Hemostatic Clay Delivery via Soluble Polymer Matrix
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Solution Overview
Problem
Current hemostatic agents for controlling bleeding, such as zeolite, chitosan, and potato starch-based products, face issues like exothermic reactions, dispersion due to blood pressure, limited shelf life, and difficulty in removal, making them ineffective for rapid and efficient hemorrhage control, especially in severe injuries.
Innovation Solution
A hemostatic agent delivery system using beneficiated hectorite clay or smectite clay combined with a soluble polymeric release member and a handle for easy application, which maintains the agent at the wound site without exothermic reactions and can be easily removed post-clotting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If zeolite material is used as hemostatic agent, then clotting is promoted through water absorption, but exothermic reaction causes burns and temperatures reach 90-100°C
Solution Approach 1:
The patent changes the chemical composition parameter of the hemostatic agent from iron-containing zeolite to iron-free or low-iron smectite clay. This parameter change eliminates the exothermic reaction with blood while retaining the water absorption and platelet concentration capabilities, thus maintaining clotting effectiveness without causing thermal burns.
Solution Approach 2:
The patent extracts and removes the harmful iron component from the zeolite structure. By using purified smectite clay that is iron-free or low-iron, the harmful exothermic reaction is eliminated while the beneficial hemostatic properties are preserved.
2Reliability
If granular zeolite material is poured on wound, then hemostatic effect is achieved, but material is dispersed by blood pressure in severe hemorrhaging
Solution Approach 1:
The patent creates a composite structure by embedding the smectite clay particles within a soluble polymer matrix. This composite material maintains the hemostatic properties of the clay while the polymer network provides structural integrity to resist dispersion under blood pressure, enabling effective treatment of severe hemorrhaging.
Solution Approach 2:
The soluble polymer forms a flexible matrix that encapsulates the clay particles. This flexible structure can conform to the wound while providing mechanical strength to prevent material dispersion, and subsequently dissolves to release the active hemostatic agent.
3Reliability
If granular zeolite material is applied to wound, then clotting is facilitated, but material is difficult to remove via irrigation and suction
Solution Approach 1:
The soluble polymer matrix acts as a temporary flexible shell that holds the clay particles in place during hemostasis. After the clotting process is complete, the polymer shell dissolves in irrigation fluid, automatically releasing and facilitating removal of the clay particles through standard irrigation and suction procedures.
Solution Approach 2:
The soluble polymer component is designed to be temporarily retained during the hemostatic process and then discarded through dissolution. This allows the clay particles to be easily recovered and removed from the wound site after they have fulfilled their hemostatic function.
4Reliability
If chitosan or poly-N-acetylglucosamine is used, then hemostatic action is achieved, but shelf life is extremely limited
Solution Approach 1:
The patent changes the chemical composition from organic biopolymers (chitosan, poly-N-acetylglucosamine) to inorganic smectite clay. This parameter change from organic to inorganic material eliminates biological degradation, providing essentially indefinite shelf life while maintaining hemostatic effectiveness through water absorption and platelet concentration.
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 system effectively delivers and retains the hemostatic agent at the hemorrhage site, facilitating rapid clotting and termination of bleeding without adverse reactions, and can be easily removed post-treatment, enhancing safety and efficacy in both military and civilian trauma scenarios.
Implementation Method 1
the release member comprises a soluble material structured to at least partially dissolve and release the hemostatic agent upon disposition directly proximate to a hemorrhage site
Implementation Method 2
This material is placed into a bleeding wound where it absorbs water molecules from the blood, thereby creating a high platelet concentration which promotes clotting
Implementation Method 3
facilitate clotting and terminate hemorrhaging
Data Source
AI summary
A hemostatic agent delivery system includes a hemostatic agent which is inert and non-reactive yet is capable of forming a stable clot when applied to an actively bleeding wound. The system also includes a delivery assembly to structure to facilitate delivery of the hemostatic agent proximate the hemorrhage site. More specifically, the delivery assembly is structured to releasably contain the hemostatic agent via a release member which is disposed in cooperative relation with a support member which contains the amount of the hemostatic agent. The release member is structured of a soluble material such that it will at least partially dissolve and release the hemostatic agent upon disposition proximate the hemorrhage site. The delivery assembly further comprises a handle member structured to facilitate delivery of the hemostatic agent to the hemorrhage site.