IV Catheter Notch Blood Containment Mechanism

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Solution Overview

Problem

Existing IV catheter assemblies with notches on the introducer needle can create a leak path for blood to escape during or after needle withdrawal, compromising the visibility of flashback blood indicating vein entry.

Innovation Solution

Incorporating a containment mechanism, either elastomeric or non-elastomeric, positioned proximal to the catheter hub and external to the catheter, which receives the notch of the introducer needle during withdrawal, preventing blood egress and maintaining visibility of flashback blood.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of information

If a notch is provided on the introducer needle to allow early visualization of flashback blood, then the visibility of vein entry indication is improved, but blood may escape through the notch creating a leak path that compromises the reliability of the flashback indication

Engineering Contradiction:

Improvevisibility of flashback bloodVSAvoidreliability of flashback indication

Core Design Contradiction:

Loss of informationVSReliability

Solution Approach 1:

The catheter assembly is divided into distinct functional zones: the distal section contains the notch for early blood visualization, while the proximal section includes the containment mechanism. This segmentation allows the blood to be contained in the distal annular space for visualization purposes without escaping proximally, thus maintaining both visibility and reliability of the flashback indication.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The containment mechanism acts as an intermediary barrier between the notch and the proximal catheter hub. It prevents blood from escaping through the notch while still allowing the blood to accumulate in the distal annular space for visualization, thus mediating between the need for visibility and the need for reliable containment.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If the catheter is moved distally over the needle to thread the tube into position, then catheter placement is achieved, but the notch may be positioned outside the catheter creating a potential leak path for blood egress

Engineering Contradiction:

Improveease of catheter placementVSAvoidblood egress through notch

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The containment mechanism is pre-positioned on the catheter hub before needle insertion. When the catheter is advanced over the needle, the containment mechanism automatically positions itself to cover the notch, preventing blood egress. This preliminary positioning ensures that the protective function is already in place before any blood contact occurs.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The containment mechanism is nested within or on the catheter hub structure, and the catheter tube is nested over the needle with the notch. As the catheter is advanced, these nested structures maintain their relative positions, ensuring the containment mechanism continuously covers the notch throughout the insertion process, preventing blood leakage while facilitating smooth catheter placement.

Inventive Principle:

Principle #7Nested doll (Nesting)

Data Source

PatentUS11565087B2Blood containment for IV catheter

Publication Date: 2023.01.31 ICU MEDICAL INC

AI summary

Catheter assemblies may include introducer needles having a notch or similar structure that allows flashback blood to enter the annular space between a catheter tube and an introducer needle of an IV catheter. The presence of flashback blood in this annular space can provide a clinician with an early, visible indication that a needle has entered a vein. The notch, however, may create a leak path for blood to escape outside of the catheter assembly, unless contained. Disclosed herein is a notch containment that prevents the notch from providing a leak path for blood to escape outside of the catheter during or after needle withdrawal.