Flexible patch for fluid delivery and monitoring body analytes

• US 10,363,363 B2
• Filed: 01/06/2016
• Issued: 07/30/2019
• Est. Priority Date: 10/23/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Stafford, Gary Ashley
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US14/989,548
• Publication Number:
  US 20160151569A1
• Time in Patent Office: 1,301 Days
• Field of Search: 600309, 600345-366
• 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 body analyte monitoring system comprising:

a flexible patch having a first axis and a second axis and configured to be adhered to an area of skin along the first axis and the second axis, wherein the flexible patch is more compliant along the first axis than along the second axis;

a percutaneous analyte sensor integrated with the flexible patch;

a power source integrated with the flexible patch;

an antenna coupled with the flexible patch, wherein the antenna is adapted for wireless communication of information from or to an external device; and

a controller integrated with the flexible patch, the controller being powered by the power source and configured to control the analyte sensor.

2. The monitoring system of claim 1, further comprising a transmitter integrated with the flexible patch, the transmitter being powered by the power source, controlled by the controller, and configured to transmit data from the analyte sensor to the external device.

3. The monitoring system of claim 1, further comprising a transceiver integrated with the flexible patch, the transceiver being powered by the power source, controlled by the controller, and configured to transmit data from the analyte sensor to the external device and to receive information from the external device.

4. The monitoring system of claim 1, wherein the analyte being measured is interstitial fluid glucose in a human being.

5. The monitoring system of claim 1, wherein the external device is a handheld user interface.

6. The monitoring system of claim 1, wherein the first axis is perpendicular to the second axis.

7. The monitoring system of claim 6, wherein the power source, the antenna and the controller are longitudinally aligned with each other along the second axis.

8. A body analyte monitoring system comprising:

a flexible patch having a first axis and a second axis and configured to be adhered to an area of skin along the first axis and the second axis, wherein the flexible patch is more compliant along the first axis than along the second axis;

an analyte sensor;

a power source coupled with the flexible patch;

an antenna coupled with the flexible patch, wherein the antenna is adapted for wireless communication of information from or to an external device; and

electronics coupled with the flexible patch and the analyte sensor, the electronics being powered by the power source and configured to control the analyte sensor.

9. The monitoring system of claim 8, wherein the coil antenna is a transducer coil.

10. The monitoring system of claim 8, wherein the power source and electronics are integrated with the flexible patch.

11. The monitoring system of claim 10, wherein the flexible patch is woven, and wherein the power source and electronics are woven into the flexible patch.

12. The monitoring system of claim 10, wherein the flexible patch comprises a multilayered fabric.

13. The monitoring system of claim 8, wherein the analyte sensor is configured to be inserted through a skin surface and into the living body.

14. The monitoring system of claim 8, wherein the analyte sensor is configured to measure glucose in the living body, wherein the living body is a human being.

15. The monitoring system of claim 8, wherein the flexible patch comprises a central area and a peripheral area, wherein the central area has a greater thickness than the peripheral area.

16. The monitoring system of claim 15, wherein the electronics are coupled to the central area and one or more openings through which the analyte sensor passes are in the peripheral area.

17. The monitoring system of claim 8, wherein the external device is a handheld user interface.