Automated Platelet Collection System with Bacterial Contamination Reduction

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Solution Overview

Problem

Current systems for collecting platelets still face a moderate risk of bacterial contamination despite sample diversion methods, as bacteria on the donor's skin may not be fully diverted to the initial blood flow, potentially leading to contamination in the separation and collection chambers, and increasing the initial blood flow volume to mitigate this risk results in increased blood loss and procedural time.

Innovation Solution

An automated system that includes a disposable fluid circuit and a reusable hardware device with a controller to manage the flow of whole blood, where a predetermined volume is initially processed without collecting platelets and returned to the donor, thereby reducing the risk of bacterial contamination without increasing blood loss or procedural time. This system uses a centrifuge to separate blood components and includes a sample pouch to divert potential contaminants.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the volume of initial blood flow diverted to sample pouch is increased to ensure greater confidence that skin plug and bacteria are diverted, then bacterial contamination risk is reduced, but blood loss in donor increases

Engineering Contradiction:
Improvebacterial contamination riskVSAvoidblood loss
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The system performs a preliminary action by diverting an initial volume of blood (e.g., 50-100 mL) to the sample pouch before the main platelet collection begins. This preliminary diversion removes potential contaminants including skin plug and surface bacteria from the donor's skin, ensuring that subsequent collected blood has reduced contamination risk without requiring excessive total blood diversion.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If the volume of initial blood flow diverted to sample pouch is increased to ensure greater confidence that skin plug and bacteria are diverted, then bacterial contamination risk is reduced, but procedural time increases

Engineering Contradiction:
Improvebacterial contamination riskVSAvoidprocedural time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system applies partial action by diverting only a specific initial volume (e.g., 50-100 mL) of blood to the sample pouch, which is sufficient to clear potential contaminants from the skin interface. This partial diversion achieves the contamination prevention goal without the need to divert excessive volumes that would extend procedural time, thus optimizing the balance between safety and efficiency.

Inventive Principle:
Principle #16Partial or excessive action

3Reliability

If sample diversion systems are used to divert initial blood flow to sample pouch, then bacterial contamination risk is reduced, but device complexity increases

Engineering Contradiction:
Improvebacterial contamination riskVSAvoidsystem complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The sample pouch serves as an intermediary component that receives and isolates the initial blood flow containing potential contaminants. By introducing this intermediary element into the blood collection system, the patent creates a dedicated containment zone for contaminants while maintaining the main collection pathway separate and protected, thus reducing contamination risk without requiring complex active control mechanisms.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 effectively reduces the risk of bacterial contamination in collected platelets by over 50% to 98% without adding significant time or blood loss to the platelet collection process, providing a more reliable method for ensuring the safety of blood products.

Implementation Method 1

the blood source is then subjected to centrifugal separation to separate the blood into a platelet rich plasma portion and a red blood cell portion

Methodology Applied
Scientific EffectCentrifugal separation: Centrifugal Separation

Implementation Method 2

a pump for withdrawing whole blood from a whole blood source, a pump for removing one or more blood components from said separation chamber

Methodology Applied
Scientific EffectPump: Pump

Data Source

PatentEP3235527B1Systems for reducing the risk of bacterial contamination in collected platelets
Publication Date: 2022.03.23 FENWAL INC
  • EP3235527B1 patent drawingFigure 1
  • EP3235527B1 patent drawingFigure 2
  • EP3235527B1 patent drawingFigure 2A

AI summary

Systems for reducing bacterial contamination of platelets are disclosed. The systems disclosed herein provide for the processing of a pre-determined volume of whole blood so as to reduce the risk that platelets separated and collected from the whole blood have a reduced risk of bacterial contamination.