Device and method for nasal inhalation

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Reexamination Certificate

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C128S204120

Reexamination Certificate

active

06645172

ABSTRACT:

The present invention relates to a device and method for nasal inhalation of substances having an activity, in particular against stress or against allergies, or an ability to assist in breathing.
More particularly, the present invention relates to a device capable of being attached to part of the nose in such a way as to release one or more active substances, for nasal inhalation, in the form of volatile emanations localized in proximity to the nostrils.
Inhalation devices have been described in FR-A-945,897, GB-A-520,491 or U.S. Pat. No. 3,788,296. In all these devices, the support containing the active substances is always arranged inside the nostrils, even in contact with the nasal mucosa, or directly opposite the nostrils, i.e., the active substance when leaving the support is aimed directly towards the nostrils. Some of these devices are intended to be used on animals. One of the problems resulting from the use of these devices lies in the fact that the emanations, oriented directly inside the nostrils and/or aimed directly towards the nostrils, can aggravate the nasal mucosa and can inconvenience the person wearing the device. The problem is particularly noticeable when the device contains aromatic substances whose scent can be very powerful. In addition, there may be problems of allergic or inflammatory reactions on account of the presence of these active substances being too close to the nasal mucosa.
In light of the foregoing, there is a need in the art for an improved inhalation device.
Accordingly, the present invention is directed to an inhalation device that substantially obviates one or more of the limitations of the related art. In particular, the present invention is preferably directed to a device of reduced size which can be worn without any appreciable inconvenience to the person wearing it, in particular at night, when lying down.
Another preferred object of the invention is to make available a device which is able to permit aromatherapy using substances, in particular based on essential oils, containing in particular camphor, eucalyptus, thyme, lavender or lily of the valley, which can have an action against stress or against allergies, an action on breathing, or any other action aimed at improving the comfort of the person who is wearing it.
One other preferred object of the invention is to provide a device having a reloadable structure.
A further preferred object of the invention is to provide a device which is easy and economical to make, and which permits a controlled flow rate of the inhaled emanations.
It should be understood that the invention could still be practiced without performing one or more of the preferred objects and/ or advantages set forth above. Still other objects will become apparent after reading the following description of the invention.
To achieve these and other advantages and in accordance with the purpose of the invention, as embodied and broadly described herein, the invention includes an inhalation device comprising at least one support containing a product including at least one active substance. The support is able to release, in the form of emanations, a volatile phase of the active substance. Attachment elements are provided to permit attachment of the device to at least one point situated near the nostrils to permit nasal inhalation of the emanations. The support and the attachment elements are configured so that the emanations when leaving the support are not aimed directly towards the nostrils and travel a distance before coming in contact with the nostrils or the nasal mucosa.
In one aspect of the invention, a device is provided which automatically stays in place on the nose, allowing the user to carry out other activities at the same time. Preferably, the device is remarkably comfortable, and no part of the support able to directly release emanations is arranged inside the user's nostrils. In practice, the support preferably is arranged sufficiently close to the nostrils to allow the nasal breath, by means of its warmth, to promote the release of the emanations. However, the emanations are not directly in contact with the nostrils or nasal mucosa, nor are they oriented directly opposite the nostrils, i.e., the emanations when leaving the support are not aimed directly at the nostrils, so as not to inconvenience the user. Good results have been obtained with the “emanating” part of the support located approximately 1 to 2 cm from the nasal orifices. This is particularly useful when the support contains essential oils, whose scent is relatively aggressive, or other active substances whose contact with the nasal mucosa or nostrils could trigger allergic or inflammatory reactions.
Within the meaning of the present invention, the term “active substance” defines a compound having either a therapeutic activity (treatment of stress, allergy, breathing, or sleep) or a comforting action (in particular by way of scents or perfumes).
As has been mentioned above, the support is preferably maintained in proximity to the nostrils, in particular above or below them, so that the warm air of respiration, in addition to the normal temperature of the body of the person wearing it, is able to promote the volatile emanations which are then inhaled by the nasal route. Preferably, the inhalation is permanent and, once the device is in place on the nose, no particular manipulation is needed.
In another aspect of the invention, the attachment elements are advantageously at least one portion of a body able to receive the support. This version affords a great many possibilities in terms of comfort, reloading of the device, metering the flow rate of the emanations, reusing the device, etc.
According to one preferred embodiment, the device includes two arm portions forming a clip. A first end of each arm is integral with the device, and a second end of each arm is free. The second free ends are spaced apart from one another and define a gap able to permit attachment of the device to the bridge of the nose, to the nasal cartilage (septum), or to at least one of the side walls defining the nostrils. The arm portions are preferably able to spread apart elastically during attachment of the device. The clip is preferably a portion of a body inside which the support is mounted. The profile, and the surfaces of the clip contacting the user during attachment, are chosen in such a way as to provide the maximum comfort for the user.
According to a preferred embodiment, the device has, essentially opposite to a median point of the gap defined by the second ends, a notch which is able to confer greater elasticity to the arm portions. This increases the hold of the device on the nose, the ease of fitting and removing the device, and the comfort which it provides.
In yet another aspect of the invention, the body preferably has a recess able to receive the support. The body is preferably made of a material impervious to the emanations, and includes at least one opening to allow the emanations to pass through. Thus, it is possible to localize the emanations in a very precise manner so as not to inconvenience the user. This, in particular, avoids the emanations from being inhaled directly from the support, which, especially with certain highly aromatic substances, can be particularly uncomfortable.
In still another aspect, the support may be mounted in a removable manner in the recess to form a reloadable structure. The body may thus be reused many times by simply changing the cartridge formed by the support. The device may be marketed in the form of a kit including a reloadable body, and a plurality of refills containing, for example, several scents with identical or different actions. In this case, the body is preferably made of a washable material.
By way of example, the body is made of a material chosen from among polypropylenes, polyethylenes, polyvinyl chlorides, and natural, synthetic or thermoplastic elastomers.
According to one particular embodiment, the device forms a substantially flat structure which includes two main faces and an edge, and the

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