Occlusive Hydrogel Delivery and Removal With Stylet-Guided Lumen Access
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Solution Overview
Problem
Existing methods for delivering and removing occlusive devices in bodily lumens, such as the vas deferens or fallopian tubes, face challenges including inaccurate placement, potential injury from sharp needles, and difficulty in confirming proper insertion and removal, leading to complications and reduced efficacy.
Innovation Solution
A system utilizing a sheath and probe mechanism that confirms intraluminal access and placement, includes methods for agitating and removing materials, and uses a lockout latch to ensure proper insertion depth, along with mechanisms for confirming occlusion and patency, minimizing invasiveness and user steps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a hypodermic needle system is used to deliver occlusive devices into bodily lumens, then the delivery can be performed, but the distal end of the needle may inadvertently miss the lumen and deliver the hydrogel in an unintended location
Solution Approach 1:
A stylet is introduced as an intermediary component within the needle system. The stylet serves as a mediator that provides tactile feedback to the operator, allowing detection of the needle's position relative to the lumen wall through tactile sensation during advancement, thereby improving placement accuracy without requiring complex imaging or guidance systems
Solution Approach 2:
The stylet provides real-time tactile feedback to the operator during the injection process. By sensing the resistance and tactile cues from the lumen wall, the operator can adjust the needle position and depth to ensure accurate intraluminal placement before hydrogel delivery, preventing unintended delivery locations
2Ease of operation
If the needle remains in the lumen throughout the procedure, then continuous access is maintained, but patient movement or physician movement can alter needle positioning and cause unintended protrusion or perforation
Solution Approach 1:
The stylet acts as a cushioning element between the needle and the lumen wall. When the needle is advanced, the stylet can be pushed forward to contact the lumen wall first, cushioning the interaction and preventing the sharp needle tip from directly perforating or protruding beyond the lumen, thereby reducing harmful effects while maintaining continuous access
Solution Approach 2:
The stylet serves as a protective intermediary that is positioned ahead of the needle tip during advancement. This mediator absorbs the mechanical interaction with tissue, preventing direct contact between the sharp needle and surrounding tissues, thus eliminating the harmful protrusion and perforation risks while allowing continuous needle presence in the lumen
3Speed
If the sharp distal end of the needle is used for initial penetration, then entry into the lumen is achieved, but the needle may embed within the wall of the vas deferens in an interstitial location
Solution Approach 1:
The stylet serves as a precision-controlled intermediary that is advanced independently of the needle. The operator can control the stylet's advancement distance to precisely match the desired needle penetration depth, ensuring the needle tip reaches exactly the lumen entrance without embedding too deeply into the wall, thus improving insertion depth control while maintaining rapid penetration capability
Solution Approach 2:
The stylet is advanced beforehand to the desired depth mark before the needle is fully inserted. This preliminary positioning of the stylet establishes a precise depth reference that guides the subsequent needle advancement, ensuring accurate insertion depth and preventing over-penetration into the lumen wall
Data Source
AI summary
Delivery systems for providing occlusive hydrogels in a tube lumen or void space within the body including but not limited to a reproductive tract such as the vas deferens or fallopian tubes for contraception are described. The delivery systems contain mechanisms that confirm proper placement of the system in the bodily lumen prior to the delivery of the occlusive material. The systems also can contain a confirmatory mechanism that demonstrates the blockage or occlusion in the bodily lumen has been achieved following the deposition of the occlusive material. Another aspect of this application is to provide a removal system that delivers dissolving material, agitates, aspirates, and confirms the patency of the bodily lumen following the removal of the occlusive material if so desired by the patient for the return to fertility.