Two-Section Hydrogel Sealant for Rapid Vascular Puncture Closure
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Solution Overview
Problem
Existing methods for sealing vascular punctures are time-consuming, costly, uncomfortable for patients, and risk hematoma due to prolonged immobilization and bleeding before hemostasis occurs.
Innovation Solution
A sealant comprising a freeze-dried hydrogel section and a non-crosslinked hydrogel precursor section that expands and crosslinks in situ upon exposure to physiological fluids, providing enhanced adhesion and hemostasis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If external pressure is applied manually or using sandbags to seal the puncture, then hemostasis is achieved, but the procedure becomes time-consuming and expensive
Solution Approach 1:
The sealant is designed to automatically seal the puncture site through its inherent properties when deployed. The expandable portion swells upon contact with body fluids to fill the puncture tract, while the crosslinking portion forms an adhesive barrier, eliminating the need for manual pressure application and significantly reducing procedure time while maintaining reliable hemostasis
Solution Approach 2:
The sealant utilizes parameter changes in its two functional portions: the expandable portion changes volume by absorbing body fluids and swelling to mechanically block the puncture, while the crosslinking portion undergoes chemical parameter change through in-situ crosslinking to form a stable adhesive seal. These automatic parameter changes eliminate manual intervention and reduce procedure time
2Reliability
If external pressure is applied to seal the puncture, then hemostasis is achieved, but the patient experiences discomfort and requires immobilization
Solution Approach 1:
The sealant performs the sealing function autonomously without requiring external pressure application or patient immobilization. The expandable portion automatically swells to fill the puncture tract, and the crosslinking portion forms an adhesive barrier, allowing the patient to be discharged promptly without discomfort or restriction
Solution Approach 2:
The patent replaces the mechanical system of external pressure application (sandbags, manual compression) with a chemical-biological system. The sealant uses absorbency, swelling, and in-situ crosslinking to achieve hemostasis, eliminating the need for mechanical compression and associated patient discomfort and immobilization requirements
3Reliability
If manual pressure is applied to seal the puncture, then hemostasis is achieved, but hematoma risk increases due to prolonged immobilization
Solution Approach 1:
The sealant autonomously establishes hemostasis through its expandable and crosslinking properties, eliminating the need for prolonged manual pressure and immobilization. This rapid sealing action prevents the development of hematoma while ensuring reliable hemostasis, as the sealant maintains closure without requiring continuous external pressure
4Reliability
If a sealant with both expandable hydrogel and crosslinking precursors is used, then adhesion and sealing effectiveness are improved, but device complexity increases
Solution Approach 1:
The sealant is segmented into two distinct functional portions: an expandable hydrogel portion for mechanical filling and a crosslinking precursor portion for adhesive bonding. This segmentation allows each portion to perform its specific function optimally while maintaining overall simplicity in deployment, as the components are delivered together but act independently and autonomously
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
Facilitates rapid and effective sealing of vascular punctures, reducing patient discomfort and immobilization time, and minimizing the risk of hematoma.
Implementation Method 1
The first section may be formed from a freeze-dried hydrogel that expands when exposed to physiological fluid within a puncture
Implementation Method 2
the precursors undergo in-situ crosslinking with one another to provide an improved adhesion of the sealant to the arteriotomy
Data Source
AI summary
A sealant is provided for sealing a puncture through tissue that includes 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 fused to and 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 second section may be formed from a solid mass of non-freeze-dried, non-crosslinked hydrogel precursors, the precursors remaining in an unreactive state until exposed to an aqueous physiological, whereupon the precursors undergo in-situ crosslinking with one another to provide an adhesive layer bonded to the first section. Apparatus and methods for delivering the sealant into a puncture through tissue are also provided.