Slide-Activated Angled Inserter And Cantilevered Ballistic Insertion For Intradermal Drug Infusion

• US 20120136299A1
• Filed: 11/22/2011
• Published: 05/31/2012
• Est. Priority Date: 11/30/2010
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Constantineau, Cole, Schoonmaker, Ryan, Bruehwiler, Michel, Bené, Eric
• Granted Patent: US 9,950,109 B2
• Time in Patent Office: Days
• US Class Current: 604/117
• 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

Abstract

An infusion set has an adhesively secured main hub, and a slidable top cover, needle hub and angled or cantilevered needle that can be used for performing an intradermal needle insertion precisely targeting the upper 3 mm of skin surface, for example, one that substantially duplicates the Mantoux insertion technique, for injecting into the intradermal layers of skin, while maintaining a degree of comfort to the user. By sliding the top cover, the cantilevered needle is loaded and released or the angled needle is slid into an insertion site, while flexible arms and adhesive are used to stretch and/or flatten a skin surface, or otherwise create skin tension, at the insertion site.

Claims

1. An infusion set configured to be secured to a skin surface, comprising:

a moveable first hub comprising a needle; and

a slidable cover, configured to slide in a direction parallel to said skin surface to move said first hub and place said needle into said skin surface.

2. An infusion set as claimed in claim 1, wherein said first hub comprises said needle, secured by said first hub at an angle relative to a bottom surface of said infusion set.

3. An infusion set as claimed in claim 1, further comprising:

a second hub, wherein said first hub is moveably disposed within said second hub, wherein said second hub is configured to be secured to a skin surface and comprises a slotted opening in a top surface; and

said slidable cover comprises a drag arm, configured to pass through said slotted opening and engage said first hub, wherein said engagement transmits slidable movement of said slidable cover into said slidable movement of said first hub and said needle.

4. An infusion set as claimed in claim 3, wherein said second hub comprises an opening in a bottom surface from which said needle extends when slid in said direction parallel to said skin surface.

5. An infusion set as claimed in claim 2, wherein said angle is between 5 degrees and 45 degrees relative to said bottom surface of said infusion set.

6. An infusion set as claimed in claim 4, wherein said second hub comprises a first and second flexible arm disposed within said opening in said bottom surface from which said needle extends, and are configured to secure a skin surface at sides of said opening and are further configured to be deflected when said first hub is slid in said direction parallel to said skin surface.

7. An infusion set as claimed in claim 6, wherein when said flexible arms reach a maximum displacement, said needle is configured to penetrate an intradermal layer of said skin and substantially replicate an angled insertion of a Mantoux technique while removing user variability.

8. An infusion set as claimed in claim 3, further comprising:

a third hub to receive an infusion tube set connection, wherein said first hub and said second hub are in communication with said third hub via a tube segment and a tortuous path adhesive segment, wherein said tube segment and tortuous path adhesive segment are configured to isolate said first hub and said second hub from movement.

9. An infusion set as claimed in claim 1, wherein said first hub comprises a cantilever arm and said needle secured at an end thereof.

10. An infusion set as claimed in claim 9, further comprising:

a second hub, wherein said first hub is moveably disposed within said second hub, wherein said second hub is configured to be secured to a skin surface and comprises a slotted opening in a top surface; and

said slidable cover comprises a beam hanger arm, configured to pass through said slotted opening and engage said cantilever beam, wherein said slidable movement of said slidable cover is configured to load said cantilever beam when moved in a first direction, and release said cantilever beam when moved in a second direction.

11. An infusion set as claimed in claim 10, wherein said second hub is configured to receive an infusion tube set connection, wherein said first hub and said second hub are in communication via a tube segment and a flexible segment, wherein said tube segment and flexible segment are configured to isolate said first hub from movement.

12. A method for targeting a desired depth to deliver content to an upper skin surface, comprising the steps of:

placing an infusion set having a moveable first hub on an infusion site, wherein said first hub comprises a needle;

sliding a cover of said infusion set parallel to a skin surface to move said first hub and place said needle into said skin surface until a desired infusion depth is reached; and

removing said cover from said infusion set and attaching an infusion pump tube attachment.

13. A method as claimed in claim 12, wherein:

said first hub comprises said needle, secured by said first hub at an angle relative to a bottom surface of said infusion set, and wherein said needle is placed into said skin surface at said angle by said sliding of said cover of said infusion set parallel to said skin surface.

14. A method as claimed in claim 12, further comprising the step of:

tensioning a skin surface at said infusion site by said sliding said cover of said infusion set parallel to said skin surface.

15. A method as claimed in claim 14, wherein said needle is configured to penetrate an intradermal layer of said skin when said skin surface is tensioned, such that said insertion substantially replicates an angled insertion of a Mantoux technique while removing user variability.

16. A method as claimed in claim 12, further comprising the step of:

attaching said infusion pump tube attachment to said first hub via a tube segment and a tortuous path adhesive segment, wherein said tube segment and tortuous path adhesive segment are configured to isolate said first hub from movement.

17. A method as claimed in claim 12, wherein said first hub comprises a cantilever arm and said needle secured at an end thereof, and wherein said needle is placed into said skin surface at a controlled rate of speed by release of said cantilever arm by said sliding of said cover of said infusion set parallel to said skin surface until a desired infusion depth is reached.

18. A method as claimed in claim 17, further comprising the step of sliding said slidable cover in a first direction to load said cantilever beam.

19. A method as claimed in claim 17, further comprising the step of sliding said slidable cover in a second direction to release said cantilever beam.

20. A method as claimed in claim 12, further comprising the step of:

attaching said infusion pump tube attachment to a second hub, wherein said first hub is moveably disposed in said second hub and wherein said second hub is adhesively secured to said skin surface of said infusion site and wherein said first hub is in communication with said second hub via a tube segment and a flexible segment, wherein said tube segment and flexible segment are configured to isolate said first hub from movement.

21. A method for targeting a desired depth to deliver content to an upper skin surface, comprising the steps of:

placing an infusion set on a skin surface at an infusion site, wherein said infusion set comprises a needle at a first angle relative to said skin surface; and

applying a motion to said needle at a second angle relative to said skin surface that is different from said first angle to insert said needle.

22. An infusion set configured to be secured to a skin surface for targeting a desired depth to deliver content to an upper skin surface, comprising:

a hub and a needle configured to travel during insertion as urged by a motion;

wherein said needle is configured to assume a first angle relative to said skin surface in a free state; and

wherein said needle is configured to return toward said first angle relative to said skin surface upon release of said motion, wherein said motion is at an angle relative to said skin surface that is different from said first angle of said needle.

23. An infusion set as claimed in claim 22, wherein:

wherein said needle is configured to assume a second angle relative to said skin surface when said hub is secured with said skin surface but prior to application of said motion; and

wherein said needle is configured to assume a third angle relative to said skin surface during application of said motion.