Lead Orientation Detection Using Image Data and Data Cube Registration

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Solution Overview

Problem

Current neuromodulation systems, such as those for Deep Brain Stimulation (DBS) and Spinal Cord Stimulation (SCS), face challenges in accurately determining the rotational orientation of leads with multiple electrodes, which complicates electrode selection and programming, leading to inefficient energy consumption and potential side effects from unintended tissue modulation.

Innovation Solution

A system that uses image data from markers on the lead to estimate its rotational orientation by generating a target data cube and registering it with a reference data cube, applying a transformation operator to determine the rotational orientation, facilitating precise electrode selection and programming.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional lead location methods are used to identify longitudinal contacts of column electrodes, then the location of electrodes can be identified, but adequate information about the rotational orientation of the lead is not provided

Engineering Contradiction:
Improvelead orientation determinationVSAvoidrotational orientation information
Core Design Contradiction:
Measurement precisionVSLoss of information

Solution Approach 1:

The lead is segmented into multiple electrodes distributed axially and circumferentially, with each electrode's position and orientation being independently identifiable through image data. This segmentation allows the system to capture both longitudinal and rotational information separately, resolving the contradiction between identifying electrode locations and determining rotational orientation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention transitions from two-dimensional lead location identification to three-dimensional orientation determination by incorporating rotational angle measurement. The system uses image data to establish not only the position of electrodes along the lead length but also their circumferential arrangement, adding the rotational dimension to the orientation assessment.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Adaptability or versatility

If a large number of electrodes are used in directional leads for DBS or SCS, then more comprehensive neural tissue coverage is achieved, but electrode selection and programming becomes complicated and time consuming

Engineering Contradiction:
Improveneural tissue coverageVSAvoidelectrode selection and programming time
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

Solution Approach 1:

The system provides visual feedback by displaying the three-dimensional orientation and position of multiple electrodes relative to the neural target. This feedback mechanism allows clinicians to quickly understand which electrodes are optimally positioned for stimulating specific neural structures, significantly reducing the time required for electrode selection and programming while maintaining comprehensive tissue coverage.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

An image-guided orientation system serves as an intermediary between the complex multi-electrode configuration and the clinician's decision-making process. The system processes the spatial relationships of numerous electrodes and presents simplified orientation information, acting as a mediator that translates complex electrode arrangements into actionable clinical insights.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If improper lead position and orientation are used, then implantation is faster or easier, but energy consumption increases and longevity of the neuromodulator is reduced

Engineering Contradiction:
Improvelead implantation easeVSAvoidneuromodulator energy consumption
Core Design Contradiction:
Ease of operationVSUse of energy by moving object

Solution Approach 1:

The invention performs preliminary orientation assessment using image data before final lead implantation and programming. By determining the three-dimensional orientation and position of electrodes in advance, the system allows clinicians to plan optimal lead placement that minimizes energy consumption from the start, rather than requiring energy-intensive adjustments after implantation.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The lead design incorporates visible markers or features that enable self-determination of its orientation and position through standard imaging modalities. This self-service capability allows the lead to provide its own orientation information without requiring complex external tracking systems, facilitating easier implantation while ensuring optimal energy efficiency through accurate positioning.

Inventive Principle:
Principle #25Self-service

Data Source

PatentEP3297719B1Detection of lead orientation
Publication Date: 2022.02.09 BOSTON SCI NEUROMODULATION CORP
  • EP3297719B1 patent drawingFigure 1
  • EP3297719B1 patent drawingFigure 2
  • EP3297719B1 patent drawingFigure 3A~3B

AI summary

Systems and methods for determining a rotational orientation of a lead for use in electrostimulation of a body tissue are disclosed. A system may receive image data of at least a portion of the lead including image data of a marker configured to identify a rotational orientation of the lead. The system may receive at least one template of the lead having a specified rotational orientation. Each template may include a reference data cube and a reference marker direction vector. The system may generate a target data cube of the marker using the image data of the marker, and register the reference data cube to the target data cube to produce a transformation operator. The system may estimate the rotational orientation of the lead using the reference marker direction vector and the determined transformation operator.