External Noise Pulse Patterns for Memory-Limited Neurostimulation
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Solution Overview
Problem
Implantable pulse generators (IPGs) have limited randomization capability, making it difficult to generate truly random noise waveforms for neurostimulation, 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, which is communicated to the IPG, 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 requirement increases
Solution Approach 1:
The patent divides the noise pulse pattern into multiple segments or windows that can be stored individually in limited memory. Instead of storing one long continuous pattern, the system stores multiple shorter segments that can be sequentially accessed and combined, thereby maintaining long-duration randomization capability without requiring proportionally large memory storage capacity.
Solution Approach 2:
The system pre-generates and stores multiple random noise pulse pattern segments in advance within the IPG's limited memory. These pre-computed segments are then reused and recombined over time to maintain therapeutic efficacy without needing to generate new patterns continuously, reducing the need for large memory storage or continuous external communication.
2Reliability
If the IPG applies more randomization operations to enhance noise waveform randomization, then habituation is reduced, but device complexity increases
Solution Approach 1:
The patent combines multiple randomization operations (such as amplitude modulation, frequency variation, and phase shifting) into a unified noise generation algorithm. By merging these operations into a single integrated process rather than implementing them as separate complex subsystems, the system achieves enhanced randomization effect while minimizing the increase in device complexity.
Solution Approach 2:
The IPG utilizes its existing internal resources (such as its clock, random number generator, and basic signal processing capabilities) to perform randomization operations on the stored noise pulse patterns. Rather than requiring additional dedicated hardware components for each randomization function, the system leverages its inherent computational resources to generate randomized waveforms, thereby reducing device complexity.
3Quantity of substance
If the external device generates and communicates noise pulse patterns to the IPG, then the IPG memory storage is reduced, but the communication and coordination complexity increases
Solution Approach 1:
The patent extracts the complex noise pulse pattern generation function from the IPG and relocates it to the external device. The external device generates the complete noise pulse patterns and communicates them to the IPG, which then simply stores and plays back the received patterns. This extraction of the generation function reduces the IPG's memory and computational requirements, while the external device handles the complexity of pattern generation.
Solution Approach 2:
The system introduces a standardized communication protocol and data format as an intermediary between the external device and IPG. This intermediary layer simplifies the communication process by defining clear rules for data exchange, allowing the external device to transmit complex noise pulse patterns without requiring complex real-time coordination or synchronization mechanisms between the two devices.
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.