Guidewire-Guided Vascular Closure Device for Large Punctures
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Solution Overview
Problem
Existing technologies face challenges in effectively sealing large punctures in blood vessels, such as those created by procedures like balloon aortic valvuloplasty and percutaneous aortic valve replacement, due to the size and complexity of the access sheaths used, which require a closure device that can securely and reliably close the puncture.
Innovation Solution
A closure device system comprising a toggle, plug, and suture, with a deployment instrument that uses a guidewire to guide the system into the vessel, allowing the toggle to engage the interior vessel wall and the plug to engage the exterior, enabling secure sealing of the puncture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a closure device is used to seal percutaneous punctures, then sealing effectiveness is improved, but device complexity increases due to multiple components (sealing member, anchor, positioning member)
Solution Approach 1:
The patent combines the sealing member and anchor into a single integrated closure member that performs both sealing and anchoring functions. The closure member includes a body portion that seals the puncture and an anchor portion that engages the vessel wall, eliminating the need for separate sealing and anchoring components while maintaining effective closure.
Solution Approach 2:
The closure member is designed as a multi-functional component that simultaneously provides sealing, anchoring, and positioning capabilities. The single closure member can be deployed through the puncture site and automatically engages the vessel wall while sealing the opening, reducing the number of steps and components needed compared to traditional multi-component systems.
2Reliability
If traditional closure devices are used for large punctures, then sealing capability is limited, but using larger closure devices increases device size and difficulty of deployment
Solution Approach 1:
The closure member is designed with dynamic deployment characteristics where it transitions from a compressed delivery state to an expanded deployed state. The closure member can be delivered in a compact form through the puncture site and then expands or engages to provide effective sealing and anchoring, allowing large punctures to be sealed without requiring permanently large device dimensions.
Solution Approach 2:
The closure member is divided into functional segments including a body portion for sealing and an anchor portion for engagement. This segmentation allows the device to be delivered through relatively small access sites while providing sufficient sealing capability for large punctures, as the segmented structure can be compressed for delivery and then deployed to full functional size at the target site.
3Object-affected harmful factors
If resorbable materials are used for the closure device, then biocompatibility is improved, but device strength decreases during the resorption process
Solution Approach 1:
The closure member is designed to undergo controlled parameter changes as it resorbs. The material properties evolve over time, with the device providing maximum strength during the critical early period when it is needed for vessel closure, and gradually reducing strength as resorption progresses and the vessel healing process advances. This allows biocompatible resorbable materials to maintain sufficient structural integrity when most needed.
Solution Approach 2:
The closure member is designed with inherent strength characteristics that provide a safety margin during the resorption process. The device maintains adequate strength beyond the minimum required period, cushioning against potential complications during the transition period when the device is losing strength but the vessel wall is still healing and gaining strength to take over the load-bearing function.
Data Source
AI summary
A closure device system for sealing a percutaneous puncture in a vessel wall can comprise a toggle configured to engage an interior surface of the vessel wall, a plug configured to engage an exterior surface of the vessel wall, and a suture that extends through the plug and through the toggle along at least a first direction so as to couple the toggle to the plug. The system can further comprise a tube that extends through the plug and through the toggle along the first direction such that a distal end of the tube is disposed distally to the toggle. The tube can define a guidewire lumen that extends therethrough along the first direction. And the guidewire lumen can be configured to receive a guidewire that protrudes from the vessel wall such that the plug, toggle, and tube are slidable along the guidewire toward the vessel wall.