Patent Document

[0001]     This application is a continuation-in-part of prior pending U.S. patent application Ser. No. 11/235,741, filed Sep. 26, 2005. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     This invention relates generally to testing of body fluid, one example being pH measurement of body fluid, such as vaginal and/or urethral fluid, or moisture, and more particularly, to a rapid, easily performed method of such testing, or obtaining such measurement, as on a preliminary rapid basis. Also, it relates to multiple purpose screening of vaginal moisture.  
         [0003]     There is continued need to obtain pH measurement of vaginal fluid, as for example in the determination of whether amniotic fluid has escaped into the vagina, during late pregnancy; another example is testing to determine need for estrogen therapy. There is also need for quick, simple test determination that positively alerts the user to possible problems indicated by changed conditions in the vagina as for example amine presence in vaginal moisture.  
       SUMMARY OF THE INVENTION  
       [0004]     It is a major object of the invention to provide an improved vaginal probe apparatus and quick test procedure which meets the above needs. Basically, the screening method of the invention includes:  
         [0005]     a) providing a manually manipulable element including a probe insertible into the vagina,  
         [0006]     b) providing one or more pH indicating first test site or sites on one portion of the probe,  
         [0007]     c) providing a vaginosis test site on another portion of the probe,  
         [0008]     d) manipulating the probe to transfer vaginal moisture to said sites,  
         [0009]     e) and, therefore, externally of the vagina, applying an hydroxide to the vaginosis test site, to come in contact with moisture at said vaginosis test site,  
         [0010]     f) and detecting presence of an amine or amines produced at said vaginosis site.  
         [0011]     Additional steps include:  
         [0012]     g) withdrawing the probe from the vagina between said steps d) and e), and  
         [0013]     h) observing the coloration of said pH indication site as an indication of pH level.  
         [0014]     As will be seen, the probe typically has opposite sides, said one portion of the probe located at one of said sides, and said other portion of the probe located at another of said opposite sides.  
         [0015]     Another object includes the provision of a carrier for said hydroxide, and manipulating said carrier to effect said application of the hydroxide to the vaginosis test site after said moisture transfer thereto. The carrier may in this regard be provided in the form of an easily manipulated ampule, which may be initially located on a support for the probe, the assembly being in kit form.  
         [0016]     A further object includes provision of the vaginosis test site in elongated form at one side of the probe, that site typically consisting of an absorbent material, examples being “waste lock” from M2 polymer, or highly absorbent “Lyocell Fiber” disclosed in “Medical Textiles”, June 2003, page 3.  
         [0017]     Test sites on the probe are preferably located at opposite sides of the probe, as for example in opposition to one another, enabling maximum site area for exposure to moisture, enhancing use efficiency as by a “whiff test” for amine.  
         [0018]     An additional object includes selection of the hydroxide from the group: 
        i) KOH,     ii) milk of magnesia,     iii) sea water,     iv) baking soda, or mixture thereof with water.        
 
         [0023]     Yet another object includes provision of the pH test, to include 
        i) a pH indicator characterized as producing a color which corresponds to pH level of vaginal moisture contacting the indicator,     ii) a local comparison zone having a color corresponding to a predetermined pH level, and positioned and shaped for quick color comparison with the color of said indicator after indicator contact with vaginal moisture.        
 
         [0026]     Another object is to provide a local comparison zone exhibiting a color which corresponds to a fixed standard, such as a predetermined pH level. That zone may be on the probe as for example in local and quick visual comparison proximity to the moisture responsive indicator.  
         [0027]     A further object is to provide both the indicator and the color comparison zone to have substantially the same sizes and shapes, for enhancement of screening visual accuracy of color comparison, especially when the color of the zone (standard) is close to the color of the indicator as driven by vaginal moisture pH.  
         [0028]     Another object is to locate the comparison zone and indicator mutually lengthwise of the probe for enhancement of “digital”, side-by-side recognition of any deviation or differences between the colors of these elements indicating possible physical problems. The comparison zone “standard” color may be located on the surface of a plastic component, in substantially planer alignment with the plane of the indicator surface. Also, the indicator is preferably located closer to the probe tip than the “standard” zone, to enable or facilitate subsequent color comparison in side-by-side relation with a pH color chart. The amine test zone is typically at another side of the probe, and spaced from the pH test zone.  
         [0029]     A yet further object is to provide a carrier for carrying the elements, and a pH color chart associated with the carrier.  
         [0030]     An added object is to provide a device and method for quick testing to determine vaginal pH and also to test for bacterial vaginosis.  
         [0031]     The method of quick screening for vaginal moisture pH level as it relates to a pre-selected pH level, includes the steps:  
         [0032]     a) providing a manually manipulable element including a probe insertible into the vagina,  
         [0033]     b) providing at least one pH indicator on that element, the indicator characterized as producing a color which corresponds to pH level of vaginal moisture contacting the indicator,  
         [0034]     c) and providing a local comparison zone on the element having a color corresponding to a predetermined pH level, and positioned and shaped relative to the indicator for quick color comparison with the color of the indicator after indicator contact with vaginal moisture.  
         [0035]     That method may include the steps of contacting the indicator with vaginal moisture, and then visually comparing the color of said “standard” zone with the color of the indicator.  
         [0036]     In these regards, the color comparison zone standard may have a color associated with pH level of about 4.5, and which does not vary with changes in pH level of moisture in contact with the zone.  
         [0037]     Yet another object is to provide a method for testing for vaginal pH and for vaginosis, using a single probe element that includes the steps:  
         [0038]     a) providing at least one pH indicator on the probe element said indicator characterized as producing a color which corresponds to the pH level of vaginal moisture contacting the indicator,  
         [0039]     b) and locating a test site for vaginosis on the probe element in sufficiently spaced relation to the pH indicator so that vaginal moisture at the test site for vaginosis will not come into contact with the pH indicator, during normal use of said method. As will be seen the test site is a lengthwise extending strip that incorporates a hydroxide reactive with a vaginal bacterial produced amine. Also, the probe element may have opposite end portions adapted to be separately inserted into the vagina, the pH indicator located at one end portion and the test site for vaginosis located at the other end portion. A further object is to provide a probe element that has a mid-portion of a length adapted to be grasped by the user, for manipulating the probe to separately insert said opposite end portions into the vagina.  
         [0040]     A yet further object is to provide a probe that has opposite sides, the pH indicator located at one of such sides, and the test site for vaginosis located at the other of such opposite sides.  
         [0041]     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  
       [0042]      FIG. 1  is a top plan view of a probe and support incorporating the invention;  
         [0043]      FIG. 2  is a bottom plan view of the  FIG. 1  probe and support;  
         [0044]      FIG. 3  is an edge view taken on lines  3 - 3  of  FIG. 1 ;  
         [0045]      FIG. 4  is a perspective view of the  FIG. 1  probe and support;  
         [0046]      FIG. 5  is a section taken on lines  5 - 5  of  FIG. 1 ;  
         [0047]      FIG. 6  is a section on line  6 - 6  of  FIG. 1 ;  
         [0048]      FIG. 7  is a view of the  FIG. 1  probe received in a protective sheath;  
         [0049]      FIG. 8  is a fragmentary view showing interlocking of the sheath and probe;  
         [0050]      FIG. 9  is an enlarged view showing details of the sheath, with probe viewing window, and color comparison measurement zones, on the sheath; and also showing comparison of a color change of a test element with different colored zones on a sheath or other carrier;  
         [0051]      FIG. 10  is a section taken on lines  10 - 10  of  FIG. 9 ;  
         [0052]      FIG. 11  is a side view of a preferred and modified apparatus;  
         [0053]      FIG. 12  is an enlarged view showing carrying on a probe of an indicator and comparison standard;  
         [0054]      FIG. 13  is a view showing a vaginal probe with multiple test sites;  
         [0055]      FIG. 14  shows another modification;  
         [0056]      FIG. 15  shows a further modification on one side of a probe;  
         [0057]      FIG. 16  shows the opposite side of the probe as seen in  FIG. 15 ;  
         [0058]      FIG. 17  shows use of the probe, as in a whiff test; and  
         [0059]      FIG. 18  shows a kit embodying probe, ampule and calorimeter elements. 
     
    
     DETAILED DESCRIPTION  
       [0060]     Referring first to  FIG. 1 , it shows a device that includes:  
         [0061]     a) a longitudinally elongated probe insertible into the vagina, for a test purpose,  
         [0062]     b) a support operatively connected with the probe projecting away from the support,  
         [0063]     c) the support including: 
        i) a manually manipulable handle,     ii) and an edge presented generally longitudinally for limiting probe insertion into the vagina. 
 
 As shown, the probe  10  of the apparatus  100  protrudes lengthwise from the support  12 , which defines a handle  12   a  that can be easily gripped between the thumb  13  and forefinger  14  of the user, as seen in  FIG. 3 . The probe and support preferably have key-like configuration, as shown. 
       
 
         [0066]     Forwardly or longitudinally presented edge  20  of the support limits insertion of the probe, as by engagement with the body  21 , and dual edges may be provided as at  20   a  and  20   b , at opposite lateral sides of the probe, for that purpose. The apparatus  100  may for example consist of plastic, metal or compressed fiber (example paper).  
         [0067]     Surface irregularities may be provided on one laterally facing side of the support, and such irregularities are shown to extend longitudinally to be grasped by the thumb and prevent lateral slippage, relative to the user&#39;s thumb. The irregularities are shown in the form of protuberances  24  which are laterally spaced apart.  
         [0068]     The probe and support, or handle may have the following dimensions for best results:  
         [0069]     probe overall length “l 1 ”1½ M to 2½ inches  
         [0070]     probe width “w 1   ”=¼ to  ½ inch  
         [0071]     support width w 2 =¾ to 1½ inch  
         [0072]     thickness “t”= 3/16 to 5/16 inch  
         [0073]     overall length l 2  of probe and support=3¼ to 3¾ inches.  
         [0074]     Preferably, l 1 ≈2 inches 
        w 1 ≈⅜ inch     w 2 ≈1¼ inch     t≈¼ inch     l 2 ≈3½ inch.        
 
         [0079]     Also, the probe has an approximately flat, oval cross section, as seen in  FIG. 6 .  
         [0080]      FIG. 1  also shows a test element or indicator  30  at the side of the probe, near its tip  31 , to be pressed toward and against the vaginal wall. Element  30  typically comprises an indicator element, as for example one of the following: 
        i) a pH indicator     ii) an amine indicator     iii) a bacteria indicator     iv) sialidase indicator     v) prolidase indicator. 
 
 The pH indicator or detector typically takes the form of a Nitrazine® strip or other carrier element adhered to the side of the probe, as for example by double sided adhesive tape. After exposure of the strip to vaginal moisture, its changed color (according to pH level) is compared with the series  41  of bands on a sheath  42 , as seen in  FIG. 9 . Each band has 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 color bands. The bands may be provided on a support strip  142  adhered to the outer surface of the sleeve or receptacle  42 . See also  FIG. 11  showing a manipulable element  145  including a probe  175  and handle  146  received in recesses  144  in a plastic carrier  180 , with support strip  146  adhered to the carrier. A series of bands  185 , like bands  41 , is located on the strip  146 . Paper strips providing such elements are known, and sold under the name HYDRION papers, by 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. 
         
         [0086]     In  FIG. 11 a  standard comparison zone is provided on the probe, one example being a plastic part  150   aa  received in a recess in the probe in proximity to the pH sensitive indicator  130   a . The outer surface of part  150   aa  has a color corresponding to a predetermined pH level, at or near neutral pH level, such as 4.5 for example, for quick visual color comparison with the color of the indicator, after indicator contact with vaginal moisture. When a Nitrazine® indicator is used, the surface of part  150   aa  can be sunflower yellow, to indicate a standard 4.5 pH. A corresponding part  150   a  is shown in  FIGS. 1, 4  and  7 .  
         [0087]     In use, the user first visually compares the color of the indicator  130   a  (after exposure to vaginal moisture) and the standard zone (such as the surface of locality  150   aa ), and any difference in color indicates a possible problem. This consists of a screen test. The color, size, and location of standard zone  150  are such as to provide prominent visual color comparison of zone  150   aa  with the indicator. Next, the probe  175  and sleeve or receptacle  180  are relatively moved, to bring the detector indicator  130   a  (after its exposure to moisture and color change as referred to above) into lateral registration with the color comparison bands  185 , enabling ready visual comparison of the color of the detector strip with the closest color of one of the bands, enabling a pH level determination. For this purpose, a window zone of the carrier sleeve adjacent the bands may be transparent to allow visual observation of the detector, through that zone, adjacent the bands.  
         [0088]     In summary, the probe is inserted into the vagina to collect moisture and withdrawn, and the quick visual screen comparison is made, viewing the probe indictor and the standard comparison zone for quick detection of a possible problem, as for example need for estrogen. Thereafter, color comparison may be made with the colored bands, to more definitively determine moisture pH level. The probe is re-inserted into the elongated carrier receptacle  180 .  
         [0089]     The color changing reactant may consist, for example, of one or more of the following: Bromocresol Green, Bromocresol Purple, Nitrazine Yellow, Bromophenol Blue, and equivalents.  
         [0090]     An optional procedure consists of obtaining a visual comparison of the color changed zone on the receiver  130   a  with a color? or different colors, or band color shades, as at  185 , where one color band may indicate presence of putrecine; another color band may indicate presence of cadaverine; and a third band may have another color or color shade close to but different from the first two, and so indicating absence of putrecine or cadaverine, or other bacterial producing amine, i.e. an amine test when compared side-by-side with the color on the receiver  130   a . Such amine indicates presence of pathogenic bacteria.  
         [0091]     In  FIG. 11 , the indicator  130   a  and comparison zone  150   a  have substantially the same sizes and shapes, for enhancement of visual accuracy of color comparison. Also, the probe  145  has a substantially flat side  175 , the indicator and comparison zones being exposed at that flat side. The local indicator and comparison zones are located in mutual proximity lengthwise of the probe, for rapid digital type color comparison readout (i.e. problem or no problem, per color visual differentiation). Both are substantially circular, and the exposed surfaces of each extend in substantially the same flat plane. Undulant edges  180   a  of the carrier and/or edges of  130   a  to  150   a  allow or facilitate relative travel of moisture along multiple paths  181  to reach the indicator  130   a  or zone  150   a . See path arrows  182 . The diameters of  130   a  and  150   a  may be between 3/16 and ⅜ inch, for optimum visual comparison effect. All of these contribute to enhancement of accurate, quick, viewing comparison to quickly detect color differences from a standard level. Carrier  180  receives the probe  145  and handle  146 , and carries the pH color comparison chart  177 .  
         [0092]      FIG. 12  shows reception of an indictor  160  and comparison zone plastic button  161 , in recesses  162  and  163  in a probe  164 , the outward facing surfaces of  160  and  161  being of generally the same size and shape and in the same plane for accuracy of comparison (equal illumination, light reflections, etc.).  
         [0093]     Vaginal conditions related to pH are indicated as follows:  
                                                           1. Bacterial Infection   above   4.5-6.5           2. Menopause   above   4.5-6.5           3. SPROM   above   4.5-7.5           4. Osteoporosis   above   4.5-6.5                      
 
         [0094]     Additional indicators and standard comparison zones may be provided on the probe, as shown at  160   a  and  161   a , in  FIG. 12 , for redundancy and color differentiation confirmation.  
         [0095]     U.S. Pat. No. 6,406,441 is incorporated herein, by reference.  
         [0096]      FIG. 13  shows a modification  199  in which elements the same as in  FIG. 11  have the same identifying numerals. In addition, an elongated strip  200  is applied to the flat side  175  of the probe  145 . Strip  200  includes, or carries, a thin layer of KOH, or other equivalent hydroxide reactive with an amine produced by vaginal bacteria, for use in testing for such an amine in the fluid sample from the vagina. See flow path arrow  182 . When contacted with an amine in vaginal moisture the KOH reacts to produce a characteristic odor, which is a “fish” type odor, from which a doctor can diagnose the presence of amine in the test sample. Accordingly, the device  199  provides multiple test sites to enable quick multiple diagnostic tests for vaginal pH as may indicate estrogen deficiency as described, and for presence of amines (produced by vaginal bacteria) indicative of BV (i.e. bacterial vaginosis). Such amines include cadavarine and putrecine.  
         [0097]      FIG. 14  shows a further modified device  210  which comprises an elongated thin stem  211  having test site zones  212  and  213  extending endwise oppositely of stem mid-portion  214 . That mid-portion is adapted to be grasped as by the user&#39;s thumb  215  and first finger  216 , during use of the device  210 . There may be concave recesses  217 , and  218  sunk in the edges  214   a  and  214   b  of stem mid-portion  214 , for grasping and stem manipulation purposes. Test sites  130   a  and  150   a  at zone  212  are the same as provided in  FIG. 13 , i.e. have the same utility and relative placement.  
         [0098]     Test site  200  has the same structure and utility as site  200  in  FIG. 13 ; however, it is located at zone  213 , remotely from sites  130   a  and  150   a . In use the stem or stick is manipulated so that either zone  212  or zone  213  is first inserted into the vagina to receive vaginal moisture, and subsequently the stem is withdrawn and endwise removed so that the other of the zones  212  or  213  can then be separately inserted into the vagina to receive vaginal moisture and then withdrawn. This procedure avoids contact of moisture on site  200  with moisture on sites  130   a  and  150   a , while still enabling rapid use and observation of all test sites  130   a ,  150   a  and  200 . Such contact of moisture on site  200  with moisture on either or both of sites  130   a  and  150   a  could detrimentally change the pH at those latter sites due to the pH of the hydroxide containing moisture at site  200 . As an alternative, the device of  FIG. 13  could be modified to place site  200  at the opposite side of the stem  175 , so that moisture on site  200  would be unlikely to be displaced as by smearing to contact moisture at sites  130   a  and  150   a , at the opposite sides of the stem.  
         [0099]     A protective film may be applied to cover site  200  until use, as for example by application to KOH or other hydroxide at the site of vaginal discharge, i.e applied for example by a Q-tip.  
         [0100]      FIGS. 15 and 16  show a preferred modification  210  in which elements the same as in  FIG. 11  have the same identifying numerals. In addition an elongated absorbent strip  211  is attached to the flat opposite side  212  of the probe  145 , where side  212  is opposite side  175 . In use, sides  175  and  212  are exposed to moisture in the vagina, and the probe is then removed. Strip  211  constitutes a test site for production of amine or amines, such as cadaverine and putrecine. An hydroxide is then applied to the test site at moistened strip  211 , externally of the vagina so contact of hydroxide with the vagina is avoided. See drops  214  of liquid hydroxide in  FIG. 17 , applied to strip  211 , the amount of applied hydroxide being easily controllable, as by manipulation of an ampule  216 .  
         [0101]     As referred to above, when contacted with an amine in vaginal moisture, the hydroxide reacts to produce a characteristic odor, which is a “fish” type odor, from which a user  219  can detect (as seen at  220  in  FIG. 17 ) the presence of amines in the test at the test site.  
         [0102]     Accordingly, the device  210  provides multiple test sites to enable quick multiple diagnostic tests for vaginal pH as may indicate estrogen deficiency as described, and for presence of amine (produced by vaginal bacteria) indicative of bacterial vaginosis.  
         [0103]     By avoiding inclusion of hydroxide on the probe at the time of insertion into the vagina, undesirable application or mixing of hydroxide with the pH test sites seen in  FIG. 16  is avoided, whereby erroneous readings of pH are avoided. Strip  211  can thus be located at the direct opposite side of the probe from the pH indicators  130   a  and  150   a , without risk of hydroxide contamination of those sites. Usable hydroxides include: KOH, milk of magnesia, baking soda and sea water, as well as others. The strip  211  may consist of a “Super Absorbent Polymer” such as “Waste Lock”, from M2 Polymer, or the highly moisture absorbent “Lyocell Fiber” referenced in “Medical Textiles”, June 2003, at page 3, as well as others, such as filter paper.  
         [0104]      FIG. 18  shows a kit  230  including a carrier tray  231 ; probe  210  on the tray; and hydroxide ampules  216  on the tray; and a pH color comparison chart  177  on the tray. That type chart use also referenced in  FIG. 11 . Elements of the kit are used as described in  FIGS. 15-17 , after removal from the tray.  
         [0105]     In the above, the word “hydroxide” is intended to include, within its scope, alkaline substances, that may for example be flowable.

Technology Category: 1