Red Blood Cell Storage Medium for Extended Room Temperature Holding

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Solution Overview

Problem

The existing methods for storing red blood cells from whole blood held at room temperature for extended periods before processing result in reduced functionality due to decreased 2,3-DPG levels, increased ATP levels followed by decline, and reduced extracellular potassium, leading to impaired storage duration and viability.

Innovation Solution

An aqueous storage solution with specific compositions including sodium citrate, sodium phosphate, dextrose, mannitol, adenine, and optional acetate and gluconate, maintaining a pH of 8.3 to 8.5, which is designed to support extended storage of red blood cells for up to 35 days, even when whole blood is held for several hours or up to 26 hours before processing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If whole blood is held at room temperature for extended periods before processing, then processing convenience and staff scheduling are improved, but red blood cell functionality deteriorates due to decreased 2,3-DPG levels and increased hemolysis

Engineering Contradiction:
Improveprocessing convenienceVSAvoidred blood cell functionality
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies preliminary action by adding specific protective agents (adenine, mannitol, and elevated glucose) to the storage medium before the red blood cells are subjected to extended room temperature holding. This pre-prepared storage medium is designed to counteract the metabolic changes that occur during prolonged holding, thereby preserving 2,3-DPG levels and reducing hemolysis even when processing is delayed up to 26 hours.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements parameter changes by modifying the composition of the storage medium with specific concentrations of adenine (1-5 mM), mannitol (20-60 mM), and glucose (80-150 mM), and by adjusting pH to 7.8-8.2. These parameter changes create an optimized environment that compensates for the extended holding period, maintaining red blood cell viability and functionality despite the delayed processing.

Inventive Principle:
Principle #35Parameter changes

2Productivity

If whole blood is held for extended periods before processing, then accumulation of multiple units for batch processing is improved, but storage duration and viability of red blood cells deteriorate

Engineering Contradiction:
Improvebatch processing efficiencyVSAvoidred blood cell storage duration
Core Design Contradiction:
ProductivityVSDuration of action of stationary object

Solution Approach 1:

The storage medium is pre-formulated with protective agents that anticipate and counteract the effects of extended holding periods required for batch processing. This allows blood centers to accumulate multiple units over several hours without compromising the eventual viability of the red blood cells when processed and stored.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

By changing the chemical parameters of the storage medium (elevated glucose, mannitol, adenine, and pH adjustment), the patent extends the acceptable holding time at room temperature from the conventional 8 hours to up to 26 hours, thereby enabling more flexible batch processing schedules without sacrificing storage duration.

Inventive Principle:
Principle #35Parameter changes

3Device complexity

If conventional storage solutions are used for red blood cells from extended-held whole blood, then simplicity of the storage system is maintained, but red blood cell functionality and storage longevity deteriorate

Engineering Contradiction:
Improvestorage system simplicityVSAvoidred blood cell functionality
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The patent modifies the conventional storage solution by adjusting key parameters: increasing glucose to 80-150 mM, adding mannitol to 20-60 mM, adding adenine to 1-5 mM, and adjusting pH to 7.8-8.2. These parameter changes enhance the protective capacity of the storage medium against extended holding effects while maintaining a relatively simple single-solution system that does not require complex multi-component assemblies.

Inventive Principle:
Principle #35Parameter changes

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 solution effectively maintains ATP levels, 2,3-DPG concentrations, and reduces hemolysis, ensuring better red blood cell functionality and storage longevity compared to traditional solutions like SAG-M, with statistically significant improvements in extracellular pH, lactate, and potassium levels throughout the storage period.

Implementation Method 1

The storage solution has a pH of 8.3 to 8.5 and includes sodium phosphate, sodium citrate, dextrose, mannitol, and adenine

Methodology Applied
Scientific EffectBuffer system:

Implementation Method 2

The storage solution effectively maintains ATP levels, 2,3-DPG concentrations, and reduces hemolysis

Methodology Applied
Scientific EffectMetabolic support:

Implementation Method 3

The storage solution includes dextrose, mannitol, and maintains statistically significant improvements in extracellular pH, lactate, and potassium levels

Methodology Applied
Scientific EffectOsmotic pressure: Osmotic Pressure

Data Source

PatentEP2468252B1Red blood cell storage medium for extended storage
Publication Date: 2016.09.07 FENWAL INC
  • EP2468252B1 patent drawingFigure 1A~1B
  • EP2468252B1 patent drawingFigure 1C~1D
  • EP2468252B1 patent drawingFigure 2A~2B

AI summary

Synthetic aqueous storage solutions and red blood cell compositions having red blood cells and in aqueous storage solution are disclosed for use in the processing and the storing of red blood cells. The compositions are useful in providing long term storage of red blood cells prepared from whole blood including cells derived from whole blood held at room temperature for an extended period before processing.