Integrated analyte sensor and infusion device and methods therefo

Abstract

Method and system for providing an integrated analyte monitoring system and on-body patch pump with multiple cannulas and a sensor combination is provided.

What is claimed is: 
     
         1 . An insulin delivery system, comprising:
 a patch pump configured to be worn on a skin surface of a user, comprising:
 a housing; 
 an adhesive patch configured to adhere a bottom surface of the housing to the skin surface of the user; 
 a reservoir configured to store insulin; 
 a cannula configured to be positioned beneath the skin surface of the user to establish a fluid path between the reservoir and an infusion site of the user when positioned beneath the skin surface, wherein in a first position the cannula is entirely retained within the housing and in a second position the cannula extends outward from the bottom surface of the housing; 
 a processor arranged within the housing, wherein the processor is configured to control delivery of insulin and to control insertion of the cannula; 
 a power supply arranged within the housing; and 
 a transmitter configured to be placed in wireless communication with a controller to receive instructions from the controller for delivering insulin; and 
 a controller in bi-directional, wireless communication with the patch pump, the controller comprising: 
 an input unit; 
 an output unit; and 
 a user interface, 
 wherein the controller is configured to receive information associated with operation of the patch pump from the patch pump and to communicate commands to the patch pump for delivery of insulin, and 
 wherein the controller is configured to transmit an instruction to the patch pump to insert the cannula such that the cannula moves from the first position to the second position. 
   
     
     
         2 . The system of  claim 1 , further comprising an insertion mechanism comprising a needle configured to pierce the skin to insert the cannula beneath the skin surface. 
     
     
         3 . The system of  claim 2 , wherein the insertion mechanism is spring-driven. 
     
     
         4 . The system of  claim 1 , wherein the controller comprises a mobile phone. 
     
     
         5 . The system of  claim 1 , wherein the controller is configured to transmit an instruction to the patch pump to retract the cannula. 
     
     
         6 . The system of  claim 1 , wherein the controller is configured to transmit an instruction to the patch pump to deliver insulin according to a programmed basal profile. 
     
     
         7 . The system of  claim 1 , wherein the controller is configured to transmit an instruction to the patch pump to deliver a bolus dosage of insulin. 
     
     
         8 . The system of  claim 1 , further comprising a glucose sensor configured to be positioned subcutaneously in the body of the user to detect glucose, wherein the transmitter of the patch pump is configured to receive signals indicative of glucose levels from the glucose sensor. 
     
     
         9 . The system of  claim 8 , wherein the controller is configured to receive the glucose levels from the transmitter of the patch pump. 
     
     
         10 . The system of  claim 1 , wherein the patch pump further comprises a port in fluid communication with the reservoir, wherein the port comprises a self-sealing septum. 
     
     
         11 . The system of  claim 1 , wherein the patch pump further comprises an output unit configured to provide an audible alert. 
     
     
         12 . An on-body patch pump configured to be worn on a body of a user to deliver insulin, wherein the on-body patch pump comprises:
 a housing;   an adhesive patch configured to adhere a bottom surface of the housing to the body of the user;   a reservoir configured to store insulin;   a cannula configured to be positioned beneath a skin surface of the user to establish a fluid path between the reservoir and an infusion site of the user when the cannula is positioned beneath the skin surface, wherein in a first position the cannula is entirely retained within the housing and in a second position the cannula extends outward from the housing;   a processor arranged within the housing, wherein the processor is configured to control delivery of insulin and to automatically insert the cannula;   a power supply arranged within the housing; and   a transmitter configured to wirelessly communicate with a controller to receive instructions for delivering insulin and to receive an instruction to insert the cannula such that the cannula moves from the first position to the second position.   
     
     
         13 . The pump of  claim 12 , further comprising an insertion mechanism comprising a needle configured to pierce the skin to insert the cannula beneath the skin surface. 
     
     
         14 . The pump of  claim 13 , wherein the insertion mechanism is spring-driven. 
     
     
         15 . The pump of  claim 12 , wherein the processor is further configured to control retraction of the cannula based on a signal received from the controller. 
     
     
         16 . The pump of  claim 12 , wherein the transmitter is configured to receive signals indicative of glucose levels from a glucose sensor positioned subcutaneously in the body of the user. 
     
     
         17 . The pump of  claim 12 , wherein the housing further comprises a port in fluid communication with the reservoir, wherein the port comprises a self-sealing septum. 
     
     
         18 . The pump of  claim 12 , further comprising an output unit configure to provide an audible alert. 
     
     
         19 . The pump of  claim 12 , further comprising a leakage sensor for detecting leakage of insulin within the housing. 
     
     
         20 . The pump of  claim 12 , wherein the cannula is configured for delivery of insulin for a period of three to four days.