Urological Valve with Pressure-Responsive Leaflets
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Solution Overview
Problem
There is a need for a urological device that improves patient quality of life by eliminating the need for a urine bag and facilitating normal social functioning, particularly for males who have experienced stress urinary incontinence due to radical prostatectomy or adjuvant radiotherapy for prostate cancer.
Innovation Solution
A urological device comprising a bladder-mounted valve with a normally closed configuration that automatically opens in response to pre-set hydrodynamic pressure, allowing fluid flow and returning to the closed state when pressure is reduced, integrated with a bladder retainer and urethral support to prevent migration and ensure proper positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a valve is designed to remain closed under high pressure spikes (e.g., 900mm H2O for less than 0.5 seconds), then continence is improved, but the valve may fail to open when needed for normal voiding
Solution Approach 1:
The valve incorporates a time-dependent pressure response mechanism that dynamically distinguishes between transient pressure spikes and sustained voiding pressure. The valve remains closed during brief high-pressure events (coughing, sneezing) but opens during sustained pressure application, achieving both continence and normal voiding function through temporal discrimination of pressure signals.
2Ease of operation
If a valve is designed to open in response to preset pressure applied over preset time (e.g., 750mm H2O for at least 5 seconds), then normal voiding is facilitated, but the device complexity increases
Solution Approach 1:
The valve utilizes the patient's own physiological pressure signals to automatically control opening and closing. The pressure-sensitive material and time-dependent response mechanism eliminate the need for external controls, batteries, or complex electronic systems, allowing the valve to self-regulate based on natural voiding physiology.
3Adaptability or versatility
If a valve made of viscoelastic polymeric foam material is used, then the valve provides automatic pressure-responsive opening, but the manufacturing precision and material selection become more challenging
Solution Approach 1:
The invention utilizes the inherent viscoelastic properties of polymeric foam materials, which naturally exhibit time-dependent mechanical response to pressure. By selecting materials with appropriate viscosity and elasticity parameters, the valve achieves automatic pressure-responsive opening without requiring complex manufacturing processes or precise fabrication tolerances.
4Ease of operation
If the valve leaflets evert on movement between closed and open configuration, then the valve provides smooth transition and reduced turbulence, but the structural integrity and durability may be compromised
Solution Approach 1:
The valve incorporates reinforcing elements within the polymeric foam structure to maintain structural integrity during the eversion and return motion of the leaflets. The composite construction allows the leaflets to flex and invert smoothly for turbulent-free flow while the reinforcing structure prevents material failure over repeated cycles.
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 device effectively manages urinary incontinence by allowing controlled fluid flow without the need for constant user intervention, reducing the risk of encrustation and extending the lifespan of catheters, and improving bladder tone and social functioning.
Implementation Method 1
The valve is automatically movable from the closed configuration to the open configuration in response to a pre-set hydrodynamic pressure applied for a pre-set time
Implementation Method 2
the valve returns to the closed configuration when flow through the valve has substantially stopped
Implementation Method 3
The valve may be of a viscoelastic polymeric foam material
Data Source
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Figure 5~8
AI summary
A urological device 800, 810, 830, 850, 860, 870, 900, 910, 920 comprises a urological valve 802, 803, 812, 861, 901, for location in the bladder of a patient and a valve support stem 801, 813, 863, 902, for location in the urethra of a patient. The valve has a normally closed configuration to prevent flow from the bladder and an open configuration for fluid flow through the valve. The valve is automatically movable from the closed configuration to the open configuration in response to a pre-set hydrodynamic pressure applied for a pre-set time. In one case the valve has a plurality of valve leaflets with a region of co-aption between the valve leaflets. In the normally closed configuration the valve leaflets are engaged at the region of co-aption and in the open configuration the leaflets are separated at the co-aption region for fluid flow through the valve.