Segmented Priming Circuit for Biological Fluid Processing

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Solution Overview

Problem

Existing biological fluid processing systems face challenges in minimizing the return of citrate to donors during priming, which can cause adverse reactions due to high concentrations or rates of citrate infusion.

Innovation Solution

A method and system for priming a biological fluid processing circuit that involves selecting a protocol, introducing a controlled amount of anticoagulant or saline solution, and then introducing biological fluid to minimize citrate exposure, using a combination of anticoagulant and saline to prime different parts of the circuit, with monitoring to ensure safe citrate levels.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If anticoagulant solution is used to prime the entire circuit, then the circuit is effectively primed and air is purged, but excessive citrate is returned to the donor causing adverse reactions

Engineering Contradiction:
Improvecircuit priming effectivenessVSAvoidcitrate exposure to donor
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The priming circuit is divided into two segments: a first portion primed with anticoagulant solution and a second portion primed with citrate-free replacement fluid. This segmentation allows the anticoagulant to be confined to a limited volume, preventing excessive citrate return to the donor while still achieving effective circuit priming and air purging.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different priming solutions are applied to different portions of the circuit based on local requirements. The anticoagulant is applied locally to the first portion where it is most needed for preventing clotting, while the citrate-free fluid is used in the second portion to minimize donor exposure to citrate.

Inventive Principle:
Principle #3Local quality

2Object-affected harmful factors

If citrate-free replacement fluid is used for priming, then citrate exposure to donor is minimized, but the circuit may not be adequately primed and air purged

Engineering Contradiction:
Improvecitrate exposure to donorVSAvoidcircuit priming effectiveness
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The circuit priming is segmented into two distinct phases: first with anticoagulant solution to ensure adequate priming and air purging, then with citrate-free replacement fluid to minimize citrate exposure. This segmented approach ensures both priming effectiveness and reduced citrate exposure are achieved.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The anticoagulant priming is performed as a preliminary action before introducing the citrate-free replacement fluid. This preliminary priming ensures the circuit is adequately filled and air is purged before switching to the safer fluid, guaranteeing priming effectiveness while minimizing subsequent citrate exposure.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If large volume of priming solution is used, then circuit is thoroughly primed, but total citrate load returned to donor increases

Engineering Contradiction:
Improvecircuit priming thoroughnessVSAvoidtotal citrate volume returned
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The priming volume is segmented between two fluids: a limited volume of anticoagulant solution followed by a larger volume of citrate-free replacement fluid. This segmentation allows thorough circuit priming using the citrate-free fluid while limiting the total citrate load to only what is contained in the smaller anticoagulant portion.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The composition parameter of the priming solution is changed from citrate-containing to citrate-free for the majority of the priming volume. This parameter change allows large priming volumes to be used for thorough circuit priming while minimizing the citrate load returned to the donor.

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

This approach effectively reduces the amount of citrate returned to the donor, minimizing adverse reactions and ensuring efficient priming of the processing circuit while maintaining separation efficiency.

Implementation Method 1

The use of an anticoagulant as a priming solution is not uncommon in biological fluid processing and blood processing, in particular.

Methodology Applied
Scientific EffectChelation:

Implementation Method 2

Typical separation techniques include centrifugation, such as in the AMICUS® separator from Fenwal, Inc. of Lake Zurich, Ill., or other centrifugal separation devices

Methodology Applied
Scientific EffectCentrifugal separation: Centrifugal Separation

Implementation Method 3

or membrane separation such as a spinning membrane-type separator, such as the AUTOPHERESIS-C® and AURORA® devices from Fenwal, Inc.

Methodology Applied
Scientific EffectMembrane separation: Semipermeable Membrane

Implementation Method 4

Priming the circuit prior to biological fluid (e.g., blood) processing assists in purging air from the system in order to prevent the hemolysis of the red blood cells.

Methodology Applied
Scientific EffectFluid displacement:

Implementation Method 5

Priming also wets the surfaces of the processing unit or separator that will be contacted by the biological fluid. For example, where the processing unit utilizes a membrane such as in the aforementioned AUTOPHERESIS-C® and AURORA® devices, priming coats the surface of the membrane thereby increasing the useable membrane surface

Methodology Applied
Scientific EffectWetting: Wetting

Data Source

PatentUS9987411B2Methods and systems for priming a biological fluid processing circuit
Publication Date: 2018.06.05 FENWAL INC
  • US9987411B2 patent drawing
  • US9987411B2 patent drawing
  • US9987411B2 patent drawing

AI summary

Methods and systems for priming biological fluid processing systems are disclosed. In accordance with such methods and systems, the disposable fluid processing circuit is primed by introducing a first priming solution into a portion of the circuit and a second priming solution into a portion of the circuit. The amount of citrate returned to the biological flood source is minimized.