Flexible Patch for Fluid Delivery and Monitoring Body Analytes

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.

1 . (canceled) 
     
     
         2 . A sensor device for measuring an analyte concentration, the sensor device comprising:
 a sensor unit comprising an in vivo portion having a tissue piercing element and a sensor body, the sensor body comprising at least one electrode and a membrane covering at least a portion of the at least one electrode; and   a mounting unit configured to support the sensor device on an exterior surface of a host's skin.   
     
     
         3 . The sensor device of  claim 2 , wherein the mounting unit comprises a guiding portion configured to guide insertion of the in vivo portion of the sensor unit through the host's skin and to support a column strength of the sensor unit such that the in vivo portion is capable of being inserted through the host's skin without substantial buckling; and
 wherein the guiding portion is configured to remain ex vivo during insertion of the in vivo portion of the sensor unit.   
     
     
         4 . The sensor device of  claim 3 , wherein the tissue piercing element, with the support of the guiding portion, is capable of withstanding an axial load without substantial buckling. 
     
     
         5 . The sensor device of  claim 2 , wherein the tissue piercing element is configured to protect the membrane from damage during insertion of the in vivo portion of the sensor unit. 
     
     
         6 . The sensor device of  claim 2 , wherein a largest dimension of a cross section transverse to a longitudinal axis of the tissue piercing element is greater than a largest dimension of a cross section transverse to a longitudinal axis of the sensor body. 
     
     
         7 . The sensor device of  claim 2 , wherein the at least one electrode comprises a working electrode and a reference electrode. 
     
     
         8 . The sensor device of  claim 2 , wherein the sensor body further comprises a support member configured to protect the membrane from damage during insertion of the sensor unit. 
     
     
         9 . The sensor device of  claim 8 , wherein the at least one electrode is a support member. 
     
     
         10 . The sensor device of  claim 8 , wherein the support member, with the support of a guiding member of the mounting unit, is capable of withstanding an axial load without substantial buckling. 
     
     
         11 . The sensor device of  claim 8 , wherein the support member is configured to support at least a portion of the at least one electrode. 
     
     
         12 . The sensor device of  claim 8 , wherein the support member is configured to substantially surround the at least one electrode. 
     
     
         13 . The sensor device of  claim 2 , wherein the mounting unit comprises a sensor electronics unit operatively and detachably connected to the sensor body. 
     
     
         14 . The sensor device of  claim 13 , wherein the sensor electronics unit is configured to be located over a sensor insertion site. 
     
     
         15 . A sensor array for measuring an analyte concentration, the sensor array comprising:
 a laminate comprising an adhesive layer configured for adhering the laminate to a host's skin; and   a plurality of sensor devices each attached to the laminate and each configured for insertion through the skin at a different insertion site, wherein each sensor device comprises a sensor unit and a mounting unit configured to support the sensor device on an exterior surface of the host's skin, the sensor unit comprising an in vivo portion having a tissue piercing element and a sensor body, the sensor body comprising at least one electrode and a membrane covering at least a portion of the at least one electrode.   
     
     
         16 . The sensor array of  claim 15 , wherein the laminate comprises sensor electronics operatively connected to the sensor devices. 
     
     
         17 . The sensor array of  claim 15 , wherein the plurality of sensor devices are configured to provide parallel measurements of analyte concentration. 
     
     
         18 . The sensor array of  claim 15 , wherein the plurality of sensor devices comprises a first sensor device and a second sensor device, wherein the first sensor device is configured to measure analyte concentration at a first range of analyte concentrations and the second sensor device is configured to measure analyte concentration at a second range of analyte concentrations, wherein the first range is different from the second range. 
     
     
         19 . The sensor array of  claim 15 , wherein the plurality of sensor devices comprises a first sensor device and a second sensor device, wherein the first sensor device comprises a first sensor body configured to reside in a host tissue at a first depth, wherein the second sensor device comprises a second sensor body configured to reside in the host tissue at a second depth, and wherein the first depth is different from the second depth.