Surgery – Liquid medicament atomizer or sprayer
Reexamination Certificate
1999-06-02
2001-05-15
Lewis, Aaron J. (Department: 3761)
Surgery
Liquid medicament atomizer or sprayer
C128S200180
Reexamination Certificate
active
06230703
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to methods of producing aerosols for delivery to patients, and in particular, to methods and devices for reducing the loss of aerosol therapeutic and diagnostic material within aerosol inhalation equipment.
BACKGROUND OF THE INVENTION
Aerosol inhalation devices are used in medical facilities in diagnostic and therapeutic procedures. Such devices are especially useful in pulmonary therapy for pneumonia and for introducing agents such as radioactive vapors for diagnosing diseases. With the advent of new treatments such as gene therapies, there are likely to be increased needs for aerosol inhalation devices that can effectively deliver medicaments to patients.
Aerosol inhalation devices include aerosol-generating equipment, and a means for delivering aerosol to a patient. An example of equipment for generating an aerosol from quid generally is a nebulizer, a device that mixes pressurized air or oxygen with diagnostic or therapeutic materials to create an aerosol. During generation of a liquid aerosol, a liquid to be aerosolized is placed in a reservoir in the nebulizer. Gas such as pressurized air or oxygen enters the nebulizer and acts to draw the liquid up through a delivery tube to an aerosol exit orifice, similar to the operation of a jet pump. At the aerosol exit orifice, the liquid is atomized into a mist referred to as an “aerosol”. In some devices, larger drops that are produced in the mist impinge on baffles above the aerosol exit orifice where they drain back into the reservoir of the nebulizer. Smaller drops are entrained by the gas and are carried through the delivery system to the patient's lungs. Nebulizers are disclosed in U.S. Pat. Nos. 4,823,784 and 5,630,409, the disclosures of which are hereby incorporated herein by reference in their entirety.
Since most aerosol inhalation devices are currently made for a single use and are thereafter disposed, any medication or diagnostic material remaining in a device becomes waste. In addition, the greater the volume of the device, the lower the efficiency of delivery of aerosol to a patient, and the greater the air or oxygen pressure that can be required to deliver the aerosol. Valves within the path of aerosol delivery can further decrease efficiency by interrupting the flow of aerosol, affecting the pressure of the gas entering the device, and/or entrapping aerosol particles.
There have been few improvements directly related to efficiency of delivery and reduction of waste. In view of these and other recognized deficiencies of current devices, a need remains for improved aerosol delivery devices.
SUMMARY OF THE INVENTION
This invention provides aerosol inhalation devices for delivering aerosols to patients. In preferred embodiments, the devices include a means for generating an aerosol, a pair of conduits for providing passage of the aerosol to the patient and exhalate from the patient, and one-way valves to control the flow of aerosol and exhalate during administration of aerosol to a patient. The devices of the present invention employ an improved system of valves that eliminates the need for complex valve mechanisms having interstices in which therapeutic materials can become entrapped. The valves are placed so that they provide minimal obstruction of the flow of aerosol.
In one aspect, the invention provides an aerosol inhalation device for delivering an aerosol to a patient. The device includes an aerosol source for generating an aerosol; a first conduit, having a proximal end, the first conduit providing passage of the aerosol to the patient; a first chamber at the proximal end of the first conduit, adjacent to the aerosol source; a second conduit providing passage of gaseous medium from the patient; a second chamber; and a first valve disposed between the first chamber and the second chamber. The first valve remains closed during exhalation by the patient and opens at least partially during inhalation. The device also includes a second valve disposed between the second conduit and the second chamber, which remains closed during inhalation by the patient and opens at least partially during exhalation by the patient. The gaseous medium exhaled by the patient can optionally contain material of which the aerosol is formed, such as liquid droplets. The device can optionally include an exhaust port, located proximally from the second conduit. The exhaust port can be adjacent to the second chamber such as, for example, above the second chamber. In addition, the exhaust valve can be connected to a device to aid or supplement breathing by the patient, such as a ventilator.
A second aspect of the invention provides a method of delivering an aerosol to a patient, comprising providing an aerosol inhalation device; inserting a distal portion of said aerosol inhalation device into a breathing passage of the patient; and permitting the patient to inhale the aerosol. The inhalation device includes an aerosol source for generating an aerosol; a first conduit, having a proximal end, the first conduit providing passage of the aerosol to the patient; a first chamber at the proximal end of the first conduit, adjacent to the nebulizer; a second conduit providing passage of a gaseous medium exhaled from the patient; a second chamber; and a first valve disposed between the first chamber and the second chamber. The first valve remains closed during exhalation by the patient and opens at least partially during inhalation. The device also includes a second valve disposed between the second conduit and said second chamber, which remains closed during inhalation by the patient and opens at least partially during exhalation by the patient. The gaseous medium exhaled by the patient can optionally contain material from which the aerosol is formed, such as liquid droplets. The device can optionally include an exhaust port, adjacent to the second chamber, such as, for example, above the second chamber.
Another aspect of the invention provides a method of manufacturing an aerosol inhalation device. The method includes providing an aerosol source for generating an aerosol; connecting to the aerosol source a first conduit, the conduit having a proximal end, for providing passage of the aerosol; positioning a first chamber at the proximal end of the first conduit, adjacent to the aerosol source; connecting a second chamber to the first chamber by a first valve disposed between said first chamber and said second chamber; and connecting to the second chamber a second conduit by a second valve disposed between the second conduit and the second chamber. The method of manufacturing an aerosol inhalation device can further include the step of connecting an exhaust port to the second chamber. For example, the exhaust port can be above the second chamber. The aerosol source can comprise a nebulizer.
These and other aspects of the invention will be apparent to one skilled in the art in view of the ensuing disclosure and appended claims.
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Duane Morris & Heckscher LLP
Lewis Aaron J.
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