Adjustable Urethral Sling Tensioning for Stress Incontinence
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Solution Overview
Problem
Existing treatments for stress urinary incontinence, such as pubovaginal slings, can cause severe damages like infection, erosion, and provide inadequate support that does not align with the body's requirements at all times.
Innovation Solution
An implantable system with a pressure sensor and processing circuit that adjusts the tensioning force of an elongate body member, using elastomeric tubes or shape memory polymers, to provide support to the urethra or bladder neck only during stress events, thereby preventing urine leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If permanent support is provided by slings to treat stress urinary incontinence, then continence is restored, but severe damages such as infection, erosion, and irritation occur
Solution Approach 1:
The sling system transitions from a static permanent support structure to a dynamic adjustable system. The sling can be tensioned or relaxed based on real-time physiological conditions (intra-abdominal pressure, bladder fullness), allowing it to provide support only when needed rather than continuously, thereby reducing tissue damage while maintaining continence restoration
Solution Approach 2:
The system changes the physical parameters of the sling (tension, position) based on sensed physiological conditions. Sensors detect intra-abdominal pressure and bladder volume, and the system adjusts the sling's tensioning force accordingly, transforming the sling from a fixed structure to an adaptively controlled support mechanism
2Reliability
If continuous support is provided by slings, then urethral closure pressure is maintained, but the support does not align with body requirements at particular instants
Solution Approach 1:
The system incorporates sensors that continuously monitor physiological parameters (intra-abdominal pressure, bladder volume) and feed this information back to the control mechanism. This feedback loop enables the sling to adjust its support level dynamically, providing urethral closure pressure only when physiological conditions require it, thus aligning support with body requirements
Solution Approach 2:
The system autonomously adjusts the sling's support level based on sensor input without requiring external intervention. The control system automatically interprets physiological signals and modulates the tensioning mechanism accordingly, enabling the sling to self-regulate its support function according to real-time body needs
3Adaptability or versatility
If adjustable tensioning force is implemented, then support is provided only when needed, but device complexity increases
Solution Approach 1:
The system introduces intermediary components (sensors, control circuitry, adjustable tensioning mechanism) that mediate between the patient's physiological state and the sling's support function. These intermediaries enable sophisticated control and adaptability while keeping the core sling structure relatively simple and the adjustment mechanisms integrated
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 system provides adequate support only when needed, reducing tissue damage and infection risks by adjusting tensioning force dynamically based on intra-abdominal pressure changes.
Implementation Method 1
a pressure sensor communicatively coupled with the elongated body member and configured to be positioned in an abdominal cavity and adapted to sense an increase in intra-abdominal pressure transferred from the abdominal cavity. The pressure sensor generates a first signal that is indicative of a change in the intra-abdominal pressure
Implementation Method 2
an elastomeric tube that is fabricated monolithically with the elongate body member. The tube may include a lumen there-through for allowing circulation of a fluid, wherein the circulation of fluid allows adjustments in the tensioning force
Implementation Method 3
a shape memory polymer member at least one of coupled with and integrated with the elongate body member. The shape memory polymer member may be configured to deform from an initial state to a second state in response to the second signal received from the processing circuit
Data Source
AI summary
An automatically adjustable implantable system for managing urinary incontinence, the implantable system comprising a sling having an elongate body member with a proximal portion, a distal portion and an intermediate portion, wherein the intermediate portion is configured to be positioned underneath urethra of a patient; and a shape memory polymer member at least one of coupled with and integrated with the elongate body member, wherein the shape memory polymer member is configured to deform from an initial state to a second state in response to a signal received from a processing circuit, wherein the deformation in the shape memory polymer member allows for adjustments in a tensioning force provided to the elongate body member upon occurrence of a stress event.