Valved intradermal delivery device and method of intradermally delivering a substance to a patient

• US 7,047,070 B2
• Filed: 04/02/2002
• Issued: 05/16/2006
• Est. Priority Date: 04/02/2002
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Wilkinson, Bradley M., Hwang, Charles G.
• Primary Examiner(s): KENNEDY, SHARON E
• Assistant Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/112,756
• Publication Number:
  US 20030187423A1
• Time in Patent Office: 1,505 Days
• Field of Search: 604/19, 604/22, 604/27, 604/28, 604/30, 604/46, 604/48, 604/500, 604/506, 604/507, 604/93.01, 604115-117, 604131-134, 604/167.01, 604/167.03, 604/167.05, 604/174, 604/176, 604179-181, 604/186, 604/187, 604/192, 604/212, 604/239, 604246-248, 604/264, 604/272, 604/274, 604/289, 604/290, 604/173, 604/20, 604/191, 600/362, 600/378, 600/383, 600/573, 606/131, 606/132, 606/167, 606/172, 606181-183, 606185-189
• US Class Current: 604/20
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• 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
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means

Abstract

An intradermal delivery device for delivery a substance into the skin of a patient has a fluid chamber for containing the substance, at least one micro skin penetrating member, and a valve controlling the flow of the substance from the fluid chamber to the micro skin penetrating member. An adhesive releasably attaches the device to the skin of the patient, the fluid chamber can be sized to hold a unit dose of the substance, and, in some embodiments, the fluid chamber can be releasably coupled to a housing of the device.

Claims

1. An intradermal delivery device for delivering a substance into the skin of a patient, comprising:

a housing;

a fluid chamber on the housing for containing the substance, said chamber having an outlet for the substance;

a manually actuatable valve member connected to said housing to control the flow of the substance through the outlet, wherein the valve member has a portion exposed to the exterior of the device for digital manipulation between a closed position in which the substance is physically prevented from flowing through the outlet and an open position in which the substance is permitted to flow through the outlet; and

a skin penetrating device on the housing and in fluid communication with the chamber for selectively delivering the substance into the skin of the patient wherein the skin penetrating member has a length of from about 50 microns to about 4,000 microns.

2. The intradermal delivery device of claim 1, wherein said valve member is integrally formed with said housing.

3. The intradermal delivery device of claim 1, wherein said housing includes a cavity communicating with the outlet of said chamber, and said skin penetrating device communicates with said cavity.

4. The intradermal delivery device of claim 3, wherein said skin penetrating device comprises at least one skin penetrating member having a passage through which the substance can flow, the passage having an inlet in fluid communication with said cavity.

5. The intradermal delivery device of claim 3, wherein said skin penetrating device comprises a plurality of spaced skin penetrating members, each of said skin penetrating members having a passage through which the substance can flow, each passage having an inlet in fluid communication with said cavity.

6. The intradermal delivery device of claim 1, wherein said skin penetrating device comprises at least one skin penetrating member having a passage through which the substance can flow, the passage having an inlet in fluid communication with said chamber.

7. The intradermal delivery device of claim 6, wherein said skin penetrating device comprises a plurality of spaced skin penetrating members, each of said skin penetrating members having a passage through which the substance can flow, each passage having an inlet in fluid communication with said chamber.

8. The intradermal delivery device of claim 1, wherein said chamber comprises a reservoir sized to be completely filled by a unit dose of the substance.

9. The intradermal delivery device of claim 1, further comprising a movable member for applying sufficient fluid pressure to the fluid chamber to deliver the substance into the skin of a patient.

10. The intradermal delivery device of claim 9, wherein said movable member is a deformable member defining at least a portion of said fluid chamber, whereby deformation of said deformable member produces a dispensing pressure on the chamber.

11. The intradermal delivery device of claim 8, wherein said housing includes a flexible top wall and a substantially rigid bottom wall defining said reservoir therebetween, said top wall being deformable to produce a dispensing pressure on said reservoir.

12. The intradermal delivery device of claim 1, wherein the fluid chamber comprises a supply container removably coupled to the housing.

13. The intradermal delivery device of claim 12, wherein the supply container contains a unit dose of the substance to be delivered.

14. The intradermal delivery device of claim 1, wherein the fluid chamber contains a unit dose of the substance to be delivered.

15. The intradermal delivery device of claim 1, wherein said housing includes a bottom face, and said skin penetrating device is coupled to said bottom face, said bottom face having a rib surrounding said skin penetrating device for impressing a containment area in the skin of a patient, around a target area on the skin.

16. The intradermal delivery device of claim 1, wherein said portion has a handle.

17. The intradermal delivery device of claim 1, wherein said housing includes a cavity communicating with the outlet of said chamber, and said skin penetrating device communicates with said cavity.

18. The intradermal delivery device of claim 17, wherein the valve element is positioned between said cavity and the outlet of the fluid chamber.

19. The intradermal delivery device of claim 18, wherein said valve element is rotatable between said open position and said closed position.

20. The intradermal delivery device of claim 3, wherein the cavity in said housing includes a bottom face, a recess in said bottom face, and said skin penetrating device is mounted in said recess to define the cavity between said skin penetrating device and said bottom face of said recess.

21. The intradermal delivery device of claim 1, wherein said fluid chamber is prefilled with the substance.

22. The intradermal delivery device of claim 1, wherein said fluid chamber is prefilled with a unit dose of the substance.

23. The intradermal delivery device of claim 9, wherein said housing includes a top wall and a bottom wall defining said reservoir therebetween.

24. The intradermal delivery device at claim 23, wherein said top wall includes said movable member.

25. The intradermal delivery device of claim 24, wherein said movable member is made of a flexible material.

26. The device of claim 25, wherein said flexible material is resilient.

27. The intradermal delivery device of claim 1, wherein said fluid chamber is integrally formed with said housing.

28. The intradermal delivery device of claim 4, wherein the skin penetrating member has a length of from about 50 microns to about 1,500 microns.

29. The intradermal delivery device of claim 4, wherein the skin penetrating member has a length of from about 500 microns to about 1,000 microns.

30. The intradermal delivery device of claim 4, wherein the skin penetrating member is a needle of from about 30 gauge to about 50 gauge.

31. The intradermal delivery device of claim 4, further comprising an adhesive for releasably attaching the device to the skin of a patient.

32. The intradermal delivery device of claim 1, wherein the exposed portion of the valve member comprises an indicator indicating the position of the valve member.

33. The device of claim 4, wherein the skin penetrating member comprises a needle having an axial passage in fluid communication with the fluid chamber for delivering the substance to the patient.

34. An intradermal delivery device for delivering a substance into the skin of a patient, comprising:

a housing;

a fluid chamber on the housing for containing the substance, said chamber having an outlet for the substance;

a manually actualize valve actuator connected to said housing and engaged to a valve disposed within the housing to control the flow of the substance through the outlet, wherein the valve actuator has a portion exposed to the exterior of the device for digital manipulation between a closed position in which the substance is physically prevented from flowing through the outlet and an open position in which the substance is permitted to flow through the outlet; and

a skin penetrating device on the housing and in fluid communication with the chamber for selectively delivering the substance into the skin of the patient wherein the skin penetrating member has a length of from about 50 microns to about 4,000 microns.

35. The intradermal delivery device of claim 34, wherein said skin penetrating device comprises at least one skin penetrating member having a passage through which the substance can flow, the passage having an inlet in fluid communication with said chamber.

36. The intradermal delivery device of claim 35, wherein said skin penetrating device comprises a plurality of spaced skin penetrating members, each of said skin penetrating members having a passage through which the substance can flow, each passage having an inlet in fluid communication with said chamber.

37. The intradermal delivery device of claim 34, wherein said chamber comprises a reservoir sized to be completely filled by a unit dose of the substance.

38. The intradermal delivery device of claim 34, further comprising a movable member for applying sufficient fluid pressure to the fluid chamber to deliver the substance into the skin of a patient.

39. The intradermal delivery device of claim 38, wherein said movable member is a deformable member defining at least a portion of said fluid chamber, whereby deformation of said deformable member produces a dispensing pressure on the chamber.

40. The intradermal delivery device of claim 37, wherein said housing includes a flexible top wall and a substantially rigid bottom wall defining said reservoir therebetween, said top wall being deformable to produce a dispensing pressure on said reservoir.