Spinal Cord Stimulation Waveforms for Paresthesia-Free Analgesia

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Solution Overview

Problem

Current spinal cord stimulation therapies often induce paresthesia, a subjective sensation of numbness or tingling, which can be undesirable for patients, and there is a need for methods and systems to manage neuromodulation therapy that produces paresthesia-free analgesia for treating chronic neuropathic pain.

Innovation Solution

A computer-implemented method and system that delivers a series of candidate stimulation waveforms with varied intensities to electrodes near nervous tissue, identifying waveforms that induce a paresthesia-abatement effect while maintaining analgesic effects, by blocking large A-beta fibers and activating medium A-beta fibers, using high frequency or burst stimulation waveforms, and sensing evoked compound action potential signals to set optimal therapy parameters.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional tonic spinal cord stimulation therapy is delivered to evoke paresthesia covering painful areas, then analgesic effect is achieved, but paresthesia sensation occurs which is undesirable for patients

Engineering Contradiction:

Improveanalgesic effectVSAvoidparesthesia sensation

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by transitioning from traditional low-frequency tonic stimulation to high-frequency stimulation (e.g., 10 kHz or above) with specific pulse widths and amplitudes. This parameter change enables activation of medium A-beta fibers for analgesia while blocking large A-beta fibers that cause paresthesia, thus resolving the contradiction between achieving pain relief and avoiding unwanted sensations

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent segments the A-beta fiber population into large A-beta fibers (which cause paresthesia) and medium A-beta fibers (which provide analgesia). By selectively targeting medium fibers through specific stimulation parameters while blocking large fibers, the treatment achieves analgesia without paresthesia. This segmentation allows differential control of nerve fiber responses

Inventive Principle:

Principle #1Segmentation

2Object-affected harmful factors

If high frequency stimulation waveforms are used to block large A-beta fibers and activate medium A-beta fibers, then paresthesia-free analgesia is achieved, but stimulation intensity must be precisely controlled

Engineering Contradiction:

Improveparesthesia-free analgesiaVSAvoidstimulation intensity control

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent incorporates feedback mechanisms where stimulation parameters are adjusted based on patient response and physiological monitoring. The system monitors the effects of high-frequency stimulation and modifies amplitude, pulse width, or frequency to maintain optimal blocking of large A-beta fibers while activating medium A-beta fibers, ensuring precise control despite the complexity of differential fiber activation

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The patent employs dynamic adjustment of stimulation parameters during treatment. Rather than fixed parameters, the system continuously adapts stimulation intensity, frequency, and pulse width based on real-time physiological feedback and patient comfort, enabling precise control over the complex process of selective fiber activation and blocking

Inventive Principle:

Principle #15Dynamics

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The solution effectively blocks large A-beta fibers that cause paresthesia and activates medium A-beta fibers for analgesia, providing paresthesia-free analgesia by adjusting stimulation intensities and waveforms, thereby improving pain management for patients with chronic neuropathic pain.

Implementation Method 1

The first candidate stimulation waveform exhibits a stimulation intensity that blocks large A-beta fibers that would otherwise induce paresthesia and activates medium A-beta fibers that would otherwise induce analgesia

Methodology Applied

Scientific EffectNerve fiber activation and blocking:

Data Source

PatentUS20230201592A1System and method to managing stimulation of select a-beta fiber components

Publication Date: 2023.06.29 PACESETTER INC

AI summary

A computer implemented method and system is provided for managing neural stimulation therapy. The method comprises under control of one or more processors configured with program instructions. The method delivers a series of candidate stimulation waveforms having varied stimulation intensities to at least one electrode located proximate to nervous tissue of interest. A parameter defines the candidate stimulation waveforms is changed to vary the stimulation intensity. The method identifies a first candidate stimulation waveform that induces a paresthesia-abatement effect, while continuing to induce a select analgesic effect. The method further identifies a second candidate stimulation waveform that does not induce the select analgesic effect. The method sets a stimulation therapy based on the first and second candidate stimulation waveforms.