Crosslinked Gelatin Hemostatic Composition for Tissue Adhesion

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Solution Overview

Problem

Existing hemostatic compositions fail to induce hemostasis in conditions with impaired hemostasis, such as after heparinization, and lack strong adherence to tissue, requiring improved formulations with enhanced properties for wound treatment.

Innovation Solution

A hemostatic composition comprising crosslinked gelatin in particulate form combined with a hydrophilic polymeric component having electrophilic reactive groups, which forms a gel upon contact with blood proteins and tissue surface proteins, providing improved adherence and hemostatic sealing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional hemostatic compositions are used, then basic hemostatic function is provided, but they fail to induce hemostasis in conditions with impaired hemostasis (e.g. after heparinization)

Engineering Contradiction:
Improvehemostatic efficacyVSAvoideffectiveness under impaired hemostasis conditions
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The invention changes the chemical parameters of the hemostatic composition by incorporating a crosslinking agent that forms covalent bonds with tissue proteins. This chemical modification enables the composition to achieve effective hemostasis even in conditions with impaired coagulation, such as after heparinization, by creating a mechanical barrier through crosslinked gel structure rather than relying solely on physiological coagulation pathways.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention uses a composite material system comprising gelatin particles, a crosslinking agent, and optionally a binder. This composite approach combines the hemostatic properties of gelatin with the adhesive and crosslinking capabilities of the additional components, creating a material that can induce hemostasis reliably even when natural coagulation is impaired.

Inventive Principle:
Principle #40Composite materials

2Reliability

If conventional hemostatic compositions are applied to tissue, then hemostatic function is provided, but strong adherence to tissue is not achieved

Engineering Contradiction:
Improvehemostatic functionVSAvoidadherence to tissue
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The invention replaces simple mechanical adhesion with chemical crosslinking. The crosslinking agent forms covalent bonds between the composition and tissue proteins, creating a chemically bonded interface that provides strong adherence. This chemical bonding mechanism substitutes for and enhances mechanical attachment, ensuring the composition remains firmly attached to the tissue surface.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The invention modifies the interaction parameters between the composition and tissue by introducing crosslinking chemistry. The crosslinking agent changes the bonding strength and nature of the interface, transforming weak physical adhesion into strong chemical bonds, thereby achieving both reliable hemostatic function and strong tissue adherence.

Inventive Principle:
Principle #35Parameter changes

3Stability of the object's composition

If hemostatic compositions require reconstitution, then storage stability is maintained, but time-consuming preparation steps are required

Engineering Contradiction:
Improvestorage stabilityVSAvoidreconstitution time
Core Design Contradiction:
Stability of the object's compositionVSLoss of time

Solution Approach 1:

The invention performs preliminary action by pre-mixing the gelatin particles with the crosslinking agent and binder in a stable formulation that can be stored without reconstitution. The composition is prepared in advance in a form that maintains stability during storage but becomes activated upon contact with blood or tissue fluids, eliminating the need for time-consuming reconstitution steps before application.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The composition is designed to be self-activating upon contact with the target tissue or blood. The crosslinking reaction is triggered automatically by the physiological environment, eliminating the need for external reconstitution or activation steps. The material performs its own preparation function by reacting with tissue proteins upon application.

Inventive Principle:
Principle #25Self-service

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 effectively induces hemostasis and adheres strongly to tissue, even in conditions with impaired hemostasis, such as after heparinization, by forming a gel that acts as a mechanical barrier against bleeding and rebleeding.

Implementation Method 1

Upon contact with bleeding tissue, a crosslinking reaction of the hydrophilic polymeric component with the blood proteins leads to formation of a gel with sealing and hemostatic properties

Methodology Applied
Scientific EffectCrosslinking reaction: Chemical Bonding

Implementation Method 2

leads to formation of a gel with sealing and hemostatic properties

Methodology Applied
Scientific EffectGel formation: Gel

Data Source

PatentEP2766058B1Hemostatic compositions
Publication Date: 2022.11.23 BAXTER INT INC
  • EP2766058B1 patent drawingFigure 1

AI summary

The invention discloses a hemostatic composition comprising: a) a biocompatible polymer in particulate form suitable for use in hemostasis, and b) one hydrophilic polymeric component comprising reactive groups.