Surgery – Liquid medicament atomizer or sprayer
Reexamination Certificate
1999-04-19
2003-06-17
Lewis, Aaron J. (Department: 3761)
Surgery
Liquid medicament atomizer or sprayer
12
Reexamination Certificate
active
06578571
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to improved drug delivery devices, preferably for use by children and infants, and to methods of delivering drugs using same. More particularly, the present invention provides an incentive inhaler device comprising (i) an inhalation device comprising a mask or mouthpiece and a connector that is linkable to a drug delivery device or other device for the delivery of an aerosol, powder or gas; and (ii) one or more external visible and/or audible inhalation/exhalation-driven incentive toys, wherein each of said toys is separated from one or more components of said inhalation device (i) by one or more valves, filters or baffles to ensure directional flow of inhaled/exhaled air which drives said toys. Preferably, said valves that ensure directional air flow air are positioned within a conduit that provides for the attachment of said inhalation/exhalation-driven incentive toy(s) Replaceable filters or baffles between the mask and the toy assembly and/or between the mask and the connector or spacer may additionally provide filtration of particles or moisture in exhaled air which might otherwise contaminate the toys or the connector or spacer. Preferably, said conduit is positioned between said inhalation/exhalation mask or mouthpiece and said connector for a drug delivery device or other device for the delivery of an aerosol, powder or gas. Preferably, the modular incentive inhaler device of the present invention further includes a spacer positioned between said inhalation/exhalation mask and said connector. More preferably, the modular incentive inhaler device of the present invention further includes a spacer positioned between said inhalation/exhalation mask or mouthpiece and said conduit, or alternatively, between said conduit and said connector.
GENERAL
Those skilled in the art will be aware that the invention described herein is subject to variations and modifications other than those specifically described. It is to be understood that the invention described herein includes all such variations and modifications. The invention also includes all such steps, features, compositions and compounds referred to or indicated in this specification, individually or collectively, and any and all combinations of any two or more of said steps or features.
Throughout this specification, unless the context requires otherwise the word “comprise”, and variations such as “comprises” and “comprising”, will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.
BACKGROUND TO THE INVENTION
A significant problem faced by the pharmaceutical industry is the need for effective means for the delivery of drugs to infants and children, in particular drugs in the form of aerosols, powders or gases which are administered by inhalation. A suitable means for the delivery of anaesthetics, and many medicaments for the treatment of respiratory ailments such as asthma, to a patient in need of treatment, is by inhalation of the drug into the airways. To achieve the delivery of gases, powders and aerosols to patients' airways, a large number of different drug delivery means have been developed including, for example, gas-borne inhalers such as asthma pumps or Metered Dose Inhalers (MDI), dry powder inhalers, breath-activated inhalers and nebulisers.
However, therapeutic regimes for the administration of aerosols, powders or gases to infants and children are often sub-optimal, because of the difficulty which this group faces in using devices for their inhalation. The efficient delivery of air-borne drugs from standard inhalation devices requires the patient to time manual activation of a drug delivery device with inhalation of the drug released therefrom, generally by achieving a slow-flow deep inspiration and adequate breath-holding, which infants and small children often find difficult to achieve without considerable training. As a consequence, many drugs delivered from standard inhalation devices are not administered efficiently to infants and small children.
There is a clear need to foster correct breathing patterns in infants and small children who use conventional inhalation devices. The lack of guidance or an incentive or encouragement in the proper use of conventional inhalation devices, for example the incentive to breathe with a pattern of normal tidal breathing, rather than with shallow hyperventilation, is clearly a disadvantage associated with the present technology.
Moreover, small children and infants typically find standard inhalation devices frightening and, as a consequence, refuse to use them. Faced with strong resistance from children, many care-givers responsible for administering medication to children report a reluctance to offer air-borne drugs for use with standard inhalation devices on a regular basis. In addition, care-givers also report that even when attempted, the delivery of aerosol/gas medication to children is often sub-optimal because the child cries and/or forcibly removes the mask from their face before the medication is taken properly.
Inhalation devices have been described which employ some form of audio or visual warning or notification of the passage of inhaled air, to ensure that the pharmaceutical drug ejected from the drug delivery means actually reaches the patient. For example, U.S. Pat. No. 4,984,158; Australian Patent No. 620375; Australian Patent No. 618789; U.S. Pat. Nos. 5,042,467; 5,363,842; 5,431,154; 5,522,380; United Kingdom Patent Application No. 2 299 512A; U.S. Pat. No. 5,758,638; French Patent Application No. 2 763 507A, and International Patent Publication No. WO 94/44974 all describe such inhalation devices.
However, inhaler devices which merely provide for an audible or visual signal to monitor a correct breathing pattern or drug delivery do not generally utilise a signal that is both capable of simple interpretation by an infant or small child, without reference to medical personnel to determine whether or not the signal generated is appropriate, and further, comprise a signal that is sufficiently pleasant to provide an inducement for their correct use by infants and small children Accordingly, such devices do not address the significant problem of overcoming the fear which children and small infants have of medical devices or encourage this user group to use inhalation devices.
A further problem encountered with conventional signalling inhalation devices is that the device becomes contaminated through use, with residual medicament that is contained in exhaled air. Additionally, when inhalation devices are used interchangeably with different drug delivery sources or MDls to administer different chemical compounds, significant cross-contamination with the different chemical compounds may occur. Accordingly, a further object of the present invention is to provide an inhalation device that does not become easily contaminated with exhaled air/medicament mixtures and is kept cleaner than conventional signalling inhalation devices.
SUMMARY OF THE INVENTION
In work leading up to the present invention, the inventors sought to develop an inhalation device that would provide an incentive to a child or small infant user as well as overcome the drug contamination problems associated with conventional devices.
The inventors realised that the signal provided by such a device must be both pleasant and provide a positive feedback to the user, in order to provide the requisite inducement. In general, devices which provide a negative feedback rather than a positive feedback to a child user, such as those which provide a visual or audible signal only during incorrect use, will not provide the necessary inducement For example, U.S. Pat. No. 5,042,467 describes a medication inhaler that includes an internal air-operated auditory warning device that generates a pleasant musical tone to alert a user that he/she is inhaling too vigorously or rapidly.
In this regard, the present invention moti
Infamed Ltd.
Knobbe Martens Olson & Bear LLP
Lewis Aaron J.
Mitchell Teena
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