Method and apparatus for epidermal delivery of a substance

• US 20040092893A1
• Filed: 09/10/2003
• Published: 05/13/2004
• Est. Priority Date: 09/10/2002
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Clarke, Richard P., Martin, Frank E., Haider, M. Ishaq, Fentress, James K., Mitszka, John A.
• Application Number:
  US10/659,245
• Publication Number:
  US 20040092893A1
• Time in Patent Office: Days
• US Class Current: 604/272
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• 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 5/3291 Shafts with additional lateral openings
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

A method and apparatus for epidermal and/or intradermal delivery of a substance is provided. A needle having at least one side port is used to penetrate the skin of a subject. The needle may be of any size. A substance is delivered through the side port and into the skin. The side port can be of any size or shape and be arranged at any location on the needle.

Claims

1. A needle, comprising:

a shaft having a wall defining a longitudinally extending bore, a first end that is open to receive a substance in the bore, a second end adapted to penetrate skin of a subject, and a penetration length of less than about 4.5 mm; and

at least one side port extending through the wall and communicating with the bore.

2. The needle of claim 1, wherein the second end comprises a sharpened tip.

3. The needle of claim 2, wherein the tip is beveled.

4. The needle of claim 3, wherein the side port is arranged on a side of the shaft opposite of the bevel.

5. The needle of claim 1, wherein the second end includes an end port communicating with the bore.

6. The needle of claim 5, wherein the side port and end port are adapted for bi-phasic delivery of a substance.

7. The needle of claim 1, wherein the side port is arranged on the shaft for epidermal delivery of a substance.

8. The needle of claim 1, wherein the side port is arranged on the shaft for intradermal delivery of a substance.

9. The needle of claim 1, wherein the side port is adapted to be about 0.025 mm to about 3 mm below a surface of the skin when the needle is inserted into a subject.

12. The apparatus of claim 11, wherein the beveled tip includes an end port communicating with the interior of the cannula.

13. The apparatus of claim 12, wherein the side port is arranged on a side of the cannula opposite the beveled tip.

10. An infusion apparatus, comprising:

a housing including a reservoir for containing a supply of liquid medication and for delivering the liquid medication under pressure;

a delivery cannula carried by and extending from the housing, the delivery cannula including a side port communicating with an interior of the cannula, the side port being arranged about 0.025 mm to about 3 mm below a surface of the skin when the needle is inserted into the skin of a subject;

and a flow channel for conducting the liquid medication from the reservoir to the delivery cannula.

11. The apparatus of claim 10, wherein the delivery cannula further comprises a beveled tip.

14. The apparatus of claim 10, further comprising at least two side ports

15. The apparatus of claim 10, wherein the side port is arranged on the delivery cannula about 200 microns from the housing.

16. The apparatus of claim 10, wherein the side port is arranged on the delivery cannula about 0.025 to about 1.5 mm from the housing.

17. The apparatus of claim 10, wherein the delivery cannula is adapted to penetrate only an intradermal layer.

18. A method of delivering a substance to a skin of a subject, comprising:

providing a needle comprising a shaft defining a longitudinally extending bore and having a first end that is open to receive a substance in the bore, a second end adapted to penetrate skin of a subject and at least one side port extending through the shaft and in communication with the bore;

penetrating the skin of a subject with the needle such that at least one side port is arranged about 0.025 mm to about 3 mm below a surface of the skin;

introducing a substance into the first end of the bore; and

delivering the substance from the bore such that the substance flows out of the side port and into an area of the skin contiguous with the side port.

19. The method of claim 18, further comprising delivering the substance via the side port to the epidermis.

20. The method of claim 18, further comprising delivering the substance via the side port intradermally.

21. The method of claim 18, wherein the needle has an end port at the second end and further comprising delivering the substance through both the side port and the end port simultaneously.

22. The method of claim 18, wherein the needle has an end port at the second end and further comprising performing bi-phasic delivery of the substance.

23. The method of claim 18, wherein the at least one side port is arranged about 0.025 mm to about 1.5 mm below a surface of the skin.

24. The method of claim 21, further comprising at least two side ports and performing triphasic delivery of the substance.

25. The method of claim 18, providing at least one of a vaccine antigen, DNA and a polysaccharide polymer vaccine as the substance.

26. The method of claim 18, further comprising delivering the substance at a steady state delivery pressure less than about 5 psi.

27. The method of claim 18, wherein the needle includes an end port and delivering the substance simultaneously through the side port for absorption into a first layer of the skin and through the end port for absorption into second layer of the skin that is different from the first layer.

28. The method of claim 27, wherein the first layer of the skin is an epidermal layer.

29. The method of claim 28, wherein the second layer of skin is an intradermal layer.

30. A method for delivering a substance to the skin, comprising:

providing a needle comprising a shaft defining a longitudinally extending bore and having a first end that is open to receive a substance in the bore, a second end adapted to penetrate skin of a subject, and at least one side port extending through the shaft and in communication with the bore;

inserting the needle into the skin of a subject;

introducing a substance into the bore via the first end; and

selectively delivering the substance via the at least one side port into the dermis to obtain absorption of the substance in the dermis.

31. The method of claim 30, providing at least one of a vaccine antigen, DNA and a polysaccharide polymer vaccine as the substance.

32. The method of claim 30, further comprising delivering the substance at a substantially constant delivery pressure.

33. The method of claim 30, further comprising inserting the needle so that at least one side port is arranged about 0.025 mm to about 3 mm below a surface of the skin.

34. The method of claim 30, wherein the needle includes an end port and further comprising delivering the substance simultaneously through the side port for absorption, wherein a volume of the substance delivered is increased relative to a volume delivered via only an end port.

35. The method of claim 30, wherein the needle includes an end port and selectively delivering the substance via the side port and end port to at least one of the epidermal and intradermal space;

the intradermal and subcutaneous space; and

the epidermal, the intradermal and subcutaneous space.

36. The method of claim 30, further comprising delivering the substance at a steady state delivery pressure less than about 5 psi.

37. A method of delivering a substance to a selected layer of the skin, comprising:

providing a delivery cannula having a side port and an end port communicating with an interior of the cannula;

inserting the needle into the skin; and

delivering the substance to the selected layer of skin via the side port and the end port wherein a volume of the substance delivered is increased relative to a volume delivered via only an end port.

38. The method of claim 37, further comprising inserting the needle into the skin until the side port is about 0.025 mm to about 3 mm below a surface of the skin.

39. The method of claim 37, wherein the side port is arranged on the needle to be 0.025 mm to about 3 mm below a surface of the skin when the needle is inserted into the skin.