Methods and devices for delivering agents across biological barriers

• US 9,011,392 B2
• Filed: 03/30/2009
• Issued: 04/21/2015
• 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:
  US12/414,330
• Publication Number:
  US 20090187160A1
• Time in Patent Office: 2,213 Days
• Field of Search: 604/22, 604/46, 604/239, 604/264, 604272-274, 141/2, 141/18
• US Class Current: 604/272
• 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• CPC Class Codes: A61M 5/322 Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston devices for protecting guide needles in combination with catheters A61M25/0612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 method of manufacturing a device for delivering an agent across a biological barrier comprising:

providing a first microneedle having a first integrated reservoir which is an opening through the entirety of the width of the first microneedle, wherein the first microneedle extends from a first substrate, wherein a first depth guard extends from the first substrate, and wherein the first microneedle, the first substrate, and the first depth guard are integrally formed as a continuous single unit; and

filling the first integrated reservoir with an agent by selectively depositing a predetermined volume of the agent into the first integrated reservoir utilizing a micropipette or a syringe, such that the agent is contained predominantly within the interior volume of the microneedle.

2. The method of manufacturing a device for transdermal delivery of an agent of claim 1 wherein filling the integrated agent reservoir comprises applying a hydrophilic compound to the interior of the integrated reservoir and applying a hydrophobic compound to a remainder of the microneedle.

3. The method of manufacturing a device for transdermal delivery of an agent of claim 1 further comprising

providing a second microneedle having a second integrated reservoir which is an opening through the entirety of the width of the second microneedle wherein the second microneedle extends from a second substrate, wherein a second depth guard extends from the second substrate, and wherein the second microneedle, the second substrate, and the second depth guard are integrally formed as a continuous single unit;

and

filling the second integrated reservoir with an agent by selectively depositing a predetermined volume of the agent into the first integrated reservoir utilizing a micropipette or a syringe, such that the agent is contained predominantly within the interior volume of the microneedle.

4. The method of manufacturing a device for delivering an agent across a biological barrier of claim 1, wherein the first integrated reservoir comprises between about 50% - 70% of the volume of the first microneedle.