IP Library Granted Patent US 9,772,291
Granted Patent B2
US 9,772,291 · App. 14/727,547 · Granted Sep 26, 2017

Fluidic medical devices and uses thereof

Inventors: Timothy Michael Kemp (Palo Alto, CA); Chris Todd (Palo Alto, CA); Ron Oral (Palo Alto, CA); Shulin Zeng (Palo Alto, CA); John Howard (Palo Alto, CA); Jeff Fenton (Palo Alto, CA)
Assignee: Theranos, Inc.
G01N21/76A61B5/1411A61B5/1427A61B5/14532A61B5/157A61B5/15142A61B5/412A61B5/417B01L3/50273G01N33/50G01N33/53G01N33/5302G01N33/54386G06F19/3406A61B5/1495A61B5/14546A61B5/150022A61B5/150099A61B5/150251A61B5/150854B01L2300/021B01L2300/023B01L2300/044B01L2300/0636B01L2300/087B01L2300/0816B01L2300/0867B01L2300/0877B01L2300/0883B01L2300/0887G01N2500/00Y10T436/10Y10T436/11Y10T436/115831Y10T436/12Y10T436/143333
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Quick Facts
Patent No.
US 9,772,291
App. No.
14/727,547
Granted
Sep 26, 2017
Kind
B2
Abstract

This invention is in the field of medical devices. Specifically, the present invention provides fluidic systems having a plurality of reaction sites surrounded by optical barriers to reduce the amount of optical cross-talk between signals detected from various reaction sites. The invention also provides a method of manufacturing fluidic systems and methods of using the systems.

Claims (38)

1. An apparatus for detecting an analyte in a biological fluid of a subject, comprising:

a plurality of reaction sites;

a sample collection unit for introducing a biological fluid in fluid communication with the plurality of reaction sites;

a plurality of reactant chambers comprising a plurality of reactants in fluid communication with said plurality of reaction sites,

wherein each of said plurality of reaction sites comprise one or more reactants bound thereto for detecting said analyte;

a system of fluidic channels to allow said biological fluid and said plurality of reactants to flow in said apparatus; and

a wall of at least one of said plurality of reaction sites comprise an optically opaque material so that light will not escape said at least one of said plurality of reaction sites through said wall;

wherein said at least one of said plurality of reaction sites comprises a reaction surface with bound reactants around a center of the at least one of said plurality of reaction sites and said bound reactants are spaced apart from a wall of the at least one of said plurality of reaction sites by a concentric ring-shaped area, said at least one of said plurality of reaction sites configured to reduce signal from any unbound conjugates remaining in the at least one of said plurality of reaction sites.

2. A system for detecting an analyte in a biological fluid of a subject, comprising

a) a cartridge comprising:

a plurality of reaction sites;

a sample collection unit for introducing a biological fluid in fluid communication with the plurality of reaction sites, wherein each of said plurality of reaction sites comprise one or more reactants bound thereto for detecting said analyte;

a plurality of reactant chambers comprising a plurality of reactants in fluid communication with said plurality of reaction sites,

a system of fluidic channels to allow said biological fluid and said plurality of reactants to flow in said cartridge;

an identifier on said cartridge;

a wall of at least one of said plurality of reaction sites comprises an optically opaque material so that light will not escape said at least one of said plurality of reaction sites through said wall;

wherein said at least one of said plurality of reaction sites comprises a reaction surface with bound reactants around a center of the at least one of said plurality of reaction sites and said bound reactants are spaced apart from a wall of the at least one of said plurality of reaction sites by a concentric ring-shaped area, said at least one of said plurality of reaction sites configured to reduce signal from any unbound conjugates remaining in the at least one of said plurality of reaction sites; and

b) a reader assembly for receiving the cartridge and comprising:

a controller; and

an identifier detector to detect the identifier on the cartridge.

3. The system of claim 2 further comprising a pressure burstable seal on at least one of the reactant chambers.

4. The system of claim 2 further comprising a layer of burstable foil enclosing at least one of the reactant chambers.

5. The system of claim 2 further comprising a valve actuation plate on the reader assembly.

6. The system of claim 5 further comprising a non-coring needle on the valve actuation plate.

7. The system of claim 2 further comprising an elastomeric cover on the cartridge.

8. A system for detecting an analyte in a biological fluid of a subject, comprising

a) a cartridge comprising:

a plurality of reaction sites;

a sample collection unit for introducing a biological fluid in fluid communication with the plurality of reaction sites, wherein each of said plurality of reaction sites comprise one or more reactants bound thereto for detecting said analyte;

a plurality of reactant chambers comprising a plurality of reactants in fluid communication with said plurality of reaction sites,

a system of fluidic channels to allow said biological fluid and said plurality of reactants to flow in said cartridge;

an identifier on said cartridge;

a wall of at least one of said plurality of reaction sites comprises an optically opaque material so that light will not escape said at least one of said plurality of reaction sites through said wall;

wherein said at least one of said plurality of reaction sites comprises a reaction surface with bound reactants around a center of the at least one of said plurality of reaction sites and said bound reactants are spaced apart from a wall of the at least one of said plurality of reaction sites by a concentric ring-shaped area, said at least one of said plurality of reaction sites configured to reduce signal from any unbound conjugates remaining in the at least one of said plurality of reaction sites; and

b) a reader assembly for receiving the cartridge and comprising:

a controller;

an identifier detector to detect the identifier on the cartridge; and

a communication assembly, wherein said identifier detector communicates with the communication assembly that is controlled by said controller.

Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 14, 2023
From: LABRADOR DIAGNOSTICS LLC
To: GOLDEN DIAGNOSTICS TOP CORP.
Reel/Frame 064262/0539 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 14, 2023
From: GOLDEN DIAGNOSTICS TOP CORP.
To: GOLDEN DIAGNOSTICS CORP.
Reel/Frame 064264/0393 →
CHANGE OF NAME Recorded Apr 7, 2020
From: THERANOS IP COMPANY LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052329/0716 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 16, 2018
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 045101/0315 →
SECURITY INTEREST Recorded Dec 12, 2017
From: THERANOS IP COMPANY, LLC
To: FORTRESS CREDIT CORP.
Reel/Frame 044839/0568 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2017
From: THERANOS INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 044838/0909 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 14, 2015
From: KEMP, TIMOTHY; TODD, CHRIS; ORAL, RON; ZENG, SHULIN; HOWARD, JOHN; FENTON, JEFF
To: THERANOS, INC.
Reel/Frame 036561/0342 →
Continuity (7)
Continuation 12625430 · Nov 24, 2009
Continuation 11388723 · Mar 24, 2006
Provisional Application 60678801 · May 9, 2005
Provisional Application 60705489 · Aug 5, 2005
Provisional Application 60717192 · Sep 16, 2005
Provisional Application 60721097 · Sep 28, 2005
Related Publication 20150377875A1 · Dec 31, 2015