Vascular Closure Anchoring Member with Offset Filaments
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Solution Overview
Problem
Existing vascular closure devices are ineffective in sealing large tissue openings, often resulting in blood leakage and complications due to improper placement and bending under blood flow, which can lead to significant blood loss and negative consequences.
Innovation Solution
A medical treatment device featuring an anchoring member with multiple filaments and stems that distribute tension evenly, ensuring proper engagement with tissue and preventing movement, along with a hemostatic valve for controlling blood flow, and a pusher system with a tapered lumen for secure placement and indication of locking.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing closures are used to seal large tissue openings, then the closure may be placed over the hole, but the closure can bend due to blood flow creating gaps between the closure and vessel tissue, resulting in blood leakage
Solution Approach 1:
The anchoring member is divided into multiple segments (first anchoring segment, second anchoring segment, third anchoring segment) that can independently engage with the tissue. This segmentation allows each segment to flex and conform to the tissue surface separately, maintaining sealing effectiveness while resisting blood flow forces that would otherwise cause the closure to bend and create gaps.
2Reliability
If external pressure is applied via the skin to the vessel to close the hole, then bleeding can be minimized, but significant blood loss can occur and vessel flow can be minimized or stopped, having negative consequences
Solution Approach 1:
The closure device is designed to be self-retaining through the engagement of multiple anchoring segments with the tissue. Once deployed, the anchoring segments mechanically interlock with the tissue, providing automatic retention and sealing without requiring continuous external pressure. This eliminates the need for manual compression and prevents the harmful effects of prolonged pressure on vessel flow.
3Reliability
If existing closures are used for large openings, then the closure may be placed over the hole, but the closure can be poorly centered allowing portions of the hole to be uncovered, resulting in blood leakage
Solution Approach 1:
The division into multiple anchoring segments provides multiple engagement points with the tissue, which helps distribute the closure across the entire opening. This segmented structure makes it more difficult for the closure to become poorly centered, as the multiple segments work together to achieve comprehensive coverage and stable positioning over the hole.
Solution Approach 2:
The anchoring segments extend in multiple directions from the central closure body, engaging with tissue in different spatial dimensions. This multi-dimensional anchoring approach ensures that the closure remains centered and properly positioned, preventing any portion of the hole from being uncovered while maintaining ease of deployment.
Data Source
AI summary
Among other things, methods and apparatus for inserting devices for closing a tissue opening are disclosed. An anchoring or sealing member has one or more stems and/or filaments that are offset from the center of the member, so that lateral adjustments or movements of the anchoring or sealing member do not uncover the opening, cause the anchoring or sealing member to stick through or pull through the opening. Embodiments including a valve adapted to accommodate a guide wire for addressing emergencies are also disclosed.