Disposable inserter for use with a medical device

Abstract

An inserter and methods of using embodiments of the inserter are described. The inserter includes a housing having a cannula assembly and an insertion mechanism. Two buttons are located on the inserter and are concomitantly actionable for actuation of the insertion mechanism, wherein the insertion mechanism is configured to place a cannula assembly in a well that is disposed on the cradle. The inserter also includes a first parts and second part, whereby the first part includes a handle and the second part comprises the entire insertion mechanism, whereby the first and second part are connected via an indentation.

What is claimed is: 
     
         1 . A disposable inserter configured to be received by a skin adherable cradle for supporting an insulin pump, the disposable inserter comprising:
 a cannula assembly;   an insertion mechanism configured to place the cannula assembly in a well disposed on the skin adherable cradle; and   an inserter base having a first part and second part, whereby the first part includes a handle and the second part comprises the insertion mechanism, whereby the first and second part are connected via an indentation, and the first part and second part fold about the indentation when the handle is pulled to release the inserter base from the skin adherable cradle.   
     
     
         2 . The disposable inserter of  claim 1 , comprising a protective ring which is put on a cylindrical portion of the insertion mechanism. 
     
     
         3 . The disposable inserter of  claim 1 , comprising feedback elements indicating the status of the insertion mechanism whereby a visible green protective ring indicates the insertion mechanism is unused and a visible red slider or parts of it indicate the insertion mechanism is used. 
     
     
         4 . The disposable inserter of  claim 1 , wherein the handle protrudes from the first part. 
     
     
         5 . The disposable inserter of  claim 1 , wherein ends of inserter base are configured to engage snaps of the cradle. 
     
     
         6 . The disposable inserter of  claim 1 , wherein the inserter base has four points of contact by which to engage the skin adherable cradle. 
     
     
         7 . The disposable inserter of  claim 1 , wherein the indentation is geometrically designed to allow the inserter to release from the cradle only when the handle is pulled away from the cradle to both deflect upwards and fold the first and second parts of the inserter base. 
     
     
         8 . The disposable inserter of  claim 1 , wherein the indentation is geometrically designed to allow the inserter to release from the cradle only when the handle is pulled away from the cradle to both deflect upwards and fold the first and second parts of the inserter base which releases both ends of the inserter base from snaps of the cradle. 
     
     
         9 . The disposable inserter of  claim 1 , wherein a septum of the cannula assembly is configured to be placed parallel to an upper plane of the well when the cannula assembly is placed in the well by the insertion mechanism. 
     
     
         10 . The disposable inserter of  claim 1 , wherein the insertion mechanism comprises insertion and retraction springs. 
     
     
         11 . The disposable inserter of  claim 10 , comprising a housing that comprises the cannula assembly and a protective ring which is put on a cylindrical portion of the insertion mechanism, wherein the springs are maintained in the housing by two latches aligned with holes disposed in the housing, and the protective ring configured to cover the entire surface area of the two buttons. 
     
     
         12 . The disposable inserter of  claim 10 , comprising a housing that comprises the cannula assembly and two buttons designed as torsion snap fit, whereby a torsion bar is a part of the housing, wherein upon actuation of the two buttons the buttons are tilted and the insertion spring is allowed to expand and to push the insertion mechanism downwards to insert the cannula into the skin and the cannula assembly into the cradle well. 
     
     
         13 . The disposable inserter of  claim 10 , wherein the springs are preloaded. 
     
     
         14 . A method of disconnecting from a skin adherable cradle, which is adapted to receive a micropump and fluidly connect the micropump to a cannula, an inserter that comprises an inserter base that has a first part and second part, whereby the first part includes a handle and the second part comprises an insertion mechanism that places a cannula assembly that comprises the cannula in a well of the skin adherable cradle, whereby the first and second part are connected via an indentation, and the first part and second part fold about the indentation when the handle is pulled to release the inserter base from the skin adherable cradle, said method comprising:
 pulling the handle and causing the first part and second part to fold about the indentation which releases the inserter base from the skin adherable cradle.   
     
     
         15 . The method of  claim 14 , further comprising indicating status of the insertion mechanism via feedback elements of the inserter. 
     
     
         16 . The method of  claim 14 , wherein disconnecting the inserter from the cradle is via pulling the handle away from the cradle to both deflect upwards and fold the first and second parts of the inserter base, thereby releasing ends of the inserter base from snaps of the cradle. 
     
     
         17 . The method of  claim 14 , wherein the pulling of the handling occurs after triggering the insertion mechanism to place the cannula assembly in the well. 
     
     
         18 . The method of  claim 17 , wherein after triggering of the insertion mechanism to place the cannula assembly in the well, said method further comprises automatically retracting a needle assembly of the insertion mechanism into a cylindrical portion of the inserter. 
     
     
         19 . The method of  claim 17 , wherein the triggering of the insertion mechanism occurs by removing a protective ring that prevents the unintentional pressing of buttons on the inserter, the buttons being configured to trigger the insertion mechanism, and by pressing concomitantly the buttons. 
     
     
         20 . The method of  claim 19 , wherein the triggering of the buttons tilts the buttons which causes an insertion spring to expand and push the insertion mechanism downwards to place the cannula assembly into the well.