Retracting Unit for Slit-Like Vascular Closure
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Solution Overview
Problem
Current methods for closing large bore vascular punctures, such as those required for complex interventional procedures, face challenges in effectively sealing large venous systems without causing vascular stenosis, as existing systems like plugs, clips, and sutures are limited in size and often lead to complications like excessive bleeding or thrombus formation.
Innovation Solution
A medical apparatus and method that involves a retracting unit to transform the puncture site into a slit-like aperture, allowing for the deployment of closing devices that stretch the perforation orthogonally to the vessel's long axis and secure it with clips or staples, thereby avoiding circular closure that could lead to stenosis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing closure systems (plugs, clips, sutures) are used for large bore vascular punctures, then hemostasis can be achieved, but vascular stenosis and thrombus formation occur
Solution Approach 1:
The closure device is divided into multiple independent elements including a retracting unit with first and second elements, and a closing unit with multiple closing elements. The retracting unit segments the aperture into opposite sides that can be independently manipulated, while the closing unit provides multiple discrete closing elements distributed along the aperture perimeter, preventing localized stenosis while achieving effective hemostasis
Solution Approach 2:
The invention transforms the closure approach from a two-dimensional planar closure to a three-dimensional spatial arrangement. The retracting unit pulls opposite sides of the aperture in opposite directions to create a slit-like configuration, and the closing elements are positioned at multiple locations along the aperture perimeter, creating a distributed three-dimensional closure pattern that maintains vascular patency while achieving hemostasis
2Reliability
If circular closure of the aperture is performed, then hemostasis is achieved, but vascular stenosis occurs
Solution Approach 1:
The invention deliberately creates an asymmetric slit-like aperture shape instead of a symmetric circular closure. The retracting unit pulls opposite sides of the aperture in opposite directions to form an asymmetric linear configuration, and the closing elements are asymmetrically distributed along the slit aperture perimeter, preventing the circular stenosis pattern while maintaining effective hemostasis
Solution Approach 2:
Instead of closing the aperture in a traditional circular manner from the inside, the invention inverts the approach by first creating a slit-like shape through retraction of opposite sides in opposite directions, then applying closing elements along the perimeter of this inverted configuration, effectively preventing stenosis while achieving hemostasis
3Adaptability or versatility
If puncture size is increased for complex interventional procedures, then procedural capability is improved, but closure difficulty and bleeding risk increase
Solution Approach 1:
The closure device is designed as a universal multi-functional system that can handle various puncture sizes (up to 30 French and larger) and different vascular locations. The retracting unit with its multiple elements and the closing unit with distributed closing elements can be adapted to different aperture sizes and geometries, providing a single versatile solution for complex interventional procedures regardless of puncture dimensions
Solution Approach 2:
The invention employs dynamic components including the retracting unit that can actively pull opposite sides of the aperture in opposite directions to create the slit-like configuration, and the closing unit with multiple closing elements that can be independently positioned and activated. This dynamic adaptability allows the device to adjust to different puncture sizes and geometries encountered in complex interventional procedures
Data Source
AI summary
The present invention relates to a medical apparatus for closing an aperture, an incision, a puncture, a passage through tissue and/or a communication with a blood vessel or other body lumen (short: aperture) of a tissue of a patient, the medical apparatus comprising a closing device holder, for releasably receiving one or more closing devices; and a retracting unit to come into contact with opposite sides of the aperture and for retracting them and/or for spreading the aperture causing it to change its shape into a slit or a slit-like or a more slit-like aperture or to spread or to augment the dimension or diameter of the aperture in at least one or in exactly one dimension of the aperture.