Transcutaneous inserter for low-profile infusion sets

Abstract

A low-profile inserter for an angled infusion set comprises an inserter housing having a bottom wall, a retainer slidably connected to the inserter housing for movement between retracted and extended positions in a direction substantially parallel with the bottom wall, and a base member connected to the inserter housing. The retainer is adapted to releasably receive a cannula assembly, including a cannula connected to a cannula housing. The base member has a lower surface that is adapted to contact a skin outer surface. The lower surface and bottom wall together form an acute angle. With this arrangement, the cannula can be inserted subcutaneously at the acute angle with respect to the skin outer surface.

1 . An inserter for a low-profile angled infusion set, the low-profile inserter comprising: 
 an inserter housing having a bottom wall, and a distal end defining an opening therein;    a retainer slideably mounted in the inserter housing for movement between retracted and extended positions in a direction substantially parallel with the bottom wall, the retainer being adapted to releasably receive the infusion set, including a cannula and an insertion needle, the cannula and insertion needle defining an insertion axis;    a tension spring for biasing said retainer toward said extended position, said tension spring being movable between an expanded position when said retainer is in said retracted position, and a contracted position when said retainer is in said extended position;    a release lever releasably holding the retainer in the retracted position;    a first release button for releasing said tension spring from said expanded position, said first release button movable in a direction substantially normal to said insertion axis; and    a base member connected to the inserter housing, the base member having a lower surface that is adapted to contact a user's skin surface, the lower surface and the bottom wall forming an acute angle, wherein the cannula and the insertion needle are guided to be inserted subcutaneously along the insertion axis at said acute angle with respect to the skin surface.    
     
     
         2 . An inserter according to  claim 1 , and further comprising a safety member slideably mounted to the inserter housing to prevent inadvertent release of the retainer.  
     
     
         3 . An inserter according to  claim 2 , wherein the release lever includes a first end portion exposed through the housing for manipulation by an operator and a second end portion for engagement with the retainer to hold the retainer in the retraced position, whereby pivotal movement of the release lever in a first rotational direction causes disengagement of the second end portion and the retainer to release the retainer.  
     
     
         4 . An inserter according to  claim 3 , wherein the release lever is biased in a second rotational direction opposite the first rotational direction, such that movement of the retainer toward the retracted position causes the second end portion of the release lever to engage and hold the retainer.  
     
     
         5 . An inserter according to  claim 4 , wherein the safety member comprises a lower surface that, in a first locking position, engages the second end portion of the release lever to block movement of the release lever in the first rotational direction.  
     
     
         6 . An inserter according to  claim 1 , wherein the acute angle is in a range of about 10 degrees to about 40 degrees.  
     
     
         7 . An inserter according to  claim 1 , wherein the acute angle is approximately 30 degrees.  
     
     
         8 . An inserter for an infusion set, the inserter comprising: 
 an inserter housing defining an opening in a distal end thereof;    a retainer slideably connected to the inserter housing for movement between retracted and extended positions, the retainer being adapted to releasably receive the infusion set including a cannula and an insertion needle, the cannula and the insertion needle defining an insertion axis;    a biasing member connected between the retainer and the inserter housing for biasing the retainer toward the extended position, said biasing member being expanded when said retainer is in said retracted position, and contracted when said retainer is in said extended position;    a first release button for releasing said biasing member from being expanded, movable in a direction substantially normal to said insertion axis; and    a base attached to a lower surface of said inserter housing defining an acute angle with respect to said inserter housing, for guiding the insertion needle and the cannula to be inserted subcutaneously in skin of a user, along the insertion axis and at the acute angle with respect to the skin.    
     
     
         9 . An inserter according to  claim 8 , further comprising a release lever mounted for pivotal movement on the retainer, the release lever including a first end portion exposed for manipulation by an operator when the retainer is in the extended position and a second end portion for engagement with the cannula assembly to hold the cannula assembly on the retainer, wherein pivotal movement of the release lever in a first rotational direction causes disengagement of the second end portion of the release lever and the cannula assembly to release the cannula assembly from the inserter.  
     
     
         10 . An inserter according to  claim 9 , wherein the release lever is biased in a second rotational direction opposite the first rotational direction, such that movement of the retainer toward the retracted position causes the second end portion of the release lever to engage and hold the retainer.  
     
     
         11 . A method for inserting an insertion needle and a cannula into skin of a user, comprising the steps of: 
 providing an inserter housing having a bottom wall, a distal end defining an opening therein, and a base member attached to the bottom wall proximate the distal end, said base member including a lower surface adapted to contact the skin and defining an acute angle with said bottom wall;    slideably mounting a retainer within said inserter housing, movable between a retracted position and an extended position, said extended position being substantially parallel with said bottom wall of said inserter housing;    mounting the cannula and the insertion needle in said retainer to define an insertion axis;    providing a tension spring for biasing said retainer toward said extended position, movable between an expanded position and a contracted position;    releasing said tension spring by pressing a release button proximate said distal end of said inserter housing, in a direction substantially normal to the insertion axis, thereby releasing said spring to move from said expanded position to said contracted position and move said retainer to said extended position, whereby said insertion needle and said cannula are guided to be inserted subcutaneously in the skin at said acute angle with respect to the skin.