Neuromodulation Programming System Perception Threshold Index

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Solution Overview

Problem

Current computerized programming systems for neuromodulation devices lack intuitive programming capabilities, particularly in determining a patient's perception threshold for electrical stimulation, leading to inefficient and time-consuming adjustments of modulation parameter sets due to lead migration and potential discomfort from paresthesia.

Innovation Solution

A method that calculates and identifies a perception threshold index for electrical modulation energy, allowing for the determination of new or modified modulation parameter sets to optimize stimulation programs, including graphical representation of indices to facilitate intuitive programming and automatic or semi-automatic adjustments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual adjustment of modulation parameter sets is performed to account for lead migration, then therapeutic efficacy can be maintained, but programming time and complexity increase significantly

Engineering Contradiction:

Improvetherapeutic efficacyVSAvoidprogramming time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The system performs preliminary calculation of a perception threshold index before actual programming adjustments. By pre-calculating the threshold based on lead position data and patient-specific parameters, the system prepares optimization parameters in advance, reducing the time required for manual adjustment while maintaining therapeutic efficacy.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The invention replaces manual mechanical adjustment of programming parameters with an automated computational system. The processor automatically calculates the perception threshold index and generates optimized modulation parameter sets, substituting the manual mechanical process of parameter adjustment with an automated electronic computation and control system.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Object-affected harmful factors

If perception threshold programming is performed to minimize paresthesia discomfort, then patient comfort improves, but the complexity of the programming system increases

Engineering Contradiction:

Improveparesthesia discomfortVSAvoidprogramming system complexity

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The perception threshold index serves as an intermediary parameter that mediates between lead position data and final modulation parameter settings. By introducing this intermediate calculation step, the system translates complex multi-parameter relationships into a single threshold value that guides parameter optimization, reducing the perceived complexity while achieving patient comfort goals.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The system changes the state of programming from manual parameter-by-parameter adjustment to automated parameter set generation based on calculated thresholds. By transforming the programming approach from direct manual control to threshold-based automated optimization, the system reduces patient discomfort while managing complexity through algorithmic processing.

Inventive Principle:

Principle #35Parameter changes

3Measurement precision

If multiple modulation parameter sets are tested to determine optimal stimulation, then programming precision improves, but the time required for programming increases

Engineering Contradiction:

Improveprogramming precisionVSAvoidprogramming efficiency

Core Design Contradiction:

Measurement precisionVSProductivity

Solution Approach 1:

The system performs preliminary sorting and prioritization of multiple modulation parameter sets based on the calculated perception threshold index. By pre-organizing parameter sets in order of expected effectiveness before actual testing, the system identifies optimal parameters more quickly while maintaining the precision benefits of evaluating multiple configurations.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS10300278B2Systems and methods for programming a neuromodulation system

Publication Date: 2019.05.28 BOSTON SCI NEUROMODULATION CORP

AI summary

A method of operating an implantable neuromodulator includes calculating an index for each of a plurality of modulation parameter sets, wherein each modulation parameter set includes a respective plurality of modulation parameters from which the respective index is calculated, serially conveying electrical modulation energy to a patient in accordance with each of the plurality of modulation parameter sets, causing the patient to perceive paresthesia in response to the conveyance of the electrical modulation energy to the tissue in accordance with one of the plurality of modulation parameter sets, identifying the calculated index for that one modulation parameter set as a perception threshold index based on the perceived paresthesia, and storing the identified perception threshold index. The method may also include determining a new modulation parameter set based on the identified perception threshold index, and conveying electrical modulation energy to the tissue in accordance with the new modulation parameter set.