Time-Varying Pulse Modulation for Spinal Cord Stimulator Optimization
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Solution Overview
Problem
Current implantable neurostimulator devices, such as spinal cord stimulation systems, face challenges in determining optimal time-varying stimulation pulses for individual patients, leading to variability in therapeutic effectiveness.
Innovation Solution
The method involves applying different modulation functions to time-invariant pulse parameters to create various time-varying pulse waveforms, which are then tested on patients to select the most effective waveform based on objective and subjective measurements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If time-invariant pulse parameters are used for stimulation, then the device complexity is reduced and energy consumption is minimized, but the therapeutic effectiveness varies and cannot be optimized for individual patients
Solution Approach 1:
The patent applies dynamics by transitioning from static, time-invariant pulse parameters to dynamic, time-varying pulse parameters. The system modulates stimulation parameters (amplitude, frequency, pulse width) over time based on patient responses and therapeutic goals, allowing the stimulation to adapt and optimize therapeutic effectiveness while managing complexity through structured modulation patterns.
Solution Approach 2:
The patent implements parameter changes by systematically varying pulse parameters (amplitude, frequency, pulse width) to create different time-varying stimulation patterns. The system tests multiple parameter combinations and selects optimal patterns based on patient responses, enabling personalized therapy optimization without requiring complete redesign of the device architecture.
2Reliability
If multiple time-varying pulse waveforms are tested to find optimal patterns, then therapeutic effectiveness is improved through personalization, but the time required for assessment and adjustment increases
Solution Approach 1:
The patent employs feedback mechanisms where patient responses to different time-varying pulse waveforms are continuously monitored and used to guide further assessment and adjustment. This feedback loop enables efficient identification of optimal stimulation patterns by leveraging patient responses to eliminate ineffective options, reducing the overall time required for personalized optimization.
Solution Approach 2:
The system performs preliminary testing of multiple pulse waveform patterns before finalizing the optimal stimulation program. By pre-assessing and ranking different time-varying patterns based on patient responses, the system prepares optimized parameters in advance, reducing the time needed for ongoing adjustment and allowing faster implementation of personalized therapy.
3Adaptability or versatility
If time-varying pulse waveforms are applied to adapt to individual patient responses, then personalized therapy is achieved, but energy consumption increases compared to fixed patterns
Solution Approach 1:
The patent utilizes periodic modulation patterns where time-varying pulse parameters are applied in cyclic sequences. This periodic action allows the system to achieve personalization through structured repetition, enabling the nervous system to adapt to rhythmic stimulation patterns while managing energy consumption through predictable, cyclic rather than continuously variable parameters.
Solution Approach 2:
The system implements parameter changes by modulating pulse characteristics (amplitude, frequency, pulse width) in controlled ways to create time-varying patterns. These parameter variations enable personalization by adapting to individual patient responses while maintaining energy efficiency through purposeful, rather than exhaustive, parameter exploration and optimization.
Data Source
AI summary
Methods, system, and computer-implementable algorithms are disclosed for determining time-varying pulses for a patient having an implantable stimulator device (ISD). At least one time-invariant tonic stimulation pulse parameter (e.g., amplitude, pulse width, or frequency) is modified by a modulation function to produce time-varying pulses (TVPs), and one or more measurements are taken to determine the effectiveness of the TVP. The measurements may be objective and taken from the patient, and/or subjective and determined based on feedback from the patient. In one example, objective measurements may comprise one or more features determined from an electrospinogram (ESG) signal detected by the ISD, which may include evoked compound action potentials. The one or more measurements are used to determine a score for the TVP, which is useful in selecting a best TVP for use with the patient, or for adjusting the modulation function applied to the tonic stimulation parameters.