Magnetic Bead Sphincter Device for Homogeneous Dilation

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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 esophageal damage, as existing devices lack controlled and uniform radial expansion and contraction mechanisms.

Innovation Solution

A sphincter augmentation device comprising a series of beads linked by wires, with strategically placed rare-earth permanent magnets that provide varying magnetic strengths to ensure uniform radial expansion and contraction, allowing for controlled movement between occluded and open states to prevent reflux while accommodating food passage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a sphincter augmentation device is placed around the LES to prevent reflux, then reflux prevention is improved, but the device may cause non-uniform expansion and contraction leading to improper function

Engineering Contradiction:
Improvereflux preventionVSAvoidcontrolled expansion and contraction
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The device is divided into multiple discrete beads (e.g., 8-16 beads) distributed around the LES circumference. Each bead contains its own magnet and can move independently along the wire, allowing segmented and controlled expansion/contraction rather than rigid uniform movement, thereby improving reliability while maintaining ease of operation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device transitions from a static structure to a dynamic system where beads can move freely along the wire. The magnetic forces create dynamic equilibrium that allows the device to adapt its shape and size, enabling controlled expansion when food needs to pass and contraction to prevent reflux, resolving the contradiction between reliability and ease of operation.

Inventive Principle:
Principle #15Dynamics

2Reliability

If magnets are placed in beads to provide magnetic bias for maintaining closed state, then reflux prevention is improved, but non-uniform magnetic field distribution causes non-homogeneous dilation

Engineering Contradiction:
Improveclosed state maintenanceVSAvoiduniform radial expansion
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

Different beads are equipped with magnets of varying strengths rather than uniform magnets throughout. This local differentiation allows certain beads to exert stronger magnetic pull than others, compensating for non-uniform geometric distribution and achieving homogeneous overall dilation while maintaining reliable closed state maintenance.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The magnetic field parameters (strength, direction) are varied across different beads to achieve uniform radial expansion. By adjusting magnetic field parameters locally in different beads, the system compensates for geometric non-uniformities and achieves homogeneous dilation, resolving the contradiction between reliability and manufacturing precision.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If the device maintains a tight closed state to prevent reflux, then reflux prevention is improved, but food passage may be obstructed

Engineering Contradiction:
Improvereflux preventionVSAvoidfood passage accommodation
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The device dynamically transitions between contracted (reflux prevention) and expanded (food passage) states through magnetic bead movement. The same magnetic mechanism that maintains the closed state can be modulated to allow expansion for food passage, providing adaptability without sacrificing reflux prevention capability.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The magnetic bead system serves multiple functions: maintaining closed state for reflux prevention, enabling controlled expansion for food passage, and providing intermediate states for gradual opening. This multi-functionality resolves the contradiction between reliability and adaptability by making the same structure capable of both preventing reflux and accommodating food passage.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 esophageal damage by maintaining a closed state with sufficient magnetic bias while allowing for food passage, ensuring balanced radial expansion and contraction, thus addressing the limitations of existing treatments.

Implementation Method 1

Adjacent beads may be magnetically attracted together at a plurality of bead-to-bead magnetic interfaces... magnets configured to magnetically bias the loop toward the contracted configuration

Methodology Applied
Scientific EffectMagnetic field: Magnetic Field

Implementation Method 2

magnets configured to magnetically bias the loop toward the contracted configuration... magnets configured to cause the loop to expand radially outwardly

Methodology Applied
Scientific EffectMagnetic force: Magnetism

Data Source

PatentUS11957352B2Implantable sphincter assistance device with controlled homogeneous dilation of the restricting elements
Publication Date: 2024.04.16 CILAG GMBH INTERNATIONAL
  • US11957352B2 patent drawing
  • US11957352B2 patent drawing
  • US11957352B2 patent drawing

AI summary

An apparatus includes at least one link and a plurality of beads. The plurality of beads are joined using the at least one link and configured to be arranged in an annular arrangement. Each bead includes at least one magnet. The annular arrangement is sized and configured to form a loop around an anatomical structure in a patient. Adjacent beads are magnetically attracted together at a plurality of magnetic interfaces that include first and second magnetic interfaces. The first magnetic interface has a first magnetic field strength. The second magnetic interface has a second magnetic field strength that is less than the first magnetic field strength so that the beads forming the second interface are configured to separate prior to the beads forming the first interface when the loop moves from the contracted configuration to the expanded configuration, thereby providing uniform radial expansion of the loop.