Surgery – Liquid medicament atomizer or sprayer – Means for selectively dispensing different fluids
Reexamination Certificate
2001-04-10
2003-09-23
Bennett, Henry (Department: 3743)
Surgery
Liquid medicament atomizer or sprayer
Means for selectively dispensing different fluids
C222S049000
Reexamination Certificate
active
06622721
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to delivery systems for delivering substances such as drugs, vaccines and the like, and more specifically relates to a drug delivery system for preferably delivering such substances intranasally, i.e., through the nose, including a holder and a prefilled drug container such as a syringe. In addition, the present invention relates to a holder for use by one hand in which the travel of the stopper is controlled to insure the application of a minimum force before activation and to divide the substance to be delivered into at least two doses.
BACKGROUND OF THE INVENTION
A number of medications may be effectively administered through the nasal passages. Devices have accordingly been developed for this purpose including either cartridges, such as those described in U.S. Pat. Nos. 5,893,484 (Fuchs et al.), 5,813,570 (Fuchs et al.), 5,655,689 (Fuchs et al.), 5,511,698 (Solignac), 5,427,280 (Fuchs), 5,289,818 (Citterio et al.), 5,284,132 (Geier) and 5,171,219 (Fujioka et al.), or syringes, such as those described in U.S. Pat. Nos. 5,601,077 (Imbert), 4,923,448 (Ennis, III), 4,767,416 (Wolf et al.) and 4,344,573 (De Felice).
The nasal syringes are usually of a more conventional construction such as that described in U.S. Pat. No. 5,601,077 (Imbert) which includes a cylindrical barrel having a blunt tip portion for insertion into a nostril. A stopper is positioned within the barrel. A plunger extends from the end of the barrel opposite to the blunt tip. The plunger controls the position of the stopper within the barrel. A flange may be provided on one end of the plunger to facilitate its use. However, limitations remain, particularly with respect to insuring that sufficient force is applied to the plunger to obtain a therapeutic effective spray.
Nasal syringes are often supplied to users pre-filled with medication. Whether pre-filled or not, it may be desirable to administer selected, and usually equal volumes of medication to each nostril. U.S. Pat. No. 4,962,868 (Borchard) discloses the use of a telescoping tube assembly which is designed for expelling the contents of a nasal syringe in two controlled doses. Also, U.S. Pat. No. 5,601,077 (Imbert) discloses the use of a dose limited in the form of a c-shaped attachment on the plunger rod for limiting movement in the distal directed so that approximately half of the substance to be delivered remains in the syringe. To continue, the user simply removes the attachment from the plunger rod. In addition, U.S. Pat. No. 5,951,526 (Korisch et al.) discloses a holder having an integral dose divider. However, it remains difficult for users to administer equal doses of medication to each nostril, especially with one hand.
Accordingly, there has been a need for a nasal drug delivery system which over comes the problems and limitations associated with the use of the prior devices for delivering a substance, especially intranasally easily with one hand, including delivery of a uniform spray which can be divided into at least two separate doses for delivery into each nostril. Also, there has been a need for a system which would permit the user to observe the substance in the system to determine, for example, if the system has been previously used.
SUMMARY OF THE INVENTION
In contrast to the prior devices discussed above, it has been found that a drug delivery system particularly suited for use in intranasally delivering substances such as drugs, vaccines and the like can be constructed in accordance with the present invention. Specifically, the invention is directed to an assembly such as a housing which allows the use of a conventional, pre-filled drug containers such as syringe while providing control of the dose to be administered. The assembly is particularly applicable to nasal syringes where it is often desirable to dispense medication in two equal doses.
The system of the present invention for delivering at least one substance in at least two doses includes a drug container including a barrel, a first end extending from the barrel, and a stopper slidably positioned within the barrel, a holder having a distal portion and a proximal portion, with the distal portion being assembled to the proximal portion, with the drug container secured therein, and means for controlling the delivery of a substance contained in the barrel of the drug container including a plurality of slots extending axially along at least one of the portions of the holder whereby upon activation of the system, the portions of the holder move towards one another upon the application of a minimum force and the stopper moves a preselected axial distance to expel at least a portion of the substance from the drug container.
In the preferred embodiment of the system, the first end of the drug container includes a spray nozzle for use in intranasally delivering the substance and the drug container is a syringe, and the distal portion of the holder acts as a plunger rod during activation of the system. In addition, the distal portion and the proximal portion of the holder each has a generally tubular interior configured to accommodate the drug container filled with a substance to be delivered and the proximal portion of the holder includes a closed end having a rod extending therefrom for engagement with the stopper of the drug container upon activation. Also, the preselected axial distance corresponds to about a dosage of the substance held in the drug container barrel desired to be administered in a first motion of the stopper, with the preselected axial distance preferably corresponding to about half the distance that the stopper is capable of moving within the barrel to administer about half of the substance held by the drug container.
Also, in the preferred system of the present invention, the distal portion and the proximal portion of the holder are attached to one another by means of flexible members and corresponding openings to avoid premature activation of the system, with the openings formed by a portion of the distal portion bridging a space between a pair of flanges extending radially outwardly form the distal portion. In addition, the distal portion includes a skirt extending from the distal portion, including the bridging portion, and the skirt covers the means for controlling the delivery of the substance. Also, the first end of the drug container includes a spray nozzle for use in intranasally delivering the substance and the drug container is a syringe, and a limiter is also associated with a first end of the distal portion, with the limiter limiting the depth of insertion of the spray nozzle into a nostril. Either the limiter or the spray nozzle is formed of a curved design to target specific areas in a nasal cavity. Further, the system includes a cap covering at least a first end of the distal portion, with the cap including a tamper evident means.
In addition, the preferred system of the present invention includes a means for securing the drug container in the distal portion of the holder with the distal portion having a first end through which the first end of the drug container can extend and a second, open end defining an opening of sufficient size for receiving the drug container. Specifically, the drug container is preferably a syringe having a rim extending from an open end thereof and the drug container securing means is situated adjacent the open end of the distal portion and includes at least one detent situated adjacent the open end and dimensioned so that the rim of the syringe may be securely retained in the distal portion by the detent. Also, a pair of flanges extend radially outwardly from the distal portion of the holder and attached thereto by a plurality of ribs, and the distal portion of the holder includes at least one window to permit visual inspect of the contents of the drug container located within the holder.
Further, the distal portion includes at least one pair of ribs and wherein the slots in the proximal portion of the holder include at least one pair of slots situated thereo
Grimard Jean Pierre
Guillory Michel
Jansen Hubert
Vedrine Lionel
Becton Dickinson and Company
Bennett Henry
Dagostino Sabrina
Fortunato David M.
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