Medical devices and methods

Patent metadata

Field	Value
Publication number	US-12315630-B2
Application number	US-202318176293-A
Country	US
Kind code	B2
Filing date	Feb 28, 2023
Priority date	Aug 31, 2009
Publication date	May 27, 2025
Grant date	May 27, 2025

Abstract

Methods and devices to monitor an analyte in body fluid are provided. Embodiments include continuous or discrete acquisition of analyte related data from a transcutaneously positioned in vivo analyte sensor automatically or upon request from a user. The in vivo analyte sensor is coupled to an electronics unit holding a memory with instruction to cause processing circuitry to initiate a predetermined time period that is longer than a predetermined life of the sensor, during the predetermined time period, convert signals from the sensor related to glucose to respective corresponding glucose levels, without relying on any post-manufacture independent analyte measurements from a reference device, and at the expiration of the predetermined time period, disable, deactivate, or cease use of one or more feature.

First claim

What is claimed is:

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.

Assignees

• Abbott Diabetes Care Inc

Inventors

• Bernstein Daniel Milfred
• Fennell Martin J
• Love Michael
• He Lei
• Thomas Christopher Allen
• Stafford Gary Ashley
• Yee Phillip
• Kiaie Namvar
• Cole Jean-Pierre
• Sicurello Jeffery Mario
• Kunich Theodore J

Classifications

• G16H40/63

  for local operation · CPC title

• A61B5/72

  Signal processing specially adapted for physiological signals or for diagnostic purposes · CPC title

• A61B5/01

  Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20) · CPC title

• A61B2560/0238

  Means for recording calibration data · CPC title

• A61B5/0022

  Monitoring a patient using a global network, e.g. telephone networks, internet · CPC title