Inhaler

Surgery – Respiratory method or device – Means for mixing treating agent with respiratory gas

Reexamination Certificate

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Details

C128S203120, C604S058000

Reexamination Certificate

active

06234169

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to inhalers for powders and other fluids such as a volatile liquid or a gel and more particularly to hand held inhalers for use without medical assistance.
BACKGROUND OF THE INVENTION
The medical community and society in general have been concerned with reducing the hazardous effects of cigarette smoking for many years. The chemicals contained in cigarette smoke produce unwanted effects, including unpleasant odours and health hazards for smokers and bystanders breathing the smoke.
Of the various chemicals contained in cigarette smoke, nicotine is primarily responsible for the pleasurable effects of smoking. Nicotine replacement devices, such as chewing gums or patches, allow a smoker to obtain doses of nicotine without inhaling the other hazardous chemicals in cigarette smoke and without creating smoke that is hazardous to bystanders. Accordingly, nicotine replacement devices may be useful in programs to reduce or eliminate the smokers' dependency on smoking.
Inhaling nicotine as a powder is an effective way to deliver nicotine to the bloodstream. The inhaled powder is deposited on the inner surfaces of the lungs and absorbed into the bloodstream. However, in addition to their desire for nicotine, smokers are also accustomed to the process of smoking. This process includes one or more of the following: handling the cigarettes, tapping the cigarettes against a hard surface before smoking, tapping the cigarette between inhalations to remove ashes and discarding the cigarette when done. Further, smokers are accustomed to inhaling on the cigarette several times to withdraw the nicotine.
Although hand held inhalers, including hand held powder inhalers, for use by a patient without medical assistance currently exist, they have various undesirable features. For example, many devices are designed for medical conditions where a patient requires immediate delivery of a medicament. These devices deliver the medicament in one or, at most, a small number of inhalations. These devices are not suitable for medicaments that are preferably delivered over several inhalations. Further, these devices rely on air currents that flow directly through or across the medicament which causes some of the medicament to travel at high speed and impact the user's airway rather than enter the user's lungs.
Other existing devices rely on complicated or awkward mechanisms for their use. For example, propellers may be used to rotate a capsule to expel powder by centrifugal force, or various rotating or sliding mechanisms may be used to deposit discrete amounts of powder into the airflow path of an inhaler. These devices are complicated and difficult to use discretely. Similarly, many devices require a person to manually insert a medicament container, such as a capsule of powder, into the device in a manner that breaks the container open, again making it difficult to use the device discretely or conveniently. The expense and size of these devices requires them to be reused whereas it would be more convenient and hygienic to make them disposable.
One inhaler of note is Priestly (U.S. Pat. No. 2,587,215). Priestly discloses a device which uses a sliding mechanism to deliver small portions of powder from a remote reservoir to a chamber. The primary airflow enters this chamber and flows through or across the powder. A downstream air inlet provides a secondary airflow that mixes with the primary airflow coming from the chamber to diffuse the powder mixture. To use the device, a person would need to first insert a capsule into the device, and then manipulate the sliding mechanism to put a portion of powder in the chamber for inhalation.
Another inhaler of note is Cavazza (U.S. Pat. No. 4,338,931). Cavazza discloses a device which has two pre-assembled telescoping components which contain a capsule of powder. Each of the two components has a hollow open ended spike which pierces the capsule when the two components are slid together. Air flows into the first spike, through the capsule and through the second spike to a mouthpiece. The device is compact and easily used, but the direct airflow through the powder would deliver most of the powder at high speed in a single inhalation.
Inhalers which comprise a hollow longitudinally extending member are known. For example, Rose et al (U.S. Pat. No. 5,441,060) discloses a hollow cylindrical member wherein the medicament is stored in a thin annular band or in a porous member. According to this patent, air passing longitudinally through the inhaler entrains the medicament. Slutsky et al. (application No. PCT/CA95/0056) also discloses such an inhaler wherein air passing longitudinally through the inhaler entrains the medicament. In these devices, the air passing through the inhaler contacts the medicament as the air travels directly through the inhaler.
SUMMARY OF THE PRESENT INVENTION
In accordance with one embodiment of this invention, there is provided an inhaler for use by an individual to inhale a medicament from a reservoir comprising:
(a) a chamber having a first end connectable to the reservoir to be in air flow communication therewith, a second end for delivering the medicament to the individual upon inhalation and a conduit defining an air flow path extending between the first end and the second end; and,
(b) an orifice in the chamber between the first end and the second end, the orifice utilizing the Coanda Effect when the reservoir is in air flow communication with the chamber and upon inhalation by the individual to draw medicament from the reservoir into the air flow path.
In accordance with another embodiment of this invention there is provided an inhaler for use by an individual to inhale a medicament from a reservoir comprising:
(a) a chamber having a first end connectable to the reservoir to be in air flow communication therewith, a second end for delivering the medicament to the individual upon inhalation and a conduit defining an air flow path extending between the first end and the second end;
(b) the conduit including a first portion adjacent the first end, the first portion having an upstream end adjacent the first end and an opposed downstream end, the cross sectional surface area of the first portion decreasing from the downstream end of the first portion to the upstream end of the first portion; and,
(c) an orifice positioned between the first end and the second end for introducing undirected air into the chamber upon inhalation by the individual.
The orifice may be positioned in the chamber adjacent the first portion. Alternately, the orifice may be positioned in the first portion. The cross sectional area preferably decreases continuously from the downstream end of the first portion to the upstream end of the first portion. More preferably, the first portion is frusto-conical in shape.
The inhaler may include a seal between the first end and the reservoir when the reservoir is connected to the inhaler, and rupturable by relative movement between the reservoir and the first end.
The inhaler may include a connector which connects the reservoir and the first end of the chamber together when the inhaler is used such that the interior of the reservoir is open to the first end of the chamber but otherwise the reservoir substantially seals the first end of the chamber. The connector may comprise a second portion of the inhaler slidably engaged in relation to the chamber between a first position and a second position, the interior of the reservoir being open to the first end of the chamber in the second position. Alternately, the reservoir may be releasably sealed in the first position and openable by the first end of the reservoir as the second portion is moved from the first position to the second position. In a more preferred embodiment, the reservoir is formed of a folded strip of material sealed at its edges between a closed end and an openable end, the openable end being releasably sealed.
In one embodiment the inhaler resembles a cigarette, the reservoir contains a nicotine formulation and the

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