DRAWING DESCRIPTION
FIG. 1 is a top plan view of a probe and support incorporating the invention;
FIG. 2 is a bottom plan view of the FIG. 1 probe and support;
FIG. 3 is an edge view taken on lines 3-3 of FIG. 1;
FIG. 4 is a perspective view of the FIG. 1 probe and support;
FIG. 5 is a section taken on lines 5-5 of FIG. 1;
FIG. 6 is a section on line 6-6 of FIG. 1;
FIG. 7 is a view of the FIG. 1 probe received in a protective sheath;
FIG. 8 is a fragmentary view showing interlocking of the sheath and probe;
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;
FIG. 10 is a section taken on lines 10-10 of FIG. 9;
FIG. 11 is a side view of a preferred and modified apparatus;
FIG. 12 is an enlarged view showing carrying on a probe of an indicator and comparison standard;
FIG. 13 is a view showing a vaginal probe with multiple test sites;
FIG. 14 shows another modification;
FIG. 15 is plan view of a probe side carrying an elongated strip to detect amine;
FIG. 16 is a section through a modified probe; and
FIG. 17 is a section through a further modified probe.
DETAILED DESCRIPTION
Referring first to FIG. 1, it shows a device that includes:
a) a longitudinally elongated probe insertable 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) 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 12a 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.
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 20a and 20b, 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).
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's thumb. The irregularities are shown in the form of protuberances 24 which are laterally spaced apart.
The probe and support, or handle may have the following dimensions for best results:
- probe overall length “l1”=1½ to 2½ inches
- probe width “w1”=¼ to ½ inch
- support width w2=¾ to 1½ inch
- thickness “t”= 3/16 to 5/16 inch
- overall length l2 of probe and support=3¼ to 3¾ inches.
- Preferably, l1≈2 inches
- w1≈⅜ inch
- w2≈1¼ inch
- t≈¼ inch
- l2≈3½ inch.
Also, the probe has an approximately flat, oval cross section, as seen in FIG. 6.
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 141 including a probe 143 and handle 144 received in recesses 144 in a plastic carrier 145, with support strip 146 adhered to the carrier. A series of bands 147, 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.
In FIG. 11 a standard comparison zone is provided on the probe, one example being a plastic part 150 received in a recess 151 in the probe in proximity to the pH sensitive indicator 130. The outer surface of part 150 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 can be sunflower yellow, to indicate a standard 4.5 pH. A corresponding part 150a is shown in FIGS. 1, 4 and 7.
In use, the user first visually compares the colors of the indicator (after exposure to vaginal moisture) and the standard zone (such as the surface of locality 150), and any difference in color indicates a possible problem. The color, size, and location of standard zone 150 are such as to provide prominent visual color comparison of zone 150 with the indicator. Next, the probe 10 and sleeve or receptacle 42 are relatively moved, lengthwise, to bring the detector strip 30 or indicator (after its exposure to moisture and color change as referred to above) into lateral registration with the color comparison bands, 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 43 of the carrier sleeve adjacent the bands may be transparent to allow visual observation of the detector, through that zone, adjacent the bands. The entire sleeve and the strip 30 may be transparent.
In FIG. 11, the key-shaped plastic element 141, including probe 143 and handle 144 is removed from the carrier 145. 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 145.
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.
FIG. 9 also represents an optional confirmation step of obtaining a visual comparison of the color changed zone on the receiver 30 with a color, or different colors, or band color shades, 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 30. Such amine indicates presence of pathogenic bacteria.
In FIG. 11, the indicator 130a and comparison zone 150a 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 180a of the carrier and/or edges of 130a to 150a allow or facilitate relative travel of moisture along multiple paths 181 to reach the indicator 130a or zone 150a. See path arrows 182. The diameters of 130a and 150a 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.
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.).
Vaginal conditions related to pH are indicated as follows:
|
1. Bacterial Infection
above
4.5–5.5
|
2. Menopause
above
4.5–6.5
|
3. SPROM
above
4.5–7.0
|
4. Osteoporosis
above
4.5–6.5
|
|
Additional indicators and standard comparison zones may be provided on the probe, as shown at 160a and 161a, in FIG. 12, for redundancy and color differentiation confirmation.
U.S. Pat. No. 6,406,441 is incorporated herein, by reference.
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.
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'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 214a and 214b of stem mid-portion 214, for grasping and stem manipulation purposes. Test sites 130a and 150a at zone 212 are the same as provided in FIG. 13, i.e. have the same utility and relative placement.
Test site 200 has the same structure and utility as site 200 in FIG. 3; however, it is located at zone 213, remotely from sites 130a and 150a. 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 130a and 150a, while still enabling rapid use and observation of all test sites 130a, 150a and 200. Such contact of moisture on site 200 with moisture on either or both of sites 130a and 150a 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 130a and 150a, at the opposite sides of the stem.
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.
FIG. 15 is generally like FIG. 11, except the reverse side 175a of the probe is shown. An elongated strip 300 is adhered to flat side 175a strip 300 that includes or carries a thin layer of KOH, or other functionally equivalent hydroxide reactive with an amine produced by vaginal bacteria, for use in testing for such an amine in the fluid sample gathered from the vagina. Elongation of the strip, as for example to a length at least as long as ½ the probe length, (and typically at least 4 times the probe width) assures that vaginal moisture will be gathered at least one or more locations along the length of the strip, upon probe insertion into the vagina. 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 physician can diagnose the presence of an amine in the test sample. Such amines include cadaverine and putrecine.
FIG. 16 shows the elongated strip 300 received in an elongated shallow recess 302 sunk in probe flat side 175b, so that edges of the strip do not protrude to uncomfortably scrape against vaginal tissue. The forward end 300a of strip 300 extends in proximity to the probe tip 175b′, to assure exposure of a substantial portion of strip 300 to moisture, despite possible shallow insertion of the probe 175 into the vagina. The pH indicator 160 and like comparison zone 161, as referred to above, are also sunk in recesses 303 and 304 and sunk in probe side 175a, for similar reasons.
In FIG. 17, the lower portion of modified elongated strip 300 is received into elongated shallow recess 302a. The upper portion of strip 300′ protrudes above probe surface 175c, for enhanced assurance of contact with vaginal moisture; however, edges of the strip, such as forward edge 300c′ and rearward edge 300d′ are not sharp, i.e. are angled or blunted (for example rounded or beveled) to prevent scraping as referred to. See also the rounded outwardly exposed surfaces 160′ of 160 and 161′ of 161, at the opposite side 175d of the probe.
In each of FIGS. 15-17, the forward end of the amine indicator and the forward portion of the pH indicator are located close to the forward end of the probe to be assuredly exposed to moisture, despite shallow insertion of the probe into the vagina.
Patent Application
20080009769
