Layered Hemostatic Composition Using Segmentation to Reduce Toxicity

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Solution Overview

Problem

Existing hemostatic products face challenges such as toxicity, complexity in use, risk of blood infection, and inadequate biodegradability, particularly in urgent bleeding situations, and require improved biocompatibility and ease of application.

Innovation Solution

A hemostatic composition comprising collagen, a stabilizer, and thrombin, packaged in a layered powder form in a container, which is mixed with a diluent to form a hydrogel for rapid application.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If cyanoacrylate-based tissue adhesives are used for rapid adhesion, then adhesion speed is improved, but toxicity increases and heat resistance deteriorates

Engineering Contradiction:
Improveadhesion speedVSAvoidtoxicity
Core Design Contradiction:
SpeedVSObject-affected harmful factors

Solution Approach 1:

The hemostatic composition is divided into three distinct layers (collagen layer, stabilizer layer, thrombin layer) that are separately packaged but can be easily mixed. This segmentation allows each component to maintain its specific properties while working together to achieve rapid hemostasis without the toxicity issues of cyanoacrylate adhesives.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention uses a composite formulation combining collagen, stabilizer, and thrombin in a layered structure. This composite material provides rapid hemostatic action while maintaining biocompatibility and avoiding the toxic side effects associated with cyanoacrylate-based adhesives.

Inventive Principle:
Principle #40Composite materials

2Object-affected harmful factors

If fibrin glue adhesives are used for biocompatibility, then biocompatibility is improved, but adhesive strength decreases and biodegradation rate increases

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidadhesive strength
Core Design Contradiction:
Object-affected harmful factorsVSStrength

Solution Approach 1:

The invention merges the advantages of fibrin glue (biocompatibility, rapid action) with the structural stability of crosslinked collagen. The combination of collagen, stabilizer, and thrombin in a layered format provides both the biocompatibility of fibrin-based materials and enhanced adhesive strength through crosslinking, while controlling the biodegradation rate.

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If hemostatic products are prepared in multi-component form for effectiveness, then hemostatic effectiveness is improved, but ease of operation deteriorates due to mixing complexity

Engineering Contradiction:
Improvehemostatic effectivenessVSAvoidease of application
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The composition is segmented into three layers (collagen, stabilizer, thrombin) that are packaged separately in a single container. This segmentation maintains the effectiveness of each component while simplifying the mixing process, as the layers can be easily combined by simply adding a diluent, eliminating the complexity of multi-step preparation procedures.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The collagen is pre-crosslinked and the components are pre-layered in the container before use. This preliminary preparation ensures that when the diluent is added, the mixing process is rapid and straightforward, maintaining hemostatic effectiveness without requiring complex operational procedures.

Inventive Principle:
Principle #10Preliminary action

4Strength

If traditional surgical techniques such as suturing are used for tensile strength, then tensile strength is improved, but patient comfort deteriorates due to pain and removal necessity

Engineering Contradiction:
Improvetensile strengthVSAvoidpatient discomfort
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The invention changes the physical and chemical parameters of the hemostatic material by using crosslinked collagen with controlled molecular weight and degree of crosslinking. This allows the material to provide tensile strength comparable to sutures while eliminating the need for removal and reducing patient discomfort through a non-invasive application process.

Inventive Principle:
Principle #35Parameter changes

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 composition provides a safe, effective, and convenient hemostatic solution with rapid mixing, low toxicity, and high biodegradability, suitable for urgent bleeding scenarios.

Implementation Method 1

mixed with a diluent to form a hydrogel for rapid application

Methodology Applied
Scientific EffectHydrogel formation: Hydrogel

Data Source

PatentEP3903808B1Hemostatic composition and receptacle comprising same
Publication Date: 2025.07.30 DALIM TISSEN
  • EP3903808B1 patent drawingFigure 1~2
  • EP3903808B1 patent drawingFigure 3~4
  • EP3903808B1 patent drawingFigure 5

AI summary

The present invention relates to a hemostatic composition including collagen, a stabilizer, and thrombin, and a container holding this hemostatic composition. The hemostatic composition and the container holding this hemostatic composition can be applied to an urgent bleeding patient by a simple method of use, and the hemostatic composition is less toxic, does not have a problem of blood infection, has a fast rate of biodegradation, has an excellent hemostatic effect, and can be usefully used as a hemostat.