Bioabsorbable Vessel Closure for Immediate Puncture Hemostasis
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Solution Overview
Problem
Existing vascular closure devices for puncture sites in blood vessels are time-consuming, uncomfortable for patients, and prone to complications such as bleeding, hematoma, and pseudo-aneurysm formation, especially in anticoagulated patients, due to reliance on clot formation and manual compression.
Innovation Solution
A vessel closure device using an intravascular anchor, extravascular cap, and bioabsorbable suture with a sealant, designed for immediate hemostasis, where the anchor and cap are formed of materials like Polyglycolic acid (PGA), Poly-L-Lactic acid (PLLA), and Polyethylene glycol (PEG) that degrade over time, providing a secure seal without the need for removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used for hemostasis, then bleeding can be stopped, but the procedure is time-consuming and requires prolonged patient recumbency
Solution Approach 1:
The patent replaces the manual compression mechanical system with a self-expanding mechanical closure device. The device comprises a body that expands radially to compress the vessel wall and form a seal, eliminating the need for prolonged manual compression while achieving reliable hemostasis. The expansion mechanism is triggered by fluid pressure from blood flow, providing automatic activation.
Solution Approach 2:
The closure device is designed to activate and seal automatically without requiring continuous manual intervention. The self-expanding mechanism responds autonomously to blood flow pressure, and the device maintains hemostasis through its structural design, freeing the patient from prolonged recumbency requirements.
2Reliability
If manual compression is used, then hemostasis can be achieved, but excessive pressure can occlude the blood vessel causing ischemia and thrombosis
Solution Approach 1:
The closure device applies localized compression only at the puncture site through its body structure, rather than requiring excessive external pressure. The device's geometry and material properties allow it to seal the vessel opening while maintaining adequate blood flow, preventing ischemia and thrombosis.
Solution Approach 2:
The device changes the pressure application parameter from high external compression force to controlled radial expansion force. This parameter change allows the device to seal the vessel while maintaining a gradient that preserves blood flow, eliminating the harmful effects of excessive pressure.
3Reliability
If external compression is applied, then bleeding stops, but the patient requires prolonged recumbency under observation
Solution Approach 1:
The closure device performs the hemostasis sealing action immediately upon deployment, before the patient needs to be observed for prolonged periods. The device proactively creates the seal rather than passively requiring continued compression, allowing patients to ambulate early while maintaining hemostasis reliability.
4Reliability
If suture or collagen plug devices are used, then the puncture site closes, but intravascular components remain causing residual bleeding and tract ooze
Solution Approach 1:
The patent extracts the intravascular component from the closure system by using a fully extravascular design. The closure device seals the puncture site from the outside, eliminating foreign material left within the vessel that would cause residual bleeding or tract ooze.
Solution Approach 2:
The device introduces a sealant layer as an intermediary between the closure body and the vessel wall. This sealant provides additional hemostasis by filling micro-gaps and preventing tract ooze, while the entire assembly remains extravascular to avoid intravascular complications.
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 achieves rapid hemostasis, reduces complications, and allows early patient ambulation by ensuring a secure seal that degrades naturally, minimizing bleeding and tissue damage, even in anticoagulated patients.
Implementation Method 1
the sealant can expand up to 4 times its original size when introduced to fluids
Implementation Method 2
Each of the intravascular anchor, extravascular cap, sealant, and suture can be formed of bioabsorbable materials
Data Source
AI summary
A vessel closure device for delivering immediate hemostasis at a puncture site in a wall of a blood vessel includes an intravascular anchor having one or more suture attachment points, an extravascular cap having a lumen, a sealant, and a suture connected to at least one of the one or more suture attachment points of the intravascular anchor and threaded through the lumen of the extravascular cap, wherein each of the intravascular anchor, extravascular cap, sealant, and suture are formed of bioabsorbable materials.