Applicator and method for applying a microneedle device to skin

• US 10,300,260 B2
• Filed: 10/10/2013
• Issued: 05/28/2019
• Est. Priority Date: 10/10/2012
• Status: Active Grant

• Current Assignee: Kindeva Drug Delivery L.P.
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Wirtanen, David J., Puckett, Kevin L., Schug, James L.
• Primary Examiner(s): Osinski, Bradley J
• Assistant Examiner(s): Shah, Nilay J
• Application Number:
  US14/432,500
• Publication Number:
  US 20150290444A1
• Time in Patent Office: 2,056 Days
• 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 2037/0046 Solid microneedles
• 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

Abstract

An applicator and method for applying a microneedle device to skin. The applicator can include a microneedle device and a housing configured to house the microneedle device. The housing can have a first surface configured to be positioned toward the skin. The applicator can include (i) an unactuated state in which the microneedle device is located within the housing and does not extend beyond the first surface of the housing, and (ii) an actuated state in which at least a portion of the microneedle device extends beyond the first surface of the housing. The applicator can further include a locking mechanism configured to lock the applicator in the actuated state. The method can include positioning the first surface of the housing of the applicator adjacent the skin; actuating the applicator to cause the applicator to change to the actuated state; and locking the applicator in the actuated state.

Claims

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

a housing having a first surface configured to be positioned toward the skin surface, the housing comprising a bore that extends through the first surface;

a deformable sheet positioned to extend across the bore of the housing, spaced a distance from the first surface of the housing, the deformable sheet having a first side oriented toward the first surface of the housing and a second side opposite the first side;

a microneedle device coupled to the first side of the deformable sheet, such that the microneedle device is oriented toward the first surface of the housing;

a plunger dimensioned to be at least partially received in the bore of the housing adjacent the second side of the deformable sheet and located opposite the deformable sheet from the microneedle device, the plunger being movable relative to the housing between a first position and a second position to move the microneedle device, respectively, between

a first position of the plunger in which the microneedle device is recessed relative to the first surface of the housing, and

a second position of the plunger in which at least a portion of the microneedle device extends beyond the first surface of the housing and towards the skin surface; and

a locking mechanism configured to lock the microneedle device in the second position, wherein;

the first position of the plunger is a first unlocked position in which the locking mechanism is not activated,

the second position of the plunger is a second locked position in which the locking mechanism is activated when the plunger is moved into the second locked position, and

the plunger is further movable to a third unlocked position of the plunger located intermediately of the first position of the plunger and the second position of the plunger in which at least a portion of the microneedle device extends beyond the first surface of the housing but in which the locking mechanism is not activated.

2. The applicator of claim 1, wherein the plunger and the microneedle device are coupled together when the plunger is in the first position of the plunger and the microneedle device is in the second position, and are also coupled together when the plunger is in the second position of the plunger and the microneedle device is in the second position.

3. The applicator of claim 1, wherein the housing comprises a first portion and a second portion that each define a portion of the bore, and wherein the deformable sheet is coupled between the first portion and the second portion to extend across the bore.

4. The applicator of claim 3, wherein the bore includes a first portion defined by the first portion of the housing and a second portion defined by the second portion of the housing, wherein the plunger resides in the first portion of the bore when the plunger is in the first position, and wherein at least a portion of the plunger resides in the second portion of the bore when the plunger is in the second position.

5. The applicator of claim 1, wherein the plunger is configured to be moved between the first position of the plunger and the second position of the plunger with manual pressure.

6. The applicator of claim 1, wherein the locking mechanism is activated when a threshold force has been overcome, and wherein a force necessary to move the plunger to the third unlocked position is not sufficient to exceed the threshold force and activate the locking mechanism.

7. The applicator of claim 6, wherein a force necessary to move the plunger to the second locked position is sufficient to activate the locking mechanism.

8. The applicator of claim 1, wherein the locking mechanism is activated when the plunger is moved into the second position.

9. The applicator of claim 1, wherein the deformable sheet has a first state and a second state, wherein the deformable sheet is in the first state when the plunger is in the first position of the plunger, and wherein the deformable sheet is in the second state when the plunger is in the second position of the plunger.

10. The applicator of claim 1, wherein the deformable sheet is formed of a nonwoven polyurethane.

11. The applicator of claim 1, wherein the locking mechanism is configured to reversibly lock the applicator in an actuated state.

12. The applicator of claim 1, wherein the locking mechanism includes at least one of a snap-fit-type engagement, a detent, a twist lock, or a combination thereof.

13. The applicator of claim 1, wherein the microneedle device includes solid microneedles.

14. The applicator of claim 1, wherein the locking mechanism is irreversible.

15. The applicator of claim 1, wherein the first surface of the housing includes a skin-contact adhesive.

16. An applicator for applying a microneedle device to a skin surface, the applicator comprising:

a housing having a first surface configured to be positioned toward the skin surface, the housing comprising a bore that extends through the first surface;

a deformable sheet positioned to extend across the bore of the housing, spaced a distance from the first surface of the housing, the deformable sheet having a first side oriented toward the first surface of the housing and a second side opposite the first side;

a microneedle device coupled to the first side of the deformable sheet, such that the microneedle device is oriented toward the first surface of the housing;

a plunger dimensioned to be at least partially received in the bore of the housing adjacent the second side of the deformable sheet and located opposite the deformable sheet from the microneedle device, the plunger being movable relative to the housing between a first position and a second position to move the microneedle device, respectively, between

a first position of the plunger in which the microneedle device is recessed relative to the first surface of the housing, and

a second position of the plunger in which at least a portion of the microneedle device extends beyond the first surface of the housing and towards the skin surface; and

a locking mechanism configured to lock the microneedle device in the second position,

wherein the deformable sheet is formed of a nonwoven polyurethane.

17. The applicator of claim 16, wherein the plunger and the microneedle device are coupled together when the plunger is in the first position of the plunger and the microneedle device is in the second position, and are also coupled together when the plunger is in the second position of the plunger and the microneedle device is in the second position.

18. The applicator of claim 16, wherein the housing comprises a first portion and a second portion that each define a portion of the bore, and wherein the deformable sheet is coupled between the first portion and the second portion to extend across the bore.

19. The applicator of claim 16, wherein the locking mechanism is activated when the plunger is moved into the second position.