Combination inhalation therapeutic and exhalation measuring...

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

Reexamination Certificate

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C128S200140, C128S200180, C128S200240, C128S203120, C128S204140, C600S538000

Reexamination Certificate

active

06679250

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the field of respiratory therapy. In particular, the invention is a unique medical instrumentation combining a meter for measuring the peak ability for exhalation of a patient with the administration of inhalation therapy for the patient.
2. Prior Art
Peak flow meters for measuring the maximum rate at which air is forced from the lungs during exhalation are used by inhalation and respiratory therapists and physicians for monitoring a patient's respiratory condition for diagnosing potential and/or existing breathing problems. The meter generally comprises an open ended cylinder, marked with a graduated scale along its length. The patient breaths into the open ended cylinder, through a mouth piece, the patient's breath impinging against a biased diaphragm. The biased diaphragm is moved down the cylinder, along the scale thus indicating a rate at which breath is exhaled from the lungs. A nebulizer is a device often used by inhalation and respiratory therapists and physicians for administering vaporized medication to a patient, presenting vaporized medication to a patient through an aerosol chamber or vapor holding cylinder. Through a mouth piece, at an end of the vapor holding cylinder, a patient inhales vaporized medication. Peak flow meters and nebulizers are each well known and often used medical instrumentations. The U.S. Pat. No. 4,944,306, issued to Alvino, Jul. 31, 1990 teaches an improved, patient adjustable, viewable, exhalation flow rate metering device or spirometer, also called a peak flow meter. A vertical housing, open at its upper end, connects, at its lower end to an horizontal cylinder with a mouth piece at one end and an open end at the other end. The connection between the vertical housing and the cylinder is at a point between the mouth piece and the open end of the cylinder. The vertical housing supports a biased piston on a positioning rod. The biased piston is in full view of the patient exhaling into the mouth piece and cylinder. Exhaled breath from the patient forces the biased piston up the positioning rod. The patient watches the piston rise up the positioning rod as the patient blows into the mouth piece. U.S. Pat. No. 5,565,630, issued to Shene, Oct. 15, 1996 teaches an improved peak flow meter for measuring peak exhalation air flow of a patient. Breath is exhaled, from the mouth, through a mouth piece, into a hollow chamber containing a biased, movable member which moves along the hollow chamber in response to pressure. A series of vent holes are provided in the wall of the chamber, along the path of the biased member. The holes increase in diameter as the length of the path increases. A graduated scale is marked on the cylinder, along the path. The biased, movable member moves along the path and graduated scale in response to pressure of a person's or patient's breath exhaled into the mouth piece. The position of the biased, movable member, along the graduated scale, indicates a peak breath flow of a person's exhalation.
Nebulizers which meter vaporized medication to a person, are well known in the medical field. Examples of United States issued patents are:
#3,353,536 issued to F.M. Bird et al
Nov. 21, 1967
#4,470,412 issued to Nowacki et al
Sept. 11, 1984
#5,040,527 issued to Larson et al
Aug. 20, 1991
#5,363,842 issued to Mishelevich et al
Nov. 15, 1994
#5,415,161 issued to Ryder
May 16, 1995
#5,431,154 issued to Seigel et al
Jul. 11, 1995
#5,743,252 issued to Rubsamen et al
Apr. 28, 1998
The U.S. patent to F. M. Bird et al, U.S. Pat. No. 3,353,536 teaches a nebulizer which is essentially a fixed or stable unit and can be used for long term use. A relatively large container supports a large amount of liquid medication. Air, flowed into a large quantity of liquid medication, vaporizing the liquid which, in vapor form is presented to the patient for inhalation. The unit is designed for long term therapy where oxygen or air is administered to a patient. The U.S. Pat. No. 4,470,412, issued to Nowacki et al, teaches an inhalation valve for an antiasthmatic medication cartridge assembly. A pressurized cannister or cartridge containing a suitable medication for inhalation is used for dispensing high velocity bursts of a pressurized medicated inhalant, in vaporized form, into a sealed chamber. One end of the chamber is sealed by a slit diaphragm valve with an open mouth piece on the output side of the split valve. The valve opens when the patient inhales, passing the vaporized medication to the patient for inhalation. The dosage of vaporized medication is user controlled. The slit valve fails to retain bursts of vaporized medication from the cannister containing pressurized medication.
The U.S. Pat. No. 5,040,527, issued to Larson et al; U.S. Pat. No. 5,363,842, issued to Mishelevich et al; U.S. Pat. No. 5,415,161, issued to Ryder; and U.S. Pat. No. 5,743,252, issued to Rubsamen et al each teach the use of a replaceable cannister containing a pressurized aerosol inhalant, a vaporized medication, under high pressure. Upon release from the cannister, an high velocity burst of vaporized medication is entrapped in and fills a patient breathing cylinder and mouth piece through which the patient is breathing. The high velocity burst of medication from the pressurized cannister results in an excess portion of the drug being administered to the patient and depositing the excess portion in the patient's mouth. The high velocity burst of medication from the pressurized cannister also results in a loss of medication through the openings in the breathing cylinder. U.S. Pat. No. 5,431,154, issued to Seigel et al also teaches the use of a replaceable, aerosol cannister of vaporized medication under pressure and further teaches limiting the pressure of the burst of high velocity spray of medication after the burst is released from the cannister.
The U.S. Pat. No. 5,522,380, issued to Dwork and U.S. Pat. No. 5,839,430, issued to Cama each teach a combination peak flow meter and metered dose inhaler. However, each patent teaches the use of a pressurized cannister which contains vaporized medication under high pressure. In the case of Cama, the complete cannister of pressurized medication is inserted into the breathing chamber of the device so that bursts of medication are emitted from the cannister directly into the mouth piece of the device and therefore into the mouth of the patient. In the case of Dwork, in the output nozzle of the high pressure cannister is inserted directly into the breathing chamber of the device. In each case, the high velocity burst of medication into the breathing chamber deposits an huge amount of medication into the mouth of the patient and medication is lost out the vent hole in the breathing chamber. Dosage from the cannister, in bursts of high velocity medication, is patient controlled. By depositing high velocity bursts of medication directly into the chamber or cylinder of the peak flow meter, medication is lost up the calibrated cylinder of the peak flow meter and inaccuracy in the peak flow meter is amplified by getting the movable diaphragm, in the case of Cama, and a ball float in the case of Dwork, wet from the vaporized medications burst into the unit.
SUMMARY OF THE INVENTION
The present invention provides a peak flow meter and nebulizer, combined to provide patients and clinicians with an improved medical device which delivers vaporized medication to a patient, for inhalation, and monitors the patient's air intake during the same respiratory cycle. Peak flow rate meters may be used to determine the severity of air flow obstruction caused by the swelling of tissue in the respiratory system. Monitoring the peak flow rate directly after medication for relief of air flow obstruction has been taken, can determine the immediate effectiveness of the medication.
A peak flow meter consists of an open ended chamber for capturing exhaled breath, in an expandable space, for measuring the flow r

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