Push-Wire Implant Fixation for Stable Urethral Coaptation
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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 their efficacy in providing urinary continence.
Innovation Solution
An implantable device with a fixation mechanism using a push wire for anchoring and releasing from tissue, allowing for precise positioning, adjustment, and repositioning or removal, featuring an adjustable membrane element and a conduit with a push wire lumen for controlling coaptation.
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 housing, creating a compact nested arrangement that provides anchoring functionality without adding external complexity to the 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 adjusting the membrane element coaptation. This multi-functionality reduces the need for separate control elements, thereby improving reliability while limiting the increase in device complexity.
2Ease of operation
If a push wire lumen is included in the conduit for accommodating the push wire, then ease of operation for device adjustment and repositioning is improved, but device complexity increases
Solution Approach 1:
The push wire lumen is merged with the conduit structure, forming an integrated component rather than a separate tube. This combining of functions reduces the total number of discrete parts, making the device easier to operate while minimizing the increase in overall complexity.
3Adaptability or versatility
If the fixation mechanism allows for release from tissue using another movement of the push wire, then adaptability for repositioning or removal is improved, but reliability may worsen due to additional failure points
Solution Approach 1:
The fixation mechanism transitions from a static anchored state to a dynamic releasable state through the push wire movement. This dynamic design allows the device to adapt between fixed and movable states, providing repositioning capability while maintaining reliability through a controlled, single-mechanism transition process.
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.