Lead Placement Evaluation via Sacrum Visual Representation
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Solution Overview
Problem
Existing pelvic or sacral nerve stimulation systems lack a reliable method to determine the correct placement of the lead, which is crucial for effective stimulation therapy, as incorrect placement can hinder treatment efficacy, especially for inexperienced medical professionals.
Innovation Solution
An electronic device with a graphical user interface displays a visual representation of the sacrum and implanted lead, allowing evaluation of lead placement by determining insertion in a predetermined region, electrode contact distance from the sacrum edge, and lead curvature, facilitating accurate implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If visual representation and automated evaluation methods are implemented, then measurement precision and reliability of lead placement assessment are improved, but device complexity increases
Solution Approach 1:
The system creates a visual representation (copy) of the sacrum and lead placement based on imaging data, allowing clinicians to assess lead position without directly interpreting complex raw imaging data. This copy enables accurate measurement while keeping the interface simple.
Solution Approach 2:
The visual representation acts as an intermediary between the complex imaging data and the clinician's assessment. It translates complex medical images into an intuitive visual format that shows lead placement relative to the sacrum, improving measurement precision without requiring the clinician to directly analyze complex imaging data.
2Measurement precision
If multiple evaluation criteria (insertion region, electrode distance, curvature) are automatically assessed, then measurement precision is improved, but device complexity and processing requirements increase
Solution Approach 1:
The evaluation process is segmented into three distinct automated criteria: (1) determining insertion in predetermined region, (2) measuring electrode contact distance from sacrum edge, and (3) assessing lead curvature. Each criterion is evaluated separately and independently, allowing comprehensive assessment while maintaining manageable system complexity through modular processing.
Solution Approach 2:
The system performs automated evaluation of multiple criteria beyond what a clinician would typically assess manually, providing comprehensive lead placement verification. This excessive automated evaluation ensures high measurement precision by checking more parameters than traditionally necessary.
3Reliability
If automated visual evaluation is provided to assist inexperienced professionals, then reliability of lead placement assessment is improved, but device complexity increases
Solution Approach 1:
The system provides automated visual feedback to clinicians regarding lead placement quality, showing whether the lead is correctly positioned in the predetermined region, the distance of electrodes from the sacrum edge, and the curvature of the lead. This feedback mechanism improves assessment reliability by guiding clinicians, especially inexperienced ones, without requiring them to have expert-level interpretation skills.
Data Source
AI summary
A method of evaluating an implantation of a lead is disclosed. Via a graphical user interface of an electronic device, a visual representation of a sacrum of the patient and a lead that is implanted in the sacrum is displayed. The lead includes a plurality of electrode contacts. An evaluation is made as to how well the lead has been implanted in the sacrum based on the visual representation of the sacrum and the lead. The evaluating comprises: determining whether the lead is inserted in a predetermined region of the sacrum, determining how far a predetermined one of the electrode contacts is located from an edge of the sacrum, and determining a degree of curvature of the lead.