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Publication Number
US-9610222-B2
Publication Date
2017-04-04
Expiration Date
Abstract
A vial adaptor having a bottom part adapted to be attached to the head section of a medical vial or any type of vessel or device that has a head section similar to that of the head of a standard medicine vial. The top part has numerous components. The apparatus also has a first locking mechanism; and a second locking mechanism. The first locking mechanism is adapted to lock a top part to the bottom part such that a tip of a spike cannot contact a stopper in the head section when the head section is being attached to the bottom part and to release the top part from the bottom part after the bottom part has been attached to the head section. The second locking mechanism is adapted to allow, after the bottom part has been attached to the head section, the spike to penetrate the stopper in the head section and to irremovably lock the top part to the bottom part.
Core Innovation
The document describes a closed transfer device for hazardous drugs that does not vent to or communicate with the environment. A vial adaptor includes a bottom part and a top part with a disk shaped central piece, a plurality of wings, and a spike element. The proximal end of a longitudinal extension is sealed by a membrane, and the spike element provides openings at the tip of the spike to allow fluid communication through the adapter.
The vial adaptor internally forms both an air channel and a liquid channel within the longitudinal extension and the spike element. The channels are adapted to provide a closed fluid communication path from the proximally located membrane to the openings at the tip of the spike, so that air and liquid are routed without venting. The adapter further includes a first locking mechanism and a second locking mechanism to control when the spike tip can contact a stopper and when it irreversibly locks after penetration.
The document further introduces a hydrophobic filter in the disk shaped central piece to address liquid leakage and contamination, in which the liquid channel is adapted to pass fluid through the vial adaptor without passing through the filter. At the same time, liquid flowing through the air channel is prevented from passing through the filter, and air flowing through the air channel is adapted to pass through the filter. The document also describes additional air-path flow control using a bypass with a one-way valve and a selective valve, including a gravity-activated selective valve with a heavy weight and an elastic layer to control sealing and opening depending on vial orientation.
Claims Coverage
The provided claim set includes two independent claims (vial adaptor with dual locking and sealed air/liquid channels; and vial adaptor further incorporating an annular hydrophobic filter with defined air/liquid passage behavior). Across these independent claims, the main inventive features number are centered on internal sealed channeling without environmental venting, dual locking behavior controlling spike-to-stopper interaction, and a hydrophobic filter and air-path valve arrangements for controlling liquid leakage in an air channel.
Closed transfer vial adaptor with internal air and liquid channels and spike tip communication
A vial adaptor comprising a top part with a disk shaped central piece, wings, a longitudinal extension with a membrane sealing the proximal end, and a spike element protruding distally from the disk center, wherein an air channel and a liquid channel are internally formed within the longitudinal extension and the spike element to provide closed fluid communication from the membrane to openings at the tip of the spike that does not vent to or communicate with the environment.
Dual locking mechanisms for controlled spike-stopper contact and irreversibly locked penetration
A vial adaptor wherein a first locking mechanism locks the top part to the bottom part such that the tip of the spike cannot contact a stopper in the head section when the head section is being attached, and releases the top part after the bottom part has been attached, and wherein a second locking mechanism allows, after attachment, the spike to penetrate the stopper and to irremovably lock the top part to the bottom part.
Annular flat hydrophobic filter configured for liquid-channel bypass and air-channel filtration
A vial adaptor wherein an annular shaped flat hydrophobic filter is located in the disk shaped central piece, and the vial adaptor and filter are adapted to allow fluid flowing in the liquid channel to pass through the vial adaptor without passing through the filter, while preventing liquid flowing through the air channel from passing through the filter and allowing air flowing through the air channel to pass through the filter.
In the independent claims provided, the invention is focused on a sealed vial adaptor that creates a closed transfer device using internal air and liquid channels communicating to a spike tip without environmental venting, a dual locking mechanism that prevents premature spike-to-stopper contact while enabling irremovable locking after penetration, and an annular flat hydrophobic filter configured so that liquid in the liquid channel bypasses the filter while liquid in the air channel is prevented from passing through the filter and air is permitted to pass through the filter.
Stated Advantages
Provides a closed transfer device that does not vent to or communicate with the environment.
Prevents liquid flowing through the air channel from passing through the hydrophobic filter.
Allows air flowing through the air channel to pass through the hydrophobic filter.
Locks the spike such that the tip cannot contact a stopper during attachment, while enabling penetration and irreversibly locking after the bottom part has been attached.
Documented Applications
Closed transfer of hazardous drugs using a closed transfer device employing a vial adaptor having internal air and liquid channels that does not vent to or communicate with the environment.
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