CA2255711A1 - Device for measuring the properties of an endogenous fluid - Google Patents
Device for measuring the properties of an endogenous fluid Download PDFInfo
- Publication number
- CA2255711A1 CA2255711A1 CA002255711A CA2255711A CA2255711A1 CA 2255711 A1 CA2255711 A1 CA 2255711A1 CA 002255711 A CA002255711 A CA 002255711A CA 2255711 A CA2255711 A CA 2255711A CA 2255711 A1 CA2255711 A1 CA 2255711A1
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- CA
- Canada
- Prior art keywords
- test strip
- protective clothing
- cover
- indicator medium
- medium layer
- Prior art date
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Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
- G01N33/521—Single-layer analytical elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B42/00—Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
- A61B42/10—Surgical gloves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B42/00—Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
- A61B42/40—Packages or dispensers
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N31/00—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
- G01N31/22—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators
- G01N31/221—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators for investigating pH value
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/42—Gynaecological or obstetrical instruments or methods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B2010/0003—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements including means for analysis by an unskilled person
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00022—Sensing or detecting at the treatment site
- A61B2017/00026—Conductivity or impedance, e.g. of tissue
- A61B2017/00035—Conductivity or impedance, e.g. of tissue pH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/0042—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping
- A61B2017/00438—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping connectable to a finger
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B42/00—Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Medical Informatics (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Immunology (AREA)
- Chemical & Material Sciences (AREA)
- Pathology (AREA)
- Hematology (AREA)
- General Physics & Mathematics (AREA)
- Physics & Mathematics (AREA)
- Biochemistry (AREA)
- Analytical Chemistry (AREA)
- Urology & Nephrology (AREA)
- Biophysics (AREA)
- Biotechnology (AREA)
- Cell Biology (AREA)
- Microbiology (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
Abstract
The invention concerns a device for measuring the properties of an endogenous fluid, in particular for measuring the pH of vaginal fluid, in a manual medical examination. The device comprises an elastic protective clothing article which can be slipped on and used for the examination, a test strip (2) comprising a coating with an indicator agent (2.2) for measuring the pH of the vaginal fluid during the examination, and a double-sided adhesive tape (2.3) for securing the test strip to a section (1.1) of the protective clothing article.
Description
CA 022~7ll l998-ll-l7 Selfcare International GmbH
SL 4473 PCT 17.06.98 Specification The invention relates to an apparatus for measuring the properties of an endogenous fluid of the kind indicated in the preamble of claim 1 (DE-U - 9 407 496).
It is known to draw upon the change of characteristics of en-dogenous fluids for diagnostic purposes and thus improve the early recognition of organic diseases or the limitation of organic functions.
One of the most common causes of infections of the vagina and of premature births, in many cases due to such infections, are bacterial colonies growing in the vagina where they cause in-fections. Such a change of the vaginal environment often goes unnoticed by women and expectant mothers. The foreign bacteria displace the lactic acid bacteria which normally are present in the vagina where they create an acidic vaginal environment by forming lactic acid. The acidic vaginal environment offers natural protection against the penetration of foreign bacteria.
A shift in the natural balance at the expense of the lactic acid content leads to a measurable change of the prevailing pH.
The sooner a pathological alteration of the vaginal environ-ment due to the entry of foreign infectious bacteria is re-cognized, the earlier promising counter-measures can be taken by the attending physician.
An examining glove for one-time use for the simultaneous rement of the pH in the vagina of a woman is known from in~407 496.
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CA 022~711 1998-11-17 With the test strip suggested in this form and provided at the ~ ;ning glove for examining the vaginal environment, erroneous assessments or at least difficulties in the qualitative assessment of the test strip applied often occur in disadvantageous manner when evaluated by the patient.
Furthermore, with the examining glove proposed, it is disadvantageously difficult for the test strip needed for the examination of the vaginal environment to be securely fastened to the ~ ining glove by way of ready-made manufacture at little expenditure.
US-A-4,042,329 discloses a test strip including a partial cover which shields the covered areas from the action of the endogenous fluid. According to a variant, the non-covered test strip carries surface areas coated with an indicator medium which are arranged directly adjacent indifferent areas of the test strip.
Starting from the shortcomings of the prior art, it is, therefore, the object of the invention to indicate an apparatus suitable for ~ in~tion of endogenous fluids, especially the vaginal fluid, designed so as to permit evaluation without much effort and with relatively great accuracy and to be manufactured by simple means at low cost.
This object is met by an apparatus as defined in claim 1.
The invention includes the finding that when producing ready-made articles of protective clothing from elastic material advantages in manufacturing t~chn;que can be achieved if the additional elements are connected to the article of protective clothing by gluing.
CA 022~711 1998-11-17 The invention further includes the finding that the qualitative assessment of a test strip, based on a change in color, can be made the more conveniently and accurately the closer the test strip is disposed to a color carrier with the color values to be drawn upon for comparison. In addition, if the background color is adapted to the starting or normal color of the indicator and if that indicator area not shielded by the CA 022~711 1998-11-17 cover which carries the background color has the configuration of a symbol of attention, either in positive or negative form, a change in color is an indication of warning or caution suit-able to be grasped even by an illiterate addressee without thinking twice. This is true also of such lettering as "CAUTION" or "WARNING" because the same effect is brought about by these characters.
According to a preferred embodiment of the invention the elastic protective clothing article to be slipped on for carrying out pH measurements of the vaginal fluid during gynecological examinations of the vagina comprises a test strip for use in measuring the pH which strip is fastened to the protective clothing article by a two-sided adhesive tape.
The test strip comprises a substrate provided with an indica-tor medium and this substrate in turn is joined to one of the two adhesive layers of the two-sided adhesive tape. The finger portion of the protective clothing article in the form of a glove provided for the ~ ;nation, preferably the forefinger (hereinafter referred to briefly as ~ ;n;ng finger) is connected to the second adhesive layer of the two-sided ad-hesive tape.
Using a two-sided adhesive tape is advantageous in particular because, on the one hand, separate application of an adhesive is avoided and, on the other hand, the amount of adhesive as well as the position thereof are fixed. Consequently any con-t~;n~tion with an excess of glue on the surface of the pro-tective clothing article which is to receive the glue, especi-ally on the examining finger is avoided. Such contamination would render the protective clothing article ~nsuitable for the intended examination.
It is especially advantageous with the invention that test strips made of the most diverse materials can be fastened kly and securely. Moreover, the protective clothing ~ o''~ a~ ~les do not need any prior preparation in any specific ( ~ ~ ~ he- in those areas which are inten~e~ ~or gluing. The .~,~ . .
CA 022~711 1998-11-17 protective clothing article according to the invention com-prises two variants, one of them being provided for the physi-cian and the other one for the patient herself. The differen-ces and advantages of both solutions will be described in greater detail below.
The two-sided adhesive tape is advantageously suited for posi-tioning the test strip on the elastic protective clothing article to be slipped on for use in the Q~ ination of an endogenous fluid, for example to measure the pH of the vaginal fluid in a gynecological examination of the vagina.
To allow qualitative assessment of the medical ~ ;nation, the inside of the protective clothing article, the area of the palm of the hand being preferred, is provided with a color chart including a legend so as to determine the current pH by a comparison with the color of the test strip. The boundary zone for a healthy vaginal environment is marked in advan-tageous manner on the color chart so that a disease may be recognized qualitatively also by an untrained person.
According to another advantageous embodiment of the invention the test strip carries a cover at its side facing the body region to be ~m; ned. This cover partly masks the layer of indicator medium which reacts by a change in color to a patho-logical change of the body region to be ~m;ned In this man-ner, advantageously, there are neutral surface sections in the immediate vicinity of those partial surfaces of the layer of indicator medium which react by a change in color, and these neutral surface sections are useful, by specific design, espe-cially coloration for analyzing the change in color of the respective partial surfaces of the indicator medium layer. In another variant, the indicator and the comparative zone are applied directly adjacent each other on the carrier to be in-troduced into the vagina, especially the finger of a glove.
~ .
Ac~ording to a favorable further development of the invention th cover on the indicator medium layer of the test strip is ,~
CA 022~711 1998-11-17 r designed as a template embodied by a monochrome opaque film provided, for example, with circular or rectangular recesses.
These recesses liberate partial surfaces of the indicator me-dium layer for chemical reaction with the body fluid and are completely enclosed by neutral-color film portions. The film-like cover is fastened in simple manner by gluing on the indi-cator medium layer.
According to another advantageous further development of the invention the cover comprises dyeing which conforms preferably to the hue adopted by the indicator medium layer when the vaginal fluid has a pH to be associated with a healthy vaginal environment. Uniform dyeing over the entire surface thus is achieved in favorable manner for the test strip when the va-ginal environment shows no pathological changes. By virtue of the cover, only those sections of the indicator medium layer which are accessible through the recesses become discolored in case of a pathological vaginal environment so that the change in color is noticeable by direct comparison of the discolored area of the indicator medium layer and the cover directly adjacent thereto.
In accordance with a variant of the invention the cover com-prises a color chart which includes a legend and extends parallel to the longitudinal axis of the test strip and is arranged beside the recesses. A color comparison between the coloration in the recesses and the color chart leads in simple manner to the current pH of the vaginal environment.
In the same manner in the color assignment is selectable for an e~m;nation of other endogenou's fluids or secretions.
This way of evaluating the test strip according to the inven-tion is suitable in particular for people untrained in me-~,- dicine because even a minor change in color of the areas of ~ e ur~d b", '~
é;~ ndicator medium layer located in the recesses of the ~' ';' coy~er'can be recognized without any difficulty by direct com-~oL with'the hu'e of the~cover. The exact quantitative ~ , CA 022~i~i711 1998-11-17 r analysis may be undertaken medical ~m; nation initiated after the early recognition described above.
According to another embodiment of the invention the recesses provided in the cover form a symbol. This symbol, for example, is designed as a caution sign or exclamation mark or as warn-ing lettering. In addition to the change in color in case of a pathological variation of the fluid of a certain body region under ~;nation, such as the vaginal fluid, a physiological effect and a optical warning thus are released in advantageous manner at the same time.
According to another advantageous further development of the invention a plurality of identical test strips arranged in series are releasably attached to a support strip. The support strip is wound up to a tear-off roll and provided with a rated rupture location between two successive test strips each. This manner of storing the test strips permits easy handling of the test strips when the protective clothing articles are to be made ready upon demand with a test strip according to the in-vention for use in a medical ex~m; n~tion.
According to an advantageous further development of the inven-tion one end of the two-sided adhesive tape carrying the test strip is provided with a section designed as a tab which is free of adhesive on both sides. This permits convenient handl-ing of the test strip when the protective clothing article is made ready with the test strip required for the examination.
It is just as favorable that the indicator medium layer of the test strip need not be touched by hand in order to be able to carry out the positioning at the seIected place. In this man-ner any influencing of the indicator medium layer is prevented which otherwise might lead to falsified results of the exami-nation or require re-~ ;nation.
ing to another embodiment of the invention the article 3~ of p~ot~ctive clothing is designed to be a fingerstall.
CA 022~711 1998-11-17 r Using a fingerstall on which a test strip of the type describ-ed above is glued, allows the gynecologist or the patient in advantageous manner to choose individually which finger to use for the examination and at which side of the finger to posi-tion the test strip.
The advantageous material provided for the glove and the fin-gerstall is polyethylene because with this material a par-ticularly secure bonding by means of a two-sided adhesive tape can be achieved in simple manner between the test strip and the chosen e~ ;ning finger of the glove or fingerstall.
Depending on the size of the test strip, the test strip af-fixed to the ex~ ;ning finger necessarily leads to certain obstruction as the examining finger is introduced into the vagina. In order to prevent any mental aversion to such an ~m; nation from developing in patients, a ratio having a value of small to 1, preferably in the order of 5 % between the surface area dimension of the test strip and the surface of the inside of the forefinger of the glove is selected ad-vantageously according to another embodiment of the invention.
Such a test strip dimension is sufficient for the optical recognition of a change in color and hardly regarded as an-noying by the patients.
It is favorable for the physician having to carry out a gynecological examination if the test strip is arranged off-center and in the region of the middle of the ex~m;ning finger of the glove since the physician must penetrate rather deeply into the vagina anyhow to perform his other palpating examina-tions. Thus the examination described here presents a side effect to be obtained practically automatically.
On the other hand, it is sufficient for an informative self-test by the patient if the test strip is arranged centrally nd in the region of the finger tip of the forefinger. The ~'S~pa~ient need only slightly insert the examining finger into ~gina GO that the Gelf-teGt can,be carried out without CA 022~711 1998-11-17 any particular problems also by someone not trained in medicine.
According to a favorable further development of the invention the test strip comprises a substrate with a layer of indicator medium which is applied by impression.
In accordance with the invention a package is provided for the protective clothing article for use in determining the pH of the vaginal fluid by means of a test strip. This package holds one or more gloves or fingerstalls, individually packed. That provides specific advantages for storage, quick and convenient access, as well as transportation of apparatus for the exami-nation of body fluids.
The package according to the invention preferably comprises a substantially rectangular bottom plate at the side edges of which hinged flaps are provided which are adapted to be folded up. The oppositely disposed flaps are folded in pairs, the flaps covering the entire bottom plate and one pair of flaps being pressed against the bottom plate by the other pair of flaps crossing over them. The free ends of those flaps which cross over are adapted to be connected to each other, for example, by a bondable overlap provided at the flap margins.
One of the flaps crossing over is provided with a tearing tongue for simplified dissolution of the bond of the over-lapping sections.
According to an advantageous further development a tongue is provided at one flap edge and adapted to be introduced into a slit-shaped recess at the edge of the other flap.
In accordance with the preferred embodiment of the invention the bottom plate comprises molded portions in which the pro-tective clothing articles are adapted to be arranged in fixed position. Each molded portion furnished with a protective cioth~ng article is sealed by a thin cover film in order to o~y~r~ ~ e~t the safe positioning. The cover fiIm consists of fi ;~ ~
~,.. j .. ,f CA 022~711 1998-11-17 plastic material and has a tab for convenient removal of the cover film for withdrawal of the protective clothing article from the opened package.
The package preferably made of cardboard or cardboard-like material is provided with an imprint indicating the contents of the package and usage thereof in order to assure proper application of the protective clothing article according to the invention in carrying out vaginal ~ m; n~tions.
According to an additional further development of the inven-tion a bottom plate of plastics is provided to prevent any un-desirable influence of moisture, especially atmospheric moisture on the package contents.
According to a variant of the invention it is advantageous to ship or store a plurality of individual packages in a supply box. At its front, the supply box comprises a dispensing open-ing adapted to be swung open or designed as a slide and per-mitting sequential access to the individual packages. A color chart mounted on the outside of the supply box and including a separately marked color range assigned to a healthy vaginal environment facilitates evaluation of the test strip used so that a preliminary rough diagnosis is possible in simple man-ner even for a person not trained in medicine.
Other advantageous further developments of the invention are characterized in the sub-claims or will be explained in grea-ter detail below, together with the description of the pre-ferred embodiment of the invention, with reference to the drawings in which:
Fig. 1 is a top plan view of a preferred embodiment of the invention, Fig. 2 shows another advantageous embodiment of the inven-tion, , ~ 3a and 3b show favorable further developments of the _.' ,,G'' ~0~ ~ embodiment of the invention illustrated in fig. 1, ~n ~ vr die 8 oJ
CA 022~7ll l998-ll-l7 Fig. 4 is a side elevational view of a detail of the embo-diment of the invention illustrated in fig. 1, Fig. 5 illustrates a possible application of the embodiment of the invention shown in fig. 1, Fig. 6 is a top plan view of another advantageous embodi-ment of the invention, Fig. 6a shows a detail of the embodiment of the invention illustrated in fig. 6, Fig. 7 shows a favorable further development of the embodi-ment of the invention illustrated in fig. 6, Figs. 8a and 8b show variants of the embodiment of the inven-tion illustrated in fig. 6, Fig. 9 shows an additional further development of the embo-diment of the invention illustrated in fig. 6, Fig. lO is a sectional elevation along line A...A in fig. 9, Fig. 11 is a perspective view of an additional variant of the invention, Fig. 12a is a top plan view of a package for the embodiment of the invention illustrated in fig. 1, Fig. 12b is a side elevational view of the package illustrat-ed in fig. 12a, Fig. 12c is a sectional elevation along line A...A in fig.
12a, Fig. 13a is a top plan view of a package for the embodiment of the invention illustrated in fig. 2, Fig. 13b is a side elevational view of the package illustrat-ed in fig. 13a, and Fig. 14 is a perspective view of another variant of a package.
The articles of protective clothing presented schematically in figs. 1 and 2 are designed as an elastic glove 1 or finger-stall 1', respectively, carrying a test strip 2 or 2', respectively, which covers a relatively large surface area of the ~m; ning finger 1' or 1.1, respectively, as compared tosize of the examining finger.
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CA 022~711 1998-11-17 Figs. 3a and 3b show proctective clothing articles 1 in top plan view, each provided with a test strip 2" or 2 "', respectively, which covers only a relatively small surface area of the ~m;ning finger 1.1" or 1.1"', respectively. The ratio between the surface of the test strip 2" or 2"', respectively, and the overall surface of the inside of the e~mining finger has a value of << 1, preferably a value of 0.05.
According to fig. 3a the test strip 2" is disposed on the cen-ter line 15 of the examining finger 1.1" in the region of the finger tip. This form of protective clothing article 1" is in-tended especially for patients who perform a self-test to find out the condition of the vaginal environment and who have to introduce the examining finger only to a little depth in the front part of the vagina. The color chart 19 attached to the inside of the glove 1" comprises two color values 19.1 and 19.2 which chromatically mark the limits of the range within which the pH lies in the normal range indicating a healthy vaginal evironment.
A protective clothing article 1"' for use by the physician is illustrated in fig. 3b. The test strip 2" has an off-center position and is located in the region of the middle of the ~ ;ning finger l.l"'. The test strip is arranged at this position because the attending physician, when performing the examination, also covers portions of the vagina located fur-ther inside where also less falsified measurement of the pH of the vaginal environment is possible.
Fig. 4 shows part of the ~ ;n;ng finger 1.1 according to fig. 1, as seen from the side.
The test strip 2 attached to the ex~ ;ning finger 1.1 of the protective clothing article 1 by means of a two-sided adhesive e 2.3 comprises a layer of indicator medium 2.2 which is ~ s~ sed on a substrate and indicates the current pH of the ~ gi al fluid by a color reaction. The type of color reaction ','~
CA 022~711 1998-11-17 makes it possible for the ex~m;ning person to make a statement about a change which perhaps may be pathological in the vaginal environment.
The tab 2.5 is convenient for use to secure the test strip 2 manually to the ~m;ning finger 1.1 of the protective clothing article 1 without touching the indication layer 2.2, the test strip already being connected by its substrate 2.1 to the side 2.4 of the two-sided adhesive tape 2.3. The adhesive layer in contact with the use finger 1.1 once the protective clothing article 1 is presented ready-made is designated 2.6.
Fig. 5 shows a typical example of application for a protective clothing article 1 slipped over the right hand, including a test strip 2 disposed on the forefinger 1.1 for determ;n;ng the pH of the vaginal environment. The female pelvic zone shown partly in section is designated 3. The forefinger 1.1 is advanced into the vagina 4 while being slightly turned in order to achieve better wetting thereof with vaginal fluid.
Thus the layer of indicator medium (cf. item 2.2 according to fig. 4) of the test strip 2 will get into the vagina 4 to a depth of up to 3 cm and becomes discolored in accordance with the pH of the environment prevailing in the vagina.
The elastic protective clothing articles illustrated in figs.
6 and 7 carry test strips 12 and 22, respectively, for Q~m;n-ing the vaginal environment, especially for determining the pH
of the vaginal fluid, which test strips carry a template-type cover 13, 23. The protective clothing articles are designed as glove 10 or fingerstall 20, respectively, and illustrated in diagrammatic form.
The test strips 12, 22 secured by a two-sided adhesive tape 11, 21 to the examining finger 10.1 of the glove 10 or to the fingerstall 20, respectively, each comprise an indicator me-m layer 16 which is masked at least in part by a cover 13 t ~3, respectively, and permits a statement to be made about '~ . .
CA 022~711 1998-11-17 the magnitude of the pH of the vaginal environment based on a color reaction.
When the pH of the vaginal environment is examined the indica-tor medium layer 16 does not get into contact with the vaginal fluid in those areas which are covered.
Recesses 1, 27, 27.1 are provided in the cover and they partly release the indicator medium layer 16, permitting contacting between the indicator medium layer and the vaginal fluid, which contacting involves a color reaction. It is in these areas only that a change in color of the indicator medium layer can take place.
Instead of a cover, a respective independent area - not cover-ing the indicator medium - may be provided. It is disposed in the direct neighborhood of the indicator range and dyed according to a predetermined indicator condition. Then it can be determined quickly and reliably by direct comparison whether a pathological change of the vaginal environment and consequently a risk to the patient is given. With this embodi-ment, too, it is no longer necessary to bring together the in-dicator and the comparative color carrier.
The cover 13, 23 consists of a plastic film and is glued to the indicator medium layer 16. The cover is dyed to be mono-chromatic and its hue conforms to the hue of the indicator medium layer 16 when the vaginal fluid has a pH corresponding to a healthy vaginal environment. Hereby the entire test strip 12, 22 has a uniform and homogeneous coloration, preferably a sunflower yellow hue when the vaginal environment is healthy.
By direct comparison between the hue of the exposed surface areas 17, 27, 27.1 of the indicator medium layer 16 and the hue of the cover 13, 23 directly surrounding them it becomes possible even for those not trained in medicine to discern en minor changes in color so that a quantitatively more ~cise gynecological examination may be initiated.
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CA 022~711 1998-11-17 The cover 13 of the test strip 12 for the glove 10 shown in fig. 6 comprises rectangular recesses 17 which become visible only upon a change in color of the surface area portions of the indicator medium layer to which the vaginal fluid has access.
Fig. 6a presents the ex~;ning finger 10.1 of fig. 6, as seen from the side. The cover 13 is bonded to the indicator medium layer 16 disposed on a substrate 18. Elements 13, 16, 18 form a test strip 12 which in turn is attached to the forefinger 10.1 of the glove by the two-sided adhesive tape 11 having adhesive surfaces 11.1, 11.2. The tab 11.3 of the adhesive tape 11 is free of adhesive and allows convenient handling of the test strip 12 when it is fastened to the selected examin-ing finger.
The recesses 27, 27.1 of the cover 23 of the test strip 22 form a sign which, in addition, releases a psychological effect due its generally valid significance when the exclama-tion mark 27, 27.1 is highlighted optically in case of a change in color provoked by pathological changes of the va-ginal environment.
The test strips 12 and 22 can be conveniently secured manually to the use finger 10.1 of the glove 10 or to the fingerstall 20 by making use of an adhesive-free tab (cf. item 2.5 in fig.
4) of the two-sided adhesive tape 11 or 21, respectively, without touching the indicator medium layer 16 located on a substrate (cf. item 28 in fig. 10).
The protective clothing articles 10, 20 designed-as a glove or fingerstall are made of polyethylene because the two-sided ad-hesive tape can be fastened most simply and, at the same time, securely to this material.
igs. 8a and 8b present film-like opaque covers 23" and 23"' ,i~ *~,~i*~top plan view. They comprise recesses 27' and 27" in the ~' ~ o~m of lettering. The recesses in simple manner constitute a ~ ~r dis e~
'~
CA 022~711 1998-11-17 symbol of attention which the patient recognizes as an indica-tion of a risk, without having to reflect, when a color reac-tion takes place in case of a pathological change of the vaginal environment and the lettering becomes distinct in color from the cover.
Figs. 9 and 10 illustrate a test strip 22', as seen from the top and in cross section, the cut being taken along line A...A
in fig. 9. The template-like cover 23' comprises not only re-cesses 27 and 27' which present an exclamation mark but also a color chart 25 arranged at the outside of the test strip 22' and extending parallel to the longitudinal axis thereof. The color chart 25 comprises a plurality of judging color shades 25.1 with which the hue developing after a color change in the coverless surface areas of the indicator medium layer 16 con-veniently can be compared by direct comparison for a pre-liminary diagnosis.
The two-sided adhesive tape for fastening the test strip 22' is designated 21, the substrate of the indicator medium layer is designated 28.
Fig. 11 illustrates a tear-off roll 40 on which there are a plurality of test strips 12 for the examination of a certain body fluid, for example the vaginal fluid. The individual test strips 12 are releasably attached in series arrangement on a rolled-up support strip 29 and may be removed from the roll 40 as and when re~uired. Between each two adjacent test strips the support strip comprises a rated rupture location 30 to facilitate the severing. Upon removal of the test strip section located on the double adhesive strip (cf. items 2.3, 21 in figs. 4 and 10) the corresponding test strip 12 can be secured by gluing to an elastic glove 10 or to a fingerstall.
.
e package 5 shown in top plan view in fig. 12a includes a ective clothing article 1 which is folded once. The ck~ge 5 comprises a bottom plate 6 in which a molded portion /~lr d~e , ~'/
,~
i CA 022~711 1998-11-17 6.1 is provided to receive the protective clothing article in a way to be firmly held in place.
Foldable flaps 7.1, 7.2 and 8.1, 8.2, respectively, are hinged at the side edges of the substantially rectangular bottom plate 6. The mutually opposing flaps 7.1, 7.2, 8.1, and 8.2 are folded up in pairs, the flaps covering the entire bottom plate, and one pair of flaps 7.1, 7.2 being pressed against the bottom plate 6 by the other pair of flaps 8.1, 8.2 cross-ing over. The free ends of the flaps 8.1, 8.2 which cross over are interconnected by a bondable overlap 8.3 provided at the flap margins, as illustrated in fig. 12b which shows a side elevation of the package 5. By connecting the flap edges, the package 5 cannot open unexpectedly.
The bond connection 8.3 at the overlap can be undone by pulling at the tearing tongue 9, and the protective clothing article 1 may be removed from the opened package.
The sectional elevation according to fig. 12c demonstrates the position of a protective clothing article 1 embodied by a glove inside the package. The glove 1 is folded once trans-versly of the longitudinal direction of the fingers and lies in the molded portion 6.1 which is sealed hygienically by a thin protective film 6.2. The tearing lobe 6.3 arranged one-sidely permits unproblematic peeling of the protective film when the glove 1 is to be taken out of the opened package. To open the package, the two flaps 8.1 and 8.2 which cross over are to be folded up, whereby the bond connection 8.3 is dis-engaged mechanically.
Figs. 13a and 13b show a package 50 for a protective clothing article designed as a fingerstall 1', in closed condition as seen from the top and from the side, respectively.
Th~Q~ gerstalls 1' lie ready for use and in stretched form, in~ividually with the test strip 2' adhered to them and \ 3~3~9l~p ~ i~g ~upwardly, in a molded portion 51.1, 51.2 provided in f~ 0"~
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CA 022~711 1998-11-17 the bottom plate 51. The molded portions 51.1, 51.2 are hygi-enically sealed by a cover film not shown, in accordance with the explanations given with respect to fig. 12c.
The flaps 53.1 and 53.2 which cross over comprise connecting means at their free edges in the form of a slit-like recess (not shown) and a tongue 54 which is inserted into the recess in order to close the package 50.
Fig. 14 shows a supply box 60 holding a plurality of in-dividual packages 5 with a protective glove 1. The supply box can be opened at the front by a slide 62 which is movable in the direction of the arrow, whereby the individual packages 5 become accessible and removable in sequence. The color chart 61 printed on the front permits convenient qualitative evalua-tion of the medical examination by color comparison with a used test strip. The color range 61.1 specifically marked is associated with the healthy vaginal environment.
The invention is not restricted in its realization to the pre-ferred embodiments indicated above. Rather, a number of vari-ants are conceivable which make use of the solution shown even e embodiments fundamentally are of different nature.
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SL 4473 PCT 17.06.98 Specification The invention relates to an apparatus for measuring the properties of an endogenous fluid of the kind indicated in the preamble of claim 1 (DE-U - 9 407 496).
It is known to draw upon the change of characteristics of en-dogenous fluids for diagnostic purposes and thus improve the early recognition of organic diseases or the limitation of organic functions.
One of the most common causes of infections of the vagina and of premature births, in many cases due to such infections, are bacterial colonies growing in the vagina where they cause in-fections. Such a change of the vaginal environment often goes unnoticed by women and expectant mothers. The foreign bacteria displace the lactic acid bacteria which normally are present in the vagina where they create an acidic vaginal environment by forming lactic acid. The acidic vaginal environment offers natural protection against the penetration of foreign bacteria.
A shift in the natural balance at the expense of the lactic acid content leads to a measurable change of the prevailing pH.
The sooner a pathological alteration of the vaginal environ-ment due to the entry of foreign infectious bacteria is re-cognized, the earlier promising counter-measures can be taken by the attending physician.
An examining glove for one-time use for the simultaneous rement of the pH in the vagina of a woman is known from in~407 496.
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CA 022~711 1998-11-17 With the test strip suggested in this form and provided at the ~ ;ning glove for examining the vaginal environment, erroneous assessments or at least difficulties in the qualitative assessment of the test strip applied often occur in disadvantageous manner when evaluated by the patient.
Furthermore, with the examining glove proposed, it is disadvantageously difficult for the test strip needed for the examination of the vaginal environment to be securely fastened to the ~ ining glove by way of ready-made manufacture at little expenditure.
US-A-4,042,329 discloses a test strip including a partial cover which shields the covered areas from the action of the endogenous fluid. According to a variant, the non-covered test strip carries surface areas coated with an indicator medium which are arranged directly adjacent indifferent areas of the test strip.
Starting from the shortcomings of the prior art, it is, therefore, the object of the invention to indicate an apparatus suitable for ~ in~tion of endogenous fluids, especially the vaginal fluid, designed so as to permit evaluation without much effort and with relatively great accuracy and to be manufactured by simple means at low cost.
This object is met by an apparatus as defined in claim 1.
The invention includes the finding that when producing ready-made articles of protective clothing from elastic material advantages in manufacturing t~chn;que can be achieved if the additional elements are connected to the article of protective clothing by gluing.
CA 022~711 1998-11-17 The invention further includes the finding that the qualitative assessment of a test strip, based on a change in color, can be made the more conveniently and accurately the closer the test strip is disposed to a color carrier with the color values to be drawn upon for comparison. In addition, if the background color is adapted to the starting or normal color of the indicator and if that indicator area not shielded by the CA 022~711 1998-11-17 cover which carries the background color has the configuration of a symbol of attention, either in positive or negative form, a change in color is an indication of warning or caution suit-able to be grasped even by an illiterate addressee without thinking twice. This is true also of such lettering as "CAUTION" or "WARNING" because the same effect is brought about by these characters.
According to a preferred embodiment of the invention the elastic protective clothing article to be slipped on for carrying out pH measurements of the vaginal fluid during gynecological examinations of the vagina comprises a test strip for use in measuring the pH which strip is fastened to the protective clothing article by a two-sided adhesive tape.
The test strip comprises a substrate provided with an indica-tor medium and this substrate in turn is joined to one of the two adhesive layers of the two-sided adhesive tape. The finger portion of the protective clothing article in the form of a glove provided for the ~ ;nation, preferably the forefinger (hereinafter referred to briefly as ~ ;n;ng finger) is connected to the second adhesive layer of the two-sided ad-hesive tape.
Using a two-sided adhesive tape is advantageous in particular because, on the one hand, separate application of an adhesive is avoided and, on the other hand, the amount of adhesive as well as the position thereof are fixed. Consequently any con-t~;n~tion with an excess of glue on the surface of the pro-tective clothing article which is to receive the glue, especi-ally on the examining finger is avoided. Such contamination would render the protective clothing article ~nsuitable for the intended examination.
It is especially advantageous with the invention that test strips made of the most diverse materials can be fastened kly and securely. Moreover, the protective clothing ~ o''~ a~ ~les do not need any prior preparation in any specific ( ~ ~ ~ he- in those areas which are inten~e~ ~or gluing. The .~,~ . .
CA 022~711 1998-11-17 protective clothing article according to the invention com-prises two variants, one of them being provided for the physi-cian and the other one for the patient herself. The differen-ces and advantages of both solutions will be described in greater detail below.
The two-sided adhesive tape is advantageously suited for posi-tioning the test strip on the elastic protective clothing article to be slipped on for use in the Q~ ination of an endogenous fluid, for example to measure the pH of the vaginal fluid in a gynecological examination of the vagina.
To allow qualitative assessment of the medical ~ ;nation, the inside of the protective clothing article, the area of the palm of the hand being preferred, is provided with a color chart including a legend so as to determine the current pH by a comparison with the color of the test strip. The boundary zone for a healthy vaginal environment is marked in advan-tageous manner on the color chart so that a disease may be recognized qualitatively also by an untrained person.
According to another advantageous embodiment of the invention the test strip carries a cover at its side facing the body region to be ~m; ned. This cover partly masks the layer of indicator medium which reacts by a change in color to a patho-logical change of the body region to be ~m;ned In this man-ner, advantageously, there are neutral surface sections in the immediate vicinity of those partial surfaces of the layer of indicator medium which react by a change in color, and these neutral surface sections are useful, by specific design, espe-cially coloration for analyzing the change in color of the respective partial surfaces of the indicator medium layer. In another variant, the indicator and the comparative zone are applied directly adjacent each other on the carrier to be in-troduced into the vagina, especially the finger of a glove.
~ .
Ac~ording to a favorable further development of the invention th cover on the indicator medium layer of the test strip is ,~
CA 022~711 1998-11-17 r designed as a template embodied by a monochrome opaque film provided, for example, with circular or rectangular recesses.
These recesses liberate partial surfaces of the indicator me-dium layer for chemical reaction with the body fluid and are completely enclosed by neutral-color film portions. The film-like cover is fastened in simple manner by gluing on the indi-cator medium layer.
According to another advantageous further development of the invention the cover comprises dyeing which conforms preferably to the hue adopted by the indicator medium layer when the vaginal fluid has a pH to be associated with a healthy vaginal environment. Uniform dyeing over the entire surface thus is achieved in favorable manner for the test strip when the va-ginal environment shows no pathological changes. By virtue of the cover, only those sections of the indicator medium layer which are accessible through the recesses become discolored in case of a pathological vaginal environment so that the change in color is noticeable by direct comparison of the discolored area of the indicator medium layer and the cover directly adjacent thereto.
In accordance with a variant of the invention the cover com-prises a color chart which includes a legend and extends parallel to the longitudinal axis of the test strip and is arranged beside the recesses. A color comparison between the coloration in the recesses and the color chart leads in simple manner to the current pH of the vaginal environment.
In the same manner in the color assignment is selectable for an e~m;nation of other endogenou's fluids or secretions.
This way of evaluating the test strip according to the inven-tion is suitable in particular for people untrained in me-~,- dicine because even a minor change in color of the areas of ~ e ur~d b", '~
é;~ ndicator medium layer located in the recesses of the ~' ';' coy~er'can be recognized without any difficulty by direct com-~oL with'the hu'e of the~cover. The exact quantitative ~ , CA 022~i~i711 1998-11-17 r analysis may be undertaken medical ~m; nation initiated after the early recognition described above.
According to another embodiment of the invention the recesses provided in the cover form a symbol. This symbol, for example, is designed as a caution sign or exclamation mark or as warn-ing lettering. In addition to the change in color in case of a pathological variation of the fluid of a certain body region under ~;nation, such as the vaginal fluid, a physiological effect and a optical warning thus are released in advantageous manner at the same time.
According to another advantageous further development of the invention a plurality of identical test strips arranged in series are releasably attached to a support strip. The support strip is wound up to a tear-off roll and provided with a rated rupture location between two successive test strips each. This manner of storing the test strips permits easy handling of the test strips when the protective clothing articles are to be made ready upon demand with a test strip according to the in-vention for use in a medical ex~m; n~tion.
According to an advantageous further development of the inven-tion one end of the two-sided adhesive tape carrying the test strip is provided with a section designed as a tab which is free of adhesive on both sides. This permits convenient handl-ing of the test strip when the protective clothing article is made ready with the test strip required for the examination.
It is just as favorable that the indicator medium layer of the test strip need not be touched by hand in order to be able to carry out the positioning at the seIected place. In this man-ner any influencing of the indicator medium layer is prevented which otherwise might lead to falsified results of the exami-nation or require re-~ ;nation.
ing to another embodiment of the invention the article 3~ of p~ot~ctive clothing is designed to be a fingerstall.
CA 022~711 1998-11-17 r Using a fingerstall on which a test strip of the type describ-ed above is glued, allows the gynecologist or the patient in advantageous manner to choose individually which finger to use for the examination and at which side of the finger to posi-tion the test strip.
The advantageous material provided for the glove and the fin-gerstall is polyethylene because with this material a par-ticularly secure bonding by means of a two-sided adhesive tape can be achieved in simple manner between the test strip and the chosen e~ ;ning finger of the glove or fingerstall.
Depending on the size of the test strip, the test strip af-fixed to the ex~ ;ning finger necessarily leads to certain obstruction as the examining finger is introduced into the vagina. In order to prevent any mental aversion to such an ~m; nation from developing in patients, a ratio having a value of small to 1, preferably in the order of 5 % between the surface area dimension of the test strip and the surface of the inside of the forefinger of the glove is selected ad-vantageously according to another embodiment of the invention.
Such a test strip dimension is sufficient for the optical recognition of a change in color and hardly regarded as an-noying by the patients.
It is favorable for the physician having to carry out a gynecological examination if the test strip is arranged off-center and in the region of the middle of the ex~m;ning finger of the glove since the physician must penetrate rather deeply into the vagina anyhow to perform his other palpating examina-tions. Thus the examination described here presents a side effect to be obtained practically automatically.
On the other hand, it is sufficient for an informative self-test by the patient if the test strip is arranged centrally nd in the region of the finger tip of the forefinger. The ~'S~pa~ient need only slightly insert the examining finger into ~gina GO that the Gelf-teGt can,be carried out without CA 022~711 1998-11-17 any particular problems also by someone not trained in medicine.
According to a favorable further development of the invention the test strip comprises a substrate with a layer of indicator medium which is applied by impression.
In accordance with the invention a package is provided for the protective clothing article for use in determining the pH of the vaginal fluid by means of a test strip. This package holds one or more gloves or fingerstalls, individually packed. That provides specific advantages for storage, quick and convenient access, as well as transportation of apparatus for the exami-nation of body fluids.
The package according to the invention preferably comprises a substantially rectangular bottom plate at the side edges of which hinged flaps are provided which are adapted to be folded up. The oppositely disposed flaps are folded in pairs, the flaps covering the entire bottom plate and one pair of flaps being pressed against the bottom plate by the other pair of flaps crossing over them. The free ends of those flaps which cross over are adapted to be connected to each other, for example, by a bondable overlap provided at the flap margins.
One of the flaps crossing over is provided with a tearing tongue for simplified dissolution of the bond of the over-lapping sections.
According to an advantageous further development a tongue is provided at one flap edge and adapted to be introduced into a slit-shaped recess at the edge of the other flap.
In accordance with the preferred embodiment of the invention the bottom plate comprises molded portions in which the pro-tective clothing articles are adapted to be arranged in fixed position. Each molded portion furnished with a protective cioth~ng article is sealed by a thin cover film in order to o~y~r~ ~ e~t the safe positioning. The cover fiIm consists of fi ;~ ~
~,.. j .. ,f CA 022~711 1998-11-17 plastic material and has a tab for convenient removal of the cover film for withdrawal of the protective clothing article from the opened package.
The package preferably made of cardboard or cardboard-like material is provided with an imprint indicating the contents of the package and usage thereof in order to assure proper application of the protective clothing article according to the invention in carrying out vaginal ~ m; n~tions.
According to an additional further development of the inven-tion a bottom plate of plastics is provided to prevent any un-desirable influence of moisture, especially atmospheric moisture on the package contents.
According to a variant of the invention it is advantageous to ship or store a plurality of individual packages in a supply box. At its front, the supply box comprises a dispensing open-ing adapted to be swung open or designed as a slide and per-mitting sequential access to the individual packages. A color chart mounted on the outside of the supply box and including a separately marked color range assigned to a healthy vaginal environment facilitates evaluation of the test strip used so that a preliminary rough diagnosis is possible in simple man-ner even for a person not trained in medicine.
Other advantageous further developments of the invention are characterized in the sub-claims or will be explained in grea-ter detail below, together with the description of the pre-ferred embodiment of the invention, with reference to the drawings in which:
Fig. 1 is a top plan view of a preferred embodiment of the invention, Fig. 2 shows another advantageous embodiment of the inven-tion, , ~ 3a and 3b show favorable further developments of the _.' ,,G'' ~0~ ~ embodiment of the invention illustrated in fig. 1, ~n ~ vr die 8 oJ
CA 022~7ll l998-ll-l7 Fig. 4 is a side elevational view of a detail of the embo-diment of the invention illustrated in fig. 1, Fig. 5 illustrates a possible application of the embodiment of the invention shown in fig. 1, Fig. 6 is a top plan view of another advantageous embodi-ment of the invention, Fig. 6a shows a detail of the embodiment of the invention illustrated in fig. 6, Fig. 7 shows a favorable further development of the embodi-ment of the invention illustrated in fig. 6, Figs. 8a and 8b show variants of the embodiment of the inven-tion illustrated in fig. 6, Fig. 9 shows an additional further development of the embo-diment of the invention illustrated in fig. 6, Fig. lO is a sectional elevation along line A...A in fig. 9, Fig. 11 is a perspective view of an additional variant of the invention, Fig. 12a is a top plan view of a package for the embodiment of the invention illustrated in fig. 1, Fig. 12b is a side elevational view of the package illustrat-ed in fig. 12a, Fig. 12c is a sectional elevation along line A...A in fig.
12a, Fig. 13a is a top plan view of a package for the embodiment of the invention illustrated in fig. 2, Fig. 13b is a side elevational view of the package illustrat-ed in fig. 13a, and Fig. 14 is a perspective view of another variant of a package.
The articles of protective clothing presented schematically in figs. 1 and 2 are designed as an elastic glove 1 or finger-stall 1', respectively, carrying a test strip 2 or 2', respectively, which covers a relatively large surface area of the ~m; ning finger 1' or 1.1, respectively, as compared tosize of the examining finger.
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CA 022~711 1998-11-17 Figs. 3a and 3b show proctective clothing articles 1 in top plan view, each provided with a test strip 2" or 2 "', respectively, which covers only a relatively small surface area of the ~m;ning finger 1.1" or 1.1"', respectively. The ratio between the surface of the test strip 2" or 2"', respectively, and the overall surface of the inside of the e~mining finger has a value of << 1, preferably a value of 0.05.
According to fig. 3a the test strip 2" is disposed on the cen-ter line 15 of the examining finger 1.1" in the region of the finger tip. This form of protective clothing article 1" is in-tended especially for patients who perform a self-test to find out the condition of the vaginal environment and who have to introduce the examining finger only to a little depth in the front part of the vagina. The color chart 19 attached to the inside of the glove 1" comprises two color values 19.1 and 19.2 which chromatically mark the limits of the range within which the pH lies in the normal range indicating a healthy vaginal evironment.
A protective clothing article 1"' for use by the physician is illustrated in fig. 3b. The test strip 2" has an off-center position and is located in the region of the middle of the ~ ;ning finger l.l"'. The test strip is arranged at this position because the attending physician, when performing the examination, also covers portions of the vagina located fur-ther inside where also less falsified measurement of the pH of the vaginal environment is possible.
Fig. 4 shows part of the ~ ;n;ng finger 1.1 according to fig. 1, as seen from the side.
The test strip 2 attached to the ex~ ;ning finger 1.1 of the protective clothing article 1 by means of a two-sided adhesive e 2.3 comprises a layer of indicator medium 2.2 which is ~ s~ sed on a substrate and indicates the current pH of the ~ gi al fluid by a color reaction. The type of color reaction ','~
CA 022~711 1998-11-17 makes it possible for the ex~m;ning person to make a statement about a change which perhaps may be pathological in the vaginal environment.
The tab 2.5 is convenient for use to secure the test strip 2 manually to the ~m;ning finger 1.1 of the protective clothing article 1 without touching the indication layer 2.2, the test strip already being connected by its substrate 2.1 to the side 2.4 of the two-sided adhesive tape 2.3. The adhesive layer in contact with the use finger 1.1 once the protective clothing article 1 is presented ready-made is designated 2.6.
Fig. 5 shows a typical example of application for a protective clothing article 1 slipped over the right hand, including a test strip 2 disposed on the forefinger 1.1 for determ;n;ng the pH of the vaginal environment. The female pelvic zone shown partly in section is designated 3. The forefinger 1.1 is advanced into the vagina 4 while being slightly turned in order to achieve better wetting thereof with vaginal fluid.
Thus the layer of indicator medium (cf. item 2.2 according to fig. 4) of the test strip 2 will get into the vagina 4 to a depth of up to 3 cm and becomes discolored in accordance with the pH of the environment prevailing in the vagina.
The elastic protective clothing articles illustrated in figs.
6 and 7 carry test strips 12 and 22, respectively, for Q~m;n-ing the vaginal environment, especially for determining the pH
of the vaginal fluid, which test strips carry a template-type cover 13, 23. The protective clothing articles are designed as glove 10 or fingerstall 20, respectively, and illustrated in diagrammatic form.
The test strips 12, 22 secured by a two-sided adhesive tape 11, 21 to the examining finger 10.1 of the glove 10 or to the fingerstall 20, respectively, each comprise an indicator me-m layer 16 which is masked at least in part by a cover 13 t ~3, respectively, and permits a statement to be made about '~ . .
CA 022~711 1998-11-17 the magnitude of the pH of the vaginal environment based on a color reaction.
When the pH of the vaginal environment is examined the indica-tor medium layer 16 does not get into contact with the vaginal fluid in those areas which are covered.
Recesses 1, 27, 27.1 are provided in the cover and they partly release the indicator medium layer 16, permitting contacting between the indicator medium layer and the vaginal fluid, which contacting involves a color reaction. It is in these areas only that a change in color of the indicator medium layer can take place.
Instead of a cover, a respective independent area - not cover-ing the indicator medium - may be provided. It is disposed in the direct neighborhood of the indicator range and dyed according to a predetermined indicator condition. Then it can be determined quickly and reliably by direct comparison whether a pathological change of the vaginal environment and consequently a risk to the patient is given. With this embodi-ment, too, it is no longer necessary to bring together the in-dicator and the comparative color carrier.
The cover 13, 23 consists of a plastic film and is glued to the indicator medium layer 16. The cover is dyed to be mono-chromatic and its hue conforms to the hue of the indicator medium layer 16 when the vaginal fluid has a pH corresponding to a healthy vaginal environment. Hereby the entire test strip 12, 22 has a uniform and homogeneous coloration, preferably a sunflower yellow hue when the vaginal environment is healthy.
By direct comparison between the hue of the exposed surface areas 17, 27, 27.1 of the indicator medium layer 16 and the hue of the cover 13, 23 directly surrounding them it becomes possible even for those not trained in medicine to discern en minor changes in color so that a quantitatively more ~cise gynecological examination may be initiated.
.~
CA 022~711 1998-11-17 The cover 13 of the test strip 12 for the glove 10 shown in fig. 6 comprises rectangular recesses 17 which become visible only upon a change in color of the surface area portions of the indicator medium layer to which the vaginal fluid has access.
Fig. 6a presents the ex~;ning finger 10.1 of fig. 6, as seen from the side. The cover 13 is bonded to the indicator medium layer 16 disposed on a substrate 18. Elements 13, 16, 18 form a test strip 12 which in turn is attached to the forefinger 10.1 of the glove by the two-sided adhesive tape 11 having adhesive surfaces 11.1, 11.2. The tab 11.3 of the adhesive tape 11 is free of adhesive and allows convenient handling of the test strip 12 when it is fastened to the selected examin-ing finger.
The recesses 27, 27.1 of the cover 23 of the test strip 22 form a sign which, in addition, releases a psychological effect due its generally valid significance when the exclama-tion mark 27, 27.1 is highlighted optically in case of a change in color provoked by pathological changes of the va-ginal environment.
The test strips 12 and 22 can be conveniently secured manually to the use finger 10.1 of the glove 10 or to the fingerstall 20 by making use of an adhesive-free tab (cf. item 2.5 in fig.
4) of the two-sided adhesive tape 11 or 21, respectively, without touching the indicator medium layer 16 located on a substrate (cf. item 28 in fig. 10).
The protective clothing articles 10, 20 designed-as a glove or fingerstall are made of polyethylene because the two-sided ad-hesive tape can be fastened most simply and, at the same time, securely to this material.
igs. 8a and 8b present film-like opaque covers 23" and 23"' ,i~ *~,~i*~top plan view. They comprise recesses 27' and 27" in the ~' ~ o~m of lettering. The recesses in simple manner constitute a ~ ~r dis e~
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CA 022~711 1998-11-17 symbol of attention which the patient recognizes as an indica-tion of a risk, without having to reflect, when a color reac-tion takes place in case of a pathological change of the vaginal environment and the lettering becomes distinct in color from the cover.
Figs. 9 and 10 illustrate a test strip 22', as seen from the top and in cross section, the cut being taken along line A...A
in fig. 9. The template-like cover 23' comprises not only re-cesses 27 and 27' which present an exclamation mark but also a color chart 25 arranged at the outside of the test strip 22' and extending parallel to the longitudinal axis thereof. The color chart 25 comprises a plurality of judging color shades 25.1 with which the hue developing after a color change in the coverless surface areas of the indicator medium layer 16 con-veniently can be compared by direct comparison for a pre-liminary diagnosis.
The two-sided adhesive tape for fastening the test strip 22' is designated 21, the substrate of the indicator medium layer is designated 28.
Fig. 11 illustrates a tear-off roll 40 on which there are a plurality of test strips 12 for the examination of a certain body fluid, for example the vaginal fluid. The individual test strips 12 are releasably attached in series arrangement on a rolled-up support strip 29 and may be removed from the roll 40 as and when re~uired. Between each two adjacent test strips the support strip comprises a rated rupture location 30 to facilitate the severing. Upon removal of the test strip section located on the double adhesive strip (cf. items 2.3, 21 in figs. 4 and 10) the corresponding test strip 12 can be secured by gluing to an elastic glove 10 or to a fingerstall.
.
e package 5 shown in top plan view in fig. 12a includes a ective clothing article 1 which is folded once. The ck~ge 5 comprises a bottom plate 6 in which a molded portion /~lr d~e , ~'/
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i CA 022~711 1998-11-17 6.1 is provided to receive the protective clothing article in a way to be firmly held in place.
Foldable flaps 7.1, 7.2 and 8.1, 8.2, respectively, are hinged at the side edges of the substantially rectangular bottom plate 6. The mutually opposing flaps 7.1, 7.2, 8.1, and 8.2 are folded up in pairs, the flaps covering the entire bottom plate, and one pair of flaps 7.1, 7.2 being pressed against the bottom plate 6 by the other pair of flaps 8.1, 8.2 cross-ing over. The free ends of the flaps 8.1, 8.2 which cross over are interconnected by a bondable overlap 8.3 provided at the flap margins, as illustrated in fig. 12b which shows a side elevation of the package 5. By connecting the flap edges, the package 5 cannot open unexpectedly.
The bond connection 8.3 at the overlap can be undone by pulling at the tearing tongue 9, and the protective clothing article 1 may be removed from the opened package.
The sectional elevation according to fig. 12c demonstrates the position of a protective clothing article 1 embodied by a glove inside the package. The glove 1 is folded once trans-versly of the longitudinal direction of the fingers and lies in the molded portion 6.1 which is sealed hygienically by a thin protective film 6.2. The tearing lobe 6.3 arranged one-sidely permits unproblematic peeling of the protective film when the glove 1 is to be taken out of the opened package. To open the package, the two flaps 8.1 and 8.2 which cross over are to be folded up, whereby the bond connection 8.3 is dis-engaged mechanically.
Figs. 13a and 13b show a package 50 for a protective clothing article designed as a fingerstall 1', in closed condition as seen from the top and from the side, respectively.
Th~Q~ gerstalls 1' lie ready for use and in stretched form, in~ividually with the test strip 2' adhered to them and \ 3~3~9l~p ~ i~g ~upwardly, in a molded portion 51.1, 51.2 provided in f~ 0"~
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CA 022~711 1998-11-17 the bottom plate 51. The molded portions 51.1, 51.2 are hygi-enically sealed by a cover film not shown, in accordance with the explanations given with respect to fig. 12c.
The flaps 53.1 and 53.2 which cross over comprise connecting means at their free edges in the form of a slit-like recess (not shown) and a tongue 54 which is inserted into the recess in order to close the package 50.
Fig. 14 shows a supply box 60 holding a plurality of in-dividual packages 5 with a protective glove 1. The supply box can be opened at the front by a slide 62 which is movable in the direction of the arrow, whereby the individual packages 5 become accessible and removable in sequence. The color chart 61 printed on the front permits convenient qualitative evalua-tion of the medical examination by color comparison with a used test strip. The color range 61.1 specifically marked is associated with the healthy vaginal environment.
The invention is not restricted in its realization to the pre-ferred embodiments indicated above. Rather, a number of vari-ants are conceivable which make use of the solution shown even e embodiments fundamentally are of different nature.
~ ~ ~0~
Claims (24)
1. An apparatus for measuring the properties of an endogenous fluid, especially measuring the pH of the vaginal fluid during a manual medical examination, comprising an article of elastic protective clothing (1, 1', 1", 1"', 10, 20) to be slipped on for use in the examination, and a test strip (2, 2', 2", 2"', 12, 22, 22') coated with an indicator medium (2.2, 2.2', 16) and secured to an examining finger (1.1";
1.1"') of the protective clothing article for measuring the pH
of the vaginal fluid, characterized in that the indicator medium layer (2.2, 2.2', 16) comprises a cover (13, 23, 23', 23", 23"') by which it is partly covered such that the covered areas are excluded from the influence of the endogenous fluid or with which the indicator medium layer is arranged in the direct vicinity of an indifferent area of the test strip, that the color of the cover or indifferent area substantially corresponds to the color of the indicator medium in the initial state and within a predetermined range of indications, and that the test strip (2", 2"') is disposed centrally and in the region of the tip of an examining finger (1.1") in the case of an examination intended for self-examination by a patient or off-center and in the region of the middle of an examining finger (1.1"') or fingerstall in the case of an embodiment for examination by a physician.
1.1"') of the protective clothing article for measuring the pH
of the vaginal fluid, characterized in that the indicator medium layer (2.2, 2.2', 16) comprises a cover (13, 23, 23', 23", 23"') by which it is partly covered such that the covered areas are excluded from the influence of the endogenous fluid or with which the indicator medium layer is arranged in the direct vicinity of an indifferent area of the test strip, that the color of the cover or indifferent area substantially corresponds to the color of the indicator medium in the initial state and within a predetermined range of indications, and that the test strip (2", 2"') is disposed centrally and in the region of the tip of an examining finger (1.1") in the case of an examination intended for self-examination by a patient or off-center and in the region of the middle of an examining finger (1.1"') or fingerstall in the case of an embodiment for examination by a physician.
2. The apparatus as claimed in claim 1, characterized in that the test strip is secured to a portion (1.1, 1.1", 1.1"', 10.1) of the protective clothing article by means of a two-sided adhesive strip (2.3, 11).
3. The apparatus as claimed in claim 2, wherein the cover (13, 23, 23', 23", 23"') is designed like a template having recesses (17, 27, 27.1, 27', 27") through which the indicator medium layer (2.2, 2.2', 16) enters into active contact with the endogenous fluid, for example the vaginal fluid.
4. The apparatus as claimed in claim 2 or 3, wherein the recess or area has the shape of a circle or rectangle (17) and/or form a symbol of attention (27, 27.1, 27', 27") which is recognized by the addressee as an indication of danger without giving it any further thought.
5. The apparatus as claimed in claim 4, wherein the symbol is provided as a caution sign or an exclamation mark (27, 27.1) and/or a generally comprehensible warning sign (27') or generally comprehensible warning lettering (27").
6. The apparatus as claimed in any one of claims 2 to 5, wherein the cover (13, 23, 23', 23", 23"') or area is embodied by an opaque film.
7. The apparatus as claimed in claim 6, wherein the cover (13, 23, 23', 23", 23"') or area is fastened on the indicator medium layer (2.2, 2.2', 16) by gluing and consists of a dyed monochrome, preferably sunflower yellow, plastic material.
8. The apparatus as claimed in claim 7, wherein the dyeing is conform with the hue which the indicator medium layer (2.2, 2.2', 16) adopts when the vaginal fluid has a pH corresponding to a healthy vaginal environment.
9. The apparatus as claimed in any one of claims 2 to 8, wherein the cover (23') or area comprises a color chart (25) with hues graded from sunflower yellow to ocher brown, extending in the direction of the longitudinal axis (22.1') of the test strip (22'), and substantially including all those hues which the indicator medium layer (2.2, 2.2', 16) may adopt in the examination of the vaginal fluid.
10. The apparatus as claimed in any one of the preceding claims, wherein a test strip is provided with a substrate (2.1, 18, 28) on which the indicator medium layer (2.2, 2.2', 16) and/or area is printed.
11. The apparatus as claimed in any one of the preceding claims, wherein the two-sided adhesive tape (2.3, 21), of the one side (2.4), is connected to the substrate (2.1, 28) of the indicator medium layer (2.2) and, at the other side (2.6), is adapted to be secured to a portion (1.1, 1.1", 1.1"', 10.1) of the protective clothing article (1, 1', 1", 1"', 10, 20) to be used for the examination.
12. The apparatus as claimed in claim 11, wherein an adhesive-free tab (2.5, 2.5', 21.1) is provided at one end of the two-sided adhesive tape (2.3, 21) used for securing the test strip (2, 2').
13. The apparatus as claimed in any one of the preceding claims, wherein a dispenser is provided in the form of a support strip (29) wound up to a tear-off roll (40) on which a plurality of identical test strips (12) are arranged in series with their longitudinal axis extending parallel to the longitudinal axis of the support strip (29).
14. The apparatus as claimed in any one of the preceding claims, wherein a modification of the protective clothing article is provided as a glove (1, 1", 1"', 10) or fingerstall (1', 20), a chart (19) which comprises at least two comparative colors 19.1, 19.2 limiting the color range of the pH for a healthy vaginal environment being provided at the inside of the glove.
15. The apparatus as claimed in claim 14, wherein the protective clothing article (1, 1', 1", 1"', 10, 20) is made of polyethylene.
16. The apparatus as claimed in claim 14, wherein the test strip (2, 2", 2"') is fastened to the forefinger (1.1, 1.1", 1.1"', 10.1) of the glove (1, 1", 1"', 10).
17. The apparatus as claimed in any one of claims 14 to 16, wherein the ratio between the surface area dimension of the test strip (2", 2"') and the surface of the inside of the examining finger (1.1", 1.1"') of the glove (1", 1"') or fingerstall has a value of small to 1, preferably in the order of 5 %.
18. The apparatus as claimed in any one of the preceding claims, wherein a package (5, 50) having a plate-shaped bottom (6, 51) is provided for a plurality of protective clothing articles, the bottom having at least one molded portion (6.1, 51.1, 51.2) to receive a protective clothing article (1, 1', 1", 1"', 10, 20) and including flaps (7.1, 7.2, 8.1, 8.2, 52.1, 52.2, 53.1, 53.2) which are hinged at its limiting edges so as to be foldable through 180 °, preferred in pairs, and which fully cover the bottom (6, 51) when in folded-up condition, provision being made for part of the flaps (7.1, 7.2, 52.1, 52.2) to be crossed over by the other flaps (8.1, 8.2, 53.1, 53.2).
19. The apparatus as claimed in claim 18, wherein the flaps (8.1, 8.2, 53.1, 53.2) which are preferred to be foldable in pairs and cross over the bottom of preferred rectangular design are designed so as to be connectable at their free ends.
20. The apparatus as claimed in claim 18, wherein the flaps (8.1, 8.2) crossing over the bottom comprise a bondable overlap (8.3) at their free ends or alternatively a slit formation and a tongue (54) adapted to be inserted in the slit formation.
21. The apparatus as claimed in claim 20, wherein a tearing tongue (9) is provided at the overlapping free end of the flap (8,1).
22. The apparatus as claimed in claim 18, wherein the molded portions (6.1, 51.1, 51.2) each are provided with a cover film (6.2) which is attached releasably and includes a tearing lobe (6.3).
23. The apparatus as claimed in claim 18, wherein the bottom (6, 51) is made of plastics, cardboard, or an essentially cardboard-like material and the foldable flaps (7.1, 7.2, 8.1, 8.2, 52.1, 52.2, 53.1, 53.2) are made of cardboard or an essentially cardboard-like material and are provided with an imprint indicating the package contents and usage thereof.
24. The apparatus as claimed in any one of claims 18 to 23, wherein the package is designed as a returnable package (5, 50).
Applications Claiming Priority (9)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DEUM29610236.9 | 1996-05-30 | ||
| DE29610236U DE29610236U1 (en) | 1996-05-30 | 1996-05-30 | Slip-on protective clothing for medical examination |
| DE29614429U DE29614429U1 (en) | 1996-08-09 | 1996-08-09 | Test strips for examining a body's own fluid |
| DEUM29614429.0 | 1996-08-09 | ||
| DEUM29620452.8 | 1996-11-15 | ||
| DEUM29620453.6 | 1996-11-15 | ||
| DE29620453U DE29620453U1 (en) | 1996-05-30 | 1996-11-15 | Slip-on protective clothing for medical examination |
| DE29620452U DE29620452U1 (en) | 1996-08-09 | 1996-11-15 | Test strips for examining a body's own fluid |
| PCT/EP1997/002747 WO1997046878A1 (en) | 1996-05-30 | 1997-05-27 | Device for measuring the properties of an endogenous fluid |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2255711A1 true CA2255711A1 (en) | 1997-12-11 |
Family
ID=27439123
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002255711A Abandoned CA2255711A1 (en) | 1996-05-30 | 1997-05-27 | Device for measuring the properties of an endogenous fluid |
Country Status (5)
| Country | Link |
|---|---|
| EP (1) | EP0912894A1 (en) |
| AU (1) | AU718050B2 (en) |
| CA (1) | CA2255711A1 (en) |
| DE (1) | DE19780517D2 (en) |
| WO (1) | WO1997046878A1 (en) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5383236A (en) * | 1991-11-25 | 1995-01-24 | Als Enterprises, Inc. | Odor absorbing clothing |
| US6409680B1 (en) | 1994-08-25 | 2002-06-25 | James C. Caillouette | pH measurement of body fluid |
| US5916176A (en) | 1994-08-25 | 1999-06-29 | Caillouette; James C. | Estrogen or estradiol need determination by vaginal or urethral acidity determination |
| US6409681B1 (en) | 1994-08-25 | 2002-06-25 | James C. Caillouette | Estrogen or estradiol need determination by vaginal or urethral acidity determination |
| US6390991B1 (en) | 1994-08-25 | 2002-05-21 | James C. Caillouette | Vaginal moisture test apparatus and method |
| US6117090A (en) | 1994-08-25 | 2000-09-12 | Caillouette; James C. | Method and apparatus for detecting amine producing organisms in the vagina |
| US20030120180A1 (en) * | 2001-12-21 | 2003-06-26 | Kimberly-Clark Worldwide, Inc. | Method and apparatus for collecting and testing biological samples |
| US7101342B1 (en) | 2004-05-24 | 2006-09-05 | Caillouette James C | Detection of menopause status and treatment thereof |
| GB2425709B (en) * | 2005-05-06 | 2009-11-25 | Sonia Papworth | One glove bed check |
| US20070215497A1 (en) * | 2006-03-20 | 2007-09-20 | Reddy Kiran K | Glove pair dispensing system |
| DE202008005662U1 (en) | 2008-04-23 | 2008-08-14 | Merossystems Merete Healthcare Gmbh | Test device for examining an endogenous fluid and packaging for this |
| US9579626B1 (en) | 2011-12-01 | 2017-02-28 | Scentlok Technologies, Inc. | Systems and methods for controlling odor |
| US9522207B1 (en) | 2011-12-01 | 2016-12-20 | Scentlok Technologies, Inc. | Systems and methods for controlling odor |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3830035A (en) * | 1969-12-29 | 1974-08-20 | Affiliated Hospital Prod | Method of forming a sealed container arrangement |
| US4042329A (en) * | 1974-12-18 | 1977-08-16 | Becton, Dickinson And Company | Method and device for detecting cholesterol |
| EP0290610B1 (en) * | 1986-10-08 | 1994-08-17 | Dai Nippon Insatsu Kabushiki Kaisha | Method for inspecting bodily fluids |
| DE3913868C1 (en) * | 1989-04-27 | 1990-05-23 | Friedrich 6701 Maxdorf De Braun | Blood parameter measuring sticky foil - has adhesive on underside and indicator zone on top side |
| DE9407496U1 (en) * | 1994-05-05 | 1994-09-22 | Heimann, Wilhelm, Dr., 59269 Beckum | Single-use examination glove for simultaneous measurement of the ph in the woman's vagina |
-
1997
- 1997-05-27 AU AU30927/97A patent/AU718050B2/en not_active Ceased
- 1997-05-27 WO PCT/EP1997/002747 patent/WO1997046878A1/en not_active Application Discontinuation
- 1997-05-27 EP EP97925956A patent/EP0912894A1/en not_active Withdrawn
- 1997-05-27 CA CA002255711A patent/CA2255711A1/en not_active Abandoned
- 1997-05-27 DE DE19780517T patent/DE19780517D2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| AU718050B2 (en) | 2000-04-06 |
| DE19780517D2 (en) | 1999-07-08 |
| AU3092797A (en) | 1998-01-05 |
| EP0912894A1 (en) | 1999-05-06 |
| WO1997046878A1 (en) | 1997-12-11 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |