Disposable infusion device facilitating tissue fold formation for cannula deployment and method

Abstract

A device and method facilitates the forming of a skin fold during deployment of a cannula. The device may be a disposable infusion device and the method comprises adhering, to a skin surface, a base member having a port for receiving a cannula, forming a skin fold having skin surfaces sloping away from opposite sides of the base member, driving a cannula through the port of the base member while maintaining the skin fold, and releasing the skin fold. To facilitate the forming of the skin fold, the device comprises a base having a base surface and a flexible layer member. The flexible layer member has a first surface adjacent the base surface and a second surface adapted to be adhered to a patient's skin. The first surface has a first portion adhered to a portion of the base surface and a second portion adherable to the base surface.

1 . A medical device comprising:
 a base having a base surface; and   a flexible layer member, the flexible layer member having a first surface adjacent the base surface and a second surface adapted to be adhered to a patient's skin, the first surface having a first portion adhered to a portion of the base surface and a second portion adherable to the base surface.   
     
     
         2 . The device of  claim 1 , wherein the base surface and the flexible layer member are arranged to permit a cannula to pass there through from the base. 
     
     
         3 . The device of  claim 2 , wherein the base is arranged to permit a cannula to pass through the first portion of the first surface. 
     
     
         4 . The device of  claim 3 , wherein the base includes a septum within the base surface to permit a cannula to pass through the first portion of the first surface. 
     
     
         5 . The device of  claim 1 , wherein the second portion of the first surface includes a layer of adhesive and a removable cover overlying the layer of adhesive. 
     
     
         6 . The device of  claim 1 , wherein the second portion of the first surface includes first and second areas on opposite sides of the first portion. 
     
     
         7 . The device of  claim 6 , wherein the base surface and the flexible layer member are arranged to permit a cannula to pass there through from the base. 
     
     
         8 . The device of  claim 7 , wherein the base is arranged to permit a cannula to pass through the first portion of the first surface. 
     
     
         9 . The device of  claim 8 , wherein the base includes a septum within the base surface to permit a cannula to pass through the first portion of the first surface. 
     
     
         10 . The device of  claim 6 , wherein the first and second areas of the first surface each includes a layer of adhesive and a removable cover overlying the layer of adhesive. 
     
     
         11 . A method of deploying a cannula of a disposable infusion device, comprising:
 adhering, to a skin surface, a base member having a port for receiving a cannula;   forming a skin fold having skin surfaces sloping away from opposite sides of the base member;   driving a cannula through the port of the base member while maintaining the skin fold; and   releasing the skin fold.   
     
     
         12 . The method of  claim 11 , wherein the step of forming the skin fold includes compressing soft tissue beneath and on opposite sides of the base member. 
     
     
         13 . The method of  claim 11 , wherein the adhering step includes adhering a first portion of the base member to the skin surface before forming the skin fold and adhering an additional portion of the base member to the skin surface after releasing the skin fold. 
     
     
         14 . The method of  claim 13 , wherein the additional portion of the base member is a portion of the base member remaining to be adhered to the skin surface. 
     
     
         15 . The method of  claim 11 , including the further step of releasably attaching to the base member a cannula driver having a cannula and a drive mechanism for driving the cannula from the cannula driver into and through the port of the base member and wherein the driving step includes actuating the drive mechanism to drive the cannula into and through the base member port. 
     
     
         16 . The method of  claim 15 , including the further step of removing the cannula driver from the base member after the cannula has been driven through the base member port to a deployed position extending from the base member to beneath the skin. 
     
     
         17 . The method of  claim 16 , wherein the step of forming the skin fold includes compressing soft tissue beneath and on opposite sides of the base member. 
     
     
         18 . The method of  claim 17 , wherein the adhering step includes adhering a first portion of the base member to the skin surface before forming the skin fold and adhering an additional portion of the base member to the skin surface after releasing the skin fold. 
     
     
         19 . The method of  claim 18 , wherein the additional portion of the base member is a portion of the base member remaining to be adhered to the skin surface.