Intradermal delivery device

• US 7,842,008 B2
• Filed: 11/21/2005
• Issued: 11/30/2010
• Est. Priority Date: 11/21/2005
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Clarke, Richard P., Klug, Richard J., Martin, Frank E., Haider, M. Ishaq
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): STOHR, LEAH C
• Application Number:
  US11/282,591
• Publication Number:
  US 20070118077A1
• Time in Patent Office: 1,835 Days
• Field of Search: 604115-117, 604/500, 604/506, 604/513
• 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 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 spring-loaded depressor for momentarily pushing against said limiter; and

a flexible needle holder engaged to a spring member wherein said spring member is cantilevered and engaged to said limiter, further comprising an adhesive for securing said device to said skin surface, wherein said flexible needle holder is secured at a first distance from said limiter 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.

2. An injectable substance delivery device as claimed in claim 1, wherein said flexible needle holder comprises a plurality of spring members for flexibly supporting said limiter.

3. An injectable substance delivery device as claimed in claim 2,

wherein said spring member preloads said limiter.

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

wherein said limiter comprises a body and an outer face, and wherein said needle extends axially from said outer face.

5. An injectable substance delivery device as claimed in claim 4,

wherein said body of said limiter is substantially cylindrical, and wherein an outside diameter of said limiter is approximately twice an outside diameter of said needle.

6. An injectable substance delivery device as claimed in claim 1,

wherein an outside diameter of said limiter is approximately 0.040 inches.

7. An injectable substance delivery device as claimed in claim 1,

wherein said needle comprises a needle between 31 gauge and 34 gauge.

8. An injectable substance delivery device as claimed in claim 1,

wherein said needle comprises a single angle 28 degree, EDM bevel, 31 gauge needle.

9. An injectable substance delivery device as claimed in claim 1,

wherein said needle comprises a single angle 28 degree, EDM bevel, 34 gauge needle.

10. An injectable substance delivery device as claimed in claim 1,

wherein said needle comprises a three angle, ground bevel, 31 gauge needle.

11. 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.

12. 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 holder are comprised of at least one of an injection molded polymer, polycarbonate, COC polymer, polyethylene, polypropylene, polyesters, and polyamides.