Device including biosensor and holder

• US 9,791,401 B2
• Filed: 11/28/2013
• Issued: 10/17/2017
• Est. Priority Date: 12/07/2012
• Status: Active Grant

• Current Assignee: Sarissa Biomedical Limited
• Original Assignee: Sarissa Biomedical Limited
• Inventors: Dale, Nicholas, Tian, Faming
• Primary Examiner(s): Noguerola, Alexander
• Application Number:
  US14/649,993
• Publication Number:
  US 20150316500A1
• Time in Patent Office: 1,419 Days
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: B01L 2300/046 Function or devices integrated in the closure
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 3/5021 Test tubes specially adapted for centrifugation purposes centrifuges B04B5/04
• CPC Class Codes: B01L 3/50825 Closing or opening means, corks, bungs closures for containers B65D; means for removing stoppers B67B7/02
• CPC Class Codes: C12Q 1/003 Functionalisation
• CPC Class Codes: G01N 2223/307 cuvettes-sample holders
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 2800/2871 Cerebrovascular disorders, e.g. stroke, cerebral infarct, cerebral haemorrhage, transient ischemic event
• CPC Class Codes: G01N 2800/302 Schizophrenia
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

A device utilizing biosensors to enable rapid electrochemical sensing of one or more analytes in a container. The device comprises a holder which incorporates at least one reference electrode and at least one sensing electrode. The sensing electrode comprising an electrically conductive substrate which is coated in a first layer of a suitable electron acceptor and subsequently with a second layer incorporating a biorecognition molecule adsorbed or within a suitable electropolymer matrix or carrier.

Claims

1. A device for a container or support, where the container or support is capable of or adapted for receiving a biological sample for use in rapid electrochemical sensing of one or more analytes using biosensors,

wherein the device forms at least part of a closure for the container or support and the device comprises a holder for holding at least one sensing electrode and at least one reference electrode, the or each sensing electrode and the or each reference electrode being held and protruding from a sample receiving surface of the holder, and

where the or each sensing electrode comprises an electrically conductive substrate comprising platinum, platinum alloy, gold, gold alloy, or carbon, with a first layer on the substrate comprising an electron acceptor, and a second layer comprising a biorecognition molecule adsorbed or within an electropolymer matrix or carrier.

2. The device of claim 1 wherein the device forms at least part of a cap for a container having at least a partial vacuum.

3. The device of claim 1 wherein the holder comprises 2, 3, 4, 5, or 6 sensing electrodes.

4. The device of claim 1 wherein the electron acceptor is Ruthenium Purple.

5. The device of claim 1 wherein the electrically conductive substrate comprises gold of at least 18 carat purity.

6. The device of claim 1 wherein the electrically conductive substrate comprises a platinum alloy with a 90:

10 weight/weight ratio of platinum to iridium.

7. The device of claim 1 wherein the electropolymer matrix comprises a sol-gel.

8. The device of claim 7 wherein the sol-gel comprises a mercaptan containing silane, a bifunctional silane, or a combination thereof.

9. The device of claim 1 wherein the or each sensing electrode includes an intermediate layer between the electron acceptor and the electropolymer matrix or carrier, where the intermediate layer comprises a polyaniline or a derivative thereof comprising one or more non-polar substituents.

10. The device of claim 1 wherein the analytes are biomarkers selected from the group consisting of hypoxanthine, adenosine, ATP, inosine, acetylcholine, choline, glucose, glutamate, lactate, and D-serine, and combinations thereof.

11. The device of claim 1 wherein the biorecognition molecule is an antibody or enzyme.

12. The device of claim 1 wherein the analytes are capable of providing indicators of biochemical abnormalities for use in diagnostic or monitoring purposes or indicators of physiological condition in healthy organisms.

13. The device of claim 1 wherein the holder comprises more than one type of sensing electrode for the analysis of more than one analyte.

14. The device of claim 1, where the device optionally forms at least part of a cap for a container having at least a partial vacuum, or where the device or the cap is optionally included in a kit for the detection of one or more analytes;

the kit comprising the device or the cap, and a set of instructions for the detection of the one or more analytes, and where the device, the cap, or the kit is adapted for single or disposable use.

15. A cap for a container having at least a partial vacuum comprising the device of claim 1.

16. A kit for the detection of one or more analytes, the kit comprising the device of claim 1, where the device optionally forms at least part of a cap for a container having at least a partial vacuum;

and a set of instructions for detecting the one or more analytes.

17. The kit of claim 16 wherein the one or more analytes are capable of being used for fetal monitoring, stroke monitoring, or schizophrenia diagnosis.

18. A method comprising using the device of claim 1 for detecting one or more analytes, where the device optionally forms at least part of a cap for a container having at least a partial vacuum, or where the device or the cap is optionally included in a kit for the detection of one or more analytes;

the kit comprising the device or the cap, and a set of instructions for the detection of the one or more analytes.

19. The method of claim 18 wherein at least one analyte has a half-life in the biological sample of less than 10 min.

20. A process for preparing the device of claim 1, the process comprising:

i) providing a substrate comprising an electrically conductive substrate surface within a holder;

ii) depositing a first layer comprising a suitable electron acceptor; and

iii) depositing a second layer comprising an electropolymer matrix with one or more biorecognition molecules absorbed on or included within said second layer.