Method for manufacturing a biological fluid sensor

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.