Intradermal delivery device

• US 20070118077A1
• Filed: 11/21/2005
• Published: 05/24/2007
• Est. Priority Date: 11/21/2005
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Martin, Frank, Haider, M., Clarke, Richard, Klug, Richard
• Granted Patent: US 7,842,008 B2
• Time in Patent Office: Days
• 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; and

a rigid stabilizer fixed 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 fixed having an extension difference comprising a second distance such that said needle, limiter, and stabilizer contact said skin surface in order, wherein said second distance is determined based upon a sharpness of said needle and said diameter of said limiter.

2. 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.

3. An injectable substance delivery device as claimed in claim 2, wherein said body of said limiter is substantially cylindrical, and wherein said diameter of said limiter is approximately twice an outside diameter of said needle.

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

5. 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.

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

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

8. 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.

9. An injectable substance delivery device as claimed in claim 8, wherein said ring member comprises an inner diameter of between about 0.10 inches and about 1.00 inches.

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

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

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

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

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

15. 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.

16. 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.

17. 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; and

a flexible needle holder 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.

18. An injectable substance delivery device as claimed in claim 17, wherein said flexible needle holder comprises at least one spring member for flexibly supporting said limiter.

19. An injectable substance delivery device as claimed in claim 18, wherein said spring member preloads said limiter.

20. An injectable substance delivery device as claimed in claim 17, wherein said limiter comprises a body and an outer face, and wherein said needle extends axially from said outer face.

21. An injectable substance delivery device as claimed in claim 20, 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.

22. An injectable substance delivery device as claimed in claim 17, wherein an outside diameter of said limiter is approximately 0.040 inches.

23. An injectable substance delivery device as claimed in claim 17, wherein said needle comprises a needle between 31 gauge and 34 gauge.

24. An injectable substance delivery device as claimed in claim 17, wherein said needle comprises a single angle 28 degree, EDM bevel, 31 gauge needle.

25. An injectable substance delivery device as claimed in claim 17, wherein said needle comprises a single angle 28 degree, EDM bevel, 34 gauge needle.

26. An injectable substance delivery device as claimed in claim 17, wherein said needle comprises a three angle, ground bevel, 31 gauge needle.

27. An injectable substance delivery device as claimed in claim 17, 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.

28. An injectable substance delivery device as claimed in claim 17, 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.

29. An injectable substance delivery device as claimed in claim 17, further comprising a spring-loaded depressor for momentarily pushing against said limiter.

30. 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; and

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 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.

31. An injectable substance delivery device as claimed in claim 30, wherein said needle holder further comprises a concave opening.

32. An injectable substance delivery device as claimed in claim 31, further comprising a vacuum fitting for providing an enclosed vacuum space about said needle.

33. 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, wherein said needle holder is secured to said skin surface and extends said needle at an angle for preventing distortion, compression, or thinning of tissue in a vicinity of a needle insertion site.

34. An injectable substance delivery device as claimed in claim 33, wherein said inclined needle holder extends said needle at an angle of about 45 degrees relative to said skin surface.

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

providing a limiter disposed about an infusion needle for contacting a skin surface during needle penetration to limit said needle insertion depth; and

providing a rigid stabilizer ring fixed at a first distance form said limiter for contacting said skin surface after said needle and limiter begin to deform said skin surface, wherein said rigid stabilizer ring minimizes deformation of said skin surface.

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

providing an intradermal needle to contact a skin surface first for injection and resulting in a tissue deflection, wherein said needle is configured to penetrate said skin surface and generally maintain said degree of tissue deflection;

providing a limiter to subsequently contact said skin surface to limit a penetration depth of said needle;

providing a stabilizer ring to subsequently contact said skin surface over a larger volume of tissue and allow said limiter to be forced against said skin surface to minimize said degree of tissue deflection without allowing said needle to overtravel or become displaced,

wherein said stabilizer ring transfers tissue compression away from said needle penetration site allowing proper penetration depth and preventing tissue distortion to minimize leakage at the penetration site.