GB2611509A

GB2611509A - Sample collection devices

Info

Publication number: GB2611509A
Application number: GB2111128.1A
Authority: GB
Inventors: Mide Christian; Gidö Schön Jimmy
Original assignee: Conceptomed AS
Current assignee: Conceptomed AS
Priority date: 2021-08-02
Filing date: 2021-08-02
Publication date: 2023-04-12
Also published as: GB202204390D0; GB2610254A; GB202111128D0

Abstract

A sample collection device (2) comprising a sample collection chamber (4) comprising a chamber outlet (28). The device further comprises a sample collection conduit (18) extending through an opening (19) of the sample collection chamber to an outside of the sample collection chamber, wherein the sample collection conduit comprises a conduit inlet (20) for receiving a fluid sample and a conduit outlet (22) for allowing the fluid sample to pass into the sample collection chamber; and a plunger (24) configured to expel the fluid out of the sample collection chamber through the chamber outlet. An embodiment is also provided in which the sample collection chamber comprises a first sub-chamber (32) defined between the plunger and the chamber outlet, wherein the conduit outlet is arranged in the first sub-chamber and wherein the sample collection chamber comprises a first fluid passageway (40) arranged to allow fluid to pass out of the first sub-chamber.

Description

Sample Collection Devices The present invention relates to sample collection devices for use in collecting fluid samples, for example oral fluid samples.

Oral fluid samples, for example fluid samples comprising human saliva or sputum, can be analysed to determine the makeup of the sample. In recent developments, human saliva may be used to determine whether a provider of the sample is infected with a virus, for example severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which may indicate that the provider of the sample has coronavirus disease (COVID-19). The testing of oral fluid samples to determine whether a provider of the sample has SARS-CoV-2 may provide an improved means for testing for the virus when compared to other prior art techniques. The same may be true for other viruses or bacteria, e.g. influenza, respiratory syncytial virus, hepatitis virus or tuberculosis. Prior art techniques for testing include the use of swabs, which are relatively invasive and can in some instances be uncomfortable for the provider of the sample.

The analysis of an oral fluid sample typically requires a relatively precise amount of sample for reliable analysis. In order to acquire a precise volume of sample, prior art techniques typically involve the use of a saliva sample kit. Such a kit often includes a number of parts, for example seven different separate components, for use in collecting and measuring a sample. Such kits normally require a user to spit or drool into a funnel which is attached to a measurement vial. The measured saliva is then poured into a secondary vial, and a lid is sealed onto both the measurement vial and the secondary vial. Use of these prior art kits presents a significant risk of contamination of a sample, particularly as the sample is transferred from one container to the other. Further, in the act spitting or drooling into the measurement vial, and subsequent transferring of the sample to the secondary vial, there is a significant risk of inadvertently leaking the sample onto vial threads and other surfaces, such as a work surface, or a user's hands. As the sample may be infected, this therefore increases the risk of infecting others which is clearly not ideal. Additionally, it has been found that spitting into a measurement vial may produce aerosols which pose a risk of airborne contamination of other individuals in the vicinity of the person delivering the sample. Furthermore, the amount of oral fluid has been shown to vary substantially when collected by the individual on its own, affecting reproducibility and confidence in the results of such analyses. -2 -

Accordingly, while efforts have been made to collect and measure an oral fluid sample for analysis, the prior art devices and techniques clearly have significant limitations and pose potential risks.

The present invention aims to address, or at least mitigate, one or more of the problems outlined above and when viewed from a first aspect provides a sample collection device, for collecting a fluid sample, comprising: a sample collection chamber for collecting a sample therein, wherein the chamber comprises a chamber outlet through which a fluid sample can pass; a sample collection conduit extending through an opening of sample collection chamber to an outside of the sample collection chamber, wherein the sample collection conduit comprises a conduit inlet for receiving a fluid sample and a conduit outlet for allowing the fluid sample to pass into the sample collection chamber; and a plunger configured to expel the fluid out of the sample collection chamber through the chamber outlet.

Accordingly, as will be appreciated by those skilled in the art, through the use of the sample collection conduit, a user may collect their own fluid sample without requiring assistance from others, e.g. healthcare personnel. The fluid sample collection device may be suitable for collecting any fluid sample, however the sample collection device may be used for collecting an oral fluid sample, e.g. comprising saliva or sputum. Given that the sample may, in some instances, be infected with bacteria or a virus, by collecting the sample themselves, the chance of healthcare personnel coming into contact with the potentially infected sample is minimized. By reducing the number of interactions of healthcare personnel with potentially infected persons, this may also reduce the consumption of personal protective equipment (PPE), such as gloves, masks, aprons, etc, which healthcare personnel often have to change frequently, when collecting samples. Further, the lack of need for assistance during sampling and further processing may also substantially reduce costs and resources, e.g. of healthcare personnel, associated with collecting and analysing samples. The opening of the sample collection chamber may be at, or considered to be, a first end of the sample collection chamber and the chamber outlet may be at, or considered to be, a second end of the sample collection chamber.

In extending through an opening of the sample collection chamber, a first portion of the sample collection conduit may extend from within the sample collection chamber such that the conduit inlet is outside of the sample collection chamber.

Further, through the use of a sample collection conduit which conveys the sample directly into the sample collection chamber, the sample may be kept isolated from the environment thereby minimizing the chance of the sample becoming contaminated. This may help to ensure that any analysis performed on the sample accurately reflects the sample of the -3 -provider, without contamination from others. Additionally, by collecting the sample using the sample collection conduit, the provider of the sample is less likely to get the sample over their hands, which reduces the likelihood of the provider going on to inadvertently deposit their sample on other surfaces. Furthermore, collection of the fluid sample using the sample collection conduit may reduce the risk of the formation of aerosols in the supplying of the fluid sample, e.g. via spitting. This may therefore reduce the risk of airborne contamination of others in the vicinity, or indeed work surfaces in the vicinity.

Use of the device may involve a user placing their mouth around the conduit inlet. The user may then transfer a sample, e.g. comprising saliva, through the sample collection conduit into the sample collection chamber. Transferring of the sample may be achieved by the user applying a spitting action into the sample collection conduit. This may have to be repeated a plurality of times, often up to and above 10 times, to achieve the sufficient volume. Once the sample collection chamber contains a sufficient volume of the sample, the sample may be controllably expelled from the sample collection chamber using the plunger. This may be performed immediately after providing the sample, or the sample may be temporarily stored within the sample collection chamber before it is expelled. The sample may be expelled into or onto in any suitable means, e.g. a means for testing. As will be appreciated, fluid such as the sample, or air subsequently blown by the user to flush the sample collection conduit of any remaining sample therein, may pass through the sample collection conduit into the sample collection chamber.

The plunger and the sample collection conduit may be provided by separate parts which may be free to move within the sample collection chamber independently. In a set of embodiments, the sample collection conduit is moveable relative to the sample collection chamber and wherein the sample collection conduit and plunger are operatively linked such that movement of the sample collection conduit causes movement of the plunger within the sample collection chamber. Operatively linking, i.e. coupling, the movement of sample collection conduit and the plunger in this manner may advantageously mean that the sample collection conduit can be used to drive movement of the plunger within the sample collection chamber. This may provide a convenient means for operation of the device. The operative link may be achieved in any suitable manner. For example, the sample collection conduit may act upon the plunger, in order to drive its movement. In a set of embodiments, however, the sample collection conduit and the plunger are integrally formed. For example, the plunger may be formed in, or on, a wall of the sample collection conduit. This wall could be a base wall or a side wall of the sample collection conduit. For example, the plunger may surround the sample collection conduit, which may be cylindrical. The plunger may be arranged part way along the length of the sample collection conduit such that the sample collection conduit extends above -4 -and below the plunger. The sample collection conduit and the plunger may be integrally formed as a single component by any suitable means, for example by integrally forming the parts together in a single mould. In such an embodiment, the movement of the plunger will be inherently coupled to the movement of the sample collection conduit. By integrally forming the sample collection conduit and plunger as a single part, the number of separately operable components on the device may be reduced, and thus the use of the device may be simplified for a user. Further, the manufacture may be simplified, and the cost of manufacture may also be reduced.

In embodiments wherein the movement of the sample collection conduit and plunger is operatively linked, i.e. coupled, the sample collection conduit may be configured to be pushed into the device by a user. This may, for example, comprise the user pushing the sample collection conduit into the sample collection device using their hand, e.g. a thumb, or by pushing the sample collection conduit against another surface. This may therefore advance the sample collection conduit and the plunger into the sample collection chamber. Alternatively, the sample collection conduit may be configured to be rotated in order to advance the sample collection conduit and plunger into the device. For example, the sample collection conduit, or a part thereof such as the plunger, may comprise a threaded portion configured to engage with a corresponding threaded portion on the sample collection chamber. Accordingly, in such embodiments, rotation of the sample collection conduit relative to the sample collection chamber results in the sample collection conduit and plunger advancing into the sample collection chamber. Such an embodiment may allow for more control over the advancement of the plunger and thus more control over the expelling of the sample from the sample collection chamber.

As discussed above, the sample collection conduit and plunger may be operative linked such that their movement is coupled. In a further set of embodiments, the sample collection conduit is movable from an initial position, whereby the sample collection conduit extends out of the sample collection chamber to receive a fluid sample, to a final position whereby the sample collection conduit is fully advanced into the sample collection chamber. As will be appreciated, during at least part of the movement from the initial position to the final position, the movement of the sample collection conduit will cause the plunger to expel the fluid sample from the sample collection chamber via the chamber outlet. In the final position, the sample collection conduit may be fully contained within the sample collection chamber such that it no longer extends to an outside of the sample collection device. As a result, once in the final position, the user may no longer be able to use the sample collection conduit as a means for providing a fluid sample. Of course in some embodiments, the sample collection conduit may still protrude out of the sample collection chamber when in the final position. -5 -

The sample collection chamber may have any suitable form that is capable of housing the fluid sample. The sample collection chamber may, for example, be substantially cylindrical in shape and be defined by an outer cylindrical wall. In a set of embodiments, the sample collection chamber comprises a first sub-chamber defined between the plunger and the chamber outlet, and wherein the conduit outlet is arranged in the first sub-chamber. In such a set of embodiments, when a fluid sample is provided via the sample collection conduit, the fluid sample will pass into and fill the first sub-chamber. The fluid sample may thus be at least partially contained within the first sub-chamber. In a further set of embodiments the sample collection chamber comprises a first fluid passageway arranged to allow fluid to pass out of the first sub-chamber. The first fluid passageway may thus advantageously allow fluid to pass out of the first sub-chamber. The first fluid passageway may allow fluid to pass into another portion of the sample collection chamber, e.g. a second sub-chamber as will be described in more detail below. The first fluid passageway may be arranged such that it is open so as to permit the passage of fluid therethrough when the sample collection conduit is in the initial position, and thus when the plunger is a corresponding initial position. The plunger and first fluid passageway may be configured such that when the plunger is in the initial position, the first fluid passageway is open. The presence of such a fluid passageway may advantageously allow excess fluid to pass out of the first sub-chamber as the first sub-chamber is filled with a fluid sample. In the exemplary case of a fluid sample in the form of saliva, the Applicant has recognised that the first fluid passageway may advantageously allow any foam within the saliva sample to pass out of the first sub-chamber via the first fluid passageway. The first fluid passageway may therefore facilitate the separation of fluids within the fluid sample, e.g. the separation of the foam and the liquid part of a saliva sample. In the case of saliva, this may result in the fluid sample within the first sub-chamber being mostly liquid.

In another set of embodiments, the sample collection device comprises a further plunger arranged within the sample collection chamber, and wherein a second sub-chamber is defined between the plunger and further plunger. In such embodiments, the first fluid passageway may fluidly connect the first sub-chamber and second sub-chamber, for example at least when the sample collection conduit is in the initial position. Any excess fluid within the first sub-chamber may therefore flow out via the first fluid passageway into the second sub-chamber. The second chamber which is delimited by the further plunger may advantageously help to prevent any fluid sample from spilling out of the sample collection chamber. Similarly to the plunger described above, the sample collection conduit and further plunger may be operatively linked such that movement of the sample collection conduit causes movement of the further plunger within the sample collection chamber. The further plunger may be provided in any suitable manner, as -6 -described above with respect to the plunger. For example, the further plunger may be integrally provided with the sample collection conduit.

In a further set of embodiments, the further plunger is configured to move together with the plunger, and wherein the sample collection chamber comprises a second fluid passageway arranged to allow fluid to pass out of the second sub-chamber. The second fluid passageway may be open, i.e. to allow the passage of fluid therethrough, when the sample collection conduit, and thereby the further plunger, is in the initial position. The second fluid passageway may advantageously permit the escape of fluid from the second sub-chamber to another portion of the sample collection device, e.g. a third sub-chamber defined between the second plunger and a cap (where provided), as discussed in further detail below. The device may comprise another plunger, i.e. a third plunger, arranged within the sample collection chamber such that the third sub-chamber is defined between the further plunger and the third plunger. The presence of another plunger closing the third sub-chamber may further reduce the risk of the fluid sample escaping the device. Of course any number of plungers and sub-chambers may be provided. Allowing fluid to escape the second sub-chamber may further facilitate the escape of fluid from the first sub-chamber which may allow any excess fluid or foam to escape the first sub-chamber more easily.

The sample collection conduit may be moved out of the initial position by advancing the sample collection conduit into the sample collection chamber. In a set of embodiments, the plunger is movable to a first intermediate position in which the first fluid passageway is closed.

In embodiments whereby the plunger is operatively linked to the sample collection conduit, this may be achieved by moving the sample collection conduit into the initial position. The plunger may act to close the first fluid passageway in any suitable manner. For example, the plunger may act on a part, e.g. a valve, which acts to close the first fluid passageway. Alternatively, the first fluid passageway may be in the form of a recess in a side wall of the sample collection chamber which allows the fluid sample to bypass the plunger when the plunger is adjacent the first fluid passageway. As will be appreciated by those skilled in the art, in such examples, when the plunger is no longer adjacent the first fluid passageway, the fluid will no longer be able to bypass the plunger and the first fluid passageway will effectively be closed. Closing of the first fluid passageway when in the first intermediate position may seal the first sub-chamber and thereby securely contain any fluid sample therein.

In a further set of embodiments, the further plunger may be moved into a corresponding first intermediate position whereby the second fluid passageway is also closed. This may be achieved by moving the sample collection conduit into the corresponding first intermediate position. In this further set of embodiments, closing of the second fluid passageway may thereby seal the second sub-chamber, and thus securely contain any fluid sample within the -7 -second sub-chamber. The further plunger may close the second fluid passageway in the same manner as described above with respect to the plunger. Closing the first and second sub-chambers may advantageously act to seal the fluid sample within the sample collection device. As a result, the fluid sample may be stored within the sample collection device and transported within the sample collection device without risk of the sample leaking. Use of the sample collection conduit, together with the plunger and further plunger as a means for securely closing the first and second fluid passageways may provide a convenient means for sealing the first and second sub-chambers.

The first sub-chamber may be dimensioned such that the volume of the first sub-chamber corresponds to a volume of fluid sample required for performing further analysis. As such, when the first sub-chamber has been filled, the entire volume of the first sub-chamber may then be dispensed out of the chamber outlet. This may effectively leave the device, i.e. the first sub-chamber, empty of the fluid sample. The position of first fluid passageway within the sample collection chamber may define the volume of fluid which is dispensed by the plunger.

However, the Applicant has recognised that particularly with fluid samples such as saliva, even when fluid is able to escape the first sub-chamber via the first fluid passageway, some foam and air bubbles may nonetheless remain in the first sub-chamber. Such foam and air bubbles reduce the amount of liquid sample which is within the first sub-chamber.

For some types of sample fluid and particular types of analysis, a specific volume of liquid sample is required in order to perform meaningful analysis. Accordingly, in a further set of embodiments, the sample collection chamber comprises a third fluid passageway arranged such that when the plunger is moved into a second intermediate position, between the first intermediate position and the final position, the third fluid passageway is open, thereby allowing fluid to pass from the first chamber into the secondary chamber, and wherein the third fluid passageway is closed when the plunger is moved into a third intermediate position between the second intermediate position and the final position. The plunger may be moved between these positions by moving the sample collection conduit into and between corresponding second and third intermediate positions. Accordingly, as will be appreciated by those skilled in the art, the third fluid passageway therefore may act to define a final volume of fluid within the first sub-chamber such that a fixed volume of fluid can be dispensed from the device. As the plunger is advanced between the second intermediate position and the third intermediate position, the third fluid passageway is open and fluid is able to escape the first sub-chamber. As the plunger may advance with the sample collection conduit, fluid within the first sub-chamber will be forced out of the first sub-chamber via the sample third fluid passageway. This may advantageously force any remaining foam and air bubbles, or at least a portion thereof, out of the first sub- -8 -chamber. As a result, the liquid content of the fluid sample within the sample collection chamber may be increased.

In a further set of embodiments, the sample collection device comprises a fourth fluid passageway arranged to allow fluid to pass out of the second sub-chamber when the sample collection conduit is in the third intermediate position. The fourth fluid passageway may facilitate the flow of fluid out of the second sub-chamber, thereby allowing fluid to flow into the second sub-chamber from the first sub-chamber more easily. In a set of embodiments, the third and fourth fluid passageways are arranged such that they are closed simultaneously, when the sample collection conduit reaches the third intermediate position. This may advantageously mitigate the risk of leakage from sample collection device.

The first, second, third and/or fourth fluid passageways may have any suitable form which allows fluid to pass between the sub-chambers, and which can be appropriately closed, e.g. by the plunger or further plunger. In a set of embodiments, the first, second, third and/or fourth fluid passageway each comprise at least one recess in an internal wall of the sample collection chamber. The recess may be integrally formed as part of a moulding process used to manufacture the device. The use of a recess in an internal wall within the sample collection chamber may provide a simple and easy to manufacture fluid passageway within the device. In such embodiments, the first, second, third or fourth fluid passageway will be open, i.e. to allow the passage of fluid, when the respective plunger is adjacent the recess, and closed when the plunger is not adjacent the recess.

The sample collection device may allow a user to measure the volume of sample provided. As discussed above, this may be important, as certain types of analysis require a specific volume of sample in order for the analysis to function properly and produce accurate results. Measurement of the sample may be achieved in any suitable manner. For example, the sample collection chamber, e.g. the first sub-chamber, may be dimensioned such that when it is full it contains the correct amount of sample required for optimal analysis. The sample collection chamber may thus be a sample measurement chamber. Accordingly, in this case, the user may simply provide their sample until the sample collection chamber is full, and then stop. The sample collection chamber, and indeed other parts of the device, may be made from a transparent material such that the user can see the sample within the device. In the exemplary case of testing for SARS-CoV-2, the first sub-chamber may have a volume of 1 ml. In embodiments comprising a third fluid passageway, the third fluid passageway may define a volume within the first sub-chamber of 1 ml. Of course the volume of the sample collection chamber, or the first sub-chamber may be dependent on the type of sample the device is intended for use with. The sample collection chamber may, for example, have a volume of between 1-20 ml, e.g. between 2-15 ml, e.g. between 3-8 ml, e.g. 7 ml. The volume of the sub- -9 -chambers within the sample collection chamber may depend on the volume of the sample collection chamber. In a set of examples, the first sub-chamber may have a volume of between 0.5 ml and 1.5 ml.

In another set of embodiments, the sample collection chamber comprises at least one volumetric marking. The at least one volumetric marking may allow a user to more accurately measure their sample as it fills the sample collection chamber. It may also mean that the device can be used to collect different volumes, depending on the purpose of the sample being provided. The at least one volumetric marking may comprise a plurality of volumetric markings. For example, the markings may include a minimum volume, a target volume, and a maximum volume markings. Such markings may allow a user to aim to provide the target volume of sample. In the exemplary case of testing for SARS-CoV-2, a minimum volume marking may correspond to 0.5 ml, a target volume marking may correspond to 1 ml and a maximum volume marking may correspond to 1.5 ml.

In a set of embodiments, the device comprises a volume control arrangement which determines how far the plunger can be advanced into the sample collection chamber. This may directly control how much fluid sample can be dispensed from the sample collection chamber. The volume control arrangement may be adjustable, so that the volume dispensed from the sample collection chamber can be adjusted. The volume control arrangement may, for example, comprise an adjustable element, e.g. a nut, which engages with a portion of the sample collection conduit. The adjustable element and/or the sample collection chamber may be shaped such that the adjustable element comes into contact with the sample collection chamber, or a part within the sample collection chamber, as the sample collection conduit is advanced into the sample collection chamber. The contact may prevent further movement of the sample collection conduit and the plunger, at least in embodiments whereby the plunger is operatively coupled to the sample collection conduit. The adjustable element may be set in position during the manufacture and/or assembly of the device. The use of such a volume control arrangement may advantageously mean that the sample collection device can be used to provide a plurality of different volumes of fluid sample, thereby potentially reducing the number of different devices which need to be manufactured.

In embodiments wherein the inlet cap may be used to advance the plunger, as described in more detail further below, the volume control arrangement may be provided at least partially on the inlet cap. For example, the inlet cap may comprise recesses, which engage with a corresponding protrusion, e.g. locking member, on the sample collection chamber. The recesses may be located at positions on the cap which corresponding to predefined volumes being dispensed from the sample collection chamber, when the inlet cap is advanced to a position whereby the recesses are engaged by the corresponding protrusion.

-10 -Accordingly, the volume of fluid dispensed may be controlled by advancing the inlet cap until the desired recess is engaged. The recesses and protrusions may form part of the restriction arrangement which is discussed further below.

The fluid sample may be dispensed from the chamber outlet into a further component, e.g. a further chamber in the form of a vial. Depending on the volume of the component into which the fluid is dispensed, and depending on the volume of fluid sample which is dispensed, sometimes there may be significant increase in pressure within the component into which the fluid is dispensed. In a set of embodiments, the sample collection device comprises a relief valve arranged to open when the plunger and/or sample collection conduit approaches a final position in the sample collection chamber. In embodiments wherein the sample collection conduit and plunger are not coupled, the relief valve may be opened when the plunger approaches a final position within the sample collection chamber. Of course, the relief valve may be opened in the final stages of movement of the sample collection conduit and/or plunger into the final position. The relief valve may be opened when the plunger and/or sample collection conduit reaches the final position in the sample collection chamber. Alternatively, the relief valve may be opened as the plunger and/or sample collection conduit approaches the final position and subsequently closed as the plunger and/or sample collection conduit reaches the final position in the sample collection chamber. Such an arrangement may advantageously allow for the release of any pressure in the final stages of movement whilst also closing of the relief valve in the final position to prevent any further fluid from leaking out of the sample collection chamber. The presence of a relief valve may be advantageous when the fluid sample is expelled out of the chamber outlet into a small vial wherein the pressure, absent the relief valve, may increase significantly. The relief valve may lower the pressure within the vial, i.e. the further component, which may reduce the pressure difference between the vial and the ambient environment. This may minimise the risk of any of the sample fluid being forcibly ejected out of the vial during separation. The relief valve may be in the form of a recess provided in a wall of the sample collection chamber and be opened to provide pressure relief when the plunger when the plunger is adjacent the recess. As the relief valve is opened, at least a portion of the fluid sample around the fluid outlet may be forced back into the sample collection chamber. This may be particularly advantageous when the fluid sample is saliva, as the saliva may otherwise collect on the chamber outlet and hang therefrom potentially causing contamination of the user of the device.

The relief valve may provide a fluid passageway between the chamber outlet and the first sub-chamber, or the second sub-chamber when the first sub-chamber has been compressed through movement of the plunger. The sample collection device may comprise further relief valves arranged to open when the sample collection conduit and/or plunger reaches the final position. A further relief valve may, for example, be positioned to provide a fluid passageway between the second sub-chamber and the third sub-chamber. The provision of additional relief valves may increase the volume into which any pressure within the further component is able to release into. The further relief valve may similarly be in the form of a recess in a wall of the sample collection chamber which is opened as the further plunger becomes adjacent the recess.

The Applicant has recognised that when providing a fluid sample, it can sometimes be difficult to determine how much sample has been provided. This is particularly the case when providing a fluid sample such as saliva which often contains air bubbles which may obscure the amount of liquid sample provided. For example, the air bubbles may produce a foam which makes it difficult to determine the liquid content within the sample collection chamber. Accordingly, in a set of embodiments, the sample collection device further comprises a float member, arranged within the sample collection chamber, configured to float on a fluid sample within the sample collection chamber. When a portion of the fluid sample comprises a liquid, the float member may have a lower density than the liquid portion of the fluid sample, but a higher density than the gaseous portion of the fluid sample. As a result, the float member will float in the liquid part of the fluid sample but sink below the gaseous, e.g. foam, part of the fluid sample. The float member may therefore be used to identify the liquid level within the sample collection chamber. The density of the float member may depend on the intended use of the sample collection device. In the exemplary case whereby the sample collection device is used to collect a saliva sample, the float member may have a density which is lower than the density of the liquid portion of the saliva, but greater than the foam portion. As a result, the float member will float in the liquid saliva within the sample collection chamber, but sit below any foam within the chamber. Liquid saliva may have a density of between 1.002-1.012 g/ml and so the float member may have a density less than 1.002 g/ml. For example, the float member may be manufactured from low density polyethylene (LOPE) which typically has a density in the range of 0.910-0.940 g/ml.

Whilst the sample collection chamber may be made from a transparent material so that a user can see into the sample collection chamber, in some instances it may nonetheless be difficult to distinguish the float member from the fluid sample. Accordingly, in a further set of embodiments, the float member has a colour distinct to the fluid sample being collected. As a result, the float member may be more identifiable within the sample collection chamber. The colour may also make the float member easier to observe through the sample collection chamber. The float member may have any colour that is distinct from the fluid sample being collected. For example, in the exemplary case of the intended use of the device being for collection of a saliva sample, the float member may be red in colour. Having a float member -12 -with a distinct colour may make it easier for a user to see the float member through the sample collection chamber, thereby allowing the user to more easily determine the fluid level within the sample collection chamber. Once a user recognises sufficient sample has been provided by observing the float member within the sample collection chamber, they may then stop providing the fluid sample. Use of a float member may therefore help to prevent overfilling of the sample collection device.

The float member may be used to indicate that sufficient fluid sample has been provided in any suitable manner. In a set of embodiments, the float member is arranged to float to a position whereby it cannot be seen when a target volume of fluid sample has been provided.

Thus, a user may monitor the sample collection device, and once the float member can no longer be seen, the user may cease providing a fluid sample. In an alternative set of embodiments, the float member is arranged to float to a position whereby it can be seen when a target volume of fluid has been provided. The float member may not be visible until at least the target volume is provided. Thus, a user may monitor the sample collection device, and once the float member can be seen, the user may cease providing the fluid sample. In another set of embodiments, the sample collection chamber comprises at least one volumetric marking, and the float member is arranged to align with the volumetric markings as a fluid sample is provided into the sample collection chamber. The at least one visible marking may comprise a plurality of visible markings. This may allow the user to align the float member with different visible markings depending on the volume of fluid required.

In a set of embodiments, the float member is configured to allow fluid to pass therethrough. Allowing fluid to pass through the float member may allow the float member to float member more readily on top of the fluid sample. This may ensure that the float member accurately reflects the fluid level within the sample collection chamber as quickly as possible.

The float member may be at least partially porous such that the fluid sample is able to pass through the float member. The float member may comprise at least one opening therein to allow fluid to pass through. The float member may, for example, be in the form of a ring with a hole at the centre. Such a hole may advantageously receive the sample collection conduit in embodiments wherein the sample collection conduit is arranged to move relative to the sample collection chamber. The float member may have any suitable configuration which enables it to float on top of the fluid sample. In a set of embodiments, the float member comprises a plurality of float members. Each of the float members may independently float with the fluid level and allow fluid to pass the float members and thereby fill the sample collection chamber. The provision of a plurality of float members may advantageously ensure that the float members are free to float in the fluid sample irrespective of the way in which the fluid sample is provided. A -13 -plurality of float members may reduce the change of a single float member becoming stuck in position within the sample collection chamber.

The float member may comprise a reagent stored therein. The reagent may be in solid or liquid form. The reagent may be configured such that it dissolves out of the float member and into the fluid sample when the fluid sample is provided. The reagent may interact with the sample once the fluid sample has been provided. The reagent may be released from the float member as the float member becomes soaked in the sample fluid being provided. The reagent may advantageously mix with the fluid sample. The reagent may comprise any suitable reagent. For example, the reagent may comprise a stabilization buffer arranged to stablise the sample fluid within the sample collection chamber. The stabilization buffer may comprise a Universal Transport Medium (UTM) 0. The stabilization buffer may help to ensure that the sample fluid remains stable whilst it is contained within the sample collection chamber. The reagent may comprise an agent configured to enhance the pre-analysis properties of the fluid sample. In the exemplary case of a fluid sample in the form of saliva, the reagent may comprise a lysis buffer which may separate out RNA within the fluid sample. This may reduce the amount of further processing of the sample which is required for analysis.

As discussed previously, as the fluid sample could potentially be infected, e.g. with a virus or bacteria, it may be important to avoid overfilling of the sample collection chamber so as to avoid spilling of the fluid sample onto a user's hands or surrounding work surfaces.

Additionally, excess fluid within the sample collection device may prevent the proper functioning of the device. Accordingly, in a set of embodiments, at least a portion of the sample collection chamber is formed from an at least partially transparent material. The at least partially transparent material may allow a user to observe the fluid level within the sample collection chamber more easily, and the user may then stop supplying a fluid sample when sufficient sample is provided. The at least partially transparent material may be fully transparent. The portion of the sample collection chamber which is at least partially transparent may correspond to a portion of the sample collection chamber which is adjacent the float member thereby allowing the float member to be seen more easily.

In a set of embodiments, at least a portion of the sample collection chamber is defined by single skin, at least partially transparent, outer wall such that there is only one wall between the fluid sample collected within the sample collection chamber and an exterior of the sample collection device. A single-skin outer wall may allow the contents of the sample collection chamber to be seen more easily. This portion may correspond to a portion within the sample collection chamber where the float member is present. This may allow both the fluid level and the float member to be observed more easily. As a result, this may minimise the likelihood of a -14 -user overfilling the sample collection chamber, thereby minimising the risk of the fluid sample leaking out onto a user's hands or other surfaces.

In some instances, despite measures which aim to avoid the excess fluid sample being provided, it may be the case that too much fluid sample is provided via the sample collection conduit, and the fluid sample may overflow the sample collection chamber. For example, the fluid sample may overspill the first, second and third sub-chambers. Thus, in a set of embodiments, the device further comprises an overspill chamber, arranged to collect any fluid sample which overspills the sample collection chamber. The overspill chamber may extend around the sample collection chamber and be in the form of a well arranged to collect any overspill. As the fluid sample may be infected, collecting any overspill in the overspill chamber may help to avoid the spreading of any infection contained within the sample.

The opening through which the sample collection conduit extends may be partially or fully closed by the sample collection conduit itself. However, in some embodiments, the opening may be open to the external environment and may remain open during and after collection of a fluid sample. However, the Applicant has recognised that keeping the sample collection chamber open could risk the fluid sample becoming contaminated, or indeed increase the chance of the fluid sample leaking out of the sample collection chamber. Accordingly, in a set of embodiments, the sample collection device further comprises an inlet cap arranged to seal the sample collection chamber. For example, the inlet cap may close, i.e. seal, the opening of the sample collection chamber through which the sample collection conduit extends.

The cap may prevent any fluid sample from escaping the sample collection chamber. In a set of embodiments, the inlet cap is pre-attached to the device before the device is used to collect a fluid sample. In such a set of embodiments, the inlet cap may be arranged to cover the sample collection conduit. This may prevent any contamination of the sample collection conduit prior to use. The inlet cap may be removed in order to provide a fluid sample.

In a further set of embodiments, the inlet cap is secured to the sample collection device by an inlet tamper element and wherein the inlet cap is separable from the inlet tamper element. The inlet tamper element may be in the form of a ring which extends around the sample collection chamber, and the inlet cap may be connected to the inlet tamper element by at least one breakable tab. The inlet tamper element may be used to indicate whether the inlet cap has previously been separated from the device, therefore indicating whether the device has previously been used or tampered with. For example, if the inlet cap has been separated from the inlet tamper element, this may indicate that the device has already been used and/or tampered with.

In the exemplary case of an inlet tamper element in the form of a ring, when the connection between the inlet cap and the connection ring is broken, the ring may fall away from -15 -the sample collection device. In this case, the lack of connection ring present on the device may be an immediate indicator that the device has been used or tampered with. However, in a set of embodiments, the inlet tamper element is in the form of a ring which extends around the sample collection chamber and wherein the ring is configured to remain around the sample collection chamber when the cap is separated from the connection ring. For example, the device may comprise a ring retaining feature, e.g. in the form of a protruding lug, which retains the ring around the sample collection chamber. The ring may extend around the sample collection chamber. As a result, the connection ring may act to reinforce any outer walls of the sample collection device, e.g. the sample collection chamber. Reinforcing the walls may be particularly advantageous in some embodiments wherein forces acting on the walls during operation tend to push them outwards.

In another set of embodiments, the inlet cap is configured, in at least one position, to seal the inlet to the sample collection conduit. For example, the inlet cap may seal the inlet to the sample collection conduit when it is reattached to the sample collection chamber. Sealing the sample collection conduit may advantageously form a vacuum within the sample collection conduit and thereby prevent any fluid sample from falling from within the sample collection conduit during dispensing of the sample. This may help to ensure that a fixed volume is dispensed from the device.

In another set of embodiments, when attached to the device the inlet cap is movable relative to the sample collection chamber, and wherein the inlet cap is arranged to drive the plunger into the sample collection chamber. The inlet cap may drive the plunger in any suitable manner. In embodiments wherein the plunger is operably linked to the sample collection conduit, the inlet cap may drive the sample collection conduit so as to drive the plunger. Driving the plunger with the inlet cap may beneficially mean that a user does not have to contact the sample collection conduit in order to advance the sample collection conduit into the sample collection chamber. As the sample collection conduit may be contaminated by the fluid sample, this may avoid the user contaminating their hands, for example. The cap may be coupled to drive movement of the sample collection conduit to drive movement thereof in any suitable manner. For example, the inlet cap may press against the conduit inlet in order to force the sample collection conduit into the sample collection chamber.

As discussed previously, in some embodiments the sample collection device may comprise a further plunger, the further plunger may also be advanced into the sample collection chamber by the inlet cap. Accordingly, in a set of embodiments, the sample collection device comprises a further plunger, and wherein the inlet cap is arranged to drive the further plunger into the sample collection chamber, and wherein as the further plunger is advanced into the sample collection chamber, the further plunger presses a wall of the sample collection chamber -16 -and a wall of the inlet cap together, thereby sealing the opening of the sample collection chamber. The Applicant has found that this arrangement may advantageously improve the seal between the inlet cap and the sample collection chamber. This may be achieved by having a sample collection chamber having wall which has a reduced internal diameter compared to another portion of sample collection chamber. The reduced internal diameter may be achieved by appropriately shaping the sample collection chamber and/or by having sections with different wall thicknesses. The further plunger may press the wall of the sample collection chamber against an inner wall of the cap, or an outer wall of the cap may be pressed against an inner wall of the sample collection chamber. As discussed above, the connection ring may remain around the sample collection chamber, and may act to prevent deformation of the sample collection chamber. This may further improve the seal achieved between the cap and the sample collection chamber. The further plunger may be operatively linked to the sample collection conduit and thus the further plunger may be advanced into the sample collection chamber by driving the sample collection conduit into the sample collection chamber.

In a set of embodiments, the sample collection device comprises a restriction arrangement configured to prevent movement of the inlet cap relative to the sample collection chamber in at least one direction. The restriction arrangement may advantageously control movement of the inlet cap relative to the sample collection chamber and thereby control the way in which the inlet cap is able to advance the plunger. The restriction arrangement may act to restrict movement of the inlet cap at multiple positions of the inlet cap relative to the sample collection chamber. For example, the restriction arrangement may prevent movement of the inlet cap when the inlet cap is in a first intermediate position corresponding to the sample collection conduit being in a first intermediate position and/or when the inlet cap is in a final position corresponding to the sample collection conduit being in the final position. In a further set of embodiments, the restriction arrangement is configured to prevent the inlet cap from be moved away from the sample collection chamber. Accordingly, once the inlet cap has been attached, the restriction arrangement may prevent its removal and thereby prevent further access to the fluid sample contained within the sample collection chamber. This may help to avoid tampering or contamination of the fluid sample once it has been provided.

The restriction arrangement may, for example, comprise a protrusion extending from the sample collection chamber arranged to engage with a recess provided on the inlet cap. When the protrusion is engaged within the recess on the inlet cap, movement of the inlet cap in at least one direction may be prevented. In a further set of embodiments, the restriction arrangement is configured to hold the inlet cap in at least two positions relative to the sample collection chamber. For example, the sample collection chamber may comprise a protrusion extending radially therefrom, and the inlet cap may comprise at least two recesses, axially -17 -disposed along the length of the inlet cap. As will be appreciated, the protrusion may engage with any of the recesses and thereby act to hold the inlet cap in the position corresponding to the position of the recess. The protrusion may be in the form of a circumferential protrusion, or a plurality of protrusions around the circumference of the sample collection chamber. The recess may be in the form of a circumferential recess, or a plurality of recesses around the internal circumference of the inlet cap. Of course, the protrusion may instead be provided on the inlet cap and the at least one recess may be provided on the sample collection chamber. The position of the protrusion and or recess may depend on how the inlet cap seals the sample collection chamber, i.e. whether the inlet cap extends around an outside wall of the sample collection chamber, or whether it seals against an inside wall of the sample collection chamber.

In another set of embodiments, the restriction arrangement is arranged to prevent the inlet cap from being advanced to drive movement of the plunger. Preventing the inlet cap from being advanced to move the plunger may advantageously prevent a user from inadvertently dispensing the fluid sample from the device before it is desired. The restriction arrangement may be configured to prevent advancement of the inlet cap in any suitable manner. In some embodiments, prevention of advancement of the inlet cap may be achieved by the same means that prevent retraction of the inlet cap as described above. In another set of embodiments, the restriction arrangement comprises a stop member arranged to engage with the inlet cap and prevent movement thereof, in at least one direction, and a release member coupled to the stop member and arranged to release engagement of the stop member and the inlet cap.

The release member may be in the form a lever member which protrudes outwards from the device. The release member may thus be accessible to a user and may, for example, be operated by a user's finger. Whilst the stop member may prevent movement of the inlet cap, in at least one direction, the stop member may be configured such that if a sufficient force is applied to the inlet cap, the stop member may be overcome and forced out of engagement with the inlet cap such that the inlet cap can be moved relative to the sample collection chamber. This may be particularly advantageous, for example where the inlet cap is operated on by a machine, e.g. a robotic arm, which is capable of applying relatively high forces and overcoming the stop member. The stop member may stop, i.e. hold, the inlet cap in a position which corresponds to the sample collection conduit being in the first intermediate position. The stop member may engage with, e.g. abut against, an end surface of the inlet cap such that the inlet cap cannot be advanced further.

The Applicant has recognised that it may also be beneficial in some instances to provide a cap on the chamber outlet. Accordingly, in a set of embodiments, the sample collection device comprises an outlet cap, arranged to cover the chamber outlet. The outlet cap may act to shield the chamber outlet during use. The outlet cap may be removable and thus be -18 -removed from the sample collection device when it is desired to dispense the fluid therein through the chamber outlet. The removable outlet cap may itself seal the chamber outlet, and thus removal of the outlet cap may open the chamber outlet.

However, in another set of embodiments, the chamber outlet is closed by a seal, and wherein at least part of the outlet cap is adjacent the seal such that the seal cannot be broken when the outlet cap is attached to the sample collection device. Positioning at least part of the outlet cap adjacent the seal in this manner may advantageously prevent a user from inadvertently breaking the seal and thereby prevent the expelling fluid out through the chamber outlet until the outlet cap has purposely been removed.

In another set of embodiments, the sample collection device comprises a further component removably connected fluidly downstream of the chamber outlet, and an outlet tamper element connected to a body of the device or the further component, wherein the outlet tamper element is configured such that when the further component is separated from the chamber outlet, the outlet tamper element breaks away from the body of the device or the further component. In such examples, the outlet tamper element may be broken away by movement of the vial relative to the tamper element. The outlet tamper element may therefore be used to indicate whether the sample collection device has been tampered with. The further component may, for example, comprise the outlet cap described above, a vial, for example a pre-filled vial containing reagents, or any other suitable component. The further component may be pre-attached to the device.

The outlet tamper element may have any suitable form. The outlet tamper element may be in the form of a ring. In a set of embodiments, the outlet tamper element is connected to a body of the device or the further component by a plurality of breakable tabs. In a further set of embodiments, rotation of the outlet tamper element, relative to the body of the device or the further component in at least one direction is prevented by the interaction of a rotation prevention feature on the outlet tamper element and a corresponding rotation prevention feature on the body of the device or the further outlet cap. For example, the rotation prevention feature may comprise a saw-tooth shaped protrusion on the cap tamper element and the corresponding rotation prevention feature may comprise a corresponding saw-tooth shaped recess. The saw-tooth shaped protrusion and corresponding recess may prevent rotation in one direction, but permit rotation in the other direction. As such, when the further component is initially attached to the device during manufacture, e.g. by rotation, the rotation prevention features may prevent rotation of the outlet tamper element, thereby avoiding breaking the breakable tabs.

Conversely, when the further component is removed, the rotation prevention features may allow rotation in the direction in which the outlet cap is undone, and thereby the breakable tabs may -19 -break, thus indicating that the outlet cap has been removed and that the device has been used and/or tampered with.

The fluid sample may be dispensed directly from the sample collection device into another chamber in which further processing or analysis of the sample may be performed.

Depending on the particular application, it may be possible to simply hold the sample collection device, specifically the chamber outlet, above a further device into which the sample is to be dispensed. However, this may not be appropriate in some instances, particularly where the sample may be infected, e.g. with a virus or bacteria, and so it may be desirable to contain the fluid sample as far as possible. Accordingly, in a set of embodiments, the sample collection device further comprises a connection arrangement arranged fluidly downstream of the chamber outlet, for connecting a further component to the sample collection device. As such, a further component may be attached to the device. The outlet cap described above may be attached to the connection arrangement. The further component may, for example, comprise a container, e.g. a vial, into which the fluid sample may be dispensed, or any other component whereby it may be desired to transfer fluid. For example, the further component may comprise a fluid connector attached to a fluid hose. The further component may, for example, comprise a sample analysis chamber which may, for example, comprise a reagent therein.

It may be desirable in some instances to be able to attach different types of further component, each having a different connection portion, to the connection arrangement.

Accordingly, in a set of embodiments, the connection arrangement comprises a first connection portion, for connecting a first further component having a complementary first connection portion, and a second connection portion for connecting a second further component having a complementary second connection portion. Therefore, as will be appreciated by those skilled in the art, further components having two different connection portions may be connected to the connection arrangement. This may increase the application of the sample collection device, potentially meaning that the sample collection device is compatible with an increased number of further components. The first connection portion and second connection portion may have any suitable format. For example, the first and second connection portion may be configured to achieve a friction fit with the corresponding first and second components. In this case, the first connection portion may have a smaller dimension than the second connection portion. In a set of embodiments, the first connection portion comprises a thread having a first diameter, and the second connection portion comprises a thread having a second, larger, diameter. As such, components with different sized external threads may be connected to the connection arrangement. This may allow a single sample collection device to be used with a wider variety of different components. Of course, the connection arrangement may comprise further connection portions.

-20 -In a set of embodiments, the chamber outlet comprises a seal which prevents the passage of fluid therethrough. The seal may therefore prevent the passage of fluid until it is desired to expel the fluid from the device. The seal may be overcome or removed in any suitable manner in order to allow fluid to pass out of the chamber outlet. For example, the seal may be manually removed by a user pulling or tearing the seal away from the sample chamber outlet. However, in a set of embodiments, the device comprises a seal arranged to seal the sample chamber outlet, the sample collection conduit is movable relative to the sample collection chamber, and wherein the sample collection conduit is configured to break the seal. Breaking the seal with the sample collection conduit may provide a convenient means for overcoming the seal and avoid a user having to come into contact with the sample chamber outlet which could potentially cause contamination of the sample. As movement of the sample collection conduit may also be used to advance the plunger, using the sample collection conduit to break the seal may advantageously break the seal at the appropriate time in order to allow the fluid to be expelled from the sample collection chamber. The sample collection conduit may be configured to break the seal in any appropriate manner. For example, the sample collection conduit may comprise a pointed tip configured to break, e.g. penetrate, the seal.

The sample collection conduit may comprise a mouthpiece configured to allow a user to seal their mouth around the sample collection conduit when providing an oral sample. Such a mouthpiece may allow a user to achieve a better seal around the sample collection conduit when providing a sample and thus the chance of leaking of the sample may be reduced. As the sample may comprise infected material, reducing the risk of any leakage, which could potentially infect others, is particularly advantageous.

The sample collection conduit may comprise a tapered friction fitting at its inlet and/or the chamber outlet may comprise a tapered friction fitting. The tapered fitting may, for example, conform to the Luer or EN Fit standard. This may advantageously allow a sample to be inserted into the sample collection device, through the sample collection conduit, if the sample is contained within other means having a fitting capable of connecting with the tapered friction fitting. Similarly, the fluid may dispensed into other means having a fitting capable of connecting with the tapered friction fitting on the chamber outlet. The sample collection conduit or chamber outlet may comprise other connection means, e.g. such as a threaded portion.

Such a threaded portion may conform to the Luer-lock or EN Fit standard.

The sample collection device may further comprise an adaptor configured to be attached fluidly downstream of the chamber outlet, e.g. on the connection arrangement. The adaptor may allow the sample collection device to be used to transfer the sample to any one of a number of different components or devices. This may advantageously increase the number applications the sample collection device can be used with.

-21 -The sample collection device may be made from any suitable material or combination of materials. As mentioned above, part or all of the sample collection device may be at least partially transparent, e.g. fully transparent, such that the user can see their sample as it passes into the device. The sample collection chamber may be made from polypropylene and the plunger may be made from polyethylene or polycarbonate. At least in those embodiments wherein the plunger(s) and conduit are integrally formed, the conduit may also be made from polyethylene or polycarbonate. Such an embodiment may advantageously remove the need to provide an 0-ring between the plunger(s) and the sample collection chamber, as well as removing the need to provide a lubricant to lubricate the movement of the plunger(s).

Removing such lubricant may be advantageous as the lubricant may potentially affect the results of any testing performed on the sample.

Whilst the various parts of the device have been described as being attached together above, the device may be provided with each of the component separately, e.g. as a kit of parts. For example, the kit of parts may comprise the sample collection chamber with the sample collection conduit and plunger(s) inserted therein, provided with a separate sample analysis chamber which may be selectively attached by the user as desired. Any combination of different components as described above may be provided in the kit of parts.

As will be appreciated by those skilled in the art, whilst the device may be particularly well suited to the collection of an oral fluid sample, as described in some of the embodiments above, the device may also be used for the collection, measurement and transfer of other fluid samples, other than oral fluid samples. For example, fluid samples may be transferred directly into the device, e.g. from another device such as a syringe.

Some preferred embodiments of the present invention will now be described, by way of example only, and with reference to the following drawings, in which: Fig. 1 shows a perspective view of a sample collection device in accordance with an embodiment of the present invention; Fig. 2 shows a cross-sectional view through the sample collection device shown in Fig. 1; Fig. 3 shows a cut-away view of the sample collection chamber of the sample collection device shown in Fig. 1; Fig. 4 shows a perspective view of the chamber outlet cap shown in Fig. 1; Fig. 5 shows a perspective view of the sample collection device shown in Fig. 1 focussing on an upper portion thereof; Fig. 6 shows a perspective view of the sample collection device shown in Fig 1 with the cap removed; Fig. 7 shows a cross-sectional view through the sample collection device shown in Fig. 1 with the cap removed; -22 -Fig. 8 shows a cross-sectional view through the sample collection device illustrating how the float member floats as the fluid level increases; Fig. 9 is a perspective view of the sample collection device shown in Fig. 1 with the cap advanced into a first intermediate position; Fig. 10 is a cross-sectional view through the sample collection device with the cap in the position shown in Fig. 9; Fig. 11 is a perspective view of the sample collection device shown in Fig 1 with a sample analysis chamber attached thereto; Fig. 12 is a cross-sectional view through the sample collection device and sample analysis chamber shown in Fig. 11; Fig. 13 is a perspective view of the sample collection device with a release member moved into a released position; Fig. 14 is a cross-sectional view of the sample collection device with the release member in the released position; Fig. 15 is a perspective view of the sample collection device with the sample collection conduit in the final position; Fig. 16 is a cross-sectional view of the sample collection device with the sample collection conduit in the final position; Fig. 17 shows a cross-sectional view of the sample collection device of Fig. 1 wherein the third and fourth fluid passageways are open; Fig. 18 shows a cross-sectional view of the sample collection device of Fig. 1 wherein the third and fourth fluid passageways are closed; Fig. 19 shows a perspective view of a sample collection device in accordance with another embodiment of the present invention; Fig. 20 shows a perspective view of the outlet cap on the sample collection device shown in Fig. 19; Fig. 21 shows a cross-sectional view of the sample collection device shown in Figure 19; Fig. 22 is a view focussing on the outlet cap and its connection to the connection arrangement; Fig. 23 is a perspective view of the connection portion with the connection arrangement with the outlet cap removed; Fig. 24 is a cross-sectional view focussing on the connection arrangement and outlet cap; Fig. 25 is an underside view of the outlet cap, of the embodiment depicted in Figure 19, in isolation; Fig 26 is a cut-away view of a sample collection chamber in accordance with another embodiment of the present invention which comprises a relief valve; -23 -Fig. 27 is a cut-away view of the sample collection chamber of Fig. 26 with a plunger fully advanced therein; Fig. 28 is a cross-sectional view of a sample collection device comprising a volume control arrangement in accordance with another embodiment of the present invention; Fig. 29 is a cut-away view of a sample collection device comprising an alternative volume control arrangement, in accordance with another embodiment of the present invention; and Fig. 30 is a cross-sectional view of the sample collection device shown in Fig. 29.

Figure 1 shows a perspective view of a sample collection device 2, hereinafter "device 2", in accordance with an embodiment of the present invention. The device 2 comprises a sample collection chamber 4. An outlet cap 3 is connected to a connection arrangement 6 at one end of the sample collection chamber 4 and an inlet cap 8 is attached at the other end thereof. The inlet cap 8 is connected to an inlet cap tamper element in the form of a connection ring 10. The connection ring 10 extends around the sample collection chamber 4 and is retained around the sample collection chamber 4 by a plurality of lugs 12. The device 2 further comprises a release member 16 which will be described in more detail in relation to later Figures. The device 2 is depicted in Figure 1 in a configuration whereby the device 2 has not yet been used to provide a fluid sample, i.e. where the inlet cap 8 is attached to the device 2 such that the connection between the inlet cap 8 and the connection ring 10 has not been broken, and with the outlet cap 3 pre-attached.

Figure 2 shows a cross-sectional view through the device 2 shown in Figure 1. As shown in this Figure, the device 2 also comprises a sample collection conduit 18, hereinafter "conduit 18". The conduit 18 extends out through an opening 19 of the sample collection chamber 4. In the configuration shown in Figure 2, the inlet cap 8 surrounds the conduit 18. This may help to ensure that the conduit 18 remains sterile before use. The conduit 18 comprises a conduit inlet 20, for receiving a fluid sample, and a conduit outlet 22 which allows the fluid sample to pass out of the conduit 18 into the sample collection chamber 4. In the embodiment depicted, the conduit outlet 22 comprises a pointed tip 23, the purpose of which will be described further below. A plunger 24 and further plunger 26 are operatively linked to the conduit 18 such that movement of the conduit 18 results in corresponding movement of the plunger 24 and further plunger 26. The plunger 24 and further plunger 26 may be integrally formed with the conduit 18, or be separate components which are acted upon by the conduit 18. At the base, i.e. the second end, of the sample collection chamber 4 is a chamber outlet 28 which is sealed by a seal 30. The seal 30 prevents fluid from passing out of the chamber outlet 28 until the seal is broken, for example by the pointed tip 23 of the conduit 18. The sample collection chamber 4 comprises a first sub-chamber 32 between the plunger 24 and the chamber outlet 28, a second sub-chamber 34 between the plunger 24 and further plunger 26, -24 -and a third sub-chamber 36 between the further plunger 26 and the inlet cap 8. The relative positions and volumes of the first, second and third sub-chambers 32, 34, 36 may change as the plungers 24, 26 are advanced into the sample collection chamber 4.

A float member 38 is arranged in the first sub-chamber 32. The float member 38 is ring-shaped and has an opening 39 passing therethrough. The opening 39 may allow fluid to pass through the float member 38 thereby allowing the float member 38 to float on top of a fluid sample. The density of the float member 38 may depend on the type of fluid sample which the device 2 is designed to collect.

The sample collection chamber 4 further comprises a first fluid passageway 40, a second fluid passageway 42, a third fluid passageway 44 and a fourth fluid passageway 46 each of which are formed by recesses in an internal wall 47 of the sample collection chamber 4. It will be appreciated that each of the first, second, third and fourth fluid passageways 40, 42, 44, 46 may comprise a plurality of recesses extending around the internal circumference of the sample collection chamber 4. The fluid passageways 40, 42, 44, 46 provide a means for fluid to bypass the plunger 24 and further plunger 26, and thereby pass between the first, second and third sub-chambers 32, 34, 36. The fluid passageways 40, 42, 44, 46, plunger 24 and further plunger 26 are configured such that when the plunger 24 or further plunger 26 is adjacent the fluid passageway 40, 42, 44, 46, fluid is able to pass through the fluid passageways 40, 42, 44, 46 from one chamber to another. Whereas, when the plunger 24 or second plunger 26 is not fully adjacent one of the fluid passageways 40, 42, 44, 46, the respective fluid passageway 40, 42, 44, 46 will be closed and thus fluid will not be able to pass between the sub-chambers 32, 34, 36. The fluid passageways 40, 42, 44, 46 will be described in further detail below with respect to Figure 3.

The inlet cap 8 comprises a first circumferential recess 48 on a lower end 49 of the cap 8 and a second circumferential recess 50 extending around a central portion 51 of the cap 50.

The first and second circumferential recesses 48, 50 are shaped to receive a locking member 52. The first and second circumferential recesses 48, 50 and the locking member 52 together form part of a restriction arrangement which acts to restrict movement of the inlet cap 8. As the inlet cap 8 is advanced towards the sample collection chamber 4, the locking member 52 will extend into one of the first or second circumferential recesses 48, 50, depending on the position of the inlet cap 8, and hold the cap 8 in position relative to the sample collection chamber 4. The inlet cap 8 further comprises a conduit seal 53 which is arranged to seal the conduit inlet 20 when the conduit seal 53 comes into contact with the conduit inlet 20. The conduit seal 53 may seal the conduit inlet 20 by an interference fit there between.

The device 2 comprises an overspill chamber 54 which is formed between an inner wall portion 56 and an outer wall portion 58 of the sample collection chamber 4. The overspill -25 -chamber 54 may collect any fluid which overspills the third sub-chamber 36. The overspill chamber 54 also serves to receive the cap 8 as the cap is advanced relative to the sample collection chamber 4.

As shown in Figure 2, the release member 16 is coupled to a stop member 60 against which a bottom edge 62 of the cap 8 will come into contact with when the cap 8 is advanced relative to the sample collection chamber 4. The stop member 60 may be moved, through operation of the release member 16, to allow the cap 8 to advance past the stop member 60. The stop member and release member 16 therefore also form part of a restriction arrangement which restricts movement of the inlet cap 8 relative to the sample collection chamber 4.

The connection arrangement 6 which is arranged adjacent the chamber outlet 28, comprises a first connection portion 64 and a second connection portion 66. In the embodiment depicted, the first connection portion 64 comprises an internal thread having a first diameter, and the second connection portion 66 comprises an internal thread having a second, smaller, diameter. The first and second connection portions 64, 66 are axially displaced with one another. Of course the first and second connection portions may have any suitable connection means. For example the first and second connection portions may instead comprise tapered connection which form a friction fit with a component attached thereto. Similarly, further connection portions may also be included.

Figure 3 shows a cut-away view of the sample collection chamber 4, with the other components of the device 2 removed. This view more clearly shows the first fluid passageway 40, second fluid passageway 42, third fluid passageway 44 and fourth fluid passageway 46 which are formed as recesses in the internal surface 47 of the sample collection chamber 4. The fluid passageways 40, 42, 44, 46 may be formed in any suitable manner during manufacture of the sample collection chamber 4. For example, the fluid passageways 40, 42, 44, 46 may be integrally formed as part of a moulding process. Also visible more clearly in this Figure are the first connection portion 64 and second connection portion 66 which each comprise internal threads.

Figure 4 shows an isometric view of the outlet cap 3 in isolation. The outlet cap 3 comprises a corresponding connection portion 59 which comprises an external thread. In the embodiment depicted, the corresponding connection portion 59 is dimensioned to engage the first connection portion 64 on the connection arrangement 6 on the sample collection chamber 4.

Use of the device 2 in collecting a fluid sample will now be described with reference to Figures 5 to 16. In order to provide a fluid sample into the device, a user may first remove the inlet cap 8. With reference to Figure 5, the inlet cap 8 may be connected to the connection ring via a plurality of connection tabs 11. In order to separate the inlet cap 8 from the connection -26 -ring 10, a user may rotate and/or pull the cap 8 so as to break the connection tabs 11. Once the cap 8 has been separated from the connection ring 10, the cap 8 may be pulled away from the sample collection chamber 4.

Figure 6 shows the outlet cap 8 separated from the sample collection chamber 4. As depicted, removal of the outlet cap 8 leaves the connection ring 10 in position around sample collection chamber 4. Specifically, the connection ring 10 remains in situ extending around the outermost wall 58 of the sample collection chamber 4. The connection ring 10 is retained in position by the lugs 14 which prevent the connection ring 10 from falling away from the sample collection chamber 4. As shown in Figure 6, once the outlet cap 8 has been removed, this reveals the conduit 18 into which a fluid sample may be provided. The outlet cap 3 may remain in position at this point to prevent the inadvertent dispensing of fluid out of the chamber outlet 28 (not visible in this Figure).

Figure 7 shows a cross sectional view of the device 2 before any fluid sample has been provided in order to illustrate the relative positions of the plungers 24, 26 within the sample collection chamber. In the configuration shown in Figure 7, the conduit 18 is in an initial, i.e. collection, position and the plunger 24 and further plunger 26 are in a corresponding initial position. In the exemplary case whereby the device 2 is used to collect a saliva sample, a user may place their mouth around the conduit inlet 20 and spit or drool their fluid sample into the conduit 18. The sample will pass through the conduit 18, pass out of the conduit outlet 22 and pass into the first sub-chamber 32 of the sample collection chamber 4. With the conduit 18 in the initial position, the plunger 24 is in a corresponding initial position adjacent the first fluid passageway 40 and the further plunger 26 is adjacent the second fluid passageway 42. As a result, both the first fluid passageway 40 and second fluid passageway 42 are open such that fluid can flow from the first sub-chamber 32 to the second sub-chamber 34 and from the second sub-chamber 34 to the third sub-chamber 36. Accordingly, as the fluid sample is provided via the conduit 18, any excess fluid sample or foam may pass out of the first sub-chamber 32 into the second sub-chamber 24. In the exemplary case of a fluid sample in the form of saliva, the saliva typically comprises a liquid portion and a foam portion which comprises a plurality of air bubbles. Advantageously, the foam portion may pass through the first fluid passageway 40.

This may increase the liquid portion of the fluid sample which is contained within the first sub-chamber 32. In the initial position, the seal 30 on the chamber outlet 28 is intact and therefore the fluid sample cannot pass out through the chamber outlet 28.

As the fluid sample begins to fill the first sub-chamber 32, the float member 38 will begin to float on the fluid sample and rise within the first sub-chamber 32. The hole 39 in the float member 38 allows the fluid sample to easily pass through the float member 38 thereby allowing the float member 38 to quickly float on top of the fluid sample.

-27 -Figure 8 shows a cross sectional view of the device 2 when the first sub-chamber 32 has been at least partially filled with a fluid sample. As shown in this Figure, the float member 38 has risen within the first sub-chamber 32 with the fluid therein. In the embodiment depicted, the float member 38 has risen to a position whereby it is adjacent a portion of the sample collection chamber 4 which comprises an inner wall 56 and outer wall 58. As a result, the float member 38 may not be visible in this position, whereas the float member 38 may have been visible in the lower portion of the first sub-chamber 32 wherein the sample collection chamber 4 comprises a single-skin outer wall 59. Accordingly, in this embodiment, a user may identify that a sufficient volume of fluid sample has been provided when the float member 38 can no longer be seen. Of course, this is just one way in which the float member 38 may be used and the sample collection chamber may instead be configured such that the float member 38 instead becomes visible when sufficient fluid sample has been provided. In addition or alternatively, the sample collection chamber 4 may be provided with volumetric markings, and alignment of the float member with the volumetric markings may be used to determine the fluid level within the sample collection chamber 4.

Once a sufficient volume of fluid sample has been provided into the device 2, the inlet cap 8 may then be replaced onto the device and pushed into a first intermediate position. This is illustrated in Figure 9. Figure 10 is a cross-sectional view of the device 2 with the inlet cap 8 arranged in the first intermediate position as shown in Figure 9. As the inlet cap 8 is pushed back onto the device 2, the conduit seal 53 will engage with the conduit inlet 20 and seal the conduit inlet 20 via an interference fit. Due to the interaction between the conduit seal 53 and the conduit inlet 20, as the inlet cap 8 is advanced into the first intermediate position shown in Figure 10, this causes the conduit 18 to move out of the initial position shown in previous Figures, and into a first intermediate position. In the first intermediate position shown in Figure 10, the plunger 24 and further plunger 26 have been advanced into the sample collection chamber 4 into a corresponding first intermediate position such that they are no longer adjacent the first fluid passageway 40 and second fluid passageway 42. In the position shown, the plunger 24 and further plunger 26 form a sealed relationship with the inner surface 47 of the sample collection chamber 4. As a result, the first sub-chamber 32 and second sub-chamber 34 are sealed and no fluid is able to escape either of these sub-chambers 32, 34.

Additionally, as the inlet cap 8 is advanced into this first intermediate position, the inlet cap 8 extends into the space defined by the overspill chamber 54. The inner surface 47 of the sample collection chamber 4 comprises an expansion portion 49 in which the internal diameter of the inner surface 47 at the expansion portion 49 is less than the external diameter of the further plunger 26. As a result, when the inlet cap 8 is advanced into the first intermediate position, and the conduit 8 is driven into the corresponding first intermediate position, the further -28 -plunger 26 will advance into the expansion portion 49. Due to the difference in the diameter of the expansion portion 49 and the further plunger 26, the further plunger 26 causes the expansion portion 49 to expand and press against an inner surface 55 of the inlet cap 8. This may improve the seal between the inlet cap 8 and the sample collection chamber 4, thereby more securely sealing the fluid sample within the sample collection chamber 4. This sealing between the inlet cap 8 and the sample collection chamber 4 may act to seal the third sub-chamber 36. As described previously, the connection ring 10 remains around the sample collection chamber 4 when the inlet cap 8 is removed. When the inlet cap 8 is reattached as described above, the connection ring 10 may reinforce the sample collection chamber 4, and prevent significant deformation thereof. This may therefore act to assist in ensuring a proper seal between the inlet cap 8 and sample collection chamber 4.

When the inlet cap 8 reaches the first intermediate position, the locking member 52 engages with the first circumferential recess 48. This engagement prevents the inlet cap 8 from being removed from the sample collection chamber 4, at least without using excessive force.

Additionally, when the inlet cap 8 is in this first position, the bottom edge 62 of the inlet cap abuts against the stop member 60. The stop member 60 therefore acts to prevent the inlet cap 8 from being advanced from this first position, and thereby prevents any further movement of the sample collection conduit. As a result, this may help to prevent a user from inadvertently advancing the inlet cap 8 which may cause the inadvertent dispensing of the fluid sample from the sample collection chamber 4.

With the inlet cap 8 and conduit 18 in the first intermediate position, and with a sufficient fluid volume within in the first sub-chamber 32, the pointed tip 23 of the conduit outlet 38 may pass through the hole 39 in the float member 38 as depicted. The hole 39 on the float member may therefore ensure that the pointed tip 23 of the conduit outlet 22 is not prevented from breaking the seal 30, when required. In the configuration shown in Figure 10, the pointed tip 23 has not yet reached the seal 30 on the chamber outlet 28, and as a result the fluid sample is contained within the sample collection chamber 4. The outlet cap 3 also remains attached to the connection arrangement 6.

In the arrangement shown in Figure 10, the fluid sample is securely contained within the device 2, as the first sub-chamber 32, second sub-chamber 34 and third sub-chamber 36 are sealed. The fluid sample may thus be stored within the device 2 and may, for example, be transported within the device 2.

Following collection of the fluid sample using the device 2, it may then be necessary to perform analysis on the fluid sample. The fluid sample may thus need to be dispensed from the device 2 into another component for further analysis. The fluid sample may be dispensed directly out of the chamber outlet 28 onto another component, e.g. part of a testing -29 -arrangement. However, Figure 11 shows an exemplary embodiment whereby a further component in the form of a vial 68 is attached to the connection arrangement 6. Figure 12 shows a cross-sectional view of the device 2 with the vial 68 attached thereto. As shown in this Figure, the vial 68 comprises an external threaded portion 70 which engages with the first connection portion 64 of the connection arrangement 6. It will be appreciated that a different vial, having an external threaded portion, e.g. a vial having a threaded portion with a smaller diameter, may also be connected to the connection arrangement 6 by engaging with the second connection portion 66. As a result, the device 2 may advantageously be used with a wider variety of further components. As depicted, when the vial 68 is initially attached, the inlet cap 8 remains in the first position such that the seal 30 remains intact and any fluid sample remains within the sample collection chamber 4.

Once the vial 68 has been attached, a user may then begin the process of dispensing the fluid sample from the sample collection chamber 4. As discussed previously, the inlet cap 8 is used to advance the conduit 18, and the plunger 24 within the sample collection chamber 4.

Accordingly, in order to dispense the fluid sample, the inlet cap 8 must first be advanced past the first intermediate position shown in Figure 10. With reference to Figure 13, the release member 16 which acts to move the stop member 60 may be operated to move the stop member 60 away from the bottom edge 62 of the inlet cap 8. The release member 16 is shown in a released position in Figure 13. The release member 16 may be arranged to pivot relative to the sample collection chamber 4. The release member 16 may, for example, be pivotally connected to the sample collection chamber 4 by an integrally formed hinge.

Figure 14 shows a cross-sectional view of the device 2 in the configuration shown in Figure 13 with the release member 16 in the released position. As shown in this Figure, when the release member 16 is operated, e.g. by rotating the release member 16 relative to the sample collection chamber 4, the stop member 60 is moved away from the bottom edge 62 of the inlet cap 8. Accordingly, the stop member 60 no longer ads to prevent movement of the inlet cap 8. The inlet cap 8 may therefore be advanced further relative to the sample collection chamber 4, and further into the overspill chamber 54. A small amount of force may be required to overcome the engagement between the locking member 52 and the circumferential rim 48.

The circumferential rim 48 and locking member 52 may be shaped such that only a small force is required to advance the inlet cap 8 further, but shaped such that a large force is required to pull the inlet cap 8 away from the sample collection chamber 4.

Figure 15 shows a perspective view of the device 2 with the vial 68 connected and with the inlet cap 8 fully advanced into a final position relative to the sample collection chamber 4, with the release member 16 in a released position. Figure 16 shows a cross-sectional view -30 -through the device 2, with the inlet cap 8 and the conduit 18 in the final position as shown in Figure 15.

When the inlet cap 8 is in the final position shown in Figure 16, the conduit 18 is advanced into the final position. As shown, in this final position, the inlet cap 8 is fully advanced into the overspill chamber 54. When in the final position, the locking member 52 engages with the second circumferential rim 50 to hold the inlet cap 8 in position and prevent the inlet cap 8 from being able to be pulled away from the sample collection chamber 4. This may advantageously prevent the device 2 from being reused.

As the inlet cap 8 is advanced from the first intermediate position shown in Figure 12 towards the final position shown in Figure 16, this will cause the conduit 18 to advance into the sample collection chamber 4 from the first intermediate position shown in in Figure 10 into the final position shown in Figure 16. Movement of the conduit 18 between the first intermediate position and final position will be described with reference to Figure 16 and Figures 17 and 18. As the inlet cap 8 advances the conduit 18 from the first intermediate position towards the final position shown in Figure 15, the conduit 18 will reach a second intermediate position as shown in Figure 17. As depicted in this Figure, in the second intermediate position, the plunger 24 is in a corresponding second intermediate position adjacent the third fluid passageway 44 and the further plunger 26 will be adjacent the fourth fluid passageway 46. As the plunger 24 is advanced, whilst adjacent the third fluid passageway 44, fluid within the first sub-chamber 32 will be forced out of the first sub-chamber 32 through the third fluid passageway 44 into the second sub-chamber 34. Simultaneously, if the second sub-chamber is full of fluid, fluid may escape the second sub-chamber 34 into the third sub-chamber 36 via the fourth fluid passageway 46. As shown in Figure 17, whilst the plunger 24 is adjacent the third fluid passageway 44, the seal 30 on the chamber outlet 28 may remain intact, i.e. the pointed tip 33 of the conduit outlet 22 will not have reached the seal 30.

As the conduit 18 advances further towards the final position, from the second intermediate position, the conduit 18 will reach a third intermediate position, as depicted in Figure 18. In this third intermediate position, the plunger 24 has reached the bottom 45 of the third fluid passageway 44 and thus the third fluid passageway 44 is closed and fluid is no longer able to escape the first sub-chamber 32. As a result, the maximum volume of fluid that will be dispensed will be the volume defined between the chamber outlet 28 and the plunger 24 when it is aligned with the bottom 45 of the third fluid passageway 44. The third fluid passageway 44 may therefore act as a means for defining a pre-set volume of fluid to be dispensed from the device 2. The fourth fluid passageway 46 is arranged such that the fourth fluid passageway 46 is closed by the further plunger 26 no longer being adjacent the fourth fluid passageway 46, at the same point at which the third fluid passageway 44 is closed. -31 -

As depicted in Figure 18, as the conduit 18 reaches the third intermediate position, the pointed tip 23 of the conduit outlet 23 simultaneously comes into contact with the breakable seal 30, thereby breaking the seal 30 and allowing fluid to pass out of the chamber outlet 28. Breaking the breakable seal 30 simultaneously with the closing of the third fluid passageway 44 may advantageously avoid a pressure build up within the first sub-chamber 32 which may otherwise prevent further movement of the conduit 18.

When the inlet cap 8 advances the conduit 28 from a position whereby the plunger 24 is just past the bottom 45 of the third fluid passageway 44, the pointed tip 30 may then break the seal 30 and the fluid sample may be forced out of the chamber outlet 28 under the pressure exerted by the plunger 24. The fluid sample will pass into the vial 68. The conduit 18 may be thus be advanced from the third intermediate position shown in Figure 18 to the final position shown in Figure 16. As the conduit 18 is moved the plunger 26 will expel the fluid sample out of the first chamber 32, through the chamber outlet 28 and into the vial 68. As will be appreciated by those skilled in the art, the conduit seal 53 which seals the conduit inlet 20 may prevent any fluid within the conduit 18 itself from being dispensed due to the formation of a vacuum. This may ensure that only the fluid within the first chamber 32 is dispensed.

Figure 19 shows a perspective view of a sample collection device 102, hereinafter "device 102", in accordance with another embodiment of the present invention. Except where explicitly described, the device 102 functions in an identical manner to the device 2 described above. The device 102 comprises an outlet cap 103 which is connected to the connection arrangement 106. An outlet tamper element 172 is connected to a lower end 171 of the connection arrangement 106 and will be described in more detail below.

Figure 20 shows a perspective view of the outlet cap 103 in isolation. Similarly to the outlet cap 3 described above, the outlet cap 103 comprises a corresponding connection portion 159 in the form of an external thread. The outlet cap further 103 further comprises a circumferential protrusion 174. The circumferential protrusion 174 is shaped to engage the tamper element 172 and the engagement therebetween will be described in further detail below with respect to Figure 24. The outlet cap 103 further comprises an axial protrusion 176. As depicted in Figure 21, which shows a cross-sectional view of the device 102, when the outlet cap 103 is attached to the connection arrangement 106, the axial protrusion 176 abuts against the seal 130 on the chamber outlet 128. As a result, when the outlet cap 103 is attached, the seal 130 cannot be broken, and thus no fluid sample is able to pass out through the chamber outlet 128, even if the user were to inadvertently advance the conduit 118 causing the pointed tip 123 to contact the seal 130.

Figure 22 shows a view focussing on the outlet cap 103, the outlet tamper element 172 and the connection arrangement 106, with the outlet cap 103 connected to the connection -32 -arrangement 106. The tamper element 172 is connected to the bottom end 171 of the connection arrangement 106 by a plurality of breakable tabs 178. The tamper element 172 is in the form of a circular ring. The tamper element 172 may be integrally formed with connection arrangement 106 during manufacture. The tamper element 172 comprises saw tooth shaped protrusions 180 which engage with corresponding saw tooth shaped recesses 182 on the connection arrangement 106. The saw toothed shaped protrusions and recesses 180, 182 together act as rotation prevention features. As will be appreciated by those skilled in the art, when the outlet cap 103 is initially screwed into the connection arrangement 106, there will be a frictional force between the outlet cap 103 and the tamper element 172 which will tend to try and rotate the tamper element 172. However, due to the engagement of the protrusions 180 and recesses 182, rotation in the direction in which the outlet cap 103 is rotated during attachment will be prevented. As a result, the breakable tabs 178 will remain in contact. The outlet cap 103 may come pre-attached to the device 102 and thus when the outlet cap 103 is pre-attached the breakable tables 178 will not be broken. It will only be once the outlet cap 103 is later removed that the outlet tabs 178 will become broken, as described in more detail below.

Figure 23 shows a view of the underside of the connection arrangement 106, with the outlet cap 103 removed. As shown, the tamper element 172 comprises a plurality of radially extending ridges 184. Whilst in the embodiment a plurality of ridges 184 are provided, it will be appreciated that a single ridge may also provide the same function. The ridges 184 comprises a chamfered edge 185 which allows the circumferential rim 174 of the outlet cap 103 to pass over the ridges 185 when the outlet cap 103 is initially attached to the connection portion 106. Figure 24 shows a cross-sectional of the device 102, focussing on the outlet cap 103 and connection arrangement 106. As shown in this Figure, the corresponding connection portion 159 of the outlet cap 103 is engaged with the second connection portion 166 such that the outlet cap 103 is attached to the connection arrangement 106. The corresponding connection portion 159 on the outlet cap 103 is in the form of an external thread, and the second connection portion 166 is in the form of an internal thread. When the outlet cap 103 has been connected, the circumferential rim 174 of the outlet cap 103 has been advanced past the ridges 184 on the tamper element 172. When the outlet cap 103 is initially attached to the connection arrangement 106, due to the chamfered edge 185 of the ridges 184 of the tamper element 172, the circumferential rim 174 will force the tamper element 174 to expand in a radial direction, thereby allowing the circumferential rim 174 to pass the ridges 184, and thus connect to the connection arrangement 106.

When it is desired to remove the outlet cap 103, e.g. when a user wishes to expel the fluid sample out of the fluid outlet (not shown on this Figure) the outlet cap 103 may be rotated.

As the outlet cap 103 is rotated, the circumferential rim 174 of the outlet cap 103 will engage a -33 -top surface 186 of the ridges 184 of the outlet tamper element 172. The top surface 186 is shaped to prevent the circumferential rim 174 from passing over the ridges 184. As a result, further rotation of the outlet cap 103 may drive rotation of the outlet tamper element 172 and/or axial movement of the outlet tamper element 172 away from the connection arrangement 106. As will be appreciated by those skilled in the art, the saw-toothed protrusions 180, and corresponding saw-toothed recesses 182 will prevent rotation in a first direction in which the outlet cap 103 is attached, but permit rotation in the opposite direction in which the outlet cap 103 is removed. As a result, the rotational and/or axial movement of the outlet cap 103 will eventually cause the breakable tabs 178 to break, thereby separating the tamper element 172 from the connection arrangement 106. Further rotation of the outlet cap 103 will cause the outlet cap 103 and tamper element 172 to become completely separated from the connection arrangement.

In the embodiment depicted, when the outlet cap 103 is removed, the outlet tamper element 172 will also be separated from the connection arrangement 106, and will remain attached to the outlet cap 103. As a result, this arrangement may be used to provide an indication that the device 102 has been previously used or tampered with.

Figure 25 shows a view of the underside of the outlet cap 103. The outlet cap 103 comprises a cavity 186 in which a plurality of radially extending ribs 188 are formed. The cavity 186 and ribs 188 may be used to support another component, e.g. a vial. For example, the outlet cap 103 may be removed from the device 102 and placed upside down on a surface such that the cavity 186 faces upwards. A vial, or other component, may then be inserted into the cavity 188 and be supported, and potentially gripped, by the ribs 188. This may be particularly advantageous for use with vials which have a rounded bottom, and are thus unable to stand vertically without some form of support. When a vial is supported in the outlet cap 103, the outlet cap 103 may advantageously lower the centre of gravity of the vial, thereby reducing the likelihood of the vial tipping over.

As shown in Figure 25, the ribs 188 have a stepped profile 190 whereby the radial extent of the ribs 188 increases such that the ribs 188 define a first support region 192 and a second support region 194. The second support region 194 has a smaller diameter such that it is capable of supporting smaller components, e.g. vials having a smaller diameter. The outlet cap 103 may therefore be capable of supporting further components, e.g. vials, having different diameters.

Figure 26 shows a cut-away view of a sample collection chamber 204 in accordance with another embodiment of the present invention. The sample collection chamber 204 is substantially the same as the sample collection chamber 4 described above, except that it further comprises a relief valve 296 in the form of a recess in the internal wall 247 of the sample -34 -collection chamber 204. The relief valve 296 is proximal to the chamber outlet 228. Use of the relief valve 296 will now be described with reference to Figure 27 which shows a cutaway view a sample collection device 202 comprising the sample collection chamber 204 shown in Figure 26. Except where described below, the sample collection device 204 is otherwise identical to the sample collection device 2 described above. As shown in Figure 27, when the sample collection conduit 218 approaches the final position, the plunger 224 becomes aligned with the relief valve 296 and as a result, the relief valve 296 is effectively opened. As a result, any air pressure that is built up in the vial 268 may be released through the relief valve 296 and into the second sub-chamber 234. As a result, the pressure in the vial 268 may be reduced, and the vial 268 may be separated from the connection portion 206 more easily. Reducing the pressure may also reduce the risk of the fluid sample from being ejected, e.g. sprayed, out of the vial 268 as it is separated. This may reduce the risk of contamination of the user, other people in the vicinity of the sample collection device 202. Of course further relief valves, e.g. between the second sub-chamber and third sub-chamber 236 may also be provided. In the embodiment depicted, the relief valve 296 is opened when the sample collection conduit 218 reaches the final position. It will be appreciated that the relief valve 296 may be arranged such that it is opened as the sample collection conduit 218 approaches the final position, but then becomes closed when the sample collection conduit 218 actually reaches the final position.

Figure 28 shows a cross-sectional view of a sample collection device 302 in accordance with another embodiment of the present invention. The sample collection device 302 is identical to the sample collection device 2 discussed above, except for the features explicitly mentioned below. The sample collection device 302 comprises an inlet cap 308 which comprises a first circumferential recess 348 and second circumferential recess 350 which are engaged by the locking member 352 in an identical manner to the embodiments discussed above. Accordingly, the inlet cap 308 may be held in the initial and final positions. The inlet cap 308 further comprises a first intermediate circumferential recess 383 and a second intermediate circumferential recess 385. The first and second intermediate recesses 383, 385 together with the locking member 352 provide a volume control arrangement. The first and second intermediate recesses 383, 385 may be positioned on the inlet cap 208 such that when they are engaged by the locking member 352, a specific predefined volume of fluid has been expelled from the sample collection chamber 304. For example, the first intermediate recess 383 may correspond to 0.5 ml being dispensed and the second intermediate recess 385 may correspond to 0.75 ml of fluid being dispensed. Appropriate marking may be provided on the inlet cap 308 to indicate the corresponding volumes. As will be appreciated, engagement of the locking member 352 and the first and second intermediate recesses 383, 385 may therefore provide a -35 -volume control arrangement which controls the amount of fluid dispensed from the sample collection chamber 304.

Figure 29 shows a cut-away view of a sample collection device 402, and Figure 30 shows a cross-sectional view of the sample collection device 402, incorporating an alternative volume control arrangement in accordance with another embodiment of the present invention. As shown, the sample collection conduit comprises an adjustable element 443, in the form of a threaded nut, which engages with an outer thread 418B provided on the lower portion 418A of the sample collection conduit 418, below the plunger 424. The position of the adjustable element 443 relative to the sample collection conduit 418 may be adjusted, e.g. during assembly of the device 402, by rotating the adjustable element 443 relative to the sample collection conduit 418. This will adjust the axial position of the adjustable element 443 relative to the sample collection conduit 418. As the sample collection conduit 418 is advanced into the sample collection chamber 404, thereby advancing the plunger 424 so as to dispense fluid from the sample collection chamber 404, the adjustable element 443 will eventually abut against the float member 438 which may abut against a lower internal wall 441 of the sample collection chamber 404. The adjustable element 443 therefore effectively engages the sample collection chamber, via the float member 438. This engagement may prevent further movement of the sample collection conduit 418, and thereby prevent further movement of the plunger 424.

If the adjustable element 443 is positioned closer to the pointed tip 423 less fluid volume will be dispensed, whereas if the adjustable element 443 is positioned closer to the plunger 424, more fluid volume will be dispensed. The adjustable element 443 may therefore provide a volume control arrangement which determines the amount of fluid dispensed from the sample collection device 402. The arrangement of the adjustable element 443 shown in Figures 29 and 30 is merely illustrative and any suitable form of adjustable element may be provided and positioned in any appropriate position within the sample collection device in order to control the amount of fluid dispensed.

While the invention has been described in detail in connection with only a limited number of embodiments, it should be readily understood that the invention is not limited to such disclosed embodiments. Rather, the invention can be modified to incorporate any number of variations, alterations, substitutions or equivalent arrangements not heretofore described, but which are commensurate with the scope of the invention. Additionally, while various embodiments of the invention have been described, it is to be understood that aspects of the invention may include only some of the described embodiments. Accordingly, the invention is not to be seen as limited by the foregoing description, but is only limited by the scope of the appended claims. -36 -

Claims

Claims 1. A sample collection device, for collecting a fluid sample, comprising: a sample collection chamber for collecting a sample therein, wherein the chamber comprises a chamber outlet through which a fluid sample can pass; a sample collection conduit extending through an opening of sample collection chamber to an outside of the sample collection chamber, wherein the sample collection conduit comprises a conduit inlet for receiving a fluid sample and a conduit outlet for allowing the fluid sample to pass into the sample collection chamber; a plunger configured to expel the fluid out of the sample collection chamber through the chamber outlet; wherein the sample collection chamber comprises a first sub-chamber defined between the plunger and the chamber outlet, and wherein the conduit outlet is arranged in the first sub-chamber and wherein the sample collection chamber comprises a first fluid passageway arranged to allow fluid to pass out of the first sub-chamber.
2. The sample collection device of claim 1, wherein the sample collection conduit is moveable relative to the sample collection chamber and wherein the sample collection conduit and plunger are operatively linked such that movement of the sample collection conduit causes movement of the plunger within the sample collection chamber.
3. The sample collection device of claim 1 or 2, wherein the sample collection conduit is movable from an initial position, whereby the sample collection conduit extends out of the sample collection chamber to receive a fluid sample, to a final position whereby the sample collection conduit is fully advanced into the sample collection chamber.
4. The sample collection device of any preceding claim, wherein the sample collection device comprises a further plunger arranged within the sample collection chamber, and wherein a second sub-chamber is defined between the plunger and further plunger.
5. The sample collection device of claim 4, wherein the further plunger is configured to move together with the plunger, and wherein the sample collection chamber comprises a second fluid passageway arranged to allow fluid to pass out of the second sub-chamber.
6. The sample collection device of any preceding claim, wherein the plunger is movable to a first intermediate position in which the first fluid passageway is closed. -37 -
7. The sample collection device of claim 6, wherein the further plunger is movable into a corresponding first intermediate position whereby the second fluid passageway is also closed.
8. The sample collection device of any preceding claim, wherein the sample collection chamber comprises a third fluid passageway arranged such that when the plunger is moved into a second intermediate position, between the first intermediate position and a final position, the third fluid passageway is open, thereby allowing fluid to pass from the first chamber into the secondary chamber, and wherein the third fluid passageway is closed when the plunger is moved into a third intermediate position between the second intermediate position and the final position.
9. The sample collection device of claim 8, wherein the sample collection device comprises a fourth fluid passageway arranged to allow fluid to pass out of the second sub-chamber when the sample collection conduit is in the third intermediate position.
10. The sample collection device of claim 9, wherein the third and fourth fluid passageways are arranged such that they are closed simultaneously, when the sample collection conduit reaches the third intermediate position.
11. The sample collection device of any preceding claim, comprising a volume control arrangement which determines how far the plunger can be advanced into the sample collection chamber.
12. The sample collection device of any preceding claim, comprising a relief valve arranged to open when the plunger and/or the sample collection conduit approaches a final position in the sample collection chamber.
13. The sample collection device of any preceding claim, comprising a float member, arranged within the sample collection chamber, configured to float on a fluid sample within the sample collection chamber.
14. The sample collection device of claim 13, wherein the float member comprises a reagent stored therein. -38 -
15. The sample collection device of any preceding claim, wherein at least a portion of the sample collection chamber is defined by single skin, at least partially transparent, outer wall such that there is only one wall between the fluid sample collected within the sample collection chamber and an exterior of the sample collection device.
16. The sample collection device of any preceding claim, comprising an inlet cap arranged to seal the sample collection chamber.
17. The sample collection device of claim 16, wherein the inlet cap is secured to the sample collection device by an inlet tamper element and wherein the inlet cap is separable from the inlet tamper element.
18. The sample collection device of any one of claims 16-17, wherein the inlet cap is configured, in at least one position, to seal the inlet to the sample collection conduit.
19. The sample collection device of any one of claims 16-18, wherein when attached to the device the inlet cap is movable relative to the sample collection chamber, and wherein the inlet cap is arranged to drive the plunger into the sample collection chamber.
20. The sample collection device of any one of claims 16-19, comprising a further plunger, and wherein the inlet cap is arranged to drive the further plunger into the sample collection chamber, and wherein as the further plunger is advanced into the sample collection chamber, the further plunger presses a wall of the sample collection chamber and a wall of the inlet cap together, thereby sealing the opening of the sample collection chamber.
21. The sample collection device of any one of claims 16-20, comprising a restriction arrangement configured to prevent movement of the inlet cap relative to the sample collection chamber in at least one direction
22. The sample collection device of preceding claim, comprising an outlet cap, arranged to cover the chamber outlet.
23. The sample collection device of any preceding claim, wherein the chamber outlet is closed by a seal, and wherein at least part of the outlet cap is adjacent the seal such that the seal cannot be broken when the outlet cap is attached to the sample collection device. -39 -
24. The sample collection device of any preceding claim, comprising a further component removably connected fluidly downstream of the chamber outlet, and an outlet tamper element connected to a body of the device or the further component, wherein the outlet tamper element is configured such that when the further component is separated from the chamber outlet, the outlet tamper element breaks away from the body of the device or the further component.
25. The sample collection device of any preceding claim, comprising a connection arrangement arranged fluidly downstream of the chamber outlet, for connecting a further component to the sample collection device.
26. The sample collection device of any preceding claim, wherein the connection arrangement comprises a first connection portion, for connecting a first further component having a complementary first connection portion, and a second connection portion for connecting a second further component having a complementary second connection portion.
27. A sample collection device, for collecting a fluid sample, comprising: a sample collection chamber for collecting a sample therein, wherein the chamber comprises a chamber outlet through which a fluid sample can pass; a sample collection conduit extending through an opening of sample collection chamber to an outside of the sample collection chamber, wherein the sample collection conduit comprises a conduit inlet for receiving a fluid sample and a conduit outlet for allowing the fluid sample to pass into the sample collection chamber; a plunger configured to expel the fluid out of the sample collection chamber through the chamber outlet.