Powdered Hemostatic Composition Using Non-Aqueous Solvent Suspension
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Solution Overview
Problem
Current hemostatic materials face challenges in achieving rapid and effective hemostasis, particularly due to the instability of acid-sensitive proteins like thrombin and fibrinogen when used with carboxylic-oxidized cellulose, which can denature these proteins, and the need for improved ease of application and rapid onset of hemostasis in surgical and wound management.
Innovation Solution
A hemostatic material comprising aggregates of fibrinogen, thrombin, and oxidized regenerated cellulose (ORC) fibers, formed by suspending these components in a non-aqueous solvent, spraying onto a substrate, and sieving to create a powdered composition that includes additives like calcium chloride and Tris, facilitating rapid clotting and strong adhesion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If carboxylic-oxidized cellulose is used as a hemostatic material, then hemostatic performance is improved, but acid-sensitive proteins like thrombin and fibrinogen denature and lose effectiveness
Solution Approach 1:
The patent introduces an intermediary substance (albumin or other compatible proteins) that acts as a protective medium between the carboxylic-oxidized cellulose and the acid-sensitive clotting proteins. This intermediary buffers the acidic environment, preventing direct contact and denaturation of thrombin and fibrinogen, while still allowing the hemostatic cellulose to perform its function.
Solution Approach 2:
The patent modifies the chemical parameters of the hemostatic composition by controlling the degree of oxidation of the cellulose and adjusting the pH balance through additives like albumin. By changing these parameters, the material maintains its hemostatic effectiveness while reducing the acidic denaturation effect on proteins.
2Reliability
If conventional hemostatic materials are used, then bleeding control is achieved, but the onset of hemostasis is not rapid enough
Solution Approach 1:
The patent incorporates clotting proteins (thrombin and fibrinogen) in advance within the hemostatic material structure, so that when the material contacts blood, the clotting reaction can begin immediately without requiring separate application of additional agents. This preliminary preparation of the clotting cascade components dramatically reduces the time to achieve hemostasis.
Solution Approach 2:
The patent creates a composite hemostatic material that integrates multiple functional components: oxidized cellulose for absorption and tamponade, albumin as a protective carrier, and clotting proteins (thrombin and fibrinogen) for rapid clot formation. This composite structure enables simultaneous multiple mechanisms of hemostasis to occur rapidly and协同ly.
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 resulting powdered hemostatic composition exhibits rapid gelling, strong clotting, and improved adhesion, effectively controlling bleeding and promoting hemostasis with enhanced uniformity and integration, as demonstrated by in vitro and in vivo testing.
Implementation Method 1
suspending a mixture of fibrinogen, thrombin, and ORC powders in a non-aqueous solvent
Implementation Method 2
spraying the suspension through a nozzle onto a substrate
Implementation Method 3
removing the hemostatic material from the substrate
Implementation Method 4
facilitating rapid clotting and strong adhesion
Data Source
AI summary
The present invention is directed to hemostatic compositions comprising at least partially integrated agglomerated ORC fibers, fibrinogen, and thrombin and methods of forming a powdered hemostatic composition, comprising the steps of: forming a suspension of a mixture comprising particles of fibrinogen, thrombin, ORC fibers in a non-aqueous low boiling solvent; spraying the suspension through a nozzle onto a substrate, allowing the non-aqueous solvent to evaporate; separating from the substrate and sieving the composition.