Septal Occluder with Catch System for PFO Closure
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Solution Overview
Problem
Current septal closure devices for patent foramen ovale (PFO) are technically complex, prone to complications such as thrombus formation, conduction system disturbances, and residual leaks, and lack anatomical conformability, leading to suboptimal performance and patient safety concerns.
Innovation Solution
A septal occluder device with a design featuring a polymer tube with cut slits forming loops and a central tube, which is deployed to exert compressive force on septal tissue, using a catch system to maintain axial length and secure the device, and optionally incorporating a tissue scaffold for enhanced tissue integration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional septal closure devices are used, then PFO closure can be achieved, but the devices are technically complex and prone to complications such as thrombus formation, conduction system disturbances, and residual leaks
Solution Approach 1:
The device is divided into two separate occluding members (first and second occluding members) that are deployed on opposite sides of the septal tissue, with a connective member joining them. This segmentation allows each occluding member to independently contact the septal tissue, distributing the occlusion function and reducing complexity of each individual component while improving overall reliability through redundant contact points
Solution Approach 2:
The occluding members and connective member are configured to be nested within a delivery catheter during insertion, with the first occluding member deployable first, followed by the second occluding member. This nested configuration enables minimally invasive percutaneous delivery while maintaining device simplicity and reducing the risk of complications during implantation
2Adaptability or versatility
If ASD closure devices are used for PFO closure, then occlusion can be achieved, but the devices lack anatomical conformability to the flap-like anatomy of PFOs, leading to suboptimal performance
Solution Approach 1:
The first and second occluding members are designed with specific geometric configurations (such as discs, hemispheres, or other shapes) that allow them to conform to the local flap-like anatomy of the PFO. The connective member connects these occluding members at specific orientations to match the angulation of the PFO tunnel, ensuring each component adapts to its local anatomical environment for optimal sealing
Solution Approach 2:
The device allows for dynamic adjustment of the angle between the first and second occluding members via the connective member, enabling the device to adapt to varying PFO angulations. This dynamic configuration capability ensures proper deployment in different anatomical scenarios, improving both conformability and occlusion effectiveness
3Reliability
If devices with large masses of foreign material are used, then occlusion can be achieved, but unfavorable body adaptation occurs due to high septal profile
Solution Approach 1:
The design extracts and eliminates excessive foreign material by using only the minimal necessary structure: two occluding members and a connective member. The occluding members are sized and shaped to contact only the necessary portions of the septal tissue, and the connective member is configured to minimize its profile. This extraction of unnecessary material reduces the device's overall mass and septal profile, improving body adaptation while maintaining secure occlusion through precise tissue contact
Data Source
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Figure 2A~2D
Figure 2E~2H
AI summary
The present invention provides a device for occluding an anatomical aperture, such as an atrial septal defect (ASD) or a patent foramen ovale (PFO). The occluder includes two sides connected by a central tube. The occluder is formed from a tube, which is cut to produce struts in each side. Upon the application of force, the struts deform into loops. The loops may be of various shapes, sizes, and configurations, and, in at least some embodiments, the loops have rounded peripheries. In some embodiments, at least one of the sides includes a tissue scaffold. The occluder further includes a catch system that maintains its deployed state in vivo. When the occluder is deployed in vivo, the two sides are disposed on opposite sides of the septal tissue surrounding the aperture and the catch system is deployed so that the occluder exerts a compressive force on the septal tissue and closes the aperture.