Sphincter Augmentation Device with Dual Zone Constriction
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Solution Overview
Problem
Current treatments for anatomical lumens, such as the esophagus, fail to effectively address the compromised ability to expand and contract due to defects or diseases like GERD, leading to reflux symptoms and tissue damage.
Innovation Solution
A sphincter augmentation device comprising a series of beads linked by interconnection elements, utilizing rare-earth magnets and adjustable constriction forces to enhance the functionality of the lower esophageal sphincter, allowing for controlled expansion and contraction to prevent reflux while allowing food passage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a sphincter augmentation device is placed around the lower esophageal sphincter to increase constriction force, then reflux prevention is improved, but the device may obstruct normal food passage
Solution Approach 1:
The device employs shape memory alloy interconnection elements that can dynamically change their mechanical properties between a constrained state (providing high constriction force to prevent reflux) and an expanded state (allowing food passage). The interconnection elements respond to thermal or mechanical stimuli to transition between these states, enabling the device to adapt its constriction force in real-time
Solution Approach 2:
The device changes the physical parameters of the interconnection elements by altering their temperature or applied force, which transforms the shape memory alloy from a rigid constrained state to a flexible expanded state. This parameter change allows the device to modulate the constriction force applied to the sphincter, balancing reflux prevention with food passage capability
2Manufacturing precision
If the device applies uniform constriction force to accommodate varying diameters, then homogeneous force application is improved, but the device structure becomes more complex
Solution Approach 1:
The device is divided into multiple modular units consisting of beads and interconnection elements. Each interconnection element independently responds to local conditions and applies force to adjacent beads, ensuring homogeneous force distribution across the device circumference while maintaining a relatively simple modular structure that is easier to manufacture and deploy
Solution Approach 2:
The device achieves homogeneous force application through symmetric arrangement of identical interconnection elements around the circular structure. Each element applies equal constriction force to its adjacent beads, ensuring uniform pressure distribution across the sphincter circumference regardless of variations in esophageal diameter
3Force
If rare-earth magnets are used to provide constriction force, then the constriction force is improved, but the device may cause tissue damage from excessive force
Solution Approach 1:
The device incorporates shape memory alloy interconnection elements that act as feedback mechanisms, automatically adjusting the constriction force based on the resistance encountered. When the sphincter tissue resists constriction, the interconnection elements flex or deform, reducing the force applied by the magnets to prevent tissue damage. This passive feedback system ensures the force remains within safe limits
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 reflux and tissue damage by maintaining a controlled constriction force, allowing for normal food passage and accommodating varying diameters and lengths to ensure homogeneous force application, thereby improving the functionality of the lower esophageal sphincter.
Implementation Method 1
utilizing rare-earth magnets and adjustable constriction forces to enhance the functionality of the lower esophageal sphincter
Data Source
AI summary
An apparatus includes a plurality of beads. Each bead includes a housing and a magnet positioned within the housing. The apparatus also includes a plurality of interconnection elements. Each interconnection element movably joins together a corresponding pair of beads. The plurality of beads and the plurality of interconnection elements are sized and configured to form an expandable loop around an anatomical structure in a patient. The expandable loop is configured to apply a constrictive force to the anatomical structure. The constrictive force has a first rate of change when a dilation ratio of the expandable loop is within a first range, a second rate of change when the dilation ratio of the expandable loop is within a second range, and a third rate of change when the dilation ratio of the expandable loop is within a third range.