Vascular Closure Toggle Release for Large-Bore Puncture Sealing
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Solution Overview
Problem
Existing vascular closure devices face challenges in efficiently and effectively sealing puncture sites in vessels after medical procedures, particularly in large bore procedures, due to complex deployment mechanisms and materials that may not adequately secure the sealing components.
Innovation Solution
A vascular closure device with a release component, delivery component, and actuator system that allows for controlled orientation and tensioning of a toggle and suture mechanism, enabling efficient sealing by deploying a toggle against the vessel wall and securing it with a plug and locking member.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a toggle and suture mechanism is used to seal puncture sites, then sealing effectiveness is improved, but device complexity increases due to the need for controlled orientation and tensioning mechanisms
Solution Approach 1:
The patent extracts the orientation and tensioning control functions from the main delivery system by using a separate release component with a locking member. This locking member can independently control the toggle's orientation and the suture's tensioning, simplifying the overall deployment mechanism while maintaining sealing effectiveness.
Solution Approach 2:
The device is segmented into distinct functional components: a delivery component for initial placement, a release component for controlled deployment, and a locking member for securing the toggle and suture. This segmentation allows each component to perform its specific function efficiently without requiring complex integrated mechanisms.
2Object-affected harmful factors
If biocompatible degradable materials are used for the toggle and suture, then patient comfort and healing are improved, but device strength and reliability may be reduced during the deployment period
Solution Approach 1:
The patent employs a locking member that secures the toggle and suture in place before the degradable materials begin to significantly degrade. This preliminary securing mechanism ensures that the device maintains full strength and reliability during the critical deployment and sealing phases, only allowing gradual degradation after the puncture site is sealed and healing begins.
Solution Approach 2:
The toggle and suture are designed with dynamic properties that allow them to transition from a non-degradable or slowly degradable state during deployment to a fully degradable state over time. This dynamic characteristic enables the materials to provide necessary strength initially while gradually becoming more biocompatible and comfortable for the patient as healing progresses.
Data Source
AI summary
A vascular closure device includes a release component, a delivery component, a sealing device and at least one actuator. The release component is elongate along a longitudinal direction, and defines a distal end and a proximal end. The delivery component extends along the release component such that at least the release component is movable relative to the delivery component. The delivery component includes a delivery tube body and defines a delivery tube channel. The sealing device has a toggle that is at least partially disposed within the release tube, a suture that is attached to the toggle and extends through the delivery tube channel, and a plug that is attached to the suture proximal to the toggle. The actuator is coupled to the release component and is in communication with the suture such that actuation of the actuator causes (i) the release component to move the proximal direction relative to the delivery component so as to release the toggle from the release component, and (ii) the suture to be pulled in a proximal direction to thereby place the filament in tension and urge the toggle against a distal end of the delivery component such that the toggle is oriented in a sealing position.