Expandable Clip for Minimally Invasive PFO Closure
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Solution Overview
Problem
Current methods for treating patent foramen ovale (PFO) are either invasive, complicated, or involve large implanted devices, posing risks and uncertainties in closure efficacy.
Innovation Solution
A minimally invasive system using an expandable clip and suture-securing fastener delivered via catheter to physically block the PFO opening, allowing for remote insertion and adjustable deployment to ensure effective closure, with options for temporary or permanent blockage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart surgery with suturing is used to close PFO, then closure efficacy is achieved, but surgical risks and invasiveness increase
Solution Approach 1:
The patent introduces a percutaneous delivery system as an intermediary between the operator and the PFO closure site, eliminating the need for open-heart surgery. The catheter-based delivery system allows the clip to be inserted through a peripheral vessel and positioned at the PFO site without direct surgical access to the heart, thereby reducing surgical risks while maintaining closure efficacy
Solution Approach 2:
The patent replaces the mechanical suturing system with a deployable clip system. Instead of using needles and sutures that require complex surgical manipulation, the invention uses a pre-formed clip that can be mechanically deployed at the target site through the catheter, simplifying the procedure and reducing surgical complexity
2Reliability
If percutaneous mesh or clamshell devices are deployed to close PFO, then closure is achieved, but device size and procedural complexity increase
Solution Approach 1:
The patent divides the closure device into two functional segments: a fixed delivery portion (catheter and deployment mechanism) and a deployable closure portion (the clip). This segmentation allows the complex deployment mechanism to remain outside the body while only the simple clip structure is introduced into the PFO, reducing procedural complexity at the treatment site
Solution Approach 2:
The patent employs a dynamic deployment system where the clip transitions from a compressed delivery state to an expanded functional state. The clip is delivered in a low-profile configuration through the catheter and then mechanically expanded at the target site, allowing complex functionality to be achieved through a simple deployment action rather than complex procedural steps
3Object-affected harmful factors
If percutaneous suture methods are used to close PFO, then minimally invasive access is achieved, but procedural time and complexity increase
Solution Approach 1:
The patent applies preliminary action by pre-forming the clip structure and pre-positioning it on the catheter before patient insertion. The clip is prepared in its delivery configuration ahead of time, eliminating the need for complex intra-procedural assembly or manipulation. This preliminary preparation significantly reduces procedural time while maintaining minimally invasive access
Data Source
AI summary
An apparatus, system, and method for repairing openings such as septal defects includes advancing a catheter to the site of the defect, grasping opposing edges of the defect, passing one or more suture lines through the opposing edges, tightening the suture lines, and deploying and expanding a fastener to secure the suture lines and close the defect. The fastener can include tissue-growth-inducing materials to encourage tissue growth onto or into the fastener and/or suture. The fastener includes a locking clip portion and a plug portion, which may be an expandable portion and/or tissue-growth-inducing portion.