Sampling Device

Abstract

A stool sampling device 100 comprises a container 101 having a body 102 and a lid 103 having a detachable sample collecting stem. A tamper indication mechanism 104 comprises at least one frangible pin

Description

The present invention relates to a stool sampling device. Background Typically stool sample kits provided comprise a spoon or a spatula and a sealable container. The spoon or spatula is used to put the required amount of stool into the container, then the container lid is shut. It can be difficult to get the stool off of the spoon / spatula and into the container, which may result in the sample being around the lid of the container and on the outside of the container. Once the sample has been taken, the spoon or spatula must be disposed of in a regular waste bin. The most common container used for a stool sample is a screw container, which can be opened and contaminated by any person handling the sample. It is an aim of the invention to provide a sampling device that mitigates one or more of the above-mentioned problems. Statements of invention According to a first aspect of the invention there is provided a stool sampling device comprising: a container comprising a body and a lid, a stem for collecting a stool sample, the stem being releasably attached to the lid, a tamper indication mechanism comprising at least one frangible pin attached to the body of the container and a receiving portion comprising at least one aperture configured to receive the at least one frangible pin in a non-reversible snap fit when the tamper indication mechanism is engaged, wherein the receiving portion is movably attached to the lid of the container. The receiving portion may comprise a living hinge. Each frangible pin may comprise a conical head portion each comprising an apex and a base. Each aperture of the receiving portion may be configured to receive the apex of each conical head portion first when the tamper indication mechanism is engaged. Each frangible pin may comprise a weakened section below the conical head portion. Each aperture may be located around each weakened section of the frangible pin when the tamper indication mechanism is engaged. Each aperture of the receiving portion may comprise a malleable inner edge. The inner edge of each aperture may be scalloped. The receiving portion may comprise a plurality of apertures, each aperture merges into each adjacent aperture. The receiving portion may comprise a thumb grip. The device may further comprise an ejection mechanism configured to detach the stem from the lid of the container. The ejection mechanism may comprise a protrusion located on the receiving portion and an aperture located on the lid of the container. The aperture located on the lid of the container may comprise a fully sealed diaphragm membrane. The ejection mechanism may be configured to detach the stem from the lid of the container when the tamper indication mechanism is engaged. The stem may comprise a hollow tube comprising a first end and a second end. The stem may be releasably attached to a protrusion on the lid of the container. The protrusion on the lid of the container may be partially received within a first end of the hollow tube. The protrusion on the lid may comprise a series of indents for preventing a buildup of back pressure when the stem is in use. The second end of the hollow tube may comprise a scoop. The stem may comprise a dissolvable material. The stem may comprise a polyvinyl alcohol. According to a second aspect of the invention there is provided a kit of parts comprising the stool sampling device and a solution for preserving a stool sample. According to a further aspect, there may be a method of collecting a stool sample using the first or second aspect, comprising collecting the sample using the stem when attached to the lid and subsequently engaging the tamper indication mechanism with the sample inside the container. Any of the optional features defined herein as relating to the first aspect may be applied to any further aspect. Detailed description Practicable embodiments of the invention are described in further detail below with reference to the accompanying drawings, of which: Figure 1 shows a perspective view of a sampling device according to an example of the invention. Figure 2 shows a perspective view of the lid of a sampling device according to an example of the invention. Figure 3 shows a first perspective view of the sampling stick and lid of a sampling device according to an example of the invention. Figure 4 shows a second perspective view of the sampling stick and lid of a sampling device according to an example of the invention. Figure 5a shows a perspective view of a sampling device in an unlocked position according to an example of the invention. Figure 5b shows a perspective view of a sampling device in a locked position according to an example of the invention. Figure 1 shows a perspective view of a sampling device 100. The sampling device 100 comprises a container 101 with a body 102 and a lid 103. The body 102 of the container 101 when in use receives the stool sample taken by the user. The container 101 is substantially cylindrical. In this example, the container body 102 comprises a tapered base. Alternatively, the container body 102 may have a flat base such that the container 101 can be placed upright on a surface during sampling. The lid 103 of the container 101 is for sealing the sample within the body 102 of the container 101. The lid 103 comprises a screw lid. The lid 103 may comprise an airtight seal. The container 101 is a suitable size for receiving a stool sample. The container 101 may come in various sizes depending on the size of the sample required. The device 100 comprises a tamper indication mechanism 104. The tamper indication mechanism 104 comprises at least one frangible portion 105, a receiving portion 106, and a connection means 107. The sampling device 100 in figure 1 is shown in an unlocked position. The unlocked position is where the tamper indication mechanism is not in operation. In the unlocked position, the lid 103 can be taken on and off the body 102 of the container 101 without the mechanism 104 indicating the lid 103 has been tampered with. When the tamper mechanism 104 is not in operation, the receiving portion 106 is not engaged with the frangible portion 105. The connection means 107 comprises a band 108 which encircles the container 101. The band 108 encircles the container 101 at the body 102 just below where the lid 103 sits when sealing the body 102 of the container 101. The band 108 rotates freely on the body 102. The band 108 comprises a rotatable lock clasp allowing the tamper indication mechanism 104 to rotate with the lid but preventing the engaged tamper indication mechanism 104 from moving vertically with the lid 103 when it is being unscrewed from the body 102. The connection means 107 further comprises a main body 109 which extends from the band 108 upward to the top end of the lid 103. The main body 109 comprises a substantially cuboid shape. Part of the band 108 extends outwardly providing a platform 110 for the main body 109 to connect to the band 108. The platform 110 provides a larger surface area for the main body 109 to connect to creating a stable connection between the band 108 and the main body 109. The platform 110 may extend partially along the band 108. The main body 109 may comprise a curved inner surface following the shape of the lid 103. The frangible portion 106 may comprise at least one frangible pin 111. In the example shown in Figure 1, there are two frangible pins 111. Alternatively, there may be any number of frangible pins 111. The frangible pins 111 each comprise a head portion 112 and a breakable connection 113 to the main body 109. The head portion 111 comprises a substantially conical shape. The base of each head portion is attached to a main body 109 by the breakable connection 113. The breakable connection 113 is designed to break when under tension. The breakable connection 113 comprises a weakened section. The weakened section may comprise holes or slits. Alternatively, the weakened section may comprise a relatively narrow cross section in comparison to the pin head portion 111 and main body 109. The breakable connection 113 may comprise the same material as the pin head portion 112. The tamper indication mechanism 104 may be formed in one piece. The receiving portion 106 comprises at least one aperture 114. In the example shown in Figure 1, the receiving portion 106 comprises two apertures 114. Alternatively, there may be any number of apertures. There is an aperture 114 corresponding to each frangible pin 111. Each aperture 114 may comprise substantially circular cross-section. Each aperture 114 may comprise a scalloped inner edge. The scalloped edge may comprise a flexible material. Each aperture 114 may merge into an adjacent aperture 114. The receiving portion 106 comprises a living hinge 115. The living hinge is located at the bottom of the receiving portion 106 and on the top of the lid 103. The living hinge 115 attaches the receiving portion 106 to the lid 103.The receiving portion 106 is movable attached to the lid 103. The receiving portion may be approximately twice the length of the diameter of the lid. The receiving portion may be substantially rectangular in shape. The receiving portion may comprise a curved edge to remove pointed edges and catching. The receiving portion may comprise a grip. The grip may be located at the top of the receiving portion further away from the living hinge 113. The apertures 114 may be located midway along the receiving portion. The apertures 114 may be located on the receiving portion 106 between the grip and the living hinge. The apertures 114 are located on the receiving portion such that they engage the pin heads 112 when the receiving portion is moved towards the lid and the tamper indication mechanism is placed in the engaged position. Figure 2 shows a perspective view of the lid 103 of the sampling device in a locked position according to an example of the invention. In the locked position, the receiving portion 106 is closed over the frangible portion 105. Each aperture 114 of the receiving portion 106 receives one of the frangible pins 111 in a non-retrievable snap fit. The head portion 112 is received within an aperture 114 of the receiving portion 106. The apex of the conical head portions 112 enters the aperture 114 first. The apex moves the mailable scalloped inner edge of the aperture 114 to allow the entirety of the head portion 112 to pass through the aperture 114. When the tamper indication mechanism is in an engaged position, as shown in Figure 2, the aperture 114 is located around the breakable portion 113 below the head portion 112 of the frangible pins 111. Once the tamper indication mechanism is engaged, the scalloped inner edge of the aperture 114 prevents the receiving portion 106 being lifted off the frangible pins 111. If the lid is unscrewed when the tamper indication mechanism is engaged, the lid moves upwards, but the tamper indication mechanism remains in the same vertical position. If the lid is unscrewed when the tamper indication mechanism is engaged, the base of the head portion 112 comes into contact with the inner edge of the apertures 114. When the receiving portion 106 is moved away from the lid, the base of the head portion 112 is the first to contact the inner edge of the aperture 114. The rotatable lock clasp of the band 108 holds the frangible pins 111 in their horizontal position relative to the lid, the band 108 rotates freely allowing the pins to move on a horizontal axis with the lid. The rotatable lock clasp of the band 108 holds the frangible pins 111 in their vertical position and prevents the frangible pins 111 from moving with the lid 103 vertically when it is being unscrewed from the body 102. The main body 109 holds the frangible pins 111 in their vertical position relative to the lid. The main body 109 prevents the frangible pins 111 moving with the receiving portion 106 when it is moved in relation to the lid. Force exerted on the breakable connection 113 will result in the weakened section of the frangible pins 111 breaking. Screw action of the lid will result in the inner edge of the aperture 106 contacting the base of the head portion 112 and exerting force on the weakened section of the frangible pins 111. Screw action of the lid will result in the weakened section of the frangible pins 111 breaking. Moving the receiving portion 106 away from the lid will result in the inner edge of the aperture 106 contacting the base of the head portion 112 and exerting force on the weakened section of the frangible pins 111. Moving the receiving portion 106 away from the lid will result the weakened section of the frangible pins 111 breaking. When the weakened section breaks, the head portion 112 of the frangible pins 111 will no longer be connected to main body 109 of the tamper mechanism. The removal of the head portion 112 of the frangible pin 111 is an indication the sample has been tampered with. The removal of the head portions 112 of the frangible pins 111 is non retrievable. Figure 3 shows a first perspective view of the lid 103 of the sampling device 100 according to an example of the invention. The lid 103 is a tamper locking lid which secures a sample within the container 101 and provides a visible tamper indication. The device 100 further comprises a sample stick 301. The sample stick 301 comprises a hollow tube. A first end of the sample stick is releasably attached to the lid 103. A second end of the sample stick sits within the body 102 of the container 101. In Figure 3 the sample stick 301 is shown detached from the lid 103. The second end of the sample stick is partially cut away to create a scoop or spoon section. The sample stick 301 is releasably attached to the lid 103. The sample stick is releasable attached to the inside of the lid 103. The sample stick is releasable attached substantially centrally on the inside of the lid 103. This attachment situates the sample stick 301 substantially centrally within the body 102 of the container 101 to prevent the sample from getting caught on the sides of the body 102. The inside of the lid 103 comprises a protrusion 302. The sample stick 301 is releasable attached to the protrusion 302. The protrusion 302 is located substantially centrally within the lid 103. The interior of the hollow tube of the sample stick 301 is held in contact with the protrusion 302. The sample stick 301 has an interference fitting with the protrusion 302. The first end of the sample stick 301 is placed over the protrusion 302. The second end of the sample stick 301 is used to retrieve a sample. The scoop or spoon is placed into a sample and moved such that the sample travels up the hollow tube of the sample stick 301 from the second end towards the first end. The sample is collected whilst the sample stick 301 is attached to the lid 103. The protrusion 302 comprises a substantially cylindrical shape. The protrusion 302 comprises a series of indents around the edge of the substantially cylindrical shape. The indents of the protrusion 302 allow air to pass through from the hollow tube of the sample stick 301 and prevent a build-up of back pressure when the sample is being collected. The receiving portion 106 of the tamper mechanism when not engaged with the frangible pins can be positioned to extend upwardly from the lid. The receiving portion 106 when in the disengaged position can be held by the user to assist with grip when collecting a sample. The protrusion 302 comprises an elastomeric material. The elastomeric material increases friction between the sample stick 301 and the protrusion 302 such that the sample stick 301 is not dislodged when a sample is being collected. The protrusion 302 is deformable. The protrusion 302 may be resiliently deformable. The protrusion 302 extends part way inside the sample stick 301. The protrusion 302 extends part way inside the first end of the sample stick 301. When in situ, the sample stick 301 does not cover the entirety of the protrusion 302. Part of the end of the protrusion 302 attached to the lid 103 is left exposed when the sample stick 301 is in situ. The length of the protrusion 302 may be of the order 0.1 times the length of the sample stick 301. For example, the length of the protrusion 302 may be 0.1,0.2, 0.3 or 0.4 times the length of the sample stick 301. The circumference of the protrusion 302 is slightly smaller than the circumference of the interior of the hollow tube of the sample stick 301. The interior of the lid 103 further comprises threading 303 for interacting with the exterior of the body in a screw fit. Figure 4 shows a second perspective view of the sampling stick 301 and lid 103 of a sampling device 100 according to an example of the invention. The device 100 further comprises an ejection mechanism 401. The lid 103 comprises an ejection mechanism 401 to release the sample stick 301 when the tamper mechanism is engaged. The ejection mechanism 401 comprises an aperture 402 within the lid 103. The aperture 402 on the lid 103 is located substantially centrally on the top surface of the lid 103. The aperture 402 comprises a fully sealed diaphragm membrane. The fully sealed diaphragm membrane creates an airtight seal when the lid 103 is screwed shut. The airtight seal prevents any leakage of the sample and any contaminants entering the body 102 of the container 101. The receiving portion 106 comprises a protrusion 403. The protrusion 403 is located between the apertures 114 and the living hinge 113. Figure 5a shows a perspective view of a sampling device 100 in an unlocked position according to an example of the invention. The device 100 is unlocked when the tamper indication mechanism is disengaged. The device 100 may comprise an indication on the lid to indicate the device is locked when the tamper indication mechanism is engaged. The writing may comprise the word LOCK and an arrow pointing towards the frangible pins. The protrusion 403 on the receiving portion 106 is located such that when the receiving portion 106 is moved to engage the tamper indication mechanism, the protrusion 403 engages aperture 402 on the surface of the lid 103. The protrusion 403 of receiving portion 106 comprises a substantially solid material such that it easily deforms the diaphragm membrane of the aperture 402. The protrusion 403 of receiving portion 106 comprises a solid plastic. When to receiving portion 106 is moved towards the lid 103 and the tamper indication mechanism is engaged, the protrusion 403 enters the aperture 402 deforming the diaphragm membrane of the aperture 402 and deforming the protrusion 303 on the inside of the lid 103. Deformation of the internal protrusion 303 causes the sample stick 301 to be ejected from the lid 103. The deformable internal protrusion 303 is widened by the solid protrusion 403 which pushes the sample stick 301 off the internal protrusion 303. Figure 5b shows a perspective view of a sampling device 100 in a locked position according to an example of the invention. The device 100 is locked when the tamper indication mechanism is engaged. When the tamper indication mechanism is engaged the ejection mechanism detached the sample stick 301 from the lid 103. When the sample stick 301 is ejected by the ejection mechanism, it falls from the lid 103. When detached from the lid 103, the sampling stick 301 falls into the body 102 of the container 101. In use, the body 102 of the container 101 will hold a solution that the sample is kept in. The sample stick 301 comprises a dissolvable material. The sample stick 301 is dissolvable in the solution which holds the stool sample. The sample stick 301 comprises a dissolvable polymer which does not affect the sample. The sample stick 301 may be formed from a water-soluble and / or biodegradable polymer. The polymer may be an oil based / derived water soluble polymer, such as a synthetic resin. The polymer used in this example comprises polyvinyl alcohol (PVOH-PVA-PVAI. In other examples, the polymer could be a starch based (i.e. non-oil based) polymer, such as polylactic acid (PLA), e.g. a PLA / starch blend. The structural integrity of the sample stick 301 as a whole may irreversible degrade within a period a period of between about one hour and one week. The sample stick 301 material may degrade to produce a liquid and gas in the presence of water and / or microorganisms. In some examples, the material could be water soluble. The structural integrity of the solid mass of PVOH in the form of a sample stick as disclosed herein will remain sufficiently intact for at least 5-10 minutes of use. The PVOH or other biodegradable polymer may be modified to get the right balance of flexibility / stiffness and / or biodegradability. This may be achieved using modifiers / additives to the polymer at master batch level, i.e. prior to moulding. Additionally or alternatively it is possible with the use of additives / modifiers to vary the polymer material’s trigger time (i.e. the delay in initiation or onset of degradation) and / or longevity (i.e. the rate of degradation through the mass of the polymer material). Method of use The sampling device is used to collect stool samples for the purpose of testing. Therefore, it is important the sample is not contaminated or tampered with in any way to ensure test results are accurate. A sampling kit is provided to a user. The sampling kit comprises the sampling device 100 and a solution. The solution may be provided separately to the device. The sampling device 100 is provided in the unlocked position as shown in Figure 5a with the receiving portion 106 in the upright position, the tamper indication mechanism 104 disengaged and the sample stick 301 attached to the lid. The user unscrews the container lid 103 and empties the solution provided separately into container body 102. The sampling stick 301 is attached to the lid 103. The user holds the lid 103, the receiving portion 106 assisting with grip, and puts the second end of the sampling stick 301 into the sample. As the user moves the sampling stick in 301 in the sample, the sample will travel up the second end of the sampling stick 301 towards the first end of the sampling stick 301. Once a sample has been collected, the used put the sample stick 301 in the body 102 of the container 101 and screws the lid 103 shut. The user engages the tamper indication mechanism when the sample is enclosed within the container 101. The user moves the receiving portion 106 towards the lid 103 such that the apertures 114 receive the frangible pin head portion 112 in a non-retrievable snap fit. At the tamper indication mechanism is engaged the ejection mechanism detaches the stick from the lid 103. When the user moves the receiving portion 106 towards the lid, the protrusion 403 on the receiving portion enters the aperture 402 on the lid 103. The protrusion 403 forces the stick 301 to detach from the protrusion 302 of the lid 103. The sample stick 301 then sits within the solution within the container 101. The sample stick 301 dissolves in the solution. Once the tamper indication mechanism is engaged if the lid is unscrewed, the frangible pins will break providing a visible indication of tampering. Once the tamper indication mechanism is engaged if the receiving portion is moved relative to the lid, the frangible pins will break providing a visible indication of tampering.

Claims

1. A stool sampling device comprising:a container comprising a body and a lid;a stem for collecting a stool sample, the stem being releasably attached to the lid;a tamper indication mechanism comprising at least one frangible pin attached to the body of the container and a receiving portion comprising at least one aperture configured to receive the at least one frangible pin in a non-retrievable snap fit when the tamper indication mechanism is engaged; wherein the receiving portion is movably attached to the lid of the container.

2. The device of claim 1 wherein the receiving portion comprises a living hinge.

3. The device of claims 1 or 2, wherein each frangible pin comprises a conical head portion each comprising an apex and a base.

4. The device of claim 3, wherein each aperture of the receiving portion is configured to receive the apex of each conical head portion first when the tamper indication mechanism is engaged.

5. The device of claims 3 and 4, wherein each frangible pin comprises a weakened section below the conical head portion.

6. The device of claim 5, wherein each aperture is located around each weakened section of the frangible pin when the tamper indication mechanism is engaged.

7. The device of any preceding claim, wherein each aperture of the receiving portion comprises a malleable inner edge.

8. The device of claim 7, wherein the inner edge of each aperture is scalloped.

9. The device of any preceding claim, wherein the receiving portion comprises a plurality of apertures, each aperture merges into each adjacent aperture.10.The device of any preceding claim, wherein the receiving portion comprises a thumb grip.11 .The device of any preceding claim, further comprising an ejection mechanism configured to detach the stem from the lid of the container.12.The device of claim 11, wherein the ejection mechanism comprises a protrusion located on the receiving portion and an aperture located on the lid of the container.13.The device of claim 12, wherein the aperture located on the lid of the container comprises a fully sealed diaphragm membrane.14.The device of claims 11 to 13, wherein the ejection mechanism is configured to detach the stem from the lid of the container when the tamper indication mechanism is engaged.

15. The device of any preceding claim wherein the stem comprises a hollow tube comprising a first end and a second end.

16. The device of claim 15 where the stem is releasably attached to a protrusion on the lid of the container.

17. The device of claim 16 wherein the protrusion on the lid of the container is partially received within a first end of the hollow tube.

18. The device of claims 16 or 17, wherein the protrusion on the lid comprises a series of indents for preventing a build-up of back pressure when the stem is in use.5 19. The device of claims 15 to 18, wherein a second end of the hollow tubecomprises a scoop.20.The device of any preceding claim, wherein the stem comprises a dissolvable material.o21 .The device of claim 20, wherein the stem comprises a polyvinyl alcohol.

22. A kit of parts comprising the device of any of the preceding claims and a solution for preserving a stool sample.

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