Segmented Cylindrical PFO Closure Device
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Solution Overview
Problem
Current treatments for patent foramen ovale, such as medicinal therapy, percutaneous catheter procedures, and open heart surgery, face challenges including difficulty in controlling dosage, invasive procedures, and risk of damaging the frail septum primum or causing thrombus formation, which can lead to cerebral stroke and migraine.
Innovation Solution
A device comprising a first part, a second part, and a third part with a pulling member that locks these parts together to prevent the septum primum from opening, using a centrifugal fluid pump apparatus to minimize load on the septum and reduce thrombus formation by maintaining the device in a configuration that restricts blood flow from the right atrium to the left atrium.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a disk-shaped film device is used to seal the patent foramen ovale by sandwiching the hole between left and right atria, then the sealing effect is improved, but the device area becomes large causing thrombus attachment and damage to the thin septum primum
Solution Approach 1:
The device is divided into multiple cylindrical parts (first, second, and third cylindrical parts) rather than using a single large disk-shaped film. This segmentation allows the device to achieve sealing through a compact structure that minimizes the area exposed to blood flow, reducing thrombus attachment risk while maintaining effective sealing of the patent foramen ovale.
Solution Approach 2:
The device uses thin-walled cylindrical structures that can flexibly adapt to the anatomical geometry of the foramen ovale and septum primum. These flexible cylindrical shells provide effective sealing through their ability to conform to the tissue contours, achieving reliable closure with minimal device area and reduced mechanical stress on the delicate septum.
2Reliability
If the device has a large area to ensure sealing, then the sealing reliability is improved, but the risk of thrombus formation and cerebral stroke increases
Solution Approach 1:
By segmenting the device into multiple small cylindrical components rather than using a single large surface, the total area exposed to blood flow is minimized. This segmentation maintains sealing reliability through the coordinated action of multiple small structures while significantly reducing the surface area that could serve as a thrombus attachment site, thereby lowering stroke risk.
Solution Approach 2:
The device employs dynamic elements including a pulling member that can adjust the configuration of cylindrical parts, and a locking mechanism that transitions the device from a deployable state to a secured sealing state. This dynamic capability allows the device to achieve effective sealing with minimal area exposure, reducing thrombus formation risk while maintaining sealing reliability.
3Reliability
If a conventional sealing device is used, then the patent foramen ovale can be sealed, but the frail septum primum may be broken during the procedure
Solution Approach 1:
The thin-walled cylindrical parts are designed to be highly flexible, allowing them to conform to the delicate septum primum without exerting excessive mechanical stress. This flexibility enables the device to achieve effective sealing while minimizing the risk of damaging the frail septum tissue during deployment and operation.
Solution Approach 2:
The device incorporates dynamic control through the pulling member and locking mechanism, allowing gradual deployment and adjustment of the cylindrical parts. This dynamic approach enables the operator to control the sealing process, applying minimal force to the septum primum while achieving reliable closure, thereby preventing tissue damage.
4Ease of operation
If the device configuration allows blood flow from right atrium to left atrium, then the natural heart function is maintained, but the patent foramen ovale cannot be sealed
Solution Approach 1:
The segmented cylindrical structure creates a precise barrier at the foramen ovale location while leaving the rest of the interatrial septum and blood flow pathways intact. This segmentation allows the device to seal only the defective opening without obstructing normal blood flow from the right atrium to the left atrium through the patent foramen ovale pathway, maintaining heart function while achieving sealing effectiveness.
Data Source
AI summary
A device for treating a patent foramen ovale has a first part having a predetermined length; a second part having a predetermined length; a third part having a predetermined length; and a pulling member which penetrates into the second part from a side face of a distal portion of the second part, crosses the second cylindrical part obliquely and extends from a side face of a proximal portion of the second part and penetrates into the third part from a side face of a distal portion of the third part, with one end of the pulling member held by a proximal portion of the first part. A part of a locking mechanism provided at other end of the pulling member and a part of the locking mechanism provided at the third part are locked to each other, when the pulling member is pulled to allow the first part and the second part proximate to each other and the second part and the third part to be proximate to each other.