Surgery – Diagnostic testing – Liquid collection
Reexamination Certificate
2000-02-07
2002-06-18
Hindenburg, Max (Department: 3736)
Surgery
Diagnostic testing
Liquid collection
Reexamination Certificate
active
06406441
ABSTRACT:
BACKGROUND OF THE INVENTION
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.
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; to test for need for estrogen treatment, and to test for presence of pathogenic bacteria.
Further, there is need for a simple, rapidly carried out method which obviates problems associated with the conventional procedure one example being need to assuredly test vaginal moisture within the vagina, but spaced from the cervix.
SUMMARY OF THE INVENTION
It is a major object of the invention to provide a significantly improved vaginal probe apparatus which meets the above need, and overcomes prior problems, as referred to. Basically, the apparatus of the invention includes:
a) a longitudinally elongated probe insertible into the vagina, for a test purpose,
b) a support operatively connected with the probe projecting away from the support,
c) the support including:
i) a manually manipulable handle,
ii) an edge presented generally longitudinally for limiting probe insertion into the vagina.
Another object is to provide the probe and support to have a key-like configuration, enhancing effective use. The support may have surface irregularities on the support for engagement by the thumb or finger of a user; and some irregularities may comprise protuberances, at one side of the support.
Recognizing that the sizes of the probe and support are important, the probe may typically have length “l” between 1½ and 2½ inches; and a width “w” between ¼ and ½ inch.
A further object includes provision of at least one vaginal moisture wettable test element on the probe; and that element may advantageously comprise one or more indicator or test elements, such as:
i) a pH indicator
ii) an amine indicator
iii) a bacteria indicator.
In this regard, the one or more of the indicators or test elements may comprise a moisture absorber, for use in a test after removal from the vagina or urethra.
Yet another object includes provision of at least one locking projection on the probe, to interlock with a storage sheath into which the probe is receivable.
For ease of use, the probe may define a longitudinally extending axis which substantially bisects the support; alternatively, the support may extend eccentrically relative to the axis of the probe.
An added object is to provide a method of using vaginal probe apparatus comprising, in combination
a) a longitudinally elongated probe insertible into the vagina, for a test purpose,
b) a support operatively connected with the probe projecting away from the support,
c) the support including:
iii) a manually manipulable handle,
iv) an edge presented generally longitudinally for limiting probe insertion into the vagina,
d) the method including inserting the probe into the vagina until said edge engages the body, to achieve said test purpose associated with an indicator at the side of the probe,
e) and withdrawing the probe from the vagina for use of the indicator to complete the test purpose.
In this regard, the probe and support may have key-like configuration with use advantages. The method further contemplates grasping the support rearward of the edge, during insertion limiting steps d) and e).
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Haefliger William W.
Hindenburg Max
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