Folding inserter for drug delivery infusion set

• US 9,675,785 B2
• Filed: 02/08/2012
• Issued: 06/13/2017
• Est. Priority Date: 02/09/2011
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Constantineau, Cole, Schoonmaker, Ryan
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US13/983,984
• Publication Number:
  US 20140163523A1
• Time in Patent Office: 1,952 Days
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

An infusion set (101) includes an inserter (121) pivotally connected to a base (111). The inserter (121) includes a catheter (173) and an introducer needle (167). The catheter (173) is movable from a first catheter position disposed substantially entirely within the inserter (121) to a second catheter position in which a free end of the catheter (173) is disposed externally of the inserter (121) and the base (111). The introducer needle (167) is movable between a first introducer needle position disposed substantially entirely within the inserter (121) and a second introducer needle position in which a free end of the introducer needle (167) is disposed externally of the inserter (121) and the base (111). An activation button (141) is movable between first and second button positions. When the button (141) is moved from the first button position to the second button position, the catheter (173) is moved from the first to the second catheter position, and the introducer needle (167) is moved from the first to the second introducer needle position to facilitate insertion of the catheter (173) and back to the first introducer needle position to store the introducer needle (167) within the inserter (121). The inserter (121) is then pivotable from an insertion position to a storage position within the base (111) of the infusion set (101).

Claims

1. An infusion set, comprising:

a base; and

an inserter pivotally connected to said base and configured to fold substantially entirely within said base, said inserter including;

a catheter movable from a first catheter position disposed substantially entirely within said inserter to a second catheter position in which a free end of said catheter is disposed externally of said inserter and said base;

an introducer needle located within said catheter and movable between a first introducer needle position disposed substantially entirely within said inserter and a second introducer needle position in which a free end of said introducer needle is disposed externally of said inserter and said base; and

an activation button movable between first and second button positions, wherein when said button is moved from said first button position to said second button position, said catheter is moved from said first to said second catheter position, said introducer needle is moved from said first to said second introducer needle position to facilitate insertion of said catheter, and said introducer needle is thereafter moved back toward said first introducer needle position to store said introducer needle within said inserter with said free end of said catheter remaining disposed externally of said inserter and said base.

2. The infusion set in accordance with claim 1, wherein

a fluid connector is removably connected to said base and connectable to a medicament source.

3. The infusion set in accordance with claim 2, wherein

said fluid connector has a penetrating member to pierce a septum in said base to create a fluid connection between said catheter and the medicament source when said fluid connector is connected to said base.

4. The infusion set in accordance with claim 2, wherein

said inserter is pivotable between a first inserter position for inserting said introducer needle and said catheter and a second inserter position in which said inserter is disposed substantially entirely within said base.

5. The infusion set in accordance with claim 4, wherein

said inserter is substantially perpendicular to said base in said first inserter position.

6. The infusion set in accordance with claim 5, wherein

said introducer needle and said catheter enter a skin surface at a substantially perpendicular angle to the skin surface.

7. The infusion set in accordance with claim 4, wherein

said septum is inaccessible when said inserter is in said first inserter position and exposed when said inserter is in said second inserter position.

8. An infusion set, comprising:

a base; and

an inserter pivotally connected to said base, said inserter including;

a body pivotable between first and second body positions;

a sleeve disposed in said inserter body for movement linearly and rotationally between first and second sleeve positions;

a catheter hub movable from a first catheter hub position to a second catheter hub position;

a catheter connected to said catheter hub, said catheter being disposed substantially entirely within said inserter body when said catheter hub is in said first catheter hub position and said catheter having a free end disposed externally of said inserter body and said base when said catheter hub is in said second catheter hub position;

an introducer hub movable between a first introducer hub position and a second introducer hub position;

an introducer needle located within said catheter and connected to said introducer hub, said introducer needle being disposed substantially entirely within said inserter body when said introducer hub is in said first introducer hub position and said introducer needle having a free end disposed externally of said inserter body and said base when said introducer hub is in said second introducer hub position; and

an activation button movable between first and second button positions, wherein when said button is in said first button position, said catheter hub and said introducer hub are in said first catheter hub position and said first introducer hub position, respectively;

when said activation button is between said first and second button positions, said sleeve moves linearly and rotationally from said first sleeve position to said second sleeve position and said catheter hub and said introducer hub are moved to said second catheter hub position and said second introducer hub position, respectively; and

when said activation button is in said second button position, said catheter hub is in said second catheter hub position and said sleeve releases said introducer hub to retract toward said first introducer hub position.

9. The infusion set in accordance with claim 8, wherein

a fluid connector is removably connected to said base and connectable to a medicament source.

10. The infusion set in accordance with claim 8, wherein

a spring member biases said introducer hub toward said first introducer hub position.

11. The infusion set in accordance with claim 10, wherein

first and second tabs on said sleeve engage grooves in said inserter body to guide axial and rotational movement of said sleeve when said sleeve is moved from said first sleeve position to said second sleeve position by said activation button.

12. The infusion set in accordance with claim 11, wherein

first and second tabs on said introducer hub are engaged by said sleeve to move said introducer hub from said first introducer hub position to said second introducer hub position when said sleeve is moved from said first sleeve position to said second sleeve position.

13. The infusion set in accordance with claim 12, wherein

said first and second introducer hub tabs engage slots in said sleeve when both said sleeve and said introducer hub are in their respective second positions such that said spring member returns said introducer hub and said introducer needle toward their respective first positions.

14. The infusion set in accordance with claim 13, wherein

said catheter hub engages a protrusion on said base to retain said catheter hub in said second catheter hub position.

15. The infusion set in accordance with claim 14, wherein

flexible arms on said inserter body engage said base to lock said inserter body in said first body position.

16. The infusion set in accordance with claim 15, wherein

said introducer needle and said catheter enter a skin surface at a substantially perpendicular angle to the skin surface.

17. The infusion set in accordance with claim 16, wherein

a septum is disposed in said catheter hub.

18. The infusion set in accordance with claim 17, wherein

said septum is inaccessible when said inserter body is in said first body position and exposed when said inserter body is in said second body position.

19. A method of inserting a catheter of an infusion set, comprising the steps of:

disposing the infusion set on a skin surface at an injection site;

inserting an introducer needle and the catheter through the skin surface with an inserter of the infusion set;

removing the inserted introducer needle from the skin surface;

storing the removed introducer needle substantially entirely within the inserter; and

pivoting the inserter from a substantially vertical to a substantially horizontal position to store the inserter within a base of the infusion set.

20. The method of inserting a catheter of an infusion set in accordance with claim 19, wherein

the removed introducer needle is not part of a fluid path between the inserted catheter and a medicament source.