Neurostimulation Lead Placement Guide for Accurate S3 Foramen Localization
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Solution Overview
Problem
Current lead placement techniques for sacral neuromodulation procedures in office settings lack accuracy due to reliance on palpable skeletal landmarks, leading to improper placement and potential failure of the procedure, especially when fluoroscopy is not used.
Innovation Solution
A system and method utilizing imaging to determine precise measurements, applying them to a guide device, and guiding a medical element into the patient to accurately locate the S3 foramen, incorporating radiopaque landmarks and image processing for enhanced accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopy or imaging guidance is used for lead placement, then placement accuracy is improved, but device complexity and procedural cost increase
Solution Approach 1:
The patent introduces a guide device as an intermediary tool that translates 2D imaging measurements into 3D anatomical navigation. The guide device includes a guide bore that directs the foramen needle along a predetermined path, acting as a mechanical mediator between the imaging system and the target foramen, thereby achieving accurate placement without requiring continuous fluoroscopic guidance.
Solution Approach 2:
The patent performs preliminary imaging and measurement actions before the actual lead placement procedure. By obtaining images, identifying landmarks, and calculating measurements in advance, the system allows the physician to set up the guide device with pre-determined parameters, eliminating the need for real-time imaging during needle insertion and reducing procedural complexity.
2Ease of operation
If blind insertion method is used in office setting, then procedural simplicity is maintained, but placement accuracy deteriorates
Solution Approach 1:
The guide device serves as a mechanical intermediary that translates 2D imaging measurements into 3D anatomical navigation. It includes a guide bore that directs the foramen needle along a predetermined path, acting as a mediator between the imaging system and the target foramen, thereby achieving accurate placement without requiring continuous fluoroscopic guidance.
Solution Approach 2:
The patent replaces the purely manual blind insertion method with a guided mechanical system. The guide device with its guide bore provides mechanical direction for needle insertion, substituting the reliance on physician experience and palpable landmarks with a structured mechanical guidance system that incorporates imaging-based measurements.
3Reliability
If multiple attempts are made to locate S3 foramen, then placement success may be achieved, but procedure time and patient discomfort increase
Solution Approach 1:
The system performs preliminary imaging, landmark identification, and measurement calculations before the actual needle insertion. By preparing the guide device with pre-calculated parameters in advance, the system enables accurate placement on the first attempt, eliminating the need for multiple retry attempts and reducing overall procedure time.
Solution Approach 2:
The system incorporates imaging feedback to verify needle placement accuracy. By using imaging to confirm that the foramen needle has successfully entered the S3 foramen, the system provides immediate feedback to the physician, allowing for correction if needed and ensuring successful placement without requiring multiple blind attempts.
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 a measurement device for inserting a needle for placing leads for the PNE procedure.