Microneedle patch applicator system

• US 9,415,198 B2
• Filed: 10/09/2015
• Issued: 08/16/2016
• Est. Priority Date: 12/22/2010
• 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.
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US14/879,501
• Publication Number:
  US 20160101272A1
• Time in Patent Office: 312 Days
• Field of Search: 604/136
• US Class Current: 1/1
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

A method and apparatus for application of a microneedle patch to a skin surface of a patient includes use of an applicator. The applicator includes a housing, a slidably disposed applicator plate, and a compression spring. The applicator plate is moveable between a retracted position and a deployed position, and has an engaging surface suitable for mashing up against a microneedle patch and pressing it against a skin surface. A docking system transfers the microneedle patch from a support to the applicator without requiring a user to handle the microneedle patch directly. Once mounted in the applicator, the microneedle patch is deployed against a skin surface of a patient for delivery of a desired agent via a microneedle array contained on the patch.

Claims

1. A microneedle patch applicator system, comprising:

an applicator, comprising;

a housing;

a slidably disposed applicator plate, moveable between a retracted position and a deployed position in a reciprocating manner, the applicator plate having an engaging surface;

a spring mounted in such a way that imparts a spring force to the applicator plate when the applicator plate is in the retracted position;

a microneedle patch docking mechanism configured in such a way that the docking mechanism captures and holds a microneedle patch in a position proximal the engaging surface of the applicator plate while the applicator plate is in the retracted position; and

a latch mechanism that when latched holds the applicator plate in place and when unlatched releases the applicator plate, enabling the applicator plate to move to the deployed position; and

a microneedle patch support, comprising;

a housing having a perimeter defining an internal area; and

an elevated hub disposed within the internal area;

wherein the microneedle patch support is sized and dimensioned to support a microneedle patch in such a way that the microneedle patch rests on the elevated hub, and any needles extending from the microneedle patch do not make contact with the microneedle patch support;

wherein upon placement of the applicator onto the microneedle patch and the support, application of force to the applicator causes retraction of the applicator plate to the retracted position and capture of the microneedle patch by the docking mechanism.

2. The system of claim 1, wherein the microneedle patch comprises a plurality of microneedles configured to deliver an agent.

3. The system of claim 2, wherein the agent comprises glucagon.

4. The system of claim 2, wherein the agent comprises insulin.

5. The system of claim 1, wherein the elevated hub comprises a substantially mesa shape with a hollow center at a substantially flat portion of a top of the elevated hub.

6. The system of claim 1, wherein the applicator further comprises a trigger mechanism configured in such a way that activation of the trigger mechanism unlatches the latch mechanism.

7. The system of claim 1, wherein unlatching of the latch mechanism when the applicator plate is in the retracted position releases the applicator plate enabling movement from the retracted position to the deployed position with a kinetic energy of between about 0.1 lbf*in and about 10 lbf*in, and preferably between about 1 lbf*in and about 2 lbf*in.

8. The system of claim 1, wherein the latch mechanism comprises a detent.

9. The system of claim 1, wherein the applicator deploys the microneedle patch with sufficient force to anchor the microneedle patch to a skin surface with a plurality of microneedles disposed thereon.

10. The system of claim 1, wherein the microneedle patch comprises a plurality of microneedles configured for anchoring the microneedle patch to a skin surface and delivering an agent.

11. The microneedle patch applicator system of claim 1, wherein the microneedle patch is stored in a sterile packaging prior to use with the applicator.

12. The microneedle patch applicator system of claim 1, wherein the microneedle patch is stored together with the support in a sterile packaging prior to use of the microneedle patch in the applicator.

13. A kit, comprising:

an applicator, comprising;

a housing;

a slidably disposed applicator plate, moveable between a retracted position and a deployed position in a reciprocating manner, the applicator plate having an engaging surface;

a spring mounted in such a way that imparts a spring force to the applicator plate when the applicator plate is in the retracted position;

a microneedle patch docking mechanism configured in such a way that the docking mechanism captures and holds a microneedle patch in a position proximal the engaging surface of the applicator plate while the applicator plate is in the retracted position; and

a latch mechanism that when latched holds the applicator plate in place and when unlatched permits releases the applicator plate to move, enabling the applicator plate to move to the deployed position; and

a microneedle patch support, comprising;

a housing having a perimeter defining an internal area; and

an elevated hub disposed within the internal area;

wherein the microneedle patch support is sized and dimensioned to support a microneedle patch in such a way that the microneedle patch rests on the elevated hub, and any needles extending from the microneedle patch do not make contact with the microneedle patch support.

14. The kit of claim 13, wherein the microneedle patch is configured for anchoring the microneedle patch to a skin surface and delivering an agent through the plurality of microneedles.

15. The kit of claim 14, wherein the agent comprises glucagon.

16. The kit of claim 14, wherein the agent comprises insulin.