Improved cartridge for use in in-vitro diagnostics and method of use thereof

Abstract

A cartridge for use in in-vitro diagnostics, the cartridge including a cartridge housing, a cartridge element, disposed within the cartridge housing and defining a plurality of operational volumes, at least some of the plurality of operational volumes being mutually linearly aligned, a fluid solution transporter operative to transfer fluid solutions from at least one of the plurality of operational volumes to at least another of the plurality of operational volumes, the fluid solution transporter including a linearly displaceable transport element operative to sequentially communicate with interiors of the at least some of the plurality of operational volumes and a venter, including a linearly displaceable venting element, operative in coordination with the fluid solution transporter to vent at least one of the plurality of operational volumes.

1 . (canceled) 
     
     
         2 . A cartridge for use in in-vitro diagnostics, the cartridge comprising:
 a cartridge housing;   a cartridge element disposed within said cartridge housing and defining a plurality of operational volumes;   a fluid solution transporter operative to transfer fluid solutions from at least one of said plurality of operational volumes to at least another of said plurality of operational volumes; and   at least one septum which sealingly communicates with at least some of said plurality of operational volumes.   
     
     
         3 . A cartridge for use in in-vitro diagnostics according to  claim 2  and wherein said at least one septum includes a plurality of septa. 
     
     
         4 . A cartridge for use in in-vitro diagnostics according to  claim 2  and wherein said at least one septum is penetrable by a penetrating element. 
     
     
         5 . A cartridge for use in in-vitro diagnostics according to  claim 2  and wherein
 at least one of said plurality of operational volumes is configured such that the interior thereof may be in magnetic communication with at least one magnet located exteriorly thereof. 
 
     
     
         6 . (canceled) 
     
     
         7 . A cartridge for use in in-vitro diagnostics according to  claim 2  and wherein said fluid solution transporter comprises:
 a linearly displaceable transport element operative to sequentially communicate with interiors of said at least some of said plurality of operational volumes; and 
 a fluid flow driving assembly communicating with said linearly displaceable transport element. 
 
     
     
         8 - 9 . (canceled) 
     
     
         10 . A cartridge for use in in-vitro diagnostics according to  claim 2  and wherein said cartridge housing comprises first and second outer housing portions which are hinged together and at least partially enclose said cartridge element. 
     
     
         11 - 12 . (canceled) 
     
     
         13 . A cartridge for use in in-vitro diagnostics according to  claim 2  and wherein said plurality of operational volumes includes a multiplicity of operational volumes, at least some of which are configured to allow injection of fluid solutions thereinto. 
     
     
         14 . A cartridge for use in in-vitro diagnostics according to  claim 2  and also comprising a microfluidic PCR array mounted within said cartridge housing. 
     
     
         15 . A cartridge for use in in-vitro diagnostics according to  claim 14  and wherein at least one of said plurality of operational volumes defines an internal passageway to a port of said microfluidic PCR array. 
     
     
         16 . A cartridge for use in in-vitro diagnostics according to  claim 2  and also comprising a sensor array mounted within said cartridge housing. 
     
     
         17 - 20 . (canceled) 
     
     
         21 . A method for use in in-vitro diagnostics, the method comprising:
 providing a cartridge having a plurality of operational volumes, at least some of said plurality of operational volumes being mutually linearly aligned;   transferring fluid solutions from at least one of said plurality of operational volumes to at least another of said plurality of operational volumes, said transferring fluid solutions including linearly displacing a transport element to sequentially communicate with interiors of said at least some of said plurality of operational volumes; and   venting said at least one of said plurality of operational volumes.   
     
     
         22 . A method for use in in-vitro diagnostics according to  claim 21  and wherein said transferring also includes driving said fluid solutions through said transport element between ones of said plurality of operational volumes. 
     
     
         23 . A method for use in in-vitro diagnostics according to  claim 21  and wherein said transferring fluid solutions includes transferring fluid solutions containing cellular material to a microfluidic PCR array mounted within said cartridge. 
     
     
         24 . A method for use in in-vitro diagnostics according to  claim 23  and wherein said transferring fluid solutions also comprises transferring fluid solutions containing cellular material from said microfluidic PCR array to a sensor array associated with said cartridge. 
     
     
         25 . A method for use in in-vitro diagnostics according to  claim 21  and also comprising injecting material into some of said plurality of operational volumes prior to supplying cellular material thereto. 
     
     
         26 . A method for use in in-vitro diagnostics according to  claim 21  and wherein said transferring fluid solutions comprises:
 locating a cell membrane breakdown material in a first operational volume; 
 locating an open end of a hollow needle into communication with said first operational volume; 
 drawing at least a portion of said cell membrane breakdown material into said hollow needle; 
 linearly displacing said open end of said hollow needle into communication with a second operational volume having a sample located therein; and 
 repeatedly drawing said sample and at least some of said cell membrane breakdown material into said hollow needle and expelling said sample and said cell membrane breakdown material from said hollow needle into said second operational volume, thereby mixing said sample and said cell membrane breakdown material. 
 
     
     
         27 . A method for use in in-vitro diagnostics according to  claim 26  and wherein said transferring fluid solutions further comprises:
 linearly displacing said open end of said hollow needle into communication with a third operational volume containing a cell lysis solution and magnetic beads; 
 drawing at least a portion of said cell lysis solution and magnetic beads into said hollow needle into engagement with said sample and said cell membrane breakdown material; and 
 repeatedly drawing said sample, at least some of said cell membrane breakdown material, said cell lysis solution and magnetic beads into said hollow needle and expelling said sample, said at least some of said cell membrane breakdown material, said cell lysis solution and said magnetic beads, from said hollow needle into said third operational volume, thereby releasing nucleic acids from said sample and binding said nucleic acids to said magnetic beads. 
 
     
     
         28 . A method for use in in-vitro diagnostics according to  claim 27  and wherein said transferring fluid solutions further comprises:
 linearly displacing said open end of said hollow needle into communication with a fourth operational volume containing a wash buffer; 
 drawing at least a portion of said wash buffer into said hollow needle into engagement with said magnetic beads together with said nucleic acids bound thereto; and 
 repeatedly drawing said wash buffer and said magnetic beads, together with said nucleic acids bound thereto, into said hollow needle, thereby washing away cell debris and unbound nucleic acids from said magnetic beads. 
 
     
     
         29 . A method for use in in-vitro diagnostics according to  claim 28  and wherein said transferring fluid solutions further comprises:
 linearly displacing said open end of said hollow needle into communication with a fifth operational volume containing an elution buffer; 
 drawing at least a portion of said elution buffer into said hollow needle into engagement with said magnetic beads, together with said nucleic acids bound thereto; and 
 repeatedly drawing said elution buffer and said magnetic beads, together with said nucleic acids bound thereto, into said hollow needle, thereby disengaging said nucleic acids from said magnetic beads. 
 
     
     
         30 . A method for use in in-vitro diagnostics according to  claim 29  and wherein said transferring fluid solutions further comprises:
 linearly displacing said open end of said hollow needle into communication with a sixth operational volume having at least one magnet juxtaposed thereto; 
 transferring said elution buffer and said magnetic beads, together with said nucleic acids disengaged therefrom, into said sixth operational volume, said at least one magnet attracting said magnetic beads; and 
 drawing said elution buffer, together with said nucleic acids, into said hollow needle. 
 
     
     
         31 - 35 . (canceled)