Partial Cuff with Porous Struts for Urethral Flow Control
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Solution Overview
Problem
Current treatments for urinary incontinence, such as implanting medical devices, often result in undesirable effects like damage to bladder, blood vessels, and nerves, and inaccurate control due to reliance on coupling with other anatomical structures, which can be challenging and difficult to implement, especially in women.
Innovation Solution
A partial cuff with a semi-cylindrical shape and struts that facilitate tissue ingrowth and fibrosis, allowing for adjustable pressure to control fluid flow in tubular organs like the urethra without occluding it, using a flexible base member with an expandable component that can be inflated or deflated to achieve desired coaptation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a medical device is implanted to treat urinary incontinence, then flow control is achieved, but damage to bladder, blood vessels, nerves and muscles occurs
Solution Approach 1:
The device is segmented into a C-shaped or U-shaped cuff structure with multiple struts and perpendicular members that can be independently adjusted. This segmentation allows the device to apply distributed pressure along the urethra rather than concentrated force at a single point, reducing tissue damage while maintaining flow control effectiveness.
Solution Approach 2:
The device incorporates adjustable and reconfigurable elements including expandable balloons, inflatable members, and movable struts that can be dynamically adjusted post-implantation. This dynamic capability allows the device to adapt to tissue healing and patient needs over time, maintaining effective flow control while minimizing tissue damage through progressive adjustment rather than fixed high-force compression.
2Stability of the object's composition
If coupling to other anatomical structures is used for flow control, then device stability is improved, but inaccurate control and damage to anatomical structures occur
Solution Approach 1:
The device extracts the flow control function from dependence on other anatomical structures by directly coupling to the urethra alone. The C-shaped cuff encircles the urethra and provides stable support through direct attachment to urethral tissue, eliminating the need to couple to bladder, prostate, or other surrounding structures. This isolation improves flow control accuracy by removing variables introduced by movement or changes in adjacent anatomical structures.
Solution Approach 2:
The device introduces a compliant intermediary layer including mesh material, fabric, or biocompatible coating between the rigid strut structure and the urethral tissue. This intermediary allows stable device positioning while distributing forces evenly across the urethra, preventing damage to surrounding anatomical structures and improving flow control accuracy through consistent, controlled pressure application.
3Reliability
If a rigid structure is used to restrict flow, then flow restriction effectiveness is improved, but tissue ingrowth and integration are hindered
Solution Approach 1:
The device incorporates porous or fenestrated structures in the form of mesh material, latticed frameworks, or perforated struts that allow tissue ingrowth through the device body. These porous regions maintain structural rigidity for effective flow restriction while providing pathways for tissue penetration and integration, solving the contradiction between mechanical support and biological integration.
Solution Approach 2:
The device uses composite construction combining rigid components (struts, frame members) with compliant, biointegrated materials (mesh, fabric, biocompatible polymers). The rigid elements provide flow restriction effectiveness while the compliant composite materials facilitate tissue ingrowth and integration, creating a unified structure that achieves both mechanical and biological objectives.
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
The solution provides effective flow restriction and continence improvement by increasing urethral resistance without damaging surrounding tissues, allowing natural voiding and minimizing incontinence, while being adjustable post-surgery to accommodate individual patient needs.
Implementation Method 1
The struts mitigate expansion of a sidewall of the tubular organ to which the struts are coupled while allowing expansion of another portion of the tubular organ between the first and second ends along the circumference
Implementation Method 2
The cuff may, but need not, incorporate an adjustable, expandable or deflatable component that applies pressure on one side of the urethra, allowing accurate adjustment to achieve desired coaptation
Implementation Method 3
The tapered edge has a length along the circumference that is less than a length along the circumference at the blunt edge, such that passage of material through the tubular organ from the tapered edge is facilitated
Data Source
AI summary
Aspects of the present disclosure are directed toward providing enhanced structural support to an organ. As may be implemented in accordance with one or more embodiments, an apparatus includes structure configured and arranged to partially encircle a tubular organ, having a semi-cylindrical shape with a tapered end and blunt end of the cylinder. A gap region provides a region of the organ that is unrestricted/unsupported. Struts/lattice facilitate ingrowth of tissue, and couple the apparatus to the organ, which allows the apparatus to provide support/restrict flow in the organ without necessarily coupling to any other structure (e.g., with the majority or all of the support provided via the apparatus as coupled onto and terminating on a sidewall of the tubular organ).