Method for manufacturing a biological fluid sensor

• US 9,645,133 B2
• Filed: 02/09/2016
• Issued: 05/09/2017
• Est. Priority Date: 03/09/2015
• Status: Active Grant

• Current Assignee: CoreSyte, Inc.
• Original Assignee: CoreSyte, Inc.
• Inventors: Pizer, Adam, Pont, Dalton
• Primary Examiner(s): Vo, Peter DungBa
• Assistant Examiner(s): Carley, Jeffrey T
• Application Number:
  US15/019,006
• Publication Number:
  US 20160270239A1
• Time in Patent Office: 455 Days
• CPC Class Codes: B23K 1/0016 Brazing of electronic components
• CPC Class Codes: B23K 1/008 Soldering within a furnace B23K1/012 takes precedence
• CPC Class Codes: B23K 2101/36 Electric or electronic devices
• CPC Class Codes: B23K 2101/42 Printed circuits
• CPC Class Codes: B23K 2103/50 Inorganic material, e.g. metals, not provided for in B23K2103/02 – B23K2103/26
• CPC Class Codes: B23K 26/38 by boring or cutting
• CPC Class Codes: B23K 26/402 involving non-metallic material, e.g. isolators
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
• CPC Class Codes: H01L 23/488 consisting of soldered or bonded constructions bump connectors H01L24/01
• CPC Class Codes: H05K 3/341 Surface mounted components
• CPC Class Codes: H05K 3/3494 Heating methods for reflowing of solder using integral heating means H05K1/0212

Abstract

The present invention presents a method of fabrication for a physiological sensor with electronic, electrochemical and chemical components. The fabrication method comprises steps for manufacturing an apparatus comprising at least one electrochemical sensor, a microcontroller, and a transceiver. The physiological sensor is operable to analyze biological fluids such as sweat.

Claims

1. A method of fabrication for a biological fluid sensor for analyzing at least one analyte in human biological fluid, said biological fluid sensor comprising electronic, electrochemical and chemical components, the method comprising:

fabricating a substrate;

fabricating a circuit on the substrate;

picking and placing the electronic components onto the circuit;

reflow soldering of the circuit;

fabricating at least two electrodes, wherein the at least two electrodes are comprised of at least one active electrode and at least one reference electrode;

fabricating a membrane on the at least one active electrode;

sealing and curing the at least one active electrode to create a sealed circuit; and

fabricating a dressing;

wherein the step of fabricating the at least two electrodes further comprises;

fabricating a metallization paste;

constructing the at least one reference electrode by applying the metallization paste on top of at least one first trace metal of the circuit and annealing; and

constructing the at least one active electrode by applying the metallization paste on top of at least one second trace metal of the circuit and annealing;

wherein the step of fabricating the membrane further comprises applying an ionophore polymer coating on the at least one active electrode and curing the ionophore polymer coating; and

wherein the step of fabricating the dressing further comprises;

laser cutting a sheet of a top cover medical textile, wherein the top cover medical textile has an adhesive side;

mechanically placing the sealed circuit on top of the adhesive side of the top cover medical textile, wherein the at least two electrodes are facing up;

laser cutting a microfluidic management layer;

circumferentially surrounding the at least two electrodes with the microfluidic management layer;

laser cutting a sheet of double-sided adhesive to create a double-sided adhesive layer;

mechanically placing the double-sided adhesive layer on top of the sealed circuit such that the double-sided adhesive layer covers the sealed circuit; and

pressing the top cover medical textile, the microfluidic management layer, the sealed circuit, and the double-sided adhesive layer for permanent bond.

2. The method of claim 1, wherein the biological fluid sensor comprises at least one electrochemical sensor, a microcontroller, and a transceiver.

3. The method of claim 1, wherein applying the ionophore polymer coating on the at least one active electrode is performed via an automated dispenser.

4. The method of claim 2, wherein the at least one electrochemical sensor is operable to detect and continuously analyze at least one biomarker of sweat.

5. The method of claim 4, wherein the at least one biomarker of sweat includes electrolytes, small molecules, proteins, or metabolites.

6. The method of claim 1, wherein about 2 microliters of the ionophore polymer coating is applied to the at least one active electrode.

7. The method of claim 1, wherein the ionophore polymer coating does not exceed more than 0.5 millimeters from the exterior edge of the at least one active electrode.

8. The method of claim 1, wherein the ionophore polymer coating is cured using heat, light, or a combination thereof.

9. The method of claim 1, wherein the metallization paste is made of at least one stable metal selected from the group consisting of silver, gold, platinum, and palladium.

10. The method of claim 1, wherein the human biological fluid is sweat.

11. The method of claim 10, wherein the biological fluid sensor is configured and designed for sensing and analyzing sweat flow rate and small protein probes.

12. The method of claim 1, wherein the at least one reference electrode and the at least one active electrode include silver, zinc, copper, gold, platinum, rhodium, carbon, or a combination thereof.

13. The method of claim 1, wherein the at least one analyte is sodium, potassium, chloride, oxygen, glucose, ammonium, or interleukins.

14. The method of claim 1, wherein the step of fabricating the dressing further includes:

mechanically separating an individual biological fluid sensor unit; and

automatically packaging the individual biological fluid sensor unit into an individualized wrapper to create an individually wrapped biological fluid sensor unit.

15. The method of claim 1, wherein the biological fluid sensor has an embedded dot-circle configuration for the at least one reference electrode.

16. The method of claim 1, wherein the circuit is printed directly on the substrate using bare die bonding.

17. The method of claim 1, wherein the double-sided adhesive layer further contains macrofluidic pores.

18. The method of claim 1, wherein the microfluidic layer is comprised of wicking paper.

19. A method of fabrication for a sweat sensor for analyzing at least one analyte in human sweat, said sweat sensor comprising electronic, electrochemical and chemical components, the method comprising:

fabricating a substrate;

fabricating a circuit on the substrate;

picking and placing the electronic components onto the circuit;

reflow soldering of the circuit;

fabricating at least two electrodes, wherein the at least two electrodes are comprised of at least one active electrode and at least one reference electrode;

fabricating a membrane on the at least one active electrode;

sealing and curing the at least one active electrode to create a sealed circuit; and

fabricating a dressing;

wherein the step of fabricating the at least two electrodes further comprises;

fabricating a metallization paste;

constructing the at least one reference electrode by applying the metallization paste on top of at least one first trace metal of the circuit and annealing; and

constructing the at least one active electrode by applying the metallization paste on top of at least one second trace metal of the circuit and annealing;

wherein the step of fabricating the membrane further comprises applying an ionophore polymer coating on the at least one active electrode and curing the ionophore polymer coating; and

wherein the step of fabricating the dressing further comprises;

laser cutting a sheet of a top cover medical textile, wherein the top cover medical textile has an adhesive side;

mechanically placing the sealed circuit on top of the adhesive side of the top cover medical textile, wherein the at least two electrodes are facing up;

laser cutting a microfluidic management layer;

circumferentially surrounding the at least two electrodes with the microfluidic management layer;

laser cutting a sheet of double-sided adhesive to create a double-sided adhesive layer;

mechanically placing the double-sided adhesive layer on top of the sealed circuit such that the double-sided adhesive layer covers the sealed circuit; and

pressing the top cover medical textile, the microfluidic management layer, the sealed circuit, and the double-sided adhesive layer for permanent bond.

20. A method of fabrication for a biological fluid sensor for analyzing at least one analyte in human biological fluid, said biological fluid sensor comprising electronic, electrochemical and chemical components, the method comprising:

fabricating a substrate;

fabricating a circuit on the substrate;

picking and placing the electronic components onto the circuit;

reflow soldering of the circuit;

fabricating at least two electrodes, wherein the at least two electrodes are comprised of at least one active electrode and at least one reference electrode;

fabricating a membrane on the at least one active electrode;

sealing and curing the at least one active electrode to create a sealed circuit; and

fabricating a dressing;

wherein the step of fabricating the at least two electrodes further comprises;

fabricating a metallization paste;

constructing the at least one reference electrode by applying the metallization paste on top of at least one first trace metal of the circuit and annealing; and

constructing the at least one active electrode by applying the metallization paste on top of at least one second trace metal of the circuit and annealing;

wherein the step of fabricating the membrane further comprises;

applying an ionophore polymer coating on the at least one active electrode using an automated dispenser; and

curing the ionophore polymer coating using heat, light, or a combination thereof;

wherein the step of fabricating the dressing further comprises;

laser cutting a sheet of a top cover medical textile, wherein the top cover medical textile has an adhesive side;

mechanically placing the sealed circuit on top of the adhesive side of the top cover medical textile, wherein the at least two electrodes are facing up;

laser cutting a microfluidic management layer;

circumferentially surrounding the at least two electrodes with the microfluidic management layer;

laser cutting a sheet of double-sided adhesive to create a double-sided adhesive layer;

mechanically placing the double-sided adhesive layer on top of the sealed circuit such that the double-sided adhesive layer covers the sealed circuit; and

pressing the top cover medical textile, the microfluidic management layer, the sealed circuit, and the double-sided adhesive layer for permanent bond.