Expandable Anchor Vascular Closure Locator
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Solution Overview
Problem
Existing vascular closure devices face challenges in ensuring proper alignment and sealing of sealing plugs at tissue puncture sites, leading to potential bleeding complications due to misalignment or failure to contact the vessel surface.
Innovation Solution
A tissue puncture locator device with an anchor assembly and sealing member, featuring an expandable anchor portion and a filling member that can change configurations to ensure accurate placement and sealing, utilizing a handle and actuator for precise deployment of a sealing plug, such as a collagen pad, adjacent to the vascular incision.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a sealing plug is placed at the tissue puncture site using a closure device sheath, then bleeding can be stopped, but misalignment of the sealing plug relative to the tissue puncture may result in improper sealing
Solution Approach 1:
The patent introduces an expandable anchor as an intermediary component between the sealing plug and the tissue puncture site. The anchor is first expanded within the vessel to provide a stable reference point, then the sealing plug is aligned and positioned relative to the anchor's known location. This intermediary structure enables precise alignment by providing a measurable reference that bridges the gap between the operator and the target puncture site, thereby improving sealing effectiveness while maintaining alignment precision.
2Reliability
If the sealing plug is ejected from within the closure device sheath to a location adjacent to the tissue puncture, then sealing can be achieved, but failure to contact the sealing plug against the outer surface of the vessel may result in an improper seal
Solution Approach 1:
The patent applies preliminary action by first deploying and expanding the anchor within the vessel before attempting to position the sealing plug. The expanded anchor creates a stable reference structure that remains in place during subsequent sealing operations. This preliminary anchoring action simplifies the subsequent deployment of the sealing plug, as the operator can now align the plug relative to the known anchor position rather than directly to the difficult-to-locate puncture site, thereby improving both sealing reliability and ease of operation.
3Measurement precision
If an expandable anchor is used to contact the inner surface of the vessel, then proper alignment can be achieved, but the device complexity increases
Solution Approach 1:
The patent segments the closure device into two functionally independent components: an expandable anchor system and a sealing plug system. The anchor can be deployed, expanded, and positioned independently to establish alignment references. The sealing plug is then separately positioned relative to the anchor. This segmentation allows each component to be optimized for its specific function while maintaining overall system manageability, achieving precise alignment without excessive device complexity.
Data Source
AI summary
A tissue puncture locator device includes an anchor assembly and a sealing member. The anchor assembly includes an anchor portion, a tube portion, and a filling member. The anchor portion is positioned at a distal end of the tube portion and configured for placement through a vascular incision into a vessel. The anchor member has an unexpanded configuration that permits passage through the vascular incision and an expanded configuration that limits passage through the vascular incision. The filling member is retained in the tube portion and adapted for insertion from the tube portion into the anchor member to provide the expanded configuration, and adapted for retraction from the anchor member into the tube portion to provide the unexpanded configuration. The sealing member is configured for placement adjacent the vascular incision outside the vessel.