Automated Artery Puncture Closure via Tethered Fasteners
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Solution Overview
Problem
Current methods for closing large puncture holes in vessels after medical procedures, such as cardiac catheterization, require manual compression by medical professionals, limiting their ability to perform other tasks and lacking effective automation for vessel wall closure.
Innovation Solution
A device and method involving a guide wire, introducer catheter, balloon catheter, and a firing mechanism with fasteners tethered to sutures, which percutaneously attach and tie fasteners to close the puncture hole, allowing for automated closure of artery punctures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used to close vessel punctures, then hemostasis can be achieved, but medical professionals are occupied and cannot perform other tasks
Solution Approach 1:
The closure device performs hemostasis automatically without requiring continuous manual compression by medical professionals. The device self-regulates the closure process through its mechanical components (pusher element, compression element, and release mechanism) that work together to close the puncture and maintain hemostasis independently.
Solution Approach 2:
The invention replaces the manual mechanical compression system with an automated mechanical system. The pusher element, compression element, and release mechanism constitute an automated mechanical apparatus that substitutes for human hands and eliminates the need for continuous manual intervention while maintaining effective hemostasis.
2Loss of time
If automated closure devices are implemented, then medical professional availability improves, but device complexity increases
Solution Approach 1:
The closure device is divided into distinct functional segments: a pusher element for initial puncture closure, a compression element for maintaining compression, and a release mechanism for controlled deployment. This segmentation allows each component to perform its specific function efficiently while keeping the overall device manageable in complexity.
Solution Approach 2:
The device employs a nested structure where the pusher element is positioned within the compression element, and both are integrated into the introducer sheath assembly. This nesting approach consolidates multiple components into a compact configuration, reducing spatial complexity while maintaining the automated closure functionality.
3Manufacturing precision
If percutaneous fastener attachment is used, then puncture closure precision improves, but procedure complexity increases
Solution Approach 1:
The fasteners are pre-loaded into the tube in a ready-to-deploy configuration before the procedure begins. This preliminary preparation ensures that when the closure procedure is initiated, the fasteners can be accurately positioned and attached to the puncture site without requiring complex real-time manipulation, thereby improving precision while managing complexity.
Data Source
AI summary
A set of devices and associated methodology for percutaneously closing a puncture through the wall of an artery. The method includes inserting a guide wire through a percutaneous entry and into the artery; using the guide wire to guide an insertion of an introducer catheter into the artery; inserting a balloon catheter through the introducer catheter and into the artery; obtaining a tube having a clamp configured to selectively clamp to the introducer catheter; loading the tube with a plurality of fasteners, each fastener individually tethered to a suture; clamping the tube loaded with fasteners onto the introducer catheter, thereby aligning the puncture with a distal working end of the tube; ejecting two or more of the fasteners from the tube to attach onto the artery; percutaneously tying together the tethered sutures of the attached fasteners to draw the attached fasteners together, closing the puncture.