Methods of Manufacture to Optimize Performance of Transdermal Sampling and Analysis Device

• US 20140275895A1
• Filed: 03/13/2014
• Published: 09/18/2014
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Cambridge Medical Technologies, LLC
• Original Assignee: Flexible Medical Systems, LLC
• Inventors: Vidalis, Joseph J., Currie, John Frederick, Marcanio, Joseph A., Snyder, Helena Woodvine, Bhatia, Vikas
• Granted Patent: US 10,898,116 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150076 by heating
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/15134 Bladeless capillary blood sampling devices, i.e. devices for perforating the skin in order to obtain a blood sample but not using a blade, needle, canula, or lancet, e.g. by laser perforation, suction or pressurized fluids
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

Methods and systems for manufacturing a transdermal sampling and analysis device for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples are provided. A method of manufacturing the device may improve performance and includes forming channel structures on the lid of the device, thereby making the spacer/channel support structures physically independent and separable from the sensing electrode. Other methods of manufacturing the device may improve performance and include forming at least one of the electrodes on each of the base and the lid, and forming a recessed second spacer layer over the channel support structures, thereby separating the channel support structures and the electrode on the lid to allow a larger area of the electrode to be exposed to the biological sample.

Claims

1. A method of making a transdermal sampling and analysis device, comprising:

forming a base structure with at least two electrodes;

forming a lid structure configured to be positioned above the at least two electrodes, wherein the lid structure has a plurality of channel support structures; and

attaching the lid structure to the base structure using an adhesive material on surfaces of the plurality of channel support structures,

wherein attaching the lid structure to the base structure forms a plurality of channels in a reservoir between the plurality of channel support structures.

2. The method of claim 1, wherein forming the base structure comprises:

depositing a conductive material on a base substrate to create a conductive material layer;

patterning the conductive material layer to form a disruptor, at least two electrodes, and interconnects; and

depositing a layer of an analyte sensing reagent on surfaces of the at least two electrodes.

3. The method of claim 1, wherein forming the lid structure comprises:

applying a photoresist material to a lid substrate;

patterning the photoresist material to form the plurality of channel support structures; and

selectively applying the adhesive material to surfaces of the plurality of channel support structures, wherein each surface comprises an outward-facing surface that directly contacts the base structure.

4. The method of claim 3, wherein selectively applying the adhesive material to surfaces of the plurality of channel support structures comprises:

coating the adhesive material on a release liner substrate;

drying the adhesive material on the release liner substrate;

attaching a first surface of the adhesive material to the surfaces of the plurality of channel support structures, wherein the first surface is on an opposite side from the release liner substrate; and

removing the release liner substrate from the adhesive material wherein a second surface of the adhesive material is exposed to the base structure.

5. A method of making a transdermal sampling and analysis device, comprising:

forming a base structure with at least one counter electrode and a plurality of channel support structures;

forming a lid configured to be positioned above the plurality of channel support structures, wherein the lid has at least one sensing electrode and an analyte sensing layer;

attaching the lid to the base structure using an adhesive material on surfaces of the plurality of channel support structures,

wherein attaching the lid to the base structure forms a plurality of channels in a reservoir between the plurality of channel support structures.

6. The method of claim 5, wherein forming the base structure comprises:

depositing a first conductive material layer on a base substrate;

patterning the first conductive material layer to form a disruptor, the at least one counter electrode, and interconnects;

applying a photoresist material to the base substrate;

patterning the photoresist material to form the plurality of channel support structures; and

selectively applying the adhesive material to top surfaces of the plurality of channel support structures, wherein the top surfaces comprise outward facing surfaces that directly contact the lid.

7. The method of claim 5, wherein forming the lid configured to be positioned above the plurality of channel support structures comprises:

depositing a second conductive material layer on a lid substrate;

patterning the second conductive material layer to form the at least one sensing electrode on the lid; and

applying a layer of an analyte sensing reagent to the lid substrate.

8. A method of making a transdermal sampling and analysis device, comprising:

forming a base structure with at least one counter electrode, a first spacer layer with a plurality of channel support structures, and a second spacer layer formed over the first spacer layer, wherein the second spacer layer is recessed back from an edge of the plurality of channel support structures;

forming a lid configured to be positioned above the second spacer layer, wherein the lid has at least one sensing electrode and an analyte sensing layer; and

attaching the lid to the base structure,

wherein attaching the lid to the base structure forms a plurality of channels in a reservoir between the plurality of channel support structures.

9. The method of claim 8, wherein forming the base structure comprises:

depositing a first conductive material layer on a base substrate;

patterning the first conductive material layer to form a disruptor, the at least one counter electrode, and interconnects;

applying a photoresist material to the base substrate over the at least one sensing electrode; and

patterning the photoresist material to form the plurality of channel support structures of the first spacer layer.

10. The method of claim 9, wherein forming the base structure further comprises:

applying a double-sided adhesive material to the first spacer layer, wherein the double-sided adhesive material is pre-cut to form the second spacer layer.

11. The method of claim 9, wherein forming the base structure further comprises:

applying a second photoresist material to the base substrate over the first spacer layer;

patterning the second photoresist material to form the second spacer layer; and

selectively applying an adhesive material to a top surface of the second spacer layer, wherein the top surface comprises an outward facing surface that directly contacts the lid.

12. The method of claim 8, wherein forming the lid configured to be positioned above the plurality of channel support structures comprises:

depositing a second conductive material layer on a lid substrate;

patterning the second conductive material layer to form the at least one sensing electrode on the lid; and

applying a layer of an analyte sensing reagent to the at least one sensing electrode on the lid.

13. The method of claim 8, wherein a thickness of the first spacer layer is approximately equal to a thickness of the second spacer layer, wherein each of the first and second spacer layers are approximately 10-20 μ

m thick.

14. A transdermal sampling and analysis device comprising:

a substrate having a first side;

at least one disruptor mounted on the first side of the substrate, wherein the at least one disruptor is configured to generate a localized heat capable of altering permeability characteristics of barrier cells of an organism to become permeable when a voltage is applied across the at least one disruptor;

a reservoir on the first side of the transdermal sampling and analysis device configured to collect and contain in a sensing chamber a biological sample that is obtained through permeable barrier cells;

a lid structure configured to enclose the reservoir;

a biological sensing element comprising at least a first electrode mounted on the first side of the substrate and at least a second electrode mounted on an underside of the lid structure, wherein the biological sensing element is configured to determine a level of an analyte in the biological sample;

a first spacer layer disposed on the first side of the substrate; and

a second spacer layer disposed over the first spacer layer, wherein the second spacer layer is configured to separate the first spacer layer from the at least second electrode on the underside of the lid structure,

wherein the sensing chamber of the reservoir is configured to contain the biological sample between the at least first electrode and the at least second electrode.

15. The transdermal sampling and analysis device of claim 14, wherein the first spacer layer comprises a plurality of channel support structures that form a plurality of channels in the sensing chamber.

16. The transdermal sampling and analysis device of claim 14, wherein the second spacer layer comprises a double-sided adhesive material that is pre-cut to form a shape recessed back from an edge of the first spacer layer.

17. The transdermal sampling and analysis device of claim 14, further comprising:

an adhesive layer on a top surface of the second spacer layer, wherein the adhesive layer is configured to adhere the lid structure to the second spacer layer.

18. The transdermal sampling and analysis device of claim 14, wherein a thickness of the first spacer layer is approximately equal to a thickness of the second spacer layer, wherein each of the first and second spacer layers are approximately 10-20 μ

m thick.