Intradermal delivery device

• US 8,419,684 B2
• Filed: 11/29/2010
• Issued: 04/16/2013
• 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. Lehag, Klug, Richard J., Martin, Frank E.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): STOHR, LEAH C
• Application Number:
  US12/955,554
• Publication Number:
  US 20110071494A1
• Time in Patent Office: 869 Days
• Field of Search: 604/46, 604115-117, 604/164.01, 604/164.06, 604/272, 604/164.07, 604/164.08, 604/164.09, 604158-163
• US Class Current: 604/117
• 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;

a limiter pre-loaded toward said skin surface for controlling a needle insertion depth, wherein said limiter controls a maximum insertion depth of said needle into said skin surface without restricting complete insertion of said needle; and

a rigid stabilizer flexibly coupled to said limiter at a first distance from said limiter for allowing an increased application force of said limiter while preventing distortion, compression, or thinning of tissue in a vicinity of a needle insertion site such that said needle length and said limiter determine the depth at which said infusion is delivered, wherein said first distance is determined based upon an amount of said substance to be infused and a diameter of said limiter, and

wherein said limiter and said rigid stabilizer are configured to have a variable extension difference comprising a second distance such that said needle, limiter, and stabilizer contact said skin surface in that order, wherein said second distance is determined based upon a sharpness of said needle and said diameter of said limiter,

wherein said limiter comprises a body and an outer face, said needle extends axially from said outer face, said body of said limiter is substantially cylindrical, and said diameter of said limiter is approximately twice an outside diameter of said needle.

2. An injectable substance delivery device as claimed in claim 1, wherein said diameter of said limiter is approximately 0.040 inches.

3. An injectable substance delivery device as claimed in claim 1, wherein:

said needle is extended beyond said limiter along an axial direction; and

said limiter is extended beyond said stabilizer by said second distance along an axial direction.

4. An injectable substance delivery device as claimed in claim 3, wherein said limiter extends by said second distance of between about 0.020 inches and about 0.100 inches beyond said stabilizer along an axial direction.

5. An injectable substance delivery device as claimed in claim 3, wherein said limiter extends by said second distance of about 0.040 inches beyond said stabilizer along an axial direction.

6. An injectable substance delivery device as claimed in claim 1, wherein said stabilizer comprises a continuous ring member concentrically located about said limiter at said first distance of approximately 0.105 inches.

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

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

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

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

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

13. An injectable substance delivery device as claimed in claim 1, wherein said 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.

14. An injectable substance delivery device as claimed in claim 1, wherein:

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

15. 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;

a limiter pre-loaded toward said skin surface for controlling a needle insertion depth, wherein said limiter controls a maximum insertion depth of said needle into said skin surface without restricting complete insertion of said needle;

a needle holder comprising an adhesive for securing said device to said skin surface and providing an enclosed air space about said needle, wherein said needle holder is flexibly coupled to said limiter at a first distance for preventing distortion, compression, or thinning of tissue in a vicinity of a needle insertion site such that said needle length and said limiter determine the depth at which said infusion is delivered, wherein said needle holder further comprises a concave opening; and

a vacuum fitting for providing an enclosed vacuum space about said needle.