Pre-filled, small-volume nebulizer

Abstract

The invention relates to a small-volume nebulizer that is pre-filled with at least one unit-dose of medicine and hermetically sealed until use. The nebulizer may be sealed at the top with a removable cap that may be detached at the time of use and replaced with a patient connector. Likewise, the nebulizer may be sealed at the bottom with a bottom cap that is replaced with a gas source at the beginning of a therapeutic aerosol treatment.

Claims

1. A pre-filled small-volume nebulizer ready for a patient to administer for respiratory care comprising: a small-volume nebulizer body comprising a housing bottom, a housing top and a hermetic seal created between said housing bottom and said housing top, wherein contained within said small-volume nebulizer body is at least one of a siphon, a jet, and a baffle; an outlet opening; a first cap removably engaged with said outlet opening; an inlet opening; a second cap removably engaged with said inlet opening; a unit-dose of medication contained within said small-volume nebulizer body.

2. The pre-filled, small-volume nebulizer according to claim 1, further comprising a means for preventing egress of said unit-dose of medication through said inlet opening.

3. The pre-filled, small-volume nebulizer according to claim 1, wherein said unit-dose of medication is a first component of a multi-component medication, and said apparatus further includes a first compartment containing a second component of said multi-component medication.

4. The pre-filled, small-volume nebulizer according to claim 1, further comprising one or more labels identifying said unit dose of medication.

5. The pre-filled, small-volume nebulizer according to claim 1, further comprising a means of preventing retrograde movement into said nebulizer housing.

6. The pre-filled, small-volume nebulizer according to claim 1, further comprising a plurality of said unit-doses of medication.

7. The pre-filled, small-volume nebulizer according to claim 6, further comprising unit-dose completion demarcation marks.

8. The pre-filled, small-volume nebulizer according to claim 1, wherein said first cap is comprised of a piercable seal.

9. The pre-filled, small-volume nebulizer according to claim 1, wherein said outlet-opening is cylindrical.

10. The pre-filled, small-volume nebulizer according to claim 1, wherein said hermetic seal, said first cap and said second cap prevent said unit-dose of medication from spilling from said small-volume nebulizer body.

11. A small-volume, pre-filled nebulizer ready for a patient to administer for respiratory care comprising: a small-volume nebulizer body, wherein contained within said small-volume nebulizer body is at least one of a siphon, a jet, and a baffle; an outlet opening; a first cap removably engaged with and sealing said outlet opening; an inlet opening; a second cap removably engaged with and sealing said inlet opening; a plurality of unit-doses of medication sealed within said small-volume nebulizer body.

12. The small-volume, pre-filled nebulizer according to claim 11, further including a means for preventing egress of said unit-dose of medication through said inlet opening.

13. The small-volume, pre-filled nebulizer according to claim 11, wherein said plurality of unit-doses of medication are a plurality of first components of a multi-component medication, and said apparatus further includes a first compartment containing a plurality of unit-doses of a second component of said multi-component medication.

14. The small-volume, pre-filled nebulizer according to claim 11, further comprising one or more labels identifying said plurality of unit-doses of medication.

15. The small-volume, pre-filled nebulizer according to claim 11, further comprising a means of preventing retrograde movement into said small-volume nebulizer housing.

16. The small-volume, pre-filled nebulizer according to claim 11, further comprising unit-dose completion demarcation marks.

17. The small-volume, pre-filled nebulizer according to claim 11, wherein said first cap is comprised of a piercable seal.

18. The small-volume, pre-filled nebulizer according to claim 11 wherein said outlet opening is cylindrical.

19. The small-volume, pre-filled nebulizer according to claim 11, wherein said small-volume nebulizer body comprises a housing bottom, a housing top and a hermetic seal created between said housing bottom and said housing top.

20. A method of administering aerosolized medicine utilizing a small-volume nebulizer pre-filled with medicine ready for a patient to administer comprising the steps of: providing said small-volume nebulizer, pre-filled with at least one unit-dose of medicine sealed within said small-volume nebulizer, wherein contained within said small-volume nebulizer is at least one of a siphon, a jet, and a baffle; removing an outlet cap removably engaged with said small-volume nebulizer; replacing said outlet cap with a patient interface; removing an inlet cap removably engaged with said small-volume nebulizer; connecting a source of gas under pressure to said small-volume nebulizer; delivering aerosolized medicine to a patient.

21. The method of claim 20 wherein said nebulizer further comprises pre-filled first and second compartments containing first and second components of a multi-component medicine, further comprising the step of breaking open at least said first compartment to cause mixing of said first and second components of a multi-component medicine.

22. The method of claim 20 wherein said small-volume nebulizer includes a medication label affixed to said small-volume nebulizer which identifies said at least one unit-dose of medicine contained within said small-volume nebulizer.

23. The method of claim 20 wherein said inlet cap is removably engaged with an inlet opening of said small-volume nebulizer and said source of gas under pressure is connected to said inlet opening of said small-volume nebulizer.

Description

A BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 is a side view of the pre-filled, small-volume nebulizer of present invention.

(2) FIG. 2 is a side view of an alternate embodiment of the pre-filled, small-volume nebulizer of present invention with a piercable outlet port cap, a one-way valve at the outlet port, a plurality of pre-filled unit-doses of medication, and unit-dose completion demarcation marks.

(3) FIG. 3 is a side view of an alternate embodiment of the pre-filled, small-volume nebulizer of the present invention containing a separation compartment for a first component of a multi-component medication housed in the outlet port cap, and a second component of a multi-component medication housed in the nebulizer housing.

DETAILED DESCRIPTION

(4) FIG. 1 shows a side view of a preferred embodiment of the pre-filled, small-volume nebulizer of present invention. Each component depicted herein may be fabricated by means of injection molding of a plastic compound, of such material as polypropylene or other plastic compound with appropriate properties for housing medication and fabricating a nebulizer. The pre-filled, small-volume nebulizer may be comprised of a housing top 10, a housing bottom 12, a housing seal 14, pre-filled unit-dose of medication 16, a siphon 18, a jet 20, a baffle 22, an outlet port 24, an outlet port cap 26, an inlet port 28, an inlet port cap 30, an inlet one-way valve 32, an outlet port cap medication label 34.

(5) The general structure and assembly of small volume nebulizers is known in the art. Housing top 10, housing bottom 12, siphon 18, jet 20, baffle 22, outlet port 24, and inlet port 28 are generally cylindrical or conical in shape and are generally co-axial with one another. Baffle 22 and outlet port 24 are typically formed as a part of housing top 10, while inlet port 28 is typically formed as a part of housing bottom 12. Typically, siphon 18 and jet 20 will be formed together in a single piece, with the resulting piece placed inside housing bottom 12. In typical prior art nebulizers, housing top 10 and housing bottom 12 are detachably joined by a threaded connection or by a press fit.

(6) In the nebulizer of the present invention, prior to joining housing top 10 and housing bottom 12, all components of the nebulizer may be sterilized. Once the unit has been sterilized, medication 16 may be introduced into housing bottom 12. Finally, housing top 10 is connected to housing bottom 12 at housing seal 14, which is hermetically sealed by glue, sonic welding, or other known sealing techniques, to form nebulizer body 36.

(7) To begin a medication therapy session with the pre-filled, small-volume nebulizer the patient or clinician may observe outlet port cap medication label 34 in order to verify the proper medicine is being used. Outlet port cap 26 may be removed, discarded, and replaced with either a mouthpiece attachment or some other type of patient interface common to the industry. To facilitate use of standard patient interface devices, outlet port 24 is of a shape, dimension and/or configuration commonly used in the industry. More specifically, outlet port 24 is preferably a generally cylindrical, tube having an outside diameter of between 15 and 30 millimeters, preferably between 20 and 25 millimeters, and most preferably of approximately 22 millimeters. Inlet port cap 30 may be removed and a source of gas under pressure such as an oxygen tube is connected to the inlet. During these maneuvers, pre-filled unit-dose of medication 16 within the nebulizer is prevented from exiting through inlet port 28 by one-way valve 32. As the therapy begins, gas under pressure enters inlet port 28 and travels through siphon 18 creating an area of relatively low pressure, which entrains at least a portion of pre-filled unit-dose of medication 16. The gas/medication mixture exits through jet 20, which directs the mixture such that it impinges against baffle 22 where the liquid medicine is broken up into small aerosol particles. The aerosol exits outlet port 24 and is delivered to the patient through a patient interface (not shown).

(8) FIG. 2 depicts a side view of an alternate embodiment of the pre-filled, small-volume nebulizer of the present invention. In this embodiment outlet port 24 is sealed by piercable outlet port cap 38, which may either be removed or may be pierced at the time of use. In a preferred embodiment, the patient interface may be equipped with a mechanical appendage such as a spike which may be used to pierce outlet port cap 38 such that pre-filled unit-dose of medication 16 may be accessed without an operator or patient touching outlet port 24, thereby further reducing the likelihood of contamination. Furthermore, patient interface (not shown) may comprise a mouthpiece connected to a mouthpiece “T” which contains a spike for the purpose of saving time in the procedure of preparing for a therapy session. Outlet port 24 also contains an outlet port one-way valve 40, which allows aerosolized medication to flow out, but prevents retrograde flow in order to help defend against contamination.

(9) The embodiment depicted in FIG. 2 further displays an alternate embodiment of the medication contained in the nebulizer. Specifically, in the embodiment depicted in FIG. 2, housing bottom 12 contains a plurality of pre-filled unit-doses of medication 16, and unit-dose completion demarcation marks 42. By providing a nebulizer body 36 pre-filled with multiple unit-doses of medicine, this embodiment of the present invention allows a patient or clinician to utilize the device for a predetermined period of time, twenty-four hours for example, without cleaning and reusing, and without disposing of the device earlier than is needed to prevent contamination. Unit-dose completion demarcation marks 42, allow a patient or clinician to determine when the delivery of a unit-dose of medication is complete and stop the therapy until it is time for the next.

(10) FIG. 3 is a side view of a further alternate embodiment of the pre-filled, small-volume nebulizer of the present invention. In this embodiment, a compartment is provided within outlet port cap 26 for keeping a first component of a multi-component medication separate from a second component of a multi-component medication until use. This embodiment may find greatest application when the medicine to be administered is a mixture of one or more components, for example the mixture of Albuterol Sulfate and Ipratropium Bromide. However, mixing of medications can lead to additional problems associated with improper dosing and contamination. In some instances, it is believed that the useable life of these medicines once mixed is undesirably short. Therefore, in practice a patient or clinician generally mixes the medicines immediately prior to treatment. Of course, the increased handling of the medicine by a patient or clinician required during mixing may increase the likelihood of contamination and/or improper dosing. Therefore, by providing a pre-filled nebulizer which can separate multiple medication components until treatment, this embodiment of the present invention may greatly reduce these risks.

(11) As shown in FIG. 3, outlet port cap 26 includes medication separation compartment 44, which may house a first component of a multi-component medication to be mixed with at least a second component of a multi-component medication at the time of use. Medication separation compartment 44 may be fabricated from a soft, malleable plastic composition such as a formulation of low density polyethylene. At the bottom of medication separation compartment 44 is a medication separation outlet gate 46 which is formed by fabricating a weak or thin portion of the plastic. As pressure is exerted at the top of medication separation compartment 44, medication separation outlet gate 46 breaks open and deposits its contents into housing bottom 12 where it mixes with pre-filled unit-dose of medication 16.