Intradermal delivery device

• US 9,452,257 B2
• Filed: 03/14/2013
• Issued: 09/27/2016
• Est. Priority Date: 11/21/2005
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Clarke, Richard P., Haider, M. Ishaq, Klug, Richard J., Martin, Frank E.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Stiles, Amber
• Application Number:
  US13/830,764
• Publication Number:
  US 20130218129A1
• Time in Patent Office: 1,293 Days
• Field of Search: 604/117, 604/506
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• 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 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion
• CPC Class Codes: A61M 5/488 Limiting injection pressure

Abstract

A system and method is provided for an injectable substance delivery device comprising a limiter, shoulder or post that controls how deep the needle is inserted into the tissue. The limiter is sized in proportions that control the maximum insertion depth of the needle into the tissue without excessively restricting the complete insertion of the needle. The system and method further comprises an normalization or stabilizer ring that prevents distortion of the tissue in the vicinity of the infusion, so that the needle length is the major determining factor as to how deep the infusion is delivered.

Claims

1. An injectable substance delivery device comprising:

at least one needle having a length sufficient to penetrate a skin surface of a patient to an intradermal depth for infusing a substance; and

an inclined needle holder comprising a limiter having a body with a longitudinal axis, an axial face configured for contacting the skin and an outer side face extending in said longitudinal direction, wherein said inclined needle holder extends said at least one needle from said outer side face at an inclined angle with respect to the longitudinal axis of said body of said limiter for preventing distortion, compression, or thinning of tissue in a vicinity of a needle insertion site, and for controlling a needle insertion depth, said inclined needle holder being movably coupled with said delivery device and movable between a first position within said delivery device and a second position extending from said delivery device toward said skin surface, wherein said inclined needle holder controls a maximum insertion depth of said at least one needle into said skin surface.

2. An injectable substance delivery device as claimed in claim 1, wherein said moveably coupled inclined needle holder is pre-loaded in a direction toward said skin surface and deflectable by contact with said skin surface away from said skin surface by contact of said needle holder with said skin surface.

3. An injectable substance delivery device as claimed in claim 1, wherein user activation moves said moveably coupled inclined needle holder between said first position within said delivery device and said second position toward said skin surface.

4. An injectable substance delivery device as claimed in claim 1, further comprising:

a rigid stabilizer fixed at a first distance from said inclined needle holder for allowing an increased application force of said inclined needle holder while preventing distortion, compression, or thinning of tissue in a vicinity of said needle insertion site such that said needle length and said inclined needle holder determine the depth at which said infusion substance is delivered.

5. An injectable substance delivery device as claimed in claim 4, wherein said inclined needle holder and said rigid stabilizer are configured to have an extension difference comprising a second distance such that said needle, said inclined needle holder, and said stabilizer contact said skin surface in that order.

6. An injectable substance delivery device as claimed in claim 4, wherein said rigid stabilizer comprises a continuous ring member concentrically located about said inclined needle holder at said first distance of approximately 0.10 inches.

7. An injectable substance delivery device as claimed in claim 6, wherein said continuous ring member comprises an inner diameter of between about 0.10 inches and about 1.00 inches.

8. An injectable substance delivery device as claimed in claim 6, wherein said continuous ring member comprises an inner diameter of about 0.25 inches.

9. An injectable substance delivery device as claimed in claim 1, wherein said at least one needle extends from said outer side face at an angle of about 30 degrees relative to said skin surface.

10. An injectable substance delivery device as claimed in claim 4, wherein:

said needle is extended beyond said inclined needle holder along an axial direction; and

said inclined needle holder is extended beyond said rigid stabilizer by a second distance along an axial direction.

11. An injectable substance delivery device as claimed in claim 10, wherein said inclined needle holder extends by said second distance of between about 0.020 inches and about 0.100 inches beyond said rigid stabilizer along an axial direction.

12. An injectable substance delivery device as claimed in claim 10, wherein said inclined needle holder extends by said second distance of about 0.040 inches beyond said rigid stabilizer along an axial direction.

13. An injectable substance delivery device as claimed in claim 1, wherein said at least one needle comprises a needle between 31 gauge and 34 gauge.

14. An injectable substance delivery device as claimed in claim 1, wherein said at least one needle comprises a single angle 28 degree, EDM bevel, 31 gauge needle.

15. An injectable substance delivery device as claimed in claim 1, wherein said at least one needle comprises a single angle 28 degree, EDM bevel, 34 gauge needle.

16. An injectable substance delivery device as claimed in claim 1, wherein said at least one needle comprises a three angle, ground bevel, 31 gauge needle.

17. An injectable substance delivery device as claimed in claim 1, wherein said at least one needle comprises a needle having a length sufficient to penetrate said skin surface to a depth between about 0.5 mm and about 1.5 mm.

18. An injectable substance delivery device as claimed in claim 4, wherein:

said at least one needle is constructed of at least one of stainless steel, tungsten steel, silicon, ceramics, glass polymers, non-reactive metals, and alloys of nickel, molybdenum, chromium, cobalt and titanium; and

said inclined needle holder and said rigid stabilizer are comprised of at least one of an injection molded polymer, polycarbonate, COC polymer, polyethylene, polypropylene, polyesters, and polyamides.

19. A method for providing an infusion wherein distortion of tissue in a vicinity of the infusion is minimized, the method comprising:

providing an inclined needle holder having a limiter disposed about an infusion needle for contacting a skin surface during needle penetration to limit a needle insertion depth,

wherein said limiter includes a body with a longitudinal axis, an axial face and an outer side face extending in said longitudinal direction, said limiter being movably coupled with a device and configured to move in said longitudinal direction from a first position within said device and a second position extending from said device toward said skin surface,

wherein said infusion needle extends from said outer side face of said body of said limiter at an inclined angle with respect to said longitudinal axis of said limiter for preventing distortion, compression, or thinning of tissue in a vicinity of a needle insertion site, and for controlling said needle insertion depth, and

wherein said inclined needle holder controls a maximum insertion depth of said infusion needle into said skin surface.

20. A method for providing an infusion as claimed in claim 19, further comprising providing a rigid stabilizer ring at a first distance from said limiter for contacting said skin surface, wherein said rigid stabilizer ring minimizes deformation of said skin surface.

21. A method for providing an infusion as claimed in claim 19, wherein said moveably coupled limiter is pre-loaded in a direction toward said skin surface and deflectable by contact with said skin surface away from said skin surface by contact of said inclined needle holder with said skin surface.

22. A method for providing an infusion as claimed in claim 19, wherein user activation moves said moveably coupled limiter between said first position within said device and said second position toward said skin surface.

23. A method for providing an infusion as claimed in claimed 19, wherein said rigid stabilizer is a rigid stabilizer ring, and said inclined needle holder and said rigid stabilizer ring are configured, whereby said infusion needle, said inclined needle holder and said rigid stabilizer ring a sequentially contact said skin surface.