Segmented Biocompatible Sheet Closure Device for PFO
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Solution Overview
Problem
Conventional nonsurgical closure devices for patent foramen ovale (PFO) and atrial septal defects are bulky, difficult to deploy, have high septal profiles, and often cause tissue damage due to their complex geometry and large foreign material presence, leading to complications like thrombosis and incomplete closure.
Innovation Solution
A closure device comprising a first and second frame with biocompatible sheets, designed to bend away from a connection point for secure deployment, utilizing a collapsible structure for easy delivery and low-profile design to minimize tissue damage and enhance stability, with a method for attaching retention members to create a stable occlusion in the bodily passageway.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional nonsurgical closure devices are used to close PFOs, then closure function is achieved, but device bulkiness and complex geometry cause tissue damage and thrombosis complications
Solution Approach 1:
The closure device is divided into two separate frames (first frame and second frame) that can be deployed independently on opposite sides of the septum. Each frame is covered with its own biocompatible sheet, allowing the device to conform to the anatomical structure without requiring a single bulky component, thereby reducing tissue damage while maintaining closure stability.
Solution Approach 2:
Biocompatible sheets are attached to both frames to provide a low-profile configuration that minimizes foreign material presence. These thin film coverings reduce the overall device bulkiness and complexity, allowing the device to integrate better with surrounding tissue and reduce complications such as thrombosis and tissue damage.
2Reliability
If conventional closure devices with high septal profiles are deployed, then closure function is achieved, but device bulkiness leads to thrombosis and incomplete closure
Solution Approach 1:
By segmenting the device into two frames deployed on opposite sides of the septum, each frame can be smaller and more compact. This segmentation allows the device to achieve complete closure without requiring a large single-volume structure, thereby reducing the overall device volume and eliminating the high septal profile that causes thrombosis.
Solution Approach 2:
The collapsible structure allows the device to be nested within a delivery catheter for minimally invasive insertion, then expanded to its functional configuration. This nesting capability enables the device to have a small delivery profile while achieving adequate closure volume when deployed, resolving the contradiction between device volume and closure completeness.
3Reliability
If conventional closure devices with complex geometry are used, then closure function is achieved, but deployment difficulty and device complexity increase
Solution Approach 1:
Dividing the device into two simpler frames with biocompatible sheet coverings reduces the overall geometric complexity compared to conventional single-structure devices. Each frame can be designed with simpler geometry that is easier to manufacture and deploy, while the segmented configuration maintains closure stability through the combined action of both frames.
Solution Approach 2:
The biocompatible sheets attached to each frame provide a simple, flexible covering that eliminates the need for complex internal structures. These thin films simplify the device geometry while maintaining structural integrity and closure stability, reducing both manufacturing and deployment complexity.
4Reliability
If conventional closure devices are deployed, then closure function is achieved, but large foreign material presence causes thrombosis complications
Solution Approach 1:
Segmenting the device into two frames with biocompatible sheet coverings reduces the total quantity of foreign material compared to conventional devices. The segmented design allows for more efficient material distribution and reduces redundant material, thereby minimizing foreign body presence while maintaining closure stability through the distributed structural support.
Solution Approach 2:
The biocompatible sheets serve as thin film coverings that provide necessary structural support with minimal material quantity. These thin films reduce the overall foreign material volume compared to bulkier conventional device constructions, thereby reducing thrombosis risk while maintaining closure stability through the sheet's structural properties.
Data Source
AI summary
A closure device for closing a bodily passageway is provided. The device includes first and second frames and first and second crossbars. A sheet of biocompatible material is attached to one or more of the frames. The first crossbar extends across the first frame and has terminal crossbar ends connectively linked to separate sites on the first frame; the second crossbar is similarly linked to the second frame. The crossbars are attached to each other at a connection point, and they are each configured to bend away from the connection point when the closure device is deployed to close a bodily passageway. A method of making the closure device is provided, as well as a method for closing a bodily passageway using such a device. Further, a closure device assembly is provided, including a closure device, a delivery catheter housing, and a delivery release member.