Sealed backpressure attachment device for nebulizer

Surgery – Liquid medicament atomizer or sprayer – Gas stream aspirating medicament from reservoir

Reexamination Certificate

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Details

C128S203160

Reexamination Certificate

active

06412481

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to a breathing device adapted for use with a nebulizer for allowing a user to inhale medication particles generated by the nebulizer device through a sealed breathing attachment device. More particularly, the present invention relates to an attachment device for a nebulizer for generating positive backpressure in the airways of the user and to thereby keep the airways open for delivery of the medication to patient's lungs.
Nebulizers are widely used in the medical field for delivery of medicine to patient's lungs through inhalation. Nebulizers are conventionally used in an emergency, when conventional method dose inhalers (MDIs) fail to reverse a constriction in the airways. The nebulizer is designed to break down the liquid medication into small particles resembling mist. The patient, bringing the medication into the lungs and airways of the user, inhales this mist.
The medication that is aerosoled by a nebulizer usually contains a chemical that reacts with receptors in the bronchioles and causes the airways to dilate. The treatments with nebulizers can last up to several hours until the desired result is achieved. If the medication still doesn't reach the constricted areas in the lungs, stronger medications may be used. Depending upon the severity of the attack, the medications can include steroids, magnesium sulfate, and bronchodilaters.
Oftentimes, a patient delivered to an emergency room has a considerable concentration of carbon dioxide in the blood and the use of a nebulizer, which works relatively slow, may require up to eight hours of treatment, dictates that another type of an emergency device, an ambu bag with a mask, is used. The mask seals the area over the patient's mouth and nose allowing delivery of the aerosol medication. The mask forces the medication into the lungs by positive pressure generated by squeezing the ambu bag.
The positive pressure delivers air into the stomach of the patient, as well as into the lungs. When the air is diverted into the stomach it causes gastric distension and vomiting, which in turn, increases the risk of aspiration when the vomited medium is inhaled or forced into the lungs.
The most critically ill patients who do not respond to the treatment with conventional nebulizers or ambu bags are put on a ventilator, an artificial breathing machine that includes placing an endotrachial tube into the trachea of the patient. The tube has an inflated cuff for sealing the inhaling airway. Then the patient can be ventilated by positive pressure. Since the patient is sedated when he is on the breathing machine, the medication produced by the nebulizer can be more effectively delivered to the patient's lungs.
However, this drastic method suffers from serious disadvantages. The strong positive pressure drives the air into the lungs, sometimes causing damage by excessive pressure, or by excessive volume of air forced into the lungs. In some instances, the patient's inspiratory muscles atrophy, particularly in the case where the patient remains on the ventilator for a long period of time. The longer the patient stays on the ventilator, the more difficult it may be to “wean” the patient from the ventilator.
The present invention contemplates elimination of drawbacks associated with the prior art through the provision of a sealed back pressure attachment device for a nebulizer that creates positive pressure on the constricted airways and causes the airways to stay open for delivery of medication. With the use of the device according to the instant invention the patient's airways are incorporated into a closed circuit with the attachment device.
SUMMARY OF THE INVENTION
It is, therefore, an object of the present invention to provide a sealed back pressure attachment for a nebulizer device that would allow creation of positive end expiratory pressure on the constricted airways of a patient suffering from asthma, emphysema, or other respiratory illness.
It is another object of the present invention to provide a sealed backpressure slow breathing attachment device for a nebulizer that can be pre-set to create the desired amount of pressure within the device to help restore a person's breathing to their normal physiological state.
It is a further object of the present invention to provide an attachment device for a nebulizer that seals the backpressure and equalizes the pressure behind the terminal bronchial path.
It is still a further object of the present invention to provide a sealed backpressure attachment device for a nebulizer that can be calibrated for creating a pre-determined amount of pressure in the airways of a patient.
It is still a further object of the present invention to provide a sealed backpressure attachment device for a nebulizer that is simple to use and inexpensive to manufacture.
These and other objects of the present invention are achieved through a provision of a sealed backpressure attachment device for a nebulizer that comprises a manifold and an elongated conduit/mixing reservoir made from a flexible resilient material. The conduit/reservoir has a one-way inlet valve for admitting ambient air into the conduit and a mouthpiece for engaging by a user's mouth. A spring-loaded calibrated adjustable pressure valve is mounted in fluid communication with the interior of the conduit to allow exhaled gases to be vented into the atmosphere.
A manifold is secured on the conduit between a mouthpiece and the calibrated pressure valve, the manifold having one portion that extends in a substantially co-axial relationship to the central axis of the conduit and a second portion that extends perpendicularly to the conduit central axis. The second portion of the manifold acts as a nebulizer connector in one embodiment and a nebulizer/pressure valve connector in the second embodiment. The manifold allows to detachably secure the sealed backpressure attachment device to a nebulizer. The manifold is mounted between the pressure valve and the mouthpiece.
When the user inhales, the ambient air is admitted into the conduit and draws aerosol medication from the nebulizer into the hollow conduit/mixing reservoir, delivering the medication into the mouthpiece and then into the user's respiratory system. When the user exhales, the one-way valve effectively prevents escape of exhaled gas through the first end of the conduit. Instead, the exhaled gas is diverted to the calibrated pressure exhalation valve, which is provided with an outlet port.
The gas pressure builds up until it is greater than the pre-set value of the valve. At that time, positive backpressure keeps exhaled gas in the user's sealed airways, which in turn causes collapsed or constricted air passages to stay open. Only after the pressure exceeds the pre-determined value the exhalation gas is allowed to escape into the atmosphere. Following this period, the medication particles are delivered into the lungs and airways of the patient, during inspiration.
The pressure exhalation valve may be preset in the range of between 5 cm of water to 10 cm of water although other pressure values may be used for the calibration of the valve, if desired. This application works because it is a sealed backpressure environment.
The present invention may be used as attachment for conventional nebulizers or, with certain modifications, with other respiratory emergency devices. The device of the present invention is believed to be particularly useful for asthma and emphysema sufferers, although other respiratory problems treatable with inhaled medications may benefit from the concept set forth in this application and the mechanical device disclosed herein.


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patent: 4354520 (1982-10-01), Easley, Jr.
patent: 4620670 (1986-11-01), Hughes
patent: 4787655 (1988-11-01), Gross et al.
patent: 4823784 (1989-04-01), Bordoni et al.
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