Fluidic medical devices and uses thereof

Patent metadata

Field	Value
Publication number	US-9772291-B2
Application number	US-201514727547-A
Country	US
Kind code	B2
Filing date	Jun 1, 2015
Priority date	May 9, 2005
Publication date	Sep 26, 2017
Grant date	Sep 26, 2017

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.

First claim

What is claimed is:

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.

Assignees

• Theranos Inc

Inventors

• Kemp Timothy Michael
• Todd Chris
• Oral Ron
• Zeng Shulin
• Howard John
• Fenton Jeff

Classifications

• G16H40/63

  for local operation · CPC title

• B01L2300/044

  pierceable, e.g. films, membranes · CPC title

• G01N33/50

  Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing (measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q) · CPC title

• Y10T436/10

  Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing · CPC title

• G01N21/76 Primary

  Chemiluminescence; Bioluminescence · CPC title