Implantable Sphincter Device with Composite Magnetic Links
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Solution Overview
Problem
Current treatments for anatomical lumens, such as the esophagus, fail to effectively address the compromised ability of biological passages 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 and links with embedded magnets, designed to be implanted around the lower esophageal sphincter, which uses magnetic attraction to maintain a closed state and allow expansion for food passage while preventing reflux, with adjustable constriction force based on dilation ratio.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a sphincter augmentation device is implanted to maintain a closed state and prevent reflux, then reflux prevention is improved, but the device's ability to allow normal food passage while maintaining constriction force becomes compromised
Solution Approach 1:
The device employs dynamic interconnection elements that can adjust their mechanical properties in response to applied forces. When food attempts to pass through, the elements flex and allow expansion; when reflux pressure is applied, they maintain constriction. This dynamic behavior resolves the contradiction between maintaining a closed state for reflux prevention and allowing normal food passage.
Solution Approach 2:
The interconnection elements change their mechanical parameters (stiffness, flexibility) based on the dilation ratio of the sphincter. As the sphincter dilates during normal swallowing, the elements adjust their constriction force accordingly, allowing food passage while maintaining sufficient pressure to prevent reflux. This parameter adjustment resolves the contradiction between fixed constriction and variable passage needs.
2Object-affected harmful factors
If the device maintains a closed state with high constriction force to prevent reflux, then reflux prevention is improved, but the device complexity increases due to the need for adjustable constriction force mechanisms
Solution Approach 1:
The interconnection elements are designed to automatically adjust their constriction force based on the sphincter's dilation ratio without requiring external control mechanisms. The elements inherently sense the state of the sphincter and adjust their mechanical properties accordingly, eliminating the need for complex active control systems while maintaining effective reflux prevention.
Solution Approach 2:
The device utilizes passive parameter changes in the interconnection elements that automatically adapt to the sphincter's state. As the dilation ratio changes during normal function, the elements' mechanical properties change accordingly, providing adjustable constriction force without requiring active control mechanisms, thereby reducing device complexity while maintaining reflux prevention efficacy.
3Strength
If composite material interconnection elements are used to provide both flexibility and strength, then structural integrity is improved, but manufacturing precision requirements increase
Solution Approach 1:
The interconnection elements are constructed from composite materials that combine flexible and strong properties in a single integrated structure. This eliminates the need for assembling multiple separate components, thereby reducing manufacturing precision requirements while maintaining structural integrity. The composite structure inherently provides both the flexibility needed for sphincter movement and the strength required for reflux prevention.
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 closed state of the lower esophageal sphincter while allowing normal passage of food, thus addressing the compromised functionality of anatomical lumens.
Implementation Method 1
A sphincter augmentation device comprising a series of beads and links with embedded magnets, designed to be implanted around the lower esophageal sphincter, which uses magnetic attraction to maintain a closed state
Data Source
AI summary
An apparatus includes a plurality of beads. Each bead of the plurality of beads includes a housing and a magnet positioned within the at least one housing. The apparatus also includes a plurality of interconnection elements. Each interconnection element movably joins together a corresponding pair of beads. Each interconnection element includes a composite material. The plurality of beads and the plurality of interconnection elements are sized and configured to form a loop around an anatomical structure in a patient. The loop formed by the plurality of beads and the plurality of interconnection elements is configured to transition between a constricted configuration and an expanded configuration. The loop in the constricted configuration is configured to prevent fluid flow through the anatomical structure. The loop in the expanded configuration is configured to permit fluid flow through the anatomical structure. The magnets are configured to magnetically bias the loop toward the constricted configuration.