GB2558612A

GB2558612A - A biological sample collection and / or storage device

Info

Publication number: GB2558612A
Application number: GB1700389.8A
Authority: GB
Inventors: Carter Juliet; Van Schie Robert
Original assignee: Nammonic Holding Ltd
Current assignee: Nammonic Holding Ltd
Priority date: 2017-01-10
Filing date: 2017-01-10
Publication date: 2018-07-18
Anticipated expiration: 2037-01-10
Also published as: GB2558612B; WO2018130825A1; GB201700389D0

Abstract

A biological sample collection and/or storage device 100 comprising a container 102 having a first part 106, a second part 108 and a hinge there between such that the container defines a cavity and maybe opened and closed, and a sample support 104 which is stored within the container and comprises at least one support leg 124 attached to the container at a first end and a sample carrier 130 with a sample substrate 144 wherein the carrier is attached to the support leg at a second end such that the sample support is movable between a folded stored condition (fig 1a) in which it is contained within the cavity and a drying condition (fig 1b) in which the sample substrate is spaced apart from the cavity. The device may further comprise a swab carrier 136 with swab 146 for collecting sample. Alternatively, the device may comprise lancet stored within the container. The sample carrier may further comprise a second support leg 126.

Description

(71) Applicant(s):

Nammonic Holding Ltd

121 Leicester Street, Lemington Spa, Warwickshire, CV32 4TB, United Kingdom (72) Inventor(s):

(56) Documents Cited:

GB 2482036 A WO 2012/163788 A1 US 20040171173 A1 (58) Field of Search:

INTCLA61B, B01L Other: WPI and EPODOC

Juliet Carter

Robert Van Schie

WO 2014/207076 A1 US 20080299605 A1 US 20040161855 A1 (74) Agent and/or Address for Service:

Vault IP Limited

5th Floor Cavendish House, 39 Waterloo Street, Birmingham, B2 5PP, United Kingdom (54) Title of the Invention: A biological sample collection and / or storage device Abstract Title: Biological sample collection and storage device (57) A biological sample collection and/or storage device 100 comprising a container 102 having a first part 106, a second part 108 and a hinge there between such that the container defines a cavity and maybe opened and closed, and a sample support 104 which is stored within the container and comprises at least one support leg 124 attached to the container at a first end and a sample carrier 130 with a sample substrate 144 wherein the carrier is attached to the support leg at a second end such that the sample support is movable between a folded stored condition (fig 1a) in which it is contained within the cavity and a drying condition (fig 1b) in which the sample substrate is spaced apart from the cavity. The device may further comprise a swab carrier 136 with swab 146 for collecting sample. Alternatively, the device may comprise lancet stored within the container. The sample carrier may further comprise a second support leg 126.

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A biological sample collection and / or storage device

The present invention is concerned with a device for the collection and / or storage of biological samples. More specifically, the present invention is concerned with an apparatus for the collection of DNA source cells for onward transit, storage and analysis.

The collection, storage and transport of biological samples is desirable in a number of fields. In particular, it is desirable to collect saliva, buccal cells or blood from an individual for subsequent DNA analysis. Biological samples, such as saliva, buccal cells and blood, may be stored on certain types of absorbent substrates. It is known to swab a person's cheek, and press the swab against the substrate to transfer the sample thereto. The substrate is then placed into a desiccant-containing pouch for storage and transport. The pouch is then placed within a substantially airtight, light-proof, moistureproof sealable container. However, the storage matrix and the pouch require handling to place them inside the container. There is also a risk of unwanted contamination and mismatching samples by incorrect identification in the handling and labelling process.

One solution to this problem has been proposed by GE Heathcare Life Sciences (TM) in the form of the Whatman (TM) EasiCollect (TM) device. The device has a body which holds the substrate (an FTA card). The FTA card is held in position with both sides exposed. A foam head is mounted to a free end of an elongate stem attached to the body via a hinge. The device is sealed within a sterile bag for transport before use.

Before use, the user opens the bag and removes the device. The sample details (e.g. subject details) are written on the reverse of the FTA card. During use, the device is completely removed from the bag and the foam pad is rubbed on the inside of a person's mouth to collect saliva and buccal cells. During this process, the user holds the body of the device. The user must therefore wear gloves to avoid contamination of the FTA card.

When the foam head is saturated, the user removes a protective film from the FTA card and the device is folded at the hinge. This folding action places the foam head in contact with the FTA card so that the sample can be transferred. A resilient clip holds the foam head in contact with the FTA card.

After transfer, the head is moved to an upper position (still held in the clip) to separate the foam pad and FTA card. This allows the FTA card to dry. The FTA card may be removed from the device and stored in a bag and container as described above.

There are several problems with this device. Firstly, the device is quite large as it must be supplied in an unfolded condition for initial use. Secondly, the device does not stack at all- its shape does not facilitate compact high density storage. Thirdly, the need to handle the body with the exposed FTA card (firstly by writing on it, then during sampling) is undesirable as it risks damage and contamination. Although the FTA card may carry a protective film, this is prone to early removal if the instructions are not followed. Fourthly, the device is laid flat to dry, which is problematic as air can only reach the upper surface. Fifthly, the device is quite expensive (and retails at over £3/unit).

It is an object of the invention to overcome, or at least mitigate the above problems.

According to a first aspect of the invention there is provided a biological sample collection and / or storage device comprising:

a container having a first part, a second part and a hinge therebetween such that the container is movable between a closed condition and an open condition, the container defining a cavity therein in the closed condition;

a sample support comprising at least one support leg attached to the container at a first end, and a sample carrier comprising a sample substrate, the sample carrier attached to the support leg at a second end such that the sample support is movable between a storage condition in which it is contained in the cavity, and a drying condition in which the sample substrate is spaced apart from the cavity.

Advantageously, the provision of a hinged container allows the sample to be selectively exposed from a storage condition to a drying condition. The container can also be made flat for stacking and compact for high density storage and economical postage. Preferably the container is configured to hermetically seal the cavity in the closed condition (i.e. the container is made air- and water-tight).

Advantageously, this facilitates sample integrity for long term transit and storage. It also facilitates convenient transport by mail without further health and safety packaging. There is also reduced risk of mix up of samples as the device is an all in one product, not requiring further external packaging.

Further, the device according to the first aspect is relatively straightforward to manufacture, and therefore of low cost. This enables the product to be sold at a low price.

Preferably the container is configured to rest on a horizontal surface in the open condition with the sample support in the drying condition. This allows the substrate to be supported away from the surface. More preferably the container is configured to rest on a horizontal surface in the open condition with the sample support in the drying condition and an axis of the hinge normal to the horizontal surface.

Preferably the hinge is configured to have an undeformed (or rest) state in which the first and second parts of the container form an angle of 10 to 100 degrees about the hinge. This stable condition allows the container to be rested on its side in a V shape.

Preferably the hinge is a live hinge, which resiles from the closed to an open condition.

Preferably the sample support comprises a tab to pull the sample carrier from the container. This prevents user contact with the substrate.

Preferably a sample support hinge is defined between the support leg and the sample carrier allowing the support leg and the carrier to be folded into the storage condition. This creates a compact arrangement for storage.

Preferably the sample support comprises a first and a second support leg joined at an apex, in which the sample carrier extends from the apex.

Preferably the first support leg is attached to the first part of the container, and the second support leg is attached to the second part of the container. More preferably the first and second support legs are attached to the respective container parts spaced apart from the container hinge, such that the legs form a quadrilateral with the container in the drying condition. This provides a stable structure to support the substrate for drying.

The sample support may comprise at least one cover member extending on one side of the sample carrier. Advantageously, these may protect the substrate when not in use.

Preferably the sample support comprises a swab carrier comprising a swab, the swab carrier having a collection position in which the swab is exposed for collection of cells, and a transfer position in which the swab is in contact with the substrate. This allows the user to collect saliva and / or buccal cells more easily. Preferably the swab carrier is an elongate structure.

Preferably the swab carrier is rotatable between the collection position and the transfer position.

The swab carrier may be attached to the sample carrier by a hinge.

Alternatively, the swab carrier may be attached to the container. In this embodiment, the container may comprise an aperture through which the swab can contact the substrate in the transfer position. The container may comprise an openable closure configured to selectively close the aperture.

Preferably the swab carrier is removable via a frangible portion, which may be coincident with the hinge.

In one embodiment, a blood lancet may be stored within the container. Preferably the sample support is attached to the first part of the container, and the lancet is attached to the second part of the container. This allows the user to draw blood and use the substrate to absorb the blood.

Preferably the sample substrate and lancet are offset in a lateral direction- in other words the do not face each other. A plaster may be stored within the container

In one embodiment, the container comprises a third part hinged to the second part such that the second part is disposed between the first and third parts in the closed condition. The first and third parts may be hinged to the second part on opposite sides of the second part such that the container forms a Z when both the first and second parts are rotated to an open position. This provides a more stable structure for standing up whilst the substrate is drying.

Preferably the sample support is provided between the second part and the third part. In this case, an aperture may be provided in the second part to provide access to the substrate from the first part side of the second part when the sample support is in the storage condition.

Preferably a blood lancet is provided between on the first part or the first part side of the second part.

Various biological sampling and storage devices will now be described by way of example and with reference to the accompanying figures in which:

FIGURES la and lb are perspective views of a first biological sampling and storage device in various conditions of use;

FIGURES 2a to 2d are perspective views of a second biological sampling and storage device in various conditions of use;

FIGURES 3a to 3e are perspective views of a third biological sampling and storage device in various conditions of use;

FIGURES 4a to 4e are perspective views of a third biological sampling and storage device in various conditions of use; and,

FIGURES 5a to 5f are perspective views of a third biological sampling and storage device in various conditions of use.

Referring to Figures la and lb, a first biological sampling and storage device 100 is shown. The device is well suited for the collection of saliva, buccal cells, blood samples and various other bodily fluids. The device is also well suited to the collection of samples from animals and even plants. The device 100 comprises a container 102 and a sample support 104 attached thereto.

The container 102 is constructed from an injection moulded plastic material and comprises a first container part 106 and a second container part 108 which are attached at a film hinge 110. The first container part 106 acts as a base, and comprises a flat planar portion 112 from which an endless rectangular wall 114 extends normal thereto. The flat planar portion 112 and the wall 114 thereby define a container inner cavity 116. The flat planar portion 112 extends from the edge of the wall 114 thereby defining a flange 118 around the wall 114. The second container part 108 is hinged to the first container part 106 at the film hinge 110 along a long side thereof. The second container part 108 comprises a flat planar portion 120 having a flange 122 at its periphery. The flange 122 is approximately the same height as the wall 114 such that engagement of the first and second parts 106, 108 hermetically seals the cavity 116 as the underside of the second container part 108 bears against the wall 114. The first and second container parts 106, 108 snap together to retain them in a closed condition. Although not described in detail here, it will be understood that such mechanisms are well known and understood in the art.

The sample support 104 comprises a first and second support leg 124, 126 which meet at a live hinge at an apex 128. A sample carrier member 130 extends from the apex 128. A first and second cover member 132,134 extend from the apex 128 either side of, and adjacent to, the sample carrier member 130. A swab carrier 136 extends from the sample carrier member 130 at the end opposite the apex 128, and is hinged thereto along a frangible hinge line 138. A tab 140 is defined at the end of the swab carrier 136 opposite the sample carrier member 130.

The sample carrier member 130 comprises a frame having a central aperture 142 in which a sample retaining substrate 144 is positioned. The swab carrier 136 has a foam swab pad 146 attached thereto.

The support legs 124,126, carrier member 130, cover members 132,134 and the swab carrier 136 are all constructed from cardboard, and are all the same shape and size (in this embodiment, square). The sample support 104 is attached to the container 102 by attaching the first leg 124 to the first container part 106 within the cavity 116 proximate the wall 114 distal to the film hinge 110. The second leg 126 is attached to the second container part 108 within the flange 122 distal to the film hinge 110.

The sample support 104 is moveable between a folded condition when the container 102 is closed, and a deployed position (Figure lb). Figure la shows the support 104 in a transition between the folded and deployed condition.

In the folded condition, the cover members 132, 134 are brought together either side of the sample carrier member 130. The swab carrier 136 is folded over the first cover member 132 (Figure la). The flat, layered cover members 132, 134, carrier member 130 and swab carrier 136 are then pushed between the legs 124, 126 so as to move the apex 128 towards the film hinge 110 of the container 102. In doing so, the legs 124, 126 enclose the flat, layered cover members 132, 134, carrier member 130 and swab carrier 136 to lie flat within the cavity 116 at which point the container 102 can be closed.

When a user is ready to collect a sample, information regarding the sample can be written on / applied to the container (for example on the second container part 108). The user then opens the container 102 at which point the swab carrier 136 and tab 140 pop up due to the natural resilience of the material at the hinge 138. The user can then grab the tab to pull the swab carrier 136 from the container 102. This pulls the carrier member 130 and thus the apex 128, which tends to pull the legs 124,126 over centre (i.e. past a point at which they are aligned and co-planar) to the position shown in Figure lb. At this point the first and second container parts 106, 108 and the legs 124, 126 form a polygon (specifically a square, or diamond shape as visible in Figure lb).

The user can then lick the foam swab pad 146 before folding the swab carrier 136 onto the carrier member 130. This places the foam swab pad 146 into contact with the substrate 144. Pressure can be applied by closing the cover members 132, 134 on either side of the carrier member 130 and swab carrier 136 and applying pressure for several seconds.

Once the sample is transferred, the container 102 is stood on its short sides (i.e. one of the sides normal to the hinge 110). Because of its V shape, it stays in position with the sample substrate 144 exposed to the air on both sides.

Once dried, (or prior to drying), the swab carrier 136 can be removed completely by tearing along the frangible hinge line 138. The cover members 132, 134 are used to enclose the carrier member 130 once more, and the sample support is replaced into the cavity 116 before the container 102 is closed and therefore hermetically sealed.

It will be noted that a desiccant material 117 is incorporated within the cavity 116 attached to the first container part 106. This facilitates further drying of the substrate 144.

Referring to Figures 2a to 2d, a second biological sampling and storage device 200 is shown. The device is well suited for the collection of saliva and buccal cell samples. The device 200 comprises a container 202 a sample support 204 and a swab carrier 236 attached thereto.

The container 202 comprises a first container part 206 and a second container part 208 which are attached at a film hinge 210. The first container part 206 comprises a flat planar portion 212 from which an endless rectangular wall 214 extends normal thereto. The flat planar portion 212 and the wall 214 thereby define a container inner cavity 216.

The second container part 208 is hinged to the first container part 206 at the film hinge 210 along a long side thereof. The second container part 208 comprises a flat planar portion 220 having a wall 222 on a first side thereof, facing the first container part 206, and an endless peripheral lip 203 surrounding the wall 222. The flat planar portion 220 defines an aperture 250 therein having an external openable closure 252 which is hinged to the second container part 208. The flat planar portion 220 further defines a clip 234 proximate the aperture 250. The clip comprises a pair of resilient arms with inwardly projecting tabs, the function of which will be described below. The wall 222 is approximately the same height as the wall 214 (Fig. 2d) such that engagement of the first and second parts 206, 208 hermetically seals the cavity 216 as the wall 222 enters the wall 214 and bears against the flat planar portion 212.

The first and second container parts 206, 208 snap together to retain them in a closed condition. Although not described in detail here, it will be understood that such mechanisms are well known and understood in the art. The container 202 is constructed from an injection moulded plastic material.

The sample support 204 comprises a first and second support leg 224, 226 which meet at a hinged apex 228. The first support leg 224 defines an aperture 258 therein. A sample carrier member 230 extends from the apex 228. A tab 240 is defined at the end of the sample carrier member 230 opposite the apex 228. The sample carrier member 230 comprises a frame having a central aperture 242 in which a sample retaining substrate 244 is positioned.

The support legs 224, 226 and carrier member 230 are all constructed from cardboard, and are all the same shape and size (in this embodiment, square). The sample support 204 is attached to the container 202 by attaching the first leg 224 to the second container part 208 within the cavity 216 proximate the wall 222 distal to the film hinge 210. The second leg 226 is attached to the first container part 206 within the wall 214 distal to the film hinge 210.

The swab carrier 236 extends from a short side of the second container part 208, and is hinged thereto along a frangible film hinge line 238. The swab carrier 236 comprises an elongate neck portion 254 and a head 256 at its free end having a foam swab pad 246 attached thereto (Figure 2a). The swab carrier 236 is configured such that the foam swab pad 246 extends to the aperture 250 when the swab carrier 236 is folded about the frangible film hinge line 238 against the second container part 208.

The sample support 204 is moveable between a folded condition (Figures 2a to 2c) and a deployed position (Figure 2d).

In the folded condition, the carrier member 230 is pushed between the legs 224, 226 so as to move the apex 228 towards the film hinge 210 of the container 202. In doing so, the legs 224, 226 enclose the carrier member 230 to lie flat within the cavity 216 at which point the container 202 can be closed. The device 200 is typically stored in a sealed, sterile bag.

When a user is ready to collect a sample, the device 200 is removed from the sterile bag. Information regarding the sample can be written on / applied to the container (for example on the first container part 206). The user then places the foam swab pad 246 into the subject's mouth to collect the sample. The device 200 can be held by the container 202 without contacting the substrate 244.

When the sample has been transferred onto the swab pad 246, the closure 252 is opened. This exposes the substrate 244 through the aperture 258 in the first support leg 224 and the aperture 250 in the second container part 208. As shown in Figure 2c, the swab carrier 236 is folded over the second container part 208 such that the foam swab pad 246 contacts the substrate 244. The swab carrier 236 is held in this position by the clip 234. When the carrier 236 enters the space between the resilient arms, it is held in place by the tabs. Further pressure (if desired) can be applied to transfer the sample to the substrate 244 by depressing the back of the head 256 either directly, or by closing the closure 252 over the swab carrier 236, although it is envisaged that the clip 234 holds the carrier 236 in position against the substrate 244.

Once the sample is transferred, the closure 252 is closed and the swab carrier 236 can be removed by tearing along the frangible film hinge line 238 (Figure 2d). The swab carrier is disposed of.

To dry the sample on the substrate 244, the container 202 is opened as shown in Figure 2d. This tends to pull the legs 224, 226 apart and thereby advance the carrier member 230 towards the open mouth of the container 202. The tab 240 can be pulled to fully expose the substrate 244, and form a polygonal shape between the container parts 206, 208 and the legs 224, 224. The device 200 can be rested on its side (per Figure 2d) to air dry the substrate 244. Because of its V shape, the container stays in position with the sample substrate 244 exposed to the air on both sides. It will be noted that none of the sample support 204 needs to contact the surface on which the device 200 rests.

Once dried, the carrier member 230 is pushed back into the container 202 once more, and the sample support 204 is replaced into the cavity 216 before the container 202 is closed and therefore hermetically sealed.

It will be noted that a desiccant material 217 is incorporated within the cavity 216 attached to the first container part 206. This facilitates further drying of the substrate 244.

Referring to Figures 3a to 3e, a third biological sampling and storage device 300 is shown. The device is well suited for the collection of blood samples. The device 300 comprises a container 302, a sample support 304 and lancet kit 360 attached thereto.

The container 302 comprises a first container part 306, a second container part 307 and a third container part 308. The container parts 306, 307, 308 are all generally rectangular. The first and second parts 306, 307 are connected at a first film hinge 309 on a first long side of the second part 307. The second and third parts 307, 308 are connected at a second film hinge 310 on a second, opposite long side of the second part 307. The first and third parts 306, 308 are disposed on opposite sides of the central second part 307 thereby forming a Z shaped container when fully open as shown in Figure 3e.

The first container part 306 comprises a flat planar portion 312 and an endless peripheral wall 314. An endless rectangular sealing flange 313 extends from the planar portion 312 defining a cavity 316.

The second container part 307 comprises a central aperture 350, a first endless wall 351 and a second endless wall 352 opposite the first endless wall 351. Both walls 351, 352 extend around the periphery of the aperture 350.

The third container part 308 comprises a flat planar portion 320 having a flange 322 at its periphery. The flange 322 is approximately the same height as the wall 352 such that engagement of the second and third parts 307, 308 seals the aperture 350 as the inside of the third container part 308 bears against the wall 352.

The first and third container parts 306, 308 each snap to the second container part 307 to retain them in a closed condition. Although not described in detail here, it will be understood that such mechanisms are well known and understood in the art. The container 302 is constructed from an injection moulded plastic material.

The sample support 304 comprises a first and second support leg 324, 326 (Figure 3c) which meet at a hinged apex 328. The second support leg 326 defines an aperture 358 therein. A sample carrier member 330 extends from the apex 328. A tab 340 is defined at the end of the sample carrier member 330 opposite the apex 328. The sample carrier member 330 comprises a frame having a central aperture 342 in which a sample retaining substrate 344 is positioned.

The support legs 324, 326 and carrier member 330 are all constructed from cardboard, and are all the same shape and size (in this embodiment, square). The sample support 304 is attached to the container 302 by attaching the first leg 324 to the third container part 308 proximate the wall 314 distal to the film hinge 310. The second leg 326 is attached to the second container part 307 within the wall 352 distal to the film hinge 310. Therefore the aperture 358 is proximate the second container part 307.

The sample support 304 is moveable between a folded condition (Figures 3a and 3c) and a deployed position (Figure 3d).

In the folded condition, the carrier member 330 is pushed between the legs 324, 326 so as to move the apex 328 towards the film hinge 310 of the container 302. In doing so, the legs 324, 326 enclose the carrier member 330 to lie flat at which point the container 302 can be closed. The device 300 is typically stored in a sealed, sterile bag.

When a user is ready to collect a sample, the device 300 is removed from the sterile bag. Information regarding the sample can be written on / applied to the container (for example on the first container part 306).

The user opens the first container part 306 relative to the second container part 307 (Figure 3b). The user then uses a blood lancet provided in the lancet kit 360 to prick a finger. After the finger has bled sufficiently, it is placed onto the substrate 344. The substrate 344 is exposed via the aperture 358 in the second support leg 326 and the aperture 350 in the second container part 307. These apertures form a common path to the substrate 344 from the side of the first container part 306 when the third container part 308 is closed with respect to the second container part 307.

When the sample has been transferred onto the substrate 344, the lancet is disposed of, and a plaster applied to the user's finger (a plaster is provided within the first container part 306 with the lancet kit).

The third container part 308 is then opened, and the tab 340 used to pull the sample carrier member 330 from the container 302 until the support legs 324, 326 over centre- i.e. move past the position in which they are parallel and aligned.

The device 300, with the two container parts 306, 308 opened with respect to the second container part 307, can be rested on its side (per Figures 3d & 3e) to air dry the substrate 344- i.e. in a Z shape. Alternatively, the container 302 can be rested in the condition shown in Figure 3c (i.e. in a V shape). Both conditions are available to the user for drying, although the Z shape is more stable.

It will be noted that none of the sample support 304 needs to contact the surface on which the device 300 rests.

Once dried, the carrier member 330 is pushed back into the container 302 once more, and the sample support 304 before the container 302 is closed and therefore hermetically sealed.

It will be noted that a desiccant material 317 is incorporated within the cavity 316 attached to the third container part 308. This facilitates further drying of the substrate 344.

Referring to Figures 4a to 4f, a fourth biological sampling and storage device 400 is shown. The device is well suited for the collection of blood samples. The device 400 comprises a container 402 and a sample support 404 attached thereto (Figure 4e).

The container 402 is constructed from an injection moulded plastic material and comprises a first container part 406 and a second container part 408 which are attached at a film hinge 410. The first container part 406 comprises a flat planar portion 412 from which an endless rectangular wall 414 extends normal thereto. The flat planar portion 412 and the wall 414 thereby define a container inner cavity 416. The flat planar portion 412 extends from the edge of the wall 414 thereby defining a flange 418 around the wall 414. The second container part 408 is hinged to the first container part 406 at the film hinge 410 along a long side thereof. The second container part 408 comprises a flat planar portion 420 having a flange 422 at its periphery. The flange 422 is approximately the same height as the wall 414 such that engagement of the first and second parts 406, 408 hermetically seals the cavity 416 as the underside of the second container part 408 bears against the wall 414. The first and second container parts 406, 408 snap together to retain them in a closed condition. Although not described in detail here, it will be understood that such mechanisms are well known and understood in the art.

The second container part 408 comprises a lancet kit 460 (comprising a removable blood lancet) and plaster 461 stored therein, attached to the flat planar portion 420.

The sample support 404 (Figure 4e) comprises a support leg 424 hinged to a sample carrier member 430 extends at a live hinge 428. A tab 440 is defined at the end of the sample carrier 430 opposite the support leg 424.

The sample carrier member 430 comprises a frame having a central aperture 442 in which a sample retaining substrate 444 is positioned.

The support leg 424 and carrier member 430 are constructed from cardboard, and all the same shape and size (in this embodiment, square). The sample support 404 is attached to the container 402 by attaching the leg 424 to the first container part 406 within the cavity 416 proximate the wall 414 distal to the film hinge 410.

The sample support 404 is moveable between a folded flat condition (Figures 4c and 4d) and a deployed position (Figure 4e). In the folded condition, the carrier member 430 lies flat on the leg 424 such that the substrate 444 is exposed when the container 402 is open.

When a user is ready to collect a sample, information regarding the sample can be written on / applied to the container (for example on the second container part 408). The user then opens the container

402 (Figure 4b). The user pricks a finger using a blood lancet from the lancet kit 460 and applies the blood to the exposed substrate 444 (Figure 4d).

Once the sample has been transferred, the plaster 461 is used. The tab 440 can be pulled from the container 402 such that the sample carrier 430 moves to the deployed position in Figure 4e (i.e. is spaced apart from the container 402). The sample can then be left to dry by standing the container 402 is stood on its short sides (i.e. one of the sides normal to the hinge 410). Because of its V shape, it stays in position with the sample substrate 444 exposed to the air on both sides.

Once dry, the sample support 430 is replaced into the cavity 416 before the container 402 is closed and therefore hermetically sealed.

It will be noted that a desiccant material 417 is incorporated within the cavity 416 attached to the second container part 408. This facilitates further drying of the substrate 444.

Referring to Figures 5a to 5f, a fifth biological sampling and storage device 500 is shown, similar to the fourth. The device is well suited for the collection of blood samples. The device 500 comprises a container 502 and a sample support 504 attached thereto (Figure 5f).

The container 502 (Figure 5f) is constructed from an injection moulded plastic material and comprises a first container part 506 and a second container part 508 which are attached at a film hinge 510. The container 502 is generally shaped as an elongate rectangle. The first container part 506 comprises a flat planar portion 512 from which an endless rectangular wall 514 extends normal thereto. The flat planar portion 512 and the wall 514 thereby define a container inner cavity 516. The flat planar portion 512 extends from the edge of the wall 514 thereby defining a flange 518 around the wall 514. The second container part 508 is hinged to the first container part 506 at the film hinge 510 along a long side thereof. The second container part 508 comprises a flat planar portion 520 having a flange 522 at its periphery. The flange 522 is approximately the same height as the wall 514 such that engagement of the first and second parts 506, 508 hermetically seals the cavity 516 as the underside of the second container part 508 bears against the wall 514. The first and second container parts 506, 508 snap together to retain them in a closed condition. Although not described in detail here, it will be understood that such mechanisms are well known and understood in the art.

With reference to Figure 5d, the second container part 508 comprises a lancet 560 attached to a first region thereof. The lancet is attached to the to the flat planar portion 520 to project therefrom. A hinged lancet cover 559 attached internally on hinged flap 562 (Figure 5b) is provided to selectively cover the lancet 560 before and after use (Figure 5d).

The sample support 504 (Figure 5e) comprises a support leg 524 hinged to a sample carrier member 530 extends at a live hinge 528. A tab 540 is defined at the end of the sample carrier 530 opposite the support leg 524.

The sample carrier member 530 comprises a frame having a central aperture 542 in which a sample retaining substrate 544 is positioned.

The support leg 524 and carrier member 530 are constructed from cardboard, and all the same shape and size (in this embodiment, square). The sample support 504 is attached to the container 502 by attaching the leg 524 to the first container part 506 within the cavity 516 proximate the wall 514 distal to the film hinge 510. A plaster 561 is provided attached externally on the hinged flap 562 (Figure 5b).

The sample support 504 is moveable between a folded flat condition (Figure 5b) and a deployed position (Figure 5f). In the folded condition, the carrier member 530 lies flat on the leg 524 such that the substrate 544 is exposed when the container 502 is open. It will be noted that the carrier member (and hence substrate 544) is positioned in a region of the cavity 516 in which it is offset from (i.e. not opposite to) the lancet 560- see Figure 5b.

When a user is ready to collect a sample, information regarding the sample can be written on / applied to the container (for example on the second container part 508). The user then opens the container 502 (Figure 5b). The user lifts the hinged flap 562 and pricks a finger using the lancet 560 (Figure 5c) and applies the blood to the exposed substrate 544 (Figure 5d).

Once the sample has been transferred, the hinged flap is returned to a closed position covering the lancet and re-exposing the plaster 561 for use (Figure 5e). The tab 540 can then be pulled from the container 502 such that the sample carrier 530 moves to the deployed position in Figure 5f (i.e. is spaced apart from the container 502). The sample can then be left to dry by standing the container 502 is stood on its short sides (i.e. one of the sides normal to the hinge 510). Because of its V shape, it stays in position with the sample substrate 544 exposed to the air on both sides.

Once dry, the sample support 530 is replaced into the cavity 516 before the container 502 is closed and therefore sealed.

It will be noted that, a desiccant material 517 is incorporated within the cavity 516 attached to the second container part 508. This facilitates further drying of the substrate 544.

Variations fall within the scope of the invention.

In a further embodiment, a barcode (or other computer-readable image) is applied to the outside of the container in addition to a space for the sample provider's name and date (or other identifying information). The same barcode is applied to the sample carrier (i.e. carrier 130; 230; 330; 430 or 530). Thus when the name and date are written on the container, there is a direct relation to the DNAcontaining biological sample inside the box.

In a still further embodiment, there is an area identified on the exterior of the container for the user 5 to apply a fingerprint as the identifying information.

In each of the above embodiments, the sample carrier 130; 230; 330; 430 or 530 may be attached to the remaining sample support structure by a frangible connection. This allows the carrier to be detached from the rest of the device e.g. for automated analysis in the lab.

Although the above-described sample supports are constructed from cardboard, it is envisaged that 10 other semi-flexible materials are suitable, such as plastics materials.

In the embodiment of Figs. 2a to 2d, a peelable, sealed film may be placed over the lip 203 to keep the swab carrier 236 clean in the folded position (wherein is is retained by the clip 234 when stored).

Claims

Claims

1. A biological sample collection and / or storage device comprising:

a container having a first part, a second part and a hinge therebetween such that the container is movable between a closed condition and an open condition, the container defining a cavity therein

5 in the closed condition;

a sample support comprising at least one support leg attached to the container at a first end, and a sample carrier comprising a sample substrate, the sample carrier attached to the support leg at a second end such that the sample support is movable between a storage condition in which it is contained in the cavity, and a drying condition in which the sample substrate is spaced apart from the

10 cavity.
2. A biological sample collection and / or storage device according to claim 1, in which the container is configured to rest on a horizontal surface in the open condition with the sample support in the drying condition.
3. A biological sample collection and / or storage device according to claim 2, in which the 15 container is configured to rest on a horizontal surface in the open condition with the sample support in the drying condition and an axis of the hinge normal to the horizontal surface.
4. A biological sample collection and / or storage device according to any preceding claim, in which the hinge is configured to have an undeformed state in which the first and second parts of the container form an angle of 10 to 100 degrees about the hinge.

20 5. A biological sample collection and / or storage device according to claim 4, in which the hinge is a live hinge.

6. A biological sample collection and / or storage device according to any preceding claim, in which the sample support comprises a tab to pull the sample carrier from the container.

7. A biological sample collection and / or storage device according to any preceding claim, in 25 which a sample support hinge is defined between the support leg and the sample carrier allowing the support leg and the carrier to be folded into the storage condition.

8. A biological sample collection and / or storage device according to any preceding claim, in which the sample support comprises a first and a second support leg joined at an apex, in which the sample carrier extends from the apex.

9. A biological sample collection and / or storage device according to claim 8, in which the first support leg is attached to the first part of the container, and the second support leg is attached to the second part of the container.

10. A biological sample collection and / or storage device according to claim 9, in which the first
5 and second support legs are attached to the respective container parts spaced apart from the container hinge, such that the legs form a quadrilateral with the container in the drying condition.

11. A biological sample collection and / or storage device according to any preceding claim, in which the sample support comprises at least one cover member extending on one side of the sample carrier.
10 12. A biological sample collection and / or storage device according to any preceding claim, in which the sample support comprises a swab carrier comprising a swab, the swab carrier having a collection position in which the swab is exposed for collection of cells, and a transfer position in which the swab is in contact with the substrate.
13. A biological sample collection and / or storage device according to claim 12, in which the swab

15 carrier is rotatable between the collection position and the transfer position.
14. A biological sample collection and / or storage device according to claim 13, in which the swab carrier is attached to the sample carrier by a hinge.
15. A biological sample collection and / or storage device according to claim 13, in which the swab carrier is attached to the container.

20
16. A biological sample collection and / or storage device according to claim 15, in which the container comprises an aperture through which the swab can contact the substrate in the transfer position.
17. A biological sample collection and / or storage device according to claim 16, in which the container comprises an openable closure configured to selectively close the aperture.

25
18. A biological sample collection and / or storage device according to any of claims 12 to 17, in which the swab carrier is removable via a frangible portion.
19. A biological sample collection and / or storage device according to any preceding claim, comprising a blood lancet stored within the container.
20. A biological sample collection and / or storage device according to claim 19, in which the sample support is attached to the first part of the container, and the lancet is attached to the second part of the container.
21. A biological sample collection and / or storage device according to claim 20, in which the sample substrate and lancet are offset in a lateral direction.
22. A biological sample collection and / or storage device according to any of claims 19 to 21, comprising a plaster stored within the container
23. A biological sample collection and / or storage device according to any preceding claim, in which the container comprises a third part hinged to the second part such that the second part is disposed between the first and third parts in the closed condition.
24. A biological sample collection and / or storage device according to claim 23, in which the first and third parts are hinged to the second part on opposite sides of the second part such that the container forms a Z when both the first and second parts are rotated to an open position.
25. A biological sample collection and / or storage device according to claim 23 or 24, in which the sample support is provided between the second part and the third part.
26. A biological sample collection and / or storage device according to claim 26, in which an aperture is provided in the second part to provide access to the substrate from the first part side of the second part when the sample support is in the storage condition.

2J. A biological sample collection and / or storage device according to claim
27, in which a blood lancet is provided between on the first part or the first part side of the second part.
28. A biological sample collection and / or storage device as described herein, with reference to, or in accordance with, the accompanying figures.

Intellectual

Property

Office

Application No: Claims searched:

GB 17003 89.8 1-27