Artificial Contractile Structure for Sphincter Function
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Solution Overview
Problem
Current artificial sphincter devices for urinary and faecal incontinence suffer from tissue erosion, necrosis, and mechanical failures due to constant pressure and heating, leading to ineffective and costly treatments with high risks of incontinence and emergency surgeries.
Innovation Solution
A medical device featuring an implantable artificial contractile structure with flexible contractile elements connected to independent actuators, allowing each element to be in a resting or activated position independently, with minimal pressure application to avoid tissue damage and optimal pressure control, using contractile materials like Nitinol fibers and electromotors for pulsatory contraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If constant pressure is applied by artificial sphincter devices to maintain sphincter function, then incontinence is prevented, but tissue erosion and necrosis occur due to excessive pressure
Solution Approach 1:
The artificial sphincter device applies pressure periodically rather than continuously. The contractile elements are activated in alternating sequences, creating pulsatory pressure cycles that maintain sphincter function while allowing tissue recovery periods, thereby preventing erosion and necrosis caused by constant pressure.
Solution Approach 2:
The sphincter is divided into multiple independent contractile elements that can be activated separately in alternating sequences. This segmentation allows different portions of the sphincter to be active at different times, distributing the pressure load and preventing localized tissue damage while maintaining overall sphincter function.
2Ease of operation
If shape memory alloy elements are heated to open the artificial sphincter, then the sphincter can be opened, but tissue burns occur due to excessive heating
Solution Approach 1:
The device replaces thermal actuation with electrical actuation. Electromotors or electroactive polymer fibers are used instead of shape memory alloys requiring heating. These electrical actuators can open and close the sphincter through electrical signals without generating harmful heat, eliminating the risk of tissue burns while maintaining ease of operation.
3Device complexity
If a single artificial sphincter device is implanted to treat incontinence, then treatment is simplified, but mechanical failures lead to emergency surgeries
Solution Approach 1:
The artificial sphincter is divided into multiple independent contractile elements rather than a single unified structure. Each element operates independently with its own actuator, creating redundant pathways for sphincter function. If one element fails, others can continue to function, preventing complete device failure and avoiding emergency surgeries.
4Strength
If contractile elements are rigid to maintain structural integrity, then device strength is improved, but flexible movement is restricted leading to tissue damage
Solution Approach 1:
The contractile elements are constructed with flexible materials such as elastic polymers or shape memory alloys that can bend and conform to tissue movement. These flexible structures maintain sufficient structural integrity to transmit contractile forces while adapting to physiological movements, preventing tissue damage caused by rigid structures.
Solution Approach 2:
The contractile elements use composite material structures combining rigid reinforcing elements with flexible matrices. This composite construction provides the necessary strength for effective contraction while maintaining flexibility to accommodate tissue movement and physiological changes without causing damage.
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 minimizes tissue damage, reduces the risk of incontinence, and offers long-term implantation with reduced healthcare costs by applying minimal pressure and allowing flexible movement, ensuring effective sphincter function and improved patient quality of life.
Implementation Method 1
Some publications describe the use of artificial sphincters comprising shape memory alloy elements suitable for opening and closing a part of an organ in a living body
Implementation Method 2
using contractile materials like Nitinol fibers and electromotors for pulsatory contraction
Data Source
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AI summary
The present invention relates to artificial contractile structures generally devised to be used in the medical field. Such structures may be advantageously used to assist the functioning of an organ. The medical device comprises an artificial contractile structure comprising at least two contractile elements (100) adapted to contract an organ, in such way that each of said contractile elements (100) can be in a resting or in an activated position, independently of the position of each other, the activated position being defined with said contractile element (100) constricting the organ and the resting position being defined with said contractile element (100) not constricting the organ, and at least one actuator designed to activate said contractile structure. Each contractile element (100) is connected to an adjacent contractile element (100), while remaining flexible one with respect to the other.