IP Library Granted Patent US 9,075,046
Granted Patent B2
US 9,075,046 · App. 12/625,430 · Granted Jul 7, 2015

Fluidic medical devices and uses thereof

Inventors: Timothy M. Kemp (San Jose, CA); Chris Todd (San Jose, CA); Ron Oral (Fremont, CA); Shulin Zeng (Gaithersburg, MD); John Howard (Saratoga, CA); Jeff Fenton (San Jose, CA)
Assignee: Theranos, Inc.
G01N33/53B01L2300/0816B01L2300/087B01L2300/021B01L2300/023B01L2300/0887B01L2300/044B01L2300/0867B01L2300/0636B01L2300/0883B01L2300/0877B01L3/50273G01N33/5302Y10T436/115831Y10T436/143333Y10T436/12Y10T436/11Y10T436/10A61B5/1411A61B5/14532A61B5/412A61B5/417G01N33/50A61B5/1427A61B5/14546A61B5/1495G06F19/3406A61B5/150022A61B5/150099A61B5/150251A61B5/150854A61B5/15142A61B5/157G01N2500/00
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Quick Facts
Patent No.
US 9,075,046
App. No.
12/625,430
Granted
Jul 7, 2015
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 (33)

1. An apparatus comprising:

a plurality of adjacent reaction sites;

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

a plurality of reagent chambers, including a plurality of reagents, in fluid communication with said reaction sites,

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

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

wherein at least one of said plurality of adjacent reaction sites is between two optical barriers, said two optical barriers comprise two non-linear channels configured to not allow photons to pass through the two non-linear channels and contaminate signals produced from the plurality of adjacent reaction sites;

walls of the at least one reaction site comprise optically opaque materials so that light will not escape said at least one reaction site through said walls, and

the two nonlinear channels provide fluid communication between the plurality of adjacent reaction sites.

2. The apparatus of claim 1 , further comprising a plurality of waste chambers in fluid communication with at least one of said adjacent reaction sites.

3. The apparatus of claim 1 wherein each of said non-linear channels located between said plurality of adjacent reaction sites is configured as an optical barrier defining a fluid pathway with at least three bends between said adjacent reaction sites.

4. The apparatus of claim 1 wherein the sample collection unit is sized to contain biological fluid that is less than about 500 microliters.

5. The apparatus of claim 1 wherein said reaction sites comprise walls of a white opaque material.

6. The apparatus of claim 1 , wherein the plurality of reagents comprise immunoassay reagents.

7. The apparatus of claim 6 , wherein said plurality of reagents are configured to react to detect a plurality of different analytes.

8. The apparatus of claim 6 , wherein the immunoassay reagents configured to react to detect a polypeptide glycoprotein, polysaccharide, lipid, nucleic acid, and a combination thereof.

9. The apparatus of claim 6 , wherein the immunoassay reagents are configured to react to detect a member selected from the group consisting of drug, drug metabolite, biomarker indicative of a disease, tissue specific marker, and biomarker specific for a cell or cell type.

10. The apparatus of claim 1 wherein said at least one of said reaction sites is fluidically coupled by a) at least a first of said non-linear channels to another of said reaction sites and b) at least a second of said non-linear channels to yet another of said reaction sites.

11. The apparatus of claim 1 wherein at least one of said non-linear channels defines a path comprising a plurality of serpentine turns.

12. The apparatus of claim 1 wherein at least one of said non-linear channels defines a path comprising a plurality of repeating turns.

13. An apparatus comprising

a plurality of adjacent reaction sites;

a sample collection unit, for introducing a biological fluid, in fluid communication with the plurality of adjacent reaction sites, wherein said plurality of adjacent reaction sites comprise a plurality of bound reactants for detecting an analyte;

a plurality of reagent chambers, including a plurality of reagents, in fluid communication with said adjacent reaction sites; and

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

wherein at least one of said plurality of adjacent reaction sites is between two optical barriers, said two optical barriers comprise two non-linear channels configured to not allow photons to pass through the two non-linear channels and contaminate signals produced from the plurality of adjacent reaction sites;

a wall of the at least one reaction site comprises an optically opaque material so that light will not escape said at least one reaction site through said walls, and

the two nonlinear channels provide fluid communication between the plurality of adjacent reaction sites;

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

14. The apparatus of claim 13 , wherein said bound reactants in the at least one reaction site are concentrated at the center of said reaction site relative to quantities at an outer edge of said at least one reaction site.

15. The apparatus of claim 14 , wherein an outer edge of the at least one reaction site is at a distance from said bound reactants at said center to reduce signals from unbound conjugates unrelated to the presence of said analyte.

16. The apparatus of claim 13 , further comprising a waste chamber in fluid communication with at least two of said adjacent reaction sites.

17. The apparatus of claim 13 wherein said at least one of said reaction sites is fluidically coupled by a) at least a first of said non-linear channels to another of said reaction sites and b) at least a second of said non-linear channels to yet another of said reaction sites.

Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 14, 2023
From: GOLDEN DIAGNOSTICS TOP CORP.
To: GOLDEN DIAGNOSTICS CORP.
Reel/Frame 064264/0393 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 14, 2023
From: LABRADOR DIAGNOSTICS LLC
To: GOLDEN DIAGNOSTICS TOP CORP.
Reel/Frame 064262/0539 →
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 045075/0310 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2017
From: THERANOS INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 044838/0909 →
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 Jun 1, 2016
From: KEMP, TIM; TODD, CHRIS; ORAL, RON; ZENG, SHULIN; HOWARD, JOHN; FENTON, JEFF
To: THERANOS, INC.
Reel/Frame 038768/0631 →
Continuity (6)
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 20100074799A1 · Mar 25, 2010