Modular Endourethral Prosthesis with Pressure-Actuated Valve
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing endo-urethral devices for treating stenosis and urinary incontinence due to prostatic hypertrophy and anatomical variations are not easily adaptable to individual patient anatomies, leading to issues such as improper fit, discomfort, and inefficiencies in urine flow and closure mechanisms.
Innovation Solution
A modular endo-urethral prosthesis kit comprising a proximal and distal part with adjustable lengths, featuring a valve element with resilient walls that change configuration based on abdominal pressure, allowing for anatomical adaptation and improved urine flow control, while minimizing stress on the urethra through axial flexibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed-length tubular casing is used for the endo-urethral device, then the manufacturing process is simplified, but the device cannot adapt to anatomical variations in different patients
Solution Approach 1:
The endo-urethral device is divided into multiple segments: a proximal tubular casing, a distal tubular casing, and an intermediate connection portion. This segmentation allows each component to be independently manufactured and then assembled to create a custom-length device that adapts to different anatomical variations in patients.
Solution Approach 2:
The connection portion between the proximal and distal tubular casings is designed with axial flexibility, allowing it to bend and adapt to the natural curvature of the urethra. This dynamic flexibility enables the device to conform to individual patient anatomy while maintaining structural integrity.
2Adaptability or versatility
If the tubular casing is made too long to accommodate all anatomical variations, then coverage is maximized, but discomfort and adverse reactions increase
Solution Approach 1:
By segmenting the device into modular components with adjustable connection portions, the system can be customized to match the exact anatomical needs of each patient, avoiding the use of excessive length that would cause discomfort while still providing adequate coverage for various anatomical variations.
Solution Approach 2:
The device allows for parameter changes in length by selecting different configurations of the connection portion and tubular casings. This enables optimization of the device length for each specific patient case, balancing coverage requirements with comfort to minimize adverse reactions.
3Ease of operation
If resilient walls are used in the valve assembly to enable automatic opening and closing, then the valve function is simplified, but imperfect opening and closure occurs leading to urine leakage
Solution Approach 1:
A magnetic plunger is introduced as an intermediary component within the valve assembly. This magnetic plunger interacts with external magnetic fields to provide precise control over the resilient walls, ensuring complete closure by overcoming the imperfections inherent in passive resilient wall mechanisms.
Solution Approach 2:
The passive mechanical resilient wall system is enhanced with magnetic actuation. External magnetic fields replace purely mechanical control, allowing for more precise and reliable valve closure while maintaining the automatic operation benefit. The magnetic plunger provides an additional degree of control to eliminate leakage.
4Ease of manufacture
If a non-modular fixed-design device is used, then manufacturing is easier and cost is lower, but the device cannot be adapted to different urethral lengths after prostatectomy
Solution Approach 1:
The device is segmented into modular components that can be assembled in different configurations. This modular design maintains manufacturing simplicity for each individual component while enabling extensive adaptability to different anatomical scenarios, including post-prostatectomy cases with varying urethral lengths.
Solution Approach 2:
The modular design creates a universal platform that can serve multiple functions and adapt to various anatomical conditions. The same basic components can be combined in different ways to address both pre-prostatectomy and post-prostatectomy scenarios, as well as various degrees of stenosis, maximizing versatility without requiring entirely different devices for each indication.
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 modular design allows for precise anatomical fitting, reducing discomfort and adverse reactions, while the valve mechanism ensures effective urine flow and control, addressing issues of improper fit and flow inefficiencies in existing devices.
Implementation Method 1
valve element with resilient walls that change configuration based on abdominal pressure
Data Source
Figure 1~4
Figure 5
Figure 6
AI summary
A kit for an endo-urethral prosthesis includes a proximal part (2) and a distal part (4), comprising respective proximal and distal tubular portions (24,46) configured to be arranged within a patient's urethra (7), and respective proximal and distal stents (21,49) configured to anchor internally to a urethra-vesical lumen and urethra, respectively, the proximal and distal tubular portions (24,46) having predetermined radial stiffness, and having, on opposite sides to the proximal and distal stents (21,49), proximal and distal connection ends (29,31) configured to fluid-tightly connect to each other forming a longitudinal duct (5) arranged to convey urine. The distal or proximal tubular portion (46,24) is divided into a first distal or proximal tubular element (35,25) and a second distal or proximal tubular element (45,34) comprising the distal or proximal connection end (31,29), wherein the first distal or proximal tubular element (35,25) and the second distal (45) or proximal tubular element (45,34) have respective mutual fluid-tight connection ends (37,44), the second distal or proximal tubular element (45,25) forming an intermediate part (3), preferably axially flexible, of the prosthesis. In this way, prostheses suitable for the many anatomical variations can be obtained by choosing the length of a single, preferably intermediate, part. In advantageous embodiments, an endo-urethral prosthesis comprises within the proximal and/or distal tubular portion (24,46), at least one valve element (50,150,250) configured to elastically deform, when an opening differential pressure (P*) is exceeded, from a rest closed configuration to a forced open configuration, so that the valve element (50,150,250) can open with an increase in abdominal pressure. In particular, a stopper element (156,256) of an improved valve element (150,250) includes resilient walls (155,255) separated by through slits (157,257) converging from a peripheral portion of the stopper element to a same convergence point (158,258) shifted from the central point of the valve element (150,250) by a predetermined distance (δ) of preferably at least 0,02 mm.