Insulin Pump Dermal Infusion Set Having Partially Integrated Mechanized Cannula Insertion With Disposable Activation Portion

• US 20120143135A1
• Filed: 11/22/2011
• Published: 06/07/2012
• Est. Priority Date: 11/30/2010
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Kadamus, Christopher J., Irwin, Stephen J., Roux, Serge, Bené, Eric, Cole, Russell S.
• Granted Patent: US 8,784,383 B2
• Time in Patent Office: Days
• US Class Current: 604/164.04
• 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 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

An infusion set has a partially integrated ballistic inserter that can insert a needle at a controlled rate of speed to a depth to deliver content to the upper 3 mm of skin surface, and a skin-securing adhesive layer to secure the skin surface at the insertion site such that the inserter that can insert a needle with a reduced risk of tenting of the skin surface. A removable turnkey or pushable handle can be provided to release a driving spring of the ballistic inserter to insert a needle at a controlled rate of speed, of 3.3 ft/sec. (1.0 m/sec.) up to and including those greater than 10 ft/sec. (3.0 m/sec.), then release from the set for disposal. The infusion set can further include an extendable interface ring that retracts when the inserter is removed from the infusion set.

Claims

1. An infusion device, comprising a partially integrated inserter that can insert a needle at a controlled rate of speed to a depth to deliver medicament to the upper 3 mm of skin surface, comprising:

an infusion device base, comprising at least one adhesive layer for releasably securing said infusion device base with said skin surface; and

an inserter, wherein said inserter comprises an activation subassembly releasably secured to said infusion device base that is configured to release at least a user contact element and a driving spring from said infusion device base upon completed activation, and leave at least a needle with said infusion device base upon completed activation.

2. An infusion device as claimed in claim 1, wherein said user contact element comprises:

a turnkey, releasably coupled with said infusion device base and configured to release said driving spring of said inserter to insert said needle when turned relative to said skin surface, and further configured to release from said infusion device base when turned further relative to said skin surface.

3. An infusion device as claimed in claim 2, wherein said activation subassembly further comprises:

a plunger, comprising said needle, wherein said plunger is configured to slidably enter and lock with said infusion device base when released by said turnkey and driven by said driving spring; and

an activation collar, configured to couple with said turnkey and releasably couple with said infusion device base.

4. An infusion device as claimed in claim 3, wherein at least one of said turnkey, infusion device base and activation collar comprises a visual indicator for denoting at least one of a turnkey turning direction and a tube connection direction.

5. An infusion device as claimed in claim 1, wherein said user contact element comprises:

a pushable handle, releasably coupled with said infusion device base and configured to release said driving spring of said inserter to insert said needle when pushed toward said skin surface, and further configured to release from said infusion device base when pushed further toward said skin surface.

6. An infusion device as claimed in claim 5, wherein said activation subassembly further comprises:

a plunger, comprising said needle, wherein said plunger is configured to slidably enter and lock with said infusion device base when released by said pushing motion of said pushable handle and driven by said driving spring; and

an inserter base configured to slidably couple with said pushable handle for securing said plunger in a retracted position until said pushable handle is pushed, and releasably couple with said infusion device base until said pushable handle is pushed further.

7. An infusion device as claimed in claim 1, further comprising an interface ring coupled with said infusion device base, wherein said ring is configured to extend from said infusion device base until said activation subassembly is released from said infusion device base after activation.

8. An infusion device as claimed in claim 1, further comprising a fluid connector assembly to releasably connect a tube to said base, wherein said fluid connector assembly comprises:

a cover configured to cover said infusion device base via placement using a motion perpendicular to said skin surface; and

a slide configured to secure said cover to said infusion device base via placement using a motion parallel to said skin surface, wherein said tube is connected to said slide, and wherein said slide comprises at least one cannula.

9. An infusion device as claimed in claim 1, wherein said driving spring of said inserter is configured to insert said needle at a speed greater than 3.3 ft/sec. (1.0 m/sec.).

10. A partially integrated inserter that can insert a needle at a controlled rate of speed to a depth to deliver medicament to the upper 3 mm of skin surface, comprising:

an activation subassembly coupled with an infusion device base, comprising a user contact element, a driving spring, and a plunger, and which is configured to release at least said user contact element and said driving spring from said infusion device base upon completed activation, and leave at least said plunger with said infusion device base upon completed activation.

11. A partially integrated inserter as claimed in claim 10, wherein said user contact element comprises:

a turnkey, releasably coupled with said infusion device base and configured to release said driving spring of said inserter to insert said needle when turned relative to said skin surface, and further configured to release from said infusion device base when turned further relative to said skin surface.

12. A partially integrated inserter as claimed in claim 11, wherein said activation subassembly further comprises:

said plunger, comprising said needle, wherein said plunger is configured to slidably enter and lock with said infusion device base when released by said turnkey and driven by said driving spring; and

an activation collar, configured to couple with said turnkey and releasably couple with said infusion device base.

13. A partially integrated inserter as claimed in claim 12, wherein at least one of said turnkey, infusion device base and activation collar comprises a visual indicator for denoting at least one of a turnkey turning direction and a tube connection direction.

14. A partially integrated inserter as claimed in claim 10, wherein said user contact element comprises:

a pushable handle, releasably coupled with said infusion device base and configured to release said driving spring of said inserter to insert said needle when pushed toward said skin surface, and further configured to release from said infusion device base when pushed further toward said skin surface.

15. A partially integrated inserter as claimed in claim 14, wherein said activation subassembly further comprises:

said plunger, comprising said needle, wherein said plunger is configured to slidably enter and lock with said infusion device base when released by said pushing motion of said pushable handle and driven by said driving spring; and

an inserter base configured to slidably couple with said pushable handle for securing said plunger in a retracted position until said pushable handle is pushed, and releasably couple with said infusion device base until said pushable handle is pushed further.

16. A partially integrated inserter as claimed in claim 10, wherein said driving spring of said inserter is configured to insert said needle at a speed greater than 3.3 ft/sec. (1.0 m/sec.).

17. An infusion device base for receiving a partially integrated inserter that can insert a needle at a controlled rate of speed to a depth to deliver medicament to the upper 3 mm of skin surface, comprising:

at least one adhesive layer disposed upon a bottom skin contact surface of said infusion device base for securing said infusion device base to an infusion site;

at least one snap for releasably securing an activation subassembly of a partially integrated inserter to said infusion device base; and

at least one snap for securing a plunger of said activation subassembly of said partially integrated inserter when driven into said infusion device base by a driving spring of said activation subassembly of said partially integrated inserter.

18. An infusion device base as claimed in claim 17, further comprising an interface ring moveably coupled with said infusion device base, wherein said ring is configured to contact said partially integrated inserter and in response extend from said bottom skin contact surface of said infusion device base and to contact said skin surface, and move substantially flush with said bottom skin contact surface of said infusion device base when said partially integrated inserter is removed.

19. An infusion device as claimed in claim 17, further comprising a fluid connector assembly to releasably connect a tube to said infusion device base, wherein said fluid connector assembly comprises:

a cover configured to cover said infusion device base via placement using a motion perpendicular to said skin surface; and

a slide configured to secure said cover to said infusion device base via placement using a motion parallel to said skin surface, wherein said tube is connected to said slide, and wherein said slide comprises at least one cannula.

20. An infusion device base for receiving a partially integrated inserter that can insert a needle at a controlled rate of speed to a depth to deliver medicament to the upper 3 mm of skin surface, comprising:

at least one adhesive layer disposed upon a bottom skin contact surface of said infusion device base for securing said infusion device base to an infusion site;

at least one snap disposed upon a top surface of said infusion device base for releasably securing a partially integrated inserter; and

an interface ring moveably coupled with said base, wherein said ring is configured to contact said partially integrated inserter and in response extend from said bottom skin contact surface of said infusion device base and to contact said skin surface, and move substantially flush with said bottom skin contact surface of said infusion device base when said partially integrated inserter is removed.

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

placing an infusion device base upon an infusion site and activating a user contact element to release a driving spring to insert a needle into said infusion site; and

further activating said user contact element to release said user contact element and said spring from said infusion device base upon completed activation, and leaving at least said needle with said infusion device base upon completed activation.

22. A method as claimed in claim 21, further comprising the steps of:

connecting a cover of a fluid connector assembly to said infusion device base via placement using a motion perpendicular to a skin surface; and

connecting a slide with said cover to secure said cover to said infusion device base via placement using a motion parallel to said skin surface, wherein said tube is connected to said slide.

23. A method as claimed in claim 21, further comprising the steps of:

turning a turnkey, releasably coupled with said infusion device base and configured to release said driving spring to insert said needle when turned relative to said skin surface, and further configured to release from said infusion device base when turned further relative to said skin surface.

24. A method as claimed in claim 21, further comprising the steps of:

pushing a pushable handle, releasably coupled with said infusion device base and configured to release said driving spring to insert said needle when pushed toward said skin surface, and further configured to release from said infusion device base when pushed further toward said skin surface.