Intra-vaginal Device with Deformable Proximal Portion for Urinary Incontinence
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Solution Overview
Problem
Current devices for treating urinary incontinence in females, such as those providing constant pressure to the urethra, are either rigid, require external inflation/deflation mechanisms, or come in various sizes to fit individual women, failing to offer a self-contained, adjustable solution that mimics natural pelvic floor muscle activation.
Innovation Solution
A dynamic intra-vaginal device with a deformable distal and proximal portion that adjusts pressure based on intra-vaginal pressure and pelvic floor muscle contraction, using a deformation controlling mechanism to apply pressure only when needed, thus preventing incontinence and allowing for pelvic floor muscle rehabilitation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a device provides constant pressure to the urethra to prevent incontinence, then incontinence prevention is improved, but tissue injury risk increases and energy consumption increases
Solution Approach 1:
The device transitions from a static constant-pressure design to a dynamic pressure-regulation system. The inflatable proximal portion can adjust its volume and pressure in real-time based on intra-abdominal pressure changes, allowing the device to provide support only when needed rather than maintaining constant pressure, thereby reducing tissue injury risk while maintaining incontinence prevention effectiveness
Solution Approach 2:
The device changes the pressure parameter dynamically rather than maintaining a fixed value. By controlling the inflation/deflation of the proximal portion in response to pressure sensors or user activation, the system adjusts pressure levels to match physiological needs, providing high pressure during stress events and low or zero pressure during normal conditions
2Stability of the object's composition
If a device is made rigid to provide structural support, then support stability is improved, but adaptability to different women decreases
Solution Approach 1:
The device employs flexible, deformable portions rather than rigid structures. The distal portion can deform to accommodate different vaginal anatomies, while the proximal portion can be inflated or deflated to adjust support levels. This dynamic flexibility allows a single device design to adapt to various women's anatomical differences without compromising structural support when activated
Solution Approach 2:
The device utilizes flexible materials and thin-walled inflatable structures that can conform to individual anatomical variations. The flexible distal portion adapts to the vaginal canal shape, while the inflatable proximal portion provides adjustable rigid support only when needed, combining flexibility for adaptation with temporary rigidity for support
3Ease of operation
If a device includes external inflation/deflation mechanisms, then pressure control is improved, but device complexity increases
Solution Approach 1:
The device incorporates automatic self-regulation through pressure sensors that detect intra-abdominal pressure changes and trigger inflation or deflation of the proximal portion without external intervention. This self-service mechanism simplifies the user experience to merely insertion and removal, while the device autonomously manages pressure control, reducing the need for complex external control systems
Solution Approach 2:
The device includes pressure sensing elements that provide feedback about intra-abdominal pressure levels to a control system, which then adjusts the inflation state of the proximal portion accordingly. This closed-loop feedback mechanism enables automatic pressure regulation, simplifying operation while managing complexity through intelligent control rather than mechanical complexity
4Reliability
If a device provides constant pressure to the urethra, then incontinence prevention is improved, but energy consumption increases
Solution Approach 1:
The device switches from continuous constant-pressure operation to periodic intermittent operation. The proximal portion inflates only during periods of increased intra-abdominal pressure that risk causing incontinence, and deflates during normal low-pressure periods. This periodic activation pattern maintains incontinence prevention effectiveness while dramatically reducing overall energy consumption by keeping the device inactive most of the time
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 prevents urinary incontinence by applying pressure only during increased intra-abdominal pressure or muscle contraction, reducing tissue injury risk and allowing for voluntary muscle strengthening, providing a self-contained, adjustable solution that fits all women without the need for external components.
Implementation Method 1
The device is inserted such that the distal end is adjacent to the urinary bladder. When the bladder is full, distal end is deflected, and the leverage provided by the increased pressure from the bladder deflects proximal end in the opposite direction, closing the urethra.
Implementation Method 2
a deformable proximal portion designed to be placed in the suburethral portion of the vagina; said deformable proximal portion is characterized by a deformable state and an un-deformable state
Implementation Method 3
upon predetermined amount of intra-vaginal pressure applied on said proximal portion, said deformation controlling mechanism is adapted to transform proximal portion from its un-deformable state to its deformable state such that pressure is applied on said urethra
Data Source
AI summary
An intra-vaginal device for controlling urinary incontinence, designed to be placed longitudinally in the vagina, includes: a. a deformable distal portion, placed in the subvesical region of the vagina, characterized by a deformable state and an un-deformable state; b. a deformable proximal portion placed in the sub-urethral portion of the vagina, characterized by a deformable state and an un-deformable state; c. a deformation controlling mechanism interconnecting said distal portion and said proximal portion, adapted to reversibly transform said distal portion and said proximal portion form said deformable state to said un-deformable state; and from said un-deformable state to said deformable state; wherein upon predetermined amount of intra-vaginal pressure applied on said proximal portion, said deformation controlling mechanism is adapted to transform proximal portion from its un-deformable state to its deformable state such that pressure is applied on said urethra.