Granted Patent B2

US 12,315,630 · App. 18/176,293 · Granted May 27, 2025

Inventors: Daniel Milfred Bernstein (El Granada, CA); Martin J. Fennell (Concord, CA); Michael Love (Pleasanton, CA); Lei He (Moraga, CA); Christopher Allen Thomas (Cheltenham, GB); Gary Ashley Stafford (Hayward, CA); Phillip Yee (San Francisco, CA); Namvar Kiaie (Danville, CA); Jean-Pierre Cole (Tracy, CA); Jeffery Mario Sicurello (Union City, CA); Theodore J. Kunich (Pleasanton, CA)

Assignee: ABBOTT DIABETES CARE INC.

G16H40/67A61B5/0017A61B5/0022A61B5/01A61B5/14532A61B5/1486A61B5/72G01N33/48792G16H40/63A61B2560/0238Y02A90/10

Abstract

Claims (49)

1. A glucose monitoring system, comprising:

an electrochemical transcutaneous glucose sensor including:

a distal portion configured to be inserted through a skin surface of a user and in contact with an interstitial fluid under the skin surface, and

a proximal portion configured to extend above the skin surface after insertion of the distal portion; and

an on-body electronics unit including:

a housing;

a printed circuit board comprising a bottom surface and a top surface, wherein a first portion of the bottom surface is coupled in electrical connection with the proximal portion of the electrochemical transcutaneous glucose sensor with a conductive material comprising silver, wherein the first portion of the bottom surface of the printed circuit board and the proximal portion of the electrochemical transcutaneous glucose sensor are at least partially encapsulated with a potting material configured to protect the printed circuit board from contaminants and moisture,

a microprocessor disposed on the top surface of the printed circuit board,

an antenna disposed on the top surface of the printed circuit board and configured to wirelessly transmit data from the on-body electronics unit to a display device, and

a temperature sensor mounted on a second portion of the bottom surface of the printed circuit board.

2. The glucose monitoring system of claim 1 , wherein the proximal portion of the electrochemical transcutaneous glucose sensor and the distal portion of the electrochemical transcutaneous glucose sensor define an angle.

3. The glucose monitoring system of claim 1 , wherein the proximal portion of the electrochemical transcutaneous glucose sensor is entirely encapsulated with the potting material.

4. The glucose monitoring system of claim 1 , wherein the potting material comprises polyurethane.

5. The glucose monitoring system of claim 1 , wherein the on-body electronics unit has a maximum thickness less than or equal to 5 mm and a maximum diameter less than or equal to 30 mm.

6. The glucose monitoring system of claim 1 , further comprising an adhesive layer attached to the housing to form an on-body electronics unit-adhesive layer assembly, and configured to attach to the skin surface of the user.

7. The glucose monitoring system of claim 6 , wherein the adhesive layer has a maximum diameter less than or equal to 40 mm.

8. The glucose monitoring system of claim 1 , wherein the wirelessly transmitted data from the on-body electronics unit comprises glucose levels determined from a signal from the electrochemical transcutaneous glucose sensor.

9. The glucose monitoring system of claim 1 , wherein the antenna is configured to wirelessly transmit data via a close-proximity protocol.

10. The glucose monitoring system of claim 1 , wherein the conductive material comprises solder.

11. The glucose monitoring system of claim 1 , wherein the on-body electronics unit further comprises a memory configured as a data logger.

12. The glucose monitoring system of claim 1 , wherein the display device further comprises:

a storage device having stored therein one or more routines;

a processing unit operatively coupled to the storage device and configured to retrieve the stored one or more routines for execution;

a data transmission component operatively coupled to the processing unit and configured to transmit data based at least in part on the one or more routines executed by the processing unit; and

a data reception component operatively coupled to the processing unit and configured to receive the wirelessly transmitted data from the on-body electronics unit and to store the received data in the storage device;

wherein the data transmission component is programmed to transmit a query to the antenna disposed on the top surface of the printed circuit board; and

wherein the data reception component receives the data from the antenna disposed on the top surface of the printed circuit board in response to the transmitted query when the on-body electronics transitions from a low power state to a fully operational state in response to detection of the query from the data transmission component by the on-body electronics.

13. A glucose monitoring system, comprising:

an electrochemical transcutaneous glucose sensor including:

a distal portion configured to be inserted through a skin surface of a user, such that at least a part of the distal portion is in contact with an interstitial fluid under the skin surface of the user, and

a proximal portion configured to extend above the skin surface after insertion of the distal portion; and

an on-body electronics unit including:

a housing;

a printed circuit board comprising a bottom surface and a top surface, wherein a first portion of the bottom surface is coupled in electrical connection with the proximal portion of the electrochemical transcutaneous glucose sensor with a conductive material comprising silver, wherein the first portion of the bottom surface of the printed circuit board and the proximal portion of the electrochemical transcutaneous glucose sensor are at least partially encapsulated with a potting material configured to protect the printed circuit board from contaminants and moisture,

a microprocessor disposed on the top surface of the printed circuit board,

an antenna disposed on the top surface of the printed circuit board and configured to wirelessly transmit data from the on-body electronics unit to a display device,

a first temperature sensor mounted on a second portion of the bottom surface of the printed circuit board, and

a second temperature sensor mounted on the top surface of the printed circuit board.

14. The glucose monitoring system of claim 13 , wherein the proximal portion of the electrochemical transcutaneous glucose sensor and the distal portion of the electrochemical transcutaneous glucose sensor define an angle.

15. The glucose monitoring system of claim 13 , wherein the proximal portion of the electrochemical transcutaneous glucose sensor is entirely encapsulated with the potting material.

16. The glucose monitoring system of claim 15 , wherein the potting material comprises polyurethane.

17. The glucose monitoring system of claim 13 , wherein the on-body electronics unit has a maximum thickness less than or equal to 5 mm and a maximum diameter less than or equal to 30 mm.

18. The glucose monitoring system of claim 13 , further comprising an adhesive layer attached to the housing and configured to attach to the skin surface of the user.

19. The glucose monitoring system of claim 18 , wherein the adhesive layer has a maximum diameter less than or equal to 40 mm.

20. The glucose monitoring system of claim 13 , wherein the wirelessly transmitted data from the on-body electronics unit comprises glucose levels determined from a signal from the electrochemical transcutaneous glucose sensor.

21. The glucose monitoring system of claim 13 , wherein the antenna is configured to wirelessly transmit data via a close-proximity protocol.

22. The glucose monitoring system of claim 13 , wherein the conductive material comprises solder.

23. The glucose monitoring system of claim 13 , wherein the on-body electronics unit further comprises a memory configured as a data logger.

24. The glucose monitoring system of claim 13 , wherein the first temperature sensor is configured to detect a skin temperature.

Assignments (2)

Continuity (12)

References Cited (400)