Vial Gate With One-Way Valves For Hemodialysis Drug Delivery

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Solution Overview

Problem

Current tubing sets for medical liquid delivery in hemodialysis machines require double transfer of drugs from vials to syringes and then to the circuit, leading to risks of contamination, glass debris, and increased workload for nursing staff, and are not suitable for use with vials of different sizes.

Innovation Solution

A tubing set with a vial gate equipped with one-way valves in the delivery and vent lumens, allowing for direct connection of vials to the circuit, eliminating the need for syringes and needles, and enabling automated drug delivery through pulsating pressure, with a design compatible with various vial sizes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional syringes and needles are used for drug transfer, then drugs can be administered to patients, but the risk of contamination and glass debris increases

Engineering Contradiction:
Improvedrug delivery safetyVSAvoidcontamination risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention extracts and eliminates the syringe and needle components from the drug transfer process. Instead of using conventional syringes to transfer drugs from vials to the hemodialysis circuit, the system uses a dedicated vial gate with a puncturable membrane that allows direct connection between the vial and the circuit, removing the intermediate transfer step that causes contamination and glass debris risks

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention introduces a membrane as an intermediary element between the vial and the hemodialysis circuit. The puncturable membrane allows fluid transfer while maintaining a sealed connection, replacing the need for needles and syringes as intermediaries. This membrane-mediated connection eliminates the harmful effects associated with needle-based transfers

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If double transfer steps are used (vial to syringe, then syringe to circuit), then drugs can be administered, but the workload for nursing staff increases

Engineering Contradiction:
Improvedrug delivery capabilityVSAvoidnursing staff efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The invention removes the syringe transfer step from the drug administration process. By implementing a vial gate that connects directly to the hemodialysis circuit, the system reduces the number of manual transfer operations from two (vial-to-syringe, syringe-to-circuit) to one (vial-to-circuit via puncturable membrane), significantly reducing nursing staff workload

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The vial gate system enables self-service drug transfer where the puncturable membrane automatically seals and disconnects after drug delivery. The system design allows for automated or semi-automated operation where the nursing staff only needs to connect the vial to the gate, and the remaining operations occur without continuous manual intervention, improving overall workflow efficiency

Inventive Principle:
Principle #25Self-service

3Ease of manufacture

If a fixed-length vent spike is used in the vial gate, then manufacturing is simplified, but the device is only suitable for vials of one size

Engineering Contradiction:
Improvevial gate productionVSAvoidvial size compatibility
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The invention transforms the static, fixed-length vent spike design into a dynamic system where the vent lumen can adapt to different vial sizes. The vent lumen is designed with sufficient length and flexibility to reach the air reservoir in vials of varying dimensions, allowing the same vial gate to work with multiple vial sizes without requiring different spike lengths

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The vial gate is designed as a universal component that can interface with vials of different sizes through the appropriately dimensioned vent lumen. The delivery lumen and vent lumen configuration allows the single vial gate design to serve multiple functions across different vial types, eliminating the need for size-specific variants

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

4Reliability

If syringes and needles are used for drug transfer, then drugs can be administered, but disposable materials are increased

Engineering Contradiction:
Improvedrug transfer capabilityVSAvoiddisposable material consumption
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The invention extracts and eliminates the disposable syringe and needle components from the drug transfer system. By using a reusable vial gate with a puncturable membrane, the system removes the need for single-use syringes and needles, significantly reducing disposable material consumption while maintaining drug transfer capability

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention implements a system where only the membrane component is discarded after single use, while the main vial gate body is recovered and can be reused. This selective discarding approach minimizes disposable material consumption compared to the conventional approach where entire syringes and needles are discarded after each use

Inventive Principle:
Principle #34Discarding and recovering

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 solution reduces contamination risks, minimizes the use of disposable materials, allows for automated and efficient drug delivery, and supports the use of different vial sizes, thereby enhancing safety and operational efficiency in hemodialysis treatments.

Implementation Method 1

a vent lumen (32), suitable for providing a replacement fluid (34, 60) from a location inside the tubing set (12) to the inside of the vial (26)

Methodology Applied
Scientific EffectOne-way valve mechanism: Valve

Implementation Method 2

The presence of the at least one one-way valve (70) allows to exploit the pulsating pressure provided in the delivery tube (68) by the pumps (74)

Methodology Applied
Scientific EffectPulsating pressure: Pressure Gradient

Data Source

PatentEP2569032B1Tubing set having an improved gate for the connection of vials
Publication Date: 2018.07.11 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
  • EP2569032B1 patent drawingFigure 1
  • EP2569032B1 patent drawingFigure 2~3
  • EP2569032B1 patent drawingFigure 4~5

AI summary

The present invention refers to a tubing set (12) suitable for use in co-operation with a medical liquid delivery device (10). The tubing set comprises: a delivery tube (68) suitable for supplying a medical liquid or blood to a patient; and a vial gate (24) for the connection of vials (26) containing drugs to be delivered into the medical liquid or blood. The vial gate comprises a delivery lumen (28), suitable for delivering the drug (30) from the vial to the delivery tube; and a vent lumen (32), suitable for providing a replacement fluid (34, 60) inside the vial in order to replace the delivered drug. The vial gate according to the invention further comprises at least one one-way valve (70, 72) placed along said vent lumen or said delivery lumen.