Surgery – Respiratory method or device – Means for mixing treating agent with respiratory gas
Reexamination Certificate
2000-07-06
2002-04-02
Weiss, John G. (Department: 3761)
Surgery
Respiratory method or device
Means for mixing treating agent with respiratory gas
C128S200140
Reexamination Certificate
active
06363932
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates generally to an improved aerosol inhalation device, and more particularly to an aerosol enhancement device which is usable in combination with both a nebulizer and a metered dose inhaler.
Aerosol inhalation devices, for the purpose of delivering medication, entrained in an aerosol spray, to a patient using inhalation therapy, as an alternative to oral medications such as capsules or pills, or to injected medications, are well known in the art. For example, U.S. Pat. No. 4,210,155 to Grimes is representative of the prior art. In the Grimes patent there is disclosed a fixed volume mist accumulation chamber for use in combination with a nebulizer and a tee connection of an inhalation conduit for accumulating medicated mist and facilitating its delivery to a patient.
However, the Grimes device, as is typical for prior art devices, is plagued with problems typical of such devices. These problems include, for example, non-uniform concentrations of medication, resulting in difficulties in regulating patient dosage, and significant waste of medication. Additionally, the Grimes device is relatively complex, so that it is expensive to manufacture and difficult to use.
Many other such devices are available which do not include a mixing chamber. In other words, the nebulizer is attached directly to the aforementioned tee connection. Of course, such devices are even less suited to satisfactory regulation of the medication being delivered to the patient than the Grimes device, because there is substantially no ability to uniformly mix the medication with entrained fluid, such as air, before delivery to the mouthpiece on which the patient is inhaling.
In addition to nebulizers, metered dose inhalers (MDI) are also available for delivering a medicated aerosol to a patient. These MDI devices differ from nebulizers primarily in that a propellant is used to deliver the medication.
It would be advantageous to have an aerosol medication delivery device which included a mixing chamber between the medication delivery apparatus and the mouthpiece, wherein the medication could be uniformly mixed with entrained air in an improved manner over that achieved by the Grimes patent apparatus. It would also be beneficial for such a device to be simple to manufacture and assemble, and easy to use. Finally, if such a device could be made universally adaptable for use with any known nebulizer on the market, as well as with MDI's, this would be a great advance in the art.
SUMMARY OF THE INVENTION
The present invention provides an aerosol medication delivery apparatus which incorporates the aforementioned advantages. The inventive device includes a fixed volume holding chamber which is constructed to allow for a uniformly mixed, concentrated bolus of medicated aerosol to be delivered with each breath. The device further includes a universal inlet, so that any standard small volume nebulizer, as well as any standard MDI, may be utilized therewith. Also filtration can be added to address contaminated patient air and aerosol. A one-way valve is positioned between the holding chamber and a tee piece for attaching the holding chamber to a patient mouthpiece, to help control the loss of aerosol, and thereby reduce waste. The device is simply constructed of two molded plastic members, which are readily engaged to complete its assembly.
More particularly, an aerosol enhancement device is provided which comprises a mouthpiece and a tower member fluidly attached to the mouthpiece. The tower member has an outer body which defines an interior volume, together with an inner wall disposed in the outer body. The inner wall extends a substantial distance through the interior volume and defines a holding chamber interiorly of the inner wall. An annular air passage is defined between the inner wall and the outer body. An inlet port is disposed in the tower member for receiving a medicated aerosol from an exterior source into the holding chamber. An air inlet port is disposed in the tower member, as well, for receiving air into the air passage. Advantageously, because of the lengthy inner wall, which may preferably comprise a tubular member, so that the resultant defined air passage is annular, the air in the air passage flows around said inner wall and into holding chamber, to be entrained with the medicated aerosol for a sufficient distance as it travels through the holding chamber to ensure thorough mixing.
A further innovation in the aforementioned device is the employment of a T-piece for attachment of the tower member to the mouthpiece, and the incorporation of a one-way valve in the T-piece for preventing medication waste. A one-way valve, preferably comprising an O-ring valve, is preferably disposed in the air inlet port, as well.
In another aspect of the invention, an aerosol enhancement device is provided which comprises a mouthpiece and a tower member fluidly attached to the mouthpiece. The tower member has an outer body which defines an interior volume. An inlet port is disposed in the tower member for receiving a medicated aerosol from an exterior source into the interior volume. Advantageously, an adapter is disposed in the medicated aerosol inlet port. The inventive adapter comprises a universal fitting which is capable of attaching the tower member to either a nebulizer or a metered dose inhaler (MDI).
Preferably, the inventive adapter is reversible, being disposable in a first orientation for attachment of the tower member to a nebulizer, and being disposable in a second orientation for attachment of the tower member to an MDI. In its preferred configuration, the universal adapter comprises a first rigid connector end and a second flexible connector end, the first rigid connector end being adapted for attachment to a nebulizer and the second flexible connector end being adapted for attachment to an MDI. The adapter preferably further comprises a flange portion for engaging the adapter with the tower member.
In still another aspect of the invention, an aerosol enhancement device is provided which comprises a mouthpiece and a T-piece attached to the mouthpiece. The T-piece has a first port for attachment to the mouthpiece, a second port which is open to atmosphere, and a third port. A medication dispenser is attached to the third port, and, advantageously, an exhalation filter is disposed in the second port.
In yet another aspect of the invention, a tower member is provided which is usable with a mouthpiece, for dispensing medicated aerosol to a patient. The inventive tower member comprises an outer body which defines an interior volume, and an an inner wall disposed in the outer body. The inner wall extends a substantial distance through the interior volume and defines a holding chamber which is disposed interiorly of the inner wall. The inner wall and the outer body define an air passage therebetween. An inlet port is disposed in the tower member for receiving a medicated aerosol from an exterior source, such as a nebulizer or MDI, into the holding chamber, and an air inlet port is disposed in the tower member for receiving air into the air passage. An outlet port for dispensing medicated aerosol entrained in air from the holding chamber to the mouthpiece is provided as well, wherein the air in the air passage flows therethrough around the inner wall and into the holding chamber, to be entrained with the medicated aerosol.
In another aspect of the invention, there is provided a tower member usable with a mouthpiece, for dispensing medicated aerosol to a patient. The tower member comprises an outer body which defines an interior volume, and an inlet port disposed in the tower member outer body for receiving a medicated aerosol from an exterior source into the interior volume. An adapter is disposed in the medicated aerosol inlet port. The adapter comprises a universal fitting which is advantageously capable of attaching the tower member to either a nebulizer or a metered dose inhaler (MDI).
In yet another aspect of the invention, there is provided a tower membe
Forchione Dennis
Johnson Robert
Clinical Technologies, Inc.
Mitchell Teena
Stout Donald E.
Stout, Uxa Buyan & Mullins, LLP
Weiss John G.
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