Implantable Urinary Continence Device With Push-Wire Anchoring
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Solution Overview
Problem
Existing implantable devices for treating urinary incontinence face challenges in maintaining accurate placement, adjustment, and preventing migration post-implantation, which affects treatment efficacy.
Innovation Solution
An implantable device with a fixation mechanism anchored to tissue using a push wire, allowing for secure positioning and adjustable coaptation of body lumens, featuring a conduit with a push wire lumen and a fixation mechanism that can be activated or deactivated for repositioning or removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a fixation mechanism is added to anchor the implantable device to tissue, then device stability and prevention of migration is improved, but device complexity increases
Solution Approach 1:
The fixation mechanism is nested within the conduit structure, with the push wire lumen integrated into the conduit wall. The push wire itself is contained within the fixation mechanism's housing or structure, creating a compact nested arrangement that provides fixation functionality without adding external complexity to the overall device profile.
Solution Approach 2:
The push wire serves multiple functions: it acts as both the actuation mechanism for the fixation mechanism and the means for deploying the adjustable membrane element. The conduit serves both as a structural housing and as a pathway for the push wire lumen. This multi-functionality reduces the need for separate components, thereby improving reliability without proportionally increasing complexity.
2Adaptability or versatility
If the fixation mechanism allows for release and repositioning, then adaptability is improved, but reliability of anchoring decreases
Solution Approach 1:
The fixation mechanism transitions from a static anchored state to a dynamic releasable state through push wire actuation. The mechanism includes movable components such as expandable arms or hooks that can be deployed to engage tissue and then retracted or disengaged through push wire movement. This dynamic design allows the same structure to provide strong anchoring when needed while enabling release when repositioning is required, balancing reliability and adaptability.
Solution Approach 2:
The fixation mechanism is designed to be temporarily discarded (released from tissue) if repositioning is needed, and can be recovered (re-deployed) at a new location. The push wire system allows for controlled release of the fixation elements from tissue engagement, and the same mechanism can be re-engaged at a different position, enabling the device to be relocated while maintaining reliable anchoring at each position.
3Ease of operation
If the push wire lumen diameter is optimized for push wire accommodation, then ease of operation is improved, but manufacturing precision requirements increase
Solution Approach 1:
The push wire lumen diameter is optimized within a specific parameter range that balances ease of push wire insertion with manufacturability. Rather than specifying an extremely tight tolerance, the design accepts a reasonable diameter range that ensures smooth push wire passage while remaining compatible with standard manufacturing capabilities. The push wire diameter itself is selected to match this optimized lumen dimension, creating a coordinated parameter set that satisfies both operational ease and manufacturing feasibility.
Data Source
AI summary
An implantable device includes a conduit, an adjustable membrane element coupled to the conduit near the front end of the conduit for controllable coaptation of a body lumen, such as coaptation of a urethra as treatment for urinary incontinence, and a fixation mechanism at or near the front end of the conduit. In various embodiments, the fixation mechanism can anchor the implantable device to the tissue using a movement of a push wire. Optionally, the fixation mechanism can also allow the implantable device to be released from the tissue using another movement of the push wire, to allow for repositioning or removal of the implantable device.