Viscous Haemostatic Gel for Controlled Wound Application

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Solution Overview

Problem

Existing haemostatic agents, such as Monsel's Solution, face issues with handling and storage due to their acidic nature and high iron content, leading to staining, crystallization, and bacterial contamination, making them unsuitable for controlled and safe application.

Innovation Solution

A viscous, thixotropic gel composition is formulated using ionic precipitating agents like ferric chloride and iron sulphate, combined with fatty alcohols and phosphate esters, which are stable and non-spreading, allowing for targeted application and reducing bacterial growth.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If aqueous haemostatic solutions with high iron content are used, then haemostatic effectiveness is improved, but staining and handling difficulties worsen

Engineering Contradiction:
Improvehaemostatic effectivenessVSAvoidstaining
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

A polysaccharide gel matrix acts as an intermediary carrier for the iron-containing haemostatic agent. The gel entraps the iron ions and acidic solution within its three-dimensional network, preventing direct contact with surrounding tissues and clothing, thereby eliminating staining while maintaining haemostatic effectiveness at the wound site.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The polysaccharide gel forms a flexible, adherent film or gel layer at the wound surface that contains the haemostatic agents. This gel layer acts as a physical barrier that prevents spread to unaffected surfaces and eliminates the need for careful handling required by free-flowing aqueous solutions.

Inventive Principle:
Principle #30Flexible shells and thin films

2Reliability

If high concentration haemostatic solutions are used, then haemostatic action is improved, but crystallization and storage stability worsen

Engineering Contradiction:
Improvehaemostatic actionVSAvoidstorage stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The invention changes the physical state and solubility parameters of the haemostatic agents by incorporating them into a polysaccharide gel matrix. This gel environment allows high concentrations of iron ions to be maintained without crystallization, as the gel network prevents supersaturation and provides a stable microenvironment that prevents precipitation during storage.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention creates a composite material system combining polysaccharide gel with iron-containing haemostatic agents. This composite structure integrates the haemostatic function with the stabilizing properties of the gel matrix, preventing crystallization while maintaining high iron concentration for effective haemostatic action.

Inventive Principle:
Principle #40Composite materials

3Ease of operation

If aqueous haemostatic solutions are used, then ease of application is improved, but bacterial contamination and spread to unaffected areas worsen

Engineering Contradiction:
Improveease of applicationVSAvoidbacterial contamination
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The polysaccharide gel forms a flexible, adherent film that stays in place at the wound site, preventing spread to unaffected areas. The gel's viscous nature and adhesion properties ensure it remains localized while providing a physical barrier that reduces bacterial contamination risk.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The gel formulation is designed for single-use application where the gel is applied to the wound and then discarded after use. This disposable approach eliminates the need for complex cleaning and sterilization procedures, reducing bacterial contamination risks while maintaining ease of application.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Reliability

If Monsel's Solution is used, then haemostatic effectiveness is improved, but handling care and safety worsen

Engineering Contradiction:
Improvehaemostatic effectivenessVSAvoidhandling care
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The polysaccharide gel forms a contained, adhesive layer that stays localized at the application site. This gel formulation eliminates the need for careful handling and monitoring of free-flowing acidic solutions, as the gel inherently prevents spread and reduces safety concerns while maintaining haemostatic effectiveness.

Inventive Principle:
Principle #30Flexible shells and thin films

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 stable, non-spreading, and easy-to-handle haemostatic agent that maintains haemostatic effectiveness while minimizing bacterial contamination and crystallization, ensuring safe and controlled application to wounds.

Implementation Method 1

The principal of its action is the presence of a ferric ion, which is a strong protein precipitant, causing coagulation which mechanically seals smaller blood vessels at a wound site.

Methodology Applied
Scientific EffectCoagulation: Coagulation

Implementation Method 2

These compositions will be solid at room temperature but liquefy on touch or pressure, allowing them to be taken up onto or into a swab or applicator, kept solid during transfer and then become liquid again on pressing or swabbing onto the wound.

Methodology Applied
Scientific EffectThixotropy: Thixotropy

Implementation Method 3

These compositions include fatty alcohols, alcohol phosphate diesters and one of an alkoxyether phosphate or a monoester phosphate of an alkoxylated fatty alcohol.

Methodology Applied
Scientific EffectGelation: Gel

Data Source

PatentEP2897688B1Viscous haemostatic compostions and method of treatment
Publication Date: 2018.06.20 EUPHARMA

AI summary

A method of promoting haemostasis in a patient is provided by the administration, to the site of blood loss, of a viscous thixotropic haemostatic composition comprising an ionic precipitating agent, a fatty alcohol, an alcohol phosphate diester and one of an alkoxyether phosphate or a monoester phosphate of an alkoxylated fatty alcohol.