PFO Closure Device with Interlocking Hinges
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Solution Overview
Problem
Current devices for closing patent foramen ovale (PFO) are complex to manufacture, difficult to deploy precisely, and may cause residual leakage or thrombus formation due to their design, which is not optimally suited for the unique anatomy of PFO.
Innovation Solution
A closure device comprising a pair of wings and arms with pivotally connected hinges and tabs, designed for collapsible delivery through a catheter, which can be expanded to interlock and exert force on the septal tissues to close the PFO, facilitating precise positioning and tissue ingrowth for sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If ASD closure devices are used to close PFO, then closure of the defect is achieved, but the device is not optimally designed for the flap-like PFO anatomy resulting in residual leakage and deployment difficulties
Solution Approach 1:
The closure device is divided into two separate arms (first arm and second arm) that can be independently positioned and deployed. Each arm has specific engagement features (protrusions and recesses) designed to interact with the unique flap-like anatomy of PFO, allowing tailored closure without forcing a standardized ASD device onto an incompatible structure.
2Reliability
If complex mechanical closure devices are used, then closure function is achieved, but manufacturing complexity and assembly difficulty increase
Solution Approach 1:
The first and second arms are connected through complementary engagement features where protrusions on one arm fit into recesses on the other arm. This merging mechanism allows the device to be manufactured as separate components that self-assemble through mechanical interlocking, reducing overall manufacturing complexity while maintaining reliable closure function.
3Manufacturing precision
If precise deployment is required for PFO closure, then proper sealing is achieved, but deployment difficulty and procedural complexity increase
Solution Approach 1:
The first and second arms have asymmetric designs with specific protrusions and recesses positioned at different locations and orientations. This asymmetry provides built-in directional guidance during deployment, ensuring that the arms engage in the correct orientation with the PFO anatomy, thereby achieving precise deployment while simplifying the operator's task through self-aligning features.
Data Source
AI summary
The present invention provides devices and methods for closing a physical anomaly comprising two overlapping layers of tissue, such as a patent foramen ovale (“PFO”). A PFO is comprised of two overlapping layers of malformed interatrial septa, the septum primum and the septum secundum, that form a tunnel between the right atrium and the left atrium. The closure device includes two wings connected to a central arm. The device is delivered through the PFO tunnel in a substantially linear configuration such that the central arm is seated within the PFO tunnel, the first wing extends into the right atrium, and the second wing extends into the left atrium. Once implanted, the closure device is reconfigured such that the arm is seated within the PFO tunnel, the first wing folds against the septum secundum, and the second wing folds against the septum primum, thereby sealing the defect.