Methods and devices for delivering agents across biological barriers

• US 9,561,042 B2
• Filed: 11/12/2009
• Issued: 02/07/2017
• Est. Priority Date: 08/05/2005
• Status: Expired due to Fees

• Current Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Original Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Inventors: McAllister, Devin V., DiMeglio, Ciro
• Primary Examiner(s): Desanto, Matthew F
• Application Number:
  US12/617,566
• Publication Number:
  US 20100152701A1
• Time in Patent Office: 2,644 Days
• Field of Search: 604/22, 604/46, 604/264, 604272-274
• US Class Current: 1/1
• 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 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/322 Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston devices for protecting guide needles in combination with catheters A61M25/0612
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

The invention provides for microneedle devices for delivering agents across biological barriers. The microneedles include agent reservoirs integrated into the bodies of the microneedles, themselves.

Claims

1. A device for delivering an agent across a biological barrier comprising:

a first microneedle comprising an integrated first reservoir which is an opening through the entirety of the width of the first microneedle and which comprises an agent stored in a dried or semi-solid state;

a first base element from which the first microneedle extends;

a substrate to which the first base element is coupled; and

a first depth guard that extends from the substrate and around a portion of the microneedle;

wherein a predetermined volume of the agent is contained predominantly within the interior volume of the microneedle; and

wherein the first microneedle, the substrate and the first depth guard are a monolithic single unit.

2. The device of claim 1, wherein the first reservoir takes up a substantial portion of the volume of the first microneedle.

3. The device of claim 2, wherein the first reservoir comprises between about 5% and about 70% of the volume of the first microneedle.

4. The device of claim 2, wherein the first reservoir comprises about 20%-50% of the volume of the first microneedle.

5. The device of claim 1, further comprising:

a second microneedle comprising an integrated second reservoir which is an opening through the entirety of one of the width and depth of the microneedle and which comprises an agent stored in a dried or semi-solid state;

a second base element from which the second microneedle extends, wherein the second base element is coupled to the substrate; and

a second depth guard that extends from the substrate;

wherein the second microneedle, the substrate and the second depth guard are a continuous single unit.

6. The device of claim 5, wherein the first reservoir and the second reservoir contain the same agent.

7. The device of claim 5, wherein the first reservoir contains a first agent and the second reservoir contains a different agent.

8. The device of claim 1, wherein the agent is stored in a semi-solid gel-like state.

9. The device of claim 1, wherein the first microneedle comprises one of stainless steel and titanium.

10. The device of claim 1, wherein the first microneedle is between about 150 μ

m to about 3000 μ

m long.

11. The device of claim 1, wherein the first microneedle is between about 300 μ

m to about 1500 μ

m long.

12. The device of claim 1, wherein the first microneedle is about 10 μ

m to about 2000 μ

m wide.

13. The device of claim 1, wherein the first microneedle is about 100 μ

m to about 500 μ

m wide.

14. The device of claim 1, wherein the agent is suitable for intradermal delivery.

15. The device of claim 1, wherein the first reservoir is filled with the agent.

16. The device of claim 1 wherein the first reservoir comprises between about 50%-70% of the volume of the first microneedle.

17. A method of delivering an agent across a biological barrier, wherein the method comprises:

providing the device of claim 1; and

applying the device against the skin of a patient, thereby piercing the skin and positioning the integrated reservoir beneath the surface of the skin.