Abstract:
Disclosed is a system and method for monitoring the breath chemistry of a patient&#39;s breath using a specially designed self-condensing sensor module mounted in a mask, nasal cannula, headband with boom apparatus, or similar device for directing the patients&#39; breath towards the self-condensing sensor. Monitoring of a patient&#39;s breath pH provided by the miniaturized self-condensing pH sensor provides for real-time monitoring of patient airway pH values. The specially designed self-condensing sensor module incorporates a 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 self-condensing pH sensor comprises a multi-tubular design with the outer tubular member housing a silver chloride reference element, an ion conducting path, and an antimony sensor plug isolated in an inner tubular member that is co-linearly or coaxially configured with the outer tubular member. 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. The pH data is transferred or updated at specific intervals, which can be varied according to the patient&#39;s needs, to the processing receiver that is engaged to the treatment apparatus. In the therapeutic configuration, the processing receiver computes and diagnoses the breath chemistry data and determines at what frequency the treatment apparatus should be activated.

Description:
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 the diagnosis or therapeutic treatment for patients suffering from respiratory diseases, such as asthma, laryngopharyngeal reflux disease (LPRD), chronic obstructive pulmonary disease (COPD), and obstructive sleep apnea (OSA). More specifically, the present invention monitors the pH level of a patient&#39;s breath and provides data for diagnosis or for determining the frequency and volume of a therapeutic dose to be administered to the patients&#39; airways. Furthermore, it details the integration of known pH sensor materials to achieve a novel and compact pH sensor probe. Because of the proximity and orientation of the sensor&#39;s elements, it is able to self-condense and monitor pH changes of humidified gases as well as liquids.  
       BACKGROUND OF THE INVENTION  
       [0003]     Recently, it has been reported that the monitoring of acidity or pH of a patient&#39;s breath could help physicians in estimating the degree of air passage inflammation, now considered a key contributor to asthma, LPR 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 increased 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 asthmatic&#39;s 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 asthmatic&#39;s 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&#39;s breath pH could lead to prompt and effective treatment, minimizing the occurrence of asthma attacks and providing overall better asthma management.  
         [0006]     It is estimated that 18-26 million people in the United States suffer from asthmatic conditions ranking this disease as the 8 th  worst chronic condition in the US. It is also believed that over 5.6 million of these asthma sufferers are under the age of 18.  
         [0007]     Studies have also shown that gastro-esophageal reflux (GER) affects approximately 40% of the US adult population and that 60-80 percent of all asthma patients have GER. Gastro-esophageal reflux is a condition in which gastric acid refluxes from the stomach into the esophagus. Frequent reflux episodes may result in a potentially severe problem known as gastro-esophageal reflux disease (GERD). GER is the most common cause of dyspepsia or heartburn. GER can also manifest in the micro-aspiration of acid from the esophagus into the airway and lungs, damaging tissue, and causing irritation of the vagus nerve. This irritation of the vagus nerve, which is common to both the esophagus and the bronchial tree, can cause constriction of the airway. Acid reflux above the lower esophageal sphincter can cause anatomical damage and is linked to sleep disordered breathing. It has also been found that bronchial dilator drugs can relax the lower esophageal sphincter and trigger GERD induced asthmatic conditions. Sleep apnea has also been found to trigger reflux events. Testing for GER and the diagnosis of GERD are typically accomplished by measuring pH with catheter based devices.  
         [0008]     These current pH monitoring methods suffer from the following drawbacks: 1) the current method requires an invasive procedure to place a pH measurement catheter or implanted pH measurement capsule in the patient&#39;s esophagus, 2) the procedure is not well tolerated by some patients, 3) the catheter or capsule placement must be performed by a physician, 4) the capsule cannot be placed above the Upper Esophageal Sphincter (UES) to measure airway pH, and 5) there are no defined standards for evaluation of pH above the UES.  
         [0009]     Accordingly, there is a need in this art for a novel, pH diagnostic and monitoring system with electronic or wireless communication linked to a processing receiver that can also be used to activate 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 breath chemistry of a patient&#39;s breath using a specially designed self-condensing sensor module mounted in a mask, nasal cannula, headband with boom apparatus, or similar device for directing the patients&#39; breath towards the self-condensing sensor. The system provides a means for communicating this data in real-time to a processing receiver for monitoring, diagnosing, or treating disease abnormalities in the patient. The system interprets the data and has a means for determining the frequency and volume of a therapeutic dose to be administered to a patient, typically with a respiratory condition such as asthma. Monitoring of a patient&#39;s breath pH is provided by the system that includes a miniaturized self-condensing pH sensor, providing for real-time monitoring of patient airway pH values.  
         [0011]     The specially designed self-condensing sensor module incorporates a 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.  
         [0012]     The self-condensing pH sensor comprises a multi-tubular design with the outer tubular member housing a silver chloride reference element, an ion conducting path, and an antimony sensor plug isolated in an inner tubular member that is co-linearly or coaxially configured with the outer tubular member.  
         [0013]     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.  
         [0014]     The pH data is transferred or updated at specific intervals, which can be varied according to the patient&#39;s needs, to the processing receiver that is engaged to the treatment apparatus. In the therapeutic configuration, the processing receiver computes and diagnoses the breath chemistry data and determines at what frequency the treatment apparatus should be activated.  
         [0015]     The present invention mask and self-condensing pH sensor module may also be fitted with a means to remove the condensed liquid through an exhaust port or a connected pneumatic hose to remove unnecessary and accumulated breath condensate.  
         [0016]     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  
       [0017]      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 pH sensing eans, an optional continuous positive airway pressure (CPAP) device connected to the mask type apparatus, a processing receiver electrically connected to said mask apparatus, and a nebulizer/atomizer/humidifier device electrically connected to the processing receiver.  
         [0018]      FIG. 2  is an exploded sectional representation view of the mask apparatus demonstrating in more detail of the orientation and components of the mask and the pH sensing holding mechanism.  
         [0019]      FIG. 3  is an inside view showing the configuration and general location of the mask air passageways.  
         [0020]      FIG. 4  is a sectional side view taken from  FIG. 3  demonstrating in more detail the relative locations of the mask air passageways, self-condensing sensor holding mechanism, the self-condensing sensor, and the general flow of the patient&#39;s breath when used in clinical applications.  
         [0021]      FIG. 5  is a perspective representation of another embodiment of the present invention systems, showing the various components of the system, including the pH self-condensing sensor means suspended from a mask-less headband apparatus with an extended boom to locate the self-condensing pH sensor within the patient&#39;s breath airway.  
         [0022]      FIG. 6  is a perspective representation of another embodiment of the present invention systems, showing the various components of the system, including the pH self-condensing sensor means incorporated within a nasal cannula to locate the self-condensing pH sensor within the patient&#39;s breath airway.  
         [0023]      FIG. 7  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.  
         [0024]      FIG. 8  is a partially sectional side view of the sensor apparatus demonstrating in detail the orientation and components of the pH sensing means.  
         [0025]      FIG. 9  is a top view of the terminal end of the sensor apparatus demonstrating the offset co-linear position of the antimony sensor and the reference wick with a condensed droplet electrically bridging the antimony sensor and the reference wick.  
         [0026]      FIG. 10  is a top view of the terminal end of another embodiment sensor apparatus demonstrating the position of the reference wick surrounding an inner coaxially positioned tubular member containing the antimony sensor with several condensed droplets electrically bridging the antimony sensor and the reference wick.  
         [0027]      FIG. 11  is an electrical schematic of the general components in the processing receiver.  
         [0028]      FIGS. 12 and 13  are flowcharts showing the sequential computational steps employed by the processing receiver. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0029]     The present invention provides a system and method for monitoring physiological parameters from a patient&#39;s exhaled breath and communicates this information to a processing computer/receiver that diagnoses, stores, or displays the information. The system can use computational instructions to activate and de-activate an electrically connected treatment nebulizer/atomizer/humidifier device, and can be integrated with a continuous positive airway pressure (CPAP) device.  
         [0030]      FIG. 1  illustrates that the present invention consisting of a system  10  comprised of several components. As shown in the Figure, a typical mask apparatus  36  is fitted with a securing strap or typical headgear apparatus  38 . The mask configuration is only one embodiment contemplated by the Applicants. The present invention can perform in a mask-less configuration, with other embodiments consisting of mounting the sensor assembly to a headband or pair of goggles that suspends the sensor assembly within the patient&#39;s breathing airway. If the example mask apparatus  36  is employed, it is generally fabricated from a polymeric and/or silicone material and configured to fit over a patient&#39;s nose, or nose and mouth, to assist in breathing conditions. The securing strap  38  is made from a flexible material and is positioned around the patient&#39;s head such that the mask substantially engages the patient&#39;s face and mouth area, minimizing ambient air from entering the boundaries of the mask. It is contemplated by the Applicants that other mask configurations, including a sensor module without mask, or mask-less configurations, and different positions of the components of the present invention, can still achieve the goal of monitoring, diagnosing and treating respiratory and medical conditions in patients.  
         [0031]     Shown attached to the front of the mask apparatus  36  is a housing  27  that contains the components necessary for condensing the patient&#39;s breath and monitoring certain chemical parameters. The housing  27  can be machined or molded from a variety of polymeric materials including polyethylene, polypropylene, polyvinyl chloride, polystyrene, ABS, nylon, delrin, or polyethylene terephthalate (PET), or from metallic materials, such as aluminum or other biocompatible metallic alloys.  
         [0032]     The mask apparatus  36  may be connected to the exit port  22  of a CPAP device  16  by means of a pneumatic hose  18 . The hose can be manufactured from a variety of materials, including polymers such as polyethylene, polypropylene, polyvinyl chloride or silicone. The material used for the hose should be resistant to water and acidic environments and should not interfere or interact with any medicaments employed in the present invention. CPAP air exits port  22  and travels along the length of the pneumatic hose  18  to the internal sampling cavity created by the general mask apparatus covering the patient&#39;s face. The CPAP device has a control means  20  for increasing and decreasing the volume of air generated by the apparatus and the output of an optional humidification device. The CPAP device and humidifier are powered by an electrical source such as a standard plug  12  and cable  14 .  
         [0033]     Shown connected to the sensor body  27  is an electrical wire  29  that communicates the sensor  34  with a processing receiver  26 . Also shown is a combined cable  30  having the electrical wire  29  from the sensor  34  and electrical means  31  connecting the therapeutic nebulizer  32  to the processing receiver  26 .  
         [0034]     Electrical wire  29  is typical in that the internal core comprises an electrically conductive metallic material and is encased by a nonconductive jacket. Processing receiver  26  is connected to the CPAP device  16  by an electrical wire  24  for controlling the activation of air generated by the CPAP device  16  and transferred to the typical mask apparatus  36 . Also, an electrical connection by means of a wire  31  to the processing receiver  26  is a treatment nebulizer/atomizer/humidifier device  32 . As an alternate method, a wireless means  40  can be utilized instead to communicate between the processing receiver  26  with an antenna  28  to the treatment nebulizer/atomizer/humidifier device  32 . Although not shown in detail in  FIG. 1 , a wireless means also can be employed to communicate between the typical mask apparatus  36  and the processing receiver  26 . In addition, a wireless means also can be employed to communicate between the processing receiver  26  and the CPAP device  16 . As appreciated by those skilled in the art, wireless means for communicating between various components can be accomplished using radio frequency waves, microwaves, ultrasonic waves, or light optics.  
         [0035]     The treatment nebulizer/atomizer/humidifier device  32  is pneumatically connected to hose  18  at some point along its length between the CPAP device  16  and the typical mask apparatus  36 . The treatment nebulizer/atomizer/humidifier device  32  has a medicament storage chamber  33  where various types of therapeutic medicaments can be delivered to the pneumatic system and to the patient at intervals commanded by the processing receiver  26 . If necessary, a scrubber can be added to the mask air outlet to remove excess medicament if it is inappropriate to vent the medicament into the room air.  
         [0036]      FIG. 2  is an exploded sectional representation view of the mask apparatus  36  demonstrating in more detail of the orientation and components of the mask and the pH sensor holding mechanism. Shown in the Figure are the intake ports  42  and exhaust ports  61 . The senor body  27  is composed of several parts including a sensor holding means  25  and an electrical communication means  50 . Also shown is the strap  38  attached to the mask apparatus  36  at various points.  
         [0037]      FIG. 3  is an inside view showing the configuration and general location of the air passageways. Shown from an inside view are the intake ports  42  and exhaust ports  61 .  
         [0038]      FIG. 4  is a sectional side view taken from  FIG. 3  demonstrating in more detail the relative locations of the mask components, the self-condensing sensor holding mechanism  27 , the self-condensing sensor  34 , and the general flow of the patient&#39;s breath when used in clinical applications.  
         [0039]      FIG. 5  is a perspective representation of another embodiment of the present invention systems, showing the various components of the system. The self-condensing pH senor  34  is shown incorporated within a shield  19  near the terminal end of an extended boom  47  attached to the mask-less headband apparatus  45 . The extended boom  47  is positioned to locate the self-condensing pH sensor  34  within the patient&#39;s breath airway.  
         [0040]     Another example of a mask-less apparatus for containing the sensor is demonstrated in  FIG. 6  where said mask-less apparatus comprises a nasal cannula  55 . The self-condensing sensor  34  is secured with a housing  27  that attached to one end of the nasal cannula  55 . The self-condensing pH sensor  34  is located in the nasal cannula  55  such that it is in pneumatic communication with the nose ports  62  of the nasal cannula  55  which are generally positioned within the nostrils of a patient.  
         [0041]     In this example, as well as the embodiment shown in  FIG. 5 , the pH of the patient&#39;s breath can be continuously monitored. Extending from the self-condensing pH sensor  34  of  FIG. 6  are the sensor electrical communication means  29  which is electrically connected to the display/processing means  26 . Alternately, as shown in  FIG. 5 a  wireless means  40  with an antenna  28  are wirelessly communicating to display/processing means  26 . The self-condensing sensor  34  can provide an immediate reading of the pH of the patient&#39;s breath or the self-condensing pH sensor  34  could be used to measure the pH of the patient&#39;s breath for a period of time to monitor and diagnose certain respiratory conditions. Another potential use of the self-condensing pH sensor  34  in clinical applications is to detect the absence of breath, a condition known as sleep apnea.  
         [0042]      FIG. 7  is a schematic representation of the treatment nebulizer/atomizer/humidifier device  32 , demonstrating a base unit having an on/off switch  102 , operating lights  104 , a medicament chamber  33 , and interconnection  108  for attaching to the pneumatic hose  18 . The treatment nebulizer/atomizer/humidifier device  32  has an outer shell surrounding various mechanical and electrical components that function to deliver the therapeutic dose. The shell can be made of a variety of materials, including plastics such as polyethylene, polystyrene, ABS, nylon, delrin, or polyethylene terephthalate (PET). The treatment nebulizer/atomizer/humidifier device  32  communicates with the processing receiver by direct wiring (not shown) or by use of wireless means employing an antenna means  110 . The base unit and various components of the treatment nebulizer/atomizer/humidifier can be fabricated from polymeric or metallic materials. Operating light  104  can consist of LED, LCD, fluorescent, or halide or other means to communicate such conditions, as on/off, medicament chamber empty, etc. Also, the Applicant contemplates that a plurality of operating lights can be employed having different functions. The art associated with atomization of particles and humidification processes are known in the art. Many commercially available units can satisfy the basic requirements for the treatment nebulizer/atomizer/humidifier device  32 . One such device is the MicroAir portable ultrasonic nebulizer manufactured by Omron Healthcare, Inc. of Vernon Hills, Ill. This device can be modified or fabricated so that 1) it can be remotely activated by the processing receiver  26 , and 2) adapted to connect to the pneumatic tube by an appropriate connection  108  as shown in  FIG. 7 .  
         [0043]     The medicament chamber  33  can contain liquid, gaseous or powdered therapeutics that the treatment nebulizer/atomizer/humidifier device  32  is designed to administer to the pneumatic system upon instructions from the processing receiver  26 . It is contemplated that the medicament chamber  33  could include a plurality of medicaments in various compartments in the medicament chamber  33 . It is also contemplated that a treatment nebulizer/atomizer/humidifier device  32  can be selected to administer one or more, or in a combination, multiple medicaments stored in the medicament chamber  33 . Either a continuous method or, to conserve medicine, a pulsed method corresponding with each breath detected by conventional means can be employed by the present invention.  
         [0044]      FIG. 8  illustrates the partially sectional side view of the self-condensing pH sensor  34 . As shown in this Figure, the partially sectional side view of the sensor apparatus demonstrates various components and their orientation.  
         [0045]     The self-condensing pH sensor  34  consists of an outer tubular member  35  that is usually fabricated by an extrusion or dip coating process using a variety of polymeric materials including polyimide, polyethylene, polypropylene, polyvinyl chloride, polystyrene, ABS, nylon, delrin, polyethylene terephthalate (PET), fluorinated ethylene-propylene (FEP) or polytetrafluoroethylene (PTFE). The outer tubular member  35  generally has an outside diameter in the range of 0.010″ to 0.050″, and preferably between 0.020″ and 0.030″. Its wall thickness is typical for its diameter and generally is in the range of 0.00025″ to 0.002″ and preferably between 0.0005″ and 0.001″. The outer tubular member may include a coating specific for certain applications, e.g. protection from acid environments, dielectric isolation, etc.  
         [0046]     Co-linearly or coaxially aligned within the outer tubular member  35  is an inner tubular member  37  that is also usually fabricated by an extrusion or dip coating process using a variety of polymeric materials including polyimide, polyethylene, polypropylene, polyvinyl chloride, polystyrene, ABS, nylon, delrin, polyethylene terephthalate (PET), fluorinated ethylene-propylene (FEP) or polytetrafluoro-ethylene (PTFE). The inner tubular member  37  has an outside diameter smaller than the inside diameter of the outer tubular member  35  and generally is in the range of 0.015″ to 0.030″, and preferably between 0.020″ and 0.028″. Its wall thickness is typical for its diameter and generally is in the range of 0.00025″ to 0.002″ and preferably between 0.0005″ and 0.001″.  
         [0047]     Located within the inner tubular member  37  is an antimony reference element  46  having a surface area  43  at the terminal end. The antimony element  46  is generally 99% pure and free from significant contaminates. The Applicant contends that the antimony sensor could be replaced with other metallic substances like antimony that exhibit a change in electrical potential when immersed in different pH fluids. Furthermore, other potential materials such as specially formulated polymers, semiconductor technology, Ion Sensitive Field Effect Transistors (“ISFET”s), optical sensing, capacitive sensing, and nanotechnology could be employed.  
         [0048]     The antimony reference element  46  is engaged at its proximal end to an electronic communication means  59 . Typically the electronic communication means  59  comprises electrical wire that has an internal core comprising an electrically conductive metallic material which is encased by a nonconductive jacket. The means of engagement typically employs standard soldering technology and can be supported by a variety of means to provide strain relief. The terminal surface  43  of the antimony reference element  46  defines the distal terminal boundary of the sensor and is the surface that is exposed to liquid or humid gaseous environments. As shown in  FIG. 8 , the antimony reference element  46  and the reference electrode  39  are substantially in the same plane. However, it is anticipated by the Applicants that several designs or embodiments in which the antimony element  46  and reference electrode  39  are not substantially in the same plane. For example, a coaxial design in which the antimony element  46 , protruding beyond the center of the sensor terminal end, has the advantage of providing a greater surface area of antimony element  46  to react with the condensing sample. In addition, a co-linear sensor in which the antimony sensor protrudes past the plane of the wick  41  and the extension that is angled towards the wick  41  provides the advantage of providing a greater surface area but additionally diminishes or reduces the angle between the reference electrodes. Reducing the angle between the wick  41  and the antimony element  46  may provide a more accurate measurement in low humidity conditions. Still another design or embodiment entails either the coaxial or co-linear design, where the antimony element  46  is recessed from the plane of the wick  41 . This design has the potential for greater stability due to the larger film thickness that condenses and resides on the antimony face. In addition, a further benefit of this design is the potential for greater sensitivity in sleep apnea clinical conditions due to the increased angle between the electrodes at the top of the recess. This increased angle may cause the surface tension to break contact between the electrodes more rapidly than on a planar design in the event of a decrease in fluid deposition.  
         [0049]     The performance of the sensor may be enhanced in some environments by the inclusion of a coating on this distal surface. One example would be a hygroscopic coating to enhance the absorption and retention of moisture on the sensor in humidified gases and aerosols. Materials such as hydrophilic polyurethanes, polyacrylamides, poly(2-hydrox-ethyl-methacrylate), other methacrylate copolymers, perfluorinated polymers, polysaccharides, polyvinylchloride polyvinyl alcohol and silicones could all be utilized as surface enhancements either alone, in combination, or with modifications.  
         [0050]     Located proximally, from a range of 1-8 centimeters from the proximal end of the antimony element  46  and preferably 3-5 centimeters, is a reference element  53 . Said reference element  53  is primarily composed of a silver core surrounded with a coating of silver chloride. Technology of dipping a silver core in a high temperature bath of silver chloride to produce the silver chloride coating is employed in the present invention. The resulting coating generally is 0.0001″ to 0.010″ in thickness, and preferably 0.001″ to 0.005″. Reference element  53  is engaged to an electrical communication means  58 , e.g. typical wire that extends to the proximal end of the outer tubular member  35  and can terminate in a typical electrical connector (not shown). An adhesive or polymer plug  65  can be placed in a proximal position to the reference element  53  that is engaged to the outer tubular member  35  which provides support for electrical communication means  58  and  59  and provides proximal sealing of the outer tubular member  35 .  
         [0051]     A reference wick  41  is located between the inside surface of the outer tubular member  35  and the outer surface of the inner tubular member  37 . In one embodiment (see  FIG. 9 ), the inner tubular member  37  is coaxially offset with the outer tubular member  35 . The reference wick  41  partially surrounds the inner tubular member  37  where the area of the offset coaxial design is large enough to contain the fabric or mesh configuration of the reference wick  41 . As discussed in more detail below, reference wick  41  has a mesh or fibrous configuration which functions to entrain or retain an ion conducting fluid  39 . As the mesh or fibrous configuration is compacted, less ion conduction fluid  39  can be entrained or retained. Reference wick  41  is physically separated from the antimony sensor  46  by the wall of the inner tubular member  37 . It is important to the present invention that the reference wick  41  does not engage or contact the antimony sensor  46  at any point. The reference wick  41  can be fabricated from a variety of polymeric based materials. Examples of such materials are polysaccharides, (cotton, regenerated cellulose) polyester, polyethylene, polypropylene, polyvinyl chloride (PVC), polystyrene, ABS, nylon, delrin, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), collagen, Hytrel (thermoplastic polyester elastomer), or any material or combination of materials which exhibit a weave, felt or mesh design that facilitates wicking or ion conduction. One example of a preferable material for the reference wick  41  is a polyester fabric mesh. The reference wick  41  functions as a plurality of capillary tubes which transport electrical ions between the antimony element face  43  and reference element  53 .  
         [0052]     The reference wick  41  is impregnated with an ion conduction fluid  39 . Typical conduction fluids include those that contain sodium chloride or potassium chloride and water. One example that can be used with the sensor is a polysaccharide based gel that is incorporated with a 2-10 percent, with a preferred range of 3-5 percent, solution of potassium chloride and water. Other materials that can function as the reference wick  41  with an ion conduction fluid  39  include ion carrying gels, hydrogels, and excipients. These gels, hydrogels, and excipients aid in reducing the diffusion of contaminants into the ion conduction fluid  39 .  
         [0053]      FIG. 9  is a top view of the terminal end of the self-condensing pH sensor apparatus  34  demonstrating the offset coaxial position of the antimony element  46  and the reference wick  41  with a condensed droplet  56  electrically bridging the antimony element  46  and the reference wick  41 . The self-condensing sensor  34  functions as an electric cell or battery where chemical energy is converted into electrical energy. The sensor utilizes the potential difference that exists between the sensor&#39;s different elements: the antimony sensor  46  and silver chloride reference  53 . When a condensed droplet joins the antimony element terminal surface  43  with the reference wick  41 , a voltage potential is created between the antimony sensor  46  and the reference element  53 . This voltage potential changes relative to the reference element  53  depending on the pH of the condensate that the sensing elements are exposed to. Therefore, by monitoring the potential difference that exists between the antimony sensor  46  and the silver chloride reference  53 , the pH of the condensed droplet can be accurately measured.  
         [0054]      FIG. 10  is a top view of the terminal end of another embodiment sensor apparatus demonstrating the position of the reference wick  41  surrounding an inner coaxially positioned tubular member  37  that contains the antimony sensor  46 . In this embodiment, there is no offset between the coaxially positioned tubular members and the inner tubular member  37 . Inner tubular member  37  is centered within the outer tubular member  35  with reference wick  41  completely surrounding the inner tubular member  37 . This embodiment has the advantage that any droplet which condenses along the circumference of the inner tubular member  37  can potentially form a bridge or junction between the antimony element  46  and the silver chloride reference  53 . Several condensed droplets  56  are shown in  FIG. 10  to electrically bridge between the antimony element  46  and the reference wick  41 . In this particular situation, the average pH of all three droplets would be represented in the potential difference and measured by the sensor apparatus  34 .  
         [0055]      FIG. 11  is a simplified electrical schematic of the general components in the processing receiver  26 . In the center is the microprocessor  70  that processes the information supplied by the thermistor/thermocouple and pH sensor  34  and uses internal instructions to control other devices. The microprocessor  70  has an EEPROM memory section that allows for specific programming to be incorporated as processing instructions. Furthermore, the microprocessor must have the capability to convert analog signals into digital information for decoding and processing. An example of a microprocessor that could be used in the processing receiver  26  is the PIC16F876 28-pin 8-Bin CMOS FLASH micro-controllers manufactured by Microchip Technology, Inc. This particular microprocessor has a 128K EEPROM Data memory bank for flash memory of specific instructions and utilizes a 35-word instruction set. It also has five 10-bit Analog-to-Digital Inputs that are necessary for converting the information obtained from the pH sensor  34  and thermistor  52  from its analog format into a digitized form for processing by the instruction sets of the microprocessor  70 .  
         [0056]     The microprocessor  70  includes a timing crystal  72  used for clocking operations and is connected to and energized by an approximate 12 volt power supply  69 . Also included in the circuit is a nominal 5-volt regulator  68 , and a ground  78 .  
         [0057]     The sensor analog data that is communicated either through direct wiring or through a wireless means that is then amplified by a circuit  74  and connected to the microprocessor  70  through one of the analog-to-digital modules.  
         [0058]     In addition, the thermistor analog data that is communicated either through direct wiring or through a wireless means is amplified by circuit  76  and connected to the microprocessor  70  through another one of the analog-to-digital modules.  
         [0059]     In certain embodiments, the transmitted data can be recorded, compressed and stored as it is received using a memory chip set or memory circuit within the microprocessor (not shown). Subsequently, the data stored can be downloaded into an external data retrieval device, which can be a computer or other analysis machine.  
         [0060]      FIGS. 12 and 13  illustrate flowcharts showing the sequential computational steps employed by the processing receiver  26 . As described above, the microprocessor  70  has an EEPROM memory section that allows for specific programming to be incorporated as processing instructions. The steps programmed in the microprocessor  70  are outlined in the flowcharts, starting with the 1) monitoring of breath chemistry  120  without CPAP support ( FIG. 12 ) 2) the monitoring of breath chemistry and breathing rates ( 122 ) with CPAP support ( FIG. 13 ). The analog information obtained from the sensor and the thermistor is converted to digital information and transferred to the microprocessor. The microprocessor uses the thermistor data to calculate an accurate pH level that is stored in a registry. Optionally, this data can be diagnosed by the microprocessor  140  and stored in a memory bank whereby the microprocessor can create diagnostic reports  150 .  
         [0061]     The stored data is then compared to a threshold value or range  160  programmed in the instruction set of the microprocessor  70 . For example, if the pH level does not reach the threshold value, then no actions are performed and the instruction set loops back to read breath chemistry ( FIG. 12 ) or breath chemistry and monitor breathing rates ( FIG. 13 ). If the pH level reaches the threshold value, then the microprocessor  70  determines the appropriate therapy  170 .  
         [0062]     It is also anticipated by the Applicants that the present invention diagnostic means will examine the pH waveform patterns produced to diagnose diseases.  
         [0063]     These computational steps can be continued over and over again to detect, record, analyze and administer the appropriate therapeutic regime to manage patients with certain respiratory conditions.  
         [0064]     The present invention will: 1) Monitor; 2) Diagnose; 3) Treat a respiratory disease, with and without CPAP therapy.  
         [0065]     While the invention has been described in detail and with reference to specific embodiments thereof, it will be apparent to one skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope thereof.