Thrombin-Coated Polymer Granules for Stable Hemostasis

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Current hemostatic compositions requiring thrombin for hemostasis face challenges in storage-stability and handling due to differing sterilization requirements between thrombin and matrix materials, necessitating separate manufacturing and reconstitution steps that are time-consuming and prone to enzymatic activity loss.

Innovation Solution

A process involving coating biocompatible polymer granules with thrombin to create thrombin-coated polymer granules, which are then filled into a container as a dry, stable composition, allowing for convenient reconstitution with a pharmaceutically acceptable diluent into a ready-to-use form, reducing handling steps and maintaining enzyme activity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If thrombin and matrix material are manufactured separately to meet different sterilization requirements, then sterilization effectiveness is improved, but manufacturing complexity and handling time increase

Engineering Contradiction:

Improvesterilization effectivenessVSAvoidmanufacturing complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines thrombin and matrix material into a single pre-mixed hemostatic composition that can be sterilized together as one unit. This eliminates the need for separate manufacturing and sterilization processes while maintaining the different requirements through careful formulation design, thereby reducing manufacturing complexity without compromising sterilization effectiveness.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent performs preliminary mixing of thrombin and matrix material before sterilization, creating a pre-prepared hemostatic composition. This preliminary action allows both components to be sterilized together in advance, eliminating the need for separate sterilization processes and reducing handling time during actual use.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If separate reconstitution steps are required for thrombin and matrix material, then enzymatic activity loss is minimized, but handling time and complexity increase

Engineering Contradiction:

Improveenzymatic activity retentionVSAvoidhandling time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent merges thrombin and matrix material into a single pre-mixed composition that requires only one reconstitution step. This combined formulation maintains enzymatic activity by protecting thrombin through the matrix structure while eliminating the need for separate reconstitution procedures, thereby reducing handling time without compromising enzyme stability.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The matrix material acts as an intermediary that protects thrombin during storage and reconstitution. The matrix structure provides a protective environment for the enzyme, allowing it to remain stable during the reconstitution process while enabling single-step preparation, thus reducing handling time without causing enzymatic activity loss.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Stability of the object's composition

If multiple handling steps are required for hemostatic composition preparation, then product stability is maintained, but ease of operation decreases

Engineering Contradiction:

Improveproduct stabilityVSAvoidease of use

Core Design Contradiction:

Stability of the object's compositionVSEase of operation

Solution Approach 1:

The patent combines multiple components into a single pre-mixed hemostatic composition that maintains product stability through unified formulation. This merged composition requires fewer handling steps during preparation and application, significantly improving ease of use while maintaining the stability needed for effective hemostasis through careful design of the combined formulation.

Inventive Principle:

Principle #5Merging (Combining)

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 process provides a storage-stable, convenient, and efficient method for delivering hemostatic compositions, ensuring high storage stability and enzymatic activity retention, facilitating quick and effective hemostasis with reduced handling complexity.

Implementation Method 1

coating the granules in said dry granular preparation with a thrombin preparation, thereby obtaining thrombin coated polymer granules

Methodology Applied

Scientific EffectCoating: Coatings

Data Source

PatentUS8940335B2Process for making dry and stable hemostatic compositions

Publication Date: 2015.01.27 BAXTER INT INC

AI summary

Described is a process for making a dry and stable hemostatic composition, said process comprisinga) providing a dry granular preparation of a biocompatible polymer suitable for use in hemostasis,b) coating the granules in said dry granular preparation with a preparation of a coagulation inducing agent, thereby obtaining coagulation inducing agent coated polymer granules,c) filling said coagulation inducing agent coated polymer granules into a final container,d) finishing the final container to a storable pharmaceutical device containing said coagulation inducing agent coated polymer granules as a dry and stable hemostatic composition.