APPLICATORS FOR MICRONEEDLES

• US 20110276027A1
• Filed: 05/04/2011
• Published: 11/10/2011
• Est. Priority Date: 05/04/2010
• Status: Active Grant

• Current Assignee: Corium Pharma Solutions, Inc.
• Original Assignee: Corium International, Inc.
• Inventors: Singh, Parminder, Trautman, Joseph C., Worsham, Robert Wade, Bourne, Douglas Joseph Scott, Le, Anthony
• Granted Patent: US 9,687,640 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• 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 37/0015 by using microneedles

Abstract

An applicator for a microprojection array is described. In one embodiment, the applicator comprises an energy-storing element. Application of force causes the compressed energy-storing element to extend or transition from first and second configurations, releasing stored energy to deploy a holding member in the application which is configured to hold an array of microprojections. In another embodiment, the applicator comprises an energy storing element with two stable configurations, a first stable configuration and second stable configuration. Application of force causes the energy-storing element to transition from the higher energy first stable configuration to the lower energy second stable configuration, releasing the difference in energies of the two states to deploy a holding member in the application which is configured to hold an array of microprojections.

Claims

1. An applicator for a microprojection array, comprising:

an energy-storing element having a first stable configuration and second stable configuration, wherein application of force to the energy-storing element causes it to transition from the first stable configuration to the second stable configuration, and wherein the force necessary for the energy storing element to transition from the first stable configuration to the second stable configuration is lower than the force necessary for the element to transition from the second stable configuration to the first stable configuration;

an actuating member that can convey external force to the energy-storing element,

a microprojection-holding member connected to the actuating member and which is acted on by the energy-storing element when it transitions from the first stable configuration to the second stable configuration,

an outer cover with an opening into which the actuating member fits slidably, and

a skin-contacting member comprising a portion which can lie flat against skin, wherein the skin-contacting member fits the outer cover and contacts the energy-storing element when it is in its first configuration.

2. The applicator of claim 1, wherein the energy-storing element has an axis of symmetry and n-fold rotational symmetry for some integer n.

3. The applicator of claim 2, wherein the energy-storing element transitions from the first stable configuration to the second stable configuration upon application of force in a direction of the axis of symmetry.

4. The applicator of any claim 2, wherein the value of n is between 3 and 6.

5. The applicator of claim 2, wherein the energy-storing element is of generally frustoconical shape with slots from the top of the frustum, from the bottom of the frustum, or from both.

6. The applicator of claim 1, wherein upon application of force to the actuator member the energy-storing element transitions from its first stable configuration, wherein it is in contact with the skin-contacting member, to its second stable configuration wherein it is in contact with the outer cover.

7. The applicator of claim 1, wherein the outer cover is manufactured from a rigid material.

8. The applicator of claim 1, wherein the actuator member moves within the outer cover between a first position and a second position, wherein in its first position the actuator member extends from an upper surface of the outer cover.

9. The applicator of claim 1, wherein the actuator member moves within the outer cover between a first position and a second position, wherein in its first position the actuator member is recessed within the outer cover.

10. The applicator of claim 1, wherein a microprojection array is attached to the microprojection-holding member, the microprojection array comprises a base, and the level of the microprojection array'"'"'s base is below a skin-contacting surface of the skin-contacting member following actuation of the actuating member.

11. The applicator of claim 1, wherein the energy-storing element is in mechanical coupling relationship with the microprojection-holding member when the energy-storing element is in its first stable configuration.

22. A device comprising an applicator according to claim 1 and a microprojection array comprising an active agent.

23. A method of administering an active agent to a patient in need of that agent, comprising placing a device according to claim 22 on a body surface of a patient, and activating the applicator by contacting the actuator.

24. The method of claim 23, further comprising releasing a safety mechanism prior to said activating.

12. An applicator for a microprojection array, comprising:

(a) a housing having a surface with an elongated opening having platforms on opposite sides of the opening,

(b) an actuation member comprising a surface upon which a microprojection array can be attached, a generally washer-shaped surface on which an energy-storage member can be placed, and a surface capable of mating with the platforms on the opening of the housing and capable of fitting through the opening,

(c) an energy-storage member situated between the actuation member and the housing,

(d) a skin-contacting area which is generally washer-shaped connected to the housing,

wherein when the actuation member is mated with the platforms on the opening, the energy-storage member has a first force of stored energy, and

wherein when the actuation member is moved within the opening so that it no longer mates with the platforms, the energy-storage member releases its stored energy and in so doing moves the actuation member.

13. The applicator of claim 12, wherein the energy-storage member when mated with the platforms on the opening has a first force of stored energy by virtue of its being compressed.

19. An applicator according to claim 12, further comprising a safety mechanism to prevent movement of the actuation member in a direction that deploys the microprojection array.

14. An applicator, comprising:

(a) a housing having a first member with a central opening and a second member having a skin contacting surface,

(b) an actuation member disposed in the central opening and comprising a surface upon which a microprojection array can be attached and a groove extending circumferentially, and

(c) an energy-storage member having an inner edge and an outer edge, and situated within the housing initially in a first stable configuration such that the inner edge is disposed in the groove and its outer edge is in contact with the second member,

wherein application of force to the actuation member moves the energy-storage member from its first stable configuration to a second stable configuration wherein the outer edge is no longer in contact with the second member.

15. The applicator of claim 14, wherein the outer edge of the energy storage member in its second stable configuration is in contact with the first member.

16. The applicator of claim 14, wherein a microprojection array holder engages the actuation member, the engagement of the actuation member and the microprojection array holder defining the groove.

17. The applicator of claim 14, wherein the energy-storage member has an axis of symmetry and n-fold rotational symmetry for some integer n, wherein application of force in a direction of the axis of symmetry causes the energy-storing element to transition from the first stable configuration to the second stable configuration, and wherein the force necessary for the energy storing element to transition from the first stable configuration to the second stable configuration is lower than the force necessary for the element to transition from the second stable configuration to the first stable configuration.

18. The applicator of claim 17, wherein the energy-storing element is of generally frustoconical shape with slots from the top of the frustum, from the bottom of the frustum, or from both.

20. The applicator of claim 17, wherein the safety mechanism comprises a protective cap over the applicator housing.

21. The applicator of claim 17, wherein the safety mechanism comprises a pin movably inserted into the actuation member on an applicator.

25. The method of aim 23, wherein the microprojection array comprises the active agent.