Stimulation Intensity Mapping for Neural Therapy Programming

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Solution Overview

Problem

The process of configuring electrical stimulation therapy parameters for medical devices is time-consuming and requires trial-and-error, often necessitating multiple programming sessions due to variations in patient physiology and lead placement inaccuracies, leading to inadequate initial programming that may require follow-up sessions.

Innovation Solution

A system that utilizes stimulation intensity values to generate paired pulse width and amplitude values, with each intensity value corresponding to a specific equal intensity function, allowing for efficient configuration of electrical stimulation therapy by activating a substantially equal volume of tissue, thereby simplifying the programming process and reducing the need for multiple sessions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If traditional manual parameter configuration is used, then the clinician can customize therapy parameters, but the programming process becomes time-consuming and requires multiple trial-and-error sessions

Engineering Contradiction:
Improveprogramming efficiencyVSAvoidprogramming time
Core Design Contradiction:
Ease of operationVSLoss of time

Solution Approach 1:

The system pre-calculates and stores multiple paired pulse width and amplitude values that correspond to equal tissue activation volumes before the programming session. When the clinician selects a desired tissue volume, the system immediately retrieves the pre-computed parameter pairs, eliminating the need for time-consuming trial-and-error adjustments during the programming session.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system transforms the traditional approach of independently adjusting pulse width and amplitude into a unified parameter selection process. By defining equal intensity functions that relate pulse width and amplitude pairs to specific tissue volumes, the system allows clinicians to select therapy parameters based on a single primary parameter (desired tissue volume) rather than manually tuning multiple parameters.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If multiple parameter combinations are tested to achieve optimal therapy, then adequate treatment efficacy can be obtained, but the complexity of the programming process increases

Engineering Contradiction:
Improvetherapy efficacyVSAvoidprogramming complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system identifies and utilizes equal intensity functions where different pulse width and amplitude combinations produce the same tissue activation volume. By presenting these equivalent parameter sets to the clinician, the system simplifies the decision-making process while maintaining therapy efficacy, as any of the paired values will achieve the desired therapeutic effect.

Inventive Principle:
Principle #12Equipotentiality

Solution Approach 2:

The system introduces equal intensity functions as an intermediary layer between the clinician's therapeutic goals and the device's parameter settings. Instead of directly manipulating pulse width and amplitude, the clinician specifies the desired tissue volume, and the system automatically determines the appropriate parameter pairs through the equal intensity function relationship.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Manufacturing precision

If precise lead placement is assumed, then initial programming can be accurate, but lead placement inaccuracies require follow-up programming sessions

Engineering Contradiction:
Improvelead placement precisionVSAvoidprogramming session duration
Core Design Contradiction:
Manufacturing precisionVSDuration of action of stationary object

Solution Approach 1:

The system provides dynamically adjustable parameter pairs that can be selected based on the actual lead placement and patient response. Rather than relying on a single fixed parameter set assumed to be optimal for perfect lead placement, the system offers multiple paired values that can be tuned to account for placement variations, allowing clinicians to optimize therapy after the fact without requiring complete re-programming.

Inventive Principle:
Principle #15Dynamics

4Reliability

If higher stimulation amplitude is used to ensure adequate tissue activation, then therapy efficacy improves, but energy consumption increases and power source longevity decreases

Engineering Contradiction:
Improvetherapy efficacyVSAvoidenergy consumption
Core Design Contradiction:
ReliabilityVSUse of energy by moving object

Solution Approach 1:

The system enables clinicians to select from multiple pulse width and amplitude pairs that all achieve the same tissue activation volume. This allows optimization for energy efficiency by choosing parameter combinations with lower amplitude and longer pulse width, or lower energy consumption overall, while maintaining the same therapeutic effect through the equal intensity relationship defined by the selected tissue volume.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP2301624B1Configuring stimulation therapy using stimulation intensity
Publication Date: 2014.01.01 MEDTRONIC INC
  • EP2301624B1 patent drawingFigure 1
  • EP2301624B1 patent drawingFigure 2
  • EP2301624B1 patent drawingFigure 3

AI summary

Techniques for configuring electrical stimulation therapy utilizing one or more stimulation intensity values are described. In one example, a method includes receiving a stimulation intensity value that corresponds to an equal intensity function; determining a pulse width value and a pulse amplitude value based on the equal intensity function; and controlling delivery of electrical stimulation pulses with the determined pulse width value and amplitude value to a patient. A stimulation intensity value may correspond to a plurality of paired pulse width and amplitude values having substantially the same intensity. For example, the plurality of paired pulse width and amplitude values may activate a substantially equal volume of tissue when a stimulation pulse with the paired values is delivered.