Dry Hemostatic Composition Merging Thrombin and Polymer

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Solution Overview

Problem

Existing hemostatic compositions require separate reconstitution and mixing of thrombin and biocompatible polymer components, which is time-consuming and prone to handling errors, especially in intensive care settings.

Innovation Solution

A process for creating a dry, storage-stable hemostatic composition by combining a dry thrombin preparation and a dry biocompatible polymer in a single container, allowing for convenient reconstitution into a ready-to-use form with a pharmaceutically acceptable diluent.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If separate reconstitution and mixing of thrombin and biocompatible polymer components is performed, then the hemostatic composition can be prepared, but the process is time-consuming and prone to handling errors

Engineering Contradiction:
Improveease of useVSAvoidpreparation time
Core Design Contradiction:
Ease of operationVSLoss of time

Solution Approach 1:

The patent combines the thrombin component and biocompatible polymer component into a single integrated container system. The thrombin is provided in a first container and the biocompatible polymer in a second container, which are designed to be coupled together, allowing both components to be delivered simultaneously to the application site without separate reconstitution and mixing steps.

Inventive Principle:
Principle #5Merging (Combining)

2Reliability

If separate reconstitution and mixing of thrombin and biocompatible polymer components is performed, then the hemostatic composition can be prepared, but handling errors increase

Engineering Contradiction:
Improveproduct safetyVSAvoidease of use
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent combines the thrombin component and biocompatible polymer component into a single integrated container system. The thrombin is provided in a first container and the biocompatible polymer in a second container, which are designed to be coupled together, allowing both components to be delivered simultaneously to the application site without separate reconstitution and mixing steps.

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If thrombin is subjected to powerful sterilization methods, then sterilization is achieved, but enzymatic activity is lost

Engineering Contradiction:
ImprovesterilityVSAvoidenzymatic activity
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The patent segments the hemostatic composition into two separate components that are sterilized independently: the thrombin component and the biocompatible polymer component. This allows each component to receive appropriate sterilization treatment without compromising the other, with the thrombin being sterilized by methods that preserve its enzymatic activity.

Inventive Principle:
Principle #1Segmentation

4Stability of the object's composition

If the hemostatic composition is provided in dry form, then storage stability is improved, but additional reconstitution steps are required

Engineering Contradiction:
Improvestorage stabilityVSAvoidease of use
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The patent combines the thrombin component and biocompatible polymer component into a single integrated container system. The thrombin is provided in a first container and the biocompatible polymer in a second container, which are designed to be coupled together, allowing both components to be delivered simultaneously to the application site without separate reconstitution and mixing steps.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentUS12208176B2Process for making dry and stable hemostatic compositions
Publication Date: 2025.01.28 BAXTER INT INC

AI summary

Described is a process for making a dry and stable hemostatic composition, said process comprisinga) providing a first component comprising a dry preparation of a coagulation inducing agent,b) providing a second component comprising a dry preparation of a biocompatible polymer suitable for use in hemostasis,c) providing said first component and said second component in a combined form in a final container,c1) either by filling said first component and said second component into said final container so as to obtain a dry mixture in said final container,c2) or by providing said first component or said second component in said final container and adding said second component or said first component so as to obtain a combination of said first component with said second component in said final container,d) finishing the final container to a storable pharmaceutical device containing said first component and said second component in a combined form as a dry and stable hemostatic composition.