Percutaneous Nerve Evaluation Without Fluoroscopy
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Solution Overview
Problem
The challenge in performing percutaneous nerve evaluations for sacral neuromodulation without access to fluoroscopic imaging equipment, which is typically required for precise needle placement in sacral neuromodulation procedures, necessitates the development of a reliable method for positioning a foramen needle in an office setting without the use of imaging equipment.
Innovation Solution
A method involving visualization with an imaging system to mark sacral landmarks on the patient's skin, creating a target box using radio-opaque rods and pointers, allowing for accurate needle placement into the sacral foramen without the need for fluoroscopic guidance, enabling the procedure to be conducted in a procedure room without imaging equipment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopic guidance is used for needle placement, then positioning precision is improved, but device complexity and procedural cost increase
Solution Approach 1:
The patent applies preliminary action by pre-marking the needle insertion site on the patient's skin before the actual needle placement procedure. The method involves visualizing sacral landmarks using fluoroscopy, marking the precise insertion point with skin markers, and then using these pre-established markers to guide needle placement without requiring continuous fluoroscopic guidance during the procedure itself. This resolves the contradiction by achieving precise positioning through advance preparation rather than complex real-time imaging equipment.
Solution Approach 2:
The patent applies the copying principle by creating a visual representation (skin markers) of the target insertion site based on fluoroscopic imaging data. The fluoroscopy is used to identify the precise anatomical landmarks, and this information is copied onto the patient's skin as visible markers that guide subsequent needle placement. This eliminates the need for continuous complex imaging equipment while maintaining positioning precision.
2Measurement precision
If fluoroscopic imaging is used during the procedure, then needle placement accuracy is improved, but procedure time and patient exposure to radiation increase
Solution Approach 1:
The patent performs the imaging and landmark identification step before the actual needle placement procedure. By using fluoroscopy only briefly to establish skin markers in advance, and then relying on these pre-marked guides during needle insertion, the procedure time is significantly reduced while maintaining accuracy. The time-consuming imaging is done beforehand rather than continuously during the procedure.
Solution Approach 2:
The patent creates a static copy of the target location information on the patient's skin through markers, eliminating the need for continuous dynamic imaging during needle placement. This single pre-procedure imaging step followed by marker-based guidance reduces both radiation exposure time and overall procedure time while preserving placement accuracy.
3Ease of operation
If percutaneous nerve evaluation is performed in an office setting without fluoroscopy, then ease of operation and accessibility are improved, but positioning precision deteriorates
Solution Approach 1:
The patent applies the copying principle by transferring the precise anatomical target information from fluoroscopic imaging onto the patient's skin as visible markers. These skin-copied markers serve as accurate guides during the office-based procedure without requiring the presence of complex fluoroscopic equipment in the treatment room. This enables precise positioning to be achieved in a simple office setting.
Solution Approach 2:
The patent performs preliminary imaging and landmark marking in advance, allowing the actual needle placement to be done in an office setting without fluoroscopy. The precision is preserved because the critical positioning information was captured beforehand and transferred to skin markers that guide the office-based procedure.
Data Source
AI summary
Practitioners who use sacral neuromodulation on a regular basis have sought ways to simplify the procedure and performing percutaneous nerve evaluations in the office setting have become increasingly more popular. However, many practitioners are limited by the lack of availability of fluoroscopy or similar imaging systems in the office setting and do not feel comfortable executing the procedure without it, for a variety of reasons. The disclosed system and method demonstrate an avenue to circumvent the lack of fluoroscopic guidance in the office setting enabling execution of percutaneous nerve evaluations successfully and efficiently.