US2017020426A1PendingUtilityA1

Systems, devices, and methods for bodily fluid sample collection

Assignee: THERANOS INCPriority: Sep 6, 2012Filed: Jun 15, 2016Published: Jan 26, 2017
Est. expirySep 6, 2032(~6.1 yrs left)· nominal 20-yr term from priority
A61B 5/150022A61L 2300/42A61B 5/150251A61L 33/0011A61B 5/150053A61B 5/150824A61B 5/15117A61B 5/1438A61B 5/150809A61B 5/15123A61B 5/15113A61B 5/150984A61B 5/15111A61B 5/15074A61B 5/150786A61B 5/1411A61B 5/154A61B 5/150946A61B 5/150351A61B 5/150213A61B 5/150343A61B 5/150793A61B 5/150076A61B 5/150755A61B 5/15144A61B 5/150099A61B 5/150412A61B 5/150992
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Claims

Abstract

Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample container for receiving the bodily fluid sample collected in the sample collection channel, the sample container operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the container provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the container.

Claims

exact text as granted — not AI-modified
1 - 59 . (canceled) 
     
     
         60 . A device for collecting a bodily fluid sample, the device comprising:
 a first portion comprising at least two sample collection channels configured to capture bodily fluid sample formed on a surface of a subject by drawing the fluid sample into the sample collection channels via a first type of motive force;   wherein each of the collection channels has at least one opening to allow air therein to be vented as sample enters therein; and   a second portion comprising a plurality of sample containers for receiving the bodily fluid sample collected in the sample collection channels, the sample containers operably engagable to be in fluid communication with the collection channels, wherein the containers are configured to use a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channels into the containers.   
     
     
         61 . The device of  claim 60 , wherein the at least two sample collection channels comprise molded channels formed in the first portion. 
     
     
         62 . The device of  claim 60  wherein said channels are configured to receive the bodily fluid sample from an interface on the first portion, wherein the interface comprises a shaped front end configured to engage target tissue on the subject. 
     
     
         63 . The device of  claim 60 , wherein each of the capillary channels further comprises a needle for engaging the one of the sample containers. 
     
     
         64 . The device of  claim 63 , wherein the needle has a non-coring penetrating end. 
     
     
         65 . The device of  claim 60 , wherein at least one of the sample containers has a reverse-plunger type configuration wherein a movable plunger portion defines at least one surface of a sample chamber of one of the sample containers and wherein movement of the plunger portion is configured to draw sample into the at least one of the sample containers. 
     
     
         66 . The device of  claim 65 , wherein the movable plunger portion has a contact area comprising a material having a hardness greater than other material along a perimeter of the plunger. 
     
     
         67 . The device of  claim 60 , wherein the sample container has a reverse-plunger type configuration wherein a movable plunger portion defines at least one surface of a sample chamber of the sample container. 
     
     
         68 . The device of  claim 60 , wherein an interior of each of the containers is at a below-atmospheric pressure to pull sample therein when in fluid communication with the collection channel. 
     
     
         69 . The device of  claim 60 , wherein interiors of each of the sample collection channels are coated with an anti-coagulant. 
     
     
         70 . The device of  claim 60 , wherein an interior of one of the sample collection channel is coated with a first anticoagulant different from a second anticoagulant of coating an interior of another of the sample collection channels. 
     
     
         71 . The device of  claim 70 , wherein the first anticoagulant is ethylenediaminetetraacetic acid (EDTA). 
     
     
         72 . The device of  claim 70 , wherein the first anticoagulant is citrate. 
     
     
         73 . The device of  claim 70 , wherein the first anticoagulant is heparin. 
     
     
         75 . The device of  claim 70  wherein the first type of motive force comprises capillary force. 
     
     
         76 . The device of  claim 70  wherein the second motive force comprises a suction force. 
     
     
         77 . The device of  claim 60 , wherein the device is further configured mix the bodily fluid sample with the interior coating prior to the sample entering one of the sample containers and doing so without having to repeatedly tilt or agitate the device. 
     
     
         78 . A device for collecting a bodily fluid sample, the device comprising:
 a first portion comprising a) at least two sample collection channels configured to capture bodily fluid sample formed on a surface of a subject by drawing the fluid sample into the sample collection channels via a first type of motive force and b) at least one fill indicator configured to show whether a desired fill level has been reached in at least one of the sample collection channels;   wherein each of the collection channels has at least one opening to allow air therein to be vented as sample enters therein; and   a second portion comprising a plurality of sample containers for receiving the bodily fluid sample collected in the sample collection channels, the sample containers operably engagable to be in fluid communication with the collection channels, wherein the containers are configured to use a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channels into the containers.   
     
     
         79 . A device for collecting a bodily fluid sample, the device comprising:
 a first portion comprising a) at least two sample collection channels configured to capture bodily fluid sample formed on a surface of a subject by drawing the fluid sample into the sample collection channels via a first type of motive force and b) at least one fill indicator configured to show whether a desired fill level has been reached in at least one of the sample collection channels; and   a second portion comprising a plurality of sample containers for receiving the bodily fluid sample collected in the sample collection channels, the sample containers operably engagable to be in fluid communication with the collection channels, wherein the containers are configured to use a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channels into the containers;   wherein each of the at least two sample collection channels comprise an adapter channel with a cross-sectional area smaller than a sample collection channel cross-sectional area.

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