Surgery – Respiratory method or device – Means for mixing treating agent with respiratory gas
Patent
1998-09-18
2000-07-04
Weiss, John G.
Surgery
Respiratory method or device
Means for mixing treating agent with respiratory gas
12820312, 604 58, A61M 1500, A61M 1600, B05D 714, B65D 8306
Patent
active
060823569
DESCRIPTION:
BRIEF SUMMARY
The invention relates to a device for pre-dosing a powder for a dispenser, and more particularly for an inhaler.
The term "inhaler" is used to mean any inhaler device whether actuated manually or by the user inhaling, whether passive, i.e. whether the powder is expelled by the flow of air created by the user, or active, i.e. where the flow of air is created by the device. The invention applies particularly to dry powder inhalers.
In the field of dry powder inhalers, there exist two main families of powder dispenser device in common use: contained in a single common reservoir, the device being provided with appropriate measuring means to ensure that it dispenses a determined quantity of powder on each actuation; and a separate cavity that is hermetically sealed.
At present, pre-dosing type devices are particularly advantageous for powders having molecules that are fragile, e.g. made up of long chains that are easily broken during handling, and that require a high degree of stability. This can be obtained only with the powder being genuinely kept separate from the atmosphere, as is typical for separately pre-dosed single-dose packaging.
In this application, packaging devices commonly referred to as "blister" packs have been found to be particularly suitable. By its very configuration, comprising a support provided with a plurality of separate dose-containing "blisters" or cavities that are hermetically sealed, e.g. by means of aluminum foil, a blister pack makes it possible to ensure that each dose is genuinely hermetically separate from the others.
Nevertheless, at present, the use of a blister pack is presently limited by numerous problems that arise in use.
One of the main drawbacks is due to the fact that to make a dose available for inhaling, it is necessary to use an inhaler which is provided with a device that is capable of opening the packaging (peeling, puncturing, or tearing the aluminum) in a manner that is effective.
At present, the following solutions are in use for obtaining this result:
The inhaler includes peeling means capable of peeling off the layer that closes each dose cavity. One such device is described, for example, in document FR-2 660 550. Nevertheless, that type of peeling device is very complicated to manufacture and assemble and is therefore very expensive.
The inhaler is provided with a needle which is used to pierce the aluminum immediately before the dose is dispensed. That solution suffers from the drawback of opening part only of the cavity that contains the powder, and also of folding aluminum back into the dose cavity. This means that portions of the dose remain trapped by the aluminum foil and consequently cannot be expelled in full by the flow of air produced by the user or by the inhaler while inhaling is taking place. This makes it very difficult to guarantee effective dose reproducibility, since it often happens that the dose is not dispensed in full.
The inhaler is provided with means somewhat similar to a small finger used for pressing against the plastic side of the blister cavity so as to create sufficient pressure inside the cavity to burst the aluminum foil and thus move the powder into the expulsion channel. That solution also suffers from a drawback. The pressure exerted on the powder, acting against the resistance provided by the aluminum foil before it breaks, causes significant compression to occur within the powder, thereby tending to agglomerate the powder into large lumps.
In document DE-44 00 083, a blister pack device is disclosed in which the cavities are provided with piercing means enabling powder compression to be reduced. Those piercing means act inside the cavity and pierce the membrane outwards. Nevertheless, that device also suffers from the aluminum membrane being opened in a manner that is partial or irregular and, in certain cases, provision is even made to detach said membrane completely from the cavity. In certain blister pack applications that is not a drawback, however it is incompatible and even dangerous in inhaler devices where a dose
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Tebro
Weiss John G.
Weiss, Jr. Joseph F.
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