Chitosan-PEG Vascular Sealant for Large-Bore Puncture Closure
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Solution Overview
Problem
Existing vascular closure methods, including mechanical and biodegradable materials, face challenges in achieving rapid and efficient hemostasis of large bore vascular punctures, often requiring prolonged manual pressure, leaving gaps, and causing discomfort or future complications.
Innovation Solution
A sealant comprising a freeze-dried hydrogel formed from chitosan bound to polyethylene glycol polymers, which expands upon exposure to physiological fluids, providing enhanced hemostasis through improved structural integrity and pro-coagulative properties, with a second section of non-cross-linked polyethylene glycol precursors for additional support.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used to seal the vascular puncture, then hemostasis can be achieved, but the procedure becomes time-consuming and requires prolonged patient immobilization
Solution Approach 1:
The patent replaces the mechanical manual compression system with a chemical/biological sealant system. The copolymer sealant is delivered via catheter to the puncture site, where it crosslinks to form a gel that seals the puncture, eliminating the need for prolonged manual pressure application while achieving reliable hemostasis
Solution Approach 2:
The copolymer sealant acts as an intermediary substance between the puncture site and the surrounding tissue. It crosslinks in situ to form a gel that mediates the sealing process, allowing hemostasis to occur without direct mechanical pressure from the operator
2Loss of time
If purely mechanical closure devices are used, then rapid hemostasis can be achieved, but permanent foreign-body implants are left that interfere with subsequent catheterization
Solution Approach 1:
The patent changes the material parameter from permanent mechanical components to biodegradable copolymer. The sealant is composed of polyethylene glycol and polyethylene glycol-fumarate copolymer, which are absorbed by the body over time, eliminating foreign-body interference while maintaining rapid hemostasis capability
Solution Approach 2:
The biodegradable nature of the copolymer sealant allows it to perform its sealing function and then be naturally absorbed and discarded by the body. The polymer degrades into harmless byproducts that are metabolized, eliminating the need for removal and preventing interference with future procedures
3Measurement precision
If mechanical suture devices are used, then precise positioning can be achieved, but point support is provided instead of continuum support leading to open micro-spaces
Solution Approach 1:
The crosslinked gel formed by the copolymer sealant creates a flexible, conforming seal that adapts to the puncture site geometry. This gel structure provides continuum support across the entire puncture area rather than discrete point support, eliminating micro-spaces while maintaining positioning accuracy through the catheter delivery system
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 chitosan-PEG copolymer sealant achieves faster hemostasis of large bore vascular punctures by combining the swelling characteristics of PEG with the hemostatic properties of chitosan, reducing patient discomfort and complications, and ensuring complete closure without gaps.
Implementation Method 1
a sealant comprising a freeze-dried hydrogel formed from chitosan bound to polyethylene glycol polymers, which expands upon exposure to physiological fluids
Implementation Method 2
providing enhanced hemostasis through improved structural integrity and pro-coagulative properties
Data Source
Figure 1~1A
Figure 2A~2B
Figure 3A
AI summary
A sealant is provided for sealing a puncture through tissue that comprises an elongate first section including a proximal end, a distal end, and a cross-section sized for delivery into a puncture through tissue, and a second section extending from the distal end of the first section. The first section may be formed from a freeze-dried hydrogel that expands when exposed to physiological fluid within a puncture. The first section comprises chitosan and at least one additional polymer. The second section may be formed from a solid mass of non-freeze-dried, non-cross-linked hydrogel precursors. The precursors are in an unreactive state until exposed to an aqueous physiological environment, whereupon the precursors undergo in-situ crosslinking with one another to provide an adhesive layer bonded to the first section. The second section may further comprise chitosan. Apparatus and methods for delivering the sealant into a puncture through tissue are also provided.