AU2014200325B2 - Device for collecting and releasing saliva - Google Patents

Abstract

Abstract 5 The invention concerns a device for collecting and releasing a sample fluid, in particular saliva. With the device, it is possible to remove and make available a first partial quantity (A-sample) and a second partial quantity (B-sample) following one-time 10 removal of a fluid sample from a person. To this end, there is provided a sample collector (13) with a first sampling tip (1) made from a dimensionally stable and porous material, and an at least second sampling tip (2) made from a dimensionally stable and 15 porous material. (Figure la) to) cr)) Ti en

Description

1 Device for collecting and releasing saliva 1. Field of the Invention 5 The invention concerns a device for collecting and releasing a sample fluid, in particular saliva. 2. Background of and Prior Art to the Invention Saliva, as a carrier of information, has become of 10 increased importance, for example in medical examinations as well as in the detection of substances administered or taken, in particular of medications and drugs. In order to examine saliva it is necessary to collect it and make it available as a sample. 15 US Patent document 6,416,715 B discloses a device for collecting and discharging saliva for diagnostic purposes. The device comprises a porous component which can collect the saliva sample and discharge it by 20 squeezing. The component is housed in slideable fashion within a container. The container is closed at one of its ends and can be opened at its other end by lifting a lid with integrated filter. In a preferred form, the container comprises a bellows structure. Saliva is 25 sampled first into the bellows via the opening upon lid removal, and is then collected in the porous component. After closing the lid and squeezing the bellows, the porous component is compressed and the previously absorbed saliva is expelled in filtered manner through 30 the filter of the closed lid. The piston is then inserted into a syringe, which contains diluting fluid and additives such as, for example, reagents.

2 US Patent document 2008/005676 Al discloses a biomolecular collection system. The biomolecular collection system comorises multiple segments and contains a large number of collecting pads which are 5 arranged side by side on a tubular element, skewer-like. US Patent document 2009/0181451 Al describes a specimen sample collection device and test system, comprising a handle and an indicator to display the degree of 10 completion of the specimen sample. US Patent document 5,393,496 B describes a specimen sampling and collection system for saliva, comprising a collection container, a saliva collector and a sample 15 container. In use, the sample container is inserted into the collection container and these become coupled together in a manner allowing fluid exchange between them by inserting and pressing the saliva collector into the sample container. This then enables collection of a 20 saliva sample, separating the sample from the collector and retaining the sample within the collection container. DE Patent document 691 012 610 T2 describes a device for collecting analytes from the oral cavity of a subject. 25 Equipment is described which simplifies the collection and analysis of an oral sample. In contrast to the container described in US Patent document 4,774,962 B, a modified centrifuge tube with a tapered end is used. 30 US Patent document 6,133,036 B describes a method for storing and protecting a liquid biological sample. The liquid biological sample is stored in a container that is filled with sodium benzoate and citric acid.

3 DE Patent document 103 28 984 B4 discloses a further device for collecting and dispensing a saliva sample for diagnostic purposes, in which a collecting tube is 5 inserted into a collecting element. US Patent document 5,260,031 B discloses a collection device for saliva. 10 US Patent document 2003/064526 A also discloses a collection device and a test facility for analysing saliva. A further device of this kind is described in patent document WO 2005/050165 A. 15 A collecting device in the form of a test cassette is known from EP patent document 1813 949 Bl. The collecting device is inserted into an analyser where the saliva sample is analysed. 20 An analyser for the chromatographic detection of a substance is known from US Patent document 2009/0253213 Al. A method for operating an analyser is disclosed in US 25 Patent document 8,262,999 B2. To provide admissible evidence in court of substances in a saliva sample taken from a subject, for example when testing for drugs during road-side random testing by 30 police, it is necessary that a first analysis result based on the first analysis of a first sample, the so called A-sample, is re-checked and confirmed. To this end, the saliva of the subject (person) who provided the 4 initial sample is analysed again, using a second sample, the so-called B-sample, and the results compared with those of the first sample, ie the first analysis. The saliva sample is used as a sampling fluid for analytical 5 examinations to determine which substances are present in the sample fluid and, if necessary, in which concentration certain substances are present in the sample fluid. In practice, a mobile analyser is used in road-side drug / alcohol testing of a subject's first 10 saliva sample (A-sample). US Patent document 2009/0253213 Al describes an analyser which is suitable for such mobile application, relying on chromatographic detection of substances in saliva, in 15 particular of drugs such as, for example, tetrahydrocannabinol (THC) . If a positive test result is obtained for a certain substance, e.g. a specific drug, a further examination and test (B-sample) for this drug is carried out at a hospital, for example. A saliva or urine 20 sample may be used for the B-sample testing. One disadvantage with this process is the time delay between taking of the A- and B-samples. Such delay may cause changes in the substance present in the saliva of 25 the sample provider, such as changes in concentration of a detected drug in the samples. Hence the results of the A-sample and the B-sample may not correspond, with the consequence that the samples do not provide admissible evidence in court of the substance initially detected. 30 It is therefore advantageous to obtain both the A-sample and an additional sample from the sampled subject at the same time; the additional sample can then later be 5 analysed as the B-sample. Because the additional sample is removed from the person at the same time as the A sample, changes in the substance in the sample provider's saliva that would occur naturally over time by 5 metabolising in the subject's body, such as changes in concentration of a detected drug, will be largely avoided. In light of the above background, it would be 10 advantageous to provide a device for collecting and releasing a sample fluid, in particular saliva, with which it is possible to obtain and provide in simple manner through removal of a single, identical sample both a first defined fluid (e.g. saliva) sample (A-sample) and 15 at least one further defined fluid sample (B-sample). It would be equally advantageous to provide a suitable arrangement, which can be handled in simple manner, in a device for collecting and discharging a sample fluid, for 20 use in a centrifuge. As used in this specification, the term 'defined saliva sample' is used to denote a filtered saliva sample of a predetermined quantity or a partial quantity of saliva. 25 The term 'identical sample provision' is intended to convey the taking of a fluid (in particular saliva) sample from a subject which will then provide one or more samples from the same sample provider taken at the same time for analysis purposes. 30 Furthermore, the term 'comprising' and 'comprises' are to be understood in its inclusive meaning so as to denote 6 the presence of a feature, and not in its exclusive meaning of 'consisting (exclusively) of'. 3. Summary of the Invention 5 In accordance with an aspect of the present invention, there is provided a device for collecting and discharging a sample fluid, such as saliva, comprising a sample collector with a holder, with a porous and dimensionally stable first sampling tip arranged at least partially in the holder, and 10 at least a second porous and dimensionally stable sampling tip for collecting the sample fluid, wherein the at least second sampling tip has an internal shape and inner surfaces shaped in such a way so as to match at least partially the outer geometric shape of the first sampling tip and receive 15 the first sampling at least partially within it, whereby lateral inner surfaces of the at least second sampling tip are at least partially in surface contact with lateral outer surfaces of the first sampling tip to provide an at least partially form-fit connection between the at least second 20 sampling tip and the first sampling tip. There is described herein, a device for collecting and releasing a sample fluid, in particular saliva, comprising a sample collector with a holder, with a porous and 25 dimensionally stable first sampling tip arranged partially inside the holder with part of the first sampling tip being arranged outside of the holder, and at least a second porous and dimensionally stable sampling tip for collecting the sample fluid, wherein the at least second sampling tip has 30 an internal shape and inner surfaces shaped in such a way so as to at least partially match the outer geometric shape of the holder and at least partially receive the holder within the at least second sampling tip, whereby lateral inner 7 surfaces of the second sampling tip are at least partially in surface contact with lateral outer surfaces of the holder to provide an at least partial form-fit between the at least second sampling tip and the holder. 5 There is also described herein an arrangement for inserting a device for collecting and discharging a sample fluid into a centrifuge, comprising a first sampling tip, a second sampling tip, a cylindrical cup with a lower opening, a 10 closing element or a cover film suitable for sealing, and an outer tube, wherein these components form part of an analysis set for mobile fluid sampling, wherein which the cylindrical cup provides a means for hygienically reliably separating the second sampling tip from the first sampling 15 tip, wherein the outer tube is designed to hold the cylindrical cup and/or wherein the arrangement is designed for insertion as a single unit into a centrifuge. There is further described herein an arrangement for 20 inserting a device for collecting and discharging a sample fluid into a centrifuge, comprising a first sampling tip, a second sampling tip, a closing element or a cover film suitable for sealing, and a tube, wherein the first sampling tip, the second sampling tip, the closing element or the 25 cover film suitable for sealing and the tube form the arrangement as an analysis set for mobile application, wherein the tube is designed such that the second sampling tip is retained in the tube in such manner that 8 the second sampling tip is retained at a distance above a lower section of the tube, wherein the tube is arranged to provide a means for a hygienically reliably separating the second sampling tip from the first sampling tip, 5 and/or wherein the arrangement is designed for insertion as a single unit into a centrifuge. The device for collecting and discharging a sample fluid is particularly suitable for collecting and delivering 10 (ie releasing, discharging) a first and a second fluid sample taken in one and the same collection operation. Possible sample fluids other than saliva are human or animal body fluids such as blood, blood plasma, lacrimal fluid, seminal fluid, cerebrospinal fluid, lymphatic 15 fluid, urine, bile, gastric juice or sweat. The device according to the invention comprises a sample collector with a holder, with a first sampling tip and with at least a second sampling tip. Within the context 20 of the present invention, the at least second sampling tip means that besides the first sampling tip there must at least be one further sampling tip present in the device for collecting and discharging of a sample fluid according to the invention, for example a second sampling 25 tip or further sampling tips, so that the device according to the invention has in total at least two or more sampling tips. By way of the first sampling tip and the at least second sampling tip it is possible, with an identical saliva sample, to obtain not only a first 30 defined saliva sample (A-sample) of a first filtered, partial quantity, but also an at least second defined saliva sample (B-sample, C-sample) from an at least 9 second filtered partial quantity, based upon the identical sample provision. Advantageously, the first sampling tip and the at least 5 second sampling tip together form a mouthpiece. The first sampling tip is made from a hydrophilic, porous and dimensionally stable, preferably largely incompressible first material, which is suitable for collecting the sample fluid. The at least second sampling tip is 10 attached on top of or to the first sampling tip. The at least second sampling tip is made from a hydrophilic, porous and dimensionally stable, preferably largely incompressible second material, which is suitable for collecting the sample fluid. 15 Prior to collecting a saliva sample, the first sampling tip and the at least second sampling tip are connected to each other in that the second sampling tip is attached to the first sampling tip. In practical application the 20 attachment may be made, for example, by pushing on or screwing the second sampling tip to the first sampling tip. The first sampling tip and the at least second sampling tip, which together are forming a single mouthpiece, are then inserted into the oral cavity of a 25 sample provider (ie subject). The attachment of the at least second sampling tip onto the first sampling tip preferably takes place when the device is assembled as a sample collector, so that a 30 usable analysis set for collecting the A-sample and the B-sample is available when required.

10 The first sampling tip is retained in the holder. The first sampling tip is arranged in such a way in the holder that at least part of the first sampling tip is located inside the holder and a further part of the first 5 sampling tip protrudes from the holder. The holder is designed as an upper component of the sample collector. In a first embodiment, the first sampling tip has essentially the geometric form of a cylinder and is 10 retained in the holder in such a way that the first upper surface of the first sampling tip protrudes fully as the upper part of the cylinder from the holder, and is essentially arranged flush with the upper edge of the holder. An essentially flush arrangement in the sense of 15 this invention means that, within the scope of the usual manufacturing tolerances, the first sampling tip protrudes with the first upper surface at the top by between 0.05 mm and 0.5 mm over the upper edge of the holder, so that when the at least second sampling tip is 20 attached to the first sampling tip, an essentially horizontal surface contact between the first upper surface of the first sampling tip and the at least second sampling tip is established. The essentially horizontal surface contact enables a fluid contact of the at least 25 second sampling tip with the first sampling tip. Fluid contact in the sense of the present invention means that a fluid exchange or fluid transport is provided and is possible for the sample fluid between the at least 30 second sampling tip and the first sampling tip. To ensure a satisfactory fluid transport, the first sampling tip with the first upper surface must finish 11 flush at the top with the holder, or protrude only slightly from the holder. According to the invention, the at least second sampling 5 tip has an the internal void, with inner surfaces, designed to cooperate with the holder or the first sampling tip. For example, the at least second sampling tip is preferably sleeve-shaped in such a way to match, at least in part, the external geometric shape of the 10 holder so that the latter can be received within the at least second sampling tip. Here the lateral inner surfaces of the at least second sampling tip are at least partially in surface contact 15 with the lateral outer surfaces of the holder, so that the surface contact establishes an at least partial form fit connection between the at least second sampling tip and the holder. 20 In the first embodiment according to the invention, the at least second sampling tip is designed such that, as a result of the surface contact between the inner contour of the at least second sampling tip and the outer contour of the holder, an at least partial form-fitting 25 connection between the holder and the at least second sampling tip is provided when attaching the at least second sampling tip to the holder. In the first embodiment according to the invention, the 30 holder is designed such that, as a result of the surface contact between the outer contour of the holder and the inner contour of the at least second sampling tip, an at least partially form-fitting connection between the 12 holder and the at least second sampling tip is provided when attaching the at least second sampling tip to the holder. 5 Preferably, the connection between the at least second sampling tip and the holder results additionally in an at least partial positive mechanical connection between the at least second sampling tip and the holder, where the at least partial positive mechanical connection between the 10 at least second sampling tip and the holder in a further preferred design is an at least partial friction-locked connection. In a second embodiment according to the invention, the 15 first sampling tip takes the geometrical shape of a cylinder and is arranged in the holder in such a way that the first sampling tip is located at least partially inside the holder, so that the first sampling tip protrudes from the holder's top with the first upper 20 surface and with at least one lateral surface at least with some parts of the circumferential surface of the cylinder. The description "protruding from the top of the at least 25 one lateral surface of the first sampling tip" means, in the sense of the present invention, that the first sampling tip protrudes with the first upper surface at the top 0.5 mm to 20 mm over the upper edge of the holder. As a result, when attaching the at least second 30 sampling tip to the first sampling tip, a vertical surface contact between the at least one lateral surface of the first sampling tip and the at least second sampling tip is provided. The essentially vertical 13 surface contact provides fluid contact between the at least second sampling tip and the first sampling tip. In the second embodiment according to the invention, the 5 at least second sampling tip has an inner void with an inner surface(s), and is preferably shaped sleeve-like in such a way that it can receive within it, at least partially, the first sampling tip, and in particular the outer shape of the first sampling tip and the inner shape 10 of the at least second sampling tip are at least partially matched to provide a form-fit engagement between the components. The respective tips are advantageously shaped such that lateral inner surfaces of the at least second sampling tip are in at least partial 15 surface contact with lateral outer surfaces of the first sampling tip, resulting in an at least partial form fitting connection via the surface contact between the at least second sampling tip and the first sampling tip. 20 In the second embodiment according to the invention, the at least second sampling tip is designed such that, through the surface contact between the inner contour of the at least second sampling tip and the outer contour of the first sampling tip, an at least partial form-fitting 25 connection is established between the first and the at least second sampling tip when attaching the at least second sampling tip to the first sampling tip. In the second embodiment according to the invention, the 30 first sampling tip is designed such that, through the surface contact between the outer contour of the first sampling tip and the inner contour of the at least second sampling tip, an at least partial form-fitting connection 14 is established between the first and the at least second sampling tip when attaching the at least second sampling tip to the first sampling tip. 5 Preferably, the connection between the at least second sampling tip and the first sampling tip results additionally in an at least partial positive mechanical connection between the at least second sampling tip and the first sampling tip, where the at least partial 10 positive mechanical connection between the at least second sampling tip and the first sampling tip in a further preferred design is an at least partial friction locked connection. 15 In a further preferred embodiment, the shape of the at least second sampling tip is designed such that, when attaching the at least second sampling tip to the first sampling tip and to the holder, the first sampling tip protrudes from the top with the first upper surface and 20 the at least one lateral surface, providing not only a vertical surface contact between the at least one lateral surface of the first sampling tip and the at least second sampling tip, but also a horizontal surface contact between the first upper surface of the first sampling tip 25 and the at least second sampling tip. The vertical and horizontal surface contact provides a fluid contact between the at least second sampling tip and the first sampling tip. 30 In a further preferred embodiment the first sampling tip is retained loosely in the holder.

15 In a further preferred embodiment the first sampling tip is retained in a moveable way in the holder by design, so that when the at least second sampling tip is attached to the first sampling tip, the first sampling tip can be 5 pushed at least partially into the holder. Thus the first sampling tip can be at least partially pushed into the holder so that the first upper surface of the first sampling tip is essentially flush with the upper edge of the holder, or protrudes only slightly from the upper 10 edge of the holder, for example by 0.1 mm to 5.0 mm. In a further preferred embodiment, the at least second sampling tip is designed in a pair formation, consisting of a second sampling tip and a third sampling tip, in 15 which the third sampling tip is formed such that it can be pushed into or onto the second sampling tip. For the purpose of obtaining identical saliva samples, with the third sampling tip it is possible to obtain a third defined saliva sample (C-sample) with a third filtered 20 partial quantity, besides the first defined saliva sample (A-sample) with the first filtered partial quantity and the second defined saliva sample (B-sample) with the second filtered partial quantity, based upon an identical sample. 25 In a first special variation of this further preferred embodiment, the connection between the second and third sampling tip is implemented as an at least partial form fitting connection. 30 In a second special variation of this further preferred embodiment, the connection between the second and third sampling tip is implemented as an at least partial 16 positive mechanical connection of the second sampling tip and the third sampling tip, in which the at least partially positive mechanical connection between the second sampling tip and the third sampling tip is, in a 5 further preferred design, an at least partial friction locked connection. As particularly preferred designs of geometrical forms of connection between the first sampling tip and the at 10 least second sampling tip are available conical, triangular or V-shaped, cylindrical barrel-shaped or conical barrel-shaped connections, as well as partially conical, partially triangular or V-shaped, partially cylindrical barrel-shaped or partially conical barrel 15 shaped connections, as well as combinations of conical, triangular or V-shaped, cylindrical barrel-shaped, conical barrel-shaped connections and/or partially conical, partially triangular or V-shaped, partially cylindrical barrel-shaped or partially conical barrel 20 shaped connections. As particularly preferred designs of geometrical forms of connection between the third sampling tip and the second sampling tip are available conical, triangular or V 25 shaped, cylindrical barrel-shaped or conical barrel shaped connections, as well as partially conical, partially triangular or V-shaped, partially cylindrical barrel-shaped or partially conical barrel-shaped connections, as well as combinations of conical, 30 triangular or V-shaped, cylindrical barrel-shaped, conical barrel-shaped connections and/or partially conical, partially triangular or V-shaped, partially 17 cylindrical barrel-shaped or partially conical barrel shaped connections. The porosity of the at least second sampling tip and the 5 porosity of the first sampling tip cause the absorption of the sample fluid, preferably absorption of saliva, due to capillary forces. The porosity of the at least second sampling tip and the 10 porosity of the first sampling tip, as well as the porosity of the second sampling tip and the porosity of the third sampling tip causes, in conjunction with the surface contact between the first sampling tip and the at least second sampling tip, and with the surface contact 15 between the third sampling tip and the second sampling tip, the transport of sample fluid from the third sampling tip to and into the second sampling tip, and a transport of sample fluid (fluid transport) from the at least second sampling tip to and into the first sampling 20 tip due to capillary forces. The first sampling tip has the purpose of collecting a first partial quantity of the sample fluid. The purpose of the at least second sampling tip is the 25 absorption of an at least second partial quantity of sample fluid, and the conveyance of the first partial quantity of sample fluid through the at least second sampling tip into the first sampling tip. The dimensional stability of the first sampling tip and of the at least 30 second sampling tip makes it possible to absorb a precisely predetermined quantity of sample fluid as first partial quantity into the first sampling tip, and as at 18 least a second partial quantity into the at least second sampling tip. A mean distribution of pore size of the first sampling 5 tip compared to a mean distribution of pore size of the at least second sampling tip is preferably chosen in such a way that the at least second sampling tip has on average larger pores than the first sampling tip. This establishes a porosity gradient from the at least second 10 sampling tip to the first sampling tip, which has the effect that the capillary action causes a fluid transport of the sample fluid from the at least second sampling tip to the first sampling tip. At the same time the surface contact causes the wetting of the touching surfaces of 15 the first and at least second sampling tip, creating an effective capillary action in conjunction with the porosity and the porosity gradient. As soon as sample fluid is applied to the at least second sampling tip, the sample fluid (saliva) travels through the at least second 20 sampling tip to the first sampling tip. When saliva samples are acquired, the fluid transport causes the saliva to travel reliably through the second sampling tip into the first sampling tip. 25 In a further preferred embodiment, the mean distribution of pore size of the second sampling tip compared to a mean distribution of pore size of the third sampling tip is chosen in such a way that the second sampling tip has on average smaller pores than the third sampling tip. 30 This establishes in this preferred way a porosity gradient from the third sampling tip to the second sampling tip, which has the effect that the capillary action causes a fluid transport of the sample fluid from 19 the third sampling tip to the second sampling tip. When saliva samples are acquired, the fluid transport causes the saliva to travel through the third sampling tip into the second sampling tip and through the second sampling 5 tip into the first sampling tip. The first sampling tip, the holder and the at least second sampling tip are components of a single mouthpiece that are produced from materials that are medically safe 10 concerning contact with mucous membranes. A combination of different types of those materials may also be used. The materials of the first and of the at least second sampling tip are distinguished in their dimensional stability, which remains intact after collecting fluid, 15 in particular while taking a sample in the oral cavity of a sample provider. Suitable preferred materials are, for example, cellulose materials such as, for example, pressed cellulose, 20 cotton, cellulose derivatives, press-formed cotton fleeces or various compounds thereof. Further suitable materials for the first and at least second sampling tip are also various plastics such as, for example, thermoplastic polymers (PE), which can be manufactured 25 and shaped in porous form as sampling tips and can be, during or after manufacture, subjected to an activation or coating process with hydrophilic characteristics, for example through a sintering process. Various plastics (polypropylene, polyethylene and polyurethane) are 30 suitable as materials for the holder, which are medically safe concerning contact with mucous membranes. A special embodiment provides for the use of varying degrees of porosity within the at least second or second sampling 20 tip, within the third sampling tip, or within the first sampling tip, preferably with a porosity gradient from outside to inside, with the pore size reducing from outside to inside of the sampling tips. 5 A coarser porosity on the outside of the sampling tips will cause a stronger capillary action in a particular way, and a finer porosity inside causes a stronger filter action in a particular way in the sampling tips. In a 10 particular variant of this special embodiment, the porosity gradient is essentially continuous, with reducing pore size from outside to inside, that is, an essentially continuously reducing pore size from the at least second to the first sampling tip. In a further 15 particular variant the porosity gradient has an essentially decreasing pore size from outside to inside, that is, with an essentially continually reducing pore size from the third to the second and to the first sampling tip. 20 In a preferred embodiment, a section of the holder is provided with a first indicator zone. The first indicator zone comprises a first moisture indicator, which indicates a successful and sufficiently large absorption 25 of sample fluid. The first moisture indicator is advantageously designed such that it indicates the presence of moisture with a colour change. The part of the holder that surrounds the first sampling tip is in this section made partially or fully transparent so that 30 it is possible to check the successful and sufficiently large sample provision through an externally visible colour change. It can thus be verified that the saliva sample in the mouth of the sample provider is indirectly 21 absorbed via the at least second sampling tip into the first sampling tip, that a sufficient quantity has been provided and is present to carry out the detection analysis for the A-sample. Since the user can recognise 5 from the outside, with the help of the indicator zone, that a sufficient quantity of saliva has been absorbed in the first sampling tip, this provides at the same time an indirect verification that a sufficient quantity of saliva has also been absorbed in the at least second 10 sampling tip and is available for detection analysis of the B-sample since the saliva from the oral cavity of the sample provider travels through the at least second sampling tip into the first sampling tip. 15 In a further preferred embodiment, the at least second sampling tip is provided with a second indicator zone. The second indicator zone comprises a second moisture indicator, which indicates the successful absorption of a sufficient quantity of sample fluid in the second 20 sampling tip. The second moisture indicator is preferably designed such that it reacts to the presence of moisture with a colour change. This provides the option to verify, independently from the indirect verification via the first indicator zone, that the at least second sampling 25 tip has absorbed a sufficient quantity of saliva from the mouth of the sample provider and that it is available for detection analysis of the B-sample. In a further preferred embodiment according to the 30 invention, the first and second sampling tips are components of an arrangement for inserting into a device for collecting and discharging a sample fluid in a centrifuge. This arrangement is preferably a component of 22 an analysis set for mobile application, for example within the scope of road traffic checks. In one design variation such an arrangement consists of a 5 first and second sampling tip, a cylindrical cup, a closing element that is designed to close the cylindrical cup on one side, and an external tube that is designed to hold the cylindrical cup. The cylindrical cup is designed to hold the second sampling tip, and the cylindrical cup 10 has an opening at the bottom. This arrangement is on the one hand designed so that it can be inserted into a centrifuge as a unit; on the other hand the cylindrical cup preferably also serves as a handling element, providing a hygienically reliable way for separating the 15 second sampling tip from the first sampling tip. A hygienic separation is required so as not to contaminate the B-sample and thus perhaps falsify the result of the B-sample analysis, and also to avoid direct contact with the B-sample by people that carry out the sample-taking 20 on the sample providers. With the centrifuge it is possible to extract a quantity of sample fluid (saliva) from the second sampling tip through the cylindrical cup and through the bottom opening into a lower section of the outer tube. 25 An alternative design of such an arrangement for inserting a device for the absorption and discharge of a sample fluid in a centrifuge consists of a tube that is designed to hold the second sampling tip, and a closing 30 element that is designed to close the tube on one side. No cylindrical cup is required in this alternative design of the arrangement. The second sampling tip is inserted 23 directly into the tube, and the tube is closed with the closing element. Due to the shape of the tube, the second sampling tip is 5 retained in the tube such that the second sampling tip is located at a distance above a lower section of the tube. Said alternative design of the arrangement is also designed so that for centrifuging it can be inserted as a unit into a centrifuge. The tube serves in addition also 10 as a handling element for a hygienically reliable mode of separating the second sampling tip from the first sampling tip. Using the centrifuge it is also possible with the alternative design of the arrangement to extract a quantity of sample fluid (saliva) from the second 15 sampling tip into the lower section of the tube. In a variant of this alternative design of the arrangement the shape of the tube is such that it has in its centre section at least one constriction so that the 20 second sampling tip cannot be inserted into the lower section of the tube. In a further variant of this alternative design of the arrangement the shape of the tube is such that it has in 25 its centre section at least one step that protrudes into the inside of the tube so that the second sampling tip cannot be inserted into the lower section of the tube. In a further preferred way the shape of the tube is such 30 that its contour from the centre section to the lower section of the tube is conically reduced.

24 After separating the tube, or separating the outer tube from the arrangement, a quantity of saliva is available in the lower section of the tube or in the outer tube as B-sample for analysis of the detected substances after 5 centrifuging to obtain evidence admissible in court that uses a sample identical to the A-sample as basis. As alternative to the closing element it is also possible to close off the cylindrical cup, the tube or the outer 10 tube with a cover film instead, which is preferably made from an elastic material. The cover film as well as the closing element serves as a sealing cover so that the B sample can be transported safely. 15 The invention is now described in more detail by way of non-limiting examples schematically depicted in the accompanying drawings. 4. Brief Description of Drawings 20 Figure la is a schematic lateral view of a sample collector with a first and a second sampling tip in accordance with a first embodiment of the invention; 25 Figures lb, 1c, 1d, le are schematic lateral views showing different types (variants) of connections between the second sampling tip 30 and the first sampling tip and the sample collector; 25 Figure 2 is a schematic lateral view of a sample collector with a first and a second sampling tip and a third sampling tip in accordance with a further embodiment of 5 the invention; Figure 3 is a schematic view of an arrangement for handling and storing of the second sampling tip according to Figures la, lb, 10 1c, ld, le, 2; and Figure 4a, 4b is a schematic view of an alternative arrangement for handling and storing the second sampling tip according to Figures 15 la, 1b, 1c, ld, le, 2. 5. Detailed description of preferred embodiments of the invention 20 Figure la depicts one embodiment of a sample collector 13 in lateral view. The sample collector 13 is preferably made rotationally symmetric and consists of a holder 30 in the form of a cylindrical pipe 10 with an internal diameter 49 as holder 30 for a first sampling tip 1, and 25 of a channel element 15, which contains a combination of fleece elements 16, as well as a handle part 17 for holding the sample collector. When inserting the sample collector into an analysis unit (not shown in Figure la) through lowering the first sampling tip 1, the fleece 30 elements 16 are brought into fluid contact with the first sampling tip 1 and conduct the sample fluid inside channel element 15 to and into the not-depicted analysis unit. The channel element 15 and the fleece elements 16 26 are only partially shown in this figure; the parts used for conveying into the not-depicted analysis unit are not shown. The first sampling tip 1 takes the form of a cylinder with the outer diameter 39 and an upper side 18, 5 which fits tightly into the inner diameter 49 of cylinder pipe 10. The first sampling tip 1 is made from a porous and dimensionally stable, preferably largely incompressible material, which is suitable for collecting a sample fluid. The cylinder pipe 10 is made from an 10 injection-mouldable thermoplastic material, for example polypropylene (PP) or polyethylene (PE), or a machinable thermosetting plastic, or a metal, preferably a non corrosive metal. A second sampling tip 2 is provided, which is in part formed as a cylindrical, tubular sleeve 15 22 and is designed to be attached to the first sampling tip 1. The walls of the partially cylindrical, tubular sleeve 22 are made of porous and dimensionally stable, preferably largely incompressible material, for example a solid material. The sample collector 13 is provided to be 20 inserted into the mouth of a sample provider, who is not shown. The second sampling tip 2 in Figure la is preferably made in form of a cylindrical pipe section 23. The section of 25 the second sampling tip 2, which is formed as a cylindrical pipe section 23, is in the drawing shown separated from the cylindrical tubular sleeve 22 by a broken line 21. The partially cylindrical pipe section 23 is made from a porous, dimensionally stable and 30 preferably largely incompressible, solid material. The partially cylindrical pipe section 23 and the partially cylindrical tubular sleeve 22 are preferably made as a 27 single component, for example as a moulded, cast or injection-moulded component. In a further preferred design the partially cylindrical 5 pipe section 23 and the partially cylindrical tubular sleeve 22 are preferably made as two components, each made individually as a moulded, cast or injection-moulded component, and joined, for example, through an interference fit or with an adhesive to a single 10 component. The second sampling tip 2 has internally a cylindrical shape with cylindrical inner surfaces that are designed to at least partially adapt to the cylindrical external form of the first sampling tip 1. Lateral inner surfaces 24 of the second sampling tip 2 15 are at least partially in a first surface contact 44 with the lateral outer surface 14. The first surface contact 44 causes a tight-fitting connection between the second sampling tip 2 and the first sampling tip 1. The second sampling tip 2 has internally a cylindrical shape with 20 cylindrical inner surfaces that are designed to at least partially adapt to the cylindrical external form of holder 30, made in form of a cylinder pipe 10. The lateral inner surfaces 24 of the second sampling tip 2 are at least partially in a first surface contact 45 with 25 the lateral outer surface 34 of holder 30. The second surface contact 45 causes a tight-fitting connection between the second sampling tip 2 and the holder 30, made in form of a cylinder pipe 10. 30 The geometries of the second sampling tip 2 and the holder 30, made in form of a cylinder pipe 10, are preferably adapted to each other in terms of dimensions 28 and tolerances so that an outer diameter 19 of cylinder pipe 10 corresponds exactly to an internal diameter 29 of the second sampling tip 2, or that the outer diameter 19 of cylinder pipe 10 is slightly larger, for example, by 5 within 0.03 to 0.2 mm than the internal diameter 29 of the second sampling tip 2, thus providing a positive mechanical connection between the second sampling tip 2 and the holder 30, made in form of a cylinder pipe 10. In a further preferred way, the geometries of the second 10 sampling tip 2 and the first sampling tip 1 are adapted to each other in terms of dimensions and tolerances so that the outer diameter 39 of the first sampling tip 1 corresponds exactly to the internal diameter 29 of the second sampling tip, or that the outer diameter 39 of the 15 first sampling tip 1 is slightly larger, for example, by within 0.03 to 0.2 mm than the internal diameter 29 of the first sampling tip 2 [sic], thus providing a positive mechanical connection between the second sampling tip 2 and the first sampling tip 1. 20 The inner surface 26 on the underside of the cylindrical pipe section 23 of the second sampling tip 2 is at least partially in a third surface contact 46 with the upper side 18 of the first sampling tip 1. A fluid contact is 25 established between the second sampling tip 2 and the first sampling tip 1 via the third surface contact 46 and/or the second surface contact 45, so that when a sample is received, the sample fluid (saliva) is conveyed via fluid transport caused by capillary forces acting in 30 the porous materials of the sampling tips 1, 2 from and through the second sampling tip 2 into the first sampling tip 1. The cylinder pipe 10 is preferably made transparent, at least partially, creating an essentially 29 annular window 140 for an indicator zone 12 arranged on the first sampling tip 1 in cylinder pipe 10 of the holder 30. If, for example, a moisture-sensitive colour change indicator is provided on the first sampling tip 1, 5 the colour change is visible from outside through window 140 on cylinder pipe 10. This can be used as a sign that a sufficient quantity of sample fluid has been absorbed into the first sampling tip 1. 10 Figures lb to le show, with sometimes direct reference to Figure la, different variations of connections between the second sampling tip 2 and the first sampling tip 1 and the sample collector by way of cylinder pipe 10, configured as the holder 30 of first sampling tip 1. Same 15 elements in the Figures la and lb to le are marked with the same reference numbers in Figures lb to le as in Figure la. Figure lb depicts a first variation of a connection 20 between the second sampling tip 2 and the first sampling tip 1 and the cylinder pipe 10, in which the entire second sampling tip 2 is formed as a tubular sleeve 22 with a single internal diameter, providing an interference fit of the second sampling tip 2 not only 25 with the first sampling tip 1 but also with the cylinder pipe 10. The first sampling tip 1 consists of parts 111 and 112, in which parts 111, 112 have different outside diameters from each other. Part 111 of the first sampling tip 1, which is located outside cylinder pipe 10, and the 30 cylinder pipe 10 have essentially the same outside diameter. Part 112 of the first sampling tip 1, which is located inside cylinder pipe 10 has, compared to part 111 of the first sampling tip 1, which is located outside 30 cylinder pipe 10, an outside diameter that is smaller by the wall thickness of cylinder pipe 10. Figure 1c depicts a second variation of a connection 5 between the second sampling tip 2 and the first sampling tip 1 and the cylinder pipe 10, in which the entire second sampling tip 2 is formed as a tubular sleeve 22 with an upper internal diameter, providing an interference fit of the second sampling tip 2 with the 10 first sampling tip 1, and with a lower internal diameter, providing an interference fit of the second sampling tip 2 with cylinder pipe 10. In this second variation sampling tip 1 and the cylinder pipe 10 have different outside diameters from each other, in which the outside 15 diameter of cylinder pipe 10 is greater than the outside diameter of the first sampling tip 1, creating a step between the first sampling tip 1 and cylinder pipe 10. Figure 1d depicts a third variation of a connection 20 between the second sampling tip 2 and the first sampling tip 1 and the cylinder pipe 10, according to Figures la, lb, 1c, in which the second sampling tip 2 is formed as a combination between cylindrical tubular sleeve 22 and a cylindrical pipe section 23 according to Figure la. This 25 combination between cylindrical tubular sleeve 22 and a cylindrical pipe section 23 may be made by joining two individual moulded components, but it is also possible to implement this combination between cylindrical tubular sleeve 22 and a cylindrical pipe section 23 as a single 30 moulded component. Figure le depicts a fourth variation of a connection between the second sampling tip 2 and the first sampling 31 tip 1 and the holder 30 taking the form of cylinder pipe 10, according to Figure la. The second sampling tip 2 is implemented as a combination between cylindrical tubular sleeve 22 and a cylindrical pipe section 23. The first 5 sampling tip 1 ends flush with the upper end 18 of holder 30, taking the form of cylinder pipe 10. The inner surface 26 of cylindrical pipe section 23 of the second sampling tip 2 is at least partially in a third surface contact 46 with the upper end 18 of the first sampling 10 tip 1. The section of the second sampling tip 2, which takes the form of cylindrical pipe section 23, is in this Figure le shown separated with a broken line 21 from the cylindrical tubular sleeve 22. In Figure le the broken line 21 also marks approximately the location of the 15 third surface contact 46. The third surface contact 46 provides a fluid contact between the second sampling tip 2 and the first sampling tip 1. Figure 2 depicts a further preferred embodiment of a 20 sample collector with holder 10, a first sampling tip 1, a second sampling tip 2 and a third sampling tip 3, shown in lateral view. The first sampling tip 1 takes the form of a cylinder that fits tightly into cylinder pipe 10. The second sampling tip 2 takes the form of a second 25 cylindrical tubular sleeve 22, which is attached to the first sampling tip 1. The attachment of the second sampling tip 2 onto the first sampling tip 1 and/or onto cylinder pipe 10 advantageously takes place according to one of the design variations in Figures la, lb, 1c, 1d or 30 le, with an essentially similar design of the surface contacts 44, 45 via the lateral surfaces 24, 14 of the first and second sampling tip 1, 2 and via the lateral surfaces 24, 34 of the second sampling tip 2 and cylinder 32 pipe 10, as well as an essentially similar design of the surface contact 46 of the upper surface 18 of the first sampling tip 1 with the lower surface 26 of the second sampling tip 2. The third sampling tip 3 is in fluid 5 contact with the second sampling tip 2 via a fourth surface contact 48, which is formed by a lower surface 27 of the third sampling tip 3 with an upper surface 28, so that the sample fluid travels via the third sampling tip 3, into and through the second sampling tip 2 into the 10 first sampling tip 1. The third sampling tip 3 is preferably formed as a spherical or hemispherical mouthpiece 31, which is attached to the second sampling tip 2. The spherical or hemispherical mouthpiece 31 is designed to be inserted into the mouth of a not-depicted 15 sample provider. Figure 3 depicts a first arrangement 300 designed for handling, storage and transport of the second sampling tip 2 according to Figures la, lb, 1c, 1d, 2. This first 20 arrangement 300 comprises a cylindrical cup 301, a closing element 302 that is designed to close the cylindrical cup 301 on one side, and an outer tube 303, which is designed to hold cylindrical cup 301. The cylindrical cup 301 is designed to hold the second 25 sampling tip 2. The cylindrical cup 301 has an opening 305 on its underside. The first arrangement 300 is on the one hand preferably designed for centrifuging so that it can be 30 inserted as a unit into a centrifuge. On the other hand the cylindrical cup 301 also serves as a handling device so that the second sampling tip 2 can be removed in a hygienically reliable way from the first sampling tip 1.

33 The centrifuge makes it possible to extract from the second sampling tip 2 a quantity of sample fluid (saliva) via the cylindrical cup 301, through opening 305 into the outer tube 303 and into the lower section 310. After 5 separating the outer tube 303 from the first arrangement 300, and after centrifuging, this quantity of saliva in the outer tube 303 is therefore available as B-sample. Together with the first sampling tip 1 and the second sampling tip 2, the first arrangement 300 forms an 10 analysis set for mobile applications, for example for road traffic checks. Instead of using the closing element 302, the cylindrical cup 301 may alternatively be closed by using a sealing film as closing element, which is preferably made in elastic form. 15 The Figures 4a and 4b depict an alternative arrangement for handling and storing the second sampling tip 2. Figure 4a is a second arrangement 400 for handling, 20 storage and transport of the second sampling tip 2 according to the Figures la, lb, 1c, 1d, 2. This second arrangement 400 consists of a tube 403, and a closing element 302, which is designed to close the tube 403 on one side. The second arrangement 400 is preferably 25 designed to be inserted as a unit into a centrifuge. The tube 403 is designed to hold the second sampling tip 2. In addition, the tube 403 serves as a handling element to provide a hygienically reliable way of separating the second sampling tip 2 from the first sampling tip 1. This 30 Figure 4a also depicts a central section 409 of tube 403 indicated by separating lines 404, 406. The second sampling tip 2 is retained in central section 409 of tube 403 by a conically-shaped constriction 407. If tube 403 34 is inserted into a centrifuge, a quantity of sample fluid (saliva) is extracted from the second sampling tip 2 into a lower section 410 of tube 403. 5 Figure 4b is a third arrangement 500 for handling, storage and transport of the second sampling tip 2 according to the Figures la, lb, 1c, 1d, 2. This third arrangement 500 consists of a tube 503, and a closing element 302, which is designed to close the tube 503 on 10 one side. The tube 503 is designed to hold the second sampling tip 2. This Figure 4b also depicts a central section 509 of tube 503 by way of separating lines 504, 506. The second sampling tip 2 is retained in central section 509 of tube 503 by a protrusion 508. If tube 503 15 is inserted into a centrifuge, a quantity of sample fluid (saliva) is extracted from the second sampling tip 2 into a lower section 510 of tube 503. The tubes 403, 503 according to Figure 4a and 4b can be 20 closed for transporting through closing element 302.

35 REFERENCE NUMBER LIST 1 First sampling tip 2 Second sampling tip 5 3 Third sampling tip 10 Cylinder pipe, holder 12 Indicator zone 13 Sample collector 14 Lateral outer surfaces of first sampling tip 1 10 15 Channel element 16 Fleece elements 17 Handle part 18 Upper end of first sampling tip 1 19 Outer diameter of cylinder pipe 10 15 21 Separating line between cylindrical tubular sleeve 22 and cylindrical pipe section 23 22 Cylindrical tubular sleeve 23 Cylindrical pipe section 24 Lateral inner surfaces of second sampling tip 2 20 26 Lower inner surfaces of second sampling tip 2 27 Lower inner surfaces of third sampling tip 3 28 Upper inner surfaces of second sampling tip 2 29 Internal diameter of second sampling tip 2 30 Holder 25 31 Mouthpiece 34 Lateral outer surfaces of cylinder pipe 44 First surface contact 45 Second surface contact 46 Third surface contact 30 48 Fourth surface contact 49 Internal diameter of cylinder pipe 10 111, 112 Parts of the first sampling tip 1 140 Window 36 300 First arrangement 301 Cup 302 Closing element 303 Outer tube 5 304 Sealing element 305 Opening 306 Handling aid 310 Lower section of tube 303 400 Second arrangement 10 403 Tube 404, 406 Separating lines 407 Conically-shaped constriction of tube 403 409 Central section of tube 403 410 Lower section of tube 403 15 500 Second arrangement 503 Tube 504, 506 Separating lines 508 Protrusion 509 Central section of tube 503 20 510 Lower section of tube 503

Claims (6)

1. Device for collecting and discharging a sample fluid, comprising a sample collector with a 5 holder, with a porous and dimensionally stable first sampling tip arranged at least partially in the holder, and at least a second porous and dimensionally stable sampling tip for collecting the sample fluid, wherein the at least second 10 sampling tip has an internal shape and inner surfaces shaped in such a way so as to match at least partially the outer geometric shape of the first sampling tip and receive the first sampling at least partially within it, whereby lateral 15 inner surfaces of the at least second sampling tip are at least partially in surface contact with lateral outer surfaces of the first sampling tip to provide an at least partially form-fit connection between the at least second sampling 20 tip and the first sampling tip.

2. Device according to claim 1, in which the lateral inner surfaces of the at least second sampling tip are at least partially in surface contact with the 25 lateral outer surfaces of the first sampling tip in such manner as to provide an at least partial positive mechanical connection, via the surface contact, between the at least second sampling tip and the first sampling tip. 30

3. Device according to claim 2, in which the positive mechanical connection between the at least second 38 sampling tip and the first sampling tip is an at least partial friction-locked connection.

4. Device according to any one of the preceding 5 claims, wherein the at least second sampling tip has a mean distribution of pore size which is on average greater compared to a mean distribution of pore size of the first sampling tip. 10

5. Device according to any one of the preceding claims, in which the first sampling tip is provided with a first indicator zone which by way of a first moisture indicator is arranged for indicating collection of sample fluid into the 15 first sampling tip and collection of sample fluid into the at least second sampling tip.

6. Device according to any one of the preceding claims, in which the at least second sampling tip 20 is provided with a second indicator zone which by way of a second moisture indicator is arranged for indicating collection of sample fluid into the at least second sampling tip. 25 DRAEGER SAFETY AG & CO KGAA WATERMARK PATENT AND TRADE MARKS ATTORNEYS P38433AU00 30