Force-controlled applicator for applying a microneedle device to skin

• US 10,406,339 B2
• Filed: 09/12/2017
• Issued: 09/10/2019
• Est. Priority Date: 11/16/2012
• Status: Active Grant

• Current Assignee: Kindeva Drug Delivery L.P.
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Simmers, Ryan P.
• Primary Examiner(s): Stiles, Amber R
• Application Number:
  US15/701,755
• Publication Number:
  US 20180001071A1
• Time in Patent Office: 728 Days
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

An applicator and method for applying a microneedle device to a skin surface. The applicator can include a first portion comprising a microneedle array, and a second portion coupled to the first portion via a connector. The connector can be configured to yield or fracture by changing from a first state in which the connector is intact to a second state in which the connector is yielded or fractured when a threshold application force is applied to at least one of the first portion and the second portion in a direction substantially perpendicular with respect to the first portion. The method can include pressing the applicator in a direction substantially perpendicular to the first portion to press the microneedle array into the skin surface until the threshold application force is met or exceeded and the connector is changed to its second state.

Claims

1. An applicator for applying a microneedle array to a skin surface, the applicator comprising:

a first portion comprising a microneedle array and defining a first major surface from which the microneedle array protrudes, the first major surface configured to be substantially parallel with the skin surface and configured to be positioned toward the skin surface; and

a second portion coupled to the first portion via one or more connectors that directly contact both the first portion and the second portion, the one or more connectors configured to fracture by changing from a first state in which the one or more connectors are intact to a second state in which the one or more connectors are fractured when an application force is applied to at least one of the first portion and the second portion in a direction substantially perpendicular with respect to the first major surface of the first portion that meets or exceeds a threshold application force, the second portion defining a second major surface, the second major surface configured to be positioned toward the skin surface;

wherein

the first portion has a total area that is defined by an outer periphery of the first portion;

wherein

the second portion comprises an inner wall having a vertical portion that is oriented in a direction that is substantially perpendicular with respect to the first major surface of the first portion;

wherein

the one or more connectors extend between the outer periphery of the first portion and the vertical portion of the inner wall of the second portion; and

wherein

the one or more connectors provide audible feedback to a user when the threshold application force is achieved.

2. The applicator of claim 1, wherein

the second portion is movable relative to the first portion between

(i) a first position in which the one or more connectors are in their first state, and the applicator is configured to be applied to the skin surface, and

(ii) a second position in which the one or more connectors are in their second state, and the microneedles are inserted into the skin;

wherein

the second portion is movable relative to the first portion by the connector being changed from its first state to its second state.

3. The applicator of claim 1, wherein the second portion is spaced a first distance from the first portion when the second portion is in its first position, wherein the second portion is spaced a second distance from the first portion when the second portion is in its second position, and wherein the second distance is less than the first distance.

4. The applicator of claim 1, wherein the applicator is configured to generate:

a first force generated by pressing the applicator into the skin surface, and

a second force generated by the resistance of the skin surface when the applicator is pressed into the skin surface, and

wherein the one or more connectors are configured to change to their second state when at least one of the (i) first force, (ii) the second force, and (iii) the sum of the magnitude of the first force and the magnitude of the second force equals or exceeds the threshold application force.

5. The applicator of claim 1, wherein the applicator is free of a stored energy element.

6. The applicator of claim 1, wherein the second portion is configured to be removed from the applicator when the one or more connectors are in their second state.

7. The applicator of claim 1, wherein the first portion is configured to remain on the skin surface with the microneedle array for a treatment period.

8. The applicator of claim 1, wherein the applicator is configured to be pressed via the second portion.

9. The applicator of claim 1, wherein the first portion and the second portion are substantially fixed with respect to one another until the one or more connectors are changed to their second state.

10. The applicator of claim 9, wherein the applicator is configured to be pressed via the second portion until the one or more connectors are changed to their second state and the second portion becomes movable with respect to the first portion.

11. The applicator of claim 1, wherein the second portion has a height that is greater than a height of the first portion and is configured to receive at least a portion of the first portion when the one or more connectors are changed to their second state.

12. The applicator of claim 1, wherein the second portion includes a recess, and wherein at least a portion of the first portion is dimensioned to be received in the recess of the second portion.

13. The applicator of claim 12, wherein the one or more connectors are positioned to connect a lower portion of an inner wall of the second portion that at least partially defines the recess with an upper portion of the first portion.

14. The applicator of claim 1, wherein the one or more connectors extend horizontally between the first portion and the second portion.

15. The applicator of claim 1, wherein at least a portion of the microneedle array extends beyond the first major surface and the second major surface when the one or more connectors are in the first state.

16. The applicator of claim 1, wherein the connector one or more connectors extend at least partially horizontally and at least partially vertically between the first portion and the second portion.

17. The applicator of claim 1, wherein the second portion includes an opening formed therein dimensioned to receive the first portion therethrough.

18. The applicator of claim 1, wherein the first portion includes an inner surface that defines a recess, and wherein the second portion includes a projection that is dimensioned to be received in the recess of the first portion when the one or more connectors are in their second state.

19. The applicator of claim 1, wherein the first portion comprises a recess opening towards the second portion;

and

the second portion comprises a projection projecting towards the first portion;

wherein

the recess is dimensioned to receive the projection.

20. A method of applying a microneedle array to a skin surface, the method comprising:

providing the applicator of claim 1;

pressing the applicator in a direction substantially perpendicular to the first major surface to press the microneedle array into the skin surface until the audible feedback is provided; and

discontinuing pressing the applicator in response to the audible feedback.

21. The microneedle device of claim 1, wherein the first portion, the second portion, and the one or more connectors are integrally formed.