PFO Closure Device Minimally Invasive Deployment
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Solution Overview
Problem
Current methods for closing patent foramen ovale (PFO) are either invasive, risky, or unsuitable for precise deployment, and existing devices are complex and difficult to retrieve or reposition, especially for PFO due to the unique anatomy of the septum primum and secundum.
Innovation Solution
A mechanical closure device with proximal and distal anchors and a closure line is deployed through the interatrial septum to bring the septum secundum and septum primum into close approximation, using a minimally invasive procedure to facilitate closure of the PFO, suitable for various anatomical configurations and defects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open heart surgery is used to close PFO, then closure effectiveness is improved, but invasiveness and surgical risk increase
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a minimally invasive percutaneous delivery system. The closure device is delivered through catheters inserted via peripheral vessels, eliminating the need for sternotomy, cardiopulmonary bypass, and direct surgical manipulation of the heart. This substitution maintains closure effectiveness while dramatically reducing invasiveness and associated surgical risks.
Solution Approach 2:
The patent introduces a closure device as an intermediary element that bridges the defect in the interatrial septum. The device includes delivery catheters, positioning mechanisms, and anchoring components that facilitate closure without direct surgical exposure. This intermediary approach enables effective PFO closure while avoiding the harmful effects of open-heart surgery.
2Reliability
If conventional ASD closure devices are used for PFO, then closure function is provided, but device complexity and difficulty of retrieval increase
Solution Approach 1:
The patent segments the closure device into distinct functional components: delivery catheters, positioning elements, anchoring mechanisms, and the actual closure element. This segmentation allows each component to be optimized for its specific function and enables staged deployment and retrieval. The modular design simplifies the overall system while maintaining closure effectiveness and improving retrievability compared to conventional monolithic ASD devices.
Solution Approach 2:
The patent incorporates dynamic elements that allow the device to adapt to the PFO anatomy and deployment conditions. The delivery system includes flexible catheters and adjustable positioning mechanisms that can be manipulated during the procedure. The closure device itself may have shape-memory or elastic properties that allow it to conform to the defect and be retrieved if needed, providing dynamic adaptability that reduces complexity and improves safety.
3Object-affected harmful factors
If percutaneous approach is used, then invasiveness is reduced, but precision of deployment becomes more difficult
Solution Approach 1:
The patent incorporates feedback mechanisms including fluoroscopic imaging, pressure sensing, and radiopaque markers that provide real-time information about catheter position and device deployment. This feedback enables the operator to precisely control the placement of the closure device through the percutaneous approach, overcoming the lack of direct visual feedback inherent in minimally invasive procedures. The feedback systems maintain deployment precision while preserving the invasiveness benefits of the percutaneous approach.
Solution Approach 2:
The patent replaces direct mechanical visualization and manipulation used in open surgery with imaging-based guidance systems. Fluoroscopy, echocardiography, and other imaging modalities substitute for direct visual inspection, enabling precise deployment through small puncture sites. This substitution maintains precision while preserving the minimally invasive nature of the procedure.
Data Source
AI summary
The present invention relates to devices for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart, and related methods of using such closure devices for closing the passageway. The method includes introducing a mechanical closure device into an atrium of the heart and transeptally deploying the closure device across the interatrial septum to provide proximation of the septum secundum and septum primum.