Expandable Vascular Closure Plug Anchoring Mechanism
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Solution Overview
Problem
Current vascular closure devices often fail to securely maintain hemostasis after vascular procedures, as the hemostatic plugs can become dislodged from the vessel opening, leading to bleeding complications.
Innovation Solution
A device comprising multiple implant members that expand and secure a plugging body at the treatment site, using a delivery cannula to deploy an anchor member and tether within the vessel, along with pusher and expander components to ensure frictional coupling and anchoring, preventing dislodgment and promoting hemostasis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single hemostatic plug is inserted into the vessel opening, then the procedure is simple and quick, but the plug can become dislodged and fail to maintain hemostasis
Solution Approach 1:
The device is divided into multiple independent components: a first implant member (hemostatic plug), a second implant member (expander), and an anchor member. These segments work together to provide secure hemostasis - the plug provides sealing, the expander provides radial force, and the anchor provides mechanical fixation, collectively solving the dislodgment problem while maintaining reasonable complexity
Solution Approach 2:
The second implant member is received within the first implant member, and both are delivered through a common delivery cannula. This nested configuration allows compact delivery while enabling sequential deployment where the expander is positioned inside the plug during insertion, then expanded outward to provide radial anchoring force
2Ease of operation
If manual compression is applied to control bleeding, then no additional devices are needed, but the patient requires prolonged compression and monitoring
Solution Approach 1:
The device performs preliminary anchoring and sealing actions during the insertion procedure itself. The expandable members are deployed to provide immediate radial force and frictional coupling before the patient leaves the procedure room, eliminating the need for prolonged post-procedure compression and monitoring
3Reliability
If the implant members are made expandable to improve anchoring, then hemostasis reliability increases, but the delivery and deployment complexity increases
Solution Approach 1:
The expandable members are designed to self-expand upon deployment through frictional coupling between the first and second implant members. The expansion is driven by the relative movement and friction between components during withdrawal from the delivery cannula, eliminating the need for complex external expansion mechanisms while achieving reliable anchoring
Solution Approach 2:
The delivery cannula serves as an intermediary that facilitates the deployment of multiple implant members in a controlled sequence. It provides a common pathway for inserting the nested components and enables their coordinated deployment through simple withdrawal motion, reducing the complexity of deploying multiple expandable components
4Reliability
If multiple implant members are used to prevent dislodgment, then hemostasis reliability improves, but the device complexity and procedural steps increase
Solution Approach 1:
Multiple implant members are combined into a single integrated delivery system where the first implant member, second implant member, and anchor member are all delivered through a common delivery cannula in a nested configuration. This merging allows sequential deployment through a single procedural action (cannula withdrawal) rather than requiring separate insertion steps for each component
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device effectively maintains hemostasis by securely anchoring the implant members within the vessel, reducing the risk of bleeding and enhancing the stability of the hemostatic plug, thereby improving patient outcomes.
Implementation Method 1
movement of at least a portion of the second implant member against the first implant member causes the first implant member to expand
Implementation Method 2
The first and second implant members can be sized and configured such that the above-noted movement causes the first and second implant members to frictionally couple to one another
Implementation Method 3
the anchor member configured to reside and anchor within the vessel upon deployment from the delivery cannula
Data Source
AI summary
Described are devices useful for providing hemostasis at a vascular access site, and related methods. Such devices can include first and second implant members cooperable when forced together to expand the first implant member in a tissue tract at the site. Such devices can also include an anchor member and a tether attached thereto. The anchor member can be deployed distally to the first implant member, within a vessel, and the tether can be tensioned to apply counterforce to the first implant member as the second implant member is forced into cooperative contact to expand the first implant member.