AR-Guided Neurostimulation Lead Placement Without Fluoroscopy
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Solution Overview
Problem
Current lead placement techniques for sacral neuromodulation procedures in office settings lack accurate visualization, leading to improper placements and potential abandonment of the treatment due to anatomic or pathologic variations, especially when fluoroscopy is not used.
Innovation Solution
An augmented reality system using a head-mounted display to superimpose calculated measurements onto a patient's live video feed, aiding precise needle placement by projecting the S3 foramen location based on imaging and identified patient points.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If fluoroscopy or imaging is not used in office settings, then the procedure can be performed without imaging equipment, but the accuracy of lead placement deteriorates due to blind insertion
Solution Approach 1:
The patent introduces an intermediary system consisting of a camera, display device, and measurement calculation system that mediates between the physician and the patient's anatomy. This intermediary provides visual feedback and measurement guidance during the blind insertion process, enabling accurate lead placement without requiring fluoroscopy equipment.
Solution Approach 2:
The patent replaces the mechanical/imaging-based fluoroscopy system with an optical/electronic system using cameras and display devices to visualize anatomical structures and guide needle placement. This substitution eliminates the need for complex imaging equipment while maintaining placement accuracy.
2Measurement precision
If multiple attempts are made to locate the S3 foramen, then the accuracy of lead placement may improve, but the procedure time and complexity increase
Solution Approach 1:
The patent applies preliminary action by calculating and displaying the required measurements and S3 foramen location on the display device before the physician begins the needle insertion procedure. This pre-planning phase allows the physician to understand the exact target location and approach angle, reducing the need for multiple trial attempts during the actual procedure.
Solution Approach 2:
The patent implements feedback by providing real-time visual information on the display device showing the calculated measurements, anatomical landmarks, and projected needle path. This continuous feedback enables the physician to adjust their insertion approach immediately, ensuring accurate placement on the first attempt and reducing overall procedure time.
3Ease of operation
If palpable skeletal landmarks are used for lead placement, then the procedure can be performed without imaging, but the accuracy deteriorates due to anatomical variations
Solution Approach 1:
The patent creates a visual copy or representation of the patient's anatomical structure and measurement requirements on the display device. This digital copy allows the physician to reference precise anatomical relationships and measurements without relying solely on palpable landmarks, compensating for anatomical variations while maintaining procedure accessibility.
Data Source
AI summary
A system and method for locating and guiding a peripheral nerve evaluation (PNE) lead. The system comprising an X-ray system to capture images of the patient. The images are processed by the system and are provided to a user to utilize an augmented reality (AR) system for inserting a needle for placing leads for the PNE procedure.