Abstract:
In the method of measuring pH of vaginal or other tissue moisture, the steps that include providing an indicator that exhibits a characteristic color when contacted with the moisture, the color being a function of moisture pH; obtaining a vaginal or other tissue moisture sample and transferring moisture from the sample to an indicator, outside the body, whereby the indicator then exhibits a characteristic color, which is a function of pH of the moisture; and providing a color comparison measurement means, and comparing the indicator characteristic color with color comparison measurement means. Also provided are test kit structures to enable performance of such pH measurement, as used for estrogen need determination and the presence or absence of amniotic fluid; and also to determine presence of amines produced by pathogenic bacteria, or flagellates (trichomonas).

Description:
BACKGROUND OF THE INVENTION  
       [0001]    This application is a continuation-in-part of prior U.S. application Ser. No. 09/072,257 filed May 4, 1998, which is a continuation-in-part of prior U.S. application Ser. No. 08/890,748 filed Jul. 11, 1997, now U.S. Pat. No. 5,916,176, which is a continuation-in-part of prior U.S. application Ser. No. 08/699,251 filed Aug. 19, 1996, now U.S. Pat. No. 5,735,801, which is a continuation-in-part of prior U.S. application Ser. No. 08/570,534 filed Dec. 11, 1995, now U.S. Pat. No. 5,762,614, which is a continuation-in-part of prior U.S. application Ser. No. 08/537,379 filed Oct. 27, 1995, now U.S. Pat. No. 5,577,512, which is a continuation-in-part of prior U.S. application Ser. No. 08/376,830 filed Jan. 23, 1995, now U.S. Pat. No. 5,664,579, which is a continuation-in-part of prior U.S. application Ser. No. 08/295,399 filed Aug. 25, 1994, now U.S. Pat. No. 5,425,377. 
     
    
     
         [0002]    This invention relates generally to pH measurement of body fluid, such as vaginal moisture, and more particularly to a rapid and easily performed method of obtaining such measurement, as well as apparatus to perform the method. The invention also relates to detection of pathogenic bacteria in the vagina, for example in association with such pH measurement, whereby more complete testing can easily be achieved.  
           [0003]    There is continual need for improvements in testing and measurement methods, as referred to; and in particular there is need for effecting such testing and measurements without introduction of possibly toxic materials or substances into the vagina or other body cavities or parts.  
         SUMMARY OF THE INVENTION  
         [0004]    It is a major object of the invention to provide improved testing and measurement methods and procedures that meet the above need, and overcome prior difficulties, as referred to.  
           [0005]    Basically, an important method provided by the invention includes the steps  
           [0006]    a) providing an indicator that exhibits a characteristic color when contacted with vaginal or other body tissue moisture, the color being a function of moisture pH,  
           [0007]    b) obtaining a vaginal or tissue moisture sample and transferring moisture from the sample to the indicator, outside the vagina or tissue sampled, whereby the indicator then exhibits a characteristic color, which is a function of pH of the moisture,  
           [0008]    c) providing a color comparison measurement means, and comparing the indicator characteristic color with the color comparison measurement means.  
           [0009]    As will appear, a vaginal or tissue moisture receiver is typically provided to be supported on a carrier, to be manipulated to obtain the vaginal or tissue moisture sample on the receiver, for transfer to the indicator, outside the vagina or other anatomic site.  
           [0010]    It is another important object to provide a package which includes structure supporting said indicator and said carrier for the receiver, and including the step of removing the carrier from the package for use in obtaining said moisture sample on the receiver.  
           [0011]    As will be seen, the color comparison measurement means is typically provided to extend proximate said indicator, in or on the package; and may be provided to include portions of varying color that are arranged in one of the following ways:  
           [0012]    i) in a generally linear sequence,  
           [0013]    ii) in a sequence to at least partially surround the indicator.  
           [0014]    Further, the indicator may include multiple sections, and the color comparison measurement means typically includes color swatches, at least one swatch located proximate each indicator.  
           [0015]    Another object is to provide the carrier in the form of an inserter, or stick, and the receiver is supported proximate an end of the stick, the receiver provided in the form of a swab, and a shoulder is provided on the stick to limit depth of insertion of the swab, into the vagina.  
           [0016]    A further object is to provide a second indicator supported by the package, the second indictor including a reactant or reactants characterized as changing color when contacted with moisture containing amine, and including transferring moisture from the sample to the second indicator, outside the vagina, whereby a change in color at the second indicator indicates the presence of pathogenic bacteria in such moisture.  
           [0017]    It is an additional object to repeat the basic pH detector method, at intervals over a time period sufficient to detect changes in vaginal or other tissue moisture pH levels, indicative of need for estrogen, antibiotics or other therapy.  
           [0018]    Yet another object is to provide apparatus that includes:  
           [0019]    a) a package,  
           [0020]    b) a pH detector on the package,  
           [0021]    c) the detector including a pH indicator responsive to reception of vaginal or other tissue moisture, to change color indicative of pH level, when such moisture is transferred to the indicator, outside the body.  
           [0022]    A yet further object is to provide a comprehensive method that includes, in combination  
           [0023]    a) providing an indicator that exhibits a characteristic color when contacted with vaginal or other tissue moisture, said color being a function of moisture pH,  
           [0024]    b) obtaining a vaginal or other tissue moisture sample and transferring moisture from the sample to the indicator, outside the body, whereby the indicator then exhibits said characteristic color, which is a function of pH of said moisture,  
           [0025]    c) providing a color comparison measurement means, and comparing said indicator characteristic color with said color comparison measurement means.  
           [0026]    In the above form of apparatus, the pH detector may typically include an indicator or indictors responsive to reception of vaginal or tissue moisture to change to a color or colors indicative of pH level, and there being color comparison measurement means associated with said indicator or indicators, on a package.  
           [0027]    Further, the color comparison measurement means typically may extend close to and at least part way about said indicator, whereby a small indicator area may be effectively employed for reception of a minimum amount of collected moisture.  
           [0028]    An additional object is to provide a pH test for presence of amniotic fluid, as may collect on a surface.  
           [0029]    These and other objects and advantages of the invention, as well as the details of an illustrative embodiment, will be more fully understood from the following specification and drawings, in which: 
       
    
    
     DRAWING DESCRIPTION  
       [0030]    [0030]FIG. 1 is a plan view of a kit or package in which one form of the invention is embodied;  
         [0031]    [0031]FIG. 2 is a section taken on lines  2 - 2  of FIG. 1;  
         [0032]    [0032]FIG. 3 is a view like FIG. 1, showing a modified form of the kit;  
         [0033]    [0033]FIG. 3 a  shows amniotic and/or other leaking fluid collection on a surface;  
         [0034]    [0034]FIG. 4 is a view like FIG. 1 showing a still further modification;  
         [0035]    [0035]FIG. 5 is a view showing a modified inserter;  
         [0036]    [0036]FIG. 6 is a plan view of a modified moisture receiver on a flexible carrier;  
         [0037]    [0037]FIG. 7 is a view like FIG. 6, but showing the carrier in the form of a flexible glove;  
         [0038]    [0038]FIG. 8 is a plan view showing a still further modified kit, or package. 
     
    
     DETAILED DESCRIPTION  
       [0039]    In FIG. 1, a kit or package  10  is elongated, and carries a pH detector such as a strip  11  of indicator material. Strip  11  may be located on the exterior surface of the package  10 , or within the package as on a removable card  12 . Also removably carried by the package, as on the removable card, is a means or device for obtaining a sample of vaginal or tissue moisture, for transfer to the indicator strip. In other words, the indicator is typically not inserted into the vagina, or other cavity since only the inert material of the moisture receiver is inserted, whereby any potential or possible toxic effect is obviated, i.e. is not presented or encountered.  
         [0040]    The moisture receiver is shown in the form of a moisture collecting swab  13 , on an elongated inserter, such as a stick  14 . In use, the card is removed endwise from a receptacle  10   a  which may be formed by the kit, and the inserter  14  with swab  13  attached is removed from the card. Since the indicator strip  11  is preferably located on the card, it too is removed from the protective receptacle  10   a  and presented for use, when the card is removed from the receptacle  10   a.    
         [0041]    After a sample of vaginal or other cavity moisture is obtained on the swab, it is transferred to the indicator strip, by rubbing of the swab on the indicator. The indicator is responsive to reception of such moisture to change to a color corresponding to moisture pH level. One such useful indicator is a NITRAZINE® strip adhered to the card. Alternatively, it may be adhered to the outer surface of the receptacle or package  10 .  
         [0042]    A pH correlating color comparison measurement means is provided as at  15  in sufficiently close association with said detector or indicator  11  to allow visual comparison of the changed color exhibited by the indicator with a pH correlated color provided by said measurement means. See for example the series of bands, each having a different color corresponding to a pH level color to which the detector strip may change. See for example the indicated pH levels 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 and 7.5 adjacent the colored bands. The bands may be provided on a strip adhered to the sleeve or receptacle  10   a.  Paper strips providing such elements are known, and sold under the name HYDRION PAPERS®. “HYDRION PAPERS” is a trademark of Micro Essential Laboratory, Inc., Brooklyn, N.Y. 11210. The band for pH 4.5 is typically bright yellow; the band for pH 6.0 is olive in color; and the band for pH 7.5 is navy blue, and color gradations appear on the intermediate bands.  
         [0043]    The indicator  11 , after its exposure to moisture and color change, as referred to, may be brought into lateral registration with the color comparison bands, as by movement of the card  12  relative to the receptacle or sleeve  10   a,  and to the bands on that sleeve. For example, the card carrying the indicator may be moved within the sleeve, which guides its endwise movement, and brings the characteristically color changed portion of the indicator into registration with successive bands, for matching purposes. The card may also be moved outside the receptacle to effect the color matching. Alternatively, the indicator and bands may be affixed or positioned on the same object, such as the card, or the outer surface of the receptacle  10   a.    
         [0044]    A zone  19  of the receptacle  11   a  may be made transparent to allow visual observation of the indicator through that zone, and adjacent the bands, as the card is moved within the receptacle.  
         [0045]    [0045]FIG. 3 shows a modification in which a card or receptacle  20  carries on its surface a fixed indicator  21  as referred to, in a localized area, to receive moisture transfer from a swab  22  on a stick  23  associated with or removable from  20 . The color comparison bands seen at  24   a - 24   f  are here presented in a generally circular sequence, extending about, or at least part way about, and close to, the localized indicator  21 . This facilitates ease of color comparison, and requires no movement of the indicator relative to the bands  24   a - 24   f,  since each of the bands extends close to the indicator. Card  20  may be received endwise within a protective receptacle seen at  25 .  
         [0046]    Also shown in FIG. 3 is a second indicator  30  carried by the receptacle  20  or card surface. That indicator constitutes an amine detector, to receive transfer of vaginal moisture. The second detector or indicator may typically include, or otherwise receive, a reactant or reactants characterized as changing color when contacted by vaginal moisture that contains an amine, such as putrecine or cadaverine. Such color change indicates the presence of pathogenic bacteria or flagelate protozoa (genus trichomonas) in the vagina or other site. The second indicator may be selected from the group consisting of Bromocresol Green, Bromocresol Purple, Nitrazine Yellow, Bromophenol Blue, and equivalents. Reactant or reactants may include an alkali substance selected from the group that consists essentially of potassium hydroxide, sodium aluminate, magnesium hydroxide, sodium hypochlorite and sodium carbonate, applied as at  26 , and from a source  26   a.  See also Caillouette U.S. Pat. Nos. 5,782,801 and 5,827,200 with regard to application of reactants, such patents incorporated herein by reference.  
         [0047]    Accordingly, the embodiment shown in FIG. 3 represents a dual test, one for pH, and the other being a colorometric test for presence of amine—the product of pathogenic organisms bacteria, or flagellates (trichomonas).  
         [0048]    It will be understood that the pH determination method may be repeated at intervals (such as daily) over a time period (and using kits or packaging as described) sufficient to detect changes in vaginal moisture pH level or levels, indicative of need for estrogen therapy. See in this regard U.S. Pat. No. 5,916,176, to Caillouette, incorporated herein by reference.  
         [0049]    [0049]FIG. 4 shows a number of indicators  54  on one card  28 , and circularly arranged color test bands  55  about each indicator, as in FIG. 3. This provides for test verification, as by multiple testing on one card. Multiple swabs  13  are also usable, for such tests.  
         [0050]    [0050]FIG. 5 shows a swab  56  on an elongated inserter  57 , with a handle area  58 . Shoulders  59  on sideward projections  60  act to limit insertion of the swab, by engagement with the body, at  61 .  
         [0051]    [0051]FIG. 6 shows a moisture receiver  70  on a flexible carrier sheet  71 , adapted for receiving user&#39;s finger pressure to receive vaginal or other tissue moisture. FIG. 7 is similar to FIG. 6, but shows use of a flexible glove  73  with the receiver  70  carried by glove finger  74 , for use with the indicators as in any of FIGS.  1 - 3 .  
         [0052]    [0052]FIG. 8 is like FIG. 4, but shows a series of indicators  80  on a card  81 , and with one color test band  82  adjacent each indicator. The bands  82  have different colors, and correspond to the color test bands  24   a - 24   f  seen in FIG. 2.  
         [0053]    In the above, the term pH is a symbol relating the hydrogen ion (H + ) concentration or activity of a solution to that of a given standard solution. Numerically, the pH is approximately equal to the negative logarithm of H +  concentration expressed in molarity. pH7 is neutral; above it alkalinity increases; and below it acidity increases.  
         [0054]    The term “vaginal moisture” as used herein shall be understood as equivalent to urethral moisture. “pH” is a measure of acidity or alkalinity, of a solution or fluid, and equal to 7 for neutral solutions. pH increases with increasing alkalinity, and decreases with increasing acidity.  
         [0055]    Referring again to FIGS.  1 - 3 , the moisture sample to be tested as by moisture application to the indicators  11  and  21  may include or consist of amniotic fluid. That sample may be collected or employed in fluid form outside the body, as seen in FIG. 3 a  at  110  collected on a support  111 , such fluid typically leaking at times from a pregnant woman onto a bed surface. Accordingly, transfer of the sample of collected moisture to the indicator  11  or  21  occurs outside the human body. As an example, the indicator may simply be dipped into contact with the sample of collected moisture. A support for the indicator may be provided, as by card  10  or card  20 . That card can be manipulated to bring the indicator and fluid into wetting contact. More generally, the support maybe provided in one of the following forms: a stick, a card, or a receptacle. Also, a pH color comparison chart is typically provided, as in FIGS. 1 and 3 for example, and the indicator color can quickly be compared with colors on said chart.  
         [0056]    The general method of testing for uterine membrane rupture accompanied by release of amniotic fluid, from the body, includes the steps:  
         [0057]    a) providing a pH indicator, the indicator characterized as changing color as a function of fluid pH,  
         [0058]    b) contacting said pH indicator with fluid that has been released via the body vaginal zone or urethral zone,  
         [0059]    c) and observing the color of the indicator to determine occurrence of a color change indicative of the presence of amniotic fluid or of another body fluid such as urine.  
         [0060]    The observing step  4  includes determining if the indicator color change is indicative of a pH at or close to 7.0, indicative of the presence of amniotic fluid. More specifically, observing includes determining:  
         [0061]    i) if the indicator color change is indicative of a pH at or close to 7.0, indicative of the presence of amniotic fluid, or  
         [0062]    ii) if the indicator color change is indicative of a pH at or close to 4.5, indicating presence of urine.