Analyte Monitoring and Fluid Dispensing System

Abstract

Disclosed is a skin adherable device for delivering therapeutic fluid into a body of a patient. The device includes a monitoring apparatus, a dispensing apparatus, and a tip for delivering the therapeutic fluid into the body of the patient and for monitoring bodily analyte in the body of the patient. The dispensing apparatus may continuously deliver the therapeutic fluid to the body of the patient and the monitoring apparatus may continuously monitor bodily analytes of the patient.

1 .- 28 . (canceled) 
     
     
         29 . A system for delivering a therapeutic fluid into the body of a patient and for sensing one or more body analytes, the system comprising:
 a subcutaneously insertable tip including:
 a cannula configured for subcutaneous placement within a body of a patient, 
 at least one electrode for interacting with one or more body analytes in subcutaneous tissue of a patient and generating a signal representative of a concentration of the one or more body analytes in the body, the at least one electrode being coupled to the cannula, and 
 at least one cannula electrical connector being in electrical communication with the at least one electrode; 
   a reusable part including:
 at least a portion of a pump, 
 a processor capable of processing the signal for determining the concentration of the one or more body analytes, and 
 at least one reusable part electrical connector being in electrical communication with the processor; 
   a disposable part including:
 a reservoir containing a therapeutic fluid, and 
 an outlet port for enabling flow of the therapeutic fluid from the reservoir to the cannula; and 
   a skin securable cradle having a well for receiving the subcutaneously insertable tip;   wherein:
 upon coupling of the reusable part to the disposable part and connection thereof to the cradle:
 electrical communication is established between the at least one electrode and the processor via the at least one cannula electrical connector and the at least one reusable part electrical connector, and 
 the pump delivers the therapeutic fluid from the reservoir to the body through the cannula. 
 
   
     
     
         30 . The system of  claim 29 , wherein the cradle further comprises:
 a first cradle electrical connector coupleable to the at least one cannula electrical connector, and   a second cradle electrical connector coupleable to the at least one reusable part electrical connector and in electrical communication with the first cradle electrical connector.   
     
     
         31 . The system of  claim 29 , wherein the disposable part further comprises:
 a first disposable part electrical connector coupleable to the at least one cannula electrical connector, and   a second disposable part electrical connector coupleable to the at least one reusable part electrical connector and in electrical communication with the first disposable part electrical connector.   
     
     
         32 . The system of  claim 29 , wherein the subcutaneously insertable tip includes current conducting elements for establishing electrical communication between the at least one electrode and the cannula electrical connector. 
     
     
         33 . The system of  claim 30 , wherein the cradle includes current conducting elements for establishing electrical communication between the first cradle electrical connector and the second cradle electrical connector. 
     
     
         34 . The system of  claim 31 , wherein the disposable part includes current conducting elements for establishing electrical communication between the first disposable part electrical connector and the second disposable part electrical connector. 
     
     
         35 . The system of  claim 29 , wherein coupling of the reusable part to the disposable part form a unit and the unit is releasably connected to the cradle enabling repeated establishment of electrical communication between the at least one electrode and the processor. 
     
     
         36 . The system of  claim 29 , wherein the at least one electrode being coated with an enzyme layer that electrochemically interacts with the one or more body analytes. 
     
     
         37 . The system of  claim 29 , wherein the cannula includes a proximal portion and a distal portion, the proximal portion including the cannula electrical connector and being securable to the well, and the distal portion including the at least one electrode and being configured for subcutaneous placement within the body of the patient. 
     
     
         38 . The system of  claim 37 , wherein the at least one electrode is in close proximity to an opening at the distal portion, the therapeutic fluid being delivered though the opening. 
     
     
         39 . The system of  claim 29 , wherein the at least one electrode is disposed on an outer surface of the cannula. 
     
     
         40 . The system of  claim 29 , wherein the at least one electrode is provided on an inner surface of the cannula and at least part of the cannula comprises a permeable or a semi-permeable wall. 
     
     
         41 . The system of  claim 29 , wherein the at least one electrode is provided along at least one of a part of a circumferential axis of the cannula and a part of a longitudinal axis of the cannula. 
     
     
         42 . The system of  claim 29 , wherein the therapeutic fluid comprises insulin and the one or more body analytes comprises glucose. 
     
     
         43 . The system of  claim 29 , wherein the processor controls each of the pump for continuously delivering the therapeutic fluid to the body of the patient and also the at least one electrode for continuously monitoring the concentration level of the one or more body analytes in the subcutaneous tissue. 
     
     
         44 . The apparatus of  claim 29 , wherein the pump is configured to deliver the therapeutic fluid to the body of the patient based on the concentration of the one or more body analytes determined by the processor. 
     
     
         45 . The system of  claim 29 , wherein the system is operable in a mode selected from the group consisting of: an open loop mode, a closed loop mode, and a semi-closed loop mode. 
     
     
         46 . The system of  claim 29 , wherein the cradle includes an adhesive layer for adhering the cradle to the skin of the patient. 
     
     
         47 . The system of  claim 29 , wherein the system further comprises a remote control, the remote control being configured for at least one of controlling, programming and managing data related to delivery of the therapeutic fluid and/or monitoring of the one or more body analytes. 
     
     
         48 . The system of  claim 47 , wherein the remote control includes a glucose monitoring apparatus. 
     
     
         49 . The system of  claim 33 , wherein at least one of the current conducting elements, the first cradle electrical connector and the second cradle electrical connector, is embedded with the cradle. 
     
     
         50 . The system of  claim 29 , wherein the cradle and the subcutaneously insertable tip are disposable. 
     
     
         51 . A system for delivering a therapeutic fluid into the body of a patient and for sensing one or more body analytes, the system comprising:
 a subcutaneously insertable tip including:
 a cannula configured for subcutaneous placement within a body of a patient, 
 at least one electrode for interacting with one or more body analytes in subcutaneous tissue of a patient and generating a signal representative of a concentration of the one or more body analytes in the body, the at least one electrode being coupled to the cannula, and 
 at least one cannula electrical connector being in electrical communication with the at least one electrode; 
   a therapeutic fluid delivery device having a processor capable of processing the signal for determining the concentration of the one or more body analytes, and at least one electrical connector being in electrical communication with the processor; and   a skin securable cradle having a well for receiving the subcutaneously insertable tip;   wherein:
 electrical communication is established between the at least one electrode and the processor via the at least one cannula electrical connector and the at least one electrical connector of the device upon connection thereof to the cradle, and 
 the pump delivers the therapeutic fluid from the reservoir to the body through the cannula. 
   
     
     
         52 . A method for delivering a therapeutic fluid into the body of a patient and for sensing one or more body analytes, the method comprising:
 providing a system for delivering a therapeutic fluid into the body of a patient and for sensing one or more body analytes, the system comprising:
 a subcutaneously insertable tip including:
 a cannula configured for subcutaneous placement within a body of a patient, 
 at least one electrode for interacting with one or more body analytes in subcutaneous tissue of a patient and generating a signal representative of a concentration of the one or more body analytes in the body, the at least one electrode being coupled to the cannula, and 
 at least one cannula electrical connector being in electrical communication with the at least one electrode; 
 
 a therapeutic fluid delivery device having a processor capable of processing the signal for determining the concentration of the one or more body analytes, and at least one electrical connector being in electrical communication with the processor; and 
 a skin securable cradle having a well for receiving the subcutaneously insertable tip; 
   establishing electrical communication between the at least one electrode and the processor via the at least one cannula electrical connector and the at least one electrical connector of the device upon connection thereof to the cradle, and   delivering therapeutic fluid from the reservoir to the body through the cannula by action of the pump.