Red Blood Cell Storage Container with Composite Plasticizers

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Solution Overview

Problem

Current storage systems for red blood cells face challenges in maintaining low hemolysis levels beyond the standard 42-day storage period, with existing plasticizers and storage media not effectively suppressing hemolysis for extended storage periods.

Innovation Solution

A flexible storage container made from a polymeric material with multiple hemolysis-suppressing agents, combined with a storage medium containing an aqueous solution and a fat emulsion of lipids, such as cholesterol and phosphatidyl choline, to maintain low hemolysis levels in red blood cells for extended periods.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional plasticizers (DEHP) are used in PVC containers for RBC storage, then hemolysis is suppressed during standard storage periods, but hemolysis levels increase beyond 42 days of storage

Engineering Contradiction:
Improvehemolysis suppressionVSAvoidstorage period
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent combines multiple plasticizers (DEHP and at least one other plasticizer from alternatives like DINCH, DEHT, or citrate esters) within the same PVC container system to achieve synergistic hemolysis suppression that lasts beyond 42 days. This merging of multiple functional components resolves the contradiction by providing both immediate hemolysis suppression and sustained suppression during extended storage periods.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention uses composite plasticizer systems where DEHP is combined with other plasticizers in specific ratios within the PVC container material. This composite approach creates a multi-functional plasticizer system that maintains membrane stability and suppresses hemolysis throughout extended storage periods, overcoming the limitation of single plasticizer systems.

Inventive Principle:
Principle #40Composite materials

2Duration of action of stationary object

If storage period is extended beyond 42 days to increase availability, then RBC function and metabolism deteriorate, but hemolysis levels increase

Engineering Contradiction:
Improvestorage periodVSAvoidRBC function and metabolism
Core Design Contradiction:
Duration of action of stationary objectVSReliability

Solution Approach 1:

The patent incorporates multiple plasticizers into the container material before storage begins, creating a pre-established hemolysis suppression system that acts continuously throughout extended storage periods. This preliminary preparation allows RBCs to maintain their membrane integrity and metabolic function during storage periods that would otherwise be too long for conventional single-plasticizer systems.

Inventive Principle:
Principle #10Preliminary action

3Ease of manufacture

If single plasticizer system is used to simplify container composition, then manufacturing is easier, but hemolysis suppression is insufficient for extended storage

Engineering Contradiction:
Improvecontainer composition simplicityVSAvoidhemolysis suppression duration
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent merges DEHP with at least one additional plasticizer (DINCH, DEHT, or citrate esters) in the PVC container formulation. This combination provides enhanced and sustained hemolysis suppression during extended storage while maintaining relatively simple manufacturing processes, as the plasticizers are incorporated during standard PVC extrusion or formation processes.

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 system achieves an average hemolysis level of less than 0.15% after 42 days and less than 0.25% after 50 days of storage, effectively extending the shelf life of red blood cells while maintaining their metabolic function and viability.

Implementation Method 1

plasticizers such as DEHP have been found to suppress hemolysis of RBCs stored in containers that include such leachable plasticizers

Methodology Applied
Scientific EffectHemolysis suppression:

Implementation Method 2

Hemolysis refers to the rupturing of the RBC membrane, believed to be caused by the oxidation of phospholipids in the cell membrane

Methodology Applied
Scientific EffectOxidation: Oxidation

Implementation Method 3

RBCs must maintain an adequate concentration of adenosine triphosphate (ATP) and 2, 3-DPG

Methodology Applied
Scientific EffectMetabolism maintenance:

Implementation Method 4

a fat emulsion comprising a mixture of two or more lipids entrained in the aqueous solution

Methodology Applied
Scientific EffectEmulsion: Emulsion

Data Source

PatentUS20230389539A1Systems for the extended storage of red blood cells
Publication Date: 2023.12.07 FENWAL INC
  • US20230389539A1 patent drawing

AI summary

Systems for the prolonged storage of red blood cells (RBCs) are disclosed. The system includes a container made of a polymeric composition including polyvinyl chloride and a mixture of two or more hemolysis suppressing agents, and a storage medium that includes a fat emulsion entrained therein.