Insulin pump dermal infusion set having partially integrated mechanized cannula insertion with disposable activation portion

• US 9,878,110 B2
• Filed: 06/30/2014
• Issued: 01/30/2018
• Est. Priority Date: 11/30/2010
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Cole, Russell S., Kadamus, Christopher J., Irwin, Stephen J., Roux, Serge, Ben, Eric
• Primary Examiner(s): Stigell, Theodore
• Application Number:
  US14/320,379
• Publication Number:
  US 20140316375A1
• Time in Patent Office: 1,310 Days
• 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 that can insert an infusion 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;

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.

2. An infusion device as claimed in claim 1, 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.

3. 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.

4. 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.

5. 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.).

6. An inserter that can insert an infusion 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 configured to be 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;

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.

7. An inserter as claimed in claim 6, 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.

8. An inserter as claimed in claim 6, 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.).