Modular Combination Of Medication Infusion And Analyte Monitoring

Abstract

Methods and systems for providing modular components in an integrated infusion device and analyte monitoring system where the components are independently replaceable are provided.

1 . An analyte monitoring device comprising:
 a non-conducting tubular structure at least partially configured for subcutaneous implantation within a patient, the tubular structure comprising a tubular wall, an exterior surface, a luminal surface and a distal end surface; and   at least one electrode, at least a portion of which is disposed on a surface of the tubular structure and positioned for contact with an analyte of the patient when the tubular structure is subcutaneously implanted.   
     
     
         2 . The analyte monitoring device of  claim 1  wherein the at least a portion of the at least one electrode is disposed on the exterior surface of the tubular structure. 
     
     
         3 . The analyte monitoring device of  claim 1  wherein the at least a portion of the at least one electrode is disposed on the luminal surface of the tubular structure. 
     
     
         4 . The analyte monitoring device of  claim 1  wherein the at least a portion of the at least one electrode is disposed on the distal end surface of the tubular structure. 
     
     
         5 . The analyte monitoring device of  claim 1  wherein at least a portion of the at least one electrode is embedded within the tubular wall. 
     
     
         6 . The analyte monitoring device of  claim 1  wherein at least a portion of the at least one electrode extends along a longitudinal axis of the tubular structure. 
     
     
         7 . The analyte monitoring device of  claim 1  wherein at least a portion of the at least one electrode is wrapped about a longitudinal axis of the tubular structure. 
     
     
         8 . The analyte monitoring device of  claim 1  wherein the at least one electrode includes at least two electrodes. 
     
     
         9 . The analyte monitoring device of  claim 8  wherein the at least two electrodes are in a side by side configuration. 
     
     
         10 . The analyte monitoring device of  claim 8  wherein the at least two electrodes are on the same side of the tubular structure. 
     
     
         11 . The analyte monitoring device of  claim 8  wherein the at least two electrodes are on opposite sides of the tubular structure. 
     
     
         12 . The analyte monitoring device of  claim 8  wherein the at least two electrodes are in a stacked configuration. 
     
     
         13 . The analyte monitoring device of  claim 8  wherein the at least two electrodes are provided on the same surface of the tubular structure. 
     
     
         14 . The analyte monitoring device of  claim 8  wherein the at least two electrodes are provided on different surfaces of the tubular structure. 
     
     
         15 . The analyte monitoring device of  claim 8  wherein the at least two electrodes are evenly spaced about the tubular structure. 
     
     
         16 . The analyte monitoring device of  claim 15  wherein the at least two electrodes comprise three electrodes and wherein the electrodes are provided in a triangular arrangement. 
     
     
         17 . The analyte monitoring device of  claim 1  wherein at least a portion each electrode is individually encased in an insulative tubing. 
     
     
         18 . The analyte monitoring device of  claim 17  wherein the at least one electrode is on the exterior surface of the tubular structure. 
     
     
         19 . The analyte monitoring device of  claim 18  wherein a sheath extends about the exterior surface of the tubular structure and the insulative tubing. 
     
     
         20 . The analyte monitoring device of  claim 19  wherein the sheath comprises an electromagnetic shield. 
     
     
         21 . The analyte monitoring device of  claim 1  wherein the tubular structure is further configured for infusion of a fluid when subcutaneously implanted. 
     
     
         22 . The analyte monitoring device of  claim 21  wherein the analyte is glucose and the fluid is insulin. 
     
     
         23 . The analyte monitoring device of  claim 1  wherein the analyte is glucose. 
     
     
         24 . An analyte monitoring device comprising:
 a non-conducting tubular structure at least partially configured for subcutaneous implantation within a patient, the tubular structure comprising a tubular wall and a lumen; and   at least one electrode extending within the lumen and spaced in a parallel relationship with the tubular wall, wherein at least a portion of the at least one electrode is positioned for contact with an analyte of the patient when the tubular structure is subcutaneously implanted.   
     
     
         25 . The analyte monitoring device of  claim 24  wherein at least a portion each electrode is individually encased in an insulative tubing. 
     
     
         26 . The analyte monitoring device of  claim 24  wherein the at least one electrode comprises three electrodes and wherein the electrodes are provided in a triangular arrangement. 
     
     
         27 . The analyte monitoring device of  claim 24  wherein the analyte is glucose. 
     
     
         28 . A medical device comprising:
 a non-conducting tubular structure, at least a portion of which is configured for subcutaneous implantation within a patient, the tubular structure comprising a tubular wall and a lumen configured for infusion of a fluid to within the patient; and   at least one electrode, at least a portion of which is disposed on an exterior surface of the implantable portion of the tubular structure and positioned for contact with an analyte of the patient when at least the portion of the tubular structure is subcutaneously implanted.   
     
     
         29 . The medical device of  claim 28  wherein the analyte is glucose and the fluid is insulin. 
     
     
         30 . A medical device, comprising:
 a cannula configured for subcutaneously infusing a fluid within a patient;   an infusion tubing in fluid communication with the cannula; and   an analyte sensor configured for subcutaneous implantation within the patient, the analyte sensor comprising at least one electrode, at least a portion of which is disposed within the infusion tubing.   
     
     
         31 . The medical device of  claim 30  further comprising a housing adapted for positioning on the skin surface, wherein the cannula and the analyte sensor are mountably coupled to the housing. 
     
     
         32 . The medical device of  claim 31  wherein the infusion tubing is operatively coupled to the housing. 
     
     
         33 . The medical device of  claim 30  wherein the analyte is glucose and the fluid is insulin. 
     
     
         34 . A medical device comprising:
 a cannula configured for subcutaneously infusing a fluid within a patient; and   an analyte sensor configured for subcutaneous implantation within the patient, wherein at least a portion of the analyte sensor is wrapped around the cannula.   
     
     
         35 . The medical device of  claim 34  further comprising a housing adapted for positioning on a skin surface of the patient, wherein the cannula and the analyte sensor are mountably coupled to the housing. 
     
     
         36 . The medical device of  claim 34  wherein the analyte is glucose and the fluid is insulin. 
     
     
         37 . A medical device, comprising:
 a layered structure including:
 a fluid channel layer configured to guide flow of a medication from outside a body to within the body; and 
 a conductive layer comprising at least one electrode trace disposed thereon and configured for extending from a subcutaneous position to a location outside the body. 
 wherein the layered structure includes a first portion configured for subcutaneous implantation within the body and a second portion configured for positioning outside the body. 
   
     
     
         38 . The medical device of  claim 37  wherein the layered structure includes an insulation layer on at least one side of the conductive layer. 
     
     
         39 . The medical device of  claim 37  wherein the layered structure includes an insulation layer on each side of the conductive layer. 
     
     
         40 . The medical device of  claim 37  wherein the layered structure includes a fluid inlet layer adjacent the fluid channel layer for coupling the fluid channel layer to a source of the medication. 
     
     
         41 . The medical device of  claim 40  wherein the layered structure includes a first insulation layer between the fluid channel layer and the conductive layer. 
     
     
         42 . The medical device of  claim 41  wherein the fluid inlet layer and the first insulation layer, at least in part, enclose a fluid channel within the fluid channel layer. 
     
     
         43 . The medical device of  claim 42  wherein the layered structure includes a second insulation layer adjacent to the conductive layer. 
     
     
         44 . The medical device of  claim 37  further comprising a pump operatively coupled to the layered structure, the pump configured to pump the medication from a reservoir through the fluid channel layer and into the body. 
     
     
         45 . The medical device of  claim 37  further comprising an analyte monitoring unit operatively coupled to the layered structure, wherein the analyte monitoring unit is electrically coupled to the at least one electrode trace disposed on the conductive layer. 
     
     
         46 . The medical device of  claim 37  wherein the portion of the layered structure configured for positioning outside the body comprises a planar configuration. 
     
     
         47 . The medical device of  claim 37  wherein the portion of the layered structure configured for subcutaneous implantation has a profile smaller than that of the portion of the layered structure configured for positioning outside the body.