IPG Noise Waveform Randomization Without Extra Memory
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Solution Overview
Problem
Implantable pulse generators (IPGs) in neurostimulation systems have limited randomization capabilities, making it difficult to generate truly random noise stimulation waveforms, which can lead to habituation and reduced efficacy over time, and require additional memory storage for longer stimulation patterns.
Innovation Solution
A method where an external device generates a noise pulse pattern with defined parameters, and the IPG applies randomization operations such as random starting index, reverse play direction, and electrode polarity reversal to enhance the randomization effect while maintaining a similar power spectral density (PSD), without expanding memory storage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the IPG stores longer noise pulse patterns to maintain therapeutic efficacy over time, then the randomization effect is improved, but the memory storage capacity is exceeded
Solution Approach 1:
The patent divides the long noise pulse pattern into multiple shorter segments that can be stored within the IPG's memory capacity. These segments are then played sequentially with randomization applied at the segment level, including random starting indices and reverse play directions. This segmentation allows the system to maintain long-duration therapeutic efficacy while staying within memory constraints.
Solution Approach 2:
The patent introduces dynamic randomization operations that are applied during playback rather than requiring static storage of extremely long patterns. The random starting index selection and reverse play direction capabilities create dynamic variability from a finite set of stored segments, effectively generating near-infinite pattern variations without proportionally increasing memory requirements.
2Reliability
If the IPG applies multiple randomization operations to enhance noise waveform randomization, then habituation is reduced, but the device complexity increases
Solution Approach 1:
The patent combines multiple randomization operations (random starting index selection, reverse play direction, and electrode polarity reversal) into a unified control framework. These operations work together synergistically to maximize habituation resistance while sharing common computational resources and control logic within the IPG, thereby reducing overall device complexity compared to implementing each operation independently.
Solution Approach 2:
The patent implements self-service mechanisms where the IPG autonomously applies randomization operations without requiring external intervention. The device automatically selects random starting indices, determines play directions, and reverses electrode polarities based on pre-programmed algorithms, reducing the need for complex external control systems and minimizing overall system complexity.
3Reliability
If the noise pulse pattern is played in reverse direction to enhance randomization, then the randomization effect is improved, but the power spectral density changes
Solution Approach 1:
The patent employs periodic alternation between forward and reverse play directions of the noise pulse pattern segments. By systematically varying the play direction in a controlled periodic manner combined with random selection, the system maintains the essential power spectral density characteristics while achieving enhanced randomization. The periodic structure ensures that the overall frequency content remains consistent with therapeutic requirements.
Data Source
AI summary
In some embodiments, a method of providing a neurostimulation therapy to a patient, comprises: generating a noise pulse pattern defining a pulse train of pulses to be generated according to a noise profile in an external device; communicated the generated noise pulse pattern to an implantable pulse generator (IPG) of a patient; generating, by the IPG, a series of pulses in sequence for noise stimulation of the patient using the noise pulse pattern from the external device, wherein the IPG applies one or more randomization operations to the pulse pattern from the external device without expanding memory storage for the pulse pattern while maintaining the noise profile of the pulse pattern from the external device; and applying the series of pulses in sequence to neural tissue of the patient using one or more electrodes of one or more stimulation leads.