Neurostimulation Lead Migration Detection via Electrical Field Modeling

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Solution Overview

Problem

Conventional neurostimulation systems lack an effective method to detect and address the migration of neurostimulation leads, which can lead to diminished therapeutic effects and difficulty in reprogramming, as they do not provide real-time information on lead movement, relying on inconvenient and costly imaging modalities.

Innovation Solution

A system and method that uses neurostimulation lead models with estimated electrical parameter data to compare with measured data, determining the position of leads through computational methods, allowing for the detection of migration and automatic reprogramming of electrodes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional imaging modalities are used to detect lead migration, then accurate lead position information can be obtained, but the process becomes inconvenient and costly

Engineering Contradiction:
Improvelead position detection accuracyVSAvoiddetection convenience
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent replaces conventional imaging modalities (mechanical/optical systems like fluoroscopy) with an electrical field-based detection system. The system uses electrical leads already implanted in the patient to generate and measure electrical fields, computing lead positions through signal processing rather than external imaging equipment. This substitution eliminates the need for costly and inconvenient imaging procedures while maintaining detection accuracy.

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

Solution Approach 2:

The patent creates an electrical field model (virtual copy) of the lead positions based on measured electrical signals. Instead of directly visualizing leads through imaging, the system computes equivalent lead positions by analyzing electrical field patterns and comparing them against a library of known field configurations. This computational copying approach provides accurate position information without requiring physical imaging.

Inventive Principle:
Principle #26Copying

2Measurement precision

If conventional imaging modalities are used to detect lead migration, then lead position can be determined, but the cost increases significantly

Engineering Contradiction:
Improvelead position detection accuracyVSAvoidcost-effectiveness
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent substitutes expensive external imaging equipment with the electrical leads already implanted in the patient. By utilizing the existing electrical infrastructure and measuring electrical fields rather than employing fluoroscopy or other imaging modalities, the system dramatically reduces detection costs while maintaining the ability to accurately determine lead positions and detect migration.

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

Solution Approach 2:

The system uses the implanted electrical leads to detect their own positions. The leads generate electrical fields that are measured and processed to compute lead locations, enabling the system to self-diagnose migration without requiring external imaging resources. This self-service approach eliminates the need for costly external detection equipment.

Inventive Principle:
Principle #25Self-service

3Adaptability or versatility

If manual reprogramming is performed after lead migration, then therapy can be adjusted, but the process becomes complex and time-consuming

Engineering Contradiction:
Improvetherapy adjustment capabilityVSAvoidreprogramming complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent implements automated feedback control by continuously monitoring electrical field patterns and comparing them against expected patterns. When lead migration is detected through computational analysis of field deviations, the system automatically triggers reprogramming procedures that adjust stimulation parameters based on the computed new lead positions. This closed-loop feedback system eliminates manual intervention and reduces reprogramming complexity.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system pre-computes the relationship between electrical field patterns and lead positions, storing a library of expected field configurations. When migration occurs, the system quickly compares current measurements against this pre-established library to determine new positions and automatically adjusts programming accordingly. This preliminary preparation of reference data accelerates the adaptation process and reduces complexity.

Inventive Principle:
Principle #10Preliminary action

4Duration of action of stationary object

If lead migration is not detected, then the system continues operating, but therapeutic effects diminish

Engineering Contradiction:
Improvecontinuous operationVSAvoidtherapeutic effectiveness
Core Design Contradiction:
Duration of action of stationary objectVSReliability

Solution Approach 1:

The patent implements continuous feedback monitoring by repeatedly measuring electrical fields and comparing them against expected patterns. This ongoing detection process allows the system to maintain continuous operation while simultaneously monitoring for lead migration. When migration is detected through computational analysis of field deviations, the system automatically triggers corrective reprogramming to restore therapeutic effectiveness, thus maintaining both continuous operation and reliable therapy delivery.

Inventive Principle:
Principle #23Feedback

Data Source

PatentUS10420940B2System and method for computationally determining migration of neurostimulation leads
Publication Date: 2019.09.24 BOSTON SCI NEUROMODULATION CORP
  • US10420940B2 patent drawing
  • US10420940B2 patent drawing
  • US10420940B2 patent drawing

AI summary

A tissue stimulation system and computer software and method of monitoring a neurostimulation lead having a plurality of electrodes implanted within a patient (e.g., adjacent the spinal cord) is provided. Neurostimulation lead models are provided, each of which includes estimated electrical parameter data (e.g., electrical field potential data) corresponding to a predetermined position of the neurostimulation lead. Electrical energy is transmitted to or from the electrodes, and electrical parameter data (e.g., electrical field potential data) is measured in response to the transmitted electrical energy. The measured electrical parameter data is compared with the estimated electrical parameter data of each of the neurostimulation lead models, and a position of the neurostimulation lead is determined based on the comparison.