Abstract:
Biological samples, such as saliva, are commonly collected on a swab and subsequently transferred to an absorbent storage medium. Embodiments of the present invention provide a biological sample collection device  600  comprising a collection portion  620  and a body portion  610 , the body portion including a holding portion  652  for holding a biological sample storage medium ( 618  FIG.  1 ), and a sample collection/transfer means. The collection portion  620  can be arranged in a first position shown in FIG.  4 , separated from the body portion for collecting a sample. The device employs depressible latches ( 630, 640  FIG.  6 ) to control the movements of the collection portion.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a filing under 35 U.S.C. 371 of international application number PCT/EP2012/071602, filed Oct. 31, 2012, published on May 10, 2013 as WO 2013/064558, which claims priority to application number 1118753.1 filed in Great Britain on Oct. 31, 2011. 
     FIELD OF THE INVENTION 
     The present invention relates to a device for collecting and storing biological samples. 
     BACKGROUND OF THE INVENTION 
     Biological samples, such as saliva taken for DNA profiling in criminal investigations, are commonly taken by swabbing a liquid containing biological material with an absorbent collection medium. Such collection media are, by necessity, exposed, and are therefore vulnerable to contamination. To maintain the integrity of the samples, they are typically transferred to and held in an absorbent storage medium, which may comprise a membrane impregnated with chemicals for stabilising the sample. The samples are allowed to dry and, once dry, the biological storage medium can be stored or transported to a testing facility for analysis. 
     Such methods of transferring biological samples from the collection medium to the storage medium typically involve bringing the collection medium into physical contact with the storage medium, perhaps with the application of a moderate amount of mechanical force; some of the liquid sample is then drawn by capillary action into the sample storage medium. Conventionally, this is a manual process and therefore consistent and uniform transfer of the biological sample from the collection medium to the storage medium depends heavily on the skill of the operator. 
     US2008/196517 proposes an integrated collection, transfer, and storage device into which a biological sample storage medium may be inserted. The device comprises a sample collection surface that can be brought into physical contact with the sample storage medium. It has been noted that the device illustrated in US2008/196517 is not simple to use and requires two hands to operate. Consequently, operation of the device is sometimes difficult in the field. Also, the construction of the device is such that direct contact between the operator and the collection portion of the device is necessary to transfer biological material; this is undesirable, as it may result in contamination of the sample and/or discomfort for the operator. Further, the force applied by an operator to cause transfer of the biological material may be uneven, causing the resulting transfer to be inconsistent and non-uniform. 
     Embodiments of the present invention address the problems mentioned above. 
     SUMMARY OF THE INVENTION 
     In accordance with a first aspect of the present invention, there is provided a biological sample collection device, comprising: 
     a body portion having an area for accepting a biological sample storage medium; and 
     a sample collection portion including a biological sample collection medium, said sample collection portion being connected to said body portion for relative movement said relative movement allowing the positioning of the collection portion relative to the body portion at least into: an open position whereby the collection portion extends away from the body portion to allow collection of the sample on said collection medium; a transfer position whereby the collection medium and the storage medium can be brought into contact to allow at least partial transfer of the sample collected on said collection medium onto said storage medium; and into a closed position intermediate the first and second positions; the device including a releasable latch for holding the sample collection portion in both said transfer and closed positions, and for selectively releasing the collection portion to allow the movement from the closed to the open position, or to allow the movement from the transfer position to the closed position; the device being characterised in that the latch is formed from at least two depressible controls each separately operable for allowing said movement from the closed to the open position, and for allowing said movement from the transfer to the closed position. 
     In an embodiment, the device further includes a further depressible control for causing the collection portion to move from the open position to the transfer position. 
     Preferably, the at least two depressible controls each comprise a cantilevered button, moveable away from the collection portion to allow movement of the collection portion. 
     In an embodiment, the body portion includes a recess for accepting the sample collection portion, the recess being open to the area for accepting the sample storage medium, and wherein, when accepted into the area, the sample storage medium is substantially inaccessible from the recess when the collection portion is in the transfer or closed positions. 
     In an embodiment, when the transfer and closed positions are obtained, the collection portion is substantially within the recess. 
     In an embodiment, when the third position is obtained the collection portion has a surface which lies within the recess, substantially flush with an outer surface of the body portion. 
     Preferably, the outer surface and the collection portion, when in the closed position defines a substantially continuously curved external surface. 
     In an embodiment, the relative movement is rotational movement substantially about a pivot axis extending through the body portion. 
     In an embodiment the collection portion is urged toward the open position by means of a resilient part connected to or forming part of the body portion. 
     Preferably, said urging is resisted by a stop at or adjacent the open position. 
     Further features and advantages of the invention will become apparent from the following description of illustrative embodiments of the invention, given by way of example only, which is made with reference to the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1, 3, 4, and 5  show perspective views of a biological sample collection device a according to the present invention; 
         FIG. 2  shows a sectional view of the device shown in  FIG. 1 ; 
         FIG. 6  shows an enlarged perspective view of components of the device shown in  FIG. 1 ; and 
         FIGS. 7 a  to 7 e    show, schematically, the operation of components illustrated in  FIG. 6 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring to  FIG. 1  there is shown a biological sample collection device  600 . This device has a body portion  610  and a relatively moveable collection arm portion  620  shown in a closed position held adjacent the body  610 . In addition the device has three depressible controls in this case in the form of latch buttons  624 ,  630  and  640 , described in more detail below. A biological sample storage medium  618  usually supplied in a card form as described above, can be inserted into a slot  650  which accepts the medium into the body  610 . 
       FIG. 2  shows a vertical mid-section through the device  600 . The arm  620  is pivotable about a pivot axis P, and is urged to move by a resilient tab  612 . However, the arm  620  is restrained from such movement by the latch button  630 . In this figure, there is shown an internal area  652  which houses the storage medium  618  in use once inserted. 
       FIG. 3  shows latch button  630  in a depressed position, pushed by a user in the direction of arrow A, such that the arm  620  is then free to pivot upwardly in the direction of arrow B. 
       FIG. 4  shows the arm  620  in its fully extended collection or open position, prevented from further pivoting by a stop member  623 . The now extended arm  620  includes a foam pad medium  626  which, as explained above, is used for biological sample collection. The extended arm  620  reveals a recess  628  in which the arm sits when not extended. It is apparent from  FIG. 6  that the recess allows the arm to sit flush in the body  610 , meaning that the body will then have a generally continuously curved outer surface with no substantial discontinuities or protuberances. Such a shape fits comfortably in a user&#39;s hand or pocket, for carrying, for example to a crime scene. The recess  628  is open to the area or portion  652  which accommodates the sample storage medium  618 . The area  652  is bounded top and bottom by ribs  654  which improve drying of the sample storage medium following transfer of a biological sample from the pad  626  to the medium. 
       FIG. 5  shows the arm  620  in a transfer position, where the button  624  has been pushed in the direction of arrow C. This action forces the arm below the latch buttons  630  and  640  and causes transfer of the sample from the pad  626  to the storage medium  618  in the storage area  652 . In practice this position is held for about 10 seconds, whereafter, the button  640  is depressed to allow the arm  620  to be urged again into the closed position which is the same position shown in  FIG. 1 . 
     In the closed position, the storage medium can dry, and either the whole device  600 , or the removed sample storage medium  618  can be shipped for DNA/RNA analysis. It will be noted that the storage medium is not accessible when the arm  620  is closed. This prevents accidental contamination of the storage medium. 
       FIG. 6  shows the latch mechanism in enlarged and exploded detail. The latch buttons  630  and  640  pivot generally via a so called ‘living hinge’ which in this case is respective flexible plastics necked portions  632  and  642  of the body  610 . Each latch button  630  and  640  is resiliently cantilevered about the hinges  632  and  642 , and each has a detent  634  and  644  respectively, at their distal ends, which, when the buttons  620  and  640  are in their undisturbed positions shown, will interfere with the movement of an opposing detent  621  on the end of the arm  620 . When depressed, the respective detents of the buttons will move out of interference with the opposing detent  62 . Shown also is the further latch button  624  formed on the back of the arm  620 . 
       FIGS. 7 a  to 7 e    illustrate the operating cycle of the device. 
       FIG. 7 a    shows the position of the buttons  630  and  640  with respect to the arm  620 , corresponding to  FIG. 1 . In this position the opposing detent  621  is captured between detent  634  and detent  644  so that the arm  620  is prevented from moving upwardly and downwardly, so the arm remains in the closed position. 
       FIG. 7 b    shows the button  630  depressed, which in turn releases the arm  620  for upward movement in the direction of arrow B as shown in  FIG. 2 . The arm is then extended into the open, collection, position as shown in  FIG. 3  and a biological sample is then collected. 
       FIG. 7 c    shows the arm  620  now in the transfer, position, corresponding to  FIG. 4 . The opposing detent  621  has been forced over the detents  634  and  644 , by pressing button  624  in the direction of arrow C, so that it is captured on the underside of the detent  644 . In this position the pad  626  maintains contact with the sample storage medium  618 . It will be noted that the storage medium  618  is aligned with the pad  626  to give substantially even contact force between the pad  626  and the medium  618 . 
       FIG. 7 d    shows the button  640  depressed so as to release the opposing detent  621  and allow the arm  620  to rise to the point shown in  FIG. 7 e   , where again the further detent  621  is captured between the two detents  634  and  644  when the button  640  is released. In this closed position, the device can be shipped, or the medium  618  can be removed and shipped separately. 
     The detents shown are merely one example of many mechanical controls which could be employed to afford the positions of the arm as described above. For example, in place of protruding detents, recesses or grooves could be used on the arm  620  or on the buttons  630  or  640  cooperating with complementary features on the opposing parts. 
     More generally, the biological sample collection device  600  described above are supplied with a storage medium, for example the card  618  in place. However, in some circumstances the storage medium may be supplied separately from the respective device. Typically, the device is for single-use; however, in some applications the collection and storage mediums described may be replaceable. 
     The biological sample device  600  described above may comprise an identification tag comprising identification information. The tag may be printed directly onto the device, or be incorporated onto an adhesive label, or be added to the device by any other means. The tag may comprise textual and/or graphical information including sample identification numbers, donor details, and/or a barcode relating to such details stored remotely in a database. Other types of tag may be used, for example an RFID tag. 
     The device  600  may be manufactured from a plastics material using an injection moulding process. The plastics material should be compliant enough to allow temporary deformation of resilient parts of the device that are required to deform, when subjected to a suitable externally applied force, and to return to their original positions, upon removal of the externally applied force. The plastics material may also be selected such that it does not easily build up a static charge when handled, since such static charge can cause problems such as different collection devices sticking together, interfering with handling. An exemplary suitable plastics material is polypropylene homopolymer resin. However, any other suitable plastics material could be used as an alternative. 
     The above described biological sample collection devices are typically used for collection of biological samples such as saliva, blood or other bodily fluids. Samples collected by operation of the devices may be subjected to processing such as DNA or RNA amplification procedures, for example as polymerase chain reaction (PCR) procedures. 
     It is to be understood that any feature described in relation to any one embodiment may be used alone, or in combination with other features described, and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments. Furthermore, equivalents and modifications not described above may also be employed without departing from the scope of the invention, which is defined in the accompanying claims.