Spinal Cord Modulation Using High Frequency Signals

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Solution Overview

Problem

Conventional spinal cord stimulation techniques often result in undesirable side effects such as unwanted motor stimulation and interference with sensory functions, and are less effective in providing consistent pain relief, as they rely on paresthesia and are sensitive to lead location and signal delivery parameters.

Innovation Solution

The use of high frequency electrical signals, typically between 3 kHz to 10 kHz, delivered through leads positioned at vertebral levels T9 to T12, which are less sensitive to lead location and signal parameters, reducing side effects and improving pain relief without inducing paresthesia.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional spinal cord stimulation techniques are used, then pain relief can be achieved, but undesirable side effects such as unwanted motor stimulation and interference with sensory functions occur

Engineering Contradiction:
Improvepain relief effectivenessVSAvoidside effects including motor stimulation and sensory interference
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the frequency parameter of the electrical stimulation from conventional low frequencies (typically below 1 kHz) to high frequencies (above 1 kHz, specifically 1-10 kHz). This parameter change fundamentally alters the physiological response, providing pain relief through a different mechanism that does not rely on paresthesia, thereby eliminating unwanted motor stimulation and sensory interference side effects

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent replaces the conventional paresthesia-based mechanism with a high-frequency electrical stimulation mechanism that directly modulates spinal cord neurons. This substitution changes the underlying physiological mechanism from sensory masking to direct neural modulation, achieving pain relief without the need to induce paresthesia and avoiding associated side effects

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If conventional spinal cord stimulation is used, then pain relief can be provided, but the therapy is sensitive to lead location and signal delivery parameters

Engineering Contradiction:
Improvepain relief consistencyVSAvoidsensitivity to lead location and parameters
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

By using high frequency stimulation (1-10 kHz), the patent creates a therapy that is less sensitive to variations in lead location and signal parameters. The high-frequency mechanism provides a broader therapeutic window and more consistent pain relief across different implantation positions and parameter settings, reducing the need for precise lead placement and extensive parameter optimization

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs dynamic parameter modulation where the stimulation parameters (frequency, amplitude, pulse width) are automatically adjusted based on real-time feedback from the patient's pain levels and physiological responses. This dynamic adaptation allows the therapy to maintain effectiveness across varying lead positions and patient activities without requiring manual reconfiguration

Inventive Principle:
Principle #15Dynamics

3Reliability

If conventional spinal cord stimulation relying on paresthesia is used, then pain relief can be achieved, but the therapy requires frequent adjustment of parameters during patient activities

Engineering Contradiction:
Improvepain relief effectivenessVSAvoidtime required for parameter adjustments
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent implements a closed-loop control system with automated parameter selection that monitors patient pain levels and automatically adjusts stimulation parameters without requiring patient intervention. The system self-regulates by detecting pain signals and modifying the high-frequency stimulation parameters in real-time, eliminating the need for patients to manually adjust settings during various activities

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent incorporates real-time feedback mechanisms where patient physiological responses and pain levels are continuously monitored and fed back to the stimulation controller. This feedback loop enables automatic parameter optimization, allowing the therapy to adapt to changing patient conditions and activities without manual intervention, thereby reducing the time loss associated with parameter adjustments

Inventive Principle:
Principle #23Feedback

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This approach provides more effective and robust pain reduction with reduced side effects, allowing patients to engage in various activities without adjusting therapy parameters, and offers improved sleep quality and reduced medication use, with a broader amplitude window for therapy delivery.

Implementation Method 1

the pulse generator applies electrical pulses to the electrodes, which in turn modify the function of the patient's nervous system

Methodology Applied
Scientific EffectElectrical stimulation: Electrical Impedance Tomography

Data Source

PatentUS11931577B2Devices for controlling spinal cord modulation for inhibiting pain, and associated systems and methods, including controllers for automated parameter selection
Publication Date: 2024.03.19 NEVRO CORP
  • US11931577B2 patent drawing
  • US11931577B2 patent drawing
  • US11931577B2 patent drawing

AI summary

Devices for controlling spinal cord modulation for inhibiting pain, and associated systems and methods, including controllers for automated parameter selection are disclosed. A particular embodiment includes receiving a first input corresponding to a location of a signal delivery device implanted in a patient, establishing a positional relationship between the signal delivery device and an anatomical feature of the patient, receiving a second input corresponding to a medical indication of the patient, and, based at least in part on the positional relationship and the indication, automatically identifying a signal delivery parameter in accordance with which a pulsed electrical signal is delivered to the patient via the signal delivery device.