Source: http://www.google.ca/patents/US9259175
Timestamp: 2017-12-15 06:11:09
Document Index: 80773024

Matched Legal Cases: ['Application No. 2007309070', 'Application No. 200780039416', 'Application No. 200780039416', 'Application No. 2009', 'Application No. 2009', 'Application No. 2013', 'Application No. 2009']

Patent US9259175 - Flexible patch for fluid delivery and monitoring body analytes - Google Patents
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...http://www.google.ca/patents/US9259175?utm_source=gb-gplus-sharePatent US9259175 - Flexible patch for fluid delivery and monitoring body analytes
Publication number US9259175 B2
Application number US 11/552,065
Also published as CA2667305A1, CN101528282A, CN101528282B, EP2083878A2, EP2083878A4, US20080119707, US20120190952, US20160151569, WO2008051924A2, WO2008051924A3
Publication number 11552065, 552065, US 9259175 B2, US 9259175B2, US-B2-9259175, US9259175 B2, US9259175B2
Patent Citations (1126), Non-Patent Citations (75), Referenced by (2), Classifications (21), Legal Events (1)
US 9259175 B2
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.
In recent years, people with diabetes have typically measured their blood glucose level by lancing a finger tip or other body location to draw blood, applying the blood to a disposable test strip in a hand-held meter and allowing the meter and strip to perform an electrochemical test of the blood to determine the current glucose concentration. Such discrete, in vitro testing is typically conducted at least several times per day. Continuous in vivo glucose monitoring devices are currently being developed to replace in vitro devices. Some of these continuous systems employ a disposable, transcutaneous sensor that is inserted into the skin to measure glucose concentrations in interstitial fluid. A portion of the sensor protrudes from the skin and is coupled with a durable controller and transmitter unit that is attached to the skin with adhesive. A wireless handheld unit is used in combination with the skin-mounted transmitter and sensor to receive glucose readings periodically, such as once a minute. Every three, five or seven days, the disposable sensor is removed and replaced with a fresh sensor which is again coupled to the reusable controller and transmitter unit. With this arrangement, a person with diabetes may continuously monitor their glucose level with the handheld unit. Detailed descriptions of such a continuous glucose monitoring system and its use are provided in U.S. Pat. No. 6,175,752, issued to Abbott Diabetes Care Inc., formerly known as TheraSense, Inc., on Jan. 16, 2001, which is incorporated by reference herein in its entirety.
Portable insulin pumps are widely available and are used by diabetic people to automatically deliver insulin over extended periods of time. Currently available insulin pumps employ a common pumping technology, the syringe pump. In a syringe pump, the plunger of the syringe is advanced by a lead screw that is turned by a precision stepper motor. As the plunger advances, fluid is forced out of the syringe, through a catheter to the patient. Insulin pumps need to be very precise to deliver the relatively small volume of insulin required by a typical diabetic (about 0.1 to about 1.0 cm3 per day) in a nearly continuous manner. The delivery rate of an insulin pump can also be readily adjusted through a large range to accommodate changing insulin requirements of an individual (e.g., various basal rates and bolus doses) by adjusting the stepping rate of the motor. In addition to the renewable insulin reservoir, lead-screw and stepper motor, an insulin pump includes a battery, a controller and associated electronics, and typically a display and user controls. A typical insulin pump has a footprint about the size of a deck of cards and can be worn under clothing or attached with a belt clip. A disposable infusion set is coupled with the pump to deliver insulin to the person. The infusion set includes a cannula that is inserted through the skin, an adhesive mount to hold the cannula in place and a length of tubing to connect the cannula to the pump.
Various analytes may be monitored using aspects of the present invention. These analytes may include, but are not limited to, lactate, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormones, hematocrit, hemoglobin (e.g. HbA1c), hormones, ketones, lactate, oxygen, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin, in samples of body fluid. Monitoring systems may also be configured to determine the concentration of drugs, such as, for example, antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs of abuse, theophylline, warfarin and the like. Such analytes may be monitored in blood, interstitial fluid and other bodily fluids. Fluids that can be delivered include, but are not limited to, insulin and other medicines.
Transcutaneous analyte sensors can be inserted into the user's skin using an automatic introducer or inserter device, such as those described in U.S. patent application Ser. No. 10/703,214, published Jul. 8, 2004 under publication number 20040133164, now U.S. Pat. No. 7,381,184, incorporated herein by reference in its entirety. An inserted sensor can be electrically connected to controller and transmitter module 16 directly, with external conductors or through internal electrical pathways within flexible patch 12. The sensors may include adhesive mounts, or some type of mounting feature such as one or more snaps, hooks, clamps, pins, clips or other means molded onto or attached to the patch to secure the sensor to flexible patch 12 or to the user's skin during use.
A fluid pump 22, such as for delivering insulin or other medicine, can also be located on flexible patch 12. In this exemplary embodiment, fluid pump 22 includes a removable fluid reservoir 36. Reservoir 36 may be a disposable or refillable vial that is replaced by another vial when depleted. Reservoir 36 may be flexible so that it collapses like a balloon when its contents are emptied, or it may include a flexible diaphragm portion. Alternatively, reservoir 36 may be a rigid cylinder with a plunger 38 that forces fluid out when advanced into the reservoir 36. Actuator 40 may be a stepper motor, a shape-memory alloy actuator or other suitable mechanism for advancing plunger 38 or otherwise moving fluid out of reservoir 36. A shape-memory alloy actuator is preferred because of its small size, simplicity and reliability. It's low cost of manufacture also allows pump 22 to be disposable with patch 22 if desired. Details of such a shape-memory alloy driven pump are provided in U.S. patent application Ser. No. 10/683,659, published Jun. 17, 2004 under Publication No. 20040115067A1, now U.S. Pat. No. 6,916,159, incorporated herein by reference in its entirety. Reservoir 36 need not be removable from pump 22 and/or patch 12, particularly if patch 12 is designed to be disposed of after the fluid is depleted.
Further information on suitable fabrics, general construction and component integration methods for flexible patch 12 may be obtained from companies currently developing “smart fabrics” or conductive textiles, such as Textronics (www.textronics.com), Konarka (www.konarka.com), Nanosonic (www.nanosonic.com), Eleksen (www.eleksen.com) and Eeonyx (www.eeonyx.com). For instance, Eeonyx has a proprietary process for coating textiles with inherently conductive polymers based on doped polypyrrole. The company polymerizes the materials in situ—or on the surface of the fabric itself—so the coating material fills interstices in the surface and forms a physical bond with the fibers. See also “Fabrics Get Smart”, by Joseph Ogando, Design News, May 15, 2006 (www.designmews.com/article/ca6330247.html), incorporated herein by reference in its entirety.
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EP1630898A1 31 Aug 2004 1 Mar 2006 Eidgenössische Technische Hochschule (ETH) Textile antenna
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US20160151569 * 6 Jan 2016 2 Jun 2016 Abbott Diabetes Care Inc. Flexible patch for fluid delivery and monitoring body analytes
International Classification A61B5/145, A61B5/1468, A61M5/172, A61B5/1473, A61M5/142, A61B5/00
Cooperative Classification A61B5/14503, A61M2230/50, A61M2230/005, A61M5/1723, A61B5/0022, A61B5/6833, A61B5/14532, A61M2205/82, A61M2230/201, A61B2560/0252, A61M2205/3592, A61B2560/0412, A61M5/14248, A61M2005/1726, A61M2205/3569