U.S. patent application number 10/050872 was filed with the patent office on 2002-05-16 for body moisture test apparatus and method.
Invention is credited to Caillouette, James C..
Application Number | 20020058886 10/050872 |
Document ID | / |
Family ID | 27574516 |
Filed Date | 2002-05-16 |
United States Patent
Application |
20020058886 |
Kind Code |
A1 |
Caillouette, James C. |
May 16, 2002 |
Body moisture test apparatus and method
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).
Inventors: |
Caillouette, James C.;
(Pasadena, CA) |
Correspondence
Address: |
William W. Haefliger
Suite 512
201 So. Lake Ave.
Pasadena
CA
91101
US
|
Family ID: |
27574516 |
Appl. No.: |
10/050872 |
Filed: |
January 18, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10050872 |
Jan 18, 2002 |
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09436332 |
Nov 8, 1999 |
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09436332 |
Nov 8, 1999 |
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09072257 |
May 4, 1998 |
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09072257 |
May 4, 1998 |
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08890748 |
Jul 11, 1997 |
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08890748 |
Jul 11, 1997 |
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08699251 |
Aug 19, 1996 |
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08699251 |
Aug 19, 1996 |
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08570534 |
Dec 11, 1995 |
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08570534 |
Dec 11, 1995 |
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08537379 |
Oct 27, 1995 |
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08537379 |
Oct 27, 1995 |
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08376830 |
Jan 23, 1995 |
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08376830 |
Jan 23, 1995 |
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08295399 |
Aug 25, 1994 |
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Current U.S.
Class: |
600/572 |
Current CPC
Class: |
A61B 10/0291 20130101;
A61B 5/14539 20130101; A61B 10/0048 20130101; A63F 2011/0018
20130101; A61B 5/14507 20130101; A61B 5/4337 20130101; A61B 5/4318
20130101; A61B 10/0012 20130101; G01N 33/84 20130101; A61B
2010/0074 20130101; A61B 5/4283 20130101; G01N 33/528 20130101;
A61B 5/00 20130101; A61B 10/0045 20130101; A61B 5/4294
20130101 |
Class at
Publication: |
600/572 |
International
Class: |
A61B 010/00 |
Claims
I claim:
1. In the method of measuring pH of vaginal or other body tissue
moisture, the steps that include 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,
b) obtaining a vaginal or tissue moisture sample and transferring
moisture from the sample to said indicator, outside the body,
whereby the indicator then exhibits said characteristic color,
which is a function of pH of said moisture, c) providing a color
comparison measurement means, and comparing said indicator
characteristic color with said color comparison measurement
means.
2. The method of claim 1 including providing a vaginal or other
tissue moisture receiver supported on a carrier, and manipulating
the carrier to obtain said sample on a receiver.
3. The method of claim 1 including providing a package which
includes structure carrying said indicator and said color
comparison measurement means.
4. The method of claim 2 including providing 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.
5. The method of claim 3 wherein said color comparison measurement
means is provided to extend proximate said indicator, in or on the
package.
6. The method of claim 5 wherein said color comparison measurement
means is provided to include portions of varying color that are
arranged in at least one of the following ways: ii) in a generally
linear sequence, iii) in a sequence to at least partially surround
the indicator.
7. The method of claim 5 wherein said color comparison measurement
means is provided in the form of swatches of varying color that
extend in a sequence about and proximate the indicator for side by
side comparison with the color of the indicator.
8. The combination of claim 5 wherein the indicator includes
multiple sections, and said color comparison measurement means is
provided in the form of swatches of varying color that extend about
and proximate each indicator section, for side-by-side comparison
with the color of each indicator section.
9. The combination of claim 5 wherein the indicator includes
multiple sections, and said color comparison measurement means
includes color swatches, at least one swatch located proximate each
indicator.
10. The method of claim 4 wherein the carrier is provided in the
form of a stick, and the receiver is supported proximate an end of
the stick, the receiver provided in the form of a swab, and a
shoulder provided on the stick to limit depth of insertion of the
swab, into the vagina.
11. The method of claim 4 wherein said indicator is provided in the
form of a strip.
12. The method of claim 4 including providing a second indicator
supported by the package, said 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 said second indicator, outside the body, whereby a
change in color at the second indicator indicates the presence of
amine from pathogenic bacteria or flagelates or protozoa in said
moisture.
13. The method of claim 12 wherein said second indicator is
selected from the group consisting of Bromocresol Green,
Bromocresol Purple, Nitrazine Yellow, Bromophenol Blue, and
equivalents.
14. The method of claim 12 wherein said amine is selected from the
group putrecine and cadavarine.
15. The method of claim 12 wherein said reactant includes an alkali
substance selected from the group that consists essentially of
potassium hydroxide, sodium aluminate, magnesium hydroxide, sodium
hypochlorite and sodium carbonate.
16. The method of claim 1 including repeating said method at
intervals and over a time period sufficient to detect changes in
vaginal or other tissue moisture pH levels indicative of need for
estrogen therapy.
17. The combination comprising a) a package, b) pH detector carried
by the package, c) an amine detector carried by the package, d) and
means removable from the package for obtaining a sample or samples
of vaginal moisture for transfer to one or both of said
detectors.
18. The combination of claim 17 wherein said pH detector includes
an indicator responsive to reception of vaginal or other tissue
moisture to change to a color indicative of pH level, and including
color measurement means associated with said indicator, on the
package.
19. The combination of claim 18 wherein said color comparison
measurement means extends close to and at least part way about said
indicator.
20. The combination of claim 17 wherein said means includes
elongated inserter and a moisture collector on the inserter, for
obtaining said sample.
21. The combination of claim 20 including a shoulder on the
inserter to limit depth of insertion of the collector, into the
vagina.
22. The combination comprising a) a package, b) a pH detector on
the package, c) said detector including a pH indicator responsive
to reception of vaginal or other tissue moisture, to change color
indication of pH level, when vaginal moisture is transferred to the
indicator, outside the body.
23. The combination of claim 22 including color indicative of pH
level, and including color measurement means associated with said
indicator, on package.
24. The combination of claim 23 wherein said color comparison
measurement means extends close to and at least part way about said
indicator.
25. The combination of claim 22 including means for obtaining a
sample of vaginal moisture for transfer to said indicator.
26. The combination of claim 25 wherein said means is carried by
and removable from said package.
27. The combination of claim 25 wherein said means includes an
elongated inserter and a moisture collector on the inserter, for
obtaining said sample.
28. The combination of claim 27 including a shoulder on the
inserter to limit depth of insertion of the collector, into the
vagina.
29. The combination of claim 22 wherein said package includes a
receptacle for said detector.
30. The method of claim 1 wherein said moisture sample includes
amniotic fluid.
31. The method of claim 30 wherein said moisture sample is
collected in fluid form outside the body.
32. The method of claim 1 wherein said transfer of a sample of
collected moisture to the indicator occurs outside the body.
33. The method of claim 32 wherein said indicator is dipped into
contact with the sample of collected moisture.
34. The method of claim 31 including providing a support for said
indicator, and manipulating said support to bring said indicator
and fluid into wetting contact.
35. The method of claim 34 wherein the support is provided in one
of the following forms: a) a stick b) a card c) a receptacle.
36. The method of claim 30 including providing a pH color
comparison chart, and comparing the indicator color with colors on
said chart.
37. The method of testing for uterine membrane rupture accompanied
by release of amniotic fluid, from the body, that includes a)
providing a pH indicator, the indicator characterized as changing
color as a function of fluid pH, b) contacting said pH indicator
with fluid that has been released via the body vaginal zone or
urethral zone, 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.
38. The method of claim 37 including providing a support for said
indicator, and manipulating said support to bring said indicator
and fluid into wetting contact.
39. The method of claim 38 wherein the support is provided in one
of the following forms: a) a stick b) a card c) a receptacle.
40. The method of claim 37 including providing a pH indicator color
comparison chart, and comparing the indicator color with colors on
said chart.
41. The method of claim 37 wherein said observing 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.
42. The method of claim 37 wherein said observing includes
determining: 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 ii) if the indicator color change is indicative of a pH at or
close to 4.5, indicating presence of urine.
43. A test kit, comprising a) a support, and b) indicator means on
the support to test for at least two of the following: i) tissue
estrogen level, ii) presence of amniotic fluid, iii) presence of
amine.
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] FIG. 1 is a plan view of a kit or package in which one form
of the invention is embodied;
[0031] FIG. 2 is a section taken on lines 2-2 of FIG. 1;
[0032] FIG. 3 is a view like FIG. 1, showing a modified form of the
kit;
[0033] FIG. 3a shows amniotic and/or other leaking fluid collection
on a surface;
[0034] FIG. 4 is a view like FIG. 1 showing a still further
modification;
[0035] FIG. 5 is a view showing a modified inserter;
[0036] FIG. 6 is a plan view of a modified moisture receiver on a
flexible carrier;
[0037] FIG. 7 is a view like FIG. 6, but showing the carrier in the
form of a flexible glove;
[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 10a 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 10a and presented for use, when the card is removed from
the receptacle 10a.
[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.RTM.
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 10a. Paper strips providing such elements
are known, and sold under the name HYDRION PAPERS.RTM.. "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 10a, 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 10a.
[0044] A zone 19 of the receptacle 11a 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] 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 24a-24f 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 24a-24f, 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 26a. 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] 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] 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] FIG. 6 shows a moisture receiver 70 on a flexible carrier
sheet 71, adapted for receiving user'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] 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 24a-24f seen in FIG. 2.
[0053] In the above, the term pH is a symbol relating the hydrogen
ion (H.sup.+) 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.sup.+ 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. 3a 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.
* * * * *