3D Printed Hemostatic Product Using Fibrillar Collagen Layers
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Solution Overview
Problem
Current hemostatic products face challenges in effectively managing bleeding, especially in complex or diffuse bleeding scenarios, due to issues like excessive swelling, inflammatory reactions, and the risk of blood-derived products leading to allergic reactions or disease transmission, and often require complex preparation and handling.
Innovation Solution
A three-dimensional hemostatic product is developed using a stack of layers made from a fibrillar collagen-based flowable mixture, comprising non-cross-linked collagen, monosaccharides, and glycosaminoglycans, which can be manufactured using a 3D additive printer, allowing for precise application and enhanced hemostasis without complex preparation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If absorbent hemostatic products comprising polysaccharides are used, then absorption capacity is improved, but excessive swelling occurs leading to undesirable pressure in closed environments
Solution Approach 1:
The patent changes the material composition from polysaccharides to a specific ratio of collagen (60-90%), gelatin (5-30%), and starch (5-20%), which modifies the absorption characteristics to reduce excessive swelling while maintaining adequate absorption capacity. This parameter change in material composition resolves the contradiction between absorption capacity and pressure generation in closed environments.
2Quantity of substance
If plant polysaccharides such as cellulose or alginates are used, then absorption capacity is improved, but inflammatory reactions occur during resorption
Solution Approach 1:
The patent uses a composite material system combining collagen, gelatin, and starch in specific ratios. This composite approach replaces plant polysaccharides with animal-derived proteins and starch that are more biocompatible and less likely to cause inflammatory reactions, while maintaining the necessary absorption capacity through the synergistic properties of the composite materials.
3Reliability
If blood-derived products containing thrombin or fibrin are used, then active hemostasis is achieved, but risks of allergies and disease transmission increase
Solution Approach 1:
The patent employs collagen, gelatin, and starch which are derived from well-established, controlled sources (animal tissues and plant starch) rather than human blood products. These materials have long been used in medical applications with proven safety profiles, effectively replacing blood-derived products to eliminate risks of allergies and disease transmission while maintaining hemostatic effectiveness through mechanical absorption and providing a scaffold for natural clot formation.
4Reliability
If mechanical solutions such as pressure or ligature are used, then immediate hemostasis is achieved, but effectiveness is limited in diffuse bleeding or hypervascularized organs
Solution Approach 1:
The patent creates a universal hemostatic product that can address multiple types of bleeding through its composite material properties. The collagen-gelatin-starch combination provides both mechanical absorption capability for immediate hemostasis and a porous structure that allows capillary action and adhesion to bleeding surfaces. This multi-functional material can be applied to various bleeding scenarios including diffuse bleeding, capillary hemorrhages, and hypervascularized organs, replacing the need for different mechanical solutions for different bleeding types.
5Reliability
If products containing both fibrin and thrombin are used, then hemostatic action is enhanced, but the product may float or coagulate on top of blood flow without blocking it
Solution Approach 1:
The patent employs collagen, gelatin, and starch materials that inherently possess blood-adhering properties through their surface characteristics and chemical composition. These materials automatically adhere to bleeding surfaces and blood clot components without requiring external activation or complex interactions with blood factors. The materials self-stabilize in blood flow through their physical properties, preventing floating or premature coagulation, and maintain contact with the bleeding site to ensure effective hemostasis.
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 product provides effective hemostasis with minimal adverse effects, easy application, and adaptability to complex bleeding areas, while avoiding the drawbacks of existing products by utilizing non-cross-linked collagen and a simplified manufacturing process.
Implementation Method 1
A three-dimensional hemostatic product made of a stack of layers deposited on one another from a first external layer up to a second external layer... wherein the three-dimensional hemostatic product can be manufactured using a three-dimensional (3D) additive printer
Implementation Method 2
Absorbent hemostatic products, notably comprising polysaccharides such as regenerated oxidized cellulose or alginates, work mainly by mechanical action and simple absorption
Data Source
AI summary
The invention relates to a printed hemostatic product having at least three-dimensions and being made of a stack of layers deposited on one another from a first external layer up to a second external layer, wherein adjacent layers of the stack of layers are joined together, and wherein at least one layer of the stack of layers has at least one portion made from an hemostatic flowable with a composition comprising: non-cross-linked collagen of the fibrillar type comprising a content of fibrous collagen and/or fibrillar collagen of at least 70% by weight relative to the total weight of the collagen; and—at least one monosaccharide. The invention also relates to a method for forming such an hemostatic product with a three-dimensional additive printer, and the use of an hemostatic flowable as a printing ink in such a three-dimensional additive printer.