Deflectable Needle Assembly for PFO Closure Delivery
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for closing patent foramen ovale (PFO) are invasive, risky, and often ineffective, with existing devices being complex, bulky, and unsuitable for precise deployment, leading to potential complications and recurrence of embolic events.
Innovation Solution
A delivery system with a deflectable needle assembly and actuator is used to deploy a mechanical closure device through the heart's septum, featuring expandable anchors and a closure line to securely close the PFO, allowing for minimally invasive procedures and precise placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional umbrella-like devices are used for PFO closure, then closure function is achieved, but device complexity and bulkiness increase, making precise deployment difficult
Solution Approach 1:
The closure device is divided into separate functional components: a delivery catheter, a deflectable needle assembly for puncture, and an anchor deployment mechanism. This segmentation allows each component to be optimized for its specific function, reducing overall device complexity while maintaining closure effectiveness.
Solution Approach 2:
The needle assembly incorporates a deflectable tip that can change orientation in three-dimensional space, allowing the device to navigate the complex anatomical geometry of the atrial septum from a peripheral venous access point, thereby simplifying the overall procedural complexity.
2Reliability
If open heart surgery is used for PFO closure, then reliable closure is achieved, but invasiveness and surgical risk increase
Solution Approach 1:
A delivery catheter serves as an intermediary tool that transports the closure device through the venous system and across the atrial septum to the PFO site, enabling minimally invasive deployment without requiring open heart surgery or general anesthesia.
Solution Approach 2:
The surgical stitching mechanism is replaced with a percutaneous needle-puncture and anchor-deployment system that achieves reliable closure through mechanical expansion and tissue anchoring, eliminating the need for surgical incisions and reducing invasiveness.
3Reliability
If conventional ASD closure devices are used for PFO, then closure is achieved, but adaptability to PFO anatomy is poor due to septum primum overlap
Solution Approach 1:
The needle assembly is designed with a deflectable tip that can be locally oriented to navigate through the overlapping septum primum tissue and accurately puncture the PFO track, providing localized adaptability to the specific PFO anatomy rather than requiring a completely different device design.
Solution Approach 2:
The needle assembly incorporates dynamic deflectability, allowing the operator to adjust the needle tip orientation in real-time during deployment to adapt to variations in PFO anatomy and septum overlap configurations, thereby improving versatility across different patient anatomies.
Data Source
AI summary
The present invention relates to a delivery system for delivering a device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart. The delivery system has an elongate member having a proximal and distal end. A deflectable needle assembly having luminal and abluminal surfaces is slideably engaged within the elongate member. An actuator is slideabley engaged within the elongate member and attached to the needle tip assembly such that translational movement of the actuator causes deflection of the deflectable needle assembly.