Unit dose dispensing device

Surgery – Respiratory method or device – Means for mixing treating agent with respiratory gas

Reexamination Certificate

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Details

C128S203210

Reexamination Certificate

active

06186141

ABSTRACT:

The present invention relates to a device for dispensing a unit dose of a substance, such as a pharmaceutical, medicinal, or therapeutic substance. More particularly the invention relates to a device for dispensing a unit dose of such a substance into a body cavity. A particularly preferred form of the invention is intended for intranasal administration.
In International Patent Application PCT/EP94/01859 (W094/28956) there is disclosed a device for administration of a pharmaceutical substance from a capsule containing the substance. The capsule is compressed with a pressure sufficient to burst the capsule and to expel the contents in spray form through a discharge outlet. While this previously proposed device does operate satisfactorily the device is relatively bulky and hence not easy to carry on the person, for example in a shirt or jacket pocket. In addition the device is adapted to be reloaded after use with a fresh capsule of substance, but due to the nature of the mechanism within the device, some difficulties may be encountered with the reloading procedure.
There have been proposed unit dose dispensers in which a pharmaceutical substance sealed within an internal chamber of the device is expelled by operation of a piston actuated manually by the user. These previously proposed devices are intended for one use only and when the unit dose has been expelled the entire device must be discarded. Due to the relatively high cost of the overall device which must be discarded after each usage, this does limit the potential application of the device.
According to the present invention there is provided a nozzle assembly for dispensing a unit dose of a substance, said nozzle assembly being intended for releasable attachment to a body having a system actuable to effect discharge of said substance, said nozzle assembly comprising a container housing a unit dose of said substance, means for releasably attaching the nozzle assembly to the body, and means co-operable with said discharge system whereby dispensing of the substance from the container is effected in response to actuation of the discharge system by the user.
Preferably, the discharge system comprises a ram and dispensing of the substance from the container occurs in response to movement of the ram.
Advantageously, the nozzle assembly comprises means for piercing the container in response to the movement of the ram.
Advantageously, the nozzle assembly includes a passage which receives the ram either when the nozzle assembly is being mounted on the body or subsequently thereto.
In a preferred embodiment of the invention, the container is in the form of a capsule mounted within a chamber in the nozzle assembly, and the piercing means comprises a first hollow needle mounted at an outer end of the chamber and a second hollow needle carried by a piston within an inner end portion of the chamber, with the capsule lying within the chamber between the first and second needles. The inner end portion of the chamber is in communication with the ram-receiving passage, the arrangement being such that the piston is displaceable within the chamber to displace the second needle towards the first needle to cause the two needles to pierce opposite ends of the capsule by movement of the ram along the passage. In this embodiment, the discharge system advantageously also includes means for injecting a gas, for example air, into the capsule via the second needle whereby the substance is dispensed from the capsule via the first needle under the effect of the gas injected via the second needle. The first needle may lead directly to an outlet orifice of the nozzle assembly or, as is preferred, the first needle may lead into a swirl chamber upstream of the outlet orifice. Preferably, the ram includes a passage through which air or other gas is injected into the capsule via the second needle.
In an especially advantageous embodiment, the means by which the nozzle assembly is attached to the body comprises a projecting tubular portion insertable into an opening in the body. The tubular portion includes a locking formation releasably engagable with locking means of the body adjacent the opening, and the tubular portion also includes the passage which receives the ram of the discharge system.
According to another aspect of the invention there is provided a body for use in cooperation with the nozzle assembly defined above, said body comprising a system to effect discharge of said substance from the nozzle assembly, means co-operable with the attachment means of the nozzle assembly to releasably retain the nozzle assembly relative to the body, and actuating means operable by a user to effect discharge.
In a preferred embodiment, the discharge system comprises a ram which is co-operable with the nozzle assembly to effect dispensing of the substance upon operation of the actuating means.
The body is preferably of a configuration such that it can be held in the hand of a user, and the actuating means of the body comprises at least one actuating member, such as a button, which can be actuated by a digit of the hand.
In one embodiment, displacement of the actuating member by the user is operative to cause displacement of the ram along the passage of the nozzle assembly. The displacement of the ram may be used to effect piercing of the container to enable the substance to be discharged. When dispensing is effected by injection of air into the container in the nozzle assembly, displacement of the actuating member is also effective to drive an air piston for charging air into the container. Preferably the air piston is spring-loaded and initial displacement of the actuating member serves to load the driving spring with spring energy which is subsequently released to drive the piston to inject air into the container. Preferably the system includes an air reservoir which communicates with an air passage through the ram and the air piston is operative to drive air from said air chamber through the air passage in the ram and into the container.
In another embodiment of the invention, mounting of the nozzle assembly to the body results in loading and cocking of a spring-driven air piston and displacement of the actuating member releases the piston to inject air into the container. The release of the piston also results in driving of the ram to effect piercing of the container.


REFERENCES:
patent: 3888253 (1975-06-01), Watt et al.
patent: 3906950 (1975-09-01), Cocozza
patent: 3949751 (1976-04-01), Birch et al.
patent: 3971377 (1976-07-01), Damani
patent: 4884565 (1989-12-01), Cocozza
patent: 4995385 (1991-02-01), Valentini et al.
patent: 5372128 (1994-12-01), Haber et al.
patent: 5471541 (1995-11-01), Ritsky et al.
patent: 5601077 (1997-02-01), Imbert
patent: 679443 (1995-11-01), None
patent: 711571 (1996-05-01), None
patent: WO 96/04947 (1996-02-01), None
patent: WO 96/12513 (1996-05-01), None
patent: WO 96/24440 (1996-08-01), None
patent: WO 96/25190 (1996-08-01), None
patent: WO 96/29109 (1996-09-01), None
patent: WO 97/02062 (1997-01-01), None
patent: WO 97/06842 (1997-02-01), None

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