Bioresorbable Sealing Tip for Vascular Closure
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Solution Overview
Problem
Existing vascular closure devices face challenges in effectively sealing tissue punctures, particularly after the removal of instruments and insertion sheaths, as they often leave a tract through the sealing material, which can lead to bleeding complications.
Innovation Solution
A vascular closure system comprising an expandable anchor, a sealing material, and a bioresorbable sealing tip with a release member that allows for the low-force release of the sealing tip within the sealing material, ensuring secure anchoring and sealing without the need for tactile force.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a temporary seal is created using an inflation balloon and sealing material, then the tissue puncture is sealed during the procedure, but a tract through the sealing material remains after balloon removal causing bleeding
Solution Approach 1:
The sealing system is divided into multiple components: an expandable anchor for temporary sealing, a sealing material for permanent sealing, and a sealing tip to fill the tract. This segmentation allows each component to perform its specific function sequentially, ensuring complete sealing while eliminating the tract that causes bleeding.
Solution Approach 2:
The sealing material is deposited on the outer surface of the tissue before the balloon is removed, creating a preliminary seal. The sealing tip is then positioned within this sealing material to fill the tract that will form, preventing bleeding before the balloon is withdrawn.
2Ease of operation
If the sealing tip is released using traditional methods, then the sealing tip is deployed, but high tensile force is applied causing tissue damage
Solution Approach 1:
The traditional mechanical release mechanism that requires high tensile force is replaced with a low-force release member system. The release member can be a filament, string, or wire that passes through the sealing tip and anchor, allowing the sealing tip to be released by simply pulling the release member through the tract, which requires minimal force and avoids tissue damage.
Solution Approach 2:
The release member acts as an intermediary between the operator and the sealing tip. Instead of directly applying force to the sealing tip, the release member transmits the release command through the sealing material and anchor, enabling gentle, controlled release without direct mechanical force on the sealing tip itself.
3Device complexity
If the sealing tip is released without a release member, then the structure is simpler, but the sealing tip cannot be reliably released within the sealing material
Solution Approach 1:
The release member is nested within the sealing tip and anchor structure during delivery. The release member passes through both components, allowing it to be pulled through the sealing material to release the sealing tip. This nesting allows the release mechanism to be integrated into the existing structure without adding significant complexity.
Data Source
AI summary
A vascular closure system includes an expandable anchor, a sealing material, a sealing tip, and a sealing tip release member. The expandable anchor is temporarily positioned through a vessel puncture within a vessel. The sealing material is positioned outside of the vessel and configured to seal the vessel puncture. The sealing tip is positioned distal of the anchor and releasable within the sealing material upon removal of the anchor and sealing tip through the sealing material. The sealing tip release member is operable to release the sealing tip without application of a tactile force.