Hinged Petal Occluder for Septal Defect Closure
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Solution Overview
Problem
Current occluders for closing septal defects, such as patent foramen ovale (PFO), may allow blood to flow from the right atrium to the left atrium, potentially leading to systemic circulation of blood clots, and existing solutions often involve permanent foreign materials and complex manufacturing processes.
Innovation Solution
A device with first and second sides, a center joint, and end pieces, featuring a plurality of petals connected by hinges, made from a single tube or multiple pieces, which can be cut to form a spongy structure with a catching mechanism to securely close the defect, potentially using a tissue scaffold for enhanced healing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional occluder design is used to close a septal defect, then the defect can be closed, but the device may allow blood to flow from the right atrium to the left atrium, potentially leading to systemic circulation of blood clots
Solution Approach 1:
The occluder device is divided into multiple petals that can be independently positioned and secured across the septal defect. This segmentation allows for more precise fitting and sealing of the defect, preventing blood flow through gaps while maintaining reliability of closure.
2Reliability
If existing occluder solutions are used, then the defect can be closed, but permanent foreign material remains in the body
Solution Approach 1:
The occluder device utilizes shape memory alloy material that changes its physical properties (from flexible to rigid) in response to temperature changes. This allows the device to be delivered in a flexible state, deployed to close the defect, and then permanently fixed in place through a phase transition, eliminating the need for permanent foreign material while maintaining closure effectiveness.
3Reliability
If complex occluder designs are used to ensure secure closure, then closure reliability improves, but manufacturing complexity increases
Solution Approach 1:
Multiple functional components (petals, hinges, securing mechanisms) are merged into a single monolithic structure made from shape memory alloy material. This integration simplifies the manufacturing process by eliminating the need to assemble multiple separate parts, while the shape memory properties provide the necessary complexity for secure closure without additional components.
4Strength
If a larger diameter delivery sheath is used to deliver the occluder device, then the device can be more robust, but delivery difficulty increases
Solution Approach 1:
The occluder device exhibits dynamic properties through its shape memory alloy construction, allowing it to transition from a compressed flexible state during delivery to a rigid expanded state after deployment. This dynamic behavior enables the device to be delivered through a small diameter sheath in a flexible configuration, then become robust and structurally sound once deployed and activated.
Data Source
AI summary
A device for closing a defect, such as a patent foramen ovale (PFO) or an atrial septal defect (ASD), has first and second sides on either side of the defect, a center joint that passes through the defect, and end pieces at the outer ends of the sides. One or both sides of the device have a plurality of petals. At least one petal on each side extends away from the center joint, and at least one petal on each side extends away from an end piece. Adjacent petals are coupled together with hinges.