Method and device for intradermally delivering a substance

• US 20030187394A1
• Filed: 04/02/2002
• Published: 10/02/2003
• Est. Priority Date: 04/02/2002
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Newby, Mark, Wilkinson, Bradley M.
• Granted Patent: US 7,115,108 B2
• Time in Patent Office: Days
• US Class Current: 604/131
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/14248 of the skin patch type

Abstract

A device for delivering a substance into the skin of a patient includes a body and a skin penetrating device having at least one skin penetrating member, such as a microneedle. The body includes an internal cavity and a device for indicating the delivery of a sufficient amount of the substance to the patient and for producing a dispensing pressure to dispense and deliver the substance from the cavity. The indicating device is visible from the exterior of the delivery device. In some embodiments, the indicating device is an elastic expandable diaphragm which, when the cavity is filled with a substance, creates the dispensing pressure.

Claims

1. An intradermal delivery device for delivering a substance to a patient, said device comprising:

a housing having an internal cavity, said cavity being dimensioned to receive a substance for delivery to a patient;

a skin penetrating device in fluid communication with said cavity; and

an indicator indicating the delivery of a sufficient amount of the substance of the patient.

2. The intradermal delivery device of claim 1, wherein said indicator comprises an indicating member having at least a portion movable to a position in which a sufficient amount of the substance has been delivered, wherein the presence of the indicating member in said position indicates that a sufficient amount of the substance has been delivered.

3. The intradermal delivery device of claim 2, wherein the movable portion of the indicating member is visible from the exterior of the intradermal delivery device when the movable portion is in said position.

4. The intradermal delivery device of claim 2, wherein said movable portion is resiliently biased to said position.

5. The intradermal delivery device of claim 4, wherein said indicating member comprises an expandable resilient member expandable from said position, the resilience of said expandable resilient member biasing said movable portion to said position.

6. The intradermal delivery device of claim 5, wherein the resilience of said expandable resilient member comprises means for producing a dispensing pressure on a substance in said cavity until a sufficient amount of the substance has been delivered.

7. The intradermal delivery device of claim 6, wherein said expandable member is expandable by introducing a substance into said cavity under pressure.

8. The intradermal delivery device of claim 2, wherein a sufficient amount of the substance to be delivered defines a volume, and said indicating member moves through a volume, the volume through which said indicating member moves being at least equal to the volume of the substance to be delivered.

9. The intradermal delivery device of claim 1, wherein said housing further includes an inlet for passing said substance into said cavity.

10. The intradermal delivery device of claim 9, further comprising a check valve connected to said inlet for preventing the substance from leaving said cavity through said inlet.

11. The intradermal delivery device of claim 5, wherein said expandable resilient member is integrally formed with said housing.

12. The intradermal delivery device of claim 11, wherein said expandable resilient member is made from an elastomeric material.

13. The intradermal delivery device of claim 5, wherein said housing includes a top wall and wherein said expandable resilient member is connected to said top wall.

14. The intradermal delivery device of claim 13, wherein said top wall includes an opening and wherein said expandable resilient member closes said opening.

15. The intradermal delivery device of claim 5, wherein the expandable resilient member is a diaphragm.

16. The intradermal delivery device of claim 15, wherein said diaphragm is made from an elastomeric material.

17. The intradermal delivery device of claim 5, wherein said expandable resilient member defines a top wall of said housing.

18. The intradermal delivery device of claim 17, further comprising an inlet for passing a substance into said cavity.

19. The intradermal delivery device of claim 1, further comprising an attaching arrangement attaching said device to the surface of said skin.

20. The intradermal delivery device of claim 13, wherein said attaching arrangement comprises an adhesive for releasably bonding said device to said skin.

21. The intradermal delivery device of claim 1, wherein said skin penetrating device comprises a skin penetrating member having a length of about 50 microns to about 1,500 microns.

22. The intradermal delivery device of claim 21, wherein said skin penetrating device comprises a plurality of said skin penetrating members.

23. The intradermal delivery device of claim 21, wherein said skin penetrating member is a needle of from about 30 gauge to about 50 gauge.

24. The intradermal delivery device of claim 1, wherein said skin penetrating device comprises a skin penetrating member having a length of about 500 microns to about 1,000 microns.

25. The intradermal delivery device of claim 24, wherein said skin penetrating device comprises a plurality of said skin penetrating members.

26. The intradermal delivery device of claim 24, wherein said skin penetrating member is a needle of from about 30 gauge to about 50 gauge.

27. The intradermal delivery device of claim 5, wherein the expandable resilient member comprises at least a portion of the internal cavity dimensioned to receive a substance for delivery to a patient.

28. The intradermal delivery device of claim 27, wherein said housing has a substantially non-expanding portion made from a substantially non-expanding material.

29. The intradermal delivery device of claim 28, wherein said substantially non-expanding portion comprises an inlet for supplying said substance to said cavity.

30. The intradermal delivery device of claim 29, further comprising a check valve connected to said inlet to prevent the substance from leaving the cavity through said inlet.

31. The intradermal delivery device of claim 1, further comprising a flexible adhesive coated member coupled to said housing for adhesively attaching said device to the skin of said patient.

32. The intradermal delivery device of claim 31, wherein said adhesive coated member is a strip.

33. The intradermal delivery device of claim 1, wherein said skin penetrating member is a needle having an axial passage in fluid communication with said cavity for delivering said substance to said patient.

34. The intradermal delivery device of claim 1, further comprising means for moving the substance from a source to the cavity in a liquid tight manner.

35. The intradermal delivery device of claim 34, wherein said means for moving comprises an inlet opening in said housing and an arrangement for removably coupling the liquid source to said housing.

36. The intradermal delivery device of claim 34, wherein said liquid source is a unit dose delivery device.

37. The intradermal delivery device of claim 34, wherein said expandable resilient diaphragm defines an external wall of said housing.

38. The intradermal delivery device of claim 37, wherein said external wall is distal to the skin penetrating device.

39. The intradermal delivery device of claim 1, wherein said housing has a bottom, and said skin penetrating device is coupled to said bottom.

40. The intradermal delivery device of claim 1, wherein the indicating member comprises at least a portion of the internal cavity dimensioned to receive a substance for delivery to a patient.

41. An intradermal delivery device for delivering a substance to a patient, said device comprising:

a housing having an internal cavity, said cavity being dimensioned to receive a substance for delivery to a patient;

a skin penetrating device in fluid communication with said cavity; and

means for indicating the delivery of a sufficient amount of the substance of the patient.

42. A method of intradermally delivering a substance to a patient, said method comprising:

providing a delivery device having a housing with an internal cavity, and having a skin penetrating device in fluid communication with said cavity, said housing being pressurizable for maintaining a dispensing pressure in said cavity;

positioning said delivery device on a target area on the skin of a patient and applying sufficient force to cause said skin penetrating device to penetrate the skin of said patient;

introducing a substance into said cavity of said housing under pressure;

using the introducing pressure to produce said dispensing pressure in said cavity; and

dispensing and delivering said substance to said patient.

43. The method of claim 42, wherein the step of providing comprises providing as the skin penetrating device comprising at least one microneedle having a length of about 50 microns to about 1,500 microns, and the step of penetrating comprises penetrating said skin with said microneedles.

44. The method of claim 42, wherein the step of providing comprises providing an expandable resilient member in the delivery device, and the step of introducing comprises introducing said substance into said cavity with a force sufficient to expand said expandable resilient member for producing said dispensing pressure in said cavity and for delivering said substance to said patient.

45. The method of claim 44, wherein said expandable resilient member is a diaphragm made of an elastomeric material.