Adjustable height needle infusion device

• US 8,795,230 B2
• Filed: 11/22/2011
• Issued: 08/05/2014
• Est. Priority Date: 11/30/2010
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Schoonmaker, Ryan, Constantineau, Cole, Bruehwiler, Michel
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US13/303,055
• Publication Number:
  US 20120136300A1
• Time in Patent Office: 987 Days
• Field of Search: 604/117, 604/164.01, 604/164.04, 604/167.01, 604/136, 604/157, 604/165.04
• US Class Current: 604/117
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14264 with means for compensating influence from the environment
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body holding devices for catheters A61M25/02
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2005/3289 with rotation of the needle, e.g. to ease penetration
• 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 5/46 having means for controlling depth of insertion
• CPC Class Codes: A61M 5/488 Limiting injection pressure

Abstract

An infusion set has a retraction dial that can be removably assembled with the infusion set and access a threaded needle hub contained therein such that the dial can be used to advance or retract a needle hub and an inserted needle to a more precisely controlled insertion depth to deliver insulin or other medicament intradermally (i.e. to the upper 3 mm of skin surface). Position of the inserted needle can be maintained by providing a separated and isolated needle hub, main base and main hub of the infusion set that can isolate the inserted needle from external forces such that the needle can be maintained at a depth to deliver content to the upper 3 mm of skin surface during normal use.

Claims

1. An infusion set, comprising:

a main base, comprising a moveable needle hub; and

a rotation element, comprising a user-rotatable top surface of said infusion set and releasably coupled with said moveable needle hub within said main base, wherein said rotation element is configured to rotate relative to said main base and wherein said rotation is translated into vertical movement of said moveable needle hub within said main base.

2. An infusion set as claimed in claim 1, further comprising a threaded engagement between said moveable needle hub and said main base.

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

a main hub, disposed on said main base, said main hub comprising a fluid channel and an inner septum at a first end of said channel, and a flexible tube at a second end of said channel;

an outer hub, separated from said main hub; and

an outer ring, rotatably captured by said outer hub and surrounding said main hub, wherein said main hub is coupled to said outer ring via said flexible tube, and wherein said main hub and said main base are separated from said outer ring and said outer hub.

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

a first adhesive layer disposed on said main base; and

a second adhesive layer disposed on said outer hub, wherein said first adhesive layer is separated from said second adhesive layer.

5. An infusion set as claimed in claim 3, further comprising at least one of:

a needle secured by said needle hub and having a first end configured to contact a skin surface, and a second end configured to pierce said inner septum, wherein said needle is configured to be inserted to a first depth and retracted to a second depth by said vertical movement of said moveable needle hub within said main base; and

a soft cannula and internal introducer needle secured by said needle hub and having a first end configured to contact a skin surface, and a second end configured to pierce said inner septum, wherein said internal introducer needle is configured to be inserted to a first depth and retracted to a second depth within said soft cannula by said vertical movement of said moveable needle hub within said main base.

6. An infusion set as claimed in claim 3, wherein said outer ring comprises a connection valve coupled with said flexible tubing, and a connection valve septum configured to pierceably receive a tube attachment cover.

7. An infusion set as claimed in claim 3, further comprising a tube attachment cover, configured to releasably couple with said outer ring and cover said main hub, without contacting said main hub.

8. An infusion set as claimed in claim 1, wherein said main base comprises a contoured skin contact surface.

9. An infusion set as claimed in claim 1, wherein said main base comprises a third adhesive layer disposed about a needle opening in said main base.

10. An infusion set as claimed in claim 1, wherein said set can be constructed of at least one of a molded plastic material, polycarbonate, thermoplastic polymer such as polyethylene (PET and PETG), or similar material.

11. An infusion set as claimed in claim 1, wherein said rotation element comprises a dial, releasably coupled with said moveable needle hub within said main base.

12. A depth-targeting infusion system, comprising:

an infusion set; and

a rotation element, comprising a user-rotatable top surface of said infusion set and releasably coupled with said infusion set, wherein said rotation element is configured to rotate relative to said infusion set and wherein said rotation is translated into vertical movement of a moveable needle hub within said infusion set.

13. An infusion system as claimed in claim 12, wherein said infusion set comprises:

a main base, comprising a moveable needle hub;

a main hub, disposed on said main base, said main hub comprising a fluid channel and an inner septum at a first end of said channel, and a flexible tube at a second end of said channel;

an outer hub, separated from said main hub; and

an outer ring, rotatably captured by said outer hub and surrounding said main hub, wherein said main hub is coupled to said outer ring via said flexible tube, and wherein said main hub and said main base are separated from said outer ring and said outer hub.

14. An infusion system as claimed in claim 13, further comprising a threaded engagement between said moveable needle hub and said main base.

15. An infusion system as claimed in claim 13, further comprising:

a first adhesive layer disposed on said main base; and

a second adhesive layer disposed on said outer hub, wherein said first adhesive layer is separated from said second adhesive layer.

16. An infusion system as claimed in claim 13, further comprising at least one of:

a needle secured by said needle hub and having a first end configured to contact a skin surface, and a second end configured to pierce said inner septum, wherein said needle is configured to be inserted to a first depth and retracted to a second depth by said vertical movement of said moveable needle hub within said main base; and

a soft cannula and internal introducer needle secured by said needle hub and having a first end configured to contact a skin surface, and a second end configured to pierce said inner septum, wherein said internal introducer needle is configured to be inserted to a first depth and retracted to a second depth within said soft cannula by said vertical movement of said moveable needle hub within said main base.

17. An infusion system as claimed in claim 13, wherein said outer ring comprises a connection valve coupled with said flexible tubing, and a connection valve septum configured to pierceably receive a tube attachment cover.

18. An infusion system as claimed in claim 13, further comprising a tube attachment cover, configured to releasably couple with said outer ring and cover said main hub, without contacting said main hub.

19. An infusion system as claimed in claim 13, wherein said main base comprises a contoured skin contact surface.

20. An infusion system as claimed in claim 13, wherein said main base comprises a third adhesive layer disposed about a needle opening in said main base.

21. An infusion system as claimed in claim 12, wherein said rotation element comprises a dial, releasably coupled with said infusion set.