Sinus Venosus ASD Device Pulmonary Vein Anchoring

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Solution Overview

Problem

There is no percutaneous interventional procedure available for treating sinus venosus atrial septal defects, which can lead to oxygenated and deoxygenated blood mixing, causing various health issues such as cardiac arrhythmia and migraines.

Innovation Solution

A sinus venosus atrial septal defect treatment device with a flexible proximal and distal portion, expandable to fit within the right upper pulmonary vein, and a self-expandable skirt to secure the device to the interatrial septum, using a balloon catheter for deployment and expansion, effectively diverting anomalous pulmonary venous drainage into the left atrium.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a percutaneous interventional procedure is developed for sinus venosus ASD treatment, then treatment accessibility and patient outcomes improve, but device complexity and procedural difficulty increase

Engineering Contradiction:

Improvetreatment effectivenessVSAvoiddevice structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The device is divided into multiple functional segments: a proximal portion with receiving plates for balloon attachment, a central portion with the defect closure function, and a distal portion with a self-expandable skirt for anchoring. This segmentation allows each part to perform its specific function while simplifying the overall deployment process through balloon catheter guidance.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The device is designed to be nested within a balloon catheter during delivery. The compressible device fits inside the balloon, allowing percutaneous access and minimally invasive deployment. Upon balloon inflation, the device expands to its functional configuration, achieving complex positioning through a simple nested structure.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Manufacturing precision

If the device is made expandable to fit within the pulmonary vein, then positioning precision and sealing effectiveness improve, but device complexity and manufacturing difficulty increase

Engineering Contradiction:

Improvepositioning accuracyVSAvoiddevice fabrication

Core Design Contradiction:

Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The device utilizes phase transitions and dimensional changes through balloon inflation. The device transitions from a compressed state during delivery to an expanded functional state at the target site. This parameter change approach allows precise positioning and sealing without requiring complex manufacturing of pre-formed three-dimensional structures.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The device incorporates dynamic elements including a self-expandable skirt that actively adjusts to the anatomical geometry of the pulmonary vein and interatrial septum. The balloon-mediated expansion provides dynamic control over device deployment timing and positioning, simplifying manufacturing while achieving high positioning accuracy.

Inventive Principle:

Principle #15Dynamics

3Strength

If the skirt is made self-expandable to secure the device, then anchoring strength and device stability improve, but device complexity and material requirements increase

Engineering Contradiction:

Improveanchoring strengthVSAvoidskirt structure

Core Design Contradiction:

StrengthVSDevice complexity

Solution Approach 1:

The distal skirt is designed as a self-expandable structure that automatically secures the device to the interatrial septum upon balloon inflation. The skirt's inherent elastic properties enable it to self-anchor without requiring additional fastening mechanisms, active control systems, or complex assembly steps, thereby achieving strong anchoring with relatively simple structure.

Inventive Principle:

Principle #25Self-service

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 closes the sinus venosus hole, preventing oxygenated blood from mixing with deoxygenated blood, thereby improving oxygen supply to the body and reducing the risk of associated health conditions.

Implementation Method 1

The opening at the first end is expandable from a first diameter when the device is being deployed through the body of the left atrium, to a second, larger diameter when the device is positioned within the right upper pulmonary vein and expanded with a balloon catheter

Methodology Applied

Scientific EffectPneumatic expansion: Pressure Increase

Implementation Method 2

The distal portion includes a self-expandable edge portion or skirt. The skirt can include a septal augmenter rim configured for securing the device to the left atrium side of the interatrial septum

Methodology Applied

Scientific EffectSelf-expansion: Elastic Recovery

Data Source

PatentUS10531867B2Sinus venosus atrial septal defect treatment device

Publication Date: 2020.01.14 ALANBAEI MUATH

AI summary

The sinus venosus atrial septal defect (“ASD”) treatment device includes has a generally tubular or funnel shaped configuration. A first end of the device can have a diameter that is less than a diameter of a second end of the device. The device can be inserted in the right upper right pulmonary vein PV. The second end of the device is configured to expand in a skirt-like configuration once the device is positioned in the right upper right pulmonary vein PV. In this manner, the device closes the upper sinus venosus hole and diverts anomalous pulmonary venous drainage into the left atrium.