Method and device for intradermally delivering a substance

• US 7,115,108 B2
• Filed: 04/02/2002
• Issued: 10/03/2006
• Est. Priority Date: 04/02/2002
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Newby, Mark, Wilkinson, Bradley M.
• Primary Examiner(s): Rodriguez, Cris L.
• Application Number:
  US10/112,933
• Publication Number:
  US 20030187394A1
• Time in Patent Office: 1,645 Days
• Field of Search: 604/246.131, 604/132, 604/141, 604/117, 604/173, 604/174, 604/180, 604/46, 604/47, 604/156, 604/237, 604/247, 604/22, 604/20, 60428801-28804, 604/890.1, 604/891.1, 604/93.01, 128/DIG.12
• US Class Current: 604/93.01
• 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 and an inlet, said cavity being dimensioned to receive a substance for delivery to a patient wherein said inlet is for passing said substance into said cavity;

a skin penetrating device in fluid communication with said cavity, wherein said skin penetrating device comprises a skin penetrating member having a length of about 500 microns to about 1,000 microns; and

an indicator having an indicating surface responsive to a pressure within said internal cavity, wherein said indicating surface indicates the delivery of a sufficient amount of the substance to the patient.

2. The intradermal delivery device of claim 1, further comprising a check valve connected to said inlet for preventing the substance from leaving said cavity through said inlet.

3. The intradermal delivery device of claim 1, wherein said indicator further comprises an indicating member on said indicating surface 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.

4. The intradermal delivery device of claim 3, 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.

5. The intradermal delivery device of claim 3, wherein said movable portion is resiliently biased to said position.

6. The intradermal delivery device of claim 5, 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.

7. The intradermal delivery device of claim 6, 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.

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

9. The intradermal delivery device of claim 6, wherein said expandable resilient member is integrally formed with said housing.

10. The intradermal delivery device of claim 9, wherein said expandable resilient member is made from an elastomeric material.

11. The intradermal delivery device of claim 6, wherein said housing includes a top wall and wherein said expandable resilient member is connected to said top wall.

12. The intradermal delivery device of claim 11, wherein said top wall includes an opening and wherein said expandable resilient member closes said opening.

13. The intradermal delivery device of claim 6, wherein the expandable resilient member comprises at least a portion of the internal cavity dimensioned to receive a substance for delivery to a patient.

14. The intradermal delivery device of claim 13, wherein said housing has a substantially non-expanding portion made from a substantially non-expanding material.

15. The intradermal delivery device of claim 14, wherein said substantially non-expanding portion contains said inlet for supplying said substance to said cavity.

16. The intradermal delivery device of claim 15, further comprising a check valve connected to said inlet to prevent the substance from leaving the cavity through said inlet.

17. The intradermal delivery device of claim 3, 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.

18. The intradermal delivery device of claim 3, wherein the indicating member comprises at least a portion of the internal cavity dimensioned to receive a substance for delivery to a patient.

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 19, 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 plurality of said skin penetrating members.

22. The intradermal delivery device of claim 1, wherein said skin penetrating member is a needle of from about 30 gauge to about 50 gauge.

23. 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.

24. The intradermal delivery device of claim 23, wherein said adhesive coated member is a strip.

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