Patent Publication Number: US-11660078-B2

Title: Sample collection device

Description:
CROSS-REFERENCE TO RELATED APPLICATION(S) 
     This patent application is a U.S. national stage entry of International Patent Application No. PCT/US2017/046374, filed on Aug. 10, 2017, which claims priority to U.S. Provisional Patent Application No. 62/373,255, filed on Aug. 10, 2016, the entire contents of each of which are fully incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The embodiments described here relate to the collection of biological samples, and more particularly, to a particle filtering and shredding device for oral sample collection. 
     BACKGROUND OF THE INVENTION 
     Oral cavity content, such as saliva, sputum, or buccal cells, can provide an immense amount of information about our health and is a viable alternative for a blood sample. Oral sampling is quite appealing due to its non-invasive nature and can be self-collected with limited assistance. 
     A variety of advancement has been achieved to simplify oral sample collection for DNA/analyte stabilization and transport at room temperature. Oral sample collection is conventionally achieved using one of two methods—either intra-orally or by soaking a swab or sponge and then either releasing it into a collection device with stabilizer or the analyte stabilizer is added later by the collector. 
     Direct spit into a tube with or without a funnel is another approach for self-collection or oral samples. Several innovations have been introduced to help stabilize the collected sample at the point of collection, the most popular being to include the stabilizing buffer in the film covered cap/lid, which breaks when it comes in contact with a piercing protrusion in the lid receiving end and then releases the stabilized content to mix with the collected oral sample. Alternatively, the stabilizing buffer may be either dried inside the sample collection tube or provided separately in an ampule for the collector to break open and dispense the content to mix with the collected oral sample for optimized stabilization of the collected sample. 
     While methods and devices exist for collecting and stabilizing oral samples, none of the existing methods or devices addresses the issues that collecting a 1-2 mL sample size may be very challenging, especially for young children or the elderly. Moreover, the conventional devices collect samples that often contain food particles and other contaminants, which (1) increases bacterial content and thus lowers the quality of the DNA downstream applications; (2) can clog pipette tips during sample processing, resulting in sample failure; (3) adds a centrifugation step prior to processing the sample to eliminate the food particles, increasing turnaround time and reducing sample processing efficiency; and (4) reduces the gDNA stability overtime. 
     SUMMARY OF THE INVENTION 
     In one embodiment, the invention provides a sample collection device including a collection tube at least partially defining a storage volume therein, a mouthpiece coupled to the collection tube, the mouthpiece defining a channel providing access to the storage volume, and a filter at least partially positioned within the channel, where the filter is configured to filter a sample as it passes through the channel and into the storage volume. 
     In another embodiment, the invention provides a filtering device for use with a collection tube defining a storage volume therein, the filtering device including a mouthpiece that is substantially conical in shape and defining a channel configured to allow a sample to flow therethrough, and a filter at least partially positioned within the channel, where the filter defines a plurality of apertures configured to filter a sample passing through the channel. 
     In yet another embodiment, the invention provides a filtering device for use with a collection tube defining a storage volume therein, the filtering device including a channel having a first end and a second end opposite the first end, a mouthpiece extending from the channel proximate the first end, where the mouthpiece is substantially conical in shape, and a perforated wall enclosing the second end of the channel, where the perforated wall defines a plurality of apertures therein. 
     Other aspects of the invention will become apparent by consideration of the detailed description and accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    illustrates a sample collection device of the present invention with the lid in the closed position. 
         FIG.  2    illustrates an exploded view of the sample collection device of  FIG.  1   . 
         FIG.  3    is a top view of the sample collection device of  FIG.  1    with the lid in the open position. 
         FIG.  4    is a front view of the sample collection device of  FIG.  1    with the lid in a closed position. 
         FIG.  5    is a detailed view of the perforated wall of the sample collection device of  FIG.  1   . 
         FIG.  6    is a section view take along line  6 - 6  of  FIG.  3   . 
         FIG.  7    is a side view of the filter device of the sample collection device of  FIG.  1    with the lid in an open position. 
         FIG.  8    illustrates a fully assembled sample collection device with the lid in a closed position. 
         FIG.  9    illustrates the sample collection device of  FIG.  8   , with the lid moved to an open position by the user. 
         FIG.  10    illustrates a user depositing a sample into the sample collection device of  FIG.  8   . 
         FIG.  11    illustrates the sample collection device of  FIG.  8    with a sample deposited therein and the lid returned to the closed position. 
         FIG.  12    illustrates the sample collection device of  FIG.  8    with the filtering device removed from the collection tube and the travel cap positioned on the collection tube. 
         FIG.  13    is a cross-section view of another embodiment of the sample collection device. 
     
    
    
     DETAILED DESCRIPTION 
     Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. 
       FIGS.  1 - 6  and  8 - 12    illustrate a sample collection device  10  for collecting, filtering, and stabilizing an oral sample such as saliva, sputum, buccal cells, and the like. The collection device  10  includes a filtering device  14  to collect and filter the sample, and a collection tube  18  where the sample is mixed with a stabilizing buffer and stored for subsequent use. During operation, the sample passes through the filtering device  14  where particulates and other debris (e.g., food particles and the like) are removed from the sample. The sample is subsequently deposited within the collection tube  18  where the sample is mixed with a volume of stabilizing buffer for long-term storage. In the illustrated embodiment, the filtering device  14  may also aid in the stabilization process by helping to mix the sample with the stabilizing buffer. Furthermore, while the filtering device  14  and collection tube  18  are shown and described as a single unit, it is to be understood that the filtering device  14  is self-contained and may be retro-fit onto existing collection tubes  18  to provide the necessary filtering, shredding, and mixing characteristics described below. Still further, while the present invention is discussed in view of the collection and processing of an oral sample, it is to be understood that the sample collection device may be used to collect any biological sample, such as but not limited to, stool, urine, blood, sweat, tissue, semen, and the like. 
     Illustrated in  FIGS.  1 - 4 , and  6   , the collection tube  18  of the sample collection device  10  is substantially cylindrical in shape defining an axis  22  extending therethrough. The collection tube  18  includes an outer annular wall  26  that has a first end  30 , and a second end  34  opposite the first end  30 . The annular wall  26  also defines a channel  38 , which in turn, is subdivided by a dividing wall  42  positioned axially between the first end  30  and the second end  34 . Together, the annular wall  26  and the dividing wall  42  at least partially define a storage volume  46  in which the sample can be stored. In the illustrated embodiment, the dividing wall  42  is positioned approximately midway between the first and second ends  30 ,  34 ; however, in alternative embodiments the position of the dividing wall  42  may be altered to change the capacity of the storage volume  46  as necessary. 
     The first end  30  of the collection tube  18  includes a set of external threads  50  and provides access to the storage volume  46  of the collection tube  18 . The external threads  50  of the first end  30  are sized to threadably engage both the internal threads of filtering device  14  (described below) and the internal threads of a travel cap  54  (described below). Although not shown, the first end  30  of the collection tube  18  may also include a gasket or other sealing device to form a seal with at least one of the filtering device  14  or the travel cap  54 . 
     Illustrated in  FIGS.  1 - 7   , the filtering device  14  of the sample collection device  10  includes a mouthpiece or collection top  58 , and a filter  62  removably coupled to the mouthpiece  58 . During use, the filtering device  14  is threadably coupled to and forms a seal with the first end  30  of the collection tube  18  such that the sample must pass through the filtering device  14  in order to enter the storage volume  46  of the collection tube  18 . The filtering device  14  is configured to collect and filter the sample as it passes therethrough so that resulting sample positioned within the storage volume  46  is substantially free of debris and food particles. 
     Illustrated in  FIGS.  1 - 4 , and  6 - 12   , the mouthpiece  58  of the filtering device  14  is generally conical in shape having a body  66  with a neck portion  70  defining a channel  74 , and a flange portion  78  extending radially outwardly from the neck portion  70  to form an outer perimeter  82 . During use, the mouthpiece  58  acts as a funnel providing an outer surface  98  or interface against which the user can place his or her mouth and that directs the sample toward the channel  74  and into the filter  62  positioned therein (described below). 
     In the illustrated embodiment, the flange portion  78  of the mouthpiece  58  includes an oval-shaped outer perimeter  82  having a height  86  and width  90  substantially corresponding to but sized larger than the height and width of a human mouth. The flange portion  78  also forms a smooth convex shape such that the forward most point  94  of the outer surface  98  of the flange portion  78  is positioned axially forward of the outer perimeter  82  (see  FIG.  4   ). In all, the flange portion  78  of the body  66  is configured to ergonomically conform to the user&#39;s lips such that a “spitting action” results in the sample being directed toward the channel  74  and into the filter  62  with limited spillage or spatter. 
     Furthermore, the height  86  and width  90  of the outer perimeter  82  is sufficiently large so that, when the mouthpiece  58  is coupled to the collection tube  18 , the resulting device  10  forms a “rest angle  102 ” sufficiently large to limit the volume of sample that can exit the storage volume  46  when the device  10  is knocked or tipped over (e.g., rotates from a substantially vertical orientation to a substantially horizontal orientation). Stated differently, the rest angle  102  represents the angle at which the device  10  will rest on a support surface in a substantially horizontal orientation (see  FIG.  4   ). In the illustrated embodiment, the rest angle  102  is large enough so that at least a portion of the open end  150  of the filter  62  is positioned vertically above the perforated wall  158  when the device  10  is positioned on a support surface. 
     For the purposes of this application, the rest angle  102  of the collection device  10  is defined as the angle formed between two rays  110   a ,  110   b  positioned on a single plane that passes through the axis  22 . More specifically, the first ray  110   a  originates at the second end  34  of the collection tube  18  and extends axially along the annular wall  26 , while the second ray  110   b  originates at the same point as the first ray  110   a  and extends outwardly such that it intersects with the outer perimeter  82  of the mouthpiece  58  (see  FIG.  4   ). In the present embodiment, the outer perimeter  82  is non-circular and therefore the rest angle  102  varies dependent upon the orientation at which the device  10  is positioned on the support surface. In such embodiments, the smallest rest angle  102  that can result is regarded as the minimum rest angle. In the illustrated embodiment, the minimum rest angle  102  is greater than approximately 10 degrees. In other embodiments, the rest angle  102  may be between approximately 5 degrees and approximately 45 degrees. In still other embodiments, the rest angle  102  may be between approximately 8 degrees and approximately 30 degrees. In still other embodiments, the rest angle  102  may be between 10 degrees and approximately 20 degrees. 
     The neck  70  of the mouthpiece  58  is substantially annular in shape having a distal end  114  and at least partially defining the channel  74  sized to allow at least a portion of the filter  62  to be positioned therein. The channel  74  includes a first or threaded portion  122  positioned proximate the distal end  114 , and a second portion  126  extending from the threaded portion  122  away from the distal end  114 . In the illustrated embodiment, the threaded portion  122  of the channel  74  includes a set of internal threads  130  that are sized to threadably engage the external threads  50  of the first end  30  of the collection tube  18 . 
     The second portion  126  of the channel  74  is sized and shaped to correspond with the exterior profile of the open end  150  of the filter  62  (described below). More specifically, the second portion  126  is configured to engage the open end  150  of the filter  62  and restrict the axial movement of the open end  150  through the channel  74 . In some embodiments, the second portion  126  may also include a gasket or other elements such that a seal is formed between the second portion  126  and the open end  150 . 
     Illustrated in  FIGS.  5 - 7   , the filter  62  of the filtering device  14  is substantially cylindrical in shape having an outer annular wall  138  defining a channel  146  therethrough. The annular wall  138 , in turn, includes a first or open end  150  that provides access to the channel  146 , and a second end  154  opposite the open end  150  that is enclosed by a perforated wall  158 . During use, the sample enters the channel  146  of the filter  62  via the open end  150 , travels along the axial length of the channel  146 , and exits the filter  62  through the perforated wall  158 . In some embodiments, the annular wall  138  may be sufficiently long so that elongated items, such as swabs, can be positioned within the channel  146  of the filter  62  during use while leaving sufficient space for a cap or lid (described below) to be used. 
     In the illustrated embodiment, the open end  150  of the filter  62  includes a ridge  162  extending radially outwardly from the annular wall  138 . During use, the ridge  162  is configured to be at least partially received within and engage the second portion  126  of the channel  74 . More specifically, the ridge  162  is substantially oval-shaped having two opposing lobes that are configured to contact corresponding recesses of the second portion  126  of the mouthpiece  58  to stop the filter  62  from completely passing axially through the channel  74  of the neck  70 . In some embodiments, the ridge  162  may also include a gasket or other geometry allowing the ridge  162  to form a seal with the second portion  126  of the channel  74 , thereby limiting any spillage and assuring the entire sample introduced into the mouthpiece  58  is ultimately directed into and passes through the filter  62 . 
     Best illustrated in  FIG.  6   , the perforated wall  158  of the filter  62  substantially encloses the second end  154  of the annular wall  138 . The perforated wall  158  defines a plurality of apertures  166  sized large enough to allow the sample and stabilizing agent to flow therethrough, yet sufficiently small to restrict the passage of any debris or particles. In the illustrated embodiment, each aperture  166  of the perforated wall  158  is substantially rectangular in shape and includes an “effective width” defined herein as the shortest width produced by the aperture  166 . While the illustrated apertures  166  are rectangular in shape, the apertures  166  may include any cross-sectional shape such as circular, oval, polygonal, and the like. 
     In the illustrated embodiment, the apertures  166  of the perforated wall  158  are arranged in a substantially rectangular array, being positioned generally evenly over the entire wall  158 . In alternative embodiments, the apertures  166  may be oriented in a radial array, or be positioned in other orientations that produce the necessary filtering attributes. The illustrated perforated wall  158  is also substantially planar in contour, defining a filter plane  174  on which each of the apertures  166  are positioned. In alternative embodiments, the perforated wall  158  may be semi-circular, conical, and the like. 
     It is to be understood that while the perforated wall  158  of the present invention is integrally formed with the annular wall  138  of the filter  62 , in alternative embodiments the perforated wall  158  may be formed separately and be removably coupled thereto. 
     The filter  62  also defines one or more by-pass apertures  170  formed into the annular wall  138  and configured to permit the stabilizing buffer to flow behind and completely encompass the sample when it is positioned within the channel  146  of the filter  62 . As shown in  FIG.  7   , the by-pass apertures  170  are oriented such that at least a portion of the apertures  170  are positioned behind or upstream of the perforated wall  158 . Stated differently, at least a portion of the by-pass apertures  170  are positioned axially offset from and behind the filter plane  174  (e.g., closer to the open end  150  of the filter  62 ). In the illustrated embodiment, each by-pass aperture  170  includes an elongated slot originating proximate the second end  154  and extending axially along the annular wall  138  toward the open end  150 . However, in alternative embodiments, the by-pass apertures  170  may include a circular or rectangular aperture formed in the annular wall  138  and displaced axially from the perforated wall  158 . In the illustrated embodiment, the by-pass apertures  170  have an effective width that is less than or equal to the effective width of the apertures  166  formed in the perforated wall  158 . 
     While the filter  62  is shown as being separate from the mouthpiece  58 , it is to be understood that in alternative embodiments the two elements may be formed together as an integral unit. Furthermore, the filter  62  may be one of multiple, interchangeable filters, each having a unique aperture size and layout corresponding to the specific types and sizes of debris it is intended to filter out or allow therethrough. 
     Illustrated in  FIGS.  1 - 4 , and  6 - 13   , the filtering device  14  also includes a cap or lid  178  to selectively seal the open end  150  of the filter  62 . The lid  178  includes a base portion  182  and a sealing projection  186  extending from the base portion  182  to form a distal end  192 . During use, the lid  178  is movable with respect to the filtering device  14  between a closed position, where at least a portion of the projection  186  is positioned within channel  146  to restricts access thereto (see  FIGS.  1 ,  4 ,  6 , and  8   ), and an open position, where the projection  186  is not positioned within and does not restrict access to the channel  146  of the filter  62  (see  FIGS.  2 ,  3 ,  7 , and  9   ) 
     The base portion  182  of the lid  178  is shaped to substantially correspond with the contour of the outer surface  98  of the mouthpiece  58 . The base portion  182  also includes a tab or handle  196  extending from the base portion  182  beyond the outer perimeter  82  of the mouthpiece  58  such that the user may grasp the tab  196  and manipulate the lid  178  between the open and closed positions. The base portion  182  may also include a lanyard or flexible connection  200  extending between the base portion  182  and the mouthpiece  58  to couple the two items together. 
     Illustrated in  FIG.  13   , the device  10  also includes a travel cap  54  removably couplable to both the first end  30  and the second end  34  of the collection tube  18 . The travel cap  54  includes a set of internal threads (not shown) sized to engage the external threads  50  of the first end  30  of the collection tube  18 , and a groove (not shown) sized to releasably receive at least a portion of the second end  34  of the collection tube  18 . The travel cap  54  may also include a set of bar codes or other identifying indicia printed thereon (not shown). 
     To pre-assemble the filtering device  14 , the user combines the filter  62  and the mouthpiece  58 . To do so, the user axially inserts the second end  154  of the filter  62  into the channel  74  of the mouthpiece  58 . The user continues to advance the filter  62  into the channel  74  until the ridge  162  of the open end  150  of the filter  62  engages with and is seated within the second portion  126  of the channel  74  forming a seal therebetween (see  FIG.  7   ). 
     Once assembled, the user may then install the filtering device  14  on a sample collection tube  18 . To do so, the user first removes the travel cap  54  from the collection tube  18  exposing the external threads  50  thereof and providing access to the storage volume  46  via the first end  30 . The user then stows the travel cap  54  by attaching it to the second end  34  of the collection tube  18  by inserting at least a portion of the second end  34  into the corresponding groove of the travel cap  54  (see position of travel cap  54  in  FIG.  12   ). 
     With the travel cap  54  removed and stowed, the user may then couple the assembled filtering device  14  to the collection tube  18 . The user does so by inserting the second end  154  of the filter  62  into the storage volume  46  and screwing the internal threads  130  of mouthpiece  58  to the external threads  50  of the collection tube  18 . Once completed, the mouthpiece  58  forms a seal with the collection tube  18  such that the storage volume  46  may only be accessed via the channel  146  of the filter  62 . As such, any fluids or samples must pass through the filter  62  (e.g., the apertures  166  of the perforated wall  158 ) in order to enter or exit the storage volume  46  (see  FIG.  6   ). 
     In some embodiments, a pre-measured volume of stabilizing buffer may be placed in the storage volume  46  via the channel  146  of the filter  62  or directly into the first end  30  before the filtering device  14  and the collection tube  18  are coupled together. However, in alternative embodiments, the stabilizing buffer may come pre-loaded in the storage volume  46 . 
     In instances where the collection device  10  is not intended to be used immediately, the user may position the lid  178  of the mouthpiece  58  in the closed position, sealing the open end  150  of the channel  146 , and as a result, restricting access to the storage volume  46 . 
     To collect a sample, the user first re-orients the lid  178  from the closed position (see  FIG.  8   ), to the open position (see  FIG.  9   ), thereby providing access to the storage volume  46  via the channel  146  of the filter  62 . Once opened, the user places his or her lips against the outer surface  98  of the mouthpiece  58  and spits until the necessary volume of sample is produced (e.g., approximately three times; see  FIG.  11   ). As described above, the shape and contour of the mouthpiece directs the resulting sample toward the open end  150  of the filter  62  and into the channel  146  thereof. The sample then travels along the channel  146  and contacts the perforated wall  158 . 
     With the sample deposited within the filter  62 , the user then closes the device  10  by replacing the lid  178  to the closed position (see  FIG.  12   ). By doing so, the user seals the open end  150  of the filter  62  and produces an isolated volume  208  within the device  10  that includes the storage volume  46  of the collection tube  18  and the channel  146  of the filter  62 . 
     Once closed, the user agitates the device until the stabilizing buffer and the sample are thoroughly mixed (e.g., shaking the device approximately 10 times). When agitating the device  10 , the agitation motion causes the stabilizing buffer and sample to slosh around within the isolated volume  208 . More specifically, the stabilizing buffer flows through both the apertures  166  of the perforated wall  158  and the by-pass apertures  170  contacting and mixing with all sides of the generally more viscous oral sample. Simultaneously, the sample itself is forced through the apertures  166  of the perforated wall  158  causing all contaminants and particles larger than the effective width of the apertures  166  to be removed therefrom. Once complete, the agitation results in a mixed and filtered sample positioned in the bottom of the storage volume  46  of the sample tube  18  and all particulates and other containments remaining positioned within the channel  146  of the filter  62 . 
     With the sample prepared, the user may then store or ship the device for future processing and testing. In some instances, the user may remove the filtering device  14  from the collection tube  18  by un-screwing the mouthpiece  58  therefrom. By doing so, the user removes the debris and other particles positioned within the channel  146  of the filter  62  from the storage volume  46 —leaving only the mixed stabilizing buffer and sample solution behind. The user can then re-thread the travel cap  54  onto the first end  30 , sealing the storage volume  46  for travel and storage (see  FIG.  12   ). 
       FIG.  13    illustrates an alternative embodiment of the sample collection device  10 ′. The sample collection device  10 ′ is substantially similar to the sample collection device  10  and therefore only the differences are described herein. The sample collection device  10 ′ includes a collection tube  18 ′ and a filter  62 ′ removably coupled to the collection tube  18 ′ directly without a mouthpiece  58  present. In such an embodiment, the lack of a mouthpiece  58  reduces the device&#39;s footprint allowing the device  10 ′ to be more easily stored and handled. Such embodiments are typically used in conjunction with swabs, cotton balls, filter paper, and the like where the enlarged entry area of the mouthpiece  58  is not necessarily needed. Furthermore, the filter  62 ′ may be sized and shaped such that the travel cap  54  may completely encompass and seal the storage volume  46 ′ with the filter  62 ′ positioned therein. 
     Although the invention has been described in detail with reference to certain preferred embodiments, variations and modifications exist within the scope and spirit of one or more independent aspects of the invention as described.