having at least a first phase having a first polarity and a second phase having a second polarity, wherein the first and second phases are separated by an interphase interval (IPI). By delivering user-configured waveforms with different IPIs, stimulation geometry, and other waveform settings, therapeutic asynchronous activation of dorsal column fibers can be obtained.