Percutaneous Artery Closure Toggle and Collagen Plug Sealing
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Solution Overview
Problem
Existing technologies face challenges in effectively sealing large punctures in arteries, such as those created by procedures like balloon aortic valvulopasty 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 comprising a toggle, a compressible collagen foam plug, and a braided multifilament suture is deployed using a deployment instrument, where the toggle is positioned within the artery and the plug is drawn towards the toggle using tension on the suture, securing it in place with a lock, and optionally using an occlusion balloon to control blood flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a closure device is used to seal percutaneous punctures, then sealing effectiveness is improved, but the complexity of the device increases
Solution Approach 1:
The closure device is divided into distinct functional components: an anchor element for securing to the vessel wall, a sealing element for closing the puncture, and a deployment mechanism. This segmentation allows each component to be optimized for its specific function while simplifying the overall device design and deployment process.
Solution Approach 2:
The closure device components are nested within a delivery catheter during deployment. The anchor and sealing elements are contained within the catheter lumen, allowing for minimally invasive percutaneous delivery while maintaining device simplicity. The nested configuration enables the complex multi-component device to be delivered through a relatively simple catheter structure.
2Adaptability or versatility
If large bore access sheaths are used for procedures like balloon aortic valvulopasty, then procedural capability is improved, but the difficulty of closing the puncture increases
Solution Approach 1:
The closure device employs dynamic elements including a deployable anchor that can be deployed after vessel access is established, and a sealing element that can be positioned and secured. The deployment mechanism allows the device to adapt from a compact delivery configuration to an expanded functional configuration, enabling closure of large punctures created by large bore sheaths.
Solution Approach 2:
The closure device utilizes materials and structures that change properties in response to physiological conditions. The sealing element may expand or conform to the vessel wall upon deployment, and the anchor elements are designed to engage the vessel wall effectively. These parameter changes enable the device to effectively close punctures of varying sizes without requiring overly complex device designs.
Data Source
AI summary
Methods for sealing a percutaneous puncture in a wall of a body passageway are disclosed herein. The methods include inserting a deployment instrument into the puncture via a toggle along the guidewire, and actuating the deployment instrument to move the first component and the second component relative to each other such that the toggle abuts the wall of the artery proximate the puncture to seal the puncture.