Therapy Patterning System for Neurological Waveform Adaptability

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Solution Overview

Problem

Current neurological stimulation systems are limited by their ability to deliver only a few types of therapeutic waveforms, such as voltage or current controlled square waves, which restricts the flexibility in treating various neurological disorders effectively.

Innovation Solution

A system that allows for the programming of arbitrary therapy patterns and waveforms, using a therapy patterning and waveform selection system that includes a microcontroller, power units, and output controllers to deliver more complex and varied waveforms while ensuring charge balancing and safety rules are maintained.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If traditional voltage or current controlled square wave stimulation is used, then the system is simple to operate and manufacture, but the therapeutic flexibility and variety of treatment options are limited

Engineering Contradiction:
Improvetherapeutic flexibilityVSAvoidsystem complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent implements dynamic waveform generation by replacing fixed square wave outputs with programmable waveforms that can be adjusted in real-time. The system allows dynamic modification of pulse duration, amplitude, frequency, and shape parameters through software control, enabling adaptation to different therapeutic needs without hardware changes.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The invention changes multiple waveform parameters simultaneously including pulse width, amplitude, frequency, and shape characteristics. The system enables continuous adjustment of these parameters within safe operational limits, allowing optimization of therapeutic effect for different neurological conditions while maintaining a single hardware platform.

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If arbitrary waveform patterns are programmed, then new therapy paradigms can be developed for various neurological conditions, but the programming and testing complexity increases

Engineering Contradiction:
Improvetherapy paradigm diversityVSAvoidprogramming complexity
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The patent creates a universal waveform generation platform that can produce multiple waveform types (square, sinusoidal, triangular, exponential, etc.) and patterns (continuous, burst, intermittent) from a single system. This multi-functional capability allows one device to address diverse neurological conditions without requiring separate specialized equipment for each therapy type.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system incorporates feedback mechanisms where clinicians can program initial waveform parameters, observe patient response, and iteratively adjust settings to optimize therapeutic effect. The feedback loop enables refinement of therapy paradigms based on actual patient outcomes, allowing development of condition-specific protocols through systematic experimentation.

Inventive Principle:
Principle #23Feedback

3Reliability

If more flexible waveform generation is implemented, then treatment effectiveness for various neurological disorders can be improved, but ensuring charge balancing and safety becomes more difficult

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidcontrol complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent implements self-service charge balancing where the waveform generation system automatically calculates and applies compensating pulses to maintain charge neutrality. The system monitors delivered charge in real-time and autonomously adjusts subsequent waveforms to ensure net zero charge accumulation at electrode-tissue interfaces, eliminating the need for manual charge balancing calculations.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The invention introduces an intermediary control layer between the waveform generation hardware and the actual stimulation output. This intermediary software module enforces safety constraints by monitoring waveform parameters, calculating charge delivery, and preventing unsafe configurations before they reach the stimulation output, thereby simplifying the overall control architecture while ensuring safety.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS10391313B2Systems and methods for the development of therapy paradigms for neurological treatments
Publication Date: 2019.08.27 BOSTON SCI NEUROMODULATION CORP
  • US10391313B2 patent drawing
  • US10391313B2 patent drawing
  • US10391313B2 patent drawing

AI summary

Methods, devices and systems for developing new therapy options for patient suffering from neurological disorders. An example may include the use of a therapy patterning system that allows significant freedom to program therapy patterns using arbitrary shapes and functions. For such patterning to be implemented, a physician may identify a condition needing new and/or alternative therapy options, link the identified condition one or more therapy parameters, program, test and assess the therapy. The process may include multiple iterations to address an initial condition and then to mitigate side effects of the initial therapy. Some embodiments comprises devices configured to deliver combinations of therapy patterns to accomplish at least first and second therapeutic purposes.