Surgery – Respiratory method or device – Means for mixing treating agent with respiratory gas
Reexamination Certificate
2000-06-30
2002-10-01
Lewis, Aaron J. (Department: 3761)
Surgery
Respiratory method or device
Means for mixing treating agent with respiratory gas
C128S200240
Reexamination Certificate
active
06457471
ABSTRACT:
FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to a dual-purpose medical device for upper airway treatment and to methods for using the device. More particularly the present invention relates to a manually operated device which is capable of both delivery of drugs and removal of unwanted secretions.
Medical disorders of the upper airway are common. Asthma affects approximately 10% of the adult population. Asthmatic patients, together with those suffering from cystic fibrosis, bronchitis, smoking related disorders and infants with difficulty maintaining adequate oral ventilation are probably found in 20-50% of households. Patients with these disorders are generally treated with drugs delivered as an aerosol suspension, or with suction to remove unwanted secretions, or with both aerosol drugs and suction.
Aerosol delivery of drugs to the airway is typically accomplished by either a stream of air created by a motorized pump, or by use of a pressurized propellant gas (e.g. aerosol canister).
Aerosol delivery devices which include a motorized pump are typically heavy, noisy and expensive. A typical device may cost a consumer in the U.S.A. 70 to 200 dollars. In addition, use of devices of this type often requires measuring and mixing of components of the aerosol. This provides an opportunity for patient error and may lead to delivery of an incorrect dose of medication.
Devices which rely upon a pressurized propellant gas are typically capable of delivering a pre-measured dose of medication with each actuation. However, medication packaged in this way is relatively expensive. In addition, patients with. poor co-ordination (e.g. young children, geriatric patients) often have difficulty using these devices. These patients typically employ a spacing chamber which allows them to draw in medication by inhaling after actuation of the device. Such a spacing chamber typically costs approximately 30 dollars. While devices of this type are often small enough to be easily portable, the spacing chambers employed with these devices are generally large enough that it is inconvenient to carry them.
Suction of unwanted secretions such as mucous from the upper airway (e.g. nose, pharynx) is often performed using devices with electric vacuum pumps. These devices are typically found primarily in hospitals and medical facilities. They are heavy, noisy and expensive. Currently, the primary solution for home suction is a portable device which is the subject of British Pat. No. 2,245,833. This patent does not teach the use of a disposable mucous trap. A re-usable mucous trap is a potential source of infection and represents a serious dis-advantage to practice of the teachings of this patent.
There is thus a widely recognized need for, and it would be highly advantageous to have, medical device for upper airway treatment devoid of the above limitation. Ideally, such a device would be a dual-purpose device capable of performing both aerosol delivery and suction treatments.
SUMMARY OF THE INVENTION
According to one aspect of the present invention there is provided a dual-purpose medical device for upper airway treatment, the device comprising: (a) a disposable cassette having a first opening, a second opening and an interior volume, the cassette being connectable to an airflow generator by means of the first opening; (b) the airflow generator; wherein the airflow generator is manually operable and relies upon ambient air to create a flow of air; and wherein the airflow generator is capable of generating a flow of air through the disposable cassette in at least two directions, such that: (i) aerosol delivery of a drug residing in the internal volume of the cassette may be accomplished if the flow of air is in a first direction into the internal volume of the cassette via the first opening and outward from the internal volume via the second opening towards an airway of a patient; and (ii) suction of unwanted secretions may be accomplished if the flow of air is in a second direction into the internal volume of the cassette via the second opening and outward from the internal volume via the first opening towards the airflow generator.
According to another aspect of the present invention there is provided a method for aerosol delivery of a drug, the method comprising the steps of: (a) connecting an airflow generator to a disposable cassette via a first opening of the cassette, the cassette comprising the first opening, a second opening and an interior volume; and (b) causing air to flow into the internal volume of the cassette via the first opening and outward from the internal volume via the second opening towards an airway of a patient such that the aerosol delivery of a drug residing in the internal volume of the cassette is accomplished; wherein the airflow generator is manually operable and relies upon ambient air to create a flow of air.
According to yet another aspect of the present invention there is provided a method for suction of unwanted secretions from an airway, the method comprising the steps of: (a) connecting an airflow generator to a disposable cassette via a first opening of the cassette, the cassette comprising the first opening, a second opening and an interior volume; and (b) causing air to flow into the internal volume of the cassette via the second opening and outward from the internal volume via the first opening towards the airflow generator such that the suction of unwanted secretions from an airway is accomplished and such that the unwanted secretions accumulate in the cassette; wherein the airflow generator is manually operable and relies upon ambient air to create a flow of air.
According to further features in preferred embodiments of the invention described below, the device further comprises (c) a re-usable holder for the cassette.
According to still further features in the described preferred embodiments the cassette further comprises: (i) at least one partition dividing the interior volume into at least two chambers; and (ii) an openable region in each of the at least one partition.
According to still further features in the described preferred embodiments the device further comprising perforations surrounding at least a portion of the openable region in each of the at least one partition such that opening thereof is facilitated by the perforations.
According to still further features in the described preferred embodiments the device further comprises (c) a mechanism for opening the openable region.
According to still further features in the described preferred embodiments the airflow generator is a compressible elastic container.
According to still further features in the described preferred embodiments compression of the compressible elastic container may cause the flow of air to be in the first direction and subsequent expansion of the compressible elastic container may cause the flow of air to be in the second direction.
According to still further features in the described preferred embodiments the device further comprises at least one element selected from the group consisting of: (i) an aerosol jet connectable to the second opening of the cassette and capable of delivering the drug as a plurality of micro-droplets; (ii) a suction tube connectable to the second opening of the cassette and insertable into a bodily orifice of a patient.
According to still further features in the described preferred embodiments the method comprises the additional step of: (c) placing the cassette within a re-usable holder.
According to still further features in the described preferred embodiments the method comprises the additional step of (c) providing within the cassette: (i) at least one partition dividing the interior volume into at least two chambers; and (ii) an openable region in each of the at least one partition wherein at least one of the chambers contains at least one component of the drug.
According to still further features in the described preferred embodiments the method comprises the additional step of providing perforations surrounding a portion of the ope
Friedman Mark M.
Lewis Aaron J.
Medihale Ltd.
Mitchell Teena K
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