Surgery – Diagnostic testing – Liquid collection
Reexamination Certificate
1999-05-10
2002-06-25
Hindenburg, Max (Department: 3736)
Surgery
Diagnostic testing
Liquid collection
Reexamination Certificate
active
06409680
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates generally to pH measurement of body fluid, such as vaginal and/or urethral fluid, or moisture, and more particularly, to a rapid, easily performed method of obtaining such measurement.
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. Amniotic fluid is normally alkaline, whereas vaginal moisture is normally acidic. This difference enables testing for pH, using a test strip, such as a Nitrazine® strip, typically handled by forceps when inserted into the vagina, urethra or other body openings for pH test purposes; however, the procedure and subsequent procedures to determine acidity or alkalinity requires considerable manipulation, including cutting of a test strip, grasping of the cut strip by forceps manipulation, subsequent insertion with risk of separation of the strip from the forceps, recovery of the strip, and its examination. There is also need to obtain pH measurement of urethral moisture.
There is need for a simple, rapidly carried out method which obviates problems associated with the conventional procedure; also, there is need for ease of excess moisture and mucous removal from the vagina, and/or urethra, at the time of the pH test.
SUMMARY OF THE INVENTION
It is a major object of the invention to provide a significantly improved method which meets the above need, and overcomes prior problems, as referred to. Basically, the method of the invention includes the steps:
a) providing an elongated first carrier,
b) providing a pH detector on the carrier at end portion thereof,
c) manipulating the carrier to effect exposure of the detector to vaginal or urethral moisture, thereby to cause the detector to exhibit a color change,
d) providing a pH correlating color comparison measurement means, in sufficiently close association with the carrier or on the package and with the detector to allow visual comparison of the changed color exhibited by the detector with a pH correlated color provided by the measurement means.
Another object is to provide a package for supporting the first carrier and the color comparison measurement means. In this regard provision may be made for removable containment of the first carrier by the package.
A further object is to provide the detector in the form of an elongated strip, the color comparison measurement means being provided in the form of a strip of material that is elongated in a direction related to the elongated direction of said detector strip to facilitate the color comparison. A method of use typically includes relatively moving the color comparison measurement means and the carrier to achieve the close association of the color comparison measurement means with the detector.
Yet another object includes providing the color comparison measurement strip on the carrier to have thickness that is everywhere less than the thickness of the carrier adjacent the measurement strip. The color comparison measurement strip may be adhered to a package for the pH detector strip on the carrier.
An additional object includes providing the color comparison measurement strip to exhibit a series of colors spaced linearly, and wherein that strip may be located in such relation to said carrier as to position the linearly spaced series of colors in parallel with the elongated detector strip.
A yet further object is to provide the color comparison measurement means on a second carrier that extends at least part way about the first carrier, and to provide the second carrier with a transparent zone to allow visual observation of the detector strip moved into registration with that zone. The second carrier may be provided to have an elongated storage receptacle into which said first carrier, such as a carrier stick, is substantially completely receivable and from which the first carrier is removable to allow its manipulation. That receptacle may provide the transparent zone proximate said color comparison measurement means, to allow ready observation of the detector strip through that zone, for color comparison.
An auxiliary object is to provide a method which includes the steps:
a) providing a pH indication, color comparison measurement, and swabbing means on a carrier stick,
b) manipulating the stick between its opposite ends to obtain pH indication of vaginal or urethral moisture at one end of the stick,
c) visually interpreting that indication to also obtain pH measurement of such moisture near that one end of the stick,
d) again manipulating the stick between its opposite ends, to swab the cervix or urethra,
e) and disposing of the stick, whereby disposition of the pH indication, measurement and swabbing means is thereby obtained in one disposal step.
In this regard, the disposal of such a stick may include inserting it into a transparent receptacle, that enables viewing of the pH indication means and color comparison means, protected in the receptacle. A kit may be provided including a support for one such receptacle to receive the carrier stick for the detector, as well as a second receptacle on the support for a second carrier stick, one in which the swab is removably received. The pH indication means on the two sticks may be respectively used to obtain pH indications from vaginal and urethral moisture zones, for comparison check.
As will appear, the a) step may include adhering a pH indication strip to one end of the stick and adhering a pH measurement calorimeter strip to the stick adjacent the pH indication strip, but between the indication strip and the swabbing means, leaving stick extent free for manual manipulation.
A smooth surfaced protective tip may be provided at the strip end of the stick, to facilitate comfortable insertion of that end of the stick in the vagina or urethra, and that tip may be provided in the form of a slotted sleeve fitted over or endwise adjacent the indicator strip. The indicator strip may have a micro-pore cover layer.
It is another object to provide pH measurement means having color gradations in a series sequence, including locating the series lengthwise along the stick, adjacent the indication means. As will be seen, pH measurement means may be provided by winding it about one end of the stick.
A further object includes maintaining an elongated gap along the stick between the pH measurement means and the swabbing means, whereby the stick may be grasped at the gap for manipulation. In this regard, the swabbing means may be provided by attaching a moisture-absorbing swab to the other end of the stick, and in lengthwise spaced relation to both pH indicating means and pH measurement means. The swab may contain an antiseptic or anaesthetic substance.
Yet another object includes the provision of the pH measurement means to have a pH numerical sequence in a series associated with the color gradations, and including also locating the numerical sequence lengthwise along the stick. Apparatus incorporating the invention includes, in combination
a) an elongated stick,
b) pH indicating first means on the stick, at one end portion thereof,
c) color comparison pH measurement second means, the stick movable relative to the second means to bring the first means into registration with the second means, for color comparison.
The first means typically comprises a strip adhered to one end of the stick, and the second means may extend lengthwise relative to the stick, and the second means typically has color gradations in a series sequence lengthwise relative to the stick.
An additional object includes the provision of a package for the pH detector strip and stick, and also carrying the color comparison measurement means, as referred to. The package may also provide for packaging of the swab.
Another object is to provide a second detector removably supported by a package. The second detector may be one of the following:
i) a pH detector
ii) an amine detector.
The second detector may be on a swab carried by a stick supported by the package, as in a receptacle.
Haefliger William W.
Hindenburg Max
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