Integrated In-Line Sampling for Apheresis Collection Sets

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Solution Overview

Problem

Existing apheresis systems face challenges in enabling in situ sampling of collected blood components due to the position of the sample or product container, which prevents efficient monitoring of sample consistency and quality during the collection process.

Innovation Solution

An in-line sampling method and device that establishes fluid communication between a fluid component collection set and a sample system, prohibiting removal until sample collection is complete, and includes a sampling system with a sample sleeve and sealing member to facilitate sampling without disrupting the collection process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the sample container is positioned separately from the collection set, then the collection process can proceed independently, but in situ sampling cannot be performed and sample monitoring efficiency deteriorates

Engineering Contradiction:

Improvesampling operationVSAvoidcollection process efficiency

Core Design Contradiction:

Ease of operationVSProductivity

Solution Approach 1:

The sample container is integrated into the fluid component collection set, merging the sampling function with the collection function. This allows the sample container to be positioned within the collection set structure, enabling in situ sampling while maintaining collection process efficiency. The sample container includes a sample port that provides access to the sample volume without requiring separate positioning.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

A sampling adapter is introduced as an intermediary component that connects the sample container to the fluid component collection set. The sampling adapter includes a sample port and establishes fluid communication between the sample container and the collection set, allowing sampling without disrupting the collection process. The adapter acts as a mediator that enables both sampling and collection operations to proceed simultaneously.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If the collection set is removed from the medical device for sampling, then sampling can be performed, but the collection process is interrupted and time is lost

Engineering Contradiction:

Improvesample accessVSAvoidcollection process time

Core Design Contradiction:

Ease of operationVSLoss of time

Solution Approach 1:

The fluid component collection set is segmented into functional modules: the collection container, the sample container integrated within or attached to the collection set, and the sampling adapter. This segmentation allows the sample container to be accessed independently through the sample port without removing the entire collection set from the medical device, enabling sampling without interrupting the collection process.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The sample container is pre-positioned within the collection set structure with the sample port accessible during collection. The sampling adapter is pre-configured to establish fluid communication when connected. This preliminary arrangement allows sampling to be performed at any point during the collection process without requiring removal or reconfiguration, eliminating time loss.

Inventive Principle:

Principle #10Preliminary action

3Ease of operation

If the sample container is integrated into the collection set, then in situ sampling is enabled, but the device complexity increases

Engineering Contradiction:

Improvein situ sampling capabilityVSAvoidcollection set structure

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The sampling adapter serves multiple functions: it connects the sample container to the fluid component collection set, establishes fluid communication between them, and provides the sample port for access. This multi-functionality reduces the need for separate components and simplifies the overall structure despite the integration of sampling capability into the collection set.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS20250332328A1Sampling Methods And Devices For Medical Equipment

Publication Date: 2025.10.30 TERUMO BCT INC

AI summary

A method for in-line sampling for a medical device includes prompting an operator of a medical device to establish a fluid communication between a fluid component collection set as received by the medical device and a sample system for sample collection, where the medical device prohibits removal of the fluid component collection set or a component thereof from fluid communication with the medical device until sample collection using the sample system is complete and the establishing of fluid communication between the fluid component collection set includes prompting the medical device to interpret a code disposed on an exterior-facing surface of the sample tube.