DE102009023460B3 - Testing device for testing vaginal fluid of women for detecting bacterial vaginosis, has distal end retracted behind distal opening of mantle in protection position, where end is pushed forward distal opening in sample retaining position - Google Patents

Abstract

The testing device (10) has a gripping part (12) fixed at a proximal end of a guiding part (14), and a sample retainer (26) axially movably guided into an interior of the guiding part. The retainer has a distal end (18) for supporting an auxiliary fluid retaining zone (30) and is movable between a protection position and a sample retaining position by a radial projection and a pushing knob supported at the guiding part. The distal end is retracted behind a distal opening (20) of the mantle in the protection position and is pushed forward the distal opening in the sample retaining position.

Description

Field of the invention

The The invention relates to a test device for vaginal fluid, comprising one in the vaginal cavity insertable long extended insertion part and a grip part fixed to the proximal end of the insertion part, the insertion part at least two fluid receiving zones, of which at least one is designed as a pH test field and of which at least another an additional fluid receiving zone represents.

State of the art

Such test devices are known from the WO 2008/051371 A2 ,

The Terms "proximal" and "distal" in the present context according to their medical equipment-related Definition uses "proximal" "closer to examining doctor "and" distal "" away from the examining doctor ".

• 1. dünnflüssiger, homogener Fluor
• 2. pH-Wert in der Scheide über 4,5
• 3. charakteristischer, ”fischartiger” Geruch des Fluors bei Reaktion mit 10%iger Kalilauge (”Whiff-Test”)
• 4. Nachweis vorgegebener Schlüsselzellen im Nativpräparat.

Bacterial vaginosis, BV for short, is the most common microbiological disorder of the vaginal milieu in women during sexual maturity. A test for the presence of a BV is therefore part of the standard repertoire of gynecological check-ups. To standardize the diagnosis, medicine has developed the four so-called "blackbird criteria", whereby, according to international convention, a BV is considered diagnosed if at least three of the four Amsel criteria are met. The blackbird criteria are:

• 1. low-viscosity, homogeneous fluorine
• 2. pH in the vagina over 4.5
• 3. characteristic, "fishy" odor of the fluorine in reaction with 10% potassium hydroxide ("whiff test")
• 4. Detection of given key cells in the native preparation.

by virtue of the frequency the test execution It is especially important to have the test as efficient as possible for the doctor possible and for to make the patient as stress-free as possible.

The The above-mentioned generic document discloses one of their shape to a key reminding test device with a widened handle part and a narrow insertion part with rounded contours. On the surface of the insertion part is near his distal end a pH test field arranged, which a Color comparison field is adjacent. On the opposite side of the insertion part is as an additional Test field a strip-shaped, KOH-impregnated Fleece arranged. At the gynecological Examining, the doctor spreads the vagina with a speculum, taking it recognizes the quantity and consistency of the fluorine (first Amsel criterion). Subsequently becomes the measuring device measuring a few centimeters of the test device into the vaginal cavity introduced, The doctor holds the device on the handle. At the Contact with the vaginal wall vaginal fluid gets to the above Test fields. The pH test field is impregnated with pH-sensitive chemical and shows according to the pH of the vaginal fluid, a color reaction with the adjacent color comparison field can be compared to the pH of the vaginal fluid shut down (second blackbird criterion). Responding on the additional test field the vaginal fluid with the KOH and possibly produces the characteristic the doctor interpretable, "fishy" odor (third blackbird criterion). In this way you can with a single investigation reviewed three of the four blackbird criteria and one safe diagnosis.

This known device is therefore cheaper than that from the US 6,019,734 known device, in which also a KOH test field and a pH test field are applied to a common, narrow, elongate carrier. However, there are the test fields attached to opposite ends of the device. The doctor grasps the device in its middle area. This arrangement requires a two-time introduction of the device in the vaginal cavity and thus means a higher burden on the patient.

adversely in the generic device is the medically unfavorable anatomical position of the fluid withdrawal positions. This is the pH test Although in medically cheaper Way with fluid performed which is removed a few centimeters from the vaginal entrance has been. However, the whiff test is also performed with fluid which a few centimeters from the vaginal entrance. This is unfavorable under diagnostic aspects because of external contamination falsify the test and especially lead to a false-positive result. diagnostic would be optimal the implementation of the whiff test with fluid that is about 6 to 8 inches away from the vaginal entrance was removed. The acidic environment near the entrance to the vagina, which under the second Amsel criterion is an effective Bacterium barrier. The presence of amine-producing bacteria therefore, before this lock is often uncritical. Lying these bacteria but also in deeper areas of the vaginal cavity, especially at the entrance of the vaginal cavity cervix before, it means that the natural Barrier overcome was and actually one BV is present.

The obvious approach, the Testvorrich tion only in an anatomically optimized way by increasing the length of the insertion and changes the arrangement of the test fields compared to the known device, ie in particular the KOH field is arranged much further distally, but is not effective. In such a reorganization, the KOH test field would be contaminated with fluid from "wrong", ie, in particular, entrance-entry-related areas when it is introduced or removed, as a result of which the result could be falsified.

From the US 4,945,921 For example, a sampling device for collecting vaginal fluid is known. In this case, a liquid-receiving, sponge-like part in the vaginal cavity is brought into contact with the vaginal fluid and a liquid sample is taken up. The liquid-receiving, spongy part is completely enclosed in a protective tube when inserted into and removed from the vagina so as to prevent adulteration of the recovered vaginal fluid. However, this known device is used solely for sampling; Any examinations and / or tests on the sample material obtained must then be carried out by means of separate chemicals and / or equipment in a separate analysis step.

From the US 6 113 856 A a test device for the diagnosis of bacterial vaginosis in the form of a separate regions having test card is known. If these areas are wetted with a fluid sample such as vaginal fluid, both a pH test and an amine detection can be carried out by means of visual indicators which, in the positive case, indicate a color change. Such a test device, which itself can not be used for sample extraction, z. B. be used in addition to the aforementioned sampling device.

task

It The object of the present invention is a generic test device for the investigation of vaginal fluid in such a way that the test results more meaningful are and in particular false-positive Results can be avoided or at least reduced.

Presentation of the invention

These Task is combined with the features of the preamble of Claim 1 solved by that the insertion part a shell formed as a distal open hollow member and an axially displaceably guided in the interior sampler whose distal end of the additional fluid receiving zone wearing, wherein the sampler is mounted by means of a handle on the part Displacement device between a protective position in which the distal end of the sampler behind the distal opening of the Mantels withdrew is a sampling position in which the distal end of the Sampler over the distal opening the shell is pushed out, is displaced.

The The present invention has two main features from the prior art. First, the arrangement of the two Fluid receiving zones on the insertion part according to the anatomical conditions and diagnostic requirements optimized. So gets the extra Fluid receiving zone under normal use of the test device according to the invention deeper into the vaginal cavity in as the designed as a pH test field fluid intake zone. This can do the extra Fluid receiving zone vaginal fluid from a region beyond the in nearby of the vaginal entrance established acid barrier. By the second important feature of the present invention the technology differs, namely the displacement of the additional Fluid receiving zone between an exposed and a jacket protected position, becomes reliable prevents the extra Fluid receiving zone when entering or running the test device with Vaginal fluid is contaminated from other than the target area. One with the fluid, by means of the additional fluid intake zone was taken, carried out test is therefore for a reliable one Statement about the vaginal flora nearby of the cervical input. For the examining physician is the operation of the test device according to the invention easy and convenient. Due to the fact that the displacement device, with the extra Sampling zone for sampling via the tube end of the introduction part pushed out or to protect against contamination in the pipe of the introduction part withdrawn is located in the handle part, the shift can be on comfortable way with one hand, For example, accomplish with a thumb movement. Also for the examined Patient is the intended examination very gentle.

Conveniently, the displacement device and / or the sampler is spring-biased in the direction of the protective position. This means that in non-actuated displacement device, the distal end of the sampler with the additional fluid receiving zone is in the protective position inside the jacket. This allows the examining doctor to work as usual during the running in and out of the test device and to handle the device in a most gentle way. Only for the actual sampling, ie the fluid intake in the additional fluid intake zone, the displacement device must be operated briefly. A targeted return is not necessary as the sampler automatically snaps back to its protection position. It is therefore not possible for the additional fluid intake zone to be accidentally left in the sampling position and contaminated when the test device is being executed.

Prefers The sampler includes a shaft that covers the inside of the jacket interspersed, d. H. above whose proximal end protrudes. On this basis, two especially cheap embodiments will be realized.

at A first development of the invention is provided that the shaft into a hollow handling area of the Handle part extends into it, where he with a wall of the handling area passing actuator connected is. In this embodiment the handle part at least partially hollow. In these Cavity protrudes into the proximal end of the sampler. An actuator that For example, as radially on the sampling shaft attaching extension may be formed, protrudes through a lateral wall opening the hollow handle portion through. This actuator represents the interface to the investigative type, which is characterized by a axial displacement of the actuating element within the Wandungsdurchbruchs an axial movement of the shaft can generate. Of course must the wall breakthrough such a movement of the actuator allow, d. H. preferably designed slot-like.

at An alternative development of the invention is provided that the shaft also passes through the hollow handle part and protrudes at least in the protective position proximally on this. at This embodiment of the invention is the shaft end itself as actuator educated.

Basically exists no restriction regarding the use of the additional fluid receiving zone absorbed vaginal fluid. In particular, the recovered fluid after running the test device to be subjected to arbitrary examinations, such as B. smear for a colored or undyed wet mount to carry out a microscopic diagnosis or the creation of a cell culture. In a specific embodiment However, the invention provides that the additional Fluid absorption zone is impregnated with potassium hydroxide, KOH, so that the second and third blackbird criterion with such a device immediately and without additional Laboratory diagnostics can be determined. Alternatively, the additional Fluid intake zone also with an indicator for visual amine detection be impregnated.

The pH test field is conveniently from the outside of the coat for her Fluid accessible. For one Such arrangement, there are a variety of detailed solutions. For example, one impregnated with appropriate chemicals Fleece on the outer surface of the Mantels applied, z. B. be glued. It may be cheaper, if the wall of the shell at least partially double-shelled formed with an inner and an outer shell is, the outer shell has an access window and into the space between the inner and outer shell a pH test strip can be inserted, its pH-sensitive range is wettable through the access window. Standardized pH test strips are Cheap can be produced or purchased to acquire. Such a test strip can be used when mounting a Test device according to the invention be sandwiched between the two shell shells, so be pH-sensitive part is accessible through the window in the outer shell shell.

Prefers is the pH test field 3-6 Centimeters from the distal end of the shell spaced. From the proximal At the end of the jacket, the pH test field is preferably 1-3 centimeters apart. This corresponds to a particularly favorable Way the above explained anatomical conditions.

Prefers is the test device according to the invention, in particular their coat and handle part, in the plastic injection molding process produced. This is economically particularly favorable. Such a plastic element is easy to do with a pH test field (eg as explained above) as well can be equipped with a sampler. However, other materials such. Metal, paper, Cellulose etc. usable.

The Fluid receiving zones are preferably formed surface enlarged, d. H. for example as a porous, formed fibrous or corrugated elements. Such a surface enlarged design elevated the absorption capacity and allows the inclusion of a larger amount of fluid.

Further Features and advantages of the present invention will become apparent the following, special description and drawings.

Brief description of the drawings

It demonstrate:

1 FIG. 2: a schematic representation of a test device according to the invention in the protective position in plan view, FIG.

2 : a schematic representation of the test device of 1 in side view, partially cut,

3 FIG. 2: a schematic representation of a test device according to the invention in sampling position in plan view, FIG.

4 : a schematic representation of the test device of 3 in side view, partially cut.

Detailed description of one preferred embodiment

The 1 to 4 show a test device according to the invention 10 in different operating positions and different views. Like reference numerals in the figures indicate like elements. The representations of the 1 to 4 are purely schematic and not to be understood as a true to life illustrations of the device according to the invention.

The test device 10 includes a flattened handle part 12 and an elongate insertion part 14 , Both elements are connected to each other and can be manufactured together as a one-part or multi-part injection-molded element. Both the handle part 12 as well as the introduction part 14 are essentially hollow. The coat 16 of the introduction part 14 indicates at its distal end 18 an opening 20 on. The wall 22 of the grip part 12 has in its central region an axially extended slot 24 on.

Inside the hollow handle part 12 and the hollow introducer 14 is a sampler 26 arranged. The sampler consists essentially of a shaft 28 , at its distal end a surface enlarged fluid receiving zone 30 is arranged. The fluid intake zone 30 may be formed, for example, as cotton ball, sponge, spoon or extension with roughened or ribbed surface. At the proximal end of the shaft 28 is a radially oriented projection 32 arranged, the recess 24 in the wall 22 of the grip part 12 interspersed and there to a slide button 34 extended. The radial projection 32 and the slide button 34 together form an actuating element with which the sampler 26 can be moved axially. The shift range is determined by the dimensions of the slot 24 certainly.

With retracted position of the slide button 34 that in the 1 and 2 is shown, is the fluid intake zone 30 behind the distal opening 20 retracted the insertion. This is the protective position in which the fluid receiving zone is in contact with the insertion part 14 surrounding fluid is protected. In the 3 and 4 however, the sampling position is shown in which the slide button 34 in its forward position, ie to the distal edge of the slot 24 pushed forward. In this position, the fluid intake zone protrudes 30 over the distal opening 20 of the introduction part 14 out. In this sampling position, the fluid intake zone 30 that the insertion part 14 absorb surrounding fluid.

In the in the 1 to 4 embodiment shown is the sampler 26 by means of a tension spring 36 spring-biased towards its protective position. The tension spring 36 is on the one hand with the wall 22 of the grip part 12 and on the other hand with the radial projection 32 at the proximal end of the shaft 28 connected. By this measure it is achieved that the fluid absorption zone 30 when you release the slide button 34 automatically recovers to its protection position.

In the 2 and 4 Furthermore, a particularly favorable embodiment of a pH test field is shown schematically. For better visibility, the half is through the breakout line 38 indicated area of the coat 16 of the introduction part 14 shown as a sectional view. In this area is the coat 16 double-shelled, wherein a depression is provided, into which a standardized pH test strip 40 can be inserted. To fix the test strip 40 is still an outer shell part 42 can be inserted into the recess. With her, the test strip 40 clamped in the recess. The outer shell part 42 has a window 44 which gives access to a pH-sensitive area 46 of the test strip 40 forms.

At gynecological examination becomes the introducer 14 the test device according to the invention 10 introduced into the vaginal cavity. The examining doctor holds the device on the handle part 12 , The broadened design of the handle part 12 in comparison to the insertion part 14 creates a natural insertion stop that ensures correct positioning of the test fields with anatomically obvious dimensioning of the insertion part. By lateral application of the window 44 to the vaginal wall becomes the pH-sensitive area of the pH test strip 40 wetted with vaginal fluid from the area of the vaginal entrance. The distal fluid receiving zone 30 at the distal end of the sampler 26 however, can not come in contact with fluid yet. Only after correct positioning of the device 10 the examining doctor actuates the slide button 34 and pushes the fluid intake zone 30 over the distal opening 20 of the introduction part 14 so that it can contact the vaginal wall and absorb fluid from the surrounding area. Then the doctor leaves the move button 34 go, so the Fluid receiving zone 30 back in their in the 1 and 2 shown protective position is returned. In this position, the device can be re-executed without the risk of contamination of the distal fluid receiving zone 30 consists. A color reaction of the pH-sensitive area 46 of the test strip 40 gives the doctor information about the acidity of the fluorine at the entrance to the vagina (introitus vaginae). That with the distal fluid intake zone 30 removed fluid can be used in any other way, for example, for a microscopic smear, a Whiff test by external wetting by KOH or otherwise. As already mentioned, it is also possible to use the fluid intake zone 30 impregnated with KOH so that the whiff test can be carried out without further external laboratory diagnostics.

Of course, the embodiments discussed in the specific description and shown in the figures represent only illustrative embodiments of the present invention. In the light of the disclosure herein, those skilled in the art will be offered a wide range of possible variations. In particular, the special shape design and choice of material of the individual elements to anatomical, practical and economic conditions to adapt. The use of a spring preload for the sampler 26 is not mandatory. A purely manual operation is conceivable, with a locking device may be helpful to maintain a selected position.

10

test device

12

handle part

14

insertion

16

Coat of 14

18

distal end of 14 / 16

20

opening

22

Wall of 12

24

Long hole

26

samplers

28

Shank of 26

30

distal Fluid receiving zone

32

radial head Start

34

sliding button

36

mainspring

38

outbreak line

40

pH test strips

42

outer shell part

44

Window in 42

46

pH-sensitive range of 40

Claims (10)

A vaginal fluid testing device comprising an elongated introducer (46) insertable into the vaginal cavity (US Pat. 14 ) and one at the proximal end of the insertion part ( 14 ) grip part ( 12 ), wherein the insertion part ( 14 ) at least two fluid receiving zones ( 30 . 46 ), of which at least one is used as a pH test field ( 46 ) and of which at least one further an additional fluid receiving zone ( 30 ), characterized in that the insertion part ( 14 ) formed as a distal open hollow element jacket ( 16 ) and an axially displaceably guided inside the sampler ( 26 ) whose distal end is the additional fluid intake zone ( 30 ), the sampler ( 26 ) by means of a handle on the part ( 12 ) mounted displacement device ( 32 . 34 ) between a protective position in which the distal end of the sampler ( 26 ) behind the distal opening ( 20 ) of the jacket ( 16 ) is withdrawn, and a sampling position in which the distal end of the sampler ( 26 ) but the distal opening ( 20 ) of the jacket ( 16 ) is pushed out, is displaceable. Apparatus according to claim 1, characterized in that the displacement device ( 32 . 34 ) and / or the sampler ( 26 ) is spring-biased in the direction of the protective position. Device according to one of the preceding claims, characterized in that the sampler ( 26 ) a shaft ( 28 ), which covers the interior of the shell ( 16 ) interspersed. Apparatus according to claim 3, characterized in that the shaft ( 28 ) into a hollow handling area of the grip part ( 12 ), where he joins the wall ( 22 ) of the handling area passing through actuator ( 32 . 34 ) connected is. Device according to claim 3, characterized in that the shaft ( 28 ) also the hollow handle part ( 12 ) interspersed and projects beyond this at least in the protective position proximally. Device according to one of the preceding claims, characterized in that the additional fluid receiving zone ( 30 ) is impregnated with potassium hydroxide, KOH. Device according to one of the preceding claims, characterized in that the additional fluid receiving zone ( 30 ) is impregnated with an indicator for visual amine detection. Device according to one of the preceding claims, characterized in that the pH test field ( 46 ) from the outside of the jacket ( 16 ) is accessible. Apparatus according to claim 8, characterized ge indicates that the pH test field ( 46 ) three to six centimeters from the distal end ( 18 ) of the jacket ( 16 ) is spaced. Device according to one of the preceding claims, characterized in that the pH test field ( 46 ) one to three centimeters from the proximal end of the shell ( 16 ) is spaced.