PFO Closure Device with Linearly Elongating Petals
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Solution Overview
Problem
Current septal closure devices for atrial septal defects and 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 inadequate occlusion and potential adverse body adaptation.
Innovation Solution
A tubular occluder device with a delivery configuration that transforms into a deployed configuration, featuring petals formed by slits in a tube, secured by a catch system, made from materials like metals, shape memory alloys, and bioabsorbable polymers, designed to minimize tissue distortion and promote secure seating on the septal tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional umbrella devices and mechanical closure devices are used to close PFO, then the procedure avoids anticoagulation therapy and invasive surgery, but the devices present technical complexity, complications (thrombus formation, fractures, conduction disturbances), and lack anatomical conformability
Solution Approach 1:
The occluder device is divided into multiple discrete components: a proximal disc with proximal petals, a distal disc with distal petals, and a central element connecting them. This segmentation allows each component to be optimized independently for its specific function while simplifying the overall device architecture and reducing manufacturing complexity.
Solution Approach 2:
The device employs petals that are initially in a compressed state during delivery and automatically expand to their full occlusive configuration upon deployment. This dynamic transformation from a compact delivery profile to an expanded occlusive state enables simplified delivery through catheters while achieving complete anatomical conformability at the implantation site.
2Adaptability or versatility
If ASD closure devices are used for PFO closure, then occlusion of the defect is achieved, but the devices do not conform to the flap-like anatomy of PFO, resulting in inadequate occlusion and potential residual leaks
Solution Approach 1:
The device features petals with varying sizes, shapes, and flexibility characteristics optimized for specific anatomical locations. The proximal petals are designed to conform to the septum primum while distal petals conform to the septum secundum, with each petal's local properties tailored to its specific sealing function to ensure complete anatomical conformability.
3Reliability
If devices with high septal profile and large masses of foreign material are used, then occlusion is achieved, but unfavorable body adaptation and tissue distortion occur
Solution Approach 1:
The device transitions from a two-dimensional flat configuration during delivery to a three-dimensional expanded configuration at the implantation site. This dimensional transformation allows the device to achieve complete occlusion of the PFO while maintaining a low septal profile that minimizes tissue distortion and promotes favorable body adaptation.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device provides a secure, anatomically conformable occlusion with reduced risk of complications, minimizing thrombus formation and promoting effective closure of septal defects while being easier to manufacture and deploy, thus enhancing patient safety and treatment efficacy.
Implementation Method 1
The occluder may be formed from a shape memory alloy, a shape memory polymer, or other suitable material. The occluder has an elongated delivery configuration and a shortened deployed configuration.
Data Source
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. In some embodiments, the occluder is formed from filaments that are joined together to define a substantially cylindrical form with openings defining struts. 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. 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 engaged so that the occluder closes the aperture.