Suture Delivery Device for Pre-Closure Access Sites
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Solution Overview
Problem
Current percutaneous suture-based vessel closure devices face challenges in pre-closing access sites during interventional procedures, requiring prior dilation and struggling with maintaining hemostasis during device exchange and removal, especially in procedures like carotid artery interventions where direct visualization is not possible.
Innovation Solution
A suture delivery device with a distal assembly and proximal housing, featuring a guidewire lumen, blood return channel, and a stabilizer for precise positioning, which allows for the deployment of sutures without previous dilation, enabling rapid hemostasis and minimizing the risk of bleeding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional sutures and suturing systems are used for percutaneous access, then sutures can be deployed to close access sites, but direct visualization is not possible making deployment challenging
Solution Approach 1:
The patent introduces a delivery device as an intermediary system that enables indirect suture deployment. The device includes a delivery catheter with a delivery tube that can be advanced through the vascular system without direct visualization, allowing suture anchors to be positioned and deployed at the access site through the delivery mechanism rather than direct visual contact.
Solution Approach 2:
The patent replaces manual mechanical suture placement with a motorized or mechanically-assisted delivery system. The delivery device uses controlled advancement of the delivery tube and push rod mechanism to automatically position and deploy suture anchors, substituting manual suturing operations with a controlled mechanical delivery process that can operate without direct visualization.
2Reliability
If prior dilation is performed before suture deployment, then access site preparation is improved, but procedural time and complexity increase
Solution Approach 1:
The patent combines the access site preparation function with the suture delivery function into a single integrated procedure. The delivery device is designed to be advanced through the access site without requiring separate prior dilation, merging the puncture, positioning, and suture deployment steps into one continuous action, thereby eliminating the time loss associated with separate dilation procedures.
Solution Approach 2:
The patent performs the necessary positioning and anchoring actions in advance during the delivery process itself. The suture anchor is positioned and secured in the target tissue before the delivery tube is withdrawn, allowing the access site to be prepared and closed in a single procedural step rather than requiring separate preliminary dilation and subsequent closure steps.
3Reliability
If sutures are deployed for pre-closure during interventional procedures, then hemostasis is improved, but maintaining hemostasis during device exchange becomes difficult
Solution Approach 1:
The patent employs a dynamic delivery system where the delivery tube can be advanced, positioned, and then retracted while maintaining suture anchor placement. The push rod mechanism allows the suture anchor to be deployed at the target location and then the delivery tube to be withdrawn without compromising the anchor's position, enabling dynamic device exchange while maintaining hemostatic closure.
Solution Approach 2:
The delivery device serves as an intermediary that facilitates both pre-closure and post-closure functions. The same delivery system can be used to deploy sutures for initial hemostasis and then repositioned or re-used to maintain that hemostasis during device exchange and removal, eliminating the need for separate procedures to maintain closure during the exchange process.
4Object-affected harmful factors
If access sites are closed after interventional procedures, then bleeding is reduced, but the closure process becomes complex and time-consuming
Solution Approach 1:
The delivery device is designed with multi-functionality to perform both the interventional procedure and the closure function using the same system. The same delivery catheter and suture delivery mechanism used for the intervention can be employed to deploy closure sutures, eliminating the need for separate closure devices and procedures, thereby reducing overall complexity and time while effectively preventing bleeding.
Data Source
AI summary
A delivery device for suture deployment for post-procedure closure of an access site after removal of an interventional device is disclosed. The delivery device includes a distal assembly comprising an elongate member, a proximal housing comprising one or more control elements for controlling one or more components of the delivery device, and a plurality of delivery tubes extending distally from the proximal housing into the elongate member. Each of the plurality of delivery tubes includes a suture anchor stored within a distal portion of that delivery tube, and a push rod configured to push the suture anchor distally out of the distal portion of that delivery tube for deployment of the suture anchor within a target tissue.