Syringe Assembly with Closed-Loop Bypass for Fluid-Restricted Patients

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Solution Overview

Problem

Fluid-restricted patients, such as neonatals, face challenges when needing a secondary drug or medical fluid infusion due to maximum allowable flowrate limitations and potential dilution issues when mixing with primary fluids, leading to ineffective or delayed delivery.

Innovation Solution

An IV administration system with a y-site and multi-way valve allows for a secondary fluid to be delivered through a syringe assembly, creating a closed-loop bypass that replaces a like volume of primary fluid, ensuring zero net volume change and effective delivery of the secondary fluid without increasing overall fluid volume, with the y-site and valve positioned downstream of the IV bag to facilitate quick and safe administration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If the second drug is injected into the primary IV bag, then the patient can receive the second drug without increasing overall fluid volume, but the second drug may be diluted and delivered slowly, reducing effectiveness

Engineering Contradiction:
Improveoverall fluid volumeVSAvoiddelivery speed of second drug
Core Design Contradiction:
Quantity of substanceVSProductivity

Solution Approach 1:

The system segments the fluid delivery path by introducing a y-site that separates the primary IV bag flow from the secondary syringe injection point. This allows the second drug to be injected separately into the line downstream of the y-site, preventing dilution in the primary bag while maintaining zero net volume increase through the bypass mechanism.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The IV line segment between the y-site and the patient acts as an intermediary volume that can temporarily hold the second drug. When the syringe injects the second drug, it displaces an equal volume of primary fluid back through the bypass to the IV bag, allowing rapid delivery of the second drug without direct mixing in the primary bag.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Quantity of substance

If the second drug is injected into the primary IV bag, then the overall fluid volume remains unchanged, but the patient must wait for the bag to be delivered, increasing time delay

Engineering Contradiction:
Improveoverall fluid volumeVSAvoidtime delay before second drug delivery
Core Design Contradiction:
Quantity of substanceVSLoss of time

Solution Approach 1:

The system performs preliminary action by positioning the y-site and bypass mechanism upstream in the fluid path, allowing the second drug to be injected and immediately flushed through the line to the patient. The primary IV fluid continuously flows through the system, ready to rapidly displace and deliver the second drug without waiting for bag delivery.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system extracts the second drug delivery from the primary IV bag system by using a separate syringe injection point at the y-site. This separates the timing of second drug administration from the primary bag delivery schedule, allowing immediate injection and rapid flush-through to the patient independent of bag position.

Inventive Principle:
Principle #2Taking out (Extraction)

3Productivity

If a bypass system is used to deliver secondary fluid, then rapid delivery is achieved, but the system complexity increases

Engineering Contradiction:
Improvedelivery speed of second drugVSAvoidIV line configuration
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The y-site serves multiple functions: it allows primary IV fluid to pass through to the patient, provides an injection port for secondary drugs, and enables the bypass mechanism to redirect displaced fluid back to the IV bag. This multi-functionality reduces the need for separate components for each function.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system merges the secondary drug delivery path with the primary IV line by using the existing IV tubing as part of the bypass mechanism. The IV line between the y-site and patient serves dual purposes as both the primary delivery path and the flush path for secondary drugs, eliminating the need for a completely separate bypass tube.

Inventive Principle:
Principle #5Merging (Combining)

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

Enables effective and rapid delivery of secondary fluids to fluid-restricted patients without increasing the overall fluid volume, ensuring timely and effective administration of critical medications, maintaining a closed system and preventing dilution issues.

Implementation Method 1

The y-site is provided in one embodiment with a check valve that prevents fluid from backflowing or traveling upstream to the IV bag

Methodology Applied
Scientific EffectCheck valve: Valve

Implementation Method 2

A multi-way valve or stopcock is located in the IV line downstream of the y-site, between the y-site and the patient access device

Methodology Applied
Scientific EffectMulti-way valve: Valve

Implementation Method 3

the syringe assembly is connected to the IV line to create a secondary closed-loop bypass. The discharge end or outlet nozzle of the syringe is connected fluidly and sealingly, e.g., threadingly, to the y-site administration port

Methodology Applied
Scientific EffectClosed-loop bypass:

Implementation Method 4

The discharge end and actuation end seals provide a sealed, variable volume within the syringe barrel

Methodology Applied
Scientific EffectSeal:

Data Source

PatentUS8814829B2Drug delivery device for fluid restricted patients
Publication Date: 2014.08.26 BAXTER INT INC
  • US8814829B2 patent drawing
  • US8814829B2 patent drawing
  • US8814829B2 patent drawing

AI summary

A syringe assembly for connecting to an intravenous (“IV”) line includes: a syringe barrel having an actuation end and a discharge end; a syringe plunger moveable within the syringe barrel, the syringe plunger including a plunger head connected to a plunger arm; a seal between the plunger arm and the syringe barrel, the seal residing on an actuation end side of the syringe plunger; and a tube in fluid communication with the syringe barrel at a location between the seal and the plunger head, the tube having a distal end configured to be connected to the IV line.