Drug delivery device

• US 9,861,801 B2
• Filed: 02/28/2014
• Issued: 01/09/2018
• Est. Priority Date: 02/28/2013
• Status: Active Grant

• Current Assignee: Sorrento Therapeutics Inc.
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Baker, Andrew, Ross, Russell F., Hagan, Luke
• Primary Examiner(s): Schmidt, Emily
• Application Number:
  US14/762,534
• Publication Number:
  US 20150360018A1
• Time in Patent Office: 1,411 Days
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 2210/04 Skin
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

A drug delivery device is disclosed that may include a skin penetrating assembly having a support defining an upper surface and a lower surface. The skin penetrating assembly may also include a plurality of skin penetrating members extending outwardly from the lower surface. Each skin penetrating member may define a channel for receiving a drug formulation. In addition, the device may include a reservoir positioned adjacent to the upper surface of the support for initially retaining the drug formulation. The reservoir may include a top surface and a bottom surface and may define a plurality of passages extending between the top and bottom surfaces. The passages may be configured such that the drug formulation is retained within the passages against gravity.

Claims

1. A drug delivery device comprising:

a skin penetrating assembly including a support defining an upper surface and a lower surface, the support further defining a plurality of apertures extending between the upper and lower surfaces, the skin penetrating assembly further including a plurality of skin penetrating members extending outwardly from the lower surface, each skin penetrating member defining a channel for receiving a drug formulation, each channel being in fluid communication with at least one of the plurality of apertures; and

a separate reservoir positioned adjacent to the upper surface of the support that initially retains the drug formulation, the reservoir including a top surface and a bottom surface and defining a plurality of passages extending between the top and bottom surfaces, the passages being configured such that the drug formulation is retained within the passages against gravity prior to delivery of the drug formulation to the skin penetrating assembly,

wherein a cross-sectional area of each passage is selected such that a capillary pressure is generated within each passage that retains the drug formulation against gravity until a negative pressure is generated within the skin penetration assembly due to skin absorption that draws the drug formulation out of the passages and into the skin penetration assembly.

2. The drug delivery device of claim 1, wherein a cross-sectional area of each channel is selected such that bodily fluid flows upward into the skin penetration assembly via capillary action when the skin penetrating members are inserted into skin.

3. The drug delivery device of claim 1, wherein a capillary pressure within each channel ranges from about −

4000 pascals to about −

300 pascals.

4. The drug delivery device of claim 3, wherein the capillary pressure within each passage is less than the capillary pressure within each channel.

5. The drug delivery device of claim 1, wherein the skin penetrating assembly is configured as a microneedle assembly including a plurality of microneedles extending outwardly from the lower surface of the support.

6. The drug delivery device of claim 1, wherein a length of each skin penetrating member is less than about 1000 micrometers.

7. The drug delivery device of claim 1, further comprising a spreading membrane disposed between the upper surface of the skin penetrating assembly and the reservoir, the spreading membrane being configured to distribute the drug formulation along the bottom surface of the reservoir.

8. The drug delivery device of claim 1, further comprising a filter positioned adjacent to the top surface of the reservoir, the filter being configured to allow air to be vented from the reservoir.

9. The drug delivery device of claim 1, further comprising a reservoir frame defining a frame opening configured to receive at least a portion of the reservoir, the skin penetrating assembly being coupled to the reservoir frame.

10. A method for delivering a drug formulation, the method comprising:

positioning a drug delivery device adjacent to skin, wherein the drug delivery device comprises;

a skin penetrating assembly including a support and a plurality of skin penetrating members extending outwardly from the support, the support defining a plurality of apertures therein, each skin penetrating member defining a channel for receiving the drug formulation, each channel being in fluid communication with at least one of the plurality of apertures; and

a separate reservoir initially retaining the drug formulation, the reservoir defining a plurality of passages; and

inserting the skin penetrating members into the skin such that a negative pressure is generated within the skin penetrating assembly due to skin absorption, wherein a cross-sectional area of each passage is selected such that a capillary pressure is generated within each passage that retains the drug formulation within the passages against gravity until the negative pressure draws the drug formulation out of the passages and into the skin penetrating assembly.

11. The method of claim 10, wherein a cross-sectional area of each channel is selected such that bodily fluid flows upward into the skin penetration assembly via capillary action when the skin penetrating members are inserted into skin.

12. The method of claim 10, wherein a capillary pressure within each channel ranges from about −

4000 pascals to about −

300 pascals.

13. The method of claim 12, wherein the capillary pressure within each passage is less than the capillary pressure within each channel.

14. The method of claim 10, wherein the skin penetrating assembly is configured as a microneedle assembly including a plurality of microneedles extending outwardly from the lower surface of the support.

15. The method of claim 10, wherein a length of each skin penetrating member is less than about 1000 micrometers.

16. The method of claim 10, further comprising a spreading membrane disposed between the skin penetrating assembly and the reservoir, the spreading membrane being configured to distribute the drug formulation along the bottom surface of the reservoir.

17. The method of claim 10, further comprising a filter positioned adjacent to the top surface of the reservoir, the filter being configured to allow air to be vented from the reservoir.