Intradermal injection device

• US 20070185460A1
• Filed: 01/30/2004
• Published: 08/09/2007
• Est. Priority Date: 08/28/2003
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Vedrine, Lionel, Alchas, Paul, Barrelle, Laurent, Korisch, Marina, Heyman, Peter
• Application Number:
  US10/569,618
• Publication Number:
  US 20070185460A1
• Time in Patent Office: Days
• US Class Current: 604/240
• CPC Class Codes: A61M 2005/311 Plugs, i.e. sealing rods or stylets closing the bore of needles
• CPC Class Codes: A61M 5/28 Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/321 Means for protection against accidental injuries by used needles
• CPC Class Codes: A61M 5/343 Connection of needle cannula to needle hub, or directly to syringe nozzle without a needle hub A61M5/322 takes precedence
• CPC Class Codes: A61M 5/349 using adhesive bond or glues
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

An intradermal injection device comprising a unitary body having an open distal end and a proximal end having a skin engaging surface defined thereon, a reservoir defined between the proximal and distal ends for accommodating a drug substance, and a channel defined at the proximal end of the unitary body and extending through, and distally from, the skin engaging surface to the reservoir. A needle cannula having a sharpened proximal end and a distal end may be provided in the channel. The needle cannula is secured in the channel with the distal end being in communication with the reservoir and the proximal end of the needle cannula extending from the skin engaging surface a distance in the range of about 0.5 mm to 3.0 mm such that the skin engaging surface limits penetration of the proximal end of the needle cannula to the dermis layer of the skin of a patient.

Claims

1. An intradermal injection device comprising:

a unitary body having an open distal end and a proximal end having a skin engaging surface defined thereon, a reservoir defined between said distal and proximal ends for accommodating a drug substance, and a channel defined at said proximal end of said unitary body and extending through, and distally from, said skin engaging surface to said reservoir; and

,

a needle cannula having a sharpened proximal end and a distal end, said needle cannula being secured in said channel with said distal end being in communication with said reservoir and said proximal end of said needle cannula extending from said skin engaging surface a distance in the range of about 0.5 mm to 3.0 mm such that said skin engaging surface limits penetration of said proximal end of said needle cannula to the dermis layer of the skin of a patient.

2. A device as in claim 1, wherein said unitary body comprises glass.

3. A device as in claim 2, wherein said unitary body is formed wholly from glass.

4. A device as in claim 1, wherein said channel has a cross-sectional shape having a non-constant width.

5. A device as in claim 4, wherein said channel has a first portion located proximal said skin engaging surface and a second portion located proximal said reservoir, said first portion having a larger cross-sectional width than said second portion.

6. A device as in claim 5, wherein said needle cannula is secured in said channel with an adhesive, said adhesive being disposed in said first portion.

7. A device as in claim 1, wherein said body further comprises a barrel having an open distal end, said reservoir being defined in said barrel, a neck portion adjacent a proximal end of said barrel, and a limiter adjacent a proximal end of said neck portion, said skin engaging surface being defined on a proximal end of said limiter.

8. A device as in claim 7, wherein said barrel has a first out diameter, said neck portion has a second outer diameter, and said limiter has a third outer diameter.

9. A device as in claim 8, wherein said outer diameter of said neck portion is tapered.

10. A device as in claim 7, wherein said limiter has an outer diameter that is no greater than 11 mm.

11. A device as in claim 7, wherein said limiter has an outer diameter that is no greater than 5.5 mm.

12. A device as in claim 1, wherein said skin engaging surface defines a plane disposed generally perpendicularly to a longitudinal axis of said needle cannula.

13. A device as in claim 1, wherein said skin engaging surface comprises portions that are substantially coplanar and that are disposed about said needle cannula.

14. A device as in claim 13, wherein said coplanar portions are disposed continuously about said needle cannula.

15. A device as in claim 13, wherein said coplanar portions are disposed discontinuously about said needle cannula.

16. A device as in claim 13, wherein said coplanar portions are defined on proximal most portions of said skin engaging surface.

17. A device as in claim 1, further comprising a plunger slidably disposed in said reservoir.

18. A device as in claim 17, wherein said plunger sealingly engages said distal end of said needle cannula upon a predetermined extent of sliding movement in said reservoir.

19. A device as in claim 17, further comprising a plunger rod for selective attachment to said plunger, said plunger rod being configured to force sliding movement of said plunger within said reservoir.

20. A device as in claim 1, wherein said needle cannula is secured in said channel with an adhesive.

21. A device as in claim 20, wherein said adhesive is recessed in said channel below said skin engaging surface.

22. An intradermal injection device comprising:

a unitary body having a open distal end and a proximal end having a first surface portion and a protrusion extending therefrom, a reservoir defined between said distal and proximal ends for accommodating a drug substance, and a channel defined at said proximal end of said unitary body and extending through, and distally from, said proximal end; and

,

a needle cannula having a sharpened proximal end and a distal end, said needle cannula being secured in said channel with said distal end being in communication with said reservoir and said proximal end of said needle cannula extending from said protrusion a distance in the range of about 0.5 mm to 3.0 mm such that said protrusion limits penetration of said proximal end of said needle cannula to the dennis layer of the skin of a patient.

23. A device as in claim 22, wherein said protrusion is generally annular and circumscribes said channel.

24. A device as in claim 23, wherein said protrusion bounds said channel.

25. A device as in claim 22, wherein said protrusion has a polygonal cross-section.

26. A device as in claim 25, wherein said protrusion has a generally rectangular cross-section.

27. A device as in claim 25, wherein said protrusion has a generally trapezoidal cross-section.

28. A device as in claim 25, wherein said protrusion has a generally square cross-section.

29. A device as in claim 25, wherein said protrusion has a height ranging from 0.2 to 1.0 mm, said protrusion terminating at a proximal free end, said proximal free end defining a width ranging from 0.2 to 0.6 mm.

30. A device as in claim 26, wherein said protrusion has a height and width, each ranging from 0.2 to 0.5 mm.

31. A device as in claim 27, wherein said protrusion has a height ranging from 0.5 to 1.0 mm, said protrusion terminating at a proximal free end, said proximal free end defining a width ranging from 0.35 to 0.6 mm.

32. A device as in claim 28, wherein said protrusion has a height and width, each ranging from 0.2 to 0.5 mm.

33. A device as in claim 22, wherein at least a portion of the cross-section of said protrusion is arcuate.

34. A device as in claim 22, wherein proximal most portions of said protrusion are disposed continuously about said needle cannula.

35. A device as in claim 22, wherein proximal most portions of said protrusion are disposed discontinuously about said needle cannula.

36. A device as in claim 22, wherein said first surface portion circumscribes said protrusion.

37. A device as in claim 22, wherein said first surface portion is generally annular.

38. A device as in claim 22, wherein said first surface portion is generally planar.

39. A device as in claim 22, wherein said unitary body comprises glass.

40. A device as in claim 39, wherein said unitary body is formed wholly from glass.

41. A device as in claim 22, wherein said channel has a cross-sectional shape having a non-constant width.

42. A device as in claim 41, wherein said channel has a first portion located proximal said skin engaging surface and a second portion located proximal said reservoir, said first portion having a larger cross-sectional width than said second portion.

43. A device as in claim 42, wherein said needle cannula is secured in said channel with an adhesive, said adhesive being disposed in said first portion.

44. A device as in claim 22, wherein said body further comprises a barrel having an open distal end, said reservoir being defined in said barrel, a neck portion adjacent a proximal end of said barrel, and a limiter adjacent a proximal end of said neck portion, said first surface portion being defined on a proximal end of said limiter.

45. A device as in claim 44, wherein said barrel has a first out diameter, said neck portion has a second outer diameter, and said limiter has a third outer diameter.

46. A device as in claim 45, wherein said outer diameter of said neck portion is tapered.

47. A device as in claim 44, wherein said limiter has an outer diameter that is no greater than 11 mm.

48. A device as in claim 44, wherein said limiter has an outer diameter that is no greater than 5.5 mm.

49. A device as in claim 22, wherein said first surface portion defines a plane disposed generally perpendicularly to a longitudinal axis of said needle cannula.

50. A device as in claim 22, further comprising a plunger slidably disposed in said reservoir.

51. A device as in claim 50, wherein said plunger sealingly engages said distal end of said needle cannula upon a predetermined extent of sliding movement in said reservoir.

52. A device as in claim 50, further comprising a plunger rod for selective attachment to said plunger, said plunger rod being configured to force sliding movement of said plunger within said reservoir.

53. A device as in claim 22, wherein said needle cannula is secured in said channel with an adhesive.

54. A device as in claim 53, wherein said adhesive is recessed in said channel below said skin engaging surface.

55. A holder for a medicament comprising a unitary body comprising a generally tubular barrel having an open distal end and a proximal end, a reservoir for accommodating a medicament for intradermal delivery being defined between said distal and proximal ends of said generally tubular barrel, a neck portion adjacent said proximal end of said generally tubular barrel, a limiter adjacent a proximal end of said neck portion having a skin engaging surface defined thereon, and a channel defined at said proximal end of said unitary body and extending through, and distally from, said skin engaging surface to said reservoir, said skin engaging surface limiting delivery of the medicament to the dermis layer of a patient'"'"'s skin.

56. A holder as in claim 55, wherein said channel has a cross-sectional shape having a non-constant width.

57. A holder as in claim 56, wherein said channel has a first portion located proximal said skin engaging surface and a second portion located proximal said reservoir, said first portion having a larger cross-sectional width than said second portion.

58. A holder as in claim 55, wherein said barrel has a first out diameter, said neck portion has a second outer diameter, and said limiter has a third outer diameter.

59. A holder as in claim 58, wherein said outer diameter of said neck portion is tapered.

60. A holder as in claim 55, wherein said limiter has an outer diameter that is no greater than 11 mm.

61. A holder as in claim 55, wherein said limiter has an outer diameter that is no greater than 5.5 mm.

62. A holder as in claim 55, wherein said skin engaging surface defines a plane disposed generally perpendicularly to a longitudinal axis of said channel.

63. A holder as in claim 55, wherein said skin engaging surface comprises portions that are substantially coplanar and that are disposed about said channel.

64. A holder as in claim 63, wherein said coplanar portions are disposed continuously about said channel.

65. A holder as in claim 63, wherein said coplanar portions are disposed discontinuously about said channel.

66. A holder as in claim 55, wherein said skin engaging surface is defined on proximal most portions of said limiter.

67. A holder as in claim 55, wherein said skin engaging surface has a protrusion extending therefrom.

68. A holder as in claim 67, wherein said protrusion is generally annular and circumscribes said channel.

69. A holder as in claim 68, wherein said protrusion bounds said channel.

70. A holder as in claim 67, wherein said protrusion has a polygonal cross-section.

71. A holder as in claim 70, wherein said protrusion has a generally rectangular cross-section.

72. A holder as in claim 70, wherein said protrusion has a generally trapezoidal cross-section.

73. A holder as in claim 70, wherein said protrusion has a generally square cross-section.

74. A holder as in claim 70, wherein said protrusion has a height ranging from 0.2 to 1.0 mm, said protrusion terminating at a proximal free end, said proximal free end defining a width ranging from 0.2 to 0.6 mm.

75. A holder as in claim 71, wherein said protrusion has a height and width, each ranging from 0.2 to 0.5 mm.

76. A holder as in claim 72, wherein said protrusion has a height ranging from 0.5 to 1.0 mm, said protrusion terminating at a proximal free end, said proximal free end defining a width ranging from 0.35 to 0.6 mm.

77. A holder as in claim 73, wherein said protrusion has a height and width, each ranging from 0.2 to 0.5 mm.

78. A holder as in claim 67, wherein at least a portion of the cross-section of said protrusion is arcuate.

79. A holder as in claim 67, wherein proximal most portions of said protrusion are disposed continuously about said needle cannula.

80. A holder as in claim 67, wherein proximal most portions of said protrusion are disposed discontinuously about said needle cannula.

81. A holder as in claim 67, wherein said first surface portion circumscribes said protrusion.

82. A holder as in claim 67, wherein said first surface portion is generally annular.

83. A holder as in claim 67, wherein said first surface portion is generally planar.

84. A holder as in claim 67, wherein said unitary body comprises glass.

85. A holder as in claim 84, wherein said unitary body is formed wholly from glass.

86. A holder as in claim 55, wherein said skin engaging surface defines a plane disposed generally perpendicularly to a longitudinal axis of said channel.