Inhaler for powdered medicaments

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Reexamination Certificate

active

06648848

ABSTRACT:

A method and device for introducing a powdered or particulare substance into a person's nostril
The present invention relates to a method for introducing a powdered or particulate substance into a persons nostril or nostrils. It is known to disperse the powdered or particulate substance in an air flow which is created by compressing a rubber bulb arranged at one end of a tube or hose having an opposite free end, which may be inserted into the nostril.
The present invention provides such method for introducing a powdered or particulate substance into a persons nostril or nostrils, said method comprising arranging a dose of the substance within an inner cavity of a tubular body, inserting a first open end of the tubular body communicating with the inner cavity between the persons lips, inserting a second open end of the tubular body communicating with the inner cavity into said nostril, and blowing into the first open end of the tubular body so as to create a flow of air through the inner cavity of the tubular body for transferring the substance to the nostril.
In the method according to the invention the person or patient being treated is creating the necessary air flow through the inner cavity of the tubular member by means of her/his expiratory blow. It has been found that the user will automatically close the connection between the nostrils and the throat by the uvula when blowing. Therefore, the powdered or particulate substance is substantially prevented from penetrating into the users trachea and gullet. Therefore, by using the method according to the invention almost the total amount of the substance blown into the nostril is applied to the mucous membrane within the nostril.
The method according to the invention may be carried out by means of a tubular body which has or may be given such a shape that one open end thereof may be inserted between the users lips while the opposite open end is inserted into the users nostril. The said second or opposite end of the tubular body may be bifurcated so as to form a pair of adjacent open ends which may be inserted into the users nostrils.
Prior to inserting the opposite ends of the tubular body into the mouth and the nostril, respectively, a suitable dose of any kind of a suitable type of an active substance is inserted into the inner cavity of the tubular body. This substance may for example be a substance or vaccine active against allergic reactions, such as allergy against pollen, animal hair, etc. Such substance or vaccine may be composed to the individual user. The substance may, alternatively, be any pharmaceutical or other product which is to be applied to the mucous membrane within a nostril, such as an antihistamine.
When a user or patient is about to insert the first open end of the tubular body into his or her mouth the patient's respiration may cause that the first open end of the tubular body is unintentionally exposed to a light suction or over pressure. This may cause unintentional movement of the powdered or particulate substance within or out from the tubular body. The risk of such unintentional movement of the powdered substance may be diminished when at least one venting opening is defined in the tubular body wall at or adjacent to said first open end. However, when the user or patient has inserted the first open end between the lips and is ready to blow through the tubular body the venting opening will be covered by the lips or be located within the oral cavity of the user.
At least one cross-sectional restriction may be formed in the inner cavity of the tubular body such that the dose of powdered or particulate substance is arranged downstream of the restriction in relation to the direction of the air flow transferring the powdered or particulate substance to the nostril. Such cross-sectional restriction will encourage the patient or user to blow more forcefully into the tubular body. Furthermore, the velocity of the air flow in the gorge or throat defined by the restriction will be relatively high which may assist in obtaining a good dispersion of the powdered or particulate substance in the air flow. When a venting opening as well as a restriction are formed at or adjacent to the open first end of the tubular body the restriction is preferably arranged downstream of the venting opening.
When used in a method according to the invention the efficiency of the tubular body may be further increased by defining the restriction by yieldable restriction means which are moveable between a first restricting position and a second position in which the restriction defined by the restriction means is substantially less. Such yieldable restriction means may yield and move from the first restricting position to the second non-restricting or less restricting position when the pressure difference between the inner cavity upstream of the restriction means and downstream of the restriction means or outside the tubular body has obtained a predetermined value. This means that a sudden forceful airflow may be created within the inner cavity of the tubular body when the restriction means are moving from their first to their second position.
The present invention also relates to a device for applying a powdered or particulate substance to a mucous membrane within a nostril of a user of the device, said device comprising a tubular body defining an inner flow passage extending longitudinally between a nasal piece ((
12
) at a first end of the tubular body to be inserted into the nostril of the user and an opposite second end of said body, and the device according to the invention is characterised in that the second end of the tubular body defines a mouthpiece to be inserted between the lips of the user, the length and the shape of the tubular body being such that the nasal piece and the mouthpiece may at the same time be positioned in the nostril and between the lips, respectively, of the user, whereby the user may blow into the mouthpiece end of the flow passage and transfer powdered or particulate substance arranged within the flow passage of the tubular body to the nostril in a dispensed condition.
The tubular body may have any suitable shape allowing the mouthpiece and the nasal piece to be correctly inserted into the mouth and nostril, respectively, of the user.
This may, for example, be obtained when the tubular body comprises an intermediate bent or bendable section. This means that the tubular body may have or may be given an angular shape. As an example, the tubular body or at least an intermediate part thereof may be made from a deformable or flexible material. Alternatively, the bent and/or bendable section may comprise adjacent, peripherally extending corrugations allowing the tubular body to be bent even when it is made from a relatively stiff material. It has been found that the inner troughs and ridges of the corrugations extending transversely to the air flow promote atomization of the particulate substance and the dispersion of the substance in the air flowing through the air flow passage. This effect is improved when the corrugations have a substantially serrated outline when viewed in a longitudinal, axial section. This means that the bottoms of the corrugation troughs and the peaks of the corrugation ridges are relatively sharp.
The device according to the invention is preferably of the disposable type. Therefore, the device may comprise a dose of a powdered or particulate substance arranged within the flow passage. When the device has been used once and the substance has been transferred to the mucous membrane of a nostril or the nostrils of a person, the device may be discarded. The said substance may be of any type which could advantageously be introduced into a nostril dispersed in an air flow, such as a substance or vaccine active against allergy, a pharmaceutical or a medicament.
When the tubular body contains a dose of the powdered or particulate substance, the opposite free ends of the mouthpiece and the nasal piece, respectively, are preferably sealed or closed by closure means, which are to b

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