Biological Testing Device and Methods of Using and Testing

Abstract

A biological sampling device for collecting biological material from within an organism can include a sheath, a collector, a handle, and optionally, an applicator. In a secured position, a collector is within the sheath and/or applicator; in a sampling position, a collector is outside the sheath and applicator. A device can be inserted into an orifice of an organism with a collector being transitioned from a secured to a sampling position, moved via a handle to collect biological material for testing, and subsequently returned to a secured position. A biological sample can be prepared from biological material collected by a biological sampling device, and a biological sample can be tested by application of a testing protocol.

1 . A biological sampling device for collecting biological material from within an organism, comprising:
 a sheath having a first sheath end, a second sheath end, and a sheath cavity that extends between the first and second sheath ends;   a collector, having an abrasive outer surface area, and being configured to transition between a secured position, in which said collector is positioned within the sheath cavity, and a sampling position, in which said collector is positioned outside of the sheath cavity; and   a handle, having a first handle end and a second handle end, and extending through the sheath cavity with the first handle end being fixed to said collector and the second handle end extending from the second sheath end;   wherein when the first sheath end is inserted into the organism through an orifice of the organism, said handle and said sheath are configured to transition said collector from the secured position to the sampling position, said handle is configured to move said collector when in the sampling position, such that the outer surface area collects the biological material by abrasively contacting an internal portion of the organism, and said handle and said sheath are configured to transition said collector from the sampling position to the secured position.   
     
     
         2 . The device of  claim 1 , wherein said sheath has a continuous exterior sheath surface. 
     
     
         3 . The device of  claim 1 , wherein at least a portion of said sheath is cylindrically shaped. 
     
     
         4 . The device of  claim 1 , wherein said sheath is provided as a combination of multiple shapes. 
     
     
         5 . The device of  claim 1 , wherein said sheath is formed, at least in part, from a plastic. 
     
     
         6 . The device of  claim 1 , wherein the first sheath end is tapered. 
     
     
         7 . The device of  claim 1 , wherein the first sheath end is rounded. 
     
     
         8 . The device of  claim 1 , wherein the first sheath end includes at least one petal. 
     
     
         9 . The device of  claim 1 , wherein the first sheath end includes a plurality of petals. 
     
     
         10 . The device of  claim 1 , wherein at least a portion of the sheath cavity is cylindrical. 
     
     
         11 . The device of  claim 1 , wherein at least a portion of the sheath cavity is coaxial with said sheath. 
     
     
         12 . The device of  claim 1 , wherein the sheath cavity has a non-uniform shape. 
     
     
         13 . The device of  claim 1 , wherein said collector is symmetric around at least one axis when said collector is in at least one of the sampling position and the secured position. 
     
     
         14 . The device of  claim 1 , wherein said collector is asymmetric around at least one axis when in at least one of the sampling position and the secured position. 
     
     
         15 . The device of  claim 1 , wherein said collector includes a plurality of bristles. 
     
     
         16 . The device of  claim 1 , wherein said collector deforms when in the secured position. 
     
     
         17 . A biological sampling device for collecting biological material from within an organism, comprising:
 a sheath having a first sheath end, a second sheath end, and a sheath cavity that extends between the first and second sheath ends;   an applicator having a first applicator end, a second applicator end, and an applicator cavity that extends between the first and second applicator ends, said applicator being disposed within the sheath cavity;   a collector, having an abrasive outer surface area, and being configured to transition between a secured position, in which said collector is positioned within at least one of the sheath cavity and applicator cavity, and a sampling position, in which said collector is positioned outside of the sheath and applicator cavities; and   a handle, having a first handle end and a second handle end, and extending through the sheath and applicator cavities with the first handle end being fixed to said collector and the second handle end extending from the second sheath and second applicator ends;   wherein when at least one of the first sheath end and the first applicator end is inserted into the organism through an orifice of the organism and said collector is in the secured position, at least two of said handle, said sheath, and said applicator are configured to transition said collector from the secured position to the sampling position, said handle is configured to move said collector when in the sampling position, such that the outer surface area collects the biological material by abrasively contacting an internal portion of the organism, and a plurality of said handle, said sheath, and said applicator are configured to transition said collector from the sampling position to the secured position.   
     
     
         18 . The device of  claim 17 , wherein said sheath has a continuous exterior sheath surface. 
     
     
         19 . The device of  claim 17 , wherein the second applicator end extends from the second sheath end. 
     
     
         20 . The device of  claim 17 , wherein at least a portion of said sheath and said applicator are cylindrically shaped. 
     
     
         21 . The device of  claim 17 , wherein at least one of said sheath and said applicator is provided as a combination of multiple shapes. 
     
     
         22 . The device of  claim 17 , wherein at least one of said sheath and said applicator is formed, at least in part, from a plastic. 
     
     
         23 . The device of  claim 17 , wherein at least one of the first sheath end and the first applicator end is tapered. 
     
     
         24 . The device of  claim 17 , wherein at least one of the first sheath end and the first applicator end is rounded. 
     
     
         25 . The device of  claim 17 , wherein at least one of the first sheath end and the first applicator end includes at least one petal. 
     
     
         26 . The device of  claim 17 , wherein at least one of the first sheath end and the first applicator end includes a plurality of petals. 
     
     
         27 . The device of  claim 17 , wherein at least a portion of at least one of the sheath cavity and the applicator cavity is cylindrical. 
     
     
         28 . The device of  claim 17 , wherein at least a portion of the sheath cavity is coaxial with said sheath. 
     
     
         29 . The device of  claim 17 , wherein at least a portion of the applicator cavity is coaxial with said applicator. 
     
     
         30 . The device of  claim 17 , wherein at least one of the sheath cavity and the applicator cavity has a non-uniform shape. 
     
     
         31 . The device of  claim 17 , wherein said collector is symmetric around at least one axis when said collector is in at least one of the sampling position and the secured position. 
     
     
         32 . The device of  claim 17 , wherein said collector is asymmetric around at least one axis when said collector is in at least one of the sampling position and the secured position. 
     
     
         33 . The device of  claim 17 , wherein said collector includes a plurality of bristles. 
     
     
         34 . The device of  claim 17 , wherein said collector deforms when in the secured position. 
     
     
         35 . A method of using a biological sampling device comprising a sheath having a first sheath end, a second sheath end, and a sheath cavity that extends between the first and second sheath ends, a collector, having an abrasive outer surface area, and being configured to transition between a secured position, in which the collector is positioned within the sheath cavity, and a sampling position, in which the collector is positioned outside of the sheath cavity, and a handle, having a first handle end and a second handle end, and extending through the sheath cavity with the first handle end being fixed to the collector and the second handle end extending from the second sheath end, said method comprising:
 inserting the sheath into an orifice of an organism;   transitioning the collector from the secured position to the sampling position, such that the collector is positioned outside of the sheath;   via the handle, moving the collector while in the sampling position, such that an outer surface of the collector abrasively moves against an internal portion of the organism to physically contact and collect biological material;   returning the collector to the secured position; and   removing the collector with the collected biological material from the orifice of the organism.   
     
     
         36 . The method of  claim 35 , further comprising: after said inserting and before said transitioning, introducing the collector into the sheath. 
     
     
         37 . The method of  claim 35 , further comprising: after said removing, withdrawing the sheath from the orifice of the organism. 
     
     
         38 . The method of  claim 35 , wherein said removing includes removing the sheath. 
     
     
         39 . A method of using a biological sampling device comprising a sheath having a first sheath end, a second sheath end, and a sheath cavity that extends between the first and second sheath ends, an applicator having a first applicator end, a second applicator end, and an applicator cavity that extends between the first and second applicator ends, the applicator being disposed within the sheath cavity, a collector, having an abrasive outer surface area, and being configured to transition between a secured position, in which the collector is positioned within at least one of the sheath cavity and applicator cavity, and a sampling position, in which said collector is positioned outside of the sheath and applicator cavities, and a handle, having a first handle end and a second handle end, and extending through the sheath and applicator cavities with the first handle end being fixed to the collector and the second handle end extending from the second sheath and second applicator ends, said method comprising:
 inserting the sheath into an orifice of an organism;   transitioning the collector from the secured position to the sampling position, such that the collector is positioned outside of the sheath and the applicator;   via the handle, moving the collector while in the sampling position, such that an outer surface of the collector abrasively moves against an internal portion of the organism to physically contact and collect biological material;   returning the collector to the secured position, such that the collector is positioned within at least one of the sheath and the applicator; and   removing the collector with the collected biological material from the orifice of the organism.   
     
     
         40 . The method of  claim 39 , further comprising: after said inserting and before said transitioning, introducing the collector into the sheath. 
     
     
         41 . The method of  claim 39 , further comprising: after said removing, withdrawing at least one of the sheath and the applicator from the orifice of the organism. 
     
     
         42 . The method of  claim 39 , wherein said removing includes removing at least one of the sheath and the applicator. 
     
     
         43 . A method of preparing a biological sample from biological material collected by a biological sampling device comprising a sheath having a first sheath end, a second sheath end, and a sheath cavity that extends between the first and second sheath ends, an applicator having a first applicator end, a second applicator end, and an applicator cavity that extends between the first and second applicator ends, the applicator being disposed within the sheath cavity, a collector, having an abrasive outer surface area and collected biological material, and being configured to transition between a secured position, in which the collector is positioned within at least one of the sheath cavity and applicator cavity, and a sampling position, in which said collector is positioned outside of the sheath and applicator cavities, and a handle, having a first handle end and a second handle end, and extending through the sheath and applicator cavities with the first handle end being fixed to the collector and the second handle end extending from the second sheath and second applicator ends, said method comprising:
 moving a transfer material against the collector to transfer at least a portion of the collected biological material to the transfer material; and   after said moving, providing the transfer material and the at least a portion of the collected biological material as the biological sample.   
     
     
         44 . The method of  claim 43 , wherein the transfer material includes is at least one of a liquid or a solid. 
     
     
         45 . The method of  claim 43 , wherein the transfer material includes a liquid, solid, or gas. 
     
     
         46 . A method of preparing a biological sample from biological material collected by a biological sampling device comprising a sheath having a first sheath end, a second sheath end, and a sheath cavity that extends between the first and second sheath ends, an applicator having a first applicator end, a second applicator end, and an applicator cavity that extends between the first and second applicator ends, the applicator being disposed within the sheath cavity, a collector, having an abrasive outer surface area and collected biological material, and being configured to transition between a secured position, in which the collector is positioned within at least one of the sheath cavity and applicator cavity, and a sampling position, in which said collector is positioned outside of the sheath and applicator cavities, and a handle, having a first handle end and a second handle end, and extending through the sheath and applicator cavities with the first handle end being fixed to the collector and the second handle end extending from the second sheath and second applicator ends, said method comprising:
 moving a transfer material against the collector to transfer at least a portion of the collected biological material to the transfer material; and   after said moving, providing the transfer material and the at least a portion of the collected biological material as the biological sample.   
     
     
         47 . The method of  claim 46 , wherein the transfer material includes a liquid or a solid. 
     
     
         48 . The method of  claim 46 , wherein the transfer material includes a liquid, solid, or gas. 
     
     
         49 . A method of testing a biological sample obtained from a biological sampling device comprising a sheath having a first sheath end, a second sheath end, and a sheath cavity that extends between the first and second sheath ends, an applicator having a first applicator end, a second applicator end, and an applicator cavity that extends between the first and second applicator ends, the applicator being disposed within the sheath cavity, a collector, having an abrasive outer surface area and collected biological material, and being configured to transition between a secured position, in which the collector is positioned within at least one of the sheath cavity and applicator cavity, and a sampling position, in which said collector is positioned outside of the sheath and applicator cavities, and a handle, having a first handle end and a second handle end, and extending through the sheath and applicator cavities with the first handle end being fixed to the collector and the second handle end extending from the second sheath and second applicator ends, said method comprising:
 applying at least one testing protocol to the biological sample; and   deriving a testing result from the at least one protocol.   
     
     
         50 . The method of  claim 49 , wherein the testing protocol is associated with a Papanicolaou Test. 
     
     
         51 . A method of testing a biological sample obtained from a biological sampling device comprising a sheath having a first sheath end, a second sheath end, and a sheath cavity that extends between the first and second sheath ends, an applicator having a first applicator end, a second applicator end, and an applicator cavity that extends between the first and second applicator ends, the applicator being disposed within the sheath cavity, a collector, having an abrasive outer surface area and collected biological material, and being configured to transition between a secured position, in which the collector is positioned within at least one of the sheath cavity and applicator cavity, and a sampling position, in which said collector is positioned outside of the sheath and applicator cavities, and a handle, having a first handle end and a second handle end, and extending through the sheath and applicator cavities with the first handle end being fixed to the collector and the second handle end extending from the second sheath and second applicator ends, said method comprising:
 applying at least one testing protocol to the biological sample; and   deriving a testing result from the at least one protocol.   
     
     
         52 . The method of  claim 51 , wherein the testing protocol is associated with a Papanicolaou Test.