Heart Occlusion Device Self-Centering Waist and ePTFE Coverings
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Solution Overview
Problem
Current heart occlusion devices for congenital cardiac defects, such as PFO, are complex to implant, have high complication rates due to thrombus formation, tissue injury, and require multiple sizes, making them inefficient and costly for clinical use.
Innovation Solution
A heart occlusion device with a self-centering mechanism using two flexible wires with shape memory properties, forming discs separated by a waist that conforms to the defect size and shape, providing a custom fit and reducing thrombogenicity through ePTFE coverings, allowing for repositionability and fewer required sizes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional heart occlusion devices are used, then the defect can be closed, but the device complexity and number of required sizes increase
Solution Approach 1:
The patent applies universality by designing a single device architecture that can accommodate multiple defect sizes through adjustable waist compression. The device functions universally across different PFO sizes by modifying the compression force applied to the waist, eliminating the need for multiple specialized device sizes while maintaining effective closure.
Solution Approach 2:
The patent implements dynamics through the adjustable waist compression mechanism. The waist can be dynamically compressed to different degrees to match various defect sizes, transforming a static device into a dynamic one that adapts to different anatomical configurations, thereby reducing device complexity.
2Reliability
If traditional heart occlusion devices are used, then the defect can be closed, but the risk of thrombus formation and tissue injury increases
Solution Approach 1:
The patent applies flexible shells and thin films by using an ePTFE covering that conforms to the defect geometry. This flexible membrane provides a smooth, non-thrombogenic surface that reduces blood clot formation while maintaining the structural integrity needed for effective defect closure.
Solution Approach 2:
The patent implements parameter changes by modifying the physical and chemical properties of the device surface through ePTFE coating. This material change reduces thrombogenicity and improves biocompatibility, directly addressing the harmful effects of thrombus formation and tissue injury while maintaining closure effectiveness.
3Adaptability or versatility
If multiple device sizes are used, then different defect sizes can be accommodated, but the manufacturing cost and clinical efficiency decrease
Solution Approach 1:
The patent applies universality by creating a single device platform that serves multiple defect size requirements. The adjustable waist compression mechanism allows one device design to fit various PFO sizes, eliminating the need to manufacture and stock multiple specialized sizes, thereby improving clinical efficiency and productivity.
Solution Approach 2:
The patent implements parameter changes by varying the compression force applied to the waist rather than changing the entire device structure. This parameter adjustment allows a single device to adapt to different defect sizes, reducing manufacturing complexity and improving clinical workflow efficiency.
4Reliability
If devices with high septal profile are used, then the defect can be occluded, but the body adaptation and patient comfort worsen
Solution Approach 1:
The patent applies flexible shells and thin films through the ePTFE covering that drapes over the waist and discs. This flexible membrane allows the device to conform to the irregular geometry of the PFO defect, creating a low-profile configuration that improves body adaptation and patient comfort while maintaining reliable occlusion.
Solution Approach 2:
The patent implements curvature by designing the waist and discs with smooth, rounded contours that follow the natural curvature of the interatrial septum. This curved geometry eliminates sharp edges and high profiles, improving device conformability and patient comfort while ensuring effective defect occlusion.
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 achieves a secure, conformable, and efficient closure of cardiac defects with reduced complications, improved anatomical conformability, and fewer sizes needed, enhancing patient safety and clinical efficiency.
Implementation Method 1
each of the first and second wires is comprised of a shape memory capability such that the wires can be collapsed and distorted in a catheter during delivery but resume and maintain their intended shape
Data Source
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AI summary
The disclosure is directed to a heart occlusion device and a method for occluding an aperture defect in a heart. The heart occlusion device includes two separate wires 12, 14. Each wire forms geometric shapes that together form a distal plate and a proximal plate. The first plate is disposed in a first plane. The second plate is disposed in a second plane that is parallel to and remote from the first plane. The distal plate and the proximal plate are separated by a self-centering waist. The proximal plate is attached to a hub. A similar hub is optional on the distal plate. The plates further include coverings which form a sealant to occlude an aperture in a tissue. The wires forming the plates have a shape-memory capability such that they can be collapsed and distorted in a catheter during delivery but resume and maintain their intended shape after delivery.