Devices, systems, and methods for self-collection of biological samples

Abstract

A universal single-handed device for self-collection of a biological sample is described herein. The single-handed device may comprise a sheath comprising a distal end for insertion into a portion of a user's body, a shaft at least partially within the sheath, having a collection head for collecting the biological sample positioned at the distal end thereof, and an actuator coupled to the shaft to transition the distal end between an open configuration and a closed configuration. The collection head is covered by the distal end in the closed configuration and is exposed when the distal end is in the open configuration.

1 . A kit for self-collecting and storing a biological sample, the kit comprising:
 a universal single-handed device configured to be self-inserted into a portion of a user's body, the universal single-handed device including a sheath comprising a distal end configured to transition between an open configuration and a closed configuration, and a collection head configured to collect the biological sample, wherein:
 in the closed configuration:
 the distal end is configured to cover the collection head, and 
 
 in the open configuration:
 the collection head is configured to advance distally, and 
 the distal end is configured to expose the collection head; and 
 
   a vial to store the biological sample.   
     
     
         2 . The kit of  claim 1 , further comprising a frame including a first cavity to receive the universal single-handed device and a second cavity to receive the vial. 
     
     
         3 . The kit of  claim 2 , wherein while transferring the biological sample from the universal single-handed device to the vial, the frame is configured to hold the vial in an upright position. 
     
     
         4 . The kit of  claim 1 , wherein the vial includes an hourglass shape to:
 guide at least a portion of the sheath into the vial, and   compress the collection head while retrieving the portion of the sheath from the vial.   
     
     
         5 . The kit of  claim 1 , wherein after collecting the biological sample, the collection head is configured to expand. 
     
     
         6 . The kit of  claim 5 , wherein a diameter of a bottom portion of the vial is greater than a diameter of the collection head when it is expanded. 
     
     
         7 . The kit of  claim 1 , wherein the vial includes a preservative fluid to store the biological sample. 
     
     
         8 . The kit of  claim 1 , wherein the vial includes at least one reagent to analyze the biological sample. 
     
     
         9 . The kit of  claim 1 , wherein the collection head includes polyurethane. 
     
     
         10 . The kit of  claim 1 , wherein the vial comprises a seal to seal a preservative inside the vial, wherein the seal is configured to be ruptured when the universal single-handed device is advanced into the vial. 
     
     
         11 . The kit of  claim 10 , wherein the vial comprises a vial adapter to guide at least a portion of the sheath into the vial. 
     
     
         12 . The kit of  claim 1 , wherein the vial includes a vial cap with a locking mechanism to seal the biological sample in the vial.