Magnetic Bead Sphincter Device for Adjustable Reflux Control

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Solution Overview

Problem

Current treatments for anatomical lumens, such as the esophagus, often 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 beads joined by links, with rare-earth permanent magnets sealed within the beads, that can transition between expanded and contracted states to manage reflux by magnetically biasing the lower esophageal sphincter, preventing acid reflux while allowing food passage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the LES is augmented with a fixed sphincter device, then reflux prevention is improved, but the device cannot adapt to varying esophageal dimensions and functional states

Engineering Contradiction:
Improvereflux preventionVSAvoidadaptability to varying esophageal dimensions
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The sphincter device incorporates a dynamic structure where beads can move relative to each other along the circumferential direction, allowing the device to transition between expanded and contracted states. This dynamic configuration enables the device to adapt to varying esophageal dimensions and functional states while maintaining reliable reflux prevention.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The device changes its physical parameters (circumferential dimension, bead spacing) through controlled expansion and contraction. By varying the distance between beads along the circumferential direction, the device can adjust its overall size to match different esophageal dimensions while maintaining the sealing function for reflux prevention.

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If the sphincter device is expanded to fit larger esophageal dimensions, then adaptability is improved, but the ability to maintain closure for reflux prevention deteriorates

Engineering Contradiction:
Improvefit to esophageal dimensionsVSAvoidclosure maintenance
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The device dynamically adjusts its state based on operational requirements. When expanded, it accommodates larger esophageal dimensions; when contracted, it maintains tight closure for reflux prevention. The beads can reposition themselves along the circumferential direction to achieve the appropriate configuration.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The sphincter device undergoes periodic expansion and contraction cycles to adapt to different functional states. During periods when accommodation is needed, the device expands; during periods when reflux prevention is critical, the device contracts to maintain closure.

Inventive Principle:
Principle #19Periodic action

3Adaptability or versatility

If the device structure is made complex to enable selective adjustment, then adaptability is improved, but device complexity increases

Engineering Contradiction:
Improveselective adjustment capabilityVSAvoidstructural complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The device is segmented into multiple discrete beads connected by spacing elements, allowing independent movement and positioning of each bead. This segmentation enables selective adjustment of bead spacing to achieve desired device dimensions without requiring complex continuous adjustment mechanisms.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The spacing elements between beads provide flexible connection that allows the device to adjust its configuration. This flexibility enables adaptability without requiring complex mechanical adjustment systems, as the spacing elements can accommodate varying distances between beads.

Inventive Principle:
Principle #30Flexible shells and thin films

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 lower esophageal sphincter in a closed state while allowing normal passage of food, reducing tissue damage and improving esophageal function.

Implementation Method 1

with rare-earth permanent magnets sealed within the beads, that can transition between expanded and contracted states to manage reflux by magnetically biasing the lower esophageal sphincter

Methodology Applied
Scientific EffectMagnetic field: Magnetic Field

Data Source

PatentUS20230190276A1Implantable sphincter assistance device with selectively adjustable bead interconnection length
Publication Date: 2023.06.22 CILAG GMBH INTERNATIONAL
  • US20230190276A1 patent drawing
  • US20230190276A1 patent drawing
  • US20230190276A1 patent drawing

AI summary

An apparatus includes a plurality of beads, a linking assembly joining the beads together, and an integrated adjustment assembly. The beads and the linking assembly are arranged in an annular arrangement and sized to form a loop around an anatomical structure in a patient. The loop may move between a contracted and expanded configuration. The loop is magnetically biased toward the contracted configuration by a magnetic bias of the beads. The integrated adjustment assembly is integrated with the plurality of beads of the linking assembly. The integrated adjustment assembly is operable to selectively adjust either the maximum radius or the minimum radius of the beads and the linking assembly while remaining integrated with the plurality of beads or the linking assembly.