ACCESS AND VAPOR CONTAINMENT SYSTEM FOR A DRUG VIAL AND METHOD OF MAKING AND USING SAME
First Claim
1. A safety vial system for enclosing a drug vial filled with a hazardous drug comprising:
- a vial adapter subsystem comprising a main body assembly, an activation housing assembly irreversibly coupled and hermetically sealed to the main body assembly and yet movable telescopically and axially in a distal direction with respect to the main body assembly between a first proximally raised position and a second distally extended lowered position, and a product integrity ring releasably coupling the vial adapter subsystem with the main body assembly to retain the activation housing assembly in the first proximally raised position until forcibly released;
a vial base subsystem including a bellows base assembly comprising a bellows base and an expandable bellows comprising a flexible bellows film having an upper surface and a lower surface and being sealingly attached to the bellows base to define an expandable bellows chamber between the upper surface of the bellows film and the bellows base; and
a vial having a central longitudinal axis, a bottom wall, a side wall joined with the bottom wall and extending around the central longitudinal axis to form an upper portion that has a top opening sealed with a stopper to define a internal reservoir for containing a medicament, the vial having an external surface and being disposed between the vial adapter subsystem and the vial base subsystem with the bottom wall directed toward the vial base subsystem;
wherein the vial adapter subsystem and the vial base subsystem are generally tubular and arranged along a common central longitudinal axis with the central longitudinal axis of the vial and the vial is supported by at least one of the vial adapter subsystem and the vial base subsystem;
wherein the vial adapter subsystem and the vial base subsystem are movably telescopically connected to each other in a first position wherein an open pathway is provided for a sterilization gas to sterilize the external surface of the vial while the vial is supported between the vial adapter subsystem and the vial base subsystem; and
wherein the vial base subsystem and the vial adapter subsystem are telescopically movable toward each other and into a second position wherein the pathway is hermetically sealed closed after the external surface of the vial is sterilized with the sterilization gas.
4 Assignments
0 Petitions
Accused Products
Abstract
A safety vial system has a vial adapter subsystem irreversibly mountable to the top of a vial containing a hazardous medicament and a vial base subsystem sealingly engaging a lower portion of the vial adapter subsystem and telescopically movable therein from a first position providing a path for gas sterilization around the vial to a second position wherein the path is closed to form a sterilized expandable, neutral pressure bellows chamber around and below the vial. The device has a removable top cap, a pierceable barrier film, a normally closed needleless valve in fluid communication with a dual lumen spike initially disposed above the film and a frangible product integrity ring holding the activation housing in place for sealed telescopic movement on a main body that surrounds the vial. The user pulls the product integrity ring and removes it, and then pushes the activation housing axially downward until it clicks to lock the device in the activated position wherein both lumens of the spike are in communication with the inside of the vial. The user removes the top cap on the activation housing assembly, and then uses a needleless syringe with an adapter thereon to add diluent and mixes if needed and withdraw drug from the vial via the valve.
9 Citations
33 Claims
-
1. A safety vial system for enclosing a drug vial filled with a hazardous drug comprising:
-
a vial adapter subsystem comprising a main body assembly, an activation housing assembly irreversibly coupled and hermetically sealed to the main body assembly and yet movable telescopically and axially in a distal direction with respect to the main body assembly between a first proximally raised position and a second distally extended lowered position, and a product integrity ring releasably coupling the vial adapter subsystem with the main body assembly to retain the activation housing assembly in the first proximally raised position until forcibly released; a vial base subsystem including a bellows base assembly comprising a bellows base and an expandable bellows comprising a flexible bellows film having an upper surface and a lower surface and being sealingly attached to the bellows base to define an expandable bellows chamber between the upper surface of the bellows film and the bellows base; and a vial having a central longitudinal axis, a bottom wall, a side wall joined with the bottom wall and extending around the central longitudinal axis to form an upper portion that has a top opening sealed with a stopper to define a internal reservoir for containing a medicament, the vial having an external surface and being disposed between the vial adapter subsystem and the vial base subsystem with the bottom wall directed toward the vial base subsystem; wherein the vial adapter subsystem and the vial base subsystem are generally tubular and arranged along a common central longitudinal axis with the central longitudinal axis of the vial and the vial is supported by at least one of the vial adapter subsystem and the vial base subsystem; wherein the vial adapter subsystem and the vial base subsystem are movably telescopically connected to each other in a first position wherein an open pathway is provided for a sterilization gas to sterilize the external surface of the vial while the vial is supported between the vial adapter subsystem and the vial base subsystem; and wherein the vial base subsystem and the vial adapter subsystem are telescopically movable toward each other and into a second position wherein the pathway is hermetically sealed closed after the external surface of the vial is sterilized with the sterilization gas. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
-
-
31. A method of making a safety vial system, comprising the steps of:
-
providing a vial filled with a drug and having a central longitudinal axis; providing a vial adapter subsystem; providing a vial base subsystem; irreversibly inserting the vial into a vial retention ring in the vial adapter; aligning the vial adapter subsystem holding the vial with the vial base subsystem so the vial base subsystem and vial adapter subsystem share a common central longitudinal axis with the vial; coupling the vial adapter subsystem and the vial base subsystem together in a first position relative to each other wherein a pathway is defined between the subsystems for a gas sterilant to reach external surfaces of the vial; placing the safety vial system in a gas sterilization chamber; sterilizing the safety vial system using a gas sterilant in a sealed gas sterilization chamber and, while the safety vial system is still in the sealed gas sterilization chamber and using a moving member in the gas sterilization chamber, telescopically moving the subsystems of the safety vial system from the first position to a second position where the pathway is sealed closed; opening the sealed gas sterilization chamber; and moving the sterilized unit out of the sealed gas sterilization chamber.
-
-
32. A kit for storage and fluid transfer of a hazardous drug comprising:
-
a safety vial system fully enclosing an elongated sealed container having a central longitudinal axis, an upper portion, a bottom wall and a side wall together defining an interior space containing a drug to be transferred, the safety vial system comprising; a vial adapter subsystem covering the upper portion of the container and comprising; a main body assembly irremovably mounted to and surrounding at least part of the upper portion of the container, the main body assembly including a tubular main body having a wall defining an interior space radially surrounding at least a part of the upper portion of the container; an activation housing assembly irreversibly coupled and hermetically sealed to the main body assembly and yet axially telescopically movable in a distal direction with respect to the main body assembly between a first proximally raised position and a second fully distally extended lowered position, the activation housing assembly comprising; a tubular activation housing; a hollow vial access member mounted in the activation housing and having a pointed distal end for accessing the interior space of the sealed container to establish fluid communication therewith, a proximal end, and fluid passage extending from the pointed distal end to the proximal end; a normally closed needleless valve mounted in the activation housing connected to the vial access member and in fluid communication with the fluid passage of the vial access member, a barrier film mounted in sealing covering relation across an upper opening of the tubular main body to isolate the interior space of the tubular main body below the barrier film from the activation housing assembly in the first position and being punctured by the vial access member as the activation housing assembly is moved to its second position, and a product integrity ring releasably coupling the activation housing with the main body assembly to retain the activation housing assembly in the first proximal raised position until the product integrity ring is forcibly released; and a sealing member operatively interposed between the tubular activation housing and the main body assembly for maintaining a hermetic movable radial seal therebetween to provide smooth relative telescopic movement; a vial base subsystem extending distally from the bottom wall of the container, the vial base subsystem being joined to and selectively movable axially with respect to the vial adapter subsystem from a first position wherein a pathway for a sterilant is defined between the vial adapter subsystem and the vial base subsystem to a second position wherein the pathway is sealed closed, the vial base subsystem supporting and enclosing an expandable bellows chamber located at least partially below the bottom wall of the container; and a needleless syringe for fluid tightly coupling with the needleless valve and withdrawing the drug from the container within the safety vial system; wherein the safety vial system is configured to expand and contract the expandable bellows chamber as needed to maintain a neutral pressure environment in the safety vial system and surrounding the container such that leaks of the drug in any form, including liquid, gas and mixtures thereof, are captured during withdrawal from the container and transfer to the needleless syringe. - View Dependent Claims (33)
-
Specification