DE10016383A1 - Versatile body fluid test pad worn at location of excretion and valued for early diagnosis of threatening diseases during pregnancy, includes indicator displaying e.g. pH - Google Patents

Abstract

An interceptor (3) for body fluid, is carried at the point of release from the body, and includes an indicator (2b). An independent claim is included for the corresponding method. Preferred features: The interceptor is located on the side facing the body. Interceptor and indicator are fastened together, e.g. by an adhesive. Between the body part secreting fluid and the indicator, a layer permeable or semi-permeable to the body fluid is located. The indicator is positioned on a panty pad or a sanitary towel. It may be arranged in briefs. The indicator registers pH. Salient features of the method include a device, e.g. like tongs, which express the bodily fluid and bring it into contact with an indicator. The indicator shows the fluid characteristics directly. The fluid is a vaginal secretion. It is urine. Especially pH is indicated. A color change takes place in the range pH 4.0-5.0. The fluid is alternatively from a wound. The indicator determines the acidity of a pH electrode. Sugar content in the bodily fluid is measured.

Description

The invention relates to devices for determining egg properties of human body fluids, in particular Body secretions according to the preamble of claims 1 and 14. It also relates to a method for determining egg properties of human body fluids.

Body secretions are becoming increasingly diagnostic Purposes. An important area here is the sub search of the vaginal milieu or vaginal secretion, esp especially in the context of modern prenatal care.  

Numerous medical studies have shown that a pH increase in the woman's vagina mostly is associated with a disturbed vaginal milieu, which is caused by the shift of the equilibrium parts is triggered by microorganisms. The pH value forms therefore an important basis for the detection of infections in the vagina. This is particularly the case with gynecologists Chen preventive antenatal care is important because it has been shown to be associated with pH increase in the vagina by pregnant women late (from 12 Weeks of pregnancy) miscarriages and premature births occur. By the vaginal mi shifted to the basic bacteria can spread to the uterus ten, which could be a reason for the miscarriages and premature births can. This danger can be particularly caused by acidifying and so that corrective treatment can be effectively avoided.

The gynecological examination includes the usual investigation often also the measurement of the pH value by inserting the electrode of a pH meter or by inserting a pH indicator strip into the Vagina. The control of the pH value is however on restricted the visit to the doctor, so that such a pH increase hunger may be very late and therefore often too late is recognized.

In G 94 07 496.8 there is therefore a device for pH measurement t provision proposed by the woman herself in regular intervals for determining the pH of the Vagina can be used. It is an on Painting glove with a pH indicator on the examination finger kator strips is attached. The glove's finger  is inserted into the vagina and the pH value can then read from the color of the pH measuring strip become.

This device has the disadvantage that the Untersu must always be performed invasively, d. H. the measuring device must be inserted into the vagina. Such self-examination is used by some women at least perceived as annoying or even with one Aversion connected.

The present invention is based on the object Methods and devices of the type mentioned at the beginning create a loading in a simpler and more convenient way tuning the properties of body fluids, especially the pH of vaginal secretions.

This object is achieved by the devices with the features of claims 1 and 14 and by Method with the features of claim 8 solved.

According to claim 1, the device is the catch to form means for collecting the body fluid so that it is at the point of exit and / or the emergence of the Body fluid is portable and the indicator agent having.

Often, in this non-invasive way used or at least without a major loss of comfort portable at the point of exit and / or emergence Collection agent also for regular control a property of the body fluid the. Under property in the sense of the present invention  every property that can be measured is to be understood hen, from which conclusions can be drawn about the state of the body let the liquid soak.

The invention is suitable for all body fluids, whose viscosity is low enough to get rid of the trapping agent to be able to be included. It is therefore not just pure Liquids to be understood by it, but expressly also all liquids, the solids or gases, contain in particular biological oligo- and polymers, such as they usually occur in or from the body be deposited.

In a preferred variant of the device, the opening is catcher arranged on a body-facing side, causing the body fluid to come into contact with the indicator medium comes and they are absorbed by the collecting agent becomes. Small amounts of body fluid are therefore sufficient Determination of the property. By including the body Perfluid in the collecting agent is prevented that Wearing an uncomfortable feeling arises and the underwear is contaminated.

In a further embodiment, the indicator means and the collecting means by a fastening means, in particular special adhesive connected. So is a quick and inexpensive attachment possible.

In a further variant, there is a gap between the liquid body part and the indicator means one for the Body fluid permeable or semipermeable layer arranges. Negative or unpleasant influences from the indicator on the part of the body where the device rests, are reduced or excluded.  

A particularly simple and inexpensive variant results if the indicator agent is in or on a slip in ge or bandage, especially for women, or a Pressmit tel is arranged. Contains a panty liner or bandage already containment and can be used once or several times be provided for use. In addition, many use Women already have panty liners, so that no change is connected.

Another advantageous variant is the indicator agent to arrange in a slip.

It is particularly preferred if on the body-facing Side of the panty liner and / or the panty a pH indicator strip is arranged as an indicator means.

The object is also achieved by a method according to the invention solved, in a first step, a collecting agent for a predetermined time at the point of exit and / or the Formation of the body fluid and thereby the Body fluid is collected by a collecting agent. In a second step, the absorbed body fluids in contact with an indicator agent and the property of the indicator means is displayed.

This is also a determination of the property of the body liquid is possible in a non-invasive way and it can fallback devices that have already been used can be used.

In the process, it is preferred that of the collecting agent ingested body fluid under pressure, especially with a mechanical press with the indi bring katormittel in contact.  

In a preferred embodiment, the collecting agent at the point of exit and / or the origin of the body liquid fixed. This will prevent slipping during largely prevented from wearing.

Once the body has been caught, liquid from the point of exit and / or origin the body fluid removed is a particularly simple one Determination of the property of the body fluid given.

In a variant of the method according to the invention bringing the body fluid into contact with the indicator gate means immediately after the absorbing step the catching agent. This has the advantage that subsequent Changes in the absorbed body fluid largely be avoided.

A device can be used to collect the body fluid be used at the point of exit and / or the Formation of body fluid is wearable and the indica has gate means. When combining the device with the procedure results in an additional control or Supplemented by two different indicator means, too at different times with the body fluid in Be brought in contact. One is when you wear it the collecting agent, d. H. when the body emerges fluid in contact with the body fluid, the others only after wearing.

In the additional control, both are indicators sensitive to the same property of the body fluids This is an indicator with additional use sensitive to another property than the other.  

When the device is used independently, only that is activated indicator means arranged in the collecting means are used, possibly at predetermined intervals supplemented by the Use of the indicator marked on the press tels.

However, it should be emphasized that the device according to one of the Claims 1 to 7 not only in combination with the inventions method according to the invention, but can also be used independently is.

The device according to claim 14 is for performing the second step of the method according to the invention hen. It has a pressing means for pressing out a Collecting agent is provided that the body fluid contains.

It is preferred that the pressing agent is the indicator has medium, so that the indicator means when pressed is brought into contact with the body fluid.

This device preferably has a type of pliers the indicator means is arranged in the jaws. At the Operating the pliers, i.e. when squeezing the collecting agent it is better guaranteed that sufficient amounts of the Kör perfluid brought into contact with the indicator means and ensure a secure display of the property is steady.

A particularly simple variant results if that Indicator means by a fastener, in particular an adhesive is connected to the pressing means.  

The following preferred embodiments of the present the invention are both for the two devices the method can also be used advantageously.

It is preferred that the collecting agent be in or on a Panty liner or bandage, especially for women, arranged is.

It is also advantageous if the indicator means own shaft of the body fluid immediately indicates.

The body fluid to be absorbed consists of vaginalse Cretan, can be used in pregnant women as well as in non-pregnant women ren without additional effort and without that the woman one in must carry out vasive measurement in the vagina by the Women themselves recognize whether a change in a property of the milieu in the vagina itself. Possibly can get a quick introduction by consulting the doctor of countermeasures.

A preferred embodiment is that the sow body fluid consists of urine. Even on my own Shafts of urine can be with the help of the process quickly draws conclusions about health stand to pull a person. So that z. B. a quick one Diabetes diagnosis possible.

Furthermore, it is preferred that the location of the exit and / or the formation of body fluid a wound is. Early detection of the condition of the wound, especially infection is possible in this way.  

It is particularly preferred here the pH of the body measure liquid with the indicator medium. From the pH value can easily be important information over body fluids and from it in turn on the Ge health condition of the person. In particular it is preferred that the indicator agent on the vaginal acid is sensitive. A simple color comparison makes it indispensable depending on complex measuring technology a sufficiently accurate The pH value can be determined to provide information on infection to get one. It can be a single indicator or a Combination of lean indicators can be used.

Furthermore, it is particularly preferred that the color change of the pH indicator in the range between pH 4.0 and pH 5.0 follows. For other tasks, it can be useful To extend the measuring range, e.g. B. up for detection a jump of the amniotic sac.

In an alternative embodiment of the ß devices the indicator means for determination of the acidity on a pH electrode.

The measurement of the sugar content, especially the Glucose content, the body fluid with the indicator with tel can be used advantageously.

The invention is described below with reference to the Figures of the drawings based on the determination of the pH of the vaginal secretion in several embodiments explained. However, it should be emphasized that a large number of other types possible uses of the present invention are. Show it:  

Figure 1 is a plan view of a device according to the invention Vorrich in the form of a panty liner with pH indicator.

Figure 2 is a side view of a first embodiment of the panty liner with a pH indicator.

Fig. 3 is a side view of another embodiment of the panty liner with pH indicator.

Fig. 4 is a side view of a Vorrich device according to the invention with pressing means, which is designed as pliers;

Fig. 5 is a plan view of processing to that shown in Figure 1 Vorrich.

Fig. 1 shows a panty liner 1 , on the body side ter 4 there is a pH indicator layer 2 . Body-facing side 4 is to be understood as the side of the panty liner 1 that lies against the body during use. The slip insert 1 is used to determine the pH of the escaping vaginal secretion. The secretion that emerges from the vagina has approximately the same pH value as inside the vagina and can therefore also be used to determine the pH value inside the vagina. For Ge use, the panty liner 1 , like any ordinary panty liner, is placed directly in front of the vagina exit, in this case the place of exit, in the panty.

When using the panty liner 1 according to the invention, the exiting vaginal secretion first reaches the pH indicator layer 2 and discolors it in a characteristic manner depending on the acidity of the vaginal secretion. It is then taken up and stored by absorbent materials as collecting means 3 , which are located in the panty liner. The secretion thus passes through or past the indicator layer 2 , so that there is hardly any moisture left and the wearing comfort is not impaired in comparison with a normal panty liner. The indicator layer can be permeable, semipermeable or also impermeable for the vaginal secretion.

A pH indicator is used, which is in the range between pH 4.0 and pH 5.0 changes in several stages, with a pH of 4.4 or 4.5 (depending on the nature of the indicator) as upper threshold is to be seen. Values above that in the vagina indicate that there is an increased risk of developing Infection. With suitable indicators, the Read the pH value particularly precisely in this area.

The pH is determined, for. B. in simple Way by the woman herself by comparing the color of the Indicator with a color scale. Such a pH determination Mung is sufficiently precise to indicate to the woman when consulting a doctor for further exams is required. It is particularly useful to do this regularly pH monitoring in pregnant women It is important to have an infection of the vagina that leads to miscarriage and Premature babies lead and in advanced stages too can spread to the fetus, to recognize early to be able to take countermeasures immediately. As meaning has a full biweekly to treat practitioners follow immediately to check possibly also daily PH measurement highlighted.

Of course, this can also apply to non-pregnant women this type of measurements for the early detection of determ vaginal infections (e.g. bacterial vaginosis) be used.  

In order to get to the panty liner 1 according to the invention with the pH indicator 2 applied, the customary panty liners or sanitary napkins available on the market can be used as they have sufficient amounts of absorbent materials, such as, for. B. have hydrogels.

The arrangement of the color indicator in or on the absorbent material is possible in a variety of ways. In Fig. 2, a layer 2 provided with a pH indicator is attached to a commercially available panty liner. In the simplest case, this indicator layer 2 can be a pH indicator paper or an indicator-provided pH test strip made of plastic, which is glued or otherwise attached to the body-facing side of the panty liner. An indicator-impregnated gauze or fleece layer is associated with greater wearing comfort. As a fastening medium, conventional adhesive tape can be used, which is provided on both sides with an adhesive layer. When using diapers and the like that are reused, the use of Velcro or other reusable fasteners is advantageous.

In a special embodiment, a pH indicator applied and the actual color reaction of the pH indicator only after use by spraying a wide one triggered their substance. Conditioning the indicator however, already takes place while wearing.

In a variant shown in FIG. 3, the indicator layer is covered with a protective intermediate layer 5 in order to reduce or completely prevent any negative influences of the indicator layer 2 on the skin. Such an intermediate layer 5 can consist, for example, of a thin nonwoven material or a membrane which is permeable or semi-permeable to the vaginal secretion. The thickness and the type of material are chosen so that the view of the indicator layer 2 is only slightly influenced and the pH value can still be read off.

In Figs. 4 and 5, the side view and top view are shown of an apparatus with a pressing means, which is designed as a chuck 6. The pliers 6 serve to squeeze out the collecting means 3 , which is arranged in a panty liner 1 on the side 4 facing the body, after it has taken up the body fluid, in this case vaginal secretions. Body-facing side 4 is to be understood as the side of the panty liner 1 that lies against the body when worn.

The secretion that emerges from the vagina has approximately the same pH value as inside the vagina and can therefore also be used to determine the pH value inside the vagina. For use, the panty liner 1 , like any other panty liner, is placed directly in front of the vagina exit, i.e. in this case the point of exit, in the panty and worn over the day or at least a few hours on the body, so that there is sufficient exposure is guaranteed with the vaginal secretion.

The pliers 6 have two jaws 7 a, 7 b, each of which has a facing surface 8 . On the surface 8 of one jaw 7 a, a pH indicator 2 a is attached. The simplest way of attaching a pH indicator 2 a is to glue a pH indicator strip to the jaw 7 a of a commercially available pair of pliers 6 using an adhesive or adhesive strip. The gluing should ensure sufficient adhesion of the pH indicator 2 a to the jaw 7 a. When using pH indicators 2 a, which are intended for single use, the liability should not be too strong, however, in order to be able to easily remove the pH indicator 2 a from the jaw 7 a after use. In addition, the pH indicator 2 a can also be connected in another way to the jaw 7 a, which allow removal after use, for. B. by plugging or clamping, inserting ben into a recess, fastening with Velcro etc.

On the other hand, are reusable indicator agents such as pH electrodes used, it is advantageous to take this to connect with the cheeks.

To squeeze out the collecting means 3 , the panty liner 1 with the part containing the collecting means 3 is placed between the jaws 7 a, 7 b of the pliers 6 in such a way that the body-facing side 4 of the panty liner 1 points in the direction of the jaw 7 a , which carries the pH indicator 2 a. The pliers 6 are then pressed together so that pressure is exerted on the panty liner 1 . By this pressure at least a part of the vaginal fluid secretions collected in the panty liner 1 is pressed out of this. The jaws 7 a, 7 b of the pliers 6 are designed so that effective squeezing is possible. A pair of pliers 6 with flat and not too small jaws 7 a, 7 b is particularly favorable.

Panty liners are usually provided with an adhesive surface on the side facing away from the body to enable attachment to the panty. This adhesive surface can be used to fasten the panty liner 1 before compression on the jaw 7 b, so that the panty liner 1 need not be held by hand before and after the pressing operation. To make it easier to remove the panty liner 1 but also the indicator 2 a from the respective jaw 7 a, 7 b, it is advantageous to provide the jaws 7 a, 7 b with a non-stick coating.

The pressed part of the vaginal secretion comes into contact with the pH indicator 2 a during the pressing process. After a predetermined pressing time, which is usually only a few seconds, the jaws of the pliers can be opened and the pH value can be read off the pH indicator 2 a. When using pH electrodes, a display device arranged on the tongs is provided.

If a longer pressing time is necessary, the pliers are on Means are provided to keep the jaws in the pressing position hold. In addition, of course, others, too Under certain circumstances, automatic pressing devices are used.

By using the pliers, it is possible to apply a defined and particularly strong pressure when pressing. Direct contact with the panty liner 1 is also avoided by the pliers, which is advisable for hygienic reasons.

The measurement of the pH should be done as directly as possible after wearing the panty liner 1 , so that the falsifications of the pH, z. B. by oxidation, be kept low.

When using the device shown in FIGS. 4 and 5 , a pH indicator 2 a is also used, which changes in several stages in the range between pH 4.0 and pH 5.0. The pH value can also be determined by the woman using this device.

The devices shown in Figs. 1 and 4 can be used particularly effectively in combination. The combination leads to an additional control or supplementation by two indicator means, which are brought into contact with the body fluid at different times. One is brought into contact with the body fluid directly when the collection agent is carried, ie when the body fluid leaks, the other only after the body has been carried.

In the additional control, both indicator means are sensitive to the same property of the body fluid, so that the accuracy and reliability of the result is significantly improved. Furthermore, differently sensitive pH indicators can be used. For example, the pH value is measured while wearing a pH indicator 2 b, while the subsequent determination is carried out with the help of a sensitive pH electrode.

When used in addition, this is an indicator another property sensitive than the other so that the Different properties are determined in parallel can. You may also have two body fluids on a property such as B. vaginal secretions and urine the pH value.

In general, not only color indices come to determine the pH value cators into consideration. Other means of loading can also be used adjustment of the pH value, which is a clear Allow the pH to be assigned. As such, esp special pH electrodes are suitable, which then make sense if a more precise determination of the pH is necessary. Through the ever smaller and cheaper electronics chips  is also in an alternative embodiment Use in combination with a pH electrode for display and evaluation purposes can be realized. Such an ad and evaluation unit can constantly use the electrode connected, but can also only after use be briefly connected to the electrode to the read pH value.

In addition, the present invention is not limited restriction of the pH of the vaginal secretions, but can be used generally to monitor properties of the body liquids, especially body secretions the. Such properties can include, for example, the content a body fluid on certain substances. Advance The only thing is that these substances with the help of indica gates or sensors of any kind qualitatively or get quantified. The sensor could also be used "Incontinence Detectors" act who carry the urinab gang informed.

So is the determination of the pH of the urine at inconti possible people. Bring a pH indicator Layer analogously inside a diaper or win delhose under or presses the diaper pants after use changes in pH value also draw conclusions. One can also be found in urine bags Means for determining the pH value, but also other indices katormittel be arranged. The indicator agent for pH who t determination of urine would, however, have to be larger Measuring range, for example pH 3 to pH 8, than at the pH Have value determination of the vaginal secretion.  

Another application is for monitoring the urine sugar level in diabetics or those at risk of diabetes. For this purpose, an absorbent material, for example a panty liner, is either provided with an appropriate sugar indicator and placed in front of the urethra. Or the tongs 6 or another pressing means has a sugar-sensitive indicator medium.

The applications described above are based on the Area related to the genital or excretory organs. In addition, the present invention can also be applied to the Determination of the pH value or the detection of bacteria serve metabolic products in wounds. For one thing a wound-absorbing wound covering material after the Pressed out and the property to be determined shows. On the other hand, the cover material with a pH-in indicator or one sensitive to metabolic products Provide indicator means. When changing the association already indicated by the indicator means whether z. Legs Infection of the wound occurs before the symptoms become apparent become.

In hospitals or for outpatient monitoring it may also be useful to have the current data of a electrically working indicator means, for example one pH electrode or other sensors, by telemetry from the Transfer device to a doctor or surveillance room In combination with a warning system, the over alarm threshold exceeded resolves, the doctor is able to enter without delay fen.  

But also the combined measurement of different properties body fluids is conceivable. Furthermore may be affected in particular by future developments of Determination method further applications of the method and devices according to the invention, who use the basic idea of the invention do.

Claims (26)

1. Apparatus for determining the properties of human body fluids, in particular body secretions, with an indicator means for determining the property, characterized by a collecting means ( 3 ) for collecting the body fluid, the collecting means ( 3 ) being designed so that it is on Location of the leakage and / or the formation of the body fluid is portable and has the indicator agent ( 2 b). 2. Device according to claim 1, characterized in that the collecting means ( 3 ) is arranged on a body-facing side (4). 3. Apparatus according to claim 1 or 2, characterized in that the indicator means ( 2 b) and the collecting means ( 3 ) are connected by a fastening means, in particular an adhesive. 4. The device according to at least one of the preceding claims, characterized in that between the liquid-secreting body part and the indicator means ( 2 b) is arranged for the body fluid permeable or semipermeable layer ( 5 ). 5. The device according to at least one of the preceding claims, characterized in that the indicator means ( 2 b) is arranged in or on a panty liner ( 1 ), a bandage, especially for women. 6. The device according to at least one of the preceding claims, characterized in that the indicator means ( 2 b) is arranged in a slip. 7. The device according to at least one of the preceding claims, characterized in that a pH indicator paper is arranged as an indicator means ( 2 b) on the body-facing side (4) of the panty liner ( 1 ) and / or the panty. 8. Method for determining properties of human body fluids, in particular body secretions, in which

• a) a collecting agent ( 3 ) is carried with a solid content at the point of exit and / or the formation of the body perfluid, wherein the body liquid is collected by the collecting agent ( 3 ), and
• b) bringing the absorbed body fluid with an in dikatormittel (2 a) in contact and the property is a) indicated by the indicator means (second

9. The method according to claim 8, characterized in that the body fluid absorbed by the collecting means ( 3 ) is brought into contact with the application of pressure, in particular with a mechanical pressing means, with the indicator means ( 2 a). 10. The method according to claim 8 or 9, characterized in that the collecting means ( 3 ) is fixed at the point of exit and / or the formation of the body fluid. 11. The method according to at least one of claims 8 to 10, characterized in that the collecting means ( 3 ) after collecting the body fluid is removed from the site of the leak and / or the formation of the body fluid. 12. The method according to at least one of claims 8 to 11, characterized in that step b) of the An saying 7 carried out immediately after step a) becomes. 13. The method according to at least one of claims 8 to 12, characterized in that for collecting the Body fluid a device according to one of the Claims 1 to 7 is used.   14. The apparatus for performing the method according to claim 8, characterized by a pressing means ( 6 ) for pressing out a collecting means ( 3 ) which contains the body fluid. 15. The apparatus according to claim 14, characterized in that the pressing means ( 6 ) has the indicator means ( 2 a), so that the indicator means ( 2 a) is brought into contact with the body fluid when pressed. 16. The apparatus of claim 14 or 15, characterized in that the pressing means comprises a pressing device in the manner of a pair of pliers ( 6 ), on the jaws in the indicator means ( 2 a) is arranged. 17. The device according to at least one of claims 14 to 16, characterized in that the indicator means ( 2 a) and the pressing means ( 6 ) are connected by a fastening means, in particular an adhesive. 18. The device or method according to at least one of the preceding claims, characterized in that the collecting means ( 3 ) in or on a panty liner ( 1 ) or bandage, in particular for women, is arranged. 19. The apparatus or method according to at least one of the preceding claims, characterized in that the indicator means ( 2 a, 2 b) immediately indicates the property of the body fluid. 20. Device or method according to at least one of the preceding claims, characterized in that the body fluid to be sucked up from vaginal secretions consists. 21. Device or method according to at least one of the preceding claims, characterized in that the body fluid to be absorbed consists of urine. 22. Device or method according to at least one of the preceding claims, characterized in that the place of exit and / or origin of the Body fluid is a wound. 23. The device or method according to at least one of the preceding claims, characterized in that the pH of the body fluid, in particular the vaginal secretion, is measured with the indicator means ( 2 a, 2 b). 24. The device or method according to claim 23, characterized in that the color change of the indicator means ( 2 a, 2 b) in the range from pH 4.0 to pH 5.0 it follows. 25. The device or method according to claim 23 or 24, characterized in that the indicator means ( 2 a, 2 b) for determining the acidity has a pH electrode. 26. The device or method according to at least one of the preceding claims, characterized in that the sugar content of the body fluid is measured with the indicator means ( 2 a, 2 b).