PIVC Flow Restriction Insert for Hemolysis-Reduced Blood Draw

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Solution Overview

Problem

Current blood draw methods using peripheral intravenous catheters (PIVCs) face challenges with hemolysis due to high shear stress on red blood cells, leading to compromised blood sample quality and potential complications.

Innovation Solution

A flow restriction device is integrated with the PIVC system to regulate fluid flow, reducing the shear stress on blood cells by altering the flow path and inducing resistance, thereby minimizing hemolysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a vacuum blood collection container is used to draw blood from a PIVC, then blood collection efficiency is improved, but hemolysis of red blood cells occurs due to high shear stress from the pressure differential

Engineering Contradiction:

Improveblood collection efficiencyVSAvoidhemolysis

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

A flow restriction device is introduced as an intermediary component between the PIVC and the vacuum blood collection container. This device mediates the pressure differential by providing controlled resistance to blood flow, thereby reducing shear stress on red blood cells while still allowing efficient blood collection through the vacuum mechanism.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The flow restriction device changes the flow parameters (velocity, pressure gradient) of blood during collection. By restricting flow through a controlled orifice or passage, the device modifies the pressure differential and flow velocity to reduce shear stress on blood cells while maintaining adequate collection rate.

Inventive Principle:

Principle #35Parameter changes

2Speed

If a high vacuum pressure is used in the blood collection container, then blood draw speed is improved, but catheter tip collapse and vein collapse occur

Engineering Contradiction:

Improveblood draw speedVSAvoidcatheter and vein stability

Core Design Contradiction:

SpeedVSReliability

Solution Approach 1:

The flow restriction device acts as an intermediary that buffers the vacuum pressure. It provides controlled resistance that prevents the full vacuum force from acting directly on the catheter tip and vein wall, thereby preventing collapse while still enabling rapid blood draw through the restricted flow path.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The flow restriction device applies partial resistance to blood flow, creating an optimal balance. Rather than allowing full vacuum force to act on the vasculature (excessive action), the device provides just enough resistance to prevent collapse while maintaining adequate draw speed through the controlled orifice.

Inventive Principle:

Principle #16Partial or excessive action

3Loss of time

If rapid blood flow is induced during collection, then collection time is reduced, but hemolysis and blood spillage increase

Engineering Contradiction:

Improvecollection timeVSAvoidhemolysis and spillage

Core Design Contradiction:

Loss of timeVSObject-affected harmful factors

Solution Approach 1:

The flow restriction device changes the flow parameters by creating a controlled pressure gradient. This restriction maintains sufficiently high flow velocity to reduce collection time while preventing excessive shear stress that would cause hemolysis, and controlling flow rate to prevent spillage.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The flow restriction device converts what would be harmful high shear stress into beneficial controlled flow. By restricting flow through a controlled orifice, the device creates turbulence and mixing that can be beneficial while simultaneously reducing the velocity and shear stress that cause hemolysis and spillage.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

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 flow restriction device effectively reduces the risk of hemolysis during blood collection, ensuring better blood sample quality and compatibility with existing PIVC systems without requiring operational changes.

Implementation Method 1

a pressure in the vein is higher than a pressure in the blood collection container, which pushes blood into the blood collection container

Methodology Applied

Scientific EffectPressure differential: Pressure Gradient

Implementation Method 2

red blood cells are in a high shear stress state and susceptible to hemolysis due to a high initial pressure differential

Methodology Applied

Scientific EffectShear stress: Shear Stress

Data Source

PatentUS12496001B2Hemolysis-reduction accessories for direct blood draw

Publication Date: 2025.12.16 CAREFUSION 303 INC

AI summary

A flow restriction device may include a housing with first and second end portions forming respective first and second openings, and a cavity configured to receive an insert body defining a fluid passage that extends from a first opening of the housing at the first end portion to a second opening of the housing at the second end portion, where the fluid passage extends in more than one direction along a path between the first and second end portions of the housing to induce a resistance to a fluid flow moving through the device, thereby reducing a flow rate and pressure of the fluid, and where the fluid is blood, reduce the hemolysis index of the blood.