Abstract:
A sensor system for diagnosing dental conditions includes a sensor unit which is in contact with an oral fluid such as saliva or gas, and which is operative to provide detectable signals indicative of at least two of hydrogen ion concentration, hydroxyl ion concentration, calcium, phosphate, sulfur, sulfur containing compounds, nitrogen containing compounds, microbial metabolites, and microbes. The system includes a signal processor which is in communication with the sensor unit and which operates to provide a processed signal indicative of one or more dental conditions. The signal processor transmits the processed signal to a storage and display device which displays a user detectable diagnostic message indicative of a dental condition, or suggestive of a remedial action.

Description:
RELATED APPLICATION  
       [0001]    This application claims priority of U.S. Provisional Patent Application No. 60/244,309 filed Oct. 30, 2000 and entitled “Dental Caries Reduction Using pH Monitoring”. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The invention relates to dental health, in particular caries reduction. More particularly, the invention relates to a system for monitoring one or more dental conditions.  
         BACKGROUND OF THE INVENTION  
         [0003]    Tooth enamel is formed from an insoluble form of calcium phosphate also known as hydroxyapatite. The enamel is formed in rods within a largely inorganic matrix material containing hydroxyapatite, some protein, and other compounds.  
           [0004]    Oral bacteria form plaque deposits around the teeth. For example, the bacterium  Streptococcus mutans  ( S. mutans ) produces a molecule called glucan which helps the bacteria to bind themselves to the teeth and form plaque deposits. The plaque bacteria metabolize sugars and carbohydrates and as a byproduct form lactic acid. Tooth enamel is slightly soluble in the acidic environment which is produced. Calcium ions and phosphate ions enter solution, and so the enamel is stripped away, a process called demineralization. However, enamel may be remineralized between meals due to the action of calcium and phosphate ions present naturally in the saliva.  
           [0005]    U.S. Pat. Nos. 5,275,161 and 5,628,313 describe systems and methods for diagnosing periodontal disease based upon the polarographic measurement of sulfide concentration in the mouth. U.S. Pat. No. 6,264,615 shows a similar method which is used to diagnose halitosis.  
           [0006]    In U.S. Pat. No. 5,993,786, Chow et al. describe how calcium compounds such as calcium phosphate may be added to toothpaste, chewing gums, gels, etc., to enhance remineralization. The combination of calcium phosphate and fluoride ions is known to enhance remineralization. Other patents also describe remineralization products.  
           [0007]    In U.S. Pat. No. 5,981,300, Moll et al. describe test kits for indicating the risk of dental caries. However, the kits include sugar-containing compositions.  
           [0008]    In U.S. Pat. No. 5,306,144, Hibst et al. describe optical viewing of caries by e.g. irradiating with blue light and viewing red light (a reflection/fluorescence method).  
           [0009]    In U.S. Pat. No. 5,357,989, Gathani describes dental floss impregnated with a pH indicator.  
           [0010]    In U.S. Pat. 4,582,795, Shibuya describes enzymatic detection of oral microorganisms. However, the test is slow.  
           [0011]    In U.S. Pat. No. 4,976,951, Rosenberg describes the localization of caries. However, this requires a slow incubation period.  
           [0012]    All of the foregoing prior art approaches involve methods for detecting various dental conditions; however, these methods all rely upon the use of specific chemical compounds and/or test apparatus. However, none of the prior art approaches are operable to simultaneously measure a number of dental parameters and to provide a user detectable diagnostic message indicative of the state of the user&#39;s health. Furthermore, none of the prior art approaches are integratable with data storage and management devices such as a personal digital assistance (PDA), personal computer, central computer, or the like. As will be detailed hereinbelow, the present invention provides a monitoring system which can be integrated with personal health monitoring equipment such as an individual, handheld calorimeter, and can be further operable in connection with personal data storage devices. The system of the present invention operates to monitor parameters indicative of dental health, and is further operative to provide a user with a display which describes the state of the user&#39;s dental health and/or suggests corrective actions. These and other advantages of the invention will be apparent from the drawings, discussion and description which follow.  
         BRIEF DESCRIPTION OF THE INVENTION  
         [0013]    There is disclosed herein a sensor system for diagnosing dental conditions. The system is based upon a sensor unit which is configured to be disposed in communication with a user&#39;s mouth so as to be contacted by oral fluids such as gas or liquid. The sensor unit is operable to provide detectable signals indicative of the presence of at least two species selected from the group consisting of: hydrogen ion, calcium ion, phosphate ion, sulfur, organosulfur compounds, nitrogen containing compounds, microbial metabolites, and microbes. (It is to be understood that these species may be detected in their ionized or unionized forms, as appropriate.) The system further includes a signal processor in communication with the sensor unit. The signal processor is operative to process the detectable signals and to provide a processed signal indicative of a dental condition. The processor is further operative to transmit the processed signal to a storage and display device which displays a user detectable diagnostic message. In some instances, the sensor is further operative to provide a detectable signal indicative of the concentration of the members of the group. The storage and display unit may comprise a personal digital assistant, computer or the like.  
           [0014]    In specific embodiments, the signal processor is operative to transmit the processed signal to the storage and display device via a wireless data link. In yet other embodiments, the sensor unit may be operable to further provide a visual display of the tooth, or a signal indicative of the integrity of the tooth. The diagnostic message displayed by the display device may be indicative of the user&#39;s dental condition and/or may suggest a remedial action to the user for the purpose of restoring dental health.  
           [0015]    The sensor unit may be configured to be disposed in the user&#39;s mouth so as to sense the composition of liquids and/or gases therein. Alternatively, the sensor unit may be disposed external of the user&#39;s mouth and be configured to receive exhaled gases from the user. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]    [0016]FIG. 1 is a sensor unit of the present invention which is configured in the form of a probe which is placed in a user&#39;s mouth;  
         [0017]    [0017]FIG. 2 is a depiction of a portion of another embodiment of sensor of the present invention configured to be placed within a user&#39;s mouth;  
         [0018]    [0018]FIG. 3 shows the probe of FIG. 2 in one mode of use;  
         [0019]    [0019]FIG. 4 shows the probe of FIG. 2 being read by a signal processor;  
         [0020]    [0020]FIG. 5 is a depiction of another embodiment of the present invention comprised of a sensor unit having a signal processor integral therewith;  
         [0021]    [0021]FIG. 6 depicts yet another embodiment of the present invention having an oral probe;  
         [0022]    [0022]FIG. 7 shows yet another probe which may be used in the present invention;  
         [0023]    [0023]FIG. 8 shows an embodiment of the present invention wherein a sensor probe is coupled to a PDA;  
         [0024]    [0024]FIG. 9 shows another embodiment of the present invention wherein a sensor probe including an ultrasonic imaging device is coupled to a PDA; and  
         [0025]    [0025]FIG. 10 shows an embodiment of the present invention as configured to sense a gaseous fluid stream. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0026]    The sensor structures of the present invention are operable to provide detectable signals indicative of at least two different parameters associated with dental health, and in specific embodiments, these detectable signals are provided simultaneously. The detectable signals may be directly, visually detectable. In other instances, the signals will only be visible after subsequent chemical treatment, in which instance they are also characterized as being chemically detectable. In yet other instances, the signals will be electronically detectable. All of such signals are collectively termed detectable.  
         [0027]    [0027]FIG. 1 shows an elongated sensor structure shown generally at  10 , preferably in the shape of a toothpick. The structure  10  has a holding end  24  adapted to be held between the fingers, and a sensing end  26 , adapted to be placed in the mouth of a person. The outer surface of the sensing end  26  is formed by a permeable layer  12 , which surrounds indicating regions  14 ,  16 , and  18 . Indicating regions are adapted to have a visible response to the oral environment. An inert material  20  forms the inner body of the holding end, and is largely surrounded by film  22  which is adapted to assist holding of the sensor structure.  
         [0028]    In one particular embodiment, as shown in FIG. 1, indicating region  14  has a visible response to pH, region  16  has a visible response to calcium (either neutral or ionized), and region  18  has a visible response to phosphate ions. In another embodiment regions  14 ,  16  and  18  have visible responses to different pH ranges, for enhanced sensitivity to pH changes. In another embodiment, one or more indicating regions have a visible response to oral bacteria. In another embodiment, one or more indicating regions have a visible response to the products of oral bacteria, such as sulfur (either neutral or ionized) sulfur-containing compounds (e.g. hydrogen sulfide or organosulfur compounds), nitrogen-containing compounds (such as pyridine derivatives), other organic compounds, and other inorganic compounds. Visible responses include color changes, fluorescence changes, and the like, as viewed in ambient light or under an external radiation source.  
         [0029]    Preferably, permeable layer  12  is transparent or translucent. The sensed analyte diffuses through permeable layer. Hence, for pH-induced calorimetric changes of the indicating regions, ions such as hydrogen ions and hydroxyl ions diffuse through the layer  12 . In another embodiment, permeable layer  12  may extend over the holding end.  
         [0030]    One or more indicating regions may be used. The functionality of indicating regions may be all different, repeated at spatial intervals, or all similar. For example, a periodic pattern of indicating regions would be used to investigate conditions at different locations within the mouth.  
         [0031]    In other embodiments, permeable layer  12  and film  22  are omitted, and the structure has form of a plastic toothpick, having a polymeric region near the sensing end providing a visible response to oral conditions, such as pH or the presence of oral bacteria.  
         [0032]    In one embodiment, the sensing end has a visible response to the presence of  S. mutans  or other oral bacteria U.S. Pat. No. 5,492,674 by Meserol, herein incorporated in its entirety by reference, describes the use of an antibody-antigen complex with a fluorescent response. Such techniques are known to those skilled in the art of immunology. FIG. 7 shows a structure  100  adapted to provide a visible response to oral bacteria. Fluorescent indicating region  106  is formed around a central cylindrical fiber  108 . The structure  100  has a radiation source  110 , preferably a light emitting diode, powered by a battery  112 . Membrane  102  covers the fluorescent indicating region, and is permeable to  S. mutans.  Film  104  assists grip of the holding end. Regions  116  and  114  are inert regions, providing mechanical strength. Radiation from the source  110  passes along fiber  108  and excites the fluorescent indicating region  106 . Region  106  is adapted to provide a fluorescent response to oral bacteria, using techniques known in the immunological arts. A switch, such as a pressure sensitive switch activated by holding the structure  100 , may be provided to control the application of power to source  110 . In another embodiment, fiber  108  is extended through the region  114 , so as to allow the exciting radiation to be provided externally, allowing the battery and source to be absent from structure  100 . In another embodiment, fiber  108  is replaced by a cavity.  
         [0033]    Other embodiments of the present invention may be used to detect the acidity, ion levels, and bacteria content of saliva samples extracted from the mouth, for example into a capillary tube lined with an indicating medium, or saliva sucked from around the base and gaps between teeth.  
         [0034]    [0034]FIG. 2 shows the sensing end of another embodiment  30 . This has a permeable layer  32 , a pH-sensitive colorimetric response layer  34 , and an inert rigid or flexible core  36 . A core such as  36  may be used to transmit light from a light source nearer the holding end, so as to excite fluorescence or illuminate a calorimetric response region.  
         [0035]    In use the structure (e.g.  10 ,  30 , or  100 ) is placed into the mouth so that the sensing end is exposed to oral environment. FIG. 3 shows structure  30  placed against teeth  40  of the person. Saliva droplets  44  contact the sensing end of the structure  30 . A color response of the sensing end  44  is preferably used to indicate acidic levels of pH of the saliva. For example, the sensing end of the structure may turn from colorless to red in the presence of an acidic environment. This warns the user that conditions exist favorable for the formation of dental caries.  
         [0036]    A color response to ion levels in the saliva is useful in preventing dental caries. A certain minimum level of calcium and phosphate ions in the saliva is desirable to assist in the remineralization of enamel between meals. If no indication of calcium ions or phosphate ions is shown using such a structure, the user would be advised take action, e.g. chewing appropriate gum, using mouthwash, applying gels, etc., to enhance the levels of these ions. Such formulations are known in the dental care art, and may contain for example calcium phosphate, calcium stearate, and other calcium-containing compounds or phosphate-containing compounds. Fluoride ions are also known to assist in enamel remineralization, so indicating regions for fluoride ions may also be used, or fluoride-containing formulations can be used. In other embodiments, the sensing end contains reference regions not exposed to the oral environment to assist the quantitative determination of pH or other ion levels from the visible response.  
         [0037]    Preferably, the visible response chemistry used in the indicating regions does not diffuse out of the permeable membrane. Preferably, the visible response chemistry is nontoxic. A polymeric material is advantageous, in which molecular moieties providing the visible response are covalently attached to a polymer backbone.  
         [0038]    [0038]FIG. 4 shows the structure  30  placed into a reading device  50  which is a plug-in accessory to a personal digital assistant (PDA)  60 . The reading device analyzes the visible response of the structure to the oral environment, and provides data such as pH which is communicated to software running on the PDA. The display  62  of PDA  60  is used to provide feedback to the person, for example to prompt the user to clean teeth, chew gum, use mouthwash, etc. The term PDA refers to any portable device with computing capability and a display (or other method to transmit information to a user), such as a portable computer, pager, e-book, wireless phone, and the like.  
         [0039]    [0039]FIG. 5 shows another embodiment. A disposable sensor structure is formed from outer membrane  78 , transparent medium  76 , indicating region  80 , and a reflector  82 . Disposable sensor  86  makes an optical interface with an electronic analysis device  70 . This device provides a radiation source  72  and radiation detector  74 . Disposable sensor  86  is placed in the mouth. Radiation emitted from source  72  in the analysis device is reflected by reflector  82  back to detector  74 . Radiation levels received by detector  74  are changed due to the visible response of indicating region  80  to the oral environment, for example saliva pH. The radiation level at the detector will increase or decrease depending on the radiation wavelength and exact nature of the visible response of the indicating region to the oral environment. A color filter may be placed in front of the detector and/or radiation source. The reflector  82  is optional, as the radiation may also be reflected from the inner curved surface  84  of the membrane  78 .  
         [0040]    Analysis circuitry within device  70  allows determination of the pH value based on the response of the detector. The pH may be shown on a display mounted on the housing, or transmitted to a PDA for display. Device  70  may be an accessory module for a PDA, such as plug-in module, in which case the display of the PDA may be used to display the measured pH and any relevant feedback.  
         [0041]    Optical fibers, preferably plastic fibers, may also be used to transmit radiation to the sensing end of the pH indicating structure, and carry back reflected or scattered radiation to the detector.  
         [0042]    [0042]FIG. 6 shows another embodiment of the invention. Electronic analysis device  70  provides a radiation source  72  and radiation detector  74 . Device  70  makes optical and mechanical connection to a plastic fiber  90 . Radiation emitted by radiation source  72  is reflected by the end of the fiber  92  back to the detector  70 . Preferably, the fiber is made from an optical plastic containing a pH indicator, which provides a visible response to ions diffusing into the fiber material. Preferably, the pH indicator is a non-toxic polymer. In one embodiment, the fiber  90  has a porous (or permeable) indicating region near the end  92 , with the visible response provided by an indicating chemistry within the indicating region. In another embodiment, the fiber may also have a fluorescent response to ions or bacteria in the saliva. The fiber may also contain radiation reflectors, optical filters, dyes, or other optical elements. The fiber is placed in the mouth, and the reflected radiation detected. Radiation emission and detection of two different wavelengths may also be used to more accurately determine the color response of the indicating chemistry, as the ratio of attenuation at two or more suitable wavelengths is a sensitive method of determining pH change from calorimetric pH indicators.  
         [0043]    In U.S. Pat. No. 5,188,109, Saito describes an artificial dental root for physiological monitoring. Such a device may also be adapted for saliva monitoring. However, it is not necessary to provide a dental root for oral environment monitoring. An artificial crown, or cap, may be provided containing pH sensing chemistry or electronic devices. The device may be powered by a piezoelectric crystal, for example by chewing or by a radiation source, or by ambient electromagnetic radiation such as is found at the frequency of mains electricity, or by using one or more radio station transmissions. The dental crown or cap may have additional finctionality. For example, the device may be used to detect sugar content of foods, chewing motion, and other diet-related parameters. Using an oscillating piezoelectric crystal within the dental crown, feedback may be provided by the mechanical coupling between the tooth and the inner ear of the person. For example, a person might hear a voice inside their head saying “stop eating now” if sugar is detected over a long time period, or if chewing is prolonged. The adapted crown may also convert wireless transmissions, e.g. from a PDA, into a signal audible to the person.  
         [0044]    The crown-based sensor may also be provided with functionality to communicate with a PDA. For example, a person may bring a PDA close to the mouth. The dental crown may be in wireless communication with a PDA, so that the PDA can communicate with the user by vibrations of the crown. Radiation from the PDA may power the sensor transmitter in the tooth crown. Sensors within the crown measure the pH of the saliva, and the value is transmitted back to the PDA. The PDA is then used to provide feedback to the person. The crown sensor may also contain ultrasonic transducers which probe the density of the tooth and surrounding bone.  
         [0045]    An accessory to a PDA (personal digital assistant) or other computing device may be used to form images of the teeth and display them conveniently to the user. FIG. 8 shows a PDA  60  with display  62  connected using cable  126  to a handheld probe  120 . Optical imaging of teeth is performed using probe  120  having an optical image sensor  124  and light source  122 . The image of tooth  128  is shown on the PDA display  62 . In an alternative embodiment, the probe may transmit image data using wireless methods, such as the Bluetooth wireless protocol. An array of optical fibers may also be used in imaging. A person may rinse first with known formulations that enhance the visibility of plaque deposits, for example by staining (e.g. as described by Yamauchi in U.S. Pat. No. 4,347,233, and Kowalyk in U.S. Pat. No. 5,456,603). Fluorescent imaging of teeth may indicate regions of possible decay, as is known in the dental arts. In the fluorescent imaging embodiment, light source  124  is preferably a blue or UJV light emitting diode. FIG. 9 shows a PDA  60  with display  62  connected using cable  126  to a handheld ultrasonic imaging device  130 . Device  130  provides micromachined ultrasonic transducer arrays  132  and  134 , which are used for imaging teeth and detecting decay. Attenuation, transit time, and broadband spectral response images of tooth  128  are shown on PDA display  62 . An advantage of this embodiment is that the computing power and display of the PDA are used in dental diagnosis.  
         [0046]    [0046]FIG. 10 shows a person breathing through a respiratory analyzer (such as an indirect calorimeter or a spirometer) shown generally at  140 , having a respiratory connector in the form of a mask  142 . Optional straps  144  or a hand are used to hold the mask against the face. A button  146  is used to initial a testing cycle. A display  148  is used to display data to the user. In another embodiment, a mouthpiece and nose clip are used instead of the mask to exclude air from the sinuses. An indirect calorimeter used in a preferred embodiment is fully described in a co-pending application to James R. Mault, M.D., Ser. No. 09/630,398. Exhaled air passing through the flow path of the respiratory analyzer is analyzed to diagnose the oral condition. In one embodiment, the exhaled air passes over a sensor for  S. mutans , preferably a fluorescent sensor. In another embodiment, a pH sensor, preferably a fluorescent sensor, is located in the flow path so as to detect acidic components of the breath. Oral-related breath acidity is determined using the response to the initial component of exhaled air, which may be termed “mouth air”.  
         [0047]    This provides a method of diagnosing an oral condition for a person, comprising of having the user exhale through a flow path, so that exhaled breath flows over fluorescence sensor adapted to provide a response correlated with the presence of acidic components in exhaled breath. Hence acidic components of the exhaled breath (such as lactic acid traces in water droplets, and other components) are qualitatively or quantitively determined, so as to provide a diagnosis of oral condition.  
         [0048]    Exhaled air contains a mixture of organic and inorganic trace gases, such as pentane, hydrogen sulfide, and others which are known in the art. The complex signature of such trace gases in the first component of exhalation (oral-related breath, or mouth breath) is diagnostic of oral conditions. Hence, determination of the ratio of concentrations of two gases in the exhaled air, such as hydrogen sulfide and ammonia, may be used to provide an indication of the oral condition, such as saliva pH. Shallow, frequent breaths are advantageous in respiratory oral diagnosis. Saliva pH influences the bacterial population distribution in the mouth, and hence detection of bacterial byproducts in exhaled breath can be used to determine oral acidity, and other indicators of oral health.  
         [0049]    Stomach bacteria such as  Helicobacter pylori  may also be detected in exhaled air, particularly if belching is induced, using fluorescent sensors in the flow path of a respiratory analyzer. The use of (for example) immunological fluorescent sensors to  H. pylori  is simpler than the detection method disclosed by Katzmann in U.S. Pat. 6,067,989.  
         [0050]    Periodontal disease may be diagnosed using the detection of compounds such as pyridine, alkyl-pyridines, hydrogen sulfide, ammonia, urea, thiols, and other sulfur and/or nitrogen containing compounds, as described by Preti in U.S. Pat. No. 4,334,540, herein incorporated by reference. Hence, embodiments of the present invention sensitive to such compounds are useful in the early detection of periodontal disease. A sensitive colorimetric response in the sensing end of a structure such as  10  may be used to indicate diagnostic levels of hydrogen sulfide in the saliva. An immunological response to bacteria related to periodontal disease may also be used, for example a fluorescent detection method. Respiration analysis may be used to detect compounds diagnostic of periodontal disease. A colorimetric, fluorescent, micromachined, or other gas sensor may be provided in the flow path of a respiratory analyzer, such as a spirometer, indirect calorimeter, or other analytic instrument. Ultrasonic transducers may be used to determine flow rates and breath flow profiles. The origin of breath components is assisted by knowing the time in the breath higher concentrations occur. For example, oral origin gases occur early in an exhalation.  
         [0051]    Yet other embodiments and variations of the present invention will be readily apparent to one of skill in the art in view of the teaching presented herein. The drawings, discussion and description are illustrative of specific embodiments of the present invention, but are not meant to be limitations upon the practice thereof. It is the following claims, including all equivalents, which define the scope of the invention.