Needleless Additive Control Valve Sterility

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Solution Overview

Problem

Conventional infusion bags face issues with needle injection, where scrapings from the additive port can mix with infusion contents, and shrouded needles are limited in use, complicating medication administration due to compatibility with specific ports.

Innovation Solution

A needleless additive control valve with a trifurcated connector body, including a self-sealing access valve and male Luer lock connector, allows for secure and sterile fluid communication without direct needle insertion, using a silicone self-sealing valve member and pre-formed slit for compression and fluid passage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If needle injection is used into the additive port, then additive can be administered to the infusion bag, but scrapings from the additive port can mix with infusion contents causing contamination

Engineering Contradiction:
Improvesterility of infusion contentsVSAvoidease of additive administration
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

A self-sealing access valve with a flexible membrane acts as an intermediary between the additive port and the infusion contents. The membrane allows needle penetration for additive injection while preventing direct contact between the additive port interior and the infusion fluid, thus eliminating contamination from scrapings while maintaining ease of administration.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If shrouded needles are used to avoid needle sticks, then patient safety is improved, but insertion into specific additive ports is precluded limiting needle versatility

Engineering Contradiction:
Improveneedle stick injuryVSAvoidcompatibility with additive ports
Core Design Contradiction:
Object-affected harmful factorsVSAdaptability or versatility

Solution Approach 1:

The additive port is designed with a self-sealing access valve that accepts both traditional exposed needles and shrouded needles. The flexible membrane and valve mechanism accommodate different needle types, making the port universal and eliminating the need to choose between patient safety and compatibility.

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

3Ease of operation

If conventional additive ports are used with exposed needles, then additive administration is simple, but contamination risk increases and compatibility with safe needles is limited

Engineering Contradiction:
Improvesimplicity of additive administrationVSAvoidcontamination and needle stick risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The self-sealing access valve with flexible membrane serves as a protective intermediary that maintains the simplicity of additive administration while eliminating both contamination risk and needle stick hazard. The membrane allows easy needle insertion and additive injection while preventing harmful exposures.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 safe and versatile administration of additives to infusion bags, preventing contamination and expanding compatibility with various needle types, ensuring reliable and efficient medication delivery.

Implementation Method 1

The access valve has a stepped exterior surface including an abutment surface and a rim. The valve member has a natural length and is so dimensioned that the entry surface is flush with the rim thereby enabling the entry surface to be readily swabbed for sterilization purposes. A male Luer connector screw threaded onto the access valve advances until it abuts against the abutment surface. During its advancement, the male Luer connector compresses the valve member to a compressed length

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 2

The needleless additive port has a lumen and is fitted with a self-sealing access valve for screw threadingly receiving a male Luer lock connector. The access valve houses a silicone self-sealing valve member with a pre-formed slit extending therealong. During its advancement, the male Luer connector compresses the valve member to a compressed length

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP1957028B1Needleless additive control valve
Publication Date: 2017.06.07 MEDIMOP MEDICAL PROJECTS
  • EP1957028B1 patent drawingFigure 1
  • EP1957028B1 patent drawingFigure 2A~3B
  • EP1957028B1 patent drawingFigure 4A~4B

AI summary

A needleless additive control valve for use with a fluid container containing an infusion liquid and having an intravenous (IV) port for administrating the infusion liquid, and an additive transfer device containing a liquid additive and having a male connector for administrating the liquid additive. The needleless additive control valve includes a trifurcated connector body having an IV spike for sealing insertion into the IV port, a substitute IV port for sealingly receiving an IV spike, and a normally closed (NC) needleless additive port with a female connector for sealingly receiving the additive transfer device's male connector. The IV spike, the substitute IV port and the NC needleless additive port are in 3 way direct and continuous fluid communication whereby the additive transfer device's liquid additive is able to be either mixed with the infusion liquid or directly administered to a patient.