Magnetic Bead Sphincter Augmentation for GERD

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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 and esophageal damage, as existing solutions do not provide sufficient sphincter augmentation to prevent acid reflux.

Innovation Solution

A sphincter augmentation device comprising a series of beads linked by wires, with rare-earth permanent magnets sealed within, that magnetically biases the device to maintain a closed state while allowing expansion for food passage, using varying magnetic strengths to ensure uniform radial expansion and contraction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional surgical procedures (fundoplication or suturing) are used to treat GERD, then the lower esophagus is tightened to prevent reflux, but the complexity of the procedure increases and requires invasive surgery

Engineering Contradiction:
Improvereflux prevention effectivenessVSAvoidsurgical procedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces complex mechanical surgical procedures (fundoplication, suturing) with a magnetic field-based system. Permanent magnets embedded in beads generate magnetic forces that augment the LES function, eliminating the need for invasive surgical manipulation while achieving reliable reflux prevention through non-contact magnetic interaction.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the physical state and properties of the treatment approach by introducing magnetic fields as a new parameter. By varying magnetic strength, bead size, and arrangement, the system achieves adjustable sphincter augmentation without altering the fundamental anatomy through complex surgery.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If the LES is tightened to prevent acid reflux, then reflux symptoms are reduced, but the ability to expand for food passage is compromised

Engineering Contradiction:
Improvereflux preventionVSAvoidexpansion capability for food passage
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent creates a dynamic system where the magnetic augmentation device can adapt between contracted and expanded states. The magnetic force maintains LES closure during reflux prevention while allowing controlled expansion during swallowing, achieving both reliable reflux protection and adequate food passage capability through dynamic magnetic interaction.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system utilizes parameter changes in magnetic field strength and bead arrangement to transition between functional states. During reflux prevention, strong magnetic forces maintain closure; during food passage, the system allows expansion by modifying magnetic interaction parameters, enabling the LES to adapt to different physiological requirements.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If uniform radial expansion is achieved through magnetic beads, then homogenous sphincter function is provided, but the device complexity increases due to magnet arrangement requirements

Engineering Contradiction:
Improveuniform expansion capabilityVSAvoidmagnet arrangement complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent divides the sphincter augmentation function into multiple discrete beads, each containing magnets. This segmentation allows uniform radial expansion through distributed magnetic forces while simplifying the overall design by using standardized, modular bead units that can be arranged in predictable patterns to achieve homogenous function.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies local quality by positioning magnets within beads at specific orientations and locations to generate uniform radial magnetic forces. Each bead is designed with specific magnetic properties that contribute to the overall uniform expansion, while the local magnet arrangement within each bead is optimized to simplify manufacturing and assembly.

Inventive Principle:
Principle #3Local quality

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 acid reflux by maintaining a closed state of the LES while allowing food passage, providing controlled homogenous expansion and contraction to accommodate normal physiological functions, thus reducing GERD symptoms.

Implementation Method 1

Adjacent beads are configured to abut one another when the device is in the closed state. Each bead includes a magnet. The magnets of the adjacent beads are oriented such that the magnetic field interactions of the adjacent beads provide a magnetic bias force toward the closed state.

Methodology Applied
Scientific EffectMagnetic field interaction: Magnetic Field

Implementation Method 2

The magnetic field interactions of the adjacent beads may be concentrated or diffused based on the magnet shapes or features. The magnet shapes or features may induce magnetic pull in predefined locations.

Methodology Applied
Scientific EffectMagnetic field concentration/diffusion: Magnetic Field

Data Source

PatentUS11957353B2Implantable sphincter assistance device with redirected or focused magnetic fields for interaction between adjacent beads
Publication Date: 2024.04.16 CILAG GMBH INTERNATIONAL
  • US11957353B2 patent drawing
  • US11957353B2 patent drawing
  • US11957353B2 patent drawing

AI summary

An apparatus includes at least one link and a plurality of beads. The plurality of beads is joined using the at least one link and is configured to be arranged in an annular arrangement. The annular arrangement is sized and configured to form a loop around an anatomical structure in a patient. The annular arrangement is configured to move between a contracted configuration and an expanded configuration. The loop in the contracted configuration is configured to prevent fluid flow through the anatomical structure. Each bead includes a housing, a magnet contained within the housing, and a secondary element that is different from the magnet. The magnet is configured to emit a magnetic field. The magnets of the plurality of beads are configured to magnetically bias the loop toward the contracted configuration. The secondary element is contained within the housing and is configured to increase the magnetic field of the magnet.