Infusion set and inserter assembly systems and methods

Abstract

An inserter assembly comprising a first unit including a skin contacting face which surrounds an opening and a second unit housed within the first unit. The second unit comprises an infusion set base disposed within the opening and having a bottom face which is substantially level with the skin contacting face and covered at least partially with adhesive and further comprising a spring biased insertion assembly. The second unit further comprising a cannula sub assembly carried by an insertion sharp of the insertion assembly. The spring biased insertion assembly and a cannula of the cannula sub assembly are driven into skin and the cannula sub assembly is coupled into the infusion set base by an insertion spring which is released from an energy storing state after the skin has been tugged upward beyond a certain distance by the adhesive as the inserter assembly is withdrawn from the body.

What is claimed is: 
     
         1 . A method of placing a medical device on a patient comprising:
 coupling a medical device cartridge containing the medical device to a reusable inserter;   coupling a portion of the medical device to the patient;   latching an insertion bias member of the inserter in a stressed state by displacing a first portion of the inserter toward a second portion of the inserter;   releasing the insertion bias member from the stressed state by displacing the first portion away from the second portion;   propelling an insertion driver and an insertion sharp of the cartridge coupled to the insertion driver toward the patient; and   releasing the medical device from the cartridge.   
     
     
         2 . The method of  claim 1 , wherein latching the insertion bias member in the stressed state comprises pressing the first portion of the inserter toward the patient and releasing the insertion bias member from the stressed state comprises pulling the first portion of the inserter away from the patient. 
     
     
         3 . The method of  claim 1 , wherein the method further comprises lifting skin coupled to the portion of the medical device from underlying body structures before completing propelling the insertion driver and insertion sharp of the cartridge toward the patient. 
     
     
         4 . The method of  claim 1 , wherein propelling the insertion driver and the insertion sharp toward the patient further comprises propelling a cannula of the medical device toward the patient and the method further comprises coupling the cannula assembly to a base of the medical device. 
     
     
         5 . The method of  claim 1 , wherein releasing the medical device from the cartridge comprises deflecting retainer arms of the cartridge out of engagement with the portion of the medical device coupled to the patient. 
     
     
         6 . The method of  claim 1 , wherein coupling the cartridge to the inserter comprises rotationally locking the cartridge in place on the inserter and coupling an insertion sharp holder of the cartridge on which the insertion sharp is borne into a port of the insertion driver. 
     
     
         7 . The method of  claim 1 , wherein the method further comprises retracting the insertion driver and insertion sharp to a retracted state. 
     
     
         8 . The method of  claim 1 , wherein displacing the first portion of the inserter toward the second portion of the inserter stresses at least one retraction spring and the method further comprises releasing the at least one retraction spring from a stressed state and propelling the insertion driver and the insertion sharp away from the patient. 
     
     
         9 . The method of  claim 1 , wherein the method further comprises detaching a remaining portion of the cartridge from the inserter by coupling an exterior housing to the remaining portion of the cartridge once the medical device has been released. 
     
     
         10 . A method of placing a medical device of an inserter assembly on a patient comprising:
 coupling the inserter assembly to skin;   lifting the skin from underlying anatomy by displacing the inserter assembly in a direction away from the skin; and   triggering an actuation assembly of the inserter assembly automatically as the skin is lifted.   
     
     
         11 . The method of  claim 10 , wherein the method further comprises releasing a bias member of the actuation assembly from an energy storing state to drive at least one insertion sharp through the skin. 
     
     
         12 . The method of  claim 11 , wherein the medical device comprises an infusion set and the method further comprises assembling the infusion set by driving a cannula assembly of the infusion set which is carried by the at least one insertion sharp into another portion of the infusion set. 
     
     
         13 . The method of  claim 11 , wherein the method further comprises releasing a retraction prevention latch and driving the at least one insertion sharp in a direction away from the skin. 
     
     
         14 . The method of  claim 10 , wherein the method further comprises removing a lock member which prevents triggering of the actuation assembly. 
     
     
         15 . The method of  claim 10 , wherein coupling the inserter assembly to the skin comprises adhering a portion of the medical device to the skin via adhesive. 
     
     
         16 . The method of  claim 10 , wherein the method further comprises inhibiting relative movement between a casing of the inserter assembly and a second portion of the inserter assembly at least when the skin begins to be lifted. 
     
     
         17 . The method of  claim 10 , wherein the method further comprises releasing the medical device from the rest of the inserter assembly. 
     
     
         18 . The method of  claim 10 , wherein the method further comprises assembling the inserter assembly by coupling a disposable cartridge containing the medical device to a reusable portion of the inserter assembly. 
     
     
         19 . A method of triggering an inserter assembly for placing an infusion set of the inserter assembly at an infusion site comprising:
 establishing an engagement between a first portion and a second portion of the inserter assembly which inhibits displacement of the first portion away from a second portion;   adhering a portion of the inserter assembly to skin at the infusion site;   pulling the skin at the infusion site away from underlying anatomy by displacing the inserter assembly in a direction away from the infusion site;   disengaging the first portion from the second portion when a force compelling separation of the first and second portion exceeds a threshold; and   increasing a magnitude of relative displacement between the first and second portion at least until an actuator of the first portion displaces into a trigger arrangement of the second portion.   
     
     
         20 . The method of  claim 19 , wherein establishing the engagement comprises placing a deflectable member of the second portion into an interfering relationship with a deflector of the first portion. 
     
     
         21 . The method of  claim 19 , wherein establishing the engagement comprises creating an interference between the first and second portions. 
     
     
         22 . The method of  claim 19 , wherein adhering the portion of the inserter assembly to the skin at the infusion site comprises adhering a first portion of the infusion set to the skin, the first portion of the infusion set being spaced and separate from a second portion of the infusion set before the actuator displaces into the trigger arrangement. 
     
     
         23 . The method of  claim 19 , wherein displacing the actuator of the first portion into the trigger arrangement comprises driving a projection of the first portion into the trigger arrangement. 
     
     
         24 . The method of  claim 19 , wherein displacing the actuator of the first portion into the trigger arrangement comprises driving the actuator of the first portion into a ledge of a spring loaded sharp bearing body, the ledge being engaged with a catch on the second portion and the method further comprises disengaging the ledge from the catch.