US2005252820A1PendingUtilityA1

Sampling kits, devices and uses thereof

Assignee: SANCHEZ-FELIX MANUEL VPriority: Jun 28, 2002Filed: Jun 27, 2003Published: Nov 17, 2005
Est. expiryJun 28, 2022(expired)· nominal 20-yr term from priority
A61B 10/0051A61B 10/02A61B 10/0045A61B 10/0096
24
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Claims

Abstract

Disclosed are sampling kits and sampling devices and uses of the same. A sampling kit is disclosed including a swab ( 10 ) with a handle ( 12 ) and a swab head ( 14 ). The kit also includes a container ( 30 ) with an optional closure ( 70 ). Sampling head ( 14 ) is detachable from the handle ( 12 ) by engaging the sampling head with engagement means and moving the handle with respect to the engagement means. The engagement means may be formed on the closure or on the container. After detachment of the sampling head from the handle, the sampling head remains in the container. The container may then be sealed using sealing means ( 220 ). Also disclosed is a sampling kit containing processing means for initiating sample processing of sample collected. The processing means disclosed is an absorbent cover means ( 88 ) which allows sample held by the sampling head to transfer to the cover means. In particular, the adsorbent material may be an impregnated paper which is capable of yielding amplifiable nucleic acid from buccal cells.

Claims

exact text as granted — not AI-modified
1 . A sampling kit having: 
 a sampling device with a sampling head and a handle;    a container for receiving the sampling head; and,    optionally, a closure for closing an open end off the container, wherein the container or closure has engagement means arranged so that the sampling head is detachable from the handle by engaging the sampling head with the engagement means and moving the handle with respect to the engagement means.    
   
   
       2 . A sampling kit according to  claim 1 , wherein, in the sampling device, the handle has a distal end and a proximal end, the proximal end being for handling by a user and the sampling head being detachably supported around a support portion at the distal end of the handle.  
   
   
       3 . A sampling kit according to  claim 2  wherein the sampling head is connected to the support portion by at least one frangible connection extending therebetween.  
   
   
       4 . A sampling kit according to  claim 2  wherein the sampling head is at least partially hollow so that, before the sampling head is detached from the handle, there is a space suitable for sample retention between an internal surface of the sampling head and a surface of the support portion.  
   
   
       5 . A sampling kit according to  claim 1  wherein the sampling head is formed so that, in use, once detached from the handle, it presents an aperture.  
   
   
       6 . A sampling kit according to  claim 5  wherein, in use, the aperture becomes enlarged compared to the cross-sectional area of the handle during detachment of the sampling head from the handle.  
   
   
       7 . A sampling kit according to  claim 1  wherein the sampling head is splittable into two or more segments, thereby allowing exposure for analysis of sampled material held inside the sampling head.  
   
   
       8 . A sampling kit according to  claim 7  wherein, in use, the segments of the sampling head which split apart abut the inner surface of the container.  
   
   
       9 . A sampling kit according to  claim 1  wherein the sampling head is formed of a material which substantially does not absorb DNA and/or water.  
   
   
       10 . A sampling kit according to  claim 1  wherein the engagement means is formed at a surface of the closure.  
   
   
       11 . A sampling kit according to  claim 10  wherein the engagement means has a tapering shape to assist, in use, detachment and/or segmentation of the sampling head.  
   
   
       12 . A sampling kit according to  claim 10  wherein the handle of the sampling device is slidable within the closure, to enable detachment of the sampling head by the engagement means.  
   
   
       13 . A sampling kit according to  claim 12  wherein the closure includes an aperture in which the handle of the sampling device is slidable the aperture being closable substantially to seal the closure when the handle is removed from the closure.  
   
   
       14 . A sampling kit according to  claim 10  wherein the closure includes an adapter and sealing means shaped to cooperate with the adapter substantially to seal the adapter.  
   
   
       15 . A sampling kit according to  claim 14  wherein the adapter is connectable to the container at the open end of the container.  
   
   
       16 . A sampling kit according to  claim 14  wherein the engagement means is formed at a surface of the adapter.  
   
   
       17 . A sampling kit according to  claim 16  wherein the engagement means is an aperture through the adapter, shaped to allow the sampling head through the adapter in a first rotational position and to prevent the sampling head passing through the adapter in a second rotational position.  
   
   
       18 . A sampling kit according to  claim 14  wherein the sampling head is detachable from the handle via relative rotational movement between the engagement means and the sampling head.  
   
   
       19 . A sampling kit according to  claim 14  wherein the sealing means is attachable to the container via attachment means independent of the cap.  
   
   
       20 . A sampling kit according to  claim 1  wherein the engagement means is formed on an internal surface of the container.  
   
   
       21 . A sampling kit according to  claim 20  wherein the engagement means is a lip, step, barb or slot formed on the internal surface of the container and shaped and/or directed to allow the sampling head to pass into the container in an entry direction, but not in an exit direction, to detach the sampling head from the handle.  
   
   
       22 . A sampling kit according to  claim 21  wherein the engagement means comprises a tapering internal cross-section of the container.  
   
   
       23 . A sampling kit according to  claim 1  wherein the container is suitable for multiple well testing, such as part of a 24, 32, 48, 96, 384 or 1536 well plate or is suitable for use in such a well plate or microplate.  
   
   
       24 . Use of a sampling kit according to  claim 1  to take a biological sample from a subject or location, with the optional further steps of storing and/or processing the sample.  
   
   
       25 . Use off a sampling device to take a biological sample from a subject, the sampling device having a handle and a detachable sampling head, the use including the step of engaging the sampling head with engagement means of a container or of an associated closure and moving the handle with respect to the engagement means to detach the sampling head from the handle, with the optional further steps of storing and/or processing the sample.  
   
   
       26 . A use according to  claim 24  wherein the sampling head is detached from the handle by manipulating the handle to force the sampling head against the engagement means and, optionally, subsequently removing the handle.  
   
   
       27 . A use according to  claim 26  wherein the sampling head is rotated from a first, entry rotational position to a second, detachment configuration, relative to the engagement means, before detachment of the sampling head from the handle.  
   
   
       28 . A use according to  claim 26  wherein the sampling head deforms during engagement with the engagement means, thereby breaking a connection between the sampling head and the handle.  
   
   
       29 . A use according to  claim 28  wherein subsequent movement of the handle with respect to the sampling head causes the sampling head to split or partially split into segments.  
   
   
       30 . A use according to  claim 23  wherein detachment of the sampling head from the handle occurs during withdrawal of the handle from the container, engaging the sampling head on the engagement means.  
   
   
       31 . A use according to any one of  claim 23  wherein detachment of the sampling head from the handle occurs during entry of the sampling device into the container.  
   
   
       32 . A use according to  claim 23  wherein the detachment of the sampling head from the handle occurs via movement of the sampling device substantially along a principal axis of the container.  
   
   
       33 . A sampling kit according to  claim 23  further including processing means for initiating sample processing of sample collected, the processing means being locatable in the container.  
   
   
       34 . A sampling kit having: 
 a sampling device with a sampling head and a handle;    a container for receiving the sampling head;    processing means for initiating sample processing of sample collected, and,    optionally, a closure for closing an open end of the container, wherein the processing means is locatable in the container.    
   
   
       35 . A sampling kit according to  claim 33  or  claim 34  wherein the processing means is an absorbent cover means to allow, in use, sample held by the sampling head to transfer to the cover means.  
   
   
       36 . A sampling kit according to  claim 35  wherein the absorbent material is an impregnated paper or fabric which is capable of yielding amplifiable nucleic acid from suitable biological material, such as buccal cells.  
   
   
       37 . A sampling kit according to  claim 35  wherein the absorbent covering means is configurable to be interposed between the sampling head and an inner surface of the container.  
   
   
       38 . A sampling kit according to  claim 33  wherein the processing means is capable of initiating or performing cell lysing on sample held, in use, in the container.  
   
   
       39 . Use of a sampling kit according to  claim 33  to take a biological sample from a subject or location, with the optional further steps of storing and/or processing the sample.  
   
   
       40 . A use according to  claim 24  further including the step of carrying out at least one of a DNA/RNA assay, forensics, chemical, biological, microbiological sampling, or cleaning validation of process equipment to be used for pharmaceuticals, foods, proteins or biological species.

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