Pudendal Nerve Electrode Placement via Introducer Sheath
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Solution Overview
Problem
Current electrical stimulation therapies for incontinence, such as sacral neuromodulation, have limited success in providing a complete cure and often require high skill and precision for lead placement, which can be challenging due to the complex anatomy of the pudendal nerve.
Innovation Solution
The use of a device comprising an introducer sheath, an obturator, and a needle to facilitate the placement of an electrode lead near the pudendal nerve, allowing for easier access and accurate placement despite the nerve's complex anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sacral neuromodulation is used to treat incontinence, then incontinence episodes are reduced, but complete cure is achieved much less frequently
Solution Approach 1:
The patent introduces an intermediary device system comprising an introducer sheath, obturator, and needle assembly that facilitates precise electrode placement on the pudendal nerve. This intermediary mechanism enables reliable electrical stimulation of the pudendal nerve, which has been shown to provide complete cure in incontinence patients, thereby resolving the contradiction between treatment reliability and cure frequency.
Solution Approach 2:
The patent replaces the conventional mechanical lead placement approach with an electrophysiological guidance system. By using electrical signals to identify and target the pudendal nerve, the system achieves more precise and reliable electrode placement, increasing the frequency of complete cure while maintaining treatment reliability.
2Manufacturing precision
If lead placement is performed with high skill and precision, then electrode placement accuracy is improved, but procedure complexity and difficulty increase
Solution Approach 1:
The patent segments the lead placement procedure into distinct functional components: an introducer sheath for initial access, an obturator for positioning, and a needle for final electrode deployment. This segmentation allows each component to perform its specific function with optimized design, reducing overall procedure complexity while maintaining high placement accuracy.
Solution Approach 2:
The patent employs an intermediary guidance system that uses electrical signals as a mediator between the operator and the target nerve. This electrophysiological feedback mechanism simplifies the placement process by providing real-time guidance, reducing the skill level required while maintaining high precision in electrode placement.
3Reliability
If pudendal nerve targeting is used to treat incontinence, then treatment effectiveness is improved, but access and lead fixation difficulty increase
Solution Approach 1:
The patent uses an intermediary device assembly as a mediator to access the pudendal nerve. The introducer sheath serves as a protective conduit that guides the electrode through the complex anatomical pathway to the pudendal nerve, while the obturator and needle components facilitate precise placement. This intermediary system simplifies the access procedure while maintaining treatment effectiveness.
Solution Approach 2:
The patent replaces conventional mechanical access methods with electrophysiological guidance to locate and target the pudendal nerve. This substitution simplifies the access procedure by using electrical signals to navigate the complex anatomy, making the procedure easier to perform while maintaining high treatment effectiveness through precise nerve targeting.
Data Source
AI summary
Provided herein are devices, systems, and methods for accessing the pudendal nerve to place an electrical lead on the pudendal nerve for treatment by electrical nerve stimulation. Described herein are devices, systems, and methods for providing electrical nerve stimulation to prevent an episode of incontinence in an individual in need thereof.