Perpendicular infusion set and disposable inserter

• US 10,398,833 B2
• Filed: 07/14/2017
• Issued: 09/03/2019
• Est. Priority Date: 09/27/2012
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Bene, Eric, Cole, Russell, Klotz, Arthur, Rosen, Melissa, Walish, Judy Lin, Bruehwiler, Michel, Creighton, Michael
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Zamory, Justin L
• Application Number:
  US15/650,468
• Publication Number:
  US 20170312424A1
• Time in Patent Office: 781 Days
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14

Abstract

An infusion set is disclosed that includes an inserter including an inserter housing having at least one flexible arm for holding an infusion set in a single axial position prior to insertion of at least a portion of a cannula of the infusion set, the inserter housing having a surface for contacting the patient'"'"'s skin. The inserter also includes a movable plunger disposed within the inserter housing for releasing the infusion set from the inserter housing, impacting the infusion set, and imparting momentum to the infusion set to insert the cannula into the patient'"'"'s skin. The inserter additionally includes a biasing element biasing the plunger toward the activated position.

Claims

1. A method of inserting at least a portion of a cannula of an infusion set a patient'"'"'s skin, the method comprising:

maintaining the infusion set in a single axial position in an inserter housing using at least one flexible arm of the inserter housing;

placing the inserter housing on the patient'"'"'s skin over an intended infusion site; and

releasing a biased plunger to move within the inserter;

wherein;

movement of the plunger releases the infusion set from the inserter housing, impacts the infusion set, and imparts momentum to the infusion set to insert the cannula into the patient'"'"'s skin;

the plunger is movable between a pre-activated position and an activated position; and

the plunger is spaced apart from the infusion set in the pre-activated position; and

the method further comprises;

engaging at least one cantilevered arm of the plunger with the inserter housing to maintain the plunger in the pre-activated position; and

engaging the at least one cantilevered arm of the plunger with the inserter housing to maintain the plunger in the activated position.

2. The method according to claim 1, further comprising removing a safety cover from the inserter housing to permit release of the plunger.

3. The method according to claim 1, further comprising:

removing a membrane cover from the inserter housing;

removing tubing from within the inserter housing;

connecting the tubing with an infusion pump to fluidly connect the infusion pump with the infusion set; and

priming the infusion set without removing the infusion set from the inserter housing.

4. The method according to claim 3, further comprising removing an adhesive backing from an adhesive pad on the distal surface of the infusion set.

5. A method of inserting at least a portion of a cannula of an infusion set into a patient'"'"'s skin, the method comprising:

maintaining the infusion set in a single axial position in an inserter sing at least one flexible arm of the inserter housing;

removing a membrane cover from a distal end of inserter housing;

removing a tray that protects the cannula and separates a majority of the tubing from the infusion set;

removing tubing from within the inserter housing;

placing the distal end of the inserter housing on the patient'"'"'s skin over an intended infusion site;

releasing a biased plunger to move within the inserter, wherein movement of the plunger releases the infusion set from the inserter housing, impacts the infusion set, and imparts momentum to the infusion set to insert the cannula into the patient'"'"'s skin;

connecting the tubing with an infusion pump to fluidly connect the infusion pump with the infusion set; and

priming the infusion set without removing the infusion set from the inserter housing.

6. The method according to claim 5, wherein removing the tray comprises removing an adhesive backing from an adhesive pad on the distal surface of the infusion set.

7. A method of inserting at least a portion of a cannula of an infusion set into a patient'"'"'s skin, the method comprising:

maintaining the infusion set in a single axial position in an inserter housing using at least one flexible arm of the inserter housing;

placing the inserter housing on the patient'"'"'s skin over an intended infusion site; and

releasing a biased plunger to move within the inserter;

wherein;

movement of the plunger releases the infusion set from the inserter housing, impacts the infusion set, and imparts momentum to the infusion set to insert the cannula into the patient'"'"'s skin;

the plunger selectively moves between a pre-activated position and an activated position; and

the at least one flexible arm comprises a plurality of cantilevered, flexible arms; and

the method further comprises displacing at least one of the cantilevered arms away from the infusion set prior to the impact of the plunger on the infusion set by movement of the plunger from the pre-activated position to the activated position.

8. A method of inserting at least a portion of a cannula of an infusion set into a patient'"'"'s skin, the method comprising:

maintaining the infusion set in a single axial position in an inserter housing using at least one flexible arm of the inserter housing;

placing the inserter housing on the patient'"'"'s skin over an intended infusion site; and

releasing a biased plunger to move within the inserter;

wherein movement of the plunger releases the infusion set from the inserter housing, impacts the infusion set, and imparts momentum to the infusion set to insert the cannula into the patient'"'"'s skin; and

wherein releasing a biased plunger to move within the inserter comprises releasing the plunger from a pre-activated position, in which the plunger prevents the at least one flexible arm from moving away from the infusion set, to move to an activated position, in which the plunger does not prevent the at least one flexible arm from moving away from the infusion set.

9. A method of inserting at least a portion of a cannula of an infusion set into a patient'"'"'s skin, the method comprising:

maintaining the infusion set in a single axial position in an inserter housing using at least one flexible arm of the inserter housing;

placing the inserter housing on the patient'"'"'s skin over an intended infusion site; and

releasing a biased plunger to move within the inserter;

wherein;

movement of the plunger releases the infusion set from the inserter housing, impacts the infusion set, and imparts momentum to the infusion set to insert the cannula into the patient'"'"'s skin

the plunger moves between a pre-activated position and an activated position;

the plunger comprises at least one cantilevered arm for engaging the inserter housing in both the pre-activated position and the activated position;

the plunger comprises a ring structure;

maintaining the infusion set in a single axial position comprises employing the ring structure to bias the at least one flexible arm toward the infusion set when the plunger is in the pre-activated position; and

releasing the biased plunger to move within the inserter comprises employing the ring structure to release the at least one flexible arm prior to the impact of the plunger on the infusion set.

10. A method of inserting at least a portion of a cannula of an infusion set into a patient'"'"'s skin the method comprising:

maintaining the infusion set in a single axial position in an inserter housing using at least one flexible arm of the inserter housing;

placing the inserter housing on the patient'"'"'s skin over an intended infusion site; and

releasing a biased plunger to move within the inserter;

wherein;

movement of the plunger releases the infusion set from the inserter housing, impacts the infusion set, and imparts momentum to the infusion set to insert the cannula into the patient'"'"'s skin

the plunger moves between a pre-activated position and an activated position;

the plunger comprises at least one cantilevered arm for engaging the inserter housing in both the pre-activated position and the activated position;

the plunger comprises a ring structure;

maintaining the infusion set in a single axial position comprises employing the ring structure to prevent the at least one flexible arm from moving away from the infusion set in the pre-activated position; and

releasing the biased plunger to move within the inserter comprises employing the ring structure to permit the at least one flexible arm to move away from the infusion set prior to the impact of the plunger on the infusion set.