Needle-Free Drug Reconstitution Tray with Dual-Ended Transfer Needle

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Solution Overview

Problem

Current drug reconstitution methods using syringes with injection needles pose risks of accidental exposure and contamination, and there is a need for a safer, more accurate, and user-friendly system for combining liquid and solid components without needles, while also reducing user handling steps.

Innovation Solution

A tray-based apparatus with a dual-ended transfer needle that aligns and pierces vials and containers under negative pressure, allowing for axial displacement to establish fluid communication without the need for syringes, ensuring central piercing and maintaining alignment for efficient reconstitution.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If syringes with injection needles are used for drug reconstitution, then the reconstitution process can be completed, but the risk of accidental exposure and contamination increases

Engineering Contradiction:
ImprovesafetyVSAvoidexposure risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention extracts and eliminates the injection needle from the reconstitution system. Instead of using a syringe with a needle to transfer the diluent, the system uses a needle-free transfer mechanism where the diluent container is inverted and the diluent flows through a controlled opening into the vial, completely removing the needle component that causes exposure risk.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention introduces an intermediary transfer mechanism between the diluent container and the vial. This intermediary system includes a controlled opening in the diluent container and a receiving structure in the vial adapter that enables fluid transfer without direct needle penetration, thereby mediating the transfer process safely without exposure risk.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If manual syringe handling is used for reconstitution, then the process can be performed, but the complexity of user handling steps increases

Engineering Contradiction:
Improveuser handlingVSAvoidhandling steps
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The invention merges multiple separate handling steps into a single integrated operation. The vial adapter combines the functions of vial holding, diluent reception, and fluid transfer control into one device. The user simply attaches the diluent container to the vial adapter, and the system automatically manages the reconstitution process, reducing multiple manual steps to a single intuitive action.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The vial adapter serves multiple functions simultaneously: it holds the vial, receives the diluent container, controls the fluid transfer, and prevents contamination. This multi-functional design eliminates the need for separate syringes, needles, and caps, simplifying the overall handling process while maintaining safety and efficacy.

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

3Productivity

If syringes are used to inject and withdraw fluids, then fluid transfer can be achieved, but fluid remains on the syringe tip creating exposure risk

Engineering Contradiction:
Improvefluid transfer efficiencyVSAvoidfluid contamination
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The invention extracts the syringe tip from the system and replaces it with a controlled opening mechanism. The diluent flows directly from the container through a controlled opening into the vial without requiring a syringe tip, eliminating the source of fluid retention and subsequent contamination risk.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The system enables self-service fluid transfer where the diluent container's own weight and the pressure differential automatically drive the fluid flow into the vial. The controlled opening self-regulates the transfer process, and the system automatically prevents fluid retention issues that plague syringe-based methods, without requiring additional wiping or cleaning steps.

Inventive Principle:
Principle #25Self-service

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 system provides a safer, more accurate, and user-friendly method for reconstituting drugs by eliminating needle exposure risks and reducing user handling, ensuring efficient and sterile reconstitution of drug solutions.

Implementation Method 1

a vial under negative pressure, wherein a tray has a vial cavity for accommodating at least a portion of the vial and a container cavity for accommodating at least a portion of the container

Methodology Applied
Scientific EffectNegative pressure: Pressure Gradient

Data Source

PatentUS20240024200A1Apparatus and system for drug reconstitution by liquid transfer
Publication Date: 2024.01.25 KAIRISH INNOTECH PTE LTD
  • US20240024200A1 patent drawing
  • US20240024200A1 patent drawing
  • US20240024200A1 patent drawing

AI summary

An apparatus for combining a first liquid component 90 stored in a container 125 and a second component stored in a vial 7 by means of negative pressure is disclosed. A tray 1 has a vial cavity 11 and a container cavity 12. A dual-ended transfer needle 131 is fixedly held at the tray 1 at an intermediate needle holding portion 13 between the vial cavity 11 and the container cavity 12 for establishing a fluid communication between the vial 7 and the container 125 by piercing a rubber stopper of the vial and a bottom of the container, respectively. The vial cavity 11 guides the vial 7 along an axial direction AD from an intermediate position towards the transfer position for fluid communication. And the container cavity 12 guides the container 125 along the axial direction AD from an intermediate position towards the transfer position for fluid communication.