Variable Angle Flat Disk Occluder for Heart Defect Adaptation

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Solution Overview

Problem

Existing occlusion devices for Patent Foramen Ovale (PFO) and other heart defects lack a combination of a flat single-layer disk and a flexible waist, leading to issues with endothelialization, thrombus formation, and inadequate adaptation to varying anatomical structures, which increases the risk of complications and prolongs recovery.

Innovation Solution

A split-structure occlusion device comprising a single-layer disk with radially-arranged support rods and a flexible waist, where the single-layer disk is formed by an annular interlocking structure with a central hole, allowing for self-adaptive morphology and improved fitting to heart structures, and the flexible waist enables flexible connection without restricting disk morphology.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a double-layer disk structure is used in the occlusion device, then the disk can be formed with sufficient strength and stability, but protrusion portions are created on the disk surface that delay endothelialization and increase thrombus risk

Engineering Contradiction:
Improvedisk strengthVSAvoidthrombus risk
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The disk is divided into multiple independent support rods arranged radially, with each rod being a separate braided structure. This segmentation allows the disk to maintain structural strength through the collective support of multiple rods while avoiding the formation of protrusion portions, as each rod contributes uniformly to the disk surface.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The disk is constructed using composite braided structures combining metal wires with polymer coatings. The metal wires provide structural strength and stability, while the polymer coating ensures a flat surface profile that promotes endothelialization and reduces thrombus risk.

Inventive Principle:
Principle #40Composite materials

2Stability of the object's composition

If a rigid waist connecting structure is used to connect the two disks, then the structural stability is improved, but the device loses the ability to adapt to varying anatomical structures

Engineering Contradiction:
Improvestructural stabilityVSAvoidanatomical adaptation
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The waist connecting structure is designed with dynamic flexibility, allowing it to bend and deform according to the anatomical requirements. The waist can adapt its shape and rigidity based on the specific anatomical structure being occluded, while still maintaining sufficient structural stability to connect the two disks.

Inventive Principle:
Principle #15Dynamics

3Device complexity

If protrusion portions are present on the disk surface, then the disk structure is simplified, but endothelialization is delayed and thrombus formation is promoted

Engineering Contradiction:
Improvedisk structure complexityVSAvoidendothelialization success
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The disk is segmented into multiple radial support rods that are evenly distributed, creating a uniform surface profile without protrusion portions. This segmentation approach maintains relative structural simplicity while ensuring smooth endothelialization across the entire disk surface.

Inventive Principle:
Principle #1Segmentation

4Object-affected harmful factors

If the disk is made flat to prevent thrombus, then thrombosis risk is reduced, but the device complexity increases due to the need for precise flatness control

Engineering Contradiction:
Improvethrombosis riskVSAvoidmanufacturing precision requirements
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The disk is constructed from multiple radial support rods that are braided together, which naturally creates a flat surface profile. This segmentation method simplifies the manufacturing process compared to traditional methods requiring complex flatness control, while ensuring the disk remains flat enough to prevent thrombus formation.

Inventive Principle:
Principle #1Segmentation

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 reduces thrombosis risk, accelerates endothelialization, and enhances the occlusion device's ability to adapt to different physiological structures, minimizing tissue damage and complications.

Implementation Method 1

an elastic occlusion instrument is compressed into a small-size or a narrow and long shape and then conveyed to a defect position through a conduit, and then the elastic occlusion instrument is self-expanded to a preset shape

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

in such occlusion devices formed by a plurality of braiding strands, even though a few strands are cracked, the crack does not easily spread to other portions of the disk, so the whole device has good fatigue resistance

Methodology Applied
Scientific EffectStress distribution:

Data Source

PatentEP2952157B1Occluder having flat disk with variable angle
Publication Date: 2020.01.15 LIFETECH SCI (SHENZHEN) CO LTD
  • EP2952157B1 patent drawingFigure 1~2
  • EP2952157B1 patent drawingFigure 3~4
  • EP2952157B1 patent drawingFigure 5~7

AI summary

Disclosed is an occlusion device having an angle variable flat disk, comprising a single-layer disk (4), a plug (6) and a waist (5) connecting the single-layer disk (4) and the plug (6). The single-layer disk (4) is braided from elastic strands and comprises a plurality of radially-arranged support rods (40). Grids braided from elastic strands are provided on the surface of the plug (6). The waist (5) comprises at least one connecting strand. An annular interlocking structure is provided in the center of the single-layer disk (4). The plurality of support rods (40) are connected into a flat integral body via the annular interlocking structure. The connecting strand of the waist (5) is connected to the annular interlocking structure and the grids of the plug (6). The occlusion device has the features of a flat single-layer disk and a flexible waist structure at the same time, and the single-layer disk has the function of adaptive regulation of morphology and is able to effectively adapt to different physiological structures while reducing complications.