Neural Dose Calculation for Spinal Cord Stimulation

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Solution Overview

Problem

Current spinal cord stimulation (SCS) technologies lack the ability to precisely measure and control the energy delivered to neural tissue, which can lead to ineffective pain management and potential harm due to unknown long-term effects of electrical signals on the body.

Innovation Solution

A device comprising a pulse generator with processing and memory capabilities to generate and record electrical signals based on a neural dose prescription, calculating the total energy delivered to neural tissue, and a remote control for operating the pulse generator to adjust energy delivery, ensuring the lowest effective amount of energy is used to mitigate symptoms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If electrical signals are delivered through a lead to stimulate neural tissue for pain relief, then pain management effectiveness is improved, but the long-term safety and precise energy control remain unknown

Engineering Contradiction:
Improvepain management effectivenessVSAvoidunknown long-term effects of electrical signals
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent implements a feedback mechanism where the pulse generator continuously monitors the actual energy delivered to neural tissue and compares it against the prescribed neural dose. The system automatically adjusts stimulation parameters to maintain energy delivery within safe and effective limits, ensuring both pain relief effectiveness and long-term safety through closed-loop control

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent changes the approach from fixed amplitude/width parameters to dynamic parameter adjustment based on calculated energy delivery. The system monitors and adjusts stimulation parameters (amplitude, pulse width, frequency) in real-time to maintain the prescribed neural dose, transforming static parameter delivery into dynamic energy-based control

Inventive Principle:
Principle #35Parameter changes

2Reliability

If higher energy electrical signals are used to ensure effective pain relief, then symptom mitigation is improved, but potential harm to neural tissue increases

Engineering Contradiction:
Improvesymptom mitigation effectivenessVSAvoidpotential harm from excessive energy
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The pulse generator incorporates continuous monitoring of actual energy delivery with automatic feedback adjustment. The system compares delivered energy against the prescribed neural dose and dynamically adjusts stimulation parameters to prevent both under-delivery (ineffective pain relief) and over-delivery (potential tissue harm), maintaining optimal therapeutic effect

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent transitions from static fixed-parameter stimulation to dynamic energy-based control. The system continuously adapts stimulation amplitude, pulse width, and frequency based on real-time energy delivery calculations, allowing the therapy to respond to changing patient needs and tissue conditions while maintaining safety limits

Inventive Principle:
Principle #15Dynamics

3Measurement precision

If the pulse generator continuously monitors and calculates energy delivery, then precise energy control is improved, but device complexity increases

Engineering Contradiction:
Improveenergy delivery measurement precisionVSAvoidprocessing and calculation capabilities
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The pulse generator performs self-monitoring and self-calculation of energy delivery using its own embedded processing device. The system automatically measures electrical parameters, calculates total energy delivered to neural tissue, and adjusts stimulation without external intervention, reducing the need for additional external monitoring equipment while maintaining measurement precision

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The pulse generator integrates multiple functions into a single device: it generates electrical signals, monitors delivery parameters, calculates total energy delivered, stores prescription data, and adjusts stimulation parameters. This multi-functionality consolidates what could be separate systems into one integrated unit, managing complexity through consolidation rather than proliferation of components

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

Data Source

PatentUS20230355985A1Neural dose calculation
Publication Date: 2023.11.09 SPIRO MEDICAL INC
  • US20230355985A1 patent drawing
  • US20230355985A1 patent drawing
  • US20230355985A1 patent drawing

AI summary

A pulse generator stores a neural dose prescription for releasing electrical signals to stimulate neural tissue. The pulse generator generates the electrical signals for delivery through a lead to the neural tissue, the electrical signals being programmed to mitigate symptoms by stimulating the neural tissue. The pulse generator records delivery of the electrical signals, and calculates a total amount of energy delivered to the neural tissue.