Collagen-Starch Hemostatic Foam for Bleeding Control
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Solution Overview
Problem
Current hemostatic devices often fail to effectively manage excessive bleeding due to limitations in their mechanisms of action, and combinations of hemostatic agents do not consistently achieve synergistic effects, leading to suboptimal hemostasis in severe trauma situations.
Innovation Solution
A coherent blend of collagen fibrils and starch particles is developed, which forms a fluffy mass that can be easily handled and applied to wounds, providing enhanced hemostatic properties by combining the tamponade effect of collagen with the clot-enhancing properties of starch particles, with a ratio of collagen to starch particles that allows minimal loss of starch particles during handling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If hemostatic devices use single mechanisms (thrombin, styptics, tamponade), then they are simple to use, but they fail to effectively manage excessive bleeding in severe trauma
Solution Approach 1:
The patent combines multiple hemostatic mechanisms (thrombin, styptics, and tamponade) into a single integrated device. The foam structure incorporates thrombin and styptic agents while providing physical tamponade, allowing all mechanisms to work simultaneously rather than requiring separate applications of each agent.
Solution Approach 2:
The device uses a composite foam structure that integrates multiple functional components. The foam matrix combines hemostatic agents with a tamponade structure, creating a material that performs multiple hemostatic functions simultaneously - chemical clotting enhancement, protein coagulation, and physical blood flow impediment.
2Reliability
If combinations of hemostatic agents are used to achieve synergistic effects, then hemostatic efficacy improves, but the device becomes complex and handling becomes difficult
Solution Approach 1:
Multiple hemostatic agents are merged into a single foam structure that maintains the physical properties needed for easy handling. The foam format allows the combination of thrombin, styptics, and tamponade components while preserving a simple, applicatable form factor that surgeons can easily deploy.
Solution Approach 2:
The foam structure provides a flexible, adaptable form factor that is easy to handle and apply to various wound geometries. The foam matrix allows the combined agents to be delivered in a single, manageable unit that can conform to different wound shapes without requiring complex manipulation.
3Reliability
If starch particles are used to enhance clotting, then hemostatic effect improves, but particles are lost during handling and application
Solution Approach 1:
The foam structure encapsulates and retains starch particles within its matrix, preventing particle loss during handling and application. The foam structure acts as a containment framework that holds the particles in place while allowing them to remain functional for clot enhancement.
Solution Approach 2:
Starch particles are integrated into the foam composite structure, where they are retained within the matrix. This composite approach combines the clot-enhancing properties of starch particles with the structural integrity of the foam, preventing particle dispersal and loss during surgical handling.
4Ease of operation
If collagen fibrils provide tamponade effect, then physical blood flow impediment is achieved, but hemostatic efficacy is insufficient for excessive bleeding
Solution Approach 1:
The foam structure merges the physical tamponade effect of collagen-like material with chemical hemostatic agents (thrombin and styptics). This integration allows the device to simultaneously provide mechanical blood flow impediment and chemical clotting enhancement, achieving superior hemostasis for excessive bleeding.
Solution Approach 2:
The foam composite combines tamponade-providing material with clotting-enhancing agents, creating a material that delivers both mechanical and chemical hemostatic actions. This composite structure overcomes the limitation of tamponade alone by incorporating agents that actively promote clot formation.
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 collagen-starch particle blend exhibits superior hemostatic efficacy and ease of application, significantly reducing bleeding in porcine models compared to using either component alone, with a high success rate in controlling bleeding and maintaining stability without significant particle loss.
Implementation Method 1
Positively charged polymers such as chitosan fibers (SoftSeal hemostatic pads, Chitogen Inc) or flakes (Celox, MedTrade Products, Ltd) attach to negative charges on tissue, platelets and red blood cells to create tamponade as well as activate platelets.
Implementation Method 2
These products rapidly imbibe water from the blood and concentrate the larger blood elements such as proteins, platelets, and red blood cells on the surface of the particle.
Implementation Method 3
Thrombin is the catalyst for the polymerization of fibrinogen (a soluble, circulating protein) into insoluble fibrin. Fibrin adheres to and strengthens the platelet plug.
Data Source
AI summary
A hemostatic composition of matter includes a coherent blend of collagen fibrils combined with starch particles as a fluffy mass with hemostatic properties better than collagen fibrils alone or starch particles alone, the composition exhibiting a level of coherence wherein the composition can be lifted, without crushing fibrils, without loss of more than 5% of 10% of a total weight of starch particles from the composition. Sheets with less than 10% by weight of additional binder are also disclosed.