Continuous analyte measurement systems and systems and methods for implanting them

• US 9,795,326 B2
• Filed: 07/22/2010
• Issued: 10/24/2017
• Est. Priority Date: 07/23/2009
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hoss, Udo, Mazza, John Charles, Le, Phu
• Primary Examiner(s): WESTON, TIFFANY C
• Application Number:
  US12/842,013
• Publication Number:
  US 20110021889A1
• Time in Patent Office: 2,651 Days
• Field of Search: 600309, 600345-347, 600365
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2562/227 Sensors with electrical connectors
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence

Abstract

Low profile continuous analyte measurement systems and systems and methods for implantation within the skin of a patient are provided.

Claims

1. A continuous analyte measurement system, comprising:

a base unit configured for mounting on a skin surface;

an analyte sensor comprising a first side edge and a second side edge defining a width of the analyte sensor, and a proximal portion and a distal portion defining a length of the analyte sensor, the analyte sensor further comprising a first and a second functional sides on opposing surfaces of the analyte sensor, a first conductive layer disposed on the first functional side at the distal portion of the analyte sensor and disposed from the first side edge to the second side edge, and a sensing layer disposed on the first conductive layer in a continuous band orthogonal to the first side edge and the second side edge to define an analyte sensor active area, the active area having a rectilinear polygon shape defined by the intersection of the first conductive layer and the sensing layer disposed on the first conductive layer, the proximal portion configured for positioning within the base unit and the distal portion configured for insertion through the skin surface;

wherein the base unit comprises a two-piece conductive member including a first piece and a second piece; and

wherein the base unit comprises a side wall including a slit through which the width of the proximal portion of the analyte sensor is positioned so that the first and second pieces of the conductive member are electrically coupled with the corresponding first and the second functional sides of the proximal portion of the analyte sensor, the base unit further including one or more features on at least one orthogonally adjacent wall to the side wall for exerting a compressive force on each of the first piece and the second piece of the two-piece conductive member, the one or more features aligned with the two-piece conductive member and comprising one or more exterior flexures of the at least one orthogonally adjacent wall to the side wall.

2. The system of claim 1, wherein at least the proximal portion of the analyte sensor has a planar configuration and wherein the conductive member is mechanically and electrically coupled to the first and the second functional sides of the analyte sensor.

3. The system of claim 1, further comprising an alignment pin extending through the proximal portion of the analyte sensor.

4. The system of claim 1, wherein the base unit comprises a non-conductive compressible material.

5. The system of claim 4, wherein the non-conductive compressible material comprises silicone.

6. The system of claim 1, wherein the conductive member comprises a conductive compressible material.

7. The system of claim 6, wherein the conductive compressible material comprises carbon-doped silicone.

8. The system of claim 1, further comprising a transmitter coupled to the base unit, wherein the base unit further comprises a first pair of receptacles for receiving a corresponding first pair of conductive pins of the transmitter, wherein the conductive pins contact the conductive member with the transmitter disposed in the base unit.

9. The system of claim 8, wherein the base unit further comprises a second pair of receptacles for receiving a corresponding second pair of conductive pins of the transmitter, wherein the conductive pins contact a battery when the transmitter is operatively mounted to the base unit.

10. The system of claim 1, wherein the base unit comprises a cradle therein for receiving and holding the conductive member.

11. The system of claim 10, wherein the cradle compresses opposing ends of the conductive member when held within the cradle.

12. The system of claim 1, wherein the base unit comprises an adhesive bottom for adhering to the skin surface.

13. The system of claim 1, wherein the base unit comprises an opening therein through which the distal portion of the analyte sensor extends.

14. The system of claim 1, wherein the sensing layer includes an analyte-responsive enzyme bonded to a polymer disposed on the analyte sensor.

15. The system of claim 14, wherein the analyte-responsive enzyme is chemically bonded to the polymer.

16. The system of claim 14, wherein the sensing layer comprises a mediator bonded to the polymer.

17. The system of claim 16, wherein the mediator is crosslinked with the polymer.

18. The system of claim 1, wherein the analyte sensor does not require a user-initiated calibration during in vivo use of the analyte sensor.

19. The system of claim 18, wherein the analyte sensor is calibrated using a factory-determined sensitivity factor.

20. The system of claim 1, wherein the sensing layer comprises a mediator bonded to a polymer disposed on the analyte sensor.

21. The system of claim 20, wherein the mediator is crosslinked with the polymer.

22. The system of claim 1, wherein a width of the sensing layer is defined by the distance between the first side edge and the second side edge at the distal portion of the analyte sensor.

23. The system of claim 22, wherein a width of the first conductive layer is defined by the distance between the first side edge and the second side edge at the distal portion of the analyte sensor.

24. The system of claim 1, wherein the analyte sensor includes a second conductive layer disposed on the second functional side at the distal portion of the analyte sensor between the first side edge and the second side edge.

25. The system of claim 24, wherein the second conductive layer includes Ag/AgCl disposed thereon.