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  Respiratory monitoring, diagnostic and therapeutic systemUSPTO Application #: 20070068811Title: Respiratory monitoring, diagnostic and therapeutic system Abstract: Disclosed is a system and method for monitoring, diagnosing, and treating certain respiratory conditions, such as asthma. The system includes a mask apparatus fitted with a pH sensor and thermocouple, a continuous positive airway pressure (CPAP) device, a processing receiver, and a therapeutic nebulizer/atomizer/humidifier device. The mask apparatus, CPAP device and therapeutic nebulizer/atomizer/humidifier device are connected by a pneumatic means. The pH sensor and the thermocouple are in electrical communication with the processing receiver that controls, through an electronic means, the CPAP device and therapeutic nebulizer/atomizer/humidifier device. The electrical communications can be in the form of a plurality of wires or employ wireless means. (end of abstract) Agent: Michael E. Klicpera - La Jolla, CA, US Inventors: Ross Tsukashima, Jeffery D. Schipper, Leo R. Roucher, Erich H. Wolf USPTO Applicaton #: 20070068811 - Class: 204433000 (USPTO) Related Patent Categories: Chemistry: Electrical And Wave Energy, Apparatus, Electrolytic, Analysis And Testing, Measuring Carbon Or Ph The Patent Description & Claims data below is from USPTO Patent Application 20070068811. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCES [0001] The present application is a continuation-in-part of patent application Ser. No. 10/693,115 filed on Oct. 24, 2003 entitled "A Respiratory Monitoring, Diagnostic and Therapeutic System" currently pending and a continuation-in-part of patent application Ser. No. 10/725,920 filed on Dec. 1, 2003 and patent application Ser. No. 10/823,941 filed on Apr. 14, 2004 both entitled "A Self-Condensing pH Sensor". These applications are incorporated herein by this reference. FIELD OF THE INVENTION [0002] The field of art to which this invention relates is in the monitoring of certain parameters and transfer of such information to facilitate therapeutic treatment for patients suffering from respiratory diseases, such as asthma. More specifically, the present invention monitors the pH level of a patient's breath and provides data for determining the frequency and volume of a therapeutic dose to be administered to the asthmatics' airways. BACKGROUND OF THE INVENTION [0003] Recently, it has been reported that the monitoring of acidity or pH of a patient's breath could help physicians in estimating the degree of air passage inflammation in the lungs, now considered a key contributor to asthma and other respiratory conditions. Asthma is characterized by symptoms of wheezing, coughing, chest tightness, and shortness of breath. Manifestations include constriction (the tightening of the muscles around the airways) and inflammation (the swelling and irritation of the airways) that can be triggered through exposure to smoking, dust mites, pets, activity, cold, infection, weather, pollen, etc. [0004] A clinical study of people with chronic obstructive pulmonary disease (COPD), bronchiectasis and asthma demonstrated more acidic levels in COPD and bronchiectasis patients, which is indicative of the chronic inflammation that these patients experience. This study also observed an increase acidic level measured from the breath of patients suffering from moderate asthma when compared to mild forms of the disease. It was also found that the asthmatics' breath was much more acidic during asthma attacks, but normalized after anti-inflammatory medication was administered. [0005] This data suggests that the monitoring of an asthmatics' breath for pH might be an effective way to measure the degree of inflammation in the air passages. Furthermore, this data suggests that close monitoring of an asthmatic's breath pH could lead to prompt and effective treatment, minimizing the occurrence of asthma attacks and provide overall better management. [0006] It is estimated that 18-26 million people in the United Stated suffer from asthmatic conditions. It is also believed that over 5.6 million of these asthma suffers are under the age of 18, ranking this disease as the 8.sup.th worst chronic condition. [0007] Studies have also shown that gastro-esophageal reflux disease (GERD) induced asthma affects approximately 40% of the US Adult Population and that 60-80 percent of all asthma patients have GERD. Gastro-esophageal reflux is a condition in which gastric acid refluxes from the stomach and into the esophagus. Frequent reflux episodes may result in a potentially severe problem known as gastro-esophageal reflux disease. GERD is the most common cause of dyspepsia or heartburn. GERD can also manifest in the micro-aspiration of acid from the esophagus and into the lungs, damaging tissue, and causing swelling and irritation of the vagus nerve. This irritation of the vagus nerve, which is common to both the esophagus and the bronchial tree, causes constriction of the airways. Acid refluxes past the lower esophageal sphincter and causes anatomical damage, sleep disordered breathing, and dietary affects. It has also been found that bronchial dilators can relax the lower esophageal sphincter and trigger GERD induced asthmatic conditions. Sleep apnea has also been found to trigger reflux events. [0008] Current pH monitoring suffers from the following drawbacks, 1) invasive procedure, 2) not well tolerated by some patients, 3) catheter or capsule placement must be performed by a physician, 4) capsule cannot be placed above the Upper Esophageal Sphincter (UES) and 5) there are no defined standards (DeMeester Score) for UES evaluation. [0009] Accordingly, there is a need in this art for a novel, pH monitoring mask with electronic or wireless communication linked to a processing receiver that activates a therapeutic nebulizer/atomizer/humidifier for treating asthmatic or other respiratory conditions. SUMMARY OF THE INVENTION [0010] The present invention pertains to an invention for monitoring the pH level of a patient's breath in a typical mask and provides a means for transferring this data to a processing receiver for diagnosing and determining the frequency and volume of a therapeutic dose to be administered to a patient with a respiratory condition such as asthma. Monitoring of a patients' breath chemistry is provided by a system that includes a miniaturized pH sensor, provides for real-time monitoring of patient airway pH values, and utilizes solid state cooling to precipitate moisture from a patient's breath. [0011] A general respiratory mask is mounted with a miniaturized pH sensor and data transfer means e.g. direct wiring or by providing a transmitter with an antenna for wireless transferring of the pH data to a processing receiver. The temperature of the pH sensor is lowered below the dew point of the exhaled patient breath by a solid-state Peltier junction engaged on one side to a heat sink. A thermocouple is provided to monitor the temperature of the sensor for more accurate pH calculations. Keeping the sensor temperature below the dew point will cause the patient's exhaled breath to condense as a liquid in close proximity to the surface of the sensor. It is commonly known that monitoring of pH is significantly more accurate if measuring a condensed liquid. A transmitter with an antenna transfers the observed pH data by employing one of many wireless methods, such as radio-frequency (RF) energy. Alternately, the transfer of observed pH data is accomplished by direct wire methods. [0012] The pH data is transferred or updated at specific intervals, which can be varied according to the patient's needs, to the processing receiver that is engaged to the treatment and humidifier apparatuses. The processing receiver computes and diagnoses the chemistry data and determines what apparatus and at what frequency it should be activated. [0013] The present invention mask is also fitted with a means to remove the condensed liquid through an exhaust port or the connected pneumatic hose to remove unnecessary and accumulated breath condensate. [0014] These and other features, aspects and advantages of the present invention will become better understood with reference to the following descriptions and claims. BRIEF DESCRIPTION OF THE DRAWINGS [0015] FIG. 1 is a perspective representation of the present invention systems, showing the various components of the system, including a mask apparatus fitted with a heat sink and pH sensing means, a continuous positive airway pressure (CPAP) device connected to the mask apparatus, a processing receiver electrically connected to the mask apparatus, and a nebulizer/atomizer/humidifier device electrically connected to the processing receiver. [0016] FIG. 2 is a sectional side view of the general mask apparatus demonstrating in more detail of the orientation and components of the mask, and pH sensing means. [0017] FIG. 3 is a sectional view taken from FIG. 1 demonstrating the general location of the pH sensor, cooling shank, thermocouple and fluid pool on the sampling plate for condensing and containing a patient's breath. [0018] FIG. 4 is a sectional side view taken from FIG. 2 demonstrating in more detail the relative locations of the heat sink, Peltier junction, body and head of cooling transfer shank, thermocouple, and pH sensor. [0019] FIG. 5 is a schematic representation of the treatment nebulizer/atomizer/humidifier device, demonstrating a base unit having an on/off switch, operating lights, a medicament storage container, and interconnection for attaching the pneumatic hose. Continue reading... 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