Fluidic medical devices and uses thereof

• US 20060264779A1
• Filed: 03/24/2006
• Published: 11/23/2006
• Est. Priority Date: 05/09/2005
• Status: Abandoned Application

• Current Assignee: Golden Diagnostics Corporation (SoftBank Group Corp.)
• Original Assignee: Golden Diagnostics Corporation (SoftBank Group Corp.)
• Inventors: Zeng, Shulin, Howard, John, Todd, Chris, Oral, Ron, Fenton, Jeff, Kemp, Timothy M.
• Application Number:
  US11/388,723
• Publication Number:
  US 20060264779A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150763 with identification means identification means for surgical instruments A61B90/90
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/417 the bone marrow
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/023 Sending and receiving of information, e.g. using bluetooth
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/087 : Multiple sequential chambers
• CPC Class Codes: B01L 2300/0877 : Flow chambers
• CPC Class Codes: B01L 2300/0883 : Serpentine channels
• CPC Class Codes: B01L 2300/0887 : Laminated structure
• CPC Class Codes: B01L 3/50273 : characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: G01N 21/76 : Chemiluminescence; Bioluminescence
• CPC Class Codes: G01N 2500/00 : Screening for compounds of potential therapeutic value
• CPC Class Codes: G01N 33/50 : 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 Class Codes: G01N 33/53 : Immunoassay; Biospecific binding assay; Materials therefor
• CPC Class Codes: G01N 33/5302 : Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54386 : Analytical elements
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10T 436/10 : Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/11 : Automated chemical analysis
• CPC Class Codes: Y10T 436/115831 : Condition or time responsive
• CPC Class Codes: Y10T 436/12 : Condition responsive control
• CPC Class Codes: Y10T 436/143333 : Saccharide [e.g., DNA, etc.]

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

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

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

b) a plurality of reactant chambers carrying a plurality of reactants in fluid communication with said reaction sites,

wherein said plurality of reaction sites comprise a plurality of reactants bound thereto for detecting said analyte; and

c) a system of fluidic channels to allow said biological fluid and said plurality of reactants to flow in said apparatus, wherein at least one channel located between said plurality of reaction sites comprises an optical barrier to reduce the amount of optical cross-talk between said plurality of said reaction sites during detection of said analyte.

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

3. The apparatus of claim 1 wherein each channel located between said plurality of reaction sites comprises an optical barrier.

4. The apparatus of claim 1 wherein the biological fluid is less than about 500 microliters.

5. The apparatus of claim 1 wherein said optical barrier comprises a nonlinear fluidic channel.

6. The apparatus of claim 1 wherein the fluid is less than about 50 microliters.

7. The apparatus of claim 1, wherein the reactants comprise immunoassay reagents.

8. The apparatus of claim 7, wherein said apparatus detects a plurality of analytes, wherein the analytes are identified by distinct signals detectable over a range of 3 orders of magnitude.

9. The apparatus of claim 7, wherein the immunoassay reagents detect a polypeptide glycoprotein, polysaccharide, lipid, nucleic acid, and a combination thereof.

10. The apparatus of claim 7, wherein the immunoassay reagents 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.

11. The apparatus of claim 1, wherein the detectable signal is a luminescent signal.

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

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

b) a plurality of reactant chambers carrying a plurality of reactants in fluid communication with said reaction sites; and

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

wherein said bound reactants in at least one reaction site are unevenly distributed.

13. The apparatus of claim 12, wherein said bound reactants in the at least one reaction site are localized around the center of said reaction site.

14. The apparatus of claim 13, wherein an outer edge of the at least one reaction site is at a distance sufficiently far from said bound reactants to reduce signals unrelated to the presence of said analyte.

15. The apparatus of claim 12, further comprising a waste chamber in fluid communication with said reaction sites.

16. The apparatus of claim 14 wherein said unbound reactant is coupled to said edge of said reaction site.

17. A method of manufacturing a fluidic device for detecting an analyte in a biological fluid of a subject, comprising:

a) providing a plurality of layers of a fluidic device;

b) ultrasonically welding said layers together such that a fluidic network exists between a sample collection unit, at least one reactant chamber, at least one reaction site, and at least one waste chamber.

18. The method of claim 17 wherein said at least one reaction chamber is vacuum sealed.

19. The method of claim 17, wherein said fluidic device comprises a system of fluidic channels to allow contact of said biological fluid with reactants in said at least one reaction site.

20. The method of claim 17, wherein said reaction site comprises an optical barrier to reduce the amount of optical cross-talk between another reaction site on the fluidic device.