PFO Closure Device with Segmented Discs and Biocompatible Sheet
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Solution Overview
Problem
Conventional nonsurgical closure devices for patent foramen ovale (PFO) and atrial septal defects are bulky, technically complex, have a high septal profile, and often fail to provide immediate and complete closure due to anatomical challenges, leading to complications such as tissue damage, thrombosis, and residual leaks.
Innovation Solution
A closure device featuring a circumferential frame with a biocompatible sheet and anchors, including flexible linear structures like coils or wires, designed for low profile deployment and enhanced stability, using a delivery catheter system that allows for precise positioning and secure anchoring within the heart tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional nonsurgical closure devices are used, then PFO closure is achieved, but the devices are bulky and have high septal profile causing anatomical challenges
Solution Approach 1:
The closure device is divided into two separate discs (first disc and second disc) that can be independently positioned on either side of the septum, allowing each component to be optimized for minimal profile while collectively achieving complete closure
Solution Approach 2:
The device components are designed to nest within each other during delivery, with the second disc and anchors contained within the delivery catheter alongside the first disc, enabling compact delivery of what would otherwise be a bulky structure
2Reliability
If conventional closure devices are used, then closure is attempted, but the devices are technically complex leading to deployment difficulties
Solution Approach 1:
The device is segmented into modular components (first disc, second disc, anchors, connecting elements) that can be independently manipulated and deployed, simplifying the overall deployment process compared to attempting to deploy a single complex structure
Solution Approach 2:
The first disc is deployed and anchored before the second disc, allowing the delivery system to be partially retracted and providing a stable foundation that simplifies subsequent deployment of remaining components
3Reliability
If conventional closure devices are used, then closure is attempted, but immediate and complete closure is not achieved due to anatomical challenges
Solution Approach 1:
The first disc is deployed and anchored in advance before the second disc is released, creating a preliminary closure structure that ensures immediate sealing while allowing controlled deployment of the complete device
Solution Approach 2:
The segmented design allows the first disc to provide immediate closure functionality while the second disc completes the sealing, enabling progressive achievement of complete closure without requiring the entire device to be deployed simultaneously
4Reliability
If conventional closure devices are used, then closure is attempted, but tissue damage and thrombosis complications occur
Solution Approach 1:
The biocompatible sheet material is applied locally at the closure site between the two discs, providing targeted sealing without requiring extensive foreign material throughout the device structure, thereby reducing thrombosis risk
Solution Approach 2:
The use of absorbable anchors and biodegradable sheet material allows the device to fulfill its closure function temporarily and then naturally integrate or dissolve, reducing long-term foreign body presence and associated complications
5Reliability
If conventional closure devices are used, then closure is attempted, but repositioning and removal are difficult
Solution Approach 1:
The anchors are designed with dynamic characteristics allowing them to be initially engaged for stable positioning during deployment, then potentially released or repositioned if needed, providing both stability and flexibility throughout the device lifecycle
Solution Approach 2:
The first disc is anchored before the second disc is released, creating a staged deployment that allows for potential correction or repositioning during the deployment sequence before final fixation
Data Source
AI summary
In one embodiment, a device for closing or occluding ASDs and PFOs, or other bodily passageways, includes a circumferential frame, a sheet of biocompatible material attached to the frame, and at least one anchor attached to the sheet of biocompatible material. In another embodiment, the closure device includes a circumferential frame, at least one crossbar extending across and attached to the frame, at least one anchor connected to at least one crossbar; and at least one sheet of biocompatible material (such as ECM material) attached to the frame. The anchor includes at least one grasping member having a structure, such as a wired loop, which is configured for releasable attachment to a delivery release member, which facilitates delivery of a closure device collapsibly disposed in a delivery catheter. Alternatively, one or more anchor end pairs may be connected to a delivery bar enhancing delivery and retrieval of the device.