Microcontroller Waveform Generation for Spinal Cord Stimulation

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Solution Overview

Problem

Current spinal cord stimulation systems are limited by their ability to generate only simple rectangular or biphasic pulse waveforms, lacking the flexibility to produce complex waveforms with multiple phases, which restricts the targeting of specific nerve fibers and reduces therapeutic effectiveness while increasing side effects.

Innovation Solution

A medical device with a state machine architecture and microcontroller-driven waveform generation circuitry capable of producing complex waveforms with an arbitrary number of phases, allowing for interleaved and repeated phases, and enabling efficient rescaling of waveform parameters without interrupting stimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If simple rectangular or biphasic pulse waveforms are used, then the device complexity is reduced, but the adaptability for targeting specific nerve fibers deteriorates

Engineering Contradiction:
Improveadaptability for targeting specific nerve fibersVSAvoiddevice complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The stimulation pulse is divided into multiple phases (e.g., first phase, second phase, third phase) with different waveform shapes and parameters. Each phase can be independently configured to target specific nerve fiber types, enabling selective activation while using a single integrated pulse generator device.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system dynamically switches between different waveform shapes (rectangular, trapezoidal, exponential, sine, triangular) and phase configurations based on the selected stimulation mode. This allows the device to adapt its output characteristics without requiring multiple separate devices, resolving the contradiction between versatility and complexity.

Inventive Principle:
Principle #15Dynamics

2Adaptability or versatility

If complex waveforms with multiple phases are generated, then the adaptability for nerve fiber targeting is improved, but the device complexity increases

Engineering Contradiction:
Improveversatility in waveform generationVSAvoiddevice complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

A single pulse generator device is designed to perform multiple functions by generating various waveform shapes and phase configurations through software-controlled parameter adjustment. This multi-functional approach eliminates the need for multiple specialized devices while providing comprehensive waveform versatility for different nerve fiber targeting requirements.

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

Solution Approach 2:

The system achieves waveform diversity by dynamically changing parameters such as pulse width, amplitude, frequency, and phase duration rather than using hardware switches between different waveform generators. This parameter-based approach maintains device simplicity while enabling complex waveform generation capabilities.

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If waveform parameters are adjusted during stimulation, then the therapeutic effectiveness is improved, but the stability of continuous stimulation deteriorates

Engineering Contradiction:
Improveflexibility in waveform adjustmentVSAvoidstability of continuous stimulation
Core Design Contradiction:
Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

Multiple waveform parameter sets are pre-configured and stored in memory before stimulation begins. When adjustment is needed, the system selects from pre-prepared configurations rather than calculating new parameters in real-time, ensuring continuous stable stimulation while maintaining flexibility in therapeutic effectiveness.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS10653884B2Digital control for pulse generators
Publication Date: 2020.05.19 CIRTEC MEDICAL CORP
  • US10653884B2 patent drawing
  • US10653884B2 patent drawing
  • US10653884B2 patent drawing

AI summary

A controller for implementing a method, device and/or system for generating arbitrary waveforms of a desired shape that can be used for generating a stimulation pulse for medical purposes such as for spinal cord stimulation therapy, where such arbitrary waveforms can also be used for charge balancing purposes.