WO2002071063A1

WO2002071063A1 - System for handling body fluids

Info

Publication number: WO2002071063A1
Application number: PCT/SE2001/000421
Authority: WO
Inventors: Björn ISAKSSON
Original assignee: Isaksson Bjoern
Priority date: 2001-03-01
Filing date: 2001-03-01
Publication date: 2002-09-12

Abstract

The invention relates to a system for handling and testing samples of body fluids, and to a container (1) and sampling device (2) included in the system. The container (1) comprises and outer envelope (10) made of a soft and flexible material, an opening (11), and a sealing means (12) for closing the opening in a leaktight manner, which outer envelope comprises a membrane (13) which permits penetration by a sharp-pointed object so that a body fluid contained in the container can be tested form the outside, and which automatically re-closes when the sharp-pointed object is removed. The sampling device (2) comprises a reagent (23), a tube (21) with a first end (22) intended to be brought into contact with the body fluid through the penetrable membrane (13) of the container (1) , and a second end at which the reagent is arranged, the tube having an internal diameter and a length adapted to give a capillary force which is sufficient to draw up body fluid from the first end to the reagent at the second end.

Description

SYSTEM FOR HANDLING BODY FLUIDS

Technical Field

The present invention relates to a system for handling and testing samples of body fluids, which system comprises at least one container for handling and storing samples of body fluids, and at least one sampling device for testing body fluids contained in such a container. The invention also relates to such a sampling device for testing body fluids .

Background Art

Large quantities of body fluid samples, for example urine samples, fertility samples, blood samples, etc., are handled particularly in medicine and nursing. When taking such samples, a first container is normally filled with a body fluid. The fluid is then poured into a second container, which is normally made of rigid plastic with a screw cap, after which the container is transported to the place where the sample of body fluid is to be tested. For this testing, the container is opened, and the test- ing is then carried out, for example, by dipping measuring rods with reagent into the sample of body fluid. For urine samples, measuring rods with several different reagent areas are normally used, which are dipped into the urine and then removed again. Such a rod normally com- prises areas for measuring sugar content, protein, red blood cells and white blood cells. After a defined period of time, for example 60 seconds, all the areas must then be read off more or less simultaneously by comparing the colour of the reagent with a colour scale marking (indi- cator scale) in order to determine the sample values. If the urine is additionally to be tested for infection of the urinary tract, the urine sample is then poured into a sterile tube and forwarded to a laboratory. However, this handling suffers from a large number of disadvantages. The containers are difficult to handle and they take up a lot of space, and at the same time the openings are relatively small, which can easily result in spillages. It is also difficult to make the container seals leaktight and secure. At a number of stages during handling, the sample of body fluid is also exposed to the environment, which results in a risk of spillage and the like. In addition, this entails a risk of the sample of body fluid being tampered with or contaminated, which represents a possible source of error at the time of analysis. The exposure of the body fluids, not least during testing with measuring rods and the like, also means that the staff handling the samples can easily come into con- tact with the body fluid, which on the one hand can be unpleasant and, on the other hand, constitutes a risk of spreading infection.

To make the containers smaller and easier to handle, GB 2,292,606 has proposed that the containers be made of a flexible material in the form of bags. One problem with these bags, however, is that it is difficult to seal them in a manner which on the one hand is simple and inexpensive and which, on the other hand, is leaktight and reliable. Moreover, this type of container also requires that the seal be opened for testing, etc.

Object of the Invention

The object of the present invention is to provide a system for handling and testing samples of body fluids which completely or at least partially eliminates the above-mentioned disadvantages, and a sampling device included in this system.

This object is achieved by means of a system and a sampling device according to the attached claims. Description of the Invention

The invention relates to a sampling device for testing samples of body fluids, comprising a reagent intended to be brought into contact with the sample of body fluid which is to be tested. The sampling device further comprises a tube with a first end intended to be brought into contact with the body fluid, and a second end at which the reagent is arranged, the tube having an internal diameter and a length adapted to give a capillary force which is sufficient to draw up body fluid from the first end to the reagent at the second end. The sampling device also preferably comprises a surface extending preferably at right angles to that of the tube, arranged in proximity to the second end of the tube, and comprising colour scale markings for interpreting changes in the reagent .

With the sampling device according to the invention, one end can be immersed in the body fluid sample, while the reagent can be arranged at a distance from this and consequently does not need to be immersed in the body fluid sample. Arranging colour scale markings in the area of the reagent also makes it easier to read off the test result .

The invention also relates to a system with a sampl- ing means as described above, and a container for handling and storing samples of body fluids, which container comprises an outer envelope made of a soft and flexible material, an opening, and a sealing means for closing the opening in a leaktight manner. A distinguishing feature of this container is that the outer envelope also comprises a membrane which permits penetration by a sharp- pointed object so that a body fluid contained in the container can be tested from the outside, and which automatically re-closes when the sharp-pointed object is removed. In this way, the body fluid sample can be tested from the outside, without the container having to be opened. By virtue of the flexible material, the container is also made easy to handle, transport and store, and it does not take up an unnecessarily large space when empty, etc. It is particularly preferable that the sealing means comprises an arm around which the opening end of the bag can be rolled up, and means for locking the bag in the rolled-up position, as this guarantees a tight and reliable seal. It can also be advantageous that the seal, when fully closed, cannot be released again, since this avoids the risk of the container accidentally coming open or of the container being opened in order to tamper with the sample.

The above system makes available a closed system for handling body fluid samples, which system reduces the risk of spillage and other inconveniences, and at the same time minimises the risk of the sample being deliberately or accidentally altered during handling.

Further advantages and characteristic features of the invention will become apparent from the following description of preferred embodiments .

Brief Description of the Drawings

The invention will now be described in more detail by way of example and with reference to the accompanying drawings, in which: Fig. 1 shows a perspective and partially exploded view of a container according to one embodiment of the invention in an open state;

Fig. 2 shows the container from Fig. 1 in a partially sealed state; Fig. 3 shows the container from Fig. 1 in a sealed state;

Fig. 4 shows a perspective view of the container from Fig. 1 and a sampling device according to one embodiment of the invention; Fig. 5 shows a side view of the sampling device from Fig. 4; Fig. 6 shows a view, partially in cross-section, of the locking mechanism of the sealing means of the container;

Fig. 7 shows an alternative embodiment of a sampling device according to the invention; and

Fig. 8 shows another alternative embodiment of a sampling device according to the invention.

Description of Preferred Embodiments The invention relates to a system for handling and testing samples of body fluids. The system comprises at least one container for handling and storing samples of body fluids, and at least one sampling device for testing body fluids contained in such a container. A container 1 according to a preferred embodiment of the invention is shown in Figs 1-3. The container comprises an outer envelope 10, an opening 11, and a sealing means 12 for closing the opening in a leaktight manner. The outer envelope is made of a soft and flexible mate- rial, such as a plastic material, and is preferably in the form of a bag. For example, a laminate of polyethylene and polyamide can be used. The outer envelope further comprises a membrane 13 which permits penetration by a sharp-pointed object so that a body fluid contained in the container can be tested from the outside, and which automatically re-closes when the sharp-pointed object is removed. Membranes of this kind are already known from other contexts and they function essentially as a nonreturn valve which prevents fluid from escaping through the pierced hole. The membrane can for example be made of silicone with a thin Teflon film on the surface.

According to a preferred embodiment, the membrane is attached directly to the outer envelope, and preferably to the outside, by means of adhesive bonding, welding or the like. This makes the production process simple and inexpensive. At the same time, the useful life and reliability of the product are increased since the outer enve- lope is entirely leaktight until the membrane is penetrated at the time of testing, and in normal circumstances the container will be relatively quickly disposed of thereafter. Optionally, a less expensive membrane can also be used.

Instead of being arranged on the outer envelope, all or part of the outer envelope can instead consist of a membrane made of a penetrable and re-closing material. The container can advantageously be wider at the opening end than elsewhere and thus have a shape which narrows away from the opening. This makes it easier to fill the container, and at the same time the volume of the container is not unnecessarily great.

The sealing means 12 has to provide a leaktight seal so that the container, after it has been filled, can be transported and handled without risk of spillage. According to a preferred embodiment, the sealing means is a clamp comprising two arms 14 which are articulated at their first end portions and which can be locked together at their second end portions. This lockable clamp can thus be clamped tight and locked around the opening of the container and thereby seal the latter. The arms also advantageously have roughened surfaces directed towards each other, and in particular with a matching longitu- dinal structure, for example tongues and grooves, which further improves the tightness of the seal .

According to a preferred embodiment, the sealing means are further adapted to allow the opening end of the bag to be rolled up one or more turns on the one arm before the bag is locked in the rolled-up position by locking means. In this way, the seal is made very tight and reliable. This type of seal can be obtained by means of the clamp discussed above. The first opening end is folded together slightly, for example by folding the outer ends towards the centre, as is shown in Fig. 2. The bag is then rolled up on one arm in one or possibly more turns, after which the other arm is guided towards the rolled-up end of the bag and is locked onto the first arm, as is shown in Fig. 3.

Alternatively, however, other types of sealing means can be used. For example, a reel or the like can be pro- vided around which the bag is rolled up, and the locking means used can be a strap, a rubber band, a cord or the like which is guided over the reel and prevents the rolled-up bag from rolling back.

The sealing means can advantageously be adapted to provide a non-releasable locking upon closure. This can for example be achieved, in the case of the previously described clamp, by designing the locking means as an insert part 15 arranged on one arm, which insert part 15 can be introduced into a corresponding opening 16 with bearing edges on the other arm. The insert part 15 can be provided with resilient barbs or the like which prevent it from escaping once it has been fully inserted through the opening. This is illustrated schematically in Fig. 6. Other ways of obtaining non-releasable locking are of course also possible.

Alternatively, instead of comprising two articulated arms, the described sealing means can comprise two separate arms, each arm thus having two ends with locking means . The container according to the invention can also advantageously be provided with a stiffening of the outer envelope at the opening, which stabilises the opening and makes it easier to introduce body fluids into the container. This stiffening can be obtained in different ways, for example by applying a stiffer material to the outer envelope around at least part of the opening. However, the stiffening preferably consists of a part of the sealing means secured to the opening, for example one arm of the previously described clamp. This is illustrated schematically by the dot-and-dash arrows in Fig. 1.

The sampling devices according to the invention are used to test body fluids and comprise a reagent intended to be brought into contact with the body fluid sample which is to be tested. The reagent is generally a chemical substance which reacts in a characteristic manner with another substance and therefore can be used to reveal the latter. In this case, the reagent can be, for example, of the same type as is used on the already known measuring rods, for testing for the presence of sugar, protein, red blood cells and white blood cells in the body fluid. However, other types of reagents are also conceivable. The sampling device comprises a tube 21 with a first end 22 intended to be brought into contact with the body fluid, and a second end at which the reagent 23 is arranged. The first end 22 can also advantageously be made pointed or sharp, which makes it easier to insert it through the perforable membrane 13 of the container. The internal diameter and length of the tube are adapted to ensure a capillary force which is sufficient to draw up body fluid from the first end 22 to the reagent 23 at the second end. The rise for a fluid resulting from the capillary force can generally be expressed as follows: h = 2σcos>9/rpg

where r is the internal radius of the tube, p is the density of the body fluid, g is the gravitational acceleration (normally 9.81 m/s²), σ is the surface tension (capillarity constant) of the fluid, and θ is the angle between the surface of the fluid and the wall, which depends on the material of the tube and the type of body fluid. Consequently, the rise for a given body fluid and a given tube material is dependent on the internal radius of the tube .

When the first end has been brought into contact with the body fluid, the capillary force ensures that body fluid is drawn up to the reagent, which is thereby wetted, and the sample values can then be read off in the usual way. In this way, the reagent does not need to be immersed in the body fluid to be tested, which permits closed handling.

The sampling devices can also advantageously comprise a surface 24 extending preferably at right angles to that of the tube, arranged in proximity to the second end of the tube, and comprising colour scale markings for interpreting changes in the reagent . It is especially preferable to arrange colour scale markings around the reagent. This makes it much easier to read off the results.

The invention affords a completely closed system for handling and analysis of body fluids and can be used in particular for urine samples.

The container can be made of a soft and flexible material, for example in the form of a bag, but it can also be made of a more rigid material, such as rigid plastic. In this case the seal can be obtained using a tight-sealing cap, and the sampling part can advantageously be arranged in the cap. Thus, the cap can in this case advantageously be provided with a perforable area. The volume of the container can expediently be less than 500 ml, suitably 75-250 ml. It is also possible for the container to be connectible to a catheter or the like, and the container can in this case constitute a collecting part for a catheter system. For this purpose, the container can either comprise a connecting piece or the like for application of the catheter, or the catheter can be made integral with the container.

As has previously been described, the sampling device can comprise a sampling button with a perforating part intended to be inserted through the penetrable part ' of the container. Alternatively, however, the sampling device can instead comprise two parts which are displaceable relative to each other, as is illustrated in Fig. 7. In this case, one part has a female component 30, with a tube 31 and a membrane 32 sealing the tube, and the other part has a male component 33 with a perforation part 34. The male component is in this case be insertable into the female component to penetrate the membrane, which permits a flow of fluid in the tube.

In this case, the female component 30 can preferably comprise the reagent 23 and the reading disc 24. The tube of the female component is designed to draw up body fluid by capillary force from the container to the reagent when the membrane has been perforated. The perforation part 34 of the male component thus does not need to be tubular, and instead it can be drawn back after penetrating the membrane, after which body fluid can be introduced through the tube of the female component. Alternatively, however, the perforation part is also tubular, as in the previously described embodiment of the sampling device. In this way the body fluid can be passed through the perforation unit 34 and onwards through the tube 31 of the female component up to the reagent 23. Alternatively, however, it is also possible in this case to instead arrange the reagent on the end of the perforation part 34 opposite the female component, in which case the body fluid is instead guided in the opposite direction.

It is also preferable for the female component and the male component to be joined together by means of a guide for stabilising the parts relative to each other, and thereby making displacement easier. This guide can, for example, comprise one or more pairs of additional tube parts 36, 37 which can be inserted into each other. However, other forms of guides in the form of brackets, hinges or the like which can be inserted into each other are also possible.

The part which comprises the reagent is also preferably welded to the wall of the container. Alternatively, however, the sampling device can also lie loosely in the container, provided that the reagent from the side oppo- site the tube is protected from incoming fluid.

By gripping the "sampling button" as described above with a thumb and pressing the male and female components together, this perforates the membrane which previously kept the fluid away from the reagent part . When the reagent comes into contact with the body fluid, it provides a readable result after a specific period of time, and this result can be read off against the surrounding indicator part without the bag having to be opened or being unusable .

The sampling device according to the invention can also be designed in different ways. In particular, the sealing means of the tube 31, with a first opening 38 for introducing the body fluid and a second opening at which the reagent 23 is arranged, can be designed in many alternative ways. The sealing means can be brought from a closed position, where transfer of body fluid from the first opening to the second opening is prevented, to an open position, in which open position transfer of body fluid between the first opening and second opening is possible. This sealing means can be designed as a valve or the like, or as a penetrable membrane, as has been discussed above. In particular, the sealing means can instead comprise a displaceable part which can be displaced between a first position, where it screens the first opening from the body fluid, and a second position where the first opening is exposed to the body fluid. This displaceable part can be a second tube 39 which is displaceably arranged relative to the first tube 31, as is illustrated in Fig. 8. The second tube comprises an opening 40 which can be displaced between a closed position, where the opening does not coincide with the first opening 38 of the first tube, and a second open position where the opening 40 at least partially coincides with the first opening 38 of the first tube.

The system according to the invention affords a completely closed system and can replace or be used together with most of the previously known methods and systems for analysis and testing of body fluids. The invention has now been described by way of examples. However, many variants of the invention are possible. For example, it is possible to use other types of sealing means, the membrane can be arranged on the outer envelope in other ways, or can also be part thereof, and other materials can be used, etc. Moreover, although the invention is especially intended for taking urine samples, it can also be used for other body fluids. These and other similar variants must be regarded as being included by the invention as it is defined by the attached claims.

Claims

1. A sampling device (2) for testing body fluids, comprising a reagent (23) intended to be brought into contact with the sample of body fluid which is to be tested, and a tube (21) with a first end (22) intended to be brought into contact with the body fluid, and a second end at which the reagent (23) is arranged, the tube hav- ing an internal diameter and a length adapted to give a capillary force which is sufficient to draw up body fluid from the first end to the reagent at the second end, c ha r a c t e r i s e d in that the first end (22) of the tube (21) is arranged to permit insertion through a perforable wall material, and is preferably designed with a sharp or sharp-pointed end.

2. A sampling device for testing body fluids, comprising a reagent (23) intended to be brought into contact with the sample of body fluid which is to be tested, and a tube (31) with a first opening for introduction of the body fluid and a second opening at which the reagent (23) is arranged, c h a r a c t e r i s e d in that it also comprises a sealing means, which sealing means can be brought from a closed position, where transfer of body fluid from the first opening to the second opening is prevented, to an open position, in which open position transfer of body fluid between the first opening and the second opening is possible.

3. A sampling device according to claim 2, wherein the sealing means comprises a membrane (32) of perforable material arranged in the tube for preventing introduction of body fluid into the tube, and a penetrating unit (34) which is displaceable relative to the membrane in order to penetrate the membrane .

4. A sampling device according to claim 2, wherein the sealing means comprises a displaceable part which is displaceable between a first position, where it screens the first opening from the body fluid, and a second position, where the first opening is exposed to the body fluid.

5. A sampling device according to claim 2, wherein the sealing means comprises a second tube which is dis- placeably arranged relative to the first tube, the second tube comprising an opening which can be displaced between a closed position, where the opening does not coincide with the first opening in the first tube, and a second open position where the opening at least partially coincides with the first opening in the first tube.

6. A sampling device according to claim 1 or 2 , wherein it further comprises a surface (24) , preferably extending at right angles to that of the tube, arranged in proximity to the second end of the tube, and comprising colour scale markings for interpreting changes in the reagent .

7. A sampling device according to claim 1, 2 or 3, wherein the surface (24) with colour scale markings extends around the reagent (23) .

8. A sampling device according to claim 2, wherein the tube has an internal diameter and a length adapted to give a capillary force which is sufficient to draw up body fluid from the first opening to the reagent at the second opening.

9. A sampling device according to claim 3, wherein the membrane is arranged in the tube (31) , and the penetrating unit (34) is introducible into the tube at least past the membrane.

10. A sampling device according to claim 3 or 9, wherein the penetrating unit is tubular and preferably has an internal diameter and a length adapted to give a capillary force which is sufficient to draw up body fluid through the same.

11. A sampling device according to any one of claims 3 , 9 or 10, wherein the tube (31) and the penetrating unit (34) are coupled to each other in a displaceable manner, and further comprise a guide for stabilising said displacement .

12. A system for handling and testing samples of body fluids, which system comprises at least one con- tainer (1) for handling and storing samples of body fluids, and at least one sampling device (2) for testing body fluids contained in such a container, c h a r a c t e r i s e d in that the container (1) comprises an outer envelope (10) made of a soft and flexible material, an opening (11) , and a sealing means (12) for closing the opening in a leaktight manner, which outer envelope comprises a membrane (13) which permits penetration by a sharp-pointed object so that a body fluid contained in the container can be tested from the outside, and which automatically re-closes when the sharp-pointed object is removed, and the sampling device (2) comprises a reagent (23) , a tube (21) with a first end (22) intended to be brought into contact with the body fluid through the penetrable membrane (13) of the container (1) , and a second end at which the reagent is arranged, the tube having an internal diameter and a length adapted to give a capillary force which is sufficient to draw up body fluid from the first end to the reagent at the second end, and the first end (22) of the tube (21) being arranged to permit introduction through the membrane and preferably being designed with a sharp or sharp-pointed end.

13. A system for handling and testing samples of body fluids, which system comprises at least one sealable container (1) , and a sampling device according to any one of claims 1-11.

14. A system according to claim 12 or 13, wherein the outer envelope (10) of the container is a bag made of a plastic material .

15. A system according to any one of claims 12-14, wherein the container has a greater width at the opening end than elsewhere and thus has a shape which narrows from the opening.

16. A system according to any one of claims 12-15, wherein the membrane (13) is arranged directly on the outer envelope (10) of the container and preferably by means of adhesive bonding or welding.

17. A system according to any one of claims 12-16, wherein the sealing means (12) for the container comprises an arm (14) around which the opening end of the bag can be rolled up, and means (15, 16) for locking the bag in the rolled-up position.

18. A system according to any one of claims 12-17, wherein the sealing means (12) for the container comprises two arms (14) which are joined to each other in an articulated manner at their first end portions and which can be locked together at their second end portions, which sealing means thus functions as a lockable clamp.

19. A system according to any one of claims 12-18, wherein the sealing means for the container is adapted to provide non-releasable locking upon closure.

20. A system according to any one of claims 12-19, wherein the container further comprises a stiffening (14) of the outer envelope at the opening, which stiffening preferably consists of a part of the sealing means (12) secured to the opening.