Magnetic LES Bead Link With Single-Use Emergency Release
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Solution Overview
Problem
Biological lumens such as the esophagus can experience compromised functionality due to conditions like GERD, leading to reflux symptoms, as the lower esophageal sphincter fails to maintain pressure differences, allowing acidic contents to reflux into the esophagus.
Innovation Solution
An implantable sphincter augmentation device with magnetically attracted beads and links is deployed around the LES to maintain a closed state, preventing reflux while allowing food passage, featuring interconnection elements with enhanced structural integrity and flexibility to accommodate normal physiological functions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the LES is augmented with an implantable device to prevent reflux, then reflux prevention is improved, but device reliability may worsen due to potential magnetic decoupling under strong magnetic fields
Solution Approach 1:
The patent incorporates a single-use emergency release decoupling interconnection link that is designed to fail safely under strong magnetic fields. This link includes a magnetic component that can be decoupled by external magnetic fields, providing a predetermined failure mode that prevents catastrophic device failure while maintaining reliability under normal operating conditions. The link acts as a safety mechanism that cushions against the harmful effects of strong magnetic fields.
Solution Approach 2:
The decoupling interconnection link is designed as a single-use, disposable component with limited structural integrity. It is intentionally made weaker than other device components so that it will fail first under extreme magnetic field exposure, protecting the rest of the device. After its protective function is exhausted, the link is discarded, embodying the disposable component principle.
2Strength
If the interconnection link is made stronger to withstand magnetic fields, then device strength is improved, but the ability to allow emergency release worsens
Solution Approach 1:
The interconnection link exhibits local quality by having different strength characteristics in different contexts. Under normal physiological conditions, the link maintains sufficient strength to hold the device together. However, under strong magnetic fields, the magnetic component's strength is deliberately reduced to allow decoupling. This spatial and contextual variation in strength properties resolves the contradiction between overall device strength and emergency release capability.
Solution Approach 2:
The magnetic component's effective strength parameter changes based on the external magnetic field environment. In normal conditions, it maintains strong magnetic coupling to ensure device integrity. Under strong external magnetic fields, the coupling strength decreases, enabling emergency release. This dynamic parameter change allows the link to satisfy both strength and ease of operation requirements under different conditions.
3Reliability
If the device structure is made more complex to improve structural integrity, then device reliability is improved, but device complexity increases
Solution Approach 1:
The device is segmented into multiple components with differentiated functions: strong structural components for maintaining device integrity, and a specifically designed decoupling interconnection link for emergency release. This segmentation allows the majority of the device to maintain high structural integrity while isolating the complexity of the magnetic decoupling mechanism to a single, well-defined component.
Solution Approach 2:
The decoupling interconnection link acts as an intermediary component between the strong structural components and the magnetic field environment. It mediates the interaction between the device structure and external magnetic fields, providing a controlled failure mode that protects the rest of the device while managing the complexity of magnetic field responses.
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 symptoms by maintaining the LES in a closed state when needed, while allowing food passage, and is designed to withstand strong magnetic fields and improve structural integrity.
Implementation Method 1
the magnetic component of the decoupling interconnection link is magnetically attracted to a magnetic component of a magnetic component of an adjacent link
Implementation Method 2
designed to withstand strong magnetic fields and improve structural integrity
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 apparatus further includes a decoupling element. The decoupling element is positioned along the loop and is configured to selectively release a first portion of the loop from a second portion of the loop in response to application of a threshold force to the at least one decoupling element in a circumferential direction relative to the loop.