WO1999021483A1

WO1999021483A1 - Device for taking a biological or cytological smear

Info

Publication number: WO1999021483A1
Application number: PCT/DE1998/003165
Authority: WO
Inventors: Emmanuel Anapliotis
Original assignee: Merete Management Gmbh
Priority date: 1997-10-25
Filing date: 1998-10-26
Publication date: 1999-05-06
Also published as: AU1555699A; DE19881598D2; DE29719659U1

Abstract

A device for taking a smear of the human or animal body has a jacket tube (2), a swab-carrier (1) provided with a swab (4) slidable in the longitudinal direction inside the jacket tube (2), and an adjusting device (3) arranged at the proximal end of the device for taking a smear. The adjusting device (3) has a handle element (3.2) and an actuating handle (3.1) for moving the swab carrier (1) from a first longitudinal position, in which the swab (4) is entirely located inside the jacket tube (2), and a second longitudinal position, in which the swab (4) projects out of the jacket tube (2), and vice-versa. The swab carrier (1) is provided at a first distance from its distal end (1.1) with a first rated break point (10.1) and the jacket tube (2, 2') is provided at a second distance from its distal opening with a second rated break point (10.2). The adjusting device has a recognisable separating position in which the first and second rated break points (10.1, 10.2) are located next to one another transversely to the longitudinal direction.

Description

Device for taking a biological or cytological smear

Sprinkling

The invention relates to a device according to the preamble of claim 1.

Numerous inflammations in the human or animal urogenital tract are due to a variety of different

Germs or microbes. For example, the etiology of fallopian tube inflammation (salpingitis) is polymic robotic. Aerobic and anaerobic germs, mycoplasma and chlamydia can be detected. This evidence can be obtained either from the Douglas fluid surrounding the fallopian tubes or by smears from the fallopian tubes. For intracellularly growing chlamydia in particular, detection from cell-rich test material has proven to be an indispensable prerequisite, since the Douglas liquid is low in cells and also has an antimicrobial effect. For this reason, the smear should also be preferred for other bacterial tests.

A number of generic devices are known for taking such biological or cytological smears. These can usually be used multiple times by attaching a new swab to the swab carrier for each new smear. To remove a smear from the fallopian tube, these devices are usually guided through a trocar to the fallopian tube. For smears in other, more easily accessible places in the urogenital tract, the use of a trocar may not be necessary.

However, the known devices have a number of disadvantages. On the one hand, they are characterized by a relatively complicated and fault-prone structure. For example, the secure and detachable attachment of the swabs to the swab carrier can only be achieved with a great deal of design effort, not only in view of the limited space, which on the one hand has a negative effect on the production costs of the individual components.

On the other hand, this design also has the disadvantage that the swab after removing the smear from the swab ferträger must be solved. However, this detachment of the swab from the swab carrier is generally only possible with the aid of appropriate aids or tools, but when used, the swab may be contaminated under certain circumstances. Such contaminations can, however, significantly falsify the test result even in the smallest amount. For example, the swabs with the smear must generally be stored in a transport liquid until later analysis in the laboratory, which means that, depending on the length of the time between sampling and evaluation, even the smallest impurities can damage or impair the smear on the swab or else of the transport liquid and thus can falsify the test result.

Another disadvantage is the relatively complex cleaning and sterilization of the reusable components of the known devices. Contaminations that have not been removed, particularly in places that are difficult to access within the mechanics of the devices, and the thermal or chemical component loads that occur during cleaning and sterilization can also have a negative impact on the susceptibility of the devices to failure

The invention is therefore based on the object of making available a device of the type mentioned at the outset which is simple and inexpensive to produce, which does not have the abovementioned disadvantages or only has them to a lesser extent and in particular guarantees the most genuine test results possible. Starting from a device according to the preamble of claim 1, the object is achieved by the features specified in the characterizing part of claim 1.

The invention includes the technical teaching that a particularly simple and inexpensive to manufacture and reliably functioning device is obtained, which guarantees as unadulterated test results as possible if at least the distal, ie. H. the part of the cladding tube and the swab carrier facing the removal point of the smear are designed as disposable components, in that the swab carrier is at a first distance from its distal end with a first structural weakening serving as a predetermined breaking point and the cladding tube is at a second distance from its distal opening with one is provided as the predetermined breaking point of the second structural weakening and the adjusting device has a detachable position recognizable for the operator, in which the first and second structural weakening for simplified and essentially simultaneous separation of the end region of the swab carrier or the distal to the respective first or second structural weakening Cladding tube are arranged adjacent to each other transversely to the longitudinal direction.

Thanks to the predetermined breaking points, the parts of the swab carrier or the cladding tube located distal to the predetermined breaking points can be separated without touching these areas to be separated, possibly with the aid of special tools or the like, which lead to contamination could. It can be broken off in a simple manner with the aid of the filled, generally cylindrical transport vessel. To do this, the distal ones to be separated Parts are inserted into the transport container filled with transport liquid from above until the predetermined breaking points are just above the opening edge of the transport container. By tilting the device relative to the transport vessel, the distal parts to be separated can then be broken off by the device and then slide into the transport vessel.

The detachable position of the adjusting device, which is recognizable for the operator, ensures in a particularly simple manner that the distal end region of the cladding tube and the swab carrier are separated essentially simultaneously and the detaching process can thus be carried out quickly and easily with one hand. The detachability of the detachment position can be ensured by a corresponding marking on the adjusting device. However, it is preferably characterized by a resistance felt by the operator when the adjusting device is actuated. This resistance is further preferably caused by an end stop provided in the adjusting device or between the cladding tube and swab carrier, beyond which no further actuation of the adjusting device is possible.

The design as a one-way component with predetermined breaking points ensures a particularly simple, inexpensive to manufacture and reliably functioning construction of the device, since, for example, no reusable fastening devices are required for the swab and, under certain circumstances, the entire adjustment mechanism is only designed for one use have to be. On the other hand, the time-consuming process is naturally eliminated Cleaning and sterilization of the device after taking the smear.

The entire device is preferably designed for single use. However, it is also possible to construct only the distal part of the device on which the predetermined breaking points are arranged from disposable components, while the proximal part of the device with the adjusting device is designed for multiple use.

In a preferred embodiment of the device according to the invention, the difference between the inner dimensions of the cladding tube and the outer dimensions of the swab carrier or swab is dimensioned such that the end region of the swab carrier located distal to the first structural weakening after it has been severed from the distal, which has likewise been severed the second structural weakening located end region of the cladding tube by the action of gravity with a corresponding inclination of the separated end region of the cladding tube to the horizontal. This enables particularly easy handling of the sample on the swab after the smear has been removed. It is sufficient here, for example, to position the distal end of the device vertically above the opening of the filled transport vessel, to grip the end region of the cladding tube distal to the second weakening of the structure by hand or by means of an appropriate tool and by tipping off the proximal parts of the distal parts Break off part of the vertical device. The broken-off part of the swab carrier on which the swab with the smear is located then releases due to the action of gravity from the broken-off part of the cladding tube which is still held and slides into the transport liquid. The held broken off part of the cladding tube is not placed in the transport container but disposed of immediately. In this variant, too, the component of the device that carries the sample to be analyzed subsequently gets into the transport vessel without touching possible sources of contamination. For this purpose, the inner dimensions of the cladding tube in the distal end region to be separated preferably have a slight oversize to the outer dimensions of the swab carrier or swab.

The difference in dimensions can, however, also be such that, in addition to gravity, the action of weak inertial forces, for example by gentle shaking or the like, releases from the separated end region of the cladding tube.

In a particularly favorable variant of the device according to the invention, which is very easy to manufacture, the first or second structural weakening is in the form of a first notch or second notch running around the outer circumference of the swab carrier or the cladding tube.

In a preferred variant of the invention, the swab carrier has at least one third structural weakening, spaced apart from the first structural weakening and serving as a predetermined breaking point, at a third distance from its distal end. The cladding tube likewise has at least one fourth structural weakening, spaced from the second structural weakening and serving as a predetermined breaking point, at a fourth distance from its distal opening. The third and fourth structural weakening are arranged adjacent to one another transversely to the longitudinal direction in the separating position of the adjusting device. This makes it easy to ne suitability of the device for the proper transport of the sample to be examined in different transport containers ensured.

The first or second or third or fourth distance is preferably at least 1 cm, preferably at least 2 cm, and does not exceed an amount of essentially 10 cm, preferably 5 cm. This ensures simple and proper transport in current transportation containers.

More preferably, the swab carrier is in its first or second longitudinal position when the adjusting device is in the detaching position, since these two positions represent required extreme positions in the longitudinal movement of the swab carrier relative to the cladding tube, which likewise require identification that can be recognized by the operator. Because one of these positions also represents the separation position, an additional device for identifying the separation position, such as a marking on the adjusting device or a corresponding stop, can be omitted.

In particularly advantageous embodiments of the present invention, a fifth structural weakening, which serves as a predetermined breaking point, is provided on the swab carrier and is arranged distally of the first structural weakening at a longitudinal distance which is substantially equal to the longitudinal distance between the first and second longitudinal positions of the swab carrier. The swab carrier is then in its second longitudinal position when the adjusting device is in the detaching position. With this arrangement, therefore, in the second longitudinal position of the swab carrier, the first and two th structure weakening is arranged adjacent to one another, while in the first longitudinal position of the swab carrier, the fifth and the second structure weakening are arranged adjacent to one another. This makes it possible in a particularly simple manner, depending on the requirements, the distal end region of the swab carrier provided with the swab both in the second longitudinal position of the swab carrier, that is to say in the extended state, and in the first longitudinal position of the swab carrier, that is to say in the cut into the tube in the manner described above.

In favorable developments of the invention, the swab carrier, the cladding tube and the adjusting device are designed such that the swab carrier can be rotated about the longitudinal axis at least in its second longitudinal position relative to the cladding tube. This ensures a simple removal of a sufficiently large amount of sample by bringing the swab into contact with the body part to be examined over its entire circumference by rotating about its longitudinal axis. This is done according to the invention without the cladding tube having to be rotated. Especially in the case of a device inserted through a trocar, such a rotation of the cladding tube is relatively difficult due to the mostly relatively tight fit of the cladding tube in the jacket tube of the trocar, or is associated with increased expenditure of force, which in turn could result in damage to the device. The design of the adjusting device can be realized in many known ways. It is thus possible, for example, to actuate the actuating handle relative to the handle element in a known manner with the aid of a guide, for example arranged on the actuating handle. To lead pin or the like, which engages in a corresponding guide groove running in the grip element. When the swab carrier is in the second longitudinal position, the guide groove must run in the circumferential direction of the cladding tube or swab carrier, so that a corresponding rotation of the swab carrier relative to the cladding tube is possible.

The swab carrier is preferably rotatable relative to the cladding tube by at least essentially one full revolution in order to advantageously use the entire circumference of the swab for taking up the sample. However, it goes without saying that even with a smaller angle of rotation satisfactory results can be achieved.

In a particularly advantageous variant because it is easy to manufacture, the actuating handle comprises a feed device and a rotating device which is fixedly connected to the proximal end of the swab carrier. The rotating device and / or the swab carrier is or are arranged on the feed device and rotatable relative to the latter about the longitudinal axis. In this case, for example, the proximal end of the swab carrier can be rotatably mounted in the feed device, the swab carrier then projecting proximally from the feed device in the longitudinal direction. On the section protruding from the feed device, the rotating device is then arranged, which can be formed, for example, by a wheel or the like sitting on the swab carrier or else only by a corresponding gripping surface on the swab carrier. However, for reasons of strength, the rotating device is preferably rotatably mounted on or in the feed device. In further preferred embodiments of the invention, the swab carrier or the cladding tube and / or the adjusting device are designed such that the longitudinal mobility of the swab carrier relative to the cladding tube is limited by a proximal stop device and a distal stop device to a longitudinal movement between its first and second longitudinal positions. This ensures a particularly simple and reliable identification of the two extreme positions and the separation position.

In advantageous developments of the device according to the invention, a first stop surface on the cladding tube and a second stop surface arranged distally to the swab carrier or on the actuating handle are provided to form the proximal stop device. To form the distal stop device, a third stop surface is also provided on the cladding tube and a fourth stop surface arranged proximally thereto is provided on the swab carrier or on the actuating handle. When the swab carrier reaches the first longitudinal position, the second stop surface lies in a first contact area at least partially on the first stop surface located proximally thereto. In the opposite direction, the fourth stop surface, when the second longitudinal position of the swab carrier is reached, lies at least partially on the third stop surface distal to it in a second contact area. The surface normals of the first or third stop surfaces run parallel to the longitudinal direction over the first or second contact area. Because of their alignment, first and third stop surfaces that can be produced in a simple manner are thereby achieved, which reliably limit the longitudinal movement of the swab carrier relative to the cladding tube. The second and fourth stop surfaces can be shaped as desired, which makes their manufacture very simple.

The first stop surface is preferably, but not necessarily, proximal to the third stop surface, since a particularly simple arrangement of the second and fourth stop surfaces is then possible.

In preferred variants, a pin-like or nose-like projection extending radially to the longitudinal axis is provided to form the stop devices and engages in a groove extending essentially in the longitudinal direction of the device. The projection is provided on the inner circumference of the cladding tube and the groove is then introduced into the swab carrier. When the first longitudinal position of the swab carrier is reached, the projection then lies against the distal end surface of the groove and when the second longitudinal position of the swab carrier is reached at the proximal end surface of the groove.

Alternatively, the protrusion is provided on the outer circumference of the swab carrier and the groove extends on the inside of the cladding tube. When the first longitudinal position of the swab carrier is reached, the projection then lies on the proximal end surface of the groove and when the second longitudinal position of the swab carrier is reached on the distal end surface of the groove.

Both variants are characterized by their particularly simple manufacture and their reliable, because simple, mechanical operating principle. The cladding tube and the swab carrier are preferably designed such that they can be rotated relative to one another about the longitudinal axis, the groove further being designed in the manner of a bayonet lock for locking the swab carrier in its first and / or second longitudinal position at its proximal end and / or its distal end. In this way, a locking of the swab carrier relative to the cladding tube is achieved in a particularly favorable manner, which ensures simple and safe handling of the device. This applies in particular to the case that one of the two locking positions also represents the detaching position of the swab carrier. A simple and reliable simultaneous separation of the distal end regions of the cladding tube and the swab carrier is then guaranteed.

In other favorable configurations of the device according to the invention, the adjusting device is designed in the manner of a screw drive generating feed in the longitudinal direction of the device, which results in a particularly simple and reliable adjustment mechanism. The cladding tube and the swab carrier are preferably designed to be rotatable relative to one another about the longitudinal axis, and the adjusting device comprises a first thread arranged on the cladding tube, which thread is used to produce a longitudinal movement of the swab carrier relative to the cladding tube when the actuating handle rotates relative to the cladding tube about the longitudinal axis interacts with a second thread provided on the swab carrier or on the actuating handle and thus causes a longitudinal movement of the swab carrier relative to the cladding tube. This variant is characterized by a particularly high variability with regard to the adjustment parameters while being easy to manufacture. So it is easily possible, per revolution the feed handle generated feed of the swab carrier to adjust relative to the cladding tube by suitable choice of thread pitch. Furthermore, multi-start threads can also be provided to increase operational safety.

There are a number of options with regard to the arrangement of the threads. Thus, the first thread can be arranged as an internal thread on the cladding tube, while the second thread must of course then be formed as an external thread, for example on the swab carrier. However, the first thread is preferably arranged on the outer circumference of the proximal end of the cladding tube and the actuating handle is designed in the manner of a screw cap, the swab carrier then being guided through an opening which is coaxial therewith at the distal end of the actuating handle and the second thread on the distal end of the actuating handle is arranged on the inner circumference of the opening. This then results in a particularly easy to manufacture, robust arrangement.

In particularly favorable variants of the invention, the pitch of the first and second threads is chosen such that the movement of the swab carrier from its first to its second longitudinal position or vice versa is effected by essentially one revolution of the actuating handle relative to the cladding tube. This results in a particularly easy-to-use device in which the swab carrier can be advanced with a single handle relative to the cladding tube with good or simple metering. The first thread and the second counter thread are preferably of multiple threads. This prevents the screw drive from jamming in a simple and therefore inexpensive manner, which in turn ensures trouble-free use of the device.

Preferably, the cladding tube and the swab carrier each consist of a biocompatible plastic, so that the risk of the test results being impaired by damage to the smear or the transport liquid by the material of the cladding tube and swab carrier is minimized.

The actuating handle is further preferably designed as a plastic body produced by means of a casting or blow molding process. This enables a particularly cost-effective production of the actuating handle in a single operation. This also applies in particular when the actuating handle is to be provided with a movement thread.

The swab preferably consists of calcium alginate or a cotton-aluminum mixture or is formed by a nylon brush, since these materials ensure particularly easy removal of the smear and no or minimal falsification of the test results due to an interaction with the smear or bring the transport liquid with it.

It is also expedient if the outer actuating handle is locked onto the inner handle element so that it cannot be lost, that an annular stop surface is provided on the handle element connected to the sleeve, which interacts with an annular stop surface when the handle element is removed from the thread This will block the actuator from being pulled off. tion handle formed by the handle part in the event that this is completely turned down from the thread.

Other advantageous developments of the invention are characterized in the subclaims or are shown below together with the description of the preferred embodiment of the invention with reference to the figures. Show it:

FIG. 1 shows a section through a preferred exemplary embodiment of the device according to the invention,

FIG. 2 shows a perspective view of a further embodiment of the device according to the invention,

FIG. 3 shows a section along line III-III from FIG. 2,

FIG. 4 shows a section along line IV-IV from FIG. 3,

Figure 5 shows a detail section through another preferred embodiment of the device according to the invention.

1 shows an embodiment of the device according to the invention with a swab carrier 1, which is arranged in a cladding tube 2, and an adjusting device 3 arranged at the proximal end of the device. The swab 4 is arranged at the distal end 1.1 of the swab carrier 1. The adjusting device comprises an actuating handle 3.1 firmly connected to the distal end 1.2 of the swab carrier 1 and a handle element 3.2 which is fixedly arranged on the cladding tube 2. At the proximal end 2.2 of the cladding tube 2 there is a first thread 5 which is designed as an external thread on the grip element 3.2. The actuating handle 3.1 is designed in the manner of a screw cap and comprises a feed device 3.3 and a rotating device 3.4 which is freely rotatable about the longitudinal axis 1.3. The actuating handle 3.1 has an opening 6 which is coaxial with the swab carrier 1 and through which the swab carrier 1 extends. Arranged on the inner circumference of the opening 6 at the distal end of the feed element 3.3 is a second thread 7 which is designed as an internal thread and which cooperates with the first thread 5 and forms a screw drive which generates feed in the longitudinal direction of the device. Consequently, if the feed element 3.3 of the actuating handle 3.1 is rotated about the longitudinal axis 1.3 relative to the cladding tube 2, the swab carrier 1, which is fixedly connected to the rotating element 3.4 of the actuating handle 3.1, performs a longitudinal movement relative to the cladding tube 2 in the direction of the longitudinal axis 1.3 distally or proximally, depending on the direction of rotation out. Depending on whether the rotating element 3.4 is also rotated in the process, the swab carrier 1 also performs a rotational movement about the longitudinal axis 1.3 in addition to the longitudinal movement.

The longitudinal movement of the swab carrier 1 relative to the cladding tube 2 is limited by a proximal stop device 8 and a distal stop device 9. The proximal stop device 8 comprises a first stop surface 8.1 arranged on the cladding tube 2 and a second stop surface 8.2 arranged distal thereto on the actuating handle 3.1, the distal stop device 9 has a third stop surface 9.1 arranged on the cladding tube 2 and a proximally to the fourth stop surface 9.2 arranged on the actuating handle 3.1.

The first stop surface 8.1 is designed as a flat, distally facing end surface of a molded on the cladding tube 2, which extends from the proximal end 2.2 of the cladding tube 2 to the proximal end and is narrow in the circumferential direction, barb-like component 8.3. The part of the component 8.3 which extends parallel to the longitudinal axis 1.3 is designed to be resilient in the radial direction in order to enable the device to be joined easily.

The surface normal of the first stop surface 8.1 runs parallel to the longitudinal axis 1.3 of the device. The second stop surface 8.2 is from the proximally pointing distal end surface of an annular groove arranged proximal to the second thread 7 in the actuating handle 3.1. The surface normal of the second stop surface 8.2 also runs parallel to the longitudinal axis 1.3 of the device. The radial distance from the center of the surface of the first stop surface

8.1 and the center circle of the second stop surface 8.2 and the radial extent of the two stop surfaces 8.2 and 8.2 correspond approximately to one another, so that the first stop surface 8.1 completely on the second stop surface

8.2 can rest in order to hinder a further longitudinal movement of the swab carrier 1 relative to the cladding tube 2 in the proximal direction.

The third stop surface 9.1 is formed on the cladding tube 2 as a flat, proximally facing surface of a distal of the first thread 5 on the grip element 3.2. The surface normal of the third stop surface 9.1 runs parallel to the longitudinal axis 1.3 of the device. The fourth stop surface 9.2 is formed by the distal end surface of the actuating handle 3.1. The surface normal of the fourth stop surface 9.2 also runs parallel to the longitudinal axis 1.3 of the device. The radial distance between the center circles and the radial extent of the two stop surfaces 9.2 and 9.2 correspond approximately to one another, so that the third stop surface 9.1 can rest completely on the fourth stop surface 9.2 in order to hinder a further longitudinal movement of the swab carrier 1 relative to the cladding tube 2 distally .

If the actuating handle 3.1 is screwed so far proximally relative to the cladding tube 2 that the first stop surface 8.1 bears on the second stop surface 8.2, the swab carrier 1 is in its first longitudinal position, shown in broken lines in FIG. 1, in which the swab is located 4 is located completely inside the cladding tube 2. In this position, the device, if necessary through the jacket tube of a trocar, is brought to the part of the body at which the smear is to be taken. The cladding tube 2 protects the swab 4 from contamination along the insertion path up to the body part to be examined.

If the actuating handle 3.1 is screwed so far distally relative to the cladding tube 2 that the third stop surface 9.1 abuts the fourth stop surface 9.2, the swab carrier 1 is in its second longitudinal position, shown in solid lines in FIG. 1, in which the distal end 1.1 of the swab carrier 1 protrudes distally from the distal end 2.1 of the cladding tube 2, the swab 4 being located completely outside the cladding tube 2 in the example shown. In this longitudinal position the swab 4 is brought into contact with the body part to be examined in order to take the smear. The operator rotates the rotating element 3.4 by at least one turn relative to the feed element 3.3 of the actuating handle 3.1 and thus also the swab carrier 1 and the swab 4 relative to the sheath tube 2, which is more or less stuck in the tubular casing of the trocar. This makes the swab 4 easier Way to take the sample over its entire circumference in contact with the body area to be examined. After the swab has been taken up by the swab 4, it is brought back into its first longitudinal position relative to the cladding tube 2 by rotating the feed element 3.3 of the actuating handle 3.1, in which it is protected by the cladding tube 2 from contamination when it is removed from the body.

For convenient and ergonomic handling of the device, the grip device 3.2 as well as the feed element 3.3 and the rotating element 3.4 have knurling or the like on their respective circumferential surface to prevent the fingers from slipping. on.

In the example shown, the pitch of the first thread 5 and the second mating thread 7 engaged with it is selected so that the swab carrier 1 by a single revolution of the feed element 3.3 of the actuating handle 3.1 about the longitudinal axis 1.3 relative to the handle device 3.2 and thus relative to the Cladding tube 2 can be brought from its first to its second longitudinal position. In order to preclude tilting of the feed element 3.3 to the grip device 3.2 in the case of such a relatively high thread pitch, and thus a trouble-free and simple longitudinal adjustment of the swab carrier 1 relative to the To ensure cladding tube 2, the first thread 5 and the second counter thread 7 are designed with multiple threads.

At a first distance from its distal end 1.1, the swab carrier 1 has a first structural weakening, which serves as a predetermined breaking point and is designed as a first notch 10.1 running around the outer circumference of the swab carrier 1. The cladding tube 2 has, at a second distance from its distal end 2.1, a second structural weakening serving as a predetermined breaking point, which is designed as a second notch 10.2 running around the outer circumference of the cladding tube. Furthermore, a third notch 10.3 or a fourth notch 10.4 is provided on the swab carrier 1 or on the cladding tube 2 at a third distance from the distal end 1.1 of the swab carrier 1 or at a fourth distance from the distal end 2.1 of the cladding tube 2. Furthermore, the swab carrier has a fifth notch 10.5, which is arranged distal to the first notch 10.1 at a distance which corresponds to the longitudinal distance between the first and second longitudinal positions of the swab carrier 1. In the example shown, the distance between the first and third notches 10.1 and 10.3 or the longitudinal distance between the second and fourth notches 10.2 and 10.4 also corresponds to the longitudinal distance between the first and second longitudinal positions of the swab carrier 1

In the example shown, shown with solid lines in FIG. 1, the swab carrier 1 is in its second longitudinal position relative to the cladding tube 2. The first notch 10.1 and the second notch 10.2 as well as the third notch 10.3 and the fourth notch 10.4 are arranged adjacent to one another in this position transversely to the longitudinal direction of the device, so that the second longitudinal position of the swab carrier 1 relative to the cladding tube 2 represents the position in which the end region of the swab carrier 1 or the cladding tube 2 located distal to the respective notches can be separated by essentially simultaneously breaking off. The corresponding detaching position of the adjusting device 3 is characterized by the fact that the distal stop device 9 becomes visible, but in any case noticeable, for the operator. In the example shown in dashed lines in FIG. 1, the swab carrier 1 is in its first longitudinal position relative to the cladding tube 2. The fifth notch 10.5 and the second notch 10.2 as well as the first notch 10.1 and the fourth notch 10.4 are arranged adjacent to one another in this position transversely to the longitudinal direction of the device, so that the first longitudinal position of the swab carrier 1 relative to the cladding tube 2 represents a further position, in the end region of the swab carrier 1 or of the cladding tube 2 located distal to the respective notches can be separated by essentially simultaneously by breaking off. The corresponding further detaching position of the adjusting device 3 is characterized by the fact that the proximal stop device 8 becomes noticeable for the operator

However, it goes without saying that the detaching position of the swab carrier 1 can also be provided at another longitudinal position relative to the cladding tube. The corresponding detaching position of the adjusting device would then have to be identified by another stop or by another visible or tactile marking. The parts of the swab carrier 1 or the casing tube 2 located distal to the predetermined breaking points can be broken off without the need to touch these areas to be separated, possibly with the aid of special tools or the like. The breaking can take place, for example, with the aid of the filled, naturally mostly cylindrical transport vessel. For this purpose, the distal parts to be separated are inserted into the transport container filled with transport liquid from above until the predetermined breaking point 10.2 or 10.4 is just above the opening edge of the transport container. By tilting the device relative to the transport vessel, the distal parts to be separated can then be broken off by the device and then slide into the transport vessel.

In the embodiment shown, the inside diameter of the cladding tube 2 has an oversize compared to the outside diameter of the swab carrier 1. If, for example in the area of the first and second notches 10.1 and 10.2, the end region of the swab carrier and the cladding tube located distal to these structural weakenings, the separated end region of the swab carrier 1 detaches after the separated end region of the swab carrier 1 after its separation from the separated end region of the cladding tube 2. It is sufficient here, for example, to position the distal end of the device vertically above the opening of the filled transport vessel, to grip the end region of the cladding tube 2 distal to the second structural weakening 10.2 by hand or by means of an appropriate tool, and to remove the distal end to be separated Break off parts by tipping the proximal part of the vertical device. The broken part of the swab carrier 1 on which the swab 4 with the swab befin ^¬ det then dissolves due to the action of gravity from the still retained broken part of the cladding tube 2 and slides in the conveying liquid. The broken off part of the cladding tube is not placed in the transport container but disposed of immediately. In this way, the separated part of the swab carrier 1 carrying the sample to be analyzed later on the swab 4 reaches the transport vessel without touching possible sources of contamination.

In the example shown, the first notch 10.1 is arranged at a first distance of approximately 5 cm, the third notch 10.3 is arranged at a third distance of approximately 8 cm from the distal end of the swab carrier 1, so that the device can be used in conjunction with suitable for the usual transport containers.

In the example shown, the swab carrier 1, the cladding tube 2 and the adjusting device 3 consist of biocompatible plastics. The actuating handle 3.1 and the handle element 3.2 are injection molded components. The swab 4 consists of calcium alginate wadding, with which unadulterated test results can be achieved particularly well.

FIG. 2 shows a perspective view of a further exemplary embodiment of the device according to the invention, which has the same basic structure as the embodiment from FIG. 1, so that only the differences will be described in more detail here. The main difference from the embodiment from FIG. 1 lies in the different design of the adjusting device 3 '. This comprises a cylindrically designed actuating handle 3.1 ', an essentially hollow-cylindrical handle element 3.2', shown partially in section in FIG. 2, a groove 11 made in the wall of the cladding tube 2 'and a round pin 12 arranged on the swab carrier 1', which is extends radially to the swab carrier 1 'into the groove 11.

As is clear from FIGS. 2, 3 and 4, the groove 11 extends in the longitudinal direction of the device and, when the device is in the assembled state, is covered to the outside by the grip element 3.2 'fixedly arranged on the cladding tube 2'. The pin 12 protrudes in the radial direction beyond the outer surface of the swab carrier 1 'and ends just before the inner surface of the grip element 3.2'. The opening width of the groove 11 has a slight oversize compared to the diameter of the pin 12, so that there is a guide of the swab carrier 1 'relative to the cladding tube 2', which has a slight play.

When the swab carrier 1 'is displaced in the longitudinal direction relative to the cladding tube 2' by correspondingly displacing the actuating handle, when the first longitudinal position of the swab carrier 1 'is reached, the proximal surface 8.2' of the pin 12, which projects beyond the circumferential surface of the swab carrier 1 ', forms the forms the second stop surface of the proximal stop device, on the proximal end surface 9.1 'of the groove 11, which correspondingly forms the first stop surface of the proximal stop device, thereby preventing a further displacement of the swab carrier 1' relative to the cladding tube 2 'in the proximal direction. In the opposite direction of displacement, when the second longitudinal position of the swab carrier 1 'is reached, the distal surface 9.2' of the pin 12, which projects beyond the lateral surface of the swab carrier 1 'and forms the fourth stop surface of the distal stop device, lies on the distal end surface 9.1' Groove 11, which correspondingly forms the third stop surface of the proximal stop device, thereby preventing a further displacement of the swab carrier 1 'relative to the cladding tube 2' in the distal direction.

The cladding tube 2 'and the swab carrier 1' are rotatable relative to one another about the longitudinal axis 1.3 '. The groove 11 is designed to lock the swab carrier 1 'relative to the cladding tube 2' in its first or second longitudinal position at its proximal end 11.1 and its distal end 11.2 in the manner of a bayonet lock. For this purpose, it runs in each of these end regions for a short distance in the circumferential direction of the cladding tube 2 '.

In the example shown, the pin 12, as can be seen in FIGS. 3 and 4, is pressed into a radial bore 12.1 in the swab carrier 1 '. However, it is understood that the pin or a corresponding projection can also be attached or molded onto the swab carrier in many other ways. In the example shown, the pin is inserted into the radial bore 12.1 before the device is installed. For easy and simple assembly of the device during its manufacture, the groove 11 runs at its proximal end 11.1 after the piece running in the circumferential direction again in the longitudinal direction as far as the proximal end of the cladding tube 2 ', so that the swab carrier 1' with the pin 12 easily runs in the cladding tube 2 'are introduced can. In order to prevent the swab carrier 1 'from being pulled out proximally from the cladding tube 2' when the swab carrier 1 'is locked in the first longitudinal position, a nose 13 is formed on the inner circumference of the grip element 3.2' and fills the area of the groove 11 , which 11 extends at its proximal end 11.1 after the piece running in the circumferential direction again in the longitudinal direction up to the proximal end of the cladding tube 2 '.

Another difference of the embodiment shown in FIG. 2 is that the swab carrier 1 'has only slight radial play with respect to the cladding tube 2' over its entire length. The swab 4 'consists of a brush 4.2' arranged on a rod 4.1 ', the rod 4.1' being firmly anchored in a bore arranged at the distal end of the swab carrier 1 'and coaxial to the longitudinal axis 1.3'. The brush 4.2 'consists of nylon, while the rod 4.1' consists of a correspondingly biocompatible metal or also of plastic.

FIG. 5 shows a section through the proximal end of a further embodiment of the invention, which essentially corresponds to the embodiment shown in FIG. 1, so that only the differences from the embodiment from FIG. 1 are discussed here. The difference to the embodiment from FIG. 1 is that the adjusting device 3 "is constructed from a plastic parts carrying threads. Here, the one-piece actuating handle 3.1" and the handle element 3.2 "each receive their final use form in one injection molding process. the first thread 5 'and the third stop surface 9.1 "and the second thread 7" and the two- te and fourth stop surface 8.2 "and 9.2" immediately their final shape. This results, on the one hand, in a particularly quick and simple manufacture of the device and, on account of the low weight and good stability of the blow molded parts, a device which is particularly light and thus easy to handle.

It is also noteworthy in this embodiment that the outer actuating handle 3.1 "" cannot be lost "is snapped onto the inner handle element 3.2" because an annular stop surface 9.1 "is provided on the handle element 3.2" connected to the sleeve. This then interacts with an annular stop surface 9.2 "when the grip element 3.2" is released from the thread. A block against the pulling off of the operating handle 3.1 "from the handle part 3.2" is then formed when it is completely turned off the thread. The actuating handle can then be turned empty and can only be pulled off with a gentle jerk, the edge of the stop surface 9.2 "having to overcome the further stop surface 9.1" forming a threshold. This can only be done by applying force with elastic deformation of the two handle parts.

The embodiment of the invention is not limited to the preferred exemplary embodiments specified above. Rather, a number of variants are conceivable which make use of the solution shown, even in the case of fundamentally different types.

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Claims

Expectations

1. Device for taking a biological or cytological smear from the human or animal body with an envelope tube (2, 2 ') which can be inserted, in particular, into a trocar and in which a swab carrier (1, 1') is arranged to be longitudinally movable , the distal end (1.1) of which is provided with a swab (4, 4 '), and an adjusting device (3, 3', 3 ") arranged at the proximal end of the device, which , 2 ') arranged handle element (3.2, 3.2', 3.2 ") and an actuating handle (3.1, 3.1 ', 3.1") connected to the proximal end (1.2) of the swab carrier (1, 1') and by their actuation the swab carrier (1, 1 ') relative to the cladding tube (2, 2') at least from a first longitudinal position, in which the swab (4, 4 ') is located completely inside the cladding tube (2, 2'), into a second Longitudinal position in which the swab (4, 4 ') for receiving the smear at least partially from the distal end (2.1) of the Jacket tube (2, 2 ') protrudes or can be moved in reverse, characterized in that the swab carrier (1, 1') at a first distance from its distal end (1.1) with a first structural weakening (10.1) serving as a predetermined breaking point and the like The cladding tube (2, 2 ') is provided at a second distance from its distal opening with a second structural weakening (10.2) serving as a predetermined breaking point and that the adjusting device has a detachable position recognizable for the operator, in which the first and second structural weakening (10.2 , 10.2) for the simplified and essentially simultaneously separating the end region of the swab carrier (1, 1 ') or the cladding tube (2, 2') located distal to the respective first or second structural weakening (10.1, 10.2) are arranged adjacent to one another transversely to the longitudinal direction.

2. Device according to claim 1, characterized in that the difference between the inner dimensions of the cladding tube (2, 2 ') and the outer dimensions of the swab carrier (1, 1') or the swab (4, 4 ') is dimensioned such that the end region of the swab carrier (1, 1 ') located distal to the first structural weakening (10.1) after it has been separated from the end region of the cladding tube (2, 2') also distal to the second structural weakening (10.2) by the action of gravity - Chending inclination of the separated end region of the cladding tube (2, 2 ') to the horizontal and / or by the action of weak inertial forces from the separated end region of the cladding tube (2, 2').

3. Apparatus according to claim 2, characterized in that the inner dimensions of the cladding tube (2, 2 ') in the distal end region to be separated have a slight oversize to the outer dimensions of the swab carrier (1, 1') or the swab (4, 4 ') .

4. Device according to one of the preceding claims, characterized in that the first or second structure weakening in the form of on the outer circumference of the swab carrier (1, 1 ') or of the cladding tube (2, 2') circumferential first notch (10.1) or second notch (10.2) are formed.

5. Device according to one of the preceding claims, characterized in that the swab carrier (1, 1 ') at least one proximal to the first structural weakening (10.1) spaced, serving as predetermined breaking point third structural weakening (10.3) at a third distance from its distal End (1.1) and the cladding tube (2, 2 ') has at least one fourth structural weakening (10.4) spaced proximally from the second structural weakening (10.2) and serving as a predetermined breaking point, at a fourth distance from its distal opening, the third and fourth structural weakening (10.3, 10.4) are arranged adjacent to one another transversely to the longitudinal direction in the separating position of the adjusting device (3, 3 ', 3 ").

6. Device according to one of the preceding claims, characterized in that the first or second or third or fourth distance is substantially at least 1 cm, preferably at least 2 cm, and an amount of substantially 10 cm, preferably 5 cm, does not exceed.

7. Device according to one of the preceding claims, characterized in that the swab carrier (1, 1 ') with the adjusting device located in the disconnected position

(3, 3 ', 3 ") is in its first or second longitudinal position.

8. Device according to one of the preceding claims, characterized in that a fifth structural weakening (10.5) serving as a predetermined breaking point is provided on the swab carrier (1, 1 ') and is arranged distally of the first structural weakening (10.1) at a longitudinal distance which is substantially equal to the longitudinal distance between the first and second longitudinal positions of the swab carrier (1, 1 '), the swab carrier (1, 1') being in its second longitudinal position when the adjusting device (3, 3 ', 3 ") is in the disconnected position located.

9. Device according to one of the preceding claims, characterized in that the Tu ferträger (1), the cladding tube (2) and the adjusting device (3 "') are designed such that the swab carrier (2) at least in its second longitudinal position is rotatable about the longitudinal axis (1.3 ') relative to the cladding tube (2).

10. The device according to claim 9, characterized in that the actuating handle (3.1) comprises a feed device (3.3) and a fixed to the proximal end of the swab carrier (1) rotating device (3.4) and the rotating device (3.3) and / or the swab carrier (1) is or are arranged on the feed device (3.3) so as to be rotatable about the longitudinal axis (1.3) relative to the feed device (3.3).

11. Device according to one of the preceding claims, characterized in that the swab carrier (1, 1 ') or the cladding tube (2, 2') and / or the adjusting device (3, 3 ', 3 ") are designed such that the longitudinal mobility the swab carrier (1, 1 ') relative to the cladding tube (2, 2') is limited to a longitudinal movement between its first and second longitudinal positions by a proximal stop device (8) and a distal stop device (9).

12. The apparatus according to claim 11, characterized in that to form the proximal stop device (8) a first stop surface (8.1, 8.1 ', 8.1 ") on the cladding tube (2, 2') and a distal second stop surface (8.2, 8.2 ', 8.2 ") is provided on the swab carrier (1') or on the actuating handle (3.1, 3.1") and, to form the distal stop device (9), a third stop surface (9.1, 9.1 ', 9.1 ") on the cladding tube (2, 2 ') and a fourth stop surface (9.2, 9.2', 9.2 ") arranged proximally thereto is provided on the swab carrier (1 ') or on the actuating handle (3.1, 3.1"), the second stop surface (8.2, 8.2', 8.2 ") at least partially on the first stop surface (8.1, 8.1 ', 8.1") when the swab carrier (1, 1') is reached in a first contact area and the fourth stop surface (9.2, 9.2 ', 9.2 ") when it is reached the second longitudinal position of the swab carrier (1, 1 ') in a second contact area at least partially e rests on the third stop surface (9.1, 9.1 ', 9.1 ") and the surface normals of the first and third stop surfaces (8.1, 8.1', 8.1", 9.1, 9.1 ', 9.1 ") are parallel over the first and second contact areas run to the longitudinal direction.

13. The apparatus according to claim 11 or 12, characterized in that to form the stop devices (8, 9) a radially to the longitudinal axis (1.3 ') extending, pin or nose-shaped projection (12) is provided, which in a groove (11) extending essentially in the longitudinal direction of the device engages, the projection (12) being provided on the inner circumference of the cladding tube (2, 2 ') and the groove (11) being introduced into the swab carrier (1, 1') and the projection (12) on reaching the first longitudinal position of the swab carrier (1, 1 ') on the distal end surface (9.1') of the groove (11) and on reaching the second longitudinal position of the swab carrier (1, 1 ') on the proximal end surface ( 8.1 ') of the groove (11), or wherein the projection (12) is provided on the outer circumference of the swab carrier (1') and the groove (11) extends on the inside of the cladding tube (2 ') and the projection (12) on reaching the first longitudinal position of the swab carrier (1 ') on de r proximal end surface (8.1 ') of the groove (11) and when the second longitudinal position of the swab carrier (1') is reached on the distal end surface (9.1 ') of the groove (11).

14. The apparatus according to claim 13, characterized in that the cladding tube (2 ') and the swab carrier (1') to each other about the longitudinal axis (1.3 ') are rotatable and the groove (11) for locking the swab carrier (1') in its first and / or second longitudinal position on hers proximal end (11.1) and / or its distal end (11.2) is designed in the manner of a bayonet lock.

15. Device according to one of claims 1 to 12, characterized in that the adjusting device (3, 3 ") is designed in the manner of a screw drive generating feed in the longitudinal direction of the device.

16. The apparatus according to claim 15, characterized in that the cladding tube (2) and the swab carrier (1) to each other about the longitudinal axis (1.3) are rotatable and the adjusting device (3, 3 ") arranged on the cladding tube (2) first Thread (5, 5 "), which for generating a longitudinal movement of the swab carrier (1) relative to the cladding tube (2) when the actuating handle (3.1, 3.1") rotates relative to the cladding tube (2) about the longitudinal axis (1.3) a second counter thread (7, 7 ") provided on the swab carrier (1) or on the actuating handle (3.1, 3.1") is engaged.

17. The apparatus according to claim 16, characterized in that the first thread (5, 5 ") is arranged on the outer circumference of the proximal end of the cladding tube (2) and the actuating handle (3.1, 3.1") is designed in the manner of a screw cap, wherein the swab carrier (1) is guided through a coaxial opening (6) at the distal end of the operating handle (3.1, 3.1 ") and the second counter thread (7, 7") at the distal end of the operating handle (3.1, 3.1 ") at the inside - The inner circumference of the opening (6) is arranged.

18. The apparatus according to claim 16 or 17, characterized in that the pitch of the first and second threads (5, 5 ", 7, 7") is selected such that the movement of the swab carrier (1) from its first to its second longitudinal - Position or vice versa by essentially one rotation of the actuating handle (3.1, 3.1 ") relative to the cladding tube (2).

19. Device according to one of claims 16 to 18, characterized in that the first thread (5, 5 ") and the second counter thread (7, 7") are multi-start.

20. Device according to one of the preceding claims, characterized in that the cladding tube (2, 2 ') and the swab carrier (1, 1') each consist of a biocompatible plastic.

21. Device according to one of the preceding claims, characterized in that the actuating handle (3.1, 3.1 ', 3.1 ") and / or the handle element (3.2, 3.2', 3.2") are designed as a plastic body produced by means of an injection molding or blow molding process .

22. Device according to one of the preceding claims, characterized in that the actuating handle (3.1 ") is snapped onto the inner handle element (3.2") by an annular stop surface (9.1 ") on the handle element connected to the sleeve (3.2") which interacts with an annular stop surface 9.2 ", occurs when the grip element 3.2 "is released from the thread.

23. Device according to one of the preceding claims, characterized in that the swab (4, 4 ', 4 ") consists of calcium alginate or a cotton-aluminum mixture or is formed by a nylon brush.

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