Gamma Sterilized Dextran Solutions for Blood Separation

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Solution Overview

Problem

Conventional blood cell isolation procedures require separate sterilization of dextran solutions, which are unstable to gamma irradiation, leading to molecular weight decomposition and increased costs and contamination risks.

Innovation Solution

Development of gamma stable dextran solutions with an initial molecular weight greater than 500 kD and the addition of ascorbic acid or its mineral salt, allowing for direct gamma sterilization while maintaining effective red blood cell aggregation performance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If dextran solution is sterilized by gamma irradiation, then sterilization is achieved, but molecular weight decomposition occurs

Engineering Contradiction:
ImprovesterilizationVSAvoidmolecular weight
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent applies preliminary action by formulating dextran solutions with higher initial molecular weights (greater than 500 kD) before sterilization. This pre-positioning of higher molecular weight compensates for the expected degradation during gamma irradiation, ensuring that post-sterilization molecular weight remains sufficient for effective RBC aggregation (above 200 kD).

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent changes the molecular weight parameter of the dextran from conventional lower weights to significantly higher weights (>500 kD initial, >200 kD after sterilization). This parameter change allows the dextran to withstand gamma irradiation-induced decomposition while maintaining functional effectiveness for blood cell separation.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If separate sterilization of dextran solution is performed, then sterilization is achieved, but manufacturing complexity and cost increase

Engineering Contradiction:
ImprovesterilizationVSAvoidmanufacturing process
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges the sterilization of dextran solution with the sterilization of the blood processing system by integrating the dextran into a sterile container or closed system that can be sterilized together with the blood sample through gamma irradiation. This eliminates separate sterilization steps, reduces manufacturing complexity, and minimizes contamination risks during assembly.

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 gamma sterilized dextran solutions enable seamless integration into the manufacturing process, reducing handling errors and costs while maintaining the molecular weight necessary for effective red blood cell sedimentation and nucleated cell recovery.

Implementation Method 1

sterilization of the kit which is accomplished by exposure to gamma irradiation at a dose between 20 and 50 kGy

Methodology Applied
Scientific EffectGamma irradiation: Radiation

Implementation Method 2

dextran in water is unstable to gamma irradiation resulting in severe molecular weight decomposition

Methodology Applied
Scientific EffectOxidation: Oxidation

Implementation Method 3

dextran as an aggregant to enhance the sedimentation of red blood cells from whole blood

Methodology Applied
Scientific EffectSedimentation: Sedimentation

Data Source

PatentUS20180292298A1Gamma sterilized dextran solutions and methods of use
Publication Date: 2018.10.11 GLOBAL LIFE SCIENCES SOLUTIONS USA LLC
  • US20180292298A1 patent drawing
  • US20180292298A1 patent drawing
  • US20180292298A1 patent drawing

AI summary

Provided herein are kit for providing a gamma sterilized aqueous dextran solution that increase the efficiency of blood separation by allowing the dextran solution to be sterilized by exposure to gamma radiation while maintaining sufficient molecular weight to act as a red blood cell aggregate. Also provided are methods of use.