Implantable Lead Orientation Detection Using Pre-Positioned Markers

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Solution Overview

Problem

Implantable medical devices face challenges in accurately determining the rotational orientation of leads implanted in patients, which is crucial for effective electrical stimulation therapy, as leads may not be implanted with a specific rotational orientation and can rotate post-implantation, affecting the targeting of specific tissue sites.

Innovation Solution

The system utilizes images of implanted leads to determine orientation by identifying electrode and orientation marker locations, projecting markers into a plane orthogonal to the lead axis, and calculating the rotational orientation using techniques such as singular value decomposition (SVD) to match lead features with template models, enabling precise visualization and adjustment of lead positioning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If leads are implanted without specific rotational orientation control, then implantation procedure is simpler, but lead orientation accuracy deteriorates

Engineering Contradiction:
Improveimplantation procedure simplicityVSAvoidlead orientation accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

Orientation markers are pre-positioned on the lead during manufacturing at known locations relative to the electrodes. This preliminary action allows the imaging system to later determine rotational orientation by detecting these pre-placed markers, resolving the contradiction by preparing the measurement capability in advance without complicating the implantation procedure itself

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Imaging devices and orientation markers serve as intermediaries between the implantation procedure and the lead orientation determination. The markers are visible to imaging devices, enabling indirect measurement of rotational orientation without requiring direct mechanical alignment control during implantation, thus maintaining procedural simplicity while achieving measurement accuracy

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If lead rotational orientation is not controlled post-implantation, then lead stability is compromised, but therapy targeting precision deteriorates

Engineering Contradiction:
Improvelead stabilityVSAvoidtissue targeting precision
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The system provides feedback by imaging the implanted lead and detecting the orientation markers to determine actual rotational orientation. This feedback information allows clinicians to verify lead positioning and adjust therapy parameters accordingly, compensating for any post-implantation rotation and maintaining therapy targeting precision despite lead instability

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

Orientation markers are pre-positioned on the lead to enable future orientation determination. This preliminary preparation allows for post-implantation orientation assessment without requiring additional surgical intervention, maintaining lead stability while enabling precision therapy through measurable orientation data

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP3958952B1Identification of orientation of implanted lead
Publication Date: 2023.05.03 MEDTRONIC INC
  • EP3958952B1 patent drawingFigure 1
  • EP3958952B1 patent drawingFigure 2
  • EP3958952B1 patent drawingFigure 3

AI summary

An example method includes obtaining an image of a lead implanted in a patient, the lead including one or more electrodes positioned along a longitudinal axis of the lead and a plurality of orientation markers; determining, in the image, respective locations of the one or more electrodes and respective locations of the plurality of orientation markers; determining, based on the respective locations of the one or more electrodes, an orientation of the longitudinal axis; projecting the respective locations of the orientation markers into a plane orthogonal to the longitudinal axis; and determining, based on a projected location of a first orientation marker of the plurality of orientation markers in the plane and a projected location of a second orientation marker of the plurality of orientation markers in the plane, a rotational orientation of the lead.