Pinging-Pulse Sensing for ECAP Measurement in Burst SCS
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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
Engineering 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
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.
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.
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
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.
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.
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
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.
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
Implementation Method 2
measuring an evoked neural response in the patient in response to the sensing signals
Data Source
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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.