Adaptive Neurostimulation Pattern for Efficacy Maintenance
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Solution Overview
Problem
Current neurostimulation systems face challenges in maintaining efficacy over time, as the prescribed therapy regimen may not stabilize for periods of days or weeks, and the benefits for patients can diminish, necessitating a method to dynamically adjust the pattern of stimulation.
Innovation Solution
The system employs a combination of hardware and software to deliver electrical neurostimulation using implantable pulse generators and leads with segmented electrodes, allowing for precise control of stimulation patterns, including changes in electrode combinations, energy distribution, and timing, based on real-time feedback from biomarker signals to adapt the therapy regimen.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If periodic pulses with uniform waveforms are delivered continuously or in bursts, then the neurostimulation system is simple to operate and program, but the efficacy of the delivered pattern decreases with time
Solution Approach 1:
The patent implements dynamic neurostimulation by varying multiple parameters (amplitude, pulse width, frequency, electrode configuration) over time according to predetermined patterns. The system transitions between different stimulation configurations within a therapy session, allowing the stimulation pattern to adapt dynamically to maintain efficacy without requiring manual reprogramming or complex decision-making by the user.
Solution Approach 2:
The system employs periodic variation of stimulation parameters where different waveform patterns are delivered in alternating intervals. This includes switching between monophasic and biphasic waveforms, varying pulse frequencies in a periodic manner, and cycling through different electrode configurations to prevent tolerance development and maintain therapeutic effectiveness over time.
2Reliability
If the neurostimulation pattern is changed to maintain efficacy, then the therapeutic effectiveness is improved, but the system complexity increases
Solution Approach 1:
The system incorporates predetermined stimulation patterns and parameter variations that are programmed in advance. Multiple therapy programs with different parameter configurations are pre-established, allowing the system to automatically transition between them according to a schedule or based on simple sensors, eliminating the need for complex real-time decision-making algorithms while maintaining therapeutic effectiveness.
Solution Approach 2:
The patent systematically varies multiple stimulation parameters including amplitude, pulse width, frequency, and electrode configuration to optimize therapeutic effectiveness. By coordinating changes across multiple parameters simultaneously, the system achieves enhanced efficacy while managing complexity through integrated control of all parameters within a unified therapy program framework.
3Ease of manufacture
If uniform waveforms are used for neurostimulation, then the device is easier to manufacture and program, but the stimulation lacks the temporal patterning needed for optimal neural modulation
Solution Approach 1:
The stimulation waveform is segmented into distinct phases including charge injection, stimulation, and recovery periods. Each phase can be independently controlled with different parameters, allowing complex temporal patterns to be constructed from simpler modular components. This segmentation enables versatile waveform shaping while maintaining manageable programming through standardized phase definitions.
Solution Approach 2:
The system dynamically adjusts waveform characteristics including switching between monophasic and biphasic configurations, varying pulse durations, and modulating frequency over time. These dynamic changes are implemented through coordinated control of stimulation parameters within predetermined patterns, providing temporal patterning capability while keeping the programming interface manageable through preset program selections.
Data Source
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AI summary
This document discusses a medical device for coupling to a plurality of implantable electrodes. The medical device includes a therapy circuit, a biomarker sensing circuit, and a control circuit operatively coupled to the therapy circuit and biomarker sensing circuit. The therapy circuit delivers electrical neurostimulation energy to the plurality of implantable electrodes. The biomarker sensing circuit generates a sensed biomarker signal representative of a physiological biomarker of a subject. The control circuit initiates delivery of bursts of pulses of the electrical neurostimulation energy to the plurality of the implantable electrodes according to a first therapy regimen and monitor efficacy of the delivered electrical neurostimulation energy using the sensed biomarker signal; and changes the electrical neurostimulation to a second therapy regimen upon detecting a reduction in the efficacy of the first therapy regimen using the sensed biomarker signal.