Technical Field

The invention relates to a sample fixation system for fixation of a sample from humans or animals, said sample fixation system comprising:

at least one fluid container containing a fluid, and

at least one sample container for reception of the fluid and the sample, said sample container comprising a piston for generating vacuum in the sample container, and where the sample fixation system further comprises

- a connecting means for providing a tight fluid connection between the fluid container and the sample container so that the transmission of fluid takes place only between the fluid container and the sample container through the connecting means.

Background

Primarily, fixation of samples from humans and animals is carried out in order to fixate a sample in a certain condition with a view to examining the sample at a later stage. Typically, a fixation is carried out by filling a sample glass or a sample container with fixing fluid, e.g. formalin or formaldehyde, the sample is placed in the sample glass, and the sample glass is closed with a screw lid. This means that during the time the sample glass is filled with fixing fluid, e.g. formalin, and the lid has not yet been put on the sample glass, the person handling the sample is exposed to the very damaging aerosols and gasses.

Today, this method is used in a large number of hospitals, with general practitioners, in laboratories, in veterinary surgeon's practices and the like.

Due to the damaging substances, e.g. formaldehyde, which is believed to be carcinogenic, it has become a requirement by the authorities that fixation of samples are to take place under supervised conditions during powerful suction, e.g. a fume cupboard. However, said fume cupboards are expensive and are rarely placed in a practical place for the persons fixating the samples. Further, the suctioned air from the fume cupboard must be subjected to either a costly purifying process or remain being damaging, but just discharged somewhere else.

WO8605683 describes a device for transferring a fluid from one vessel to a second vessel. The vessels are connected to each other by a connecting member comprising a through cannula. Both vessels comprise a membrane-like device which, by mounting on the connecting member, is penetrated by the cannula, whereby fluid communication may take place from one vessel to the other vessel.

The present invention eliminates the above disadvantages of the prior art at least partly.

Disclosure of the Invention

It is a first aspect of the present invention to provide a sample fixation system ensuring that persons fixating samples from humans and animals are not exposed to fluids from the fixing fluid in connection with the fixation.

In a second aspect of the present invention, a sample fixation system is provided, which may be used without the use of suction, e.g. a fume cupboard.

In a third aspect of the present invention, a sample fixation system is provided, which may easily be used in various places.

For the achievement of the said aspects, the system according to the present invention is characteristic by a sample fixation system for fixation of a sample from humans or animals, said sample fixation system comprising:

- at least one fluid container containing a fluid,

at least one sample container for reception of the fluid and the sample, and where the sample fixation system further comprises

- a connecting means for providing a tight fluid connection between the fluid container and the sample container so that the transmission of fluid takes place only between the fluid container and the sample container through the connecting means, wherein the sample fixation system is characterised in that the fluid container is a drip bag of a polymer, such as polypropylene, polyamide or polyurethane, and in that the connecting means is separated in two units, a first unit end and a second unit end.

In this way it is achieved that the fluid can be transferred from the fluid container to the sample container without the fluid being in contact with the surrounding environment at any time. The sample fixation system is thus a closed circuit. This means that fixation of samples is not limited to specially equipped areas, e.g. fume cupboards or the like. On the contrary, fixation of samples may be conducted at places without suction. By this, it is possible to fixate a sample at the location where it has been selected and unnecessary transport is thus avoided. By this, it is achieved that the sample is fresh when it is fixated.

In another embodiment, the sample container may comprise a piston for generating vacuum in the sample container.

By generating vacuum in the sample container it is achieved that the fluid is extracted from the fluid container to the sample container. The vacuum results in a pressure dif- ference between the fluid container and the sample container. Said pressure difference activates a mechanism so that fluid communication is allowed between the fluid container and the sample container.

In yet another embodiment, the piston may comprise a concavity for reception of the sample on the vacuum side.

The concavity enables that the sample is only in contact with the piston and not the sides of the sample container, when the sample is placed in the sample container. By this it is achieved that the sides of the sample glass remain as clean as possible.

In addition, the fluid container may be a drip bag of a polymer, such as polypropylene, polyamide or polyurethane.

Drip bags are well-known in the typical situations where the fixation system is used, and special training of the staff in handling drip bags is therefore not required. Drip bags made of polymers are especially suited as they can withstand typical fixing fluids, such as formaldehyde and formalin.

In another embodiment, the sample container may comprise sealing means so that the sample container is gastight in uncoupled position.

By this it is achieved that after fixing fluid has been filled in the sample container, the container is tight and may thus e.g. be stored in a room without suction, e.g. a laboratory or the like.

In an advantageous embodiment, the sealing means may comprise at least one partly exposed membrane. This way it is possible to conduct the fluid through the membrane, e.g. by penetrating the membrane with a cannula and still achieve that the sample container is tight, when it is not penetrated by a cannula.

It is also advantageous that the sample container may comprise a removable lid. With this it is possible to easily place the sample in the sample container. In addition, the removable lid can be adjusted so that it is adapted for special conditions, e.g. in connection with transport or storage.

In another embodiment, the removable lid may be provided with a membrane. Thus, it is possible to adapt the sample container for various purposes and other connecting means.

In a preferred embodiment, the removable lid may be provided with a branch. The branch enables that the removable lid and thus the sample container may be coupled to a connecting means with a smaller diameter than the removable lid.

In yet another preferred embodiment, the sample container may further comprise a re- movable cap wherein the membrane is mounted. This enables that the removable lid is used with various types of connecting means. The cap may be replaced so that the sample container can be adapted to several types of connecting means.

In another embodiment, the piston may form the sample container bottom. This em- bodiment renders it possible to place a sample in the container by removing the piston, reinserting it with the sample, and adding the fixing fluid. In this embodiment, the sam- pie container may comprise a ventilation valve. In another embodiment, the sample container may comprise two membranes. By this, it is possible to use one of the membranes for fluid input to the sample container and the second membrane for air out of the sample container. In yet another embodiment, the sample fixation system may comprise a pump. This way it is possible to press or suck fluid into a sample container with two membranes.

In yet another embodiment, the piston may comprise a detachable piston rod. When the piston rod is detachable, e.g. screwed or broken off, the sample container takes up less space when it is in use. The piston rod is to be detached when the piston has been pulled to the desired position.

In another embodiment according to the invention, the connecting means may comprise a stop valve. This renders it possible to close off the permeation of fluid in the connecting means. The stop valve may be an integrated part of the second unit end of the connecting means.

In yet another embodiment according to the invention, the connecting means may comprise a locking device. With this the connecting means may be locked to the fluid container. The locking device may be integrated with part of the connecting means penetrating the fluid container. The locking device may comprise a cup-shaped part with a number of recesses in the sides of the cup so that a number of locking fingers are formed. The locking fingers may be yielding. The cup-shaped part of the locking device may comprise a projection. When the projection is taken past a projection on the fluid container, the fluid container and the locking device are engaging. After the locking fingers engage with the fluid container, the locking fingers may be locked by a locking ring.

In another embodiment according to the invention, the first unit end of the connecting means may be integrated with the locking device.

In yet another embodiment according to the invention, the fluid container may, at least partly, comprise a non-transparent material. As a large number of fluid bags and drip bags are used at e.g. laboratories and in hospitals, it is important for the safety to be able to identify the fluid containers. Furthermore, the non-transparent material may also be opaque, so that e.g. the rays of the sun do not damage the fluid. The non- transparent material may be cardboard, paper boards or foil.

In yet another advantageous embodiment, the connecting means may comprise a can- nula, which penetrates the membrane by connecting the sample container and the connecting means. This enables fluid communication between the fluid container and the sample container. The membrane is penetrable by a cannula and remains tight when the cannula is retracted again.

Further, the invention relates to the use of a sample fixation system, where the sample fixation system is used for fixation of samples from humans and animals in formalin or formaldehyde. Formalin or formaldehyde is an especially suitable fluid for fixation of samples from humans or animals. The sample fixation system according to the present invention may also be used with other types of fixing fluids.

Further, the invention relates to a method for fixation of samples from humans and animals with a sample fixation system according to the invention, wherein the method comprises the steps:

- the fluid container containing a fluid is connected with the connecting means,

a sample is placed in the sample container,

the sample container is connected with the connecting means,

a pressure difference is provided between the sample container and the fluid container so that a fluid communication is achieved between the fluid container and the sample container thus resulting in transmission of fluid from the fluid container to the sample container, and

the sample container is disconnected from the connecting means.

By this method it is ensured that persons fixating samples by means of the sample fixation system according to the invention are not exposed to fluids or aerosols from fixing fluid. Thus, it is possible to use the sample fixation system at the location where the sample is selected from a human or an animal. Brief Description of the Drawings

The invention is explained in detail below with reference to the drawings, in which

Fig. 1 shows a sample fixation system according to the present invention,

Fig. 2 shows the sample fixation system in Fig. 1 partly in exploded view,

Fig. 3A - 3C show placement of a sample in a sample fixation system according to the invention,

Fig. 4 shows a second embodiment of the sample container of the sample fixation system,

Fig. 5 shows a third embodiment of the sample container of the sample fixation system,

Fig. 6 shows a fourth embodiment of the sample container of the sample fixation system, and

Fig. 7 shows another embodiment of the sample fixation system according to the invention comprising a locking device.

Detailed description of the Invention

Fig. 1 shows an embodiment of a sample fixation system 1 according to the present invention. Marked with dotted lines, it is shown that the sample fixation system 1 comprises a sample container 2 connected to a connecting means 3, where the connecting means 3 is also connected to a fluid container 4. The fluid container 4 contains a fluid 5. In this embodiment, the fluid container 4 comprises a protruding part 6, which may be used for suspension of the fluid container 4 and thus the entire sample fixation system on a hook or the like. Such suspension is similar to the one used for regular drip bags, and special training is therefore not required for handling the sample fixation system 1. However, most drip bags are not resistant to fixing fluids 5, and therefore a drip bag of polymer is used. However, the protruding part 6 may be formed in many ways. The connecting means 3 has a first unit end 7 connected to the fluid container 4, and the connecting means 3 has a second unit end 8 connected to the sample container 2. The first unit end 7 is partly inserted in the fluid container 4 and thus enables fluid communication between the fluid container 4 and the connecting means 3. The second unit end 8 of the connecting means 3 is connected to the sample container 2, and fluid communication is therefore possible from the fluid container 4 through the connecting means 3 to the sample container 2. The connection between the connecting means 3 and the sample container 2 takes place through a branch 9 (only partly visible) protruding from a removable lid 10, which is mounted on a sample casing 11. With dotted lines, a piston 12 is shown inside the sample casing 11. A piston rod 13 is connected to the piston 12, said piston rod 13 is partly inside the sample casing 11 (shown with dotted lines) and partly outside the sample casing 11. In this embodiment, the piston rod 13 is mounted with a gripping part making it easy to obtain a tight grip on the piston rod 13. The piston rod 13 is led out through a casing bottom 15.

Fig. 2 shows an exploded view of the sample fixation system 1 in Fig. 1. It is shown that the connecting means 3 is divided into two units, the first unit end 7 and the second unit end 8. In another embodiment, the first unit end 7 and the second unit end 8 may be integrated in a joint unit. Since the second unit end 8 is separable from the first unit end 7 it is achieved that if upon desire another sample container 2 with a branch 9 having another shape or another diameter is to be used, it is only necessary to replace the second unit end 8. The connecting means 3 may comprise a membrane or the like (not shown) for automatic stop of fluid by disconnection from the second unit end 8.

In the embodiment shown in Fig. 2, the first unit end 7 is adapted so as to only allow passage of fluid, when the second unit end 8 is connected to the first unit end 7, and when a pressure difference is also applied over the first unit end 7. This enables automatic opening and closing for fluid communication. This is also achievable by a valve, which is opened when it is desired to activate the fluid communication between the fluid container 4 and the sample container 2. The second unit end 8 is provided with a can- nula 16 (shown with a dotted line), which is protected with a shell 17.

The branch 9 of the sample container 2 comprises a membrane 18. The membrane 18 functions as a sealing means. By connection of the branch 9 of the sample container 2 and the second unit end 8 of the connecting means 3, the branch 9 is pressed up in the second unit end 8, so that the cannula 16 penetrates the membrane 18. When the branch 9 is pressed upwards, the shell 17 is pushed off, and the cannula 16 penetrates the shell 17. When the cannula 16 has thus penetrated the membrane 18, fluid communication can take place between the fluid container 4 and the sample container 2. In this embodiment, the first unit end 7 of the connecting means 3 is adapted so as to allow fluid 5 to pass through the first unit end 7 of the connecting means 3, when a vac- uum is generated in the sample container 2. This is described more thoroughly in Fig. 3.

Fig. 3A - 3C show how a sample 19 is placed in the sample casing 11 of the sample container 2, where it is caught by the piston 12. The piston 12 may comprise a concav- ity, so that the sample 19 is placed in the concavity of the piston 12. As the piston 12 can generate vacuum in the sample container 2 in the part of the sample casing 11 containing the sample 19, the piston 12 will be concave towards the vacuum side. The piston 12 may have many shapes, and the shape may be adapted to the type of sample 19, which will typically be used in the sample container 2. The piston 12 and the sample casing 11 require a tightness, a fit, ensuring that no aerosols or gasses can leak between them. Fig 3A shows that the removable lid 10 has been removed in order for the sample 19 to be placed in the sample casing 11 or directly in the piston 12 with the concavity. It is shown that the piston 12 is pulled slightly downwards. This is not necessarily always the case, but in this embodiment it depends on the end amount of fluid 5 in the sample container 2. Fig. 3B shows that the sample 19 is placed in the sample container 2 and that the removable lid 10 has been screwed on. The removable lid 10 may be removable in various ways. In this embodiment, the removable lid 10 is a screw lid. In other embodiments, it could be spring-loaded locking devices or the like. As the sample 19 is now placed in the sample container 2, the sample container 2 is ready to be induced fixing fluid or fluid 5. Fig. 3C shows that the second unit end 8 of the connecting means 3 is connected to the branch 9 on the removable lid 10. Due to illustrative reasons, only the second unit end 8 and the sample container 2 are shown in Fig. 3C. It is shown that the cannula 16 has penetrated the membrane 18, and fluid communication has thus been enabled between the fluid container 4 (not shown) and the sample container 2 at the connecting means (only shown partly). By pulling the piston rod 13 and thereby pulling the piston 12 towards the casing bottom 15, a vacuum is generated between the piston 12 and the first unit end 7 (not shown) of the connecting means 3. Said vacuum results in the connecting means 3 opening up to fluid communication so that fluid 5 flows from the fluid container 4 to the sample container 2. When an appropriate amount of fluid 5 has flown from the fluid container 4 to the sample container 2, the piston 12 is not pulled further backwards, and the sample container 2 is disconnected from the connecting means 3. The membrane 18 of the sample container 2 ensures that no aerosols are released from the sample container 2. The cannula 16 and the shell 17 (not shown) ensure that no aerosols are released from the connecting means 3.

Thus, it has been achieved that the fluid 5 is transferred from the fluid container 4 to the sample container 2 without the fluid 5 having been in contact with the surrounding environment, e.g. a laboratory or a similar hospital unit. It has thus been achieved that the sample 19, which is to be fixated, has been fixated without the person performing the fixation having been exposed to aerosols.

Fig. 4-6 show other embodiments of the sample container 2. Fig. 4 shows an embodiment wherein the piston rod 13 may be removed, e.g. broken off, when the piston 12 is pulled towards the casing bottom 15. Fig. 5 shows an embodiment of the sample con- tainer 2 without casing bottom 15 and without removable lid 10. As there is no removable lid it is necessary to be able to place the sample 19 inside the sample casing 11 in another way. In this case, the piston 12 with piston rod 13 will be delivered without being inserted in the sample casing 11. The sample 19 is therefore placed directly in or on the piston 12, and the piston 12 is reinserted in the sample casing 11. In order for the piston 12 to be pressed inside in practice, there may be a ventilation valve or like device allowing that air in the sample container 2 can be released when the piston 12 is inserted. When the piston rod 13 is being pulled in order to pull fluid into the sample container 2, said valve is locked in order to ensure that no fixing fluid or aerosols can leak. The pulling of the piston is stopped and thus forms the bottom of the sample con- tainer 2. A device, which may function as ventilation when the piston 12 is pressed inside, is shown in another embodiment of the sample container 2 shown in Fig. 6. Fig. 6 shows a cap 20 mounted on the branch 9 of the sample container 2. The cap 20 comprises a membrane 18. Thus, it is not necessary that the branch 9 comprises a membrane 18. The cap 20 is thus mounted on the open branch 9, and with this it is achieved that the branch 9 can be mounted with a membrane 18. In an embodiment (not shown) where the cap 20 is used on the sample container 2 as shown in Fig. 5, the piston 12 can be pressed inside before the cap 20 is mounted on the branch 9 thus enabling ventilation. When the cap 20 is mounted after the piston 12 with sample 19 has been pressed inside, a vacuum may be formed in the sample container 2, and fluid communication as described above may take place. Said cap 20 may also be used with the previously mentioned embodiments of the sample container 2. Further, the cap 20 may facilitate easy adaption of the sample container 2 with the connection means 3. Even in case the branch 9 already comprises a membrane, the form or diameter of the branch 9 can be changed, as it will not affect the effect of the sample fixation system 1 that there are two membranes on the sample container 2, i.e. a membrane 18 on the branch 9 and a similar membrane in the cap 20.

Fig. 7 shows an embodiment where the system comprises a stop valve 21 with an aperture 22, where the stop valve 21 is connected with a locking device 23. The stop valve 21 is shown in closed position. In this embodiment, the locking device 23 has a number of locking fingers 24. As the locking device 23 is in all essentials cup-shaped, the locking fingers 24 are formed by recesses in the sides of the cup. On the inside of the cup, i.e. the inside of the locking fingers 24, there is a projection. As the locking fingers are yielding, the projection can be pressed past a projection on the attachment of the fluid container 4. The attachment may e.g. be a branch. For additional fastening, the locking device 23 may be provided with a locking ring (not shown), so that the yielding locking fingers are pressed more tightly around the attachment of the fluid container 4. The stop valve 21 further comprises a knob 25 so that the aperture 22 can be turned from closed position (as shown) to open position (not shown).

The second unit end 8 of the connecting means 3 is connected to a sample container 2. In this embodiment, the stop valve 21 is integrated with the second unit end 8 of the connecting means 3.