Flexible patch for fluid delivery and monitoring body analytes

• US 9,259,175 B2
• Filed: 10/23/2006
• Issued: 02/16/2016
• Est. Priority Date: 10/23/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Stafford, Gary Ashley
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US11/552,065
• Publication Number:
  US 20080119707A1
• Time in Patent Office: 3,403 Days
• Field of Search: 600345-365, 600/309
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/82 Internal energy supply devices
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A wearable, conductive textile patch is provided that may include any of a number of features for monitoring body analytes and/or delivering fluids to a body. In one embodiment of the invention, a single, patch-mounted system monitors glucose levels of a diabetic person and provides appropriate doses of insulin in response to the glucose measurements. A hand-held user interface can be provided for wirelessly controlling the system and/or receiving information from it. Conductive pathways can be formed in the fabric of the patch. Components that can be integrated into the flexible patch include a power source, controller, transmitter, antenna, temperature and other sensors, fluid pump, infusion set, electrical pathways, switches, controls, electrodes, connectors, resistors and other circuit elements. Such components can be embedded, interwoven or coated on to the flexible patch instead of or in addition to surface mounting. Methods associated with use of the flexible patch system are also covered.

Claims

1. A method for measuring analyte utilizing a body analyte monitoring system, the body analyte monitoring system having a flexible patch, a first analyte sensor, a second analyte sensor, a power source, and a controller, wherein a plurality of sensor insertion sites are on the flexible patch, and wherein the flexible patch is configured to be worn on a skin surface and to receive one or more analyte sensors at one or more of the plurality of sensor insertion sites, the method comprising:

inserting the first analyte sensor into one of the plurality of predefined sensor insertion sites through the skin surface and in contact with fluid under the skin surface at the one of the plurality of predefined sensor insertion sites;

removing the first analyte sensor from the one of the plurality of predefined sensor insertion sites after the lifetime of the first analyte sensor has expired while the flexible patch is retained on the skin surface;

inserting the second analyte sensor in another one of the plurality of predefined sensor insertion sites through the skin surface and in contact with the fluid under the skin surface at the another one of the plurality of predefined sensor insertion sites after the first analyte sensor is removed from the one of the predefined sensor insertion sites and while the flexible patch is retained on the skin surface; and

communicating signals from the second analyte sensor to the controller, wherein the controller is powered by the power source.

2. The method of claim 1, further comprising transmitting data from the second analyte sensor to a second device using a transmitter integrated with the flexible patch, wherein the transmitter is powered by the power source controlled by the controller.

3. The method of claim 2, further comprising transmitting the data using a flexible antenna integrated with the flexible patch.

4. The method of claim 1, further comprising transmitting data corresponding the monitored analyte level and receiving information from a second device using a transceiver integrated with the flexible patch.

5. The method of claim 4, further comprising transmitting signals from the transceiver and receiving signals from the second device using an antenna integrated with the flexible patch.

6. The method of claim 1, wherein the second analyte sensor generates signals corresponding the monitored analyte level in the fluid under the skin surface.

7. The method of claim 5, wherein the controller, the transceiver, and the antenna are located along a longitudinal axis of the flexible patch.

8. The method of claim 1, wherein the flexible patch includes a material with elastomeric properties.

9. The method of claim 5, wherein at least one of the first or the second analyte sensors, the power source, the controller, the transceiver, and the antenna are woven into the flexible patch.

10. The method of claim 1, wherein one or more of the first and second analyte sensors includes a plurality of electrodes, wherein the plurality of electrodes include a working electrode comprising an analyte-responsive enzyme chemically bonded to a polymer disposed on the working electrode.

11. The method of claim 10, wherein the analyte-responsive enzyme is crosslinked with the polymer.

12. The method of claim 10, wherein the working electrode comprises a mediator.

13. The method of claim 12, wherein the mediator is chemically bonded to the polymer disposed on the working electrode.

14. The method of claim 1, wherein one or more of the first and second analyte sensors includes a plurality of electrodes, wherein the plurality of electrodes include a working electrode comprising a mediator chemically bonded to a polymer.

15. The method of claim 14, wherein the mediator is crosslinked with the polymer disposed on the working electrode.

16. The method of claim 1, wherein the power source associated with the flexible patch is flexible.

17. The method of claim 16, wherein the power source includes a flexible battery directly integrated with the flexible patch.

18. The method of claim 1, wherein the flexible patch is removed from the skin surface after the second analyte sensor is removed from the another one of the plurality of predefined sensor insertion sites.