Needle-Free API Bag-to-Syringe Transfer for Secure Dosing

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Solution Overview

Problem

The production of prefilled syringes is complex, time-consuming, and expensive, and they often suffer from issues such as loss of tightness due to deformation of the barrel material around the stopper, leading to concentration variation and degradation of the API, while existing transfer methods using needles pose risks of needle-stick injuries and difficulty in handling.

Innovation Solution

A bag containing a liquid API with a female connection part of a male-female tubular connector system is used to fill a syringe, allowing for needle-free transfer and administration via a syringe pump, reducing the need for sharp devices and ensuring secure, accurate dosing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If prefilled syringes are used to store and administer API, then sterility and handling are enhanced, but production complexity and cost increase, and tightness is compromised due to barrel deformation around the stopper

Engineering Contradiction:

Improvesterility and handlingVSAvoidproduction complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The system separates the storage function (bag with API solution) from the administration function (syringe with pump), connected via a needle-free connector. This segmentation allows each component to be optimized independently - the bag for simple, low-cost storage and the syringe for precise administration - while avoiding the complexity of prefilled syringes.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A needle-free connector acts as an intermediary between the bag and syringe, enabling secure connection and fluid transfer without the need for puncturing devices. This intermediary eliminates the stopper-deformation problem in prefilled syringes while maintaining sterility and ease of handling.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If needles or spikes are used to access vials or pouches for transferring API solution, then transfer is possible, but risk of needle-stick injuries and handling difficulties increase

Engineering Contradiction:

Improvetransfer capabilityVSAvoidneedle-stick injury risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The mechanical puncturing system (needles, spikes) is replaced with a needle-free connector system that uses a male-female coupling mechanism. This substitution eliminates the harmful effects of sharp devices while maintaining the ability to transfer fluid between containers.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The needle-free connector serves as a safe intermediary device that enables fluid transfer without requiring puncturing of the bag or syringe walls, thereby eliminating needle-stick injuries and handling difficulties associated with sharp devices.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Ease of operation

If ampoules are used to store API solution, then access is provided through open neck, but risk of glass particles and need for inline filters increase

Engineering Contradiction:

Improveaccess easeVSAvoidglass particles

Core Design Contradiction:

Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The invention uses a disposable plastic bag with a integrated needle-free connector instead of reusable glass ampoules. This eliminates the risk of glass particles while maintaining easy access through the connector, and the disposable nature ensures sterility without requiring complex cleaning or filtering systems.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

4Quantity of substance

If vials or pouches are used for storing API, then storage is possible, but needle-free transfer compatible designs are not available in prior art

Engineering Contradiction:

Improvestorage capacityVSAvoidneedle-free compatibility

Core Design Contradiction:

Quantity of substanceVSAdaptability or versatility

Solution Approach 1:

The invention merges the storage bag and the connector into a single integrated unit. The needle-free connector is directly attached to the bag opening, combining the storage function with the transfer interface, thereby enabling needle-free compatibility while maintaining storage capacity.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The integrated connector serves as a built-in intermediary that enables needle-free transfer from the bag to the syringe. This design makes the storage container itself compatible with needle-free systems, eliminating the need for separate transfer devices or adapters.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentEP4670697A1Active pharmaceutical ingredient for use in a treatment for a patient in need thereof

Publication Date: 2025.12.31 B BRAUN MELSUNGEN AG

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AI summary

An active pharmaceutical ingredient (API) for use in the treatment of a patient in need thereof, wherein the treatment comprises providing a liquid comprising the API in a bag, filling the liquid from the bag into a syringe yielding a filled syringe, and administering the liquid via the filled syringe to the patient, preferably via a syringe pump comprising the filled syringe, wherein the bag comprises an opening comprising a female connection part of a male-female tubular connector system and the syringe comprises an opening comprising a male connection part of the male-female tubular connector system.