Bandage type of continuous glucose monitoring system

• US 10,251,605 B2
• Filed: 02/16/2015
• Issued: 04/09/2019
• Est. Priority Date: 02/16/2015
• Status: Active Grant

• Current Assignee: Google LLC (Alphabet Inc.)
• Original Assignee: Verily Life Sciences LLC (Alphabet Inc.)
• Inventors: Liu, Zenghe, Otis, Brian, Wasson, Jaclyn Leverett, Biederman, William James
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan (JJ)
• Application Number:
  US14/623,012
• Publication Number:
  US 20160235365A1
• Time in Patent Office: 1,513 Days
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/07 Endoradiosondes
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61B 5/6848 Needles

Abstract

A flexible, body-mountable analyte sensing device includes a flexible substrate configured for mounting to skin of a living body. The sensing device additionally includes a sensor probe attached to the flexible substrate and configured to penetrate the skin such that a sensor disposed on the sensor probe can detect an analyte in interstitial fluid. The sensor probe can include an elongate extension of the flexible substrate. The sensor can be, for example, an electrochemical sensor or an optical sensor. The sensing device is configured to wirelessly indicate detected concentrations or other information about the analyte in the interstitial fluid. The flexible substrate of the sensing device is configured to be adhered or otherwise mounted to the skin in a manner that minimally impacts activities of the living body.

Claims

1. A body-mountable device comprising:

a flexible substrate having a first side and a second side opposite the first side, wherein the flexible substrate is mountable to a skin surface, and wherein the flexible substrate is shaped to have an elongate extension having a distal end configured to extend beneath the skin surface to contact interstitial fluid;

an adhesive layer disposed on the first side of the flexible substrate, wherein the adhesive layer is configured to adhere the flexible substrate to the skin surface;

a sensor, wherein the sensor is disposed at the distal end of the elongate extension, and wherein the sensor is configured to detect an analyte in the interstitial fluid;

one or more electronic components disposed on the flexible substrate, wherein the one or more electronic components are configured to (i) use the sensor to obtain data related to the analyte and (ii) communicate the data related to the analyte to an external device, wherein at least one of the one or more electronic components is disposed on the first side of the flexible substrate; and

a battery, wherein the battery is disposed on the flexible substrate.

2. The body-mountable device of claim 1, wherein the flexible substrate comprises polyimide.

3. The body-mountable device of claim 1, wherein the flexible substrate and the one or more electronic components disposed thereon have a combined thickness of less than 0.5 millimeters.

4. The body-mountable device of claim 1, wherein the flexible substrate has a diameter of less than 11 millimeters.

5. The body-mountable device of claim 1, wherein the elongate extension of the flexible substrate has a length greater than 2 millimeters.

6. The body-mountable device of claim 1, further comprising an antenna disposed on the flexible substrate, wherein the electronic components are configured to communicate the data related to the analyte to the external device using the antenna.

7. The body-mountable device of claim 1, wherein the one or more electronic components include a memory configured to store the data related to the analyte.

8. The body-mountable device of claim 1, wherein the battery comprises a flexible lithium ion battery.

9. The body-mountable device of claim 1, wherein the sensor comprises at least two electrodes and is configured to detect the analyte electrochemically.

10. The body-mountable device of claim 1, further comprising an optical fiber disposed on the elongate extension of the flexible substrate, wherein the optical fiber extends from a proximal end of the elongate extension to the distal second end of the elongate extension, wherein the sensor comprises an analyte-sensitive chemical, wherein the analyte-sensitive chemical has an optical property that is related to the analyte, wherein the one or more electronic components include a light emitter, a light detector, and a controller configured to (i) operate the light emitter to illuminate, via the optical fiber, the analyte-sensitive chemical and (ii) operate the light detector to detect, via the optical fiber, a property of light emitted from the analyte-sensitive chemical in response to the illumination, wherein the detected property of the emitted light is related to the analyte.

11. The body-mountable device of claim 1, further comprising a conductive trace patterned on a surface of the flexible substrate, wherein the battery is connected to the flexible substrate via the conductive trace.

12. The body-mountable device of claim 1, wherein the adhesive layer is disposed on the first side of the flexible substrate such that the adhesive layer covers the at least one of the one or more electronic components that is disposed on the first side of the flexible substrate.

13. The body-mountable device of claim 1, wherein at least one of the one or more electronic components is disposed on the second side of the flexible substrate.

14. A method comprising:

mounting a body-mountable device to a skin surface, wherein the body-mountable device comprises;

a flexible substrate having a first side and a second side opposite the first side, wherein the flexible substrate is mountable to a skin surface, and wherein the flexible substrate is shaped to have an elongate extension having a distal end configured to extend beneath the skin surface to contact interstitial fluid;

an adhesive layer disposed on the first side of the flexible substrate, wherein the adhesive layer is configured to adhere the flexible substrate to the skin surface;

a sensor, wherein the sensor is disposed on the distal end of the elongate extension, and wherein the sensor is configured to detect an analyte in the interstitial fluid;

one or more electronic components disposed on the flexible substrate, wherein at least one of the one or more electronic components disposed on the flexible substrate is disposed on the first side of the flexible substrate; and

a battery, wherein the battery is disposed on the flexible substrate;

operating the body-mountable device to obtain, by the one more electronic components, data related to the analyte using the sensor; and

operating the body-mountable device to communicate, by the one or more electronic components, the data related to the analyte to an external device.

15. The method of claim 14, wherein the body-mountable device further comprises an antenna disposed on the flexible substrate, and wherein communicating, by the one or more electronic components, the data related to the analyte to an external device comprises:

communicating the data related to the analyte via the antenna.

16. The method of claim 14, wherein the one or more electronic components include a memory, and further comprising:

operating the body-mountable device to store the data related to the analyte in the memory.

17. The method of claim 14, further comprising:

coupling the elongate extension of the flexible substrate to a needle; and

inserting the needle with the elongate extension of the flexible substrate coupled thereto into the skin surface such that the sensor is in a position to contact interstitial fluid.

18. The method of claim 17, further comprising:

retracting the needle from the skin surface such that the sensor remains in the position to contact interstitial fluid.

19. The method of claim 14, wherein the body-mountable device further comprises a conductive trace patterned on a surface of the flexible substrate, wherein the battery is connected to the flexible substrate via the conductive trace.

20. The method of claim 14, wherein at least one of the one or more electronic components is disposed on the second side of the flexible substrate.