Fluent material handling – with receiver or receiver coacting mea – Filling or refilling of dispensers
Reexamination Certificate
1998-06-05
2001-07-31
Jacyna, J. Casimer (Department: 3751)
Fluent material handling, with receiver or receiver coacting mea
Filling or refilling of dispensers
C141S025000, C141S326000, C604S092000
Reexamination Certificate
active
06267154
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to medical devices for the preparation and administration of drugs and other therapeutic solutions, and more particularly to a drug delivery system which includes a container and a syringe for administering the drug which are pre-filled with a drug and a liquid diluent, respectively.
BACKGROUND OF THE INVENTION
Modem healthcare facilities typically have available a large number of drug or pharmaceutical solutions and other medicaments to administer to patients. Often, drug solutions or premixed solutions may be administered without further preparation. For some drugs, it may be necessary to store the drug in a concentrated form, which may be either liquid or particulate in nature, to maintain the stability and potency of the drug for a reasonable shelf life. Also, concentrated compositions facilitate efficient storage and handling.
To concentrate a drug which is in liquid form, a lyophilization process is used. The drug is subjected to a vacuum in a chamber to remove most of the water and then to concentrate the drug. After lyophilization the drug is sealed and prepared for shipment to a healthcare facility.
At the healthcare facility, the concentrated drug is reconstituted by a syringe mixing system. The concept of separately packaging and then mixing drug and diluent components within a vial and/or a syringe barrel is known. However, many of the known syringe mixing systems require special or unusual components, require many operational steps, and/or require the use of a sharp, hollow needle or cannula which can be hazardous.
Additionally, for some drugs, particularly protein based drugs, a silicone free environment is desirable. A container closing structure which does not require a silicone sealing oil that is typically used in conjunction with reciprocatable stoppers, would be advantageous. It would be also advantageous if the closing structure would maintain sterility of the container during reconstitution.
SUMMARY OF THE INVENTION
The present invention provides a container useable in a system to facilitate the efficient and convenient packaging of a concentrated drug, the reconstitution of the drug in a solution, and the administration of the solution.
The container comprises a cover structure at one end with a first Luer lock fitting that defines a delivery opening and a closing structure at an opposite end.
The first Luer lock fitting is configured to engage a complimentary (second) Luer fitting on a syringe. The first Luer lock fitting includes a thread form for engaging a complimentary thread form on the second Luer lock on the syringe.
The closing structure may be formed either as a substantially closed unitary end wall with the sidewall of a first barrel, or as a stopper or other plug-like member adapted to slide within the first barrel. The use of the unitary end wall avoids the use of a reciprocating grommet or stopper. This is particularly advantageous because silicone sealing/lubricating oil is not required.
As an alternative to the unitary end wall structure, the closing structure includes a stopper adapted to slide within the first barrel and a holder configured to fit onto the first barrel of the container. The holder is capable of moving between two positions with respect to the first barrel. In the first position, the barrel can vent vapor during lyophilization. In the second position, the holder is sealed to the first barrel and it cannot vent vapor.
The holder includes a top wall and a surrounding annular side wall extending therefrom. The top wall includes a central recess with a central hole. The central recess is sized to receive therein a microbial filter. In the first position of the holder, the stopper is held within the holder above the end of the first barrel. The holder includes a hook extending from the top wall for releasably holding the stopper within the holder. The stopper includes inclined wall formations for engagement by the hooks. The holder includes a vent for removing vapors during lyophilization.
During the vacuum phase of the lyophilization process, the holder and stopper held within are positioned in the first elevated position on the barrel with the vent open. After lyophilization is completed, the holder and stopper are depressed downwardly into the second position onto the barrel and the vent is thereby closed by a wall position of the barrel.
The holder and stopper can be forced downwardly by mechanical means assisted by differential pressure on the stopper as the holder vent is closed, and into the second locked position.
When vacuum conditions are terminated in the chamber, the differential pressure within the barrel uncouples the stopper from the holder and draws the stopper further into the barrel. The stopper is sized to tightly, slidably fit within the barrel.
The microbial filter maintains the barrel in a sterile condition while allowing the stopper to slidably move within the barrel. That is, the filter allows the air to pass into and out of the barrel between the stopper and the barrel open end, during movement of the stopper.
The cover structure with first Luer lock fitting of the container can be formed as a unitary structure with the first barrel, or the first barrel can have an otherwise open end which is substantially closed by an overfitting cover piece having an integral Luer lock fitting. The cover piece can be snap fitted onto the barrel using a flange of the first barrel for engagement.
The container has a first removable closure or plug engaged to the first Luer lock fitting that temporarily seals the delivery opening.
Similar to the function of the holder, the cover piece can be constructed to move between two positions with respect to the first barrel. In a first, elevated position, the first barrel can vent vapor through or around the cover piece during lyophilization. After lyophilization is completed, the cover piece can then be snapped down onto the first barrel by mechanical means to a second position. In this second position, the cover piece is sealed to the first barrel and the barrel cannot vent vapor.
With all embodiments of the closing structure or the cover structure the sterility of the drug is maintained during lyophilization and reconstitution.
As previously described, the container includes a cover structure and closing structure. In one embodiment, both the cover structure and closing structure are each constructed entirely as a unitary structure with the barrel of the container. In another embodiment, the cover structure is constructed as a unitary structure with the barrel and the closing structure is constructed to include or employ the stopper and holder described above. In yet another embodiment, the cover structure includes the moveable cover piece described above and the closing structure is constructed as a unitary structure with the barrel.
The container of the present invention is particularly adapted for use with a mixing system which also includes a syringe. The syringe has a second or syringe barrel and a Luer lock fitting that defines a discharge opening into a discharge passage of the syringe barrel. A removable closure is engaged to the Luer lock fitting and seals the discharge opening. A piston is slidably and sealingly disposed in the syringe barrel to define a diluent chamber adjacent the discharge passage.
The Luer lock fittings of the container and syringe are mutually engageable for coupling the drug-containing container end-to-end with the diluent-containing syringe to establish fluid communication between the delivery passage and the discharge passage after the removable closures are removed from the container and the syringe.
A plunger is provided in the diluent syringe and engaged with the piston so that movement of the plunger inwardly will force the diluent into the connected drug-containing container for reconstituting the drug in solution form. The reconstituted drug in solution can then be drawn from the container into the syringe by outward movement of the plunger. The syringe can then be removed from
Felicelli Robert
Grabenkort Richard W.
Lasaitis Con A.
Smith Gary N.
Ziegler John S.
Abbott Laboratories
Jacyna J. Casimer
Vrioni Beth A.
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