PFO Closure Device with Radially Extensible Tissue Anchor
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current devices for closing patent foramen ovale (PFO) are complex, unsuitable for percutaneous entry, and cause significant trauma due to their design, which is not aligned with the offset openings and channel-like structure of PFO, unlike atrial septal defects (ASD).
Innovation Solution
A device with an elongated tissue anchor and a closure element, such as a staple, that can be percutaneously introduced to penetrate and deploy between the septum and flap, aligning them for secure closure with a radially extensible mechanism and actuator to maintain registry and seal the foramen ovale.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If conventional ASD repair devices are used for PFO closure, then the device structure is simple and easy to manufacture, but the device is ill-suited for the offset channel-like structure of PFO and cannot achieve effective closure
Solution Approach 1:
The device is divided into distinct functional segments: a tissue anchor portion for penetrating and anchoring in the septal wall, and a closure element portion for sealing the foramen ovale. This segmentation allows each component to be optimized for its specific function - the anchor for secure attachment and the closure element for effective sealing - thereby achieving reliable closure while maintaining manufacturing simplicity through modular construction
Solution Approach 2:
The device transitions from a single-dimensional plug approach to a two-dimensional configuration with the tissue anchor extending through the septum and the closure element positioned in the foramen ovale plane. This dimensional change allows the device to address the offset channel-like structure of PFO by creating a planar sealing surface that bridges the discontinuous openings, achieving effective closure where simple plugs fail
2Reliability
If open heart surgical methods are used for PFO repair, then the closure is generally effective, but the method is intrusive, costly, and requires extended recovery period
Solution Approach 1:
The invention replaces the mechanical surgical system (sutures, incisions, open chest cavity access) with a percutaneous delivery system. The device is delivered through a catheter inserted via peripheral vein, eliminating the need for chest incisions and direct surgical manipulation of the heart. This substitution maintains closure effectiveness while dramatically reducing patient trauma, cost, and recovery time associated with open heart surgery
Solution Approach 2:
A catheter serves as an intermediary delivery vehicle that transports the closure device through the bloodstream to the foramen ovale without requiring direct surgical access to the heart. This intermediary approach allows percutaneous delivery of the anchor and closure element, achieving effective closure while avoiding the harmful effects of open heart surgery including chest incisions, cardiopulmonary bypass, and extended recovery
3Ease of operation
If percutaneous methods with conventional occluder devices are used, then the entry technique is established, but the devices are complex mechanically and require high level of skill to insert properly
Solution Approach 1:
The device is segmented into an anchor portion and closure element portion that can be delivered separately through the catheter and deployed in sequence. This segmentation simplifies the mechanical requirements compared to single-piece occluders, as each segment has a dedicated function and can be manipulated independently during insertion, reducing the skill level required while maintaining percutaneous accessibility
Solution Approach 2:
The tissue anchor is designed with radially extensible portions that can be dynamically deployed after penetration. This dynamic feature allows the anchor to transition from a compact delivery configuration to an expanded anchored configuration, providing secure attachment without requiring complex mechanical structures during the insertion phase. The dynamic deployment simplifies the overall device mechanics while enabling effective anchoring
Data Source
AI summary
A device for closure of a patent foramen ovale. The device includes at least one elongated tissue anchor at the distal end of the device. A distal end portion of the tissue anchor is selectively deployable between a closed position in which the distal end portion of the tissue anchor is capable of penetrating the septum and the flap, and a radially extensible position in which the distal end portion of the tissue anchor is capable of engaging the septum or flap so that the septum and flap may be urged into registry. A deployment member is associated with the tissue anchor for selectively deploying the distal end portion of the tissue anchor between the closed position and the radially extensible position. A closure element is disposed at the distal end of the device. The closure element is engageable with the septum and the flap when the septum and flap are in registry, for maintaining such registry. An actuator is associated with the closure element for selectively engaging the closure element with the septum and flap.