Hemostatic Composition Using Crosslinked Gelatin

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Solution Overview

Problem

Existing hemostatic compositions fail to induce hemostasis effectively, especially under impaired conditions such as heparinization, and lack strong adherence to tissue, requiring improved formulations for enhanced hemostatic properties and convenience in application.

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 bleeding tissue, providing improved adherence and sealing properties.

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 under impaired conditions such as heparinization

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

Solution Approach 1:

The patent uses a composite material system combining crosslinked gelatin particles with hydrophilic polymeric components containing reactive groups. This composite structure enables the composition to function effectively under both normal and impaired hemostatic conditions by providing multiple mechanisms for hemostasis induction, including physical occlusion and chemical crosslinking with tissue proteins.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent modifies the chemical parameters of the hemostatic composition by incorporating polymeric components with specific reactive groups that can form covalent bonds with tissue proteins. This parameter change allows the composition to adhere strongly to tissue even when the natural hemostatic pathway is impaired, providing reliable hemostasis across varying physiological conditions.

Inventive Principle:
Principle #35Parameter changes

2Strength

If hemostatic compositions are designed for strong tissue adherence, then sealing properties are improved, but manufacturing and handling complexity increases

Engineering Contradiction:
Improvetissue adherenceVSAvoidmanufacturing convenience
Core Design Contradiction:
StrengthVSEase of manufacture

Solution Approach 1:

The patent applies preliminary action by pre-crosslinking the gelatin particles before final assembly into the hemostatic composition. This pre-crosslinking step creates stable particles with controlled adhesive properties, simplifying subsequent manufacturing steps while ensuring strong tissue adherence when applied. The reactive polymeric components are also prepared in advance with appropriate crosslinking agents.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent segments the hemostatic composition into distinct functional components: crosslinked gelatin particles providing structural framework and swelling, and hydrophilic polymeric components with reactive groups providing tissue adhesion. This segmentation allows each component to be optimized and manufactured separately, then combined in a controlled manner, reducing overall manufacturing complexity.

Inventive Principle:
Principle #1Segmentation

3Stability of the object's composition

If hemostatic compositions require reconstitution before use, then storage stability is improved, but application time and convenience are reduced

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

Solution Approach 1:

The patent implements self-service by designing a composition where the crosslinked gelatin particles and hydrophilic polymeric components are pre-assembled in stable dry form but automatically reconstitute and activate upon contact with tissue fluid or blood. The composition performs its own reconstitution process at the application site, eliminating the need for separate reconstitution steps and reducing application time while maintaining storage stability.

Inventive Principle:
Principle #25Self-service

4Strength

If crosslinking agents are added to improve adhesion, then tissue sealing is enhanced, but biocompatibility concerns arise

Engineering Contradiction:
Improvetissue sealingVSAvoidbiocompatibility
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent carefully controls the parameters of crosslinking by selecting biocompatible crosslinking agents and optimizing crosslinking conditions to achieve sufficient tissue adhesion while maintaining biocompatibility. The crosslinking degree is controlled to provide strong sealing without creating excessive crosslinked structures that could cause adverse reactions.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses biodegradable crosslinking agents and materials that provide temporary strong adhesion during the critical hemostasis period, then gradually degrade and are eliminated by the body. This approach provides strong tissue sealing when needed while minimizing long-term biocompatibility concerns, as the crosslinking structures are transient and replaceable by natural tissue repair processes.

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

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 of impaired hemostasis, such as after heparinization, and is conveniently applied without reconstitution steps, making it suitable for various bleeding sites including surgical and traumatic injuries.

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

the polymer particles have the ability to absorb liquid and to swell upon contact with tissue fluid

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentEP2766060B1Hemostatic composition
Publication Date: 2022.11.23 BAXTER INT INC

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.