Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/02—Burettes; Pipettes
  • B01L3/021—Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/06—Auxiliary integrated devices, integrated components
  • B01L2300/0627—Sensor or part of a sensor is integrated
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/08—Geometry, shape and general structure
  • B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2400/00—Moving or stopping fluids
  • B01L2400/04—Moving fluids with specific forces or mechanical means
  • B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
  • B01L2400/0481—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure squeezing of channels or chambers

Definitions

• the present invention relates to a simplified device for sampling and testing of flu - ids, more particularly bodily fluids, for the presence of microorganisms, suitable for being operated by one hand, while also minimising the ⁇ sk of contamination, such as e g undesirable bacterial growth on the outside of the device
• the device comprises a tip, a container, flexible and resilient actuating means substantially seal- mgly connected to the container, which actuating means, together with said con- tamer, defines a continuous compartment with an opening, and a displaceable member exhibiting an active test surface, disposed inside the container
• the invention also relates to a simplified method for sampling and testing fluids for the presence of microorganisms, by which method problems related to contam a- tton, such as e g undesirable bacterial growth, can be minimised
• testing and analysis of bodily fluids have for a long time been performed for various reasons, and are still of paramount clinical importance, for example in detecting and monitoring numerous pathological conditions
• analysis of urine is one of the oldest, simplest and most widely used laboratory tests in the clinical medicine
• the testing can for example be of great value in finding a suitable antibiotic for the spe- cific condition
• testing has been relatively complex, and often involved many steps, some of which involve transferring the microorganisms, m a state in which they are more or less isolated from the surrounding environment, from one place to another
• the handling of the microorganisms, such as, for example, during incubation and culti- vation thereof, during such testing has exposed laboratory personnel to the risk of infection, as many of the microorganisms of interest are pathogenic.
• devices have been developed for simplified analysis of a liquid sample, such as urine, for the presence of microorganisms (such as bacteria).
• Such testing devices also markedly reduce any possible exposure of the personnel involved in the testing to the microorganisms, as well reduce the risk of contamination of the samples during the handling thereof.
• US 4 054 491 describes a device and method for the examination of a sample which may contain microorganisms, whereby the sample is mLxed with a microorganism growth medium, and optionally an indicator, the mixture is incubated and thereafter examined for the presence of growing colonies.
• the sample is first brought into the device by means of the action of a piston, and thereafter the growth medium is brought into the device in the same manner, whereby mixing of the sample and medium inside the device will be accomplished.
• the device exhibits transparent portions for visibility of the colonies.
• a device for urine testing containing one or more test plates which test plates have been coated with culture media and optionally also with antibiotics.
• the spout of the device is immersed into a urine containing disposable glass container or the like, and a reduced pressure within the device is accomplished by means of the movement of the piston, whereby urine will enter the cylindrical reservoir of the device through the spout.
• the plates have been moistened with urine, the urine is emptied from said reservoir, and the device placed in an incubator for cultivation.
• a tip having first and second openings
• a displaceable member comprising a first portion directed towards the opening, a second portion, and a test surface, accommodated inside the container
• said actuating means is flexible and resilient, and is connected to the container, said actuating means and said container define a continuos compartment with an opening, and said second portion of the displaceable member is provided to be mechanically affected by said actuating means.
• A) providing a device for sampling and testing of fluids comprising:
• the device of the present invention allows for improved ease of testing of fluids for the presence of microorganisms. Also, the absence of a piston or plunger allows for a simplified construction of the device. According to another embodiment of the in- vention the device exhibits a removable tip, thereby the risk of contamination and undesirable bacterial growth, primarily due to parts of the outside of the device being brought into contact with the microorganism-containing fluid while sampling said fluid, can be markedly reduced. According to further embodiments, the opening of the container can be sealed by means of displacing the member exhibiting a test surface accommodated inside the container.
• the member accommodated inside the container at least will be mechanically affected, and thus also displaced by, the actuating means, as said means is brought into a second further compressed state, and preferably, as the actuating means is compressed further from a first compressed state.
• a second further compressed state is preferably an essentially fully or fully compressed state.
• the relatively simple construction of the device of the present invention will also allow for low production costs, and a minimum of different parts to be used. Also, the amount of material used to form a device can be kept very low.
• the device of the present invention allows for a releasable tip to be released from the opening of the container by means of displacement of the member accommo- dated inside the container.
• Such displacement can be accomplished by means of compression of the actuating means of the device.
• the tip of the device can be elongated, so as to conveniently be able to be used with test tubes.
• the container of the device can be provided with an at least translucent portion, so that any visible results on the test surface(s) of the displaceable member accommo- dated inside the container can be seen from outside the device through said portion, such as after cultivation of microorganisms, or after any other desired chemical reaction has taken place on said test surfaces.
• the whole container is manufactured from such an at least translucent material.
• the space occupied by a piston or plunger in the prior art devices can now instead be used for accommodating a larger test surface area.
• the ratio of testing surface area to volume of the container can also be increased.
• the test surface area is exhibited by a displaceable member accommodated inside the container. Accordingly, the device of the present invention will also enable a reduced amount of sample liquid to be used for adequate wetting of the test surfaces, and thus for the overall testing.
• the tip is removable, whereby the total contaminated area of the device, after a liquid sample has been taken, can be substantially minimised or virtually eliminated.
• the tip is released by means of compressing the actuating means on the upper end of the device in the longitudinal direction of the device, such as merely by the pressing of the thumb.
• the release of the tip can conveniently be effected by pressing of the thumb of the one hand while holding the device in one and the same hand.
• the tip can be released without the exterior of the same being contacted, the risk of any undeliberate transfer of any microorganism-containing fluid remaining on the outside of the tip will thereby be substantially minimised.
• the tip can thereafter be discarded or reused after cleaning, as desired.
• the test-surface exhibiting member is thereby also locked m its corresponding position
• a device comprising means for locking the actuating means in a second further compressed state.
• the member accommodated inside the container can be formed so, as to tightly seal the container as the member is dis- placed in the direction towards the opening of the container and the tip thereby is released
• the actuating means is removable, whereby the member accommodated inside the container can be accessed, such as for closer inspection or monitoring of the testing results.
• the opening of the container can be sealed by means of a separate closure means, so that any residual liquid in the container will be prevented from leaving the container via the opening thereof as the member accommodated inside the container is removed.
• closure means can be extenor or interior in relation to the container.
• the closing action of the separate closure means is preferably accomplished by the displacement of the displaceable member, such as by mechanical action of the first portion of the displaceable member accommodated inside the container This is especially preferred when separate interior closure means is used.
• an interior separate closure means should preferably be formed such as to allow for the closure of the container to be accomplished by means of mechanical action of the first portion of the displaceable member accommodated inside the container.
• the removable actuating means and the displaceable member accommodated inside the container can be locked to one another, so that the displaceable member can be removed merely by means of removing the actuating means.
• the removable actuating means and the displaceable member accommodated inside the container exhibit means for locking said actuating means to said member.
• Such locking can be established merely by mechanical locking action, such as by means of friction. The locking can be accomplished during assembling of the device, and, in the case of mechanical locking, also during operation of the device.
• test surface is defined as the total test surface(s) exhibited by the member accommodated inside the container.
• FIG. 1 shows a front view and a side view of an embodiment of the invention
• FIG. 2 same embodiment as in FIG. 1 is shown, wherein the flexible and resilient actuating means is in a first compressed state, allowing for ingress of fluid.
• FIG. 3 depicts the same embodiment as in FIGS. 1 and 2, wherein the actuating means is in a second further compressed state, and the elongate tip has been released.
• FIG. 4 shows the exterior of an embodiment of the invention in three different views.
• FIG. 5 illustrates a separate interior closure means provided in the container of the device according to one embodiment.
• FIG. 6 shows means for locking of the displaceable member and the actuating means to one another.
• the device 10 shown in the drawings comprises an elongate releasable tip 20, having first and second openings 21 and 22, respectively, a container 30 having a transparent portion and an opening 31 connectable with at least one opening of the tip, flexible and resilient actuating means 40 in the form of a collapsible dome for displacing gas inside the container by mechanical action on the outside of said means, said means being connected to said container, and a displaceable member 50 exhibiting a test surface 51, accommodated inside the container, which test surface is visible from outside the container through the transparent portion thereof.
• the displacement of the displaceable member 50 according to the present invention is effected by means of the actuating means 40 mechanically affecting, such as being brought into contact with, the second portion 53 of said member. Accordingly, for displacement of the displaceable member, such contact must as least be established as the actuating means is being brought into a second further compressed state, and preferably, as the actuating means is compressed further from a first compressed state. This requirement will obviously also be fulfilled by an embodiment in which such contact is pre-established, such as during assembly, or manu- facture of the device, in which case said second portion 53 will be mechanicalh- affected by the actuating means whenever the actuating means is compressed.
• the non-compressed flexible and resilient actuating means 40 As shown in FIG. 1, is compressed into a first compressed state, and the second opening 22 of the tip 20 is thereafter immersed in the fluid of interest, while the actuating means still is held in the first compressed state, as shown in FIG. 2.
• said member By releasing the exterior pressure exerted on the actuating means, said member will retain its original non-compressed form as shown in FIG. 1 , and fluid will thereby be brought to flow into the container 30 through the tip and wet the test surface(s) 51 of the displaceable member 50.
• said fluid inside the container is ejected by exertion of mechanical pressure on the actuating means, thereby compressing said means to a first compressed state corresponding to the state shown in FIG. 2.
• said means By compressing the actuating means 40 into a second further compressed state as shown in FIG. 3, said means will mechanically effect member 50 so that said member will be displaced in a direction towards opening 31.
• the first portion 52 of the member is inserted into the opening 31 of the container.
• the releasable tip inserted in said opening is thereby displaced and released.
• the tip displacing action of the first portion 52 is suitably accomplished by exertion of mechanical action thereof on the rim of the first opening 21 of said tip. Said tip will thereby be released from the container.
• the device freed from its tip, as shown in FIG. 3, can then be cultivated in this state, in case of a microorganism-containing fluid being tested.
• the actuating means 40 preferably exhibits means for locking the actuating means 40 in said second further compressed position.
• Such means can for example be ac- complished by the generally self-locking action provided by the inversion of a flexible member, such as the inversion of a collapsible dome, such as shown in the Figures.
• the means of locking is not critical and can be accomplished by any means as long as the function of the actuating means thereby is not inhibited.
• the actuating means 40 is preferably removable Thereby, the accommodated member will be easily accessible, for example, for a closer examination or assessment of the testing results.
• said means 40 can suitably be threaded along the rim thereof.
• other types of fittings will also make the actuating means removable, such as various friction fittings, such as, for example, a snap locking of said means to the container 30.
• actuating means 40 and the displaceable member 50 exhibit connecting means 70 and 71 for establishing a mechanical connection thereof, as the actuating means is brought into contact with the second portion 53 of said member
• the mechanical connection can be accomplished by means of a friction locking, such as for example by means of a ball snap locking
• the locking action of the connecting means is accomplished during operation of the device.
• the specific type of connection is not critical according to the present invention. It preferred that the connection thus established is as rigid as possible, so that any undesired movements of the displaceable member, when said member has been pulled out of the container, in relation to the actuating means are restncted.
• a removable threaded actuating means in case of a removable threaded actuating means
• connection can be accomplished already during manufacture or assembly of the device
• the function of the mechanical connection is still the same, the only difference being that the displaceable member will be displaced whenever the actuating means is compressed and also when said actuating means is allowed to retain its initial non-compressed state, since the contact of the actuating means 40 and the second portion 53 of the displaceable member is pre- established.
• the connecting means are not critical, and suitable connecting means will be evident to the person skilled in the art from reading the present description, and can for example be a rod-like portion 70 extending from the actuating means into a corresponding hole 71 in the second portion of the displaceable member Although not allowing for rotation, it is also conceivable to make the mechanical connection permanent and thus the actuating means and accommodated member integral.
• the elongate tip 20 is inserted into the opening of the container and releasably locked in such position in the opening of the container by means of friction. Accordingly, the pressure to be exerted on the actuating means in order to release the tip will at least correspond to the forces of friction holding the tip in its inserted position in the opening of the container.
• the friction locking is not critical and can be established by any conventional manner known in the art. The required friction can for example be established merely by a tight fit of the circumferencial area of the upper end of the tip inserted into the opening 31, as shown in the drawings, or can be established by a snap fitting of the tip into the opening of the container (not shown), or any other suitably means.
• the junction between the tip and container must be sufficiently air and liquid tight in order for the required elevated and reduced pressure in the container to be established by means of the action of the actuating means 40. Otherwise the function of the device will be jeopardised and spillage is likely to be encountered during operation of the device. Accordingly, in an embodiment of the invention having a releasable tip attached to the device, the tip must be substantially seal- ingly connected to the opening 31 of the container 30.
• the geometric shape of the first portion 52 of the member 50 is not critical, but should preferably be such as to allow said portion to be inserted into the opening 31, or at least displace the tip 20, such as by exerting mechanical action on at least parts of the rim of first opening 21.
• the first portion 52 can be formed so as to be able to tightly seal the opening 31, when introduced into said opening, as shown in FIG. 3.
• the first portion 52 will have to exhibit a geometrical shape suitable for forming a correspondingly tight juncture along its circumference with the opening 31, and at the same time be able to displace an inserted tip 20.
• this can be accomplished in various ways and is not critical to the function of the invention.
• the first portion 52 preferably exhibits a corresponding shape, fitting into said opening.
• the length of said first portion should only be the length required in order to displace an inserted tip 20 from the opening, and should preferably not reach outside said opening.
• a separate interior closure means 60 is provided in the container.
• said means 60 is provided with opening(s) 61 allowing for ingress and egress of fluid into the container.
• closure means 60 will be brought into a position where openings opening(s) 61 are sealed off and no further flow can pass through said openings.
• openings 61 are displaced around the upper circumferencial area of said means. This closure means will allow for removal of the accommodated member after testing while any residual liquid fluid in the container is prevented form leaving the container via the opening 31 thereof. Thus, any residual liquid fluid in the container will be prevented from contaminate the surrounding environment.
• an exterior separate closure means 60 is used.
• Such exterior means can merely consist in a stopper, apt to be fitted to the opening 31.
• the stopper can for example suitably be formed so that one end thereof fits the opening 22, and the opposite end fits opening 31.
• the flexible and resilient actuating means 40 is a gas displacing member, and can suitable be comprised of a flexible collapsible dome as shown in the drawings.
• the shape of actuating means 40 is not critical as long as it is effective for creating elevated and reduced pressures in the container. As will be readily realised, the shape must be such that the member is able to be substantially sealingly connected to the container, in order for member 40 to be able to perform its intended function. Al- though illustrated in the drawings with a collapsible dome fitted inside opening 32.
• dome also can be fitted outside said opening
• the dome could be replaced by any other suitable gas displacing means, such as, for example, a bellow-like member, which member also must be able to be brought into contact with the displaceable member for displacement thereof.
• suitable gas displacing means such as, for example, a bellow-like member, which member also must be able to be brought into contact with the displaceable member for displacement thereof.
• the form of the device, and primarily the container is not critical. It is however preferred that the geometric shape of the container essentially corresponds to the geometric shape of the accommodated displaceable member, since in this manner, the volume of fluid required for filling the container will be minimised. That is, the space of the container, apart from the portion thereof 33 adjacent to the actuating means 40, should preferably be substantially occupied by the member 50.
• the embodiment shown in the drawings is a preferred embodiment, wherein the form of the container allows for a large total test surface, and also for a small vol- ume of liquid to fill the container, while offering an ergonomic geometric shape of the device, so that it can easily be operated by merely one hand.
• the container is preferably formed from an inert, transparent, or translucent material, such as glass or plastic. Suitable materials for use in the container can be se- lected depending on the chemical characteristics of the fluids that the device will be contacted by.
• Thermoplastic materials which are compatible with the biological solutions, for which the device is expected to have most widespread applicability, are preferred.
• examples of such materials are polystyrene, polycarbonates, and polyolefms, such as polypropylene and polyethylene.
• the material employed to make the container member should be substantially inert to any reagents employed.
• inert refers to a lack of chemical reactivity towards solvents and reagents which may be employed and substances present in the specimen, particularly in biological samples such as bodily fluids, and at various pH conditions, particularly those encountered in biological fluids.
• the material should also be such as to allow for cultivation of the microorganisms of interest on the test surface(s) on the displaceable member while still inside the container.
• the actuating means 40 can be made from any material allowing for the flexible and resilient characteristics of said actuating means to be obtained, which does not unduly interfere with the function of the device. Accordingly, such material should preferably be inert to any reagents and fluids employed. Suitable materials to be used in the actuating means 40 are known to the person skilled in the art.
• the term flexible and resilient, as used herein, is used in order to define an actuating means which will return back into a non-compressed state; such as shown in FIG. 1, when released from a first compressed state, such as shown in FIG.2.
• any of the test surface(s) 51 of the displaceable member 50 accommodated inside the container can be subdivided into a multitude of different surface areas, for example holding a layer of agar, optionally provided with other agents, such an antibiotic.
• the different test surfaces, whether subdivided or not can have any suitable geometrical shape and is not critical to the invention. Different test surfaces, whether subdivided or not, can be provided with different functions, for example relating to different characteristics of the fluid desirous to be tested, or for different tests to be carried out, for example in respect of certain analytes of interest contained in the fluid to be tested. Such tests could be carried out simultaneously or as alternatives, as governed by the specific conditions used. Accordingly, the test surfaces can be provided with any suitable chemical re- actants and indicators, probes, oligonucleotides, growth media etc.
• test surfaces will be restricted by the shape of the accommodated member 50.
• Such member can for ex- ample exhibit a rectangular cross-section seen from the drawings, in which case the two large surfaces are especially suitable as test surfaces, or a triangular cross- section, in which case three surfaces suitable as test surfaces can be obtained, depending on the angels of the triangular cross-section.
• Any other suitable shape of member 50 can be used, such as a geometric shape having a circular or oval cross- section.
• One or more basins could also be formed in a test surface of member 50.
• Such basin could be used for accommodating a relatively thicker testing layer, for example an agar plate, such as a relatively thick cast agar plate, such as 2 - 5 mm deep.
• the tip 20 can be made from any suitable material, which does not unduly interfere with the function of the device. Accordingly, such material should preferably be inert to any reagents and fluids employed, and can be metal, glass or plastic.
• the choice of material can be decided on an economical basis, for example, if a reusable tip is desired, a more persistent material could suitably be used, which will resist repeated cleaning operations by any suitable means, such as radiation or by means of chemical agents, autoclaves etc.
• a material offering a cost efficient a production and a simple production process should be used.
• a plastic material is usually preferred.
• the tip can be provided with a filter contained inside the tip (not shown).
• a filter contained inside the tip (not shown).
• Such filter can be any filter conventionally known in the art, and can, if desired, also contain a reagent desirable to be added to the liquid fluid sample.
• the filter matrix contained in the lumen of the tip can be provided for filtering off any par- ticulates, which if entering into the container of the device would interfere with the testing in some manner.
• Such filter matrix could also be provided in order to allow for simple addition of a desired substance, which previously has been incorporated into the filter, as the sample fluid flow through said matrix into the container, or for a combination of such functions.
• Suitable substances to be incorporated into the filter could be any substances desirous to be added to the sample fluid, such as reagents, or activating agents for the testing surface(s), indicators, such specific labelling agents for specific analytes contained in the sampled fluid, complexing agents, sequestering agents, colouring agents, and the like.
• the displaceable member 50 can if desired exhibit an elevated rim or portions thereof along the edges of surface 51, or elevated ridges subdividing said surface, which portions are elevated from the plane of the test surface(s) of member 50, in order to separate the test surface from contacting the interior of the container (not shown) and/or reducing the amount of friction encountered during displacement of the member.
• the device While described with reference to testing of liquid fluids for the presence of microorganisms, it should be realised that the device also could be used for any other testing involving substances, which is desired to be confined into a container, for example due to beta radiation or other toxic qualities, rendering said substances hazardous to contact with human skin, for example.

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• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Clinical Laboratory Science (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Analytical Chemistry (AREA)
• General Health & Medical Sciences (AREA)
• Hematology (AREA)
• Apparatus Associated With Microorganisms And Enzymes (AREA)
• Sampling And Sample Adjustment (AREA)
• Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
• Investigating Or Analysing Biological Materials (AREA)

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• 2002
  • 2002-09-27 DE DE60211743T patent/DE60211743T8/de active Active
  • 2002-09-27 EP EP02773105A patent/EP1456344B1/fr not_active Expired - Lifetime
  • 2002-09-27 ES ES02773105T patent/ES2265054T3/es not_active Expired - Lifetime
  • 2002-09-27 WO PCT/SE2002/001764 patent/WO2003027222A1/fr active IP Right Grant
  • 2002-09-27 AT AT02773105T patent/ATE327317T1/de active

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