Analyte sensor and fabrication methods

• US 8,696,917 B2
• Filed: 02/03/2010
• Issued: 04/15/2014
• Est. Priority Date: 02/09/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Petisce, James R., Zhou, David, Valiket, Mena
• Primary Examiner(s): Tran, Binh X
• Application Number:
  US12/699,302
• Publication Number:
  US 20100200538A1
• Time in Patent Office: 1,532 Days
• Field of Search: 216/13, 216/17, 216/20, 216/36, 600/347
• US Class Current: 216/13
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: B32B 2309/105 Thickness
• CPC Class Codes: B32B 2311/02 Noble metals
• CPC Class Codes: B32B 2457/00 Electrical equipment
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 37/025 Transfer laminating
• CPC Class Codes: B81C 1/00539 Wet etching
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

Methods for fabricating analyte sensor components using IC- or MEMs-based fabrication techniques and sensors prepared therefrom. Fabrication of the analyte sensor component comprises providing an inorganic substrate having deposited thereon a release layer, a first flexible dielectric layer and a second flexible dielectric layer insulating there between electrodes, contact pads and traces connecting the electrodes and the contact pads of a plurality of sensors. Openings are provided in one of the dielectric layers over one or more of the electrodes to receive an analyte sensing membrane for the detection of an analyte of interest and for electrical connection with external electronics. The plurality of fabricated sensor components are lifted off the inorganic substrate.

Claims

1. A method for fabricating a flexible electrochemical sensor component comprising:

providing a substrate;

depositing a release layer on substantially all the substrate;

depositing a first flexible dielectric layer on substantially all of the release layer;

forming a plurality of individual continuously connected electrodes, traces and contact pads comprised of a conductive material over the first flexible dielectric layer;

depositing a second flexible dielectric layer over the first flexible dielectric layer and the plurality of individual continuously connected electrodes, traces and contact pads;

forming openings in the second flexible dielectric layer exposing at least a portion of at least one of the individual continuously connected electrodes and contact pads; and

removing the release layer between the first flexible dielectric material and the substrate, whereby the flexible electrochemical sensor component is released from the substrate.

2. The method of claim 1, wherein the release layer comprises at least one of (i) a material having a solubility in a solvent that does not substantially dissolve the first or second flexible dielectric layers;

(ii) a material having an etch rate (wet or dry) faster than that of the first flexible dielectric layer;

or (iii) a pressure sensitive adhesive material interposed between the first dielectric material and the substrate.

3. The method of claim 1, wherein the release layer is silicon dioxide, silica glass, or aluminum.

4. The method of claim 1, wherein the release layer is chemically removed.

5. The method of claim 1, further comprising depositing a first adhesion layer between at least a portion of the first flexible dielectric material and the conductive material and depositing a second adhesion layer between the conductive material and at least a portion of the second flexible dielectric material.

6. The method of claim 1, further comprising depositing an analyte sensing membrane in the opening positioned over the electrode.

7. The method of claim 6, wherein the analyte sensing membrane comprises:

a hydrophilic polymer layer;

an interference layer;

an enzyme layer; and

a flux-limiting layer.

8. The method of claim 6, wherein the analyte sensing membrane encapsulates the opening over the electrode.