Flexible PFO Closure Device with Segmented Anchor and Occluding Wires
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Solution Overview
Problem
Conventional nonsurgical closure devices for patent foramen ovale (PFO) are complex, bulky, and difficult to deploy, often causing tissue damage and complications such as thrombosis and residual leaks, due to their high septal profile and inability to remain flat within the defect, requiring large delivery catheters and foreign material that can lead to unfavorable body reactions.
Innovation Solution
A closure device comprising flexible outwardly radiating occluding wires connected to biocompatible sheet materials, anchored by a flexible structure that can be deployed to bias against tissue, using a delivery system with a smaller catheter size, facilitating stable and permanent closure through angiogenesis and endothelialization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional nonsurgical closure devices are used, then PFO closure is achieved, but the devices are complex, bulky, and difficult to deploy with high septal profile
Solution Approach 1:
The closure device is divided into two separate components: an anchor component that is deployed first and secured in the septal tissue, and an occluding component that is subsequently attached to complete the closure. This segmentation allows each component to be optimized independently - the anchor provides stable fixation while the occluding component provides the closure function, reducing overall device complexity and deployment difficulty.
Solution Approach 2:
The occluding component is nested within or attached to the anchor component during deployment. The anchor serves as a base structure that supports and positions the occluding component, allowing the device to be delivered through a smaller catheter while maintaining the necessary structural integrity for effective PFO closure.
2Reliability
If conventional closure devices are deployed, then PFO closure is achieved, but tissue damage and complications such as thrombosis and residual leaks occur
Solution Approach 1:
The occluding component utilizes a flexible disc or sheet structure that can conform to the irregular geometry of the PFO defect and surrounding septal tissue. This flexibility allows the device to adapt to the patient's anatomy rather than forcing the anatomy to fit the device, reducing tissue trauma and improving sealing effectiveness to prevent residual leaks.
Solution Approach 2:
The device employs materials and structural parameters that change under physiological conditions - the flexible occluding component may deform or expand after deployment to achieve optimal contact with the tissue, and the anchoring mechanism may adjust its grip strength. These parameter changes allow the device to achieve secure fixation and effective closure while minimizing tissue damage and reducing the risk of complications such as thrombosis.
3Reliability
If conventional closure devices are used, then PFO closure is achieved, but large delivery catheters are required
Solution Approach 1:
By dividing the closure device into separate anchor and occluding components that can be deployed sequentially, the overall device profile during delivery is reduced. The anchor component has a compact structure suitable for delivery through smaller catheters, and the occluding component is attached or positioned afterward, eliminating the need for large-bore catheters required by conventional single-piece devices.
4Reliability
If conventional closure devices are deployed, then PFO closure is attempted, but the devices have high septal profile and inability to remain flat within the defect
Solution Approach 1:
The occluding component is designed as a thin, flexible disc or sheet that can lie flat against the septal defect. This flexible structure conforms to the tissue surface and remains flat within the defect, providing effective closure without the high profile characteristic of conventional rigid or semi-rigid devices. The flexibility allows the device to adapt to the irregular geometry of the PFO while maintaining contact with the tissue.
Data Source
AI summary
A device for occluding septal defects or other bodily passageways including PFOs, includes an occluding body formed from a plurality of flexible outwardly radiating occluding wires connected to one or more biocompatible sheet materials. The occluding wires are joined together at proximal wire ends. Linking members connectively link the occluding body to a flexible, substantially linear anchor formed from at least one tube, coil, or bar. The anchor is configured for placement on one side of bodily passageway, whereby the longitudinal axis of at least one anchor extends across a transverse cross-section of the bodily passageway, anchoring the occluding body in place against the other side of a bodily passageway to close, occlude, or fill at least a lumenal portion of a bodily passageway. The anchor may include one or more grasping member(s) integrally formed or connected to the tube, coil, or bar for releasable attachment to an anchor engaging member, such as a biopsy forceps. In a further aspect, a closure device assembly includes a delivery catheter housing a collapsibly disposed closure device linked to a biopsy forceps. The biopsy forceps may be positioned in a locking catheter, which is configured to prevent inadvertent release of the closure device when held in a compressed state inside the delivery catheter. By positioning the catheter near a bodily passageway, such as a PFO, and disengaging the anchor engaging member from the grasping member, the closure device may be released so as to facilitate stable closure of the bodily passageway.