Tissue Access Site Closure Device for Large Bore Vascular Procedures
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Solution Overview
Problem
Current vascular closure devices are ineffective for large bore access sites, requiring manual suturing and being time-consuming and invasive, while existing devices are designed for smaller access sites, leading to inefficiencies and patient discomfort.
Innovation Solution
A system that includes a tissue cutting element for generating a tissue access site with predetermined geometry and a closure device for attaching closure elements, such as sutures, to ensure controlled access site generation and closure, minimizing tissue damage and facilitating efficient closure of large bore access sites.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used to close small access sites, then closure can be achieved, but patient discomfort increases and procedure time increases
Solution Approach 1:
The patent replaces manual compression with a mechanical closure device that uses a suture loop mechanism to close access sites. The device includes a delivery catheter with a suture loop that is positioned around the access site and then tightened to close the tissue, eliminating the need for manual compression and reducing patient discomfort while maintaining closure effectiveness
Solution Approach 2:
The patent introduces a closure device as an intermediary between the access site and the closure process. This device includes a suture loop, delivery catheter, and manipulation wires that work together to automatically close the access site without requiring manual compression, thereby improving patient comfort while maintaining reliable closure
2Adaptability or versatility
If existing closure devices are used for large bore access sites, then closure might be achieved, but the devices are ineffective and require manual suturing
Solution Approach 1:
The patent modifies the closure device parameters to accommodate large bore access sites. The suture loop is designed with increased size and strength, the delivery catheter is enlarged to accommodate larger sheaths, and the overall device dimensions are scaled up to effectively close access sites greater than 18 French, making the device adaptable to various access site sizes while maintaining closure effectiveness
Solution Approach 2:
The patent segments the closure device into modular components including a delivery catheter, suture loop, and manipulation wires that can be independently adjusted and positioned. This segmentation allows the device to be adapted for different access site sizes, particularly enabling effective closure of large bore sites by adjusting the suture loop dimensions and tension
3Reliability
If manual suturing is performed for large bore access sites, then closure can be achieved, but the procedure becomes time-consuming and invasive
Solution Approach 1:
The patent implements a self-service closure mechanism where the suture loop automatically closes the access site after being positioned by the delivery catheter. The operator simply needs to manipulate the wires to tighten the suture, and the device itself performs the closure action, eliminating the need for time-consuming manual suturing while maintaining effective closure of large bore sites
4Productivity
If automated closure devices are introduced, then procedure time is reduced and patient access is improved, but the devices are only effective for small access sites
Solution Approach 1:
The patent designs a universal closure device that can effectively close access sites across a wide range of sizes, from small to large bore (greater than 18 French). The device incorporates adjustable suture loops and scalable components that can be configured for different access site dimensions, making it universally applicable while maintaining the efficiency benefits of automated closure
Data Source
AI summary
A tissue access site system is provided. In one embodiments, the system includes a tissue cutting element designed for generating a tissue access site through a tissue, the tissue access site being surrounded by tissue edge portions of a predetermined geometry; and a tissue closure device being for attaching at least one closure element to the tissue at a region corresponding to at least one of the tissue edge portions.