US2016025721A1PendingUtilityA1

Modular point-of-care devices, systems, and uses thereof

Assignee: THERANOS INCPriority: Oct 2, 2007Filed: Oct 1, 2015Published: Jan 28, 2016
Est. expiryOct 2, 2027(~1.2 yrs left)· nominal 20-yr term from priority
G16H 10/40G01N 33/5758G01N 33/6803G01N 2333/4737B01J 2219/00369A61B 5/15B01L 3/021B01L 2200/148G01N 33/48B01L 2200/0689B01J 2219/00466B01L 2300/0829A61B 10/0051B01L 2300/0654B01J 2219/00371B01J 2219/00292G01N 35/028B01L 3/0262B01L 2300/1805G01N 35/10G01N 2800/26A61B 2010/0077B01J 2219/00283A61B 10/02B01L 2400/043A61B 10/0045G01N 2333/71B01J 19/0046B01L 2200/04G01N 2035/00881B01J 2219/00693B01J 2219/00315G01N 2800/60B01L 2200/141B01J 2219/00495A61B 5/151B01J 2219/005A61B 10/0038G01N 2333/91205A61B 2010/0074Y10T29/49826Y10T436/25375G01N 2035/0097B01J 2219/00385B01L 9/543A61B 10/0058G01N 1/38G01N 33/54326A61B 10/007G01N 2035/1048G01N 2035/1032G01N 33/5091B01L 3/5025G01N 2035/00237G01N 2333/475G01N 33/5304G01N 33/54366G01N 2333/9129B01L 3/527G01N 35/1074G01N 35/1065G01N 33/56966G01N 33/94G01N 35/08G01N 2333/912G01N 2035/1034B01J 2219/00702G01N 33/53G01N 35/00732G01N 33/5302B01L 7/5255B01L 7/52G01N 2035/00851G01N 35/00871A61B 5/150755G01N 33/54386B01L 3/0275G01N 2035/103C12M 1/266G01N 35/02G01N 37/00C12M 1/02G01N 33/50
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Claims

Abstract

The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.

Claims

exact text as granted — not AI-modified
1 - 78 . (canceled) 
     
     
         79 . A device for detecting an analyte in a bodily fluid sample, comprising:
 a fluid transfer device comprising at least one pipette head configured to engage with at least one pipette tip;   a detector for detecting a signal indicative of a presence or absence of the analyte;   a stage for receiving a cartridge; and   a temperature control unit.   
     
     
         80 . The device of  claim 79 , wherein the temperature control unit controls the temperature of the device at a temperature of about 0° C. to about 100° C. 
     
     
         81 . The device of  claim 79 , wherein the temperature control unit controls the temperature of the device at a temperature of about 15° C. to about 50° C. 
     
     
         82 . The device of  claim 79 , wherein the temperature control unit controls the temperature of the device at a temperature of about 30° C. to about 40° C. 
     
     
         83 . The device of  claim 79 , wherein the temperature control unit provides active cooling. 
     
     
         84 . The device of  claim 79 , wherein the temperature control unit comprises a thermoelectric device. 
     
     
         85 . The device of  claim 79 , wherein the temperature control unit comprises a heating block. 
     
     
         86 . The device of  claim 85 , wherein the heating block is configured to receive at least one assay unit. 
     
     
         87 . The device of  claim 86 , wherein the heating block is configured to receive a plurality of assay units. 
     
     
         88 . The device of  claim 87 , wherein the heating block provides the same temperature to the plurality of assay units. 
     
     
         89 . The device of  claim 87 , wherein the heating block provides a different temperature to the plurality of assay units. 
     
     
         90 . The device of  claim 85 , wherein the heating block provides a temperature of about 20° C. to about 70° C. 
     
     
         91 . A system for detecting an analyte in a bodily fluid sample, comprising:
 a device comprising:
 a fluid transfer device comprising at least one pipette head configured to engage with at least one pipette tip; 
 a detector for detecting a signal indicative of a presence or absence of the analyte; 
 a stage for receiving a cartridge; and 
 a temperature control unit; 
   and the cartridge comprising:
 at least one sample collection unit for receiving a bodily fluid sample; 
 the at least one pipette tip; 
   at least one assay unit; and
 at least one reagent unit comprising at least one reagent for performing an assay on the bodily fluid sample to detect the analyte; 
 wherein the at least one assay unit and the at least one reagent unit are moveable and are not in fluid communication with each other. 
   
     
     
         92 . The system of  claim 91 , wherein the temperature control unit controls the temperature of the device at a temperature of about 0° C. to about 100° C. 
     
     
         93 . The device of  claim 91 , wherein the temperature control unit controls the temperature of the device at a temperature of about 15° C. to about 50° C. 
     
     
         94 . The system of  claim 91 , wherein the temperature control unit controls the temperature of the device at a temperature of about 30° C. to about 40° C. 
     
     
         95 . The system of  claim 91 , wherein the temperature control unit provides active cooling. 
     
     
         96 . The system of  claim 91 , wherein the temperature control unit comprises a thermoelectric device. 
     
     
         97 . The system of  claim 91 , wherein the temperature control unit comprises a heating block. 
     
     
         98 . The system of  claim 97 , wherein the heating block is configured to receive at least one assay unit. 
     
     
         99 . The system of  claim 98 , wherein the heating block is configured to receive a plurality of assay units. 
     
     
         100 . The system of  claim 99 , wherein the heating block provides the same temperature to the plurality of assay units. 
     
     
         101 . The system of  claim 99 , wherein the heating block provides a different temperature to the plurality of assay units. 
     
     
         102 . The system of  claim 97 , wherein the heating block provides a temperature of about 20 to about 70° C. 
     
     
         103 . A method for detecting an analyte in a bodily fluid sample, comprising:
 receiving in a device a cartridge comprising a bodily fluid sample obtained from a subject, wherein the cartridge further comprises:
 at least one pipette tip; 
 at least one assay unit; and 
 at least one reagent unit comprising at least one reagent for performing an assay on the bodily fluid sample to detect the analyte; 
 wherein the at least one assay unit and the at least one reagent unit are and moveable and are not in fluid communication with each other; 
   and wherein the device comprises:
 a fluid transfer device comprising at least one pipette head configured to engage with the at least one pipette tip; 
 a detector for detecting a signal indicative of a presence or absence of the analyte; 
 a stage for receiving the cartridge; and 
 a thermal control unit; 
   transferring by the fluid transfer device, at least a portion of the bodily fluid sample and the at least one reagent into fluid communication in the at least one assay unit;   incubating the at least one assay unit at a temperature controlled by the thermal control unit; and   detecting the signal with the detector.   
     
     
         104 . The method of  claim 103 , wherein the temperature controlled by the thermal control unit is about 0° C. to about 100° C. 
     
     
         105 . The method of  claim 103 , wherein the thermal control unit comprises a heating block configured to receive at least one assay unit. 
     
     
         106 . The method of  claim 105 , wherein the heating block is configured to receive a plurality of assay units. 
     
     
         107 . The method of  claim 106 , wherein the heating block provides the same temperature to the plurality of assay units. 
     
     
         108 . The method of  claim 106 , wherein the heating block provides a different temperature to the plurality of assay units.

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