Sacral Neuromodulation Needle Positioning via Fluoroscopy Markings
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Solution Overview
Problem
Current sacral neuromodulation procedures for treating overactive bladder and bowel control disorders are invasive and require skilled surgical technique for optimal lead placement, leading to variable outcomes and potential complications, deterring some patients from seeking this effective treatment due to expense and inconvenience.
Innovation Solution
A method for precise needle positioning using fluoroscopy to mark and locate the sacral foramen, adjusting the needle angle for optimal placement, and confirming with electrical stimulation to ensure effective lead implantation for sacral neuromodulation, adaptable to individual patient anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional surgical technique is used for needle insertion, then the procedure can be performed with standard equipment, but the lead placement precision is insufficient leading to variable clinical outcomes
Solution Approach 1:
The method performs preliminary skin markings and fluoroscopic localization of the sacral foramen before needle insertion. The procedure includes marking the midline, horizontal line through sacroiliac joints, and vertical lines indicating foramen positions, allowing precise needle placement without complex real-time guidance equipment.
Solution Approach 2:
The patent uses fluoroscopy as an intermediary imaging modality to visualize the sacral foramen and confirm needle position. The fluoroscopic images serve as a mediator between the surgeon's visual field and the actual anatomical structures, enabling precise lead placement without requiring complex surgical robots or advanced navigation systems.
2Reliability
If skilled medical staff perform the procedure with optimal technique, then clinical outcomes are effective, but the procedure remains expensive and inaccessible to many patients
Solution Approach 1:
The method enables the procedure to be self-guiding through systematic skin markings and fluoroscopic verification. The markings themselves serve as the guidance system, eliminating the need for highly skilled operators to perform complex real-time judgment. Any trained provider can follow the marking protocol to achieve consistent, effective outcomes.
3Reliability
If multiple procedures are performed to improve clinical outcome, then better results can be achieved, but the expense and inconvenience increase significantly
Solution Approach 1:
The procedure performs all necessary planning and localization actions before needle insertion, including skin markings, fluoroscopic verification of foramen position, and confirmation of needle placement. This preliminary preparation ensures that the lead is placed correctly on the first attempt, eliminating the need for revision procedures and reducing total treatment time.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This method enhances the precision and effectiveness of sacral neuromodulation lead placement, improving clinical outcomes and reducing the need for additional procedures, thereby increasing accessibility and success rates for patients.
Implementation Method 1
visualizing with fluoroscopy an anterior/posterior view of the sacrum and sacroiliac joints of the patient
Implementation Method 2
confirming with electrical stimulation to ensure effective lead implantation
Data Source
AI summary
A method for needle positioning for lead implantation for sacral neuromodulation uses fluoroscopy to locate anatomical landmarks. Markings on the skin of the patient are made to determine optimal positioning of a foramen needle used to position the leads and electrodes of an implantable electrical stimulator.