Fluent material handling – with receiver or receiver coacting mea – Filling or refilling of dispensers – By operation of means causing or controlling dispensing
Reexamination Certificate
2001-12-13
2004-02-03
Mancene, Gene (Department: 3751)
Fluent material handling, with receiver or receiver coacting mea
Filling or refilling of dispensers
By operation of means causing or controlling dispensing
C141S027000, C141S330000, C141S384000, C604S414000
Reexamination Certificate
active
06684918
ABSTRACT:
This invention relates to a novel device being a nozzle suitable for the oral administration of a paediatric fluid medicament from a dosing device such as a dosing syringe or a collapsible capsule. In particular the invention relates to such a nozzle which facilitates connection between containers of the fluid medicament. The invention also relates to a dosing device provided with such a nozzle, and to a connector device suitable for enabling a dosing device such as a syringe or compressible capsule having such a nozzle to be connected to a container such as a pharmaceutical vial.
Devices for the oral administration of fluid medicaments to paediatric patients are known, generally comprising a container for the medicament, in particular a dosing syringe provided with a teat nozzle in the form of a conduit for the medicament, terminating in a nozzle opening. Another such device comprises a compressible capsule, containing the liquid medicament, made of soft plastic material also provided with a teat nozzle in the form of a conduit for the medicament, terminating in a nozzle opening. Such devices are particularly suitable for use with very young children and babies who are incapable of drinking a fluid medicament from a cup or spoon, and can only suck from a teat. In use the nozzle is inserted into the mouth of a paediatric patient and a liquid medicament from the syringe is injected into the patient's mouth. One such fluid medicament is that provide for treatment (curative and/or prophylactic) of the Rotavirus infection in paediatric patients.
It is known to provide syringes and like devices with connection means so that they can be connected to a second container of the medicament, in particular a vial of the medicament, e.g. by a screw connection. Such vials are often provided closed by a closure which includes a puncturable rubber seal, and connection means for such vials are known which include a hollow puncturing spike which can be driven through the seal, and through the hollow interior of which the medicament can be extracted from the vial into for example a dosing syringe.
Such connection means are required to comply with an international standard, ISO 594/1 “Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment”, which specifies their mode of construction, shape and dimensions, so as to enable interconnectability of such connection means.
A problem exists with dosing syringe nozzles made according to this international standard in providing connection means which can be readily adapted for use with oral dosing of small children and babies. It is an objection of this invention to provide a connection means which in part at least solves this problem.
According to the present invention a teat nozzle suitable for paediatric oral dosing of a fluid medicament comprises a tubular conduit having an internal channel along which a fluid medicament may be caused to flow toward a nozzle opening of the conduit, characterised in that the conduit is engageable in a male-female co-operation with a female socket, and the conduit is provided externally with at least one engagement part which can engage with an internal thread in such a female socket, to thereby facilitate connection between the conduit and the socket.
The conduit is suitably externally in the form of a substantially cylindrical tube having at least its part immediately adjacent to and upstream of the nozzle opening tapering in a shallow cone being narrowest at the nozzle opening end of the cone. The base of such a cone is adjacent to the cylindrical part of the conduit upstream of the cone, and the cross section of the base of the cone may be the same or different, e.g. smaller to the cross section of an immediately adjacent cylindrical part. Such a cone may for example comprise 25-75% of the length of the teat nozzle extending upstream from the nozzle opening. Alternatively all or substantially all of the conduit may be externally of a shallow conical shape. Alternatively the conduit may have a cylindrical part immediately adjacent to and extending upstream of the nozzle opening, and of a shallow conical shape over its further upstream part, the cylindrical part meeting the apex of the cone.
The term “cylindrical” as used herein includes oval and other distorted circular cross sections. The term “conical” as used herein includes truncated cones, and includes both true cones, i.e. with straight sides and circular cross sections at all points along their base-apex axis, and distorted cones, e.g. with stepped or concave or convex curved sides and oval and other distorted circular cross sections. A typical amount of conical taper is ca. 2-10°. For example the cone may be of the 6% cone shape defined in ISO 594/1 “Conical fittings with a 6% (Luer) taper”. The terms “upstream” and “downstream” as used herein refer to the direction in which the fluid medicament flows from a dosing device through the nozzle towards the patient's mouth during dosing to a patient.
Such a shallow cone shape is particularly advantageous for use as a teat which can be inserted, for dosing, into the mouth of a small child or baby, and which will be comfortable for such a patient.
The conduit may be shaped and dimensioned externally out of compliance with ISO 594/1 mentioned above, in particular being made larger than the dimensions given therein, so that it is impossible to fit a standard hypodermic needle to the conduit. This would prevent any accidental use of the nozzle of the invention with such a needle when it is intended for oral use. This is important because dosing devices such as syringes etc. intended for oral use are not necessarily provided for use in a sterile state, whereas for use with a hypodermic needle for injections through the skin a sterile dosing device must be used.
When the conduit comprises a conical part and an upstream cylindrical part, the engagement part(s) is/are preferably provided upstream of the conical part, for example immediately adjacent upstream of the conical part, or at the junction between the conical part and the cylindrical part. For example the engagement part(s) may be provided at or immediately upstream of the wide base of such a conical part. When the conduit comprises a cylindrical part and an upstream conical part, the engagement part(s) is/are preferably provided upstream of the cylindrical part, for example immediately adjacent upstream of the cylindrical part, or at the junction between the conical part and the cylindrical part. For example the engagement part(s) may be provided at or immediately upstream of the wide base of such a conical part. When substantially the whole of the conduit is externally conical the engagement part(s) may be provided at any point upstream of the nozzle opening. Preferably the engagement part(s) may be provided between 25-75% of the length between the nozzle opening and the other end of the teat nozzle, e.g. the point where the nozzle is joined to a dosing device.
The at least one engagement part(s) may be suitable for engagement with a helical or part helical internal thread on the said female socket. A screw thread enables a tight connection to be made, which can help resist build up of pressure within the device and socket. Preferably the engagement parts comprise at least two, but suitably two, rounded bumps, e.g. wings, on the outer surface of the conduit. Such bumps may for example be smoothly curved e.g. substantially hemispherical or rounded conical, and may be regularly circumferentially disposed around the conduit. For example if two such bumps are present they may be oppositely disposed around the circumference, e.g. 180° apart. Such bumps may be engageable with an internal helical thread on the female socket having a section corresponding to that of the bumps. The use of such bumps is advantageous as they can have a smoothly rounded profile which is comfortable to the mouth of small children and babies for which the device is used for oral dosing.
In another aspect the invention also provides a dosing
Thilly Jacques
Vandecasserie Christian
deVore Peter
Gimmi Edward R.
Kinzig Charles M.
Mancene Gene
SmithKline Beecham Biologicals (s.a.)
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