Flow restriction system and method for patient infusion device

Abstract

A device for delivering fluid, such as insulin for example, to a patient. The device includes a flow path having an exit port assembly adapted to connect to a transcutaneous patient access tool, and a reservoir connected to the exit port assembly. The device also includes a flow restriction system having an air removal filter communicating with the flow path and allowing air to exit the flow path and preventing fluid from exiting the flow path, and a flow restrictor positioned within the flow path between the air removal filter and the exit port assembly. Among other features and advantages, the flow restriction system of the present invention allows the flow path of the fluid delivery device to be purged of air, or “primed” prior to operation, such that desired volumes of fluid can be accurately delivered by the device.

1 . A device for delivering fluid to a patient, comprising: 
 A) a flow path including,    an exit port assembly adapted to connect to a transcutaneous patient access tool, and    a reservoir connected to the exit port assembly; and    B) a flow restriction system including,    an air removal filter communicating with the flow path and allowing air to exit the flow path and preventing fluid from exiting the flow path, and    a flow restrictor positioned within the flow path between the air removal filter and the exit port assembly;    wherein,    the flow restrictor of the flow restriction system comprises an outlet plug removably connected to the exit port assembly to prevent fluid from exiting the flow path through the exit port assembly;    the exit port assembly includes a transcutaneous patient access tool comprising a needle having a distal end for insertion into a patient and the outlet plug comprises: 
 a sleeve having a first end removably received in a substantially fluid-tight manner on the distal end of the needle; and  
 a cap connected to a second end of the sleeve.  
   
     
     
         2 . A device according to  claim 1 , wherein the sleeve and the cap of the outlet plug are unitarily formed from a resiliently flexible material.  
     
     
         3 . A device according to  claim 1 , wherein the air removal filter is seated in the cap of the outlet plug and prevents fluid from passing out of the needle and allows air to pass out of the needle.  
     
     
         4 . A device according to  claim 3 , wherein the air removal filter of the outlet plug comprises one of PTFE and polyethylene.  
     
     
         5 . A device according to  claim 3 , wherein the air removal filter of the outlet plug is provided with predetermined physical properties such that the filter expands upon the flow path being substantially primed.  
     
     
         6 . A device according to  claim 5 , wherein the air removal filter includes visual indicia for indicating when the flow path is substantially primed.  
     
     
         7 . A device according to  claim 6 , wherein the visual indicia comprises a drawing on the filter that changes shape upon the filter expanding.  
     
     
         8 . A device according to  claim 3 , wherein the air removal filter of the outlet plug is adapted to allow fluid to pass out of the needle upon a pressure within the flow path exceeding a desired maximum level of flow path pressure.  
     
     
         9 . A device according to  claim 3 , wherein the air removal filter of the outlet plug includes: 
 an outer layer; and    an inner layer having predetermined physical properties that allow the inner layer to expand to contact the outer layer upon the flow path being substantially primed.    
     
     
         10 . A device according to  claim 9 , wherein the outer layer of the air removal filter is relatively transparent and the inner layer of the air removal filter is darker in coloring than the outer transparent layer such that the inner layer can be seen through the outer layer when the inner layer contacts the outer layer.  
     
     
         11 . A device according to  claim 9 , wherein the flow restriction system further includes a filter sensor for providing a signal when the inner layer contacts the outer layer.  
     
     
         12 . A device according to  claim 3 , wherein the air bubble removal filter of the outlet plug is comprised of needle septum material.  
     
     
         13 . A device for delivering fluid to a patient, comprising: 
 A) a flow path including,    an exit port assembly adapted to connect to a transcutaneous patient access tool, and    a reservoir connected to the exit port assembly; and    B) a flow restriction system including,    an air removal filter communicating with the flow path and allowing air to exit the flow path and preventing fluid from exiting the flow path, and    a flow restrictor positioned within the flow path between the air removal filter and the exit port assembly;    wherein,    the flow restrictor of the flow restriction system comprises an outlet plug removably connected to the exit port assembly to prevent fluid from exiting the flow path through the exit port assembly; and    the outlet plug further comprises a needle septum.    
     
     
         14 . A device for delivering fluid to a patient, comprising: 
 A) a flow path including,    an exit port assembly adapted to connect to a transcutaneous patient access tool, and    a reservoir connected to the exit port assembly; and    B) a flow restriction system including,    an air removal filter communicating with the flow path and allowing air to exit the flow path and preventing fluid from exiting the flow path, and    a flow restrictor positioned within the flow path between the air removal filter and the exit port assembly;    wherein,    the flow restrictor of the flow restriction system comprises an outlet plug removably connected to the exit port assembly to prevent fluid from exiting the flow path through the exit port assembly; and    the outlet plug includes a pressure relief valve actuable upon a pressure within the flow path exceeding a desired maximum level of flow path pressure.    
     
     
         15 . A device for delivering fluid to a patient, comprising: 
 A) a flow path including,    an exit port assembly adapted to connect to a transcutaneous patient access tool, and    a reservoir connected to the exit port assembly; and    B) a flow restriction system including,    an air removal filter communicating with the flow path and allowing air to exit the flow path and preventing fluid from exiting the flow path, and    a flow restrictor positioned within the flow path between the air removal filter and the exit port assembly;    wherein,    the flow restrictor of the flow restriction system comprises an outlet plug removably connected to the exit port assembly to prevent fluid from exiting the flow path through the exit port assembly; and    further comprising:    a housing containing the flow path, wherein the exit port assembly extends at least partly through a port in the housing;    an adhesive layer provided in at least one continuous band on an exterior surface of the housing surrounding the port of the housing; and    a protective layer removably covering the adhesive layer, wherein the outlet plug of the flow restriction system is secured to the protective layer so that removal of the protective layer removes the outlet plug from the exit port assembly.    
     
     
         16 . A device for delivering fluid to a patient, comprising: 
 A) a flow path including,    an exit port assembly adapted to connect to a transcutaneous patient access tool, and    a reservoir connected to the exit port assembly; and    B) a flow restriction system including,    an air removal filter communicating with the flow path and allowing air to exit the flow path and preventing fluid from exiting the flow path, and    a flow restrictor positioned within the flow path between the air removal filter and the exit port assembly;    wherein,    the flow restrictor of the flow restriction system comprises an outlet plug removably connected to the exit port assembly to prevent fluid from exiting the flow path through the exit port assembly; and    further comprising a switch arranged to be closed upon removal of the outlet plug from the exit port assembly.    
     
     
         17 . A device according to  claim 16 , wherein the outlet plug includes a handle for supporting the fluid delivery device during filling of the device through the fill port.  
     
     
         18 . A device according to  claim 17 , wherein the handle of the outlet plug includes an outer contour that nests with an outer contour of the fluid delivery device.  
     
     
         19 . A packaging system including a device according to  claim 16 , and further including: 
 a container holding the fluid delivery device; and    a protective cover removably sealing the fluid delivery device within the container, wherein the outlet plug of the flow restriction system is secured to the protective cover so that removal of the protective cover from the container removes the outlet plug from the exit port assembly.    
     
     
         20 . The packaging system of  claim 19 , wherein the container includes an inner contour that nests with an outer contour of the fluid delivery device.  
     
     
         21 . The packaging system of  claim 19 , wherein the fluid delivery device includes a switch and the protective cover includes an insert extending into the fluid delivery device to normally hold the switch open.