Pinging-Pulse Sensing for ECAP Measurement in Burst SCS

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Conventional spinal cord stimulation (SCS) techniques face challenges in accurately measuring evoked compound action potentials (ECAPs) due to low signal strength and noise ratios, particularly in paresthesia-free stimulation methods like high-frequency and burst stimulation, which complicates the assessment and control of neural recruitment.

Innovation Solution

Implementing sensing signal stimulation techniques that utilize non-therapeutic pinging-pulses to evoke ECAPs without eliciting paresthesia, such as interleaved or postfixed configurations with pinging-pulses, allowing for reliable measurement and analysis of neural responses during paresthesia-free stimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If high-frequency stimulation (1500-10000 Hz) is used to provide paresthesia-free therapy, then patient comfort is improved by eliminating tingling sensations, but measurement precision of ECAPs deteriorates due to low signal strength and noise ratios

Engineering Contradiction:
Improveparesthesia (tingling sensation)VSAvoidECAP measurement precision
Core Design Contradiction:
Object-affected harmful factorsVSMeasurement precision

Solution Approach 1:

The stimulation train is segmented into individual pulses, with specific pulses (e.g., every 10th pulse) designated as sensing pulses for ECAP measurement. This segmentation allows ECAP measurement without requiring the entire stimulation train to be at high amplitude, thereby maintaining paresthesia-free therapy while enabling adequate signal measurement at selected intervals.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Instead of reducing the amplitude of all stimulation pulses (which would compromise therapeutic effectiveness), the invention applies partial action by selectively increasing the amplitude of only certain sensing pulses within the train. This partial excessive action on specific pulses provides sufficient ECAP signal strength for measurement while keeping the majority of pulses at therapeutic, paresthesia-free levels.

Inventive Principle:
Principle #16Partial or excessive action

2Measurement precision

If stimulation amplitude is increased to improve ECAP signal strength for measurement, then measurement precision improves, but patient comfort deteriorates by inducing paresthesia

Engineering Contradiction:
ImproveECAP signal strengthVSAvoidparesthesia (tingling sensation)
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The stimulation train is segmented into individual pulses, with specific pulses (e.g., every 10th pulse) designated as sensing pulses for ECAP measurement. This segmentation allows ECAP measurement without requiring the entire stimulation train to be at high amplitude, thereby maintaining paresthesia-free therapy while enabling adequate signal measurement at selected intervals.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different pulses within the stimulation train are assigned different qualities: sensing pulses have high amplitude optimized for ECAP measurement, while therapeutic pulses maintain lower amplitudes for paresthesia-free therapy. This local differentiation of pulse qualities allows simultaneous optimization of both measurement and therapeutic functions.

Inventive Principle:
Principle #3Local quality

3Reliability

If conventional ECAP measurement is attempted during paresthesia-free stimulation, then therapy effectiveness can be monitored, but measurement precision deteriorates due to low signal-to-noise ratio

Engineering Contradiction:
Improvetherapy assessment capabilityVSAvoidsignal-to-noise ratio
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The system performs preliminary action by pre-configuring specific pulses within the stimulation train as sensing pulses with elevated amplitude. This preliminary preparation ensures that when ECAP measurement is needed, adequate signal strength is already present in the predetermined sensing pulses, eliminating the need for post-hoc amplitude adjustments and ensuring reliable measurement capability is built into the therapy delivery itself.

Inventive Principle:
Principle #10Preliminary action

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

Enables accurate assessment and control of neural recruitment in paresthesia-free spinal cord stimulation by reliably eliciting ECAPs, maintaining the comfort level for patients and ensuring effective pain management without inducing tingling sensations.

Implementation Method 1

an implantable pulse generator is provided that delivers electrical sensing signals to tissue

Methodology Applied
Scientific EffectElectrical stimulation: Electrical Impedance Tomography

Implementation Method 2

measuring an evoked neural response in the patient in response to the sensing signals

Methodology Applied
Scientific EffectAction potential generation:

Data Source

PatentEP4326390B1Systems facilitating sensing responsive signals in association with paresthesia-free stimulation
Publication Date: 2026.03.25 ADVANCED NEUROMODULATION SYSTEMS INC
  • EP4326390B1 patent drawingFigure 1A
  • EP4326390B1 patent drawingFigure 1B
  • EP4326390B1 patent drawingFigure 1C

AI summary

Systems and methods which provide for and enable sensing responsive signals with respect to the application of paresthesia-free stimulation are described. Sensing signal initiators may be utilized comprising one or more non-therapeutic and/or non-tonic pulses in the form of pinging-pulses configured for invoking responsive signals suitable for measurement and/or analysis in association with the application of neural stimuli. A sensing signal initiator technique may provide an interleaved implementation to introduce one or more pinging-pulses between burst groups of a burst stimulation regimen. Additionally or alternatively, a sensing signal initiator technique may provide a postfixed implementation to introduce one or more pinging-pulses by modifying a therapeutic stimulation burst so that the last phase of the passive discharge is replaced with pinging-pulse providing an active discharge.