Bioabsorbable Tissue Clip for Vascular Puncture Closure
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Solution Overview
Problem
Current vascular sealing methods and devices often incompletely seal holes in tissues, leading to complications such as hemorrhage, hematoma, and the need for permanent foreign materials in the body, which can cause thrombosis or hinder future procedures.
Innovation Solution
A bioabsorbable tissue closure device that engages tissue externally, featuring a deployable sheath and tissue eversion apparatus to form an everted tissue region, which is then secured within a concave annular-shaped body to close the opening, allowing for complete wound closure with minimal endothelial disruption.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional vascular sealing methods are used, then the vessel is sealed from the outside, but the sealing is incomplete leading to hemorrhage and hematoma
Solution Approach 1:
The clip is designed to invert from a convex configuration to a concave configuration upon tissue engagement. This inversion allows the clip to properly conform to the tissue surface and achieve complete sealing, resolving the inadequate sealing problem of conventional devices.
Solution Approach 2:
The clip transitions from a static convex shape to a dynamic concave shape through the inversion mechanism. This dynamic transformation enables the clip to adapt to the tissue geometry and achieve reliable sealing, addressing the completeness issue.
2Reliability
If non-bioabsorbable materials are used for vascular devices, then the device provides permanent sealing, but it remains in the body causing thrombosis risk and preventing future reaccess
Solution Approach 1:
The clip uses bioabsorbable materials that degrade and are absorbed by the body over time. This temporary presence provides the necessary sealing durability while eliminating the long-term harmful effects of permanent foreign materials, including thrombosis risk and reaccess obstruction.
Solution Approach 2:
The material properties change over time as the bioabsorbable clip degrades. The clip maintains its structural integrity and sealing function initially, then gradually loses strength as it is absorbed, transitioning from a permanent to a temporary device that eliminates long-term complications.
3Device complexity
If the clip remains in convex configuration, then the structure is simple, but the tissue engagement and sealing are inadequate
Solution Approach 1:
The clip inverts from convex to concave upon tissue engagement, transforming a simple initial structure into an effective sealing configuration. This inversion mechanism maintains structural simplicity while achieving reliable tissue engagement and sealing.
Data Source
AI summary
A tissue engaging device and a corresponding deployment apparatus. The tissue engaging device has a generally annular-shaped body disposed about a central axis. The body has a plurality of inwardly protruding members separated by corresponding intermember spaces. The body is movable between a first position where the body is substantially convex before engagement with the tissue and a second position where the body is substantially concave when the body is engaged with the tissue. The tissue engaging device may be bioabsorbable. The deployment apparatus has a sheath and a tissue eversion apparatus for everting the tissue and positioning the everted tissue within the tissue engaging device.