Microneedle injection apparatus comprising a dual cover

• US 10,391,290 B2
• Filed: 01/10/2018
• Issued: 08/27/2019
• Est. Priority Date: 05/31/2013
• Status: Active Grant

• Current Assignee: Kindeva Drug Delivery L.P.
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Burton, Scott A., Ng, Chin-Yee, Mathias, Richard R., Ford, Thomas D. R.
• Primary Examiner(s): Bouchelle, Laura A
• Assistant Examiner(s): Ulsh, Dung T
• Application Number:
  US15/866,526
• Publication Number:
  US 20180140816A1
• Time in Patent Office: 594 Days
• CPC Class Codes: A61M 2005/2414 from the side
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/322 Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston devices for protecting guide needles in combination with catheters A61M25/0612

Abstract

A microneedle injection apparatus comprising a dual cover. The apparatus can include a housing having a base and a cavity; a microneedle array comprising a first side comprising a plurality of microneedles; and a microneedle array holder configured to hold a microneedle array and located in the housing. The microneedle array holder can be movable between a retracted position, and an extended position. The apparatus can further include a cover configured to be positioned to cover the opening in the base of the housing. The cover can include (i) a first portion configured to cover at least a portion of the base of the housing adjacent the opening, and (ii) a second portion configured to be received in the cavity of the housing and further configured to cover the plurality of microneedles on the microneedle array when the microneedle array holder is in the retracted position.

Claims

1. A method of actuating a microneedle injection apparatus, the microneedle injection apparatus comprising:

a housing having a base and a cavity that extends through the base to define an opening in the base, wherein the base of the housing is configured to be positioned toward a skin surface;

a microneedle array comprising a first side comprising a plurality of microneedles;

a microneedle array holder configured to hold a microneedle array and located in the housing, the microneedle array holder movable with respect to the opening in the base of the housing between

a retracted position in which the microneedle array is recessed within the housing such that the microneedle array does not contact the skin surface when the apparatus is positioned on the skin surface and the microneedle array is coupled to the microneedle array holder, and

an extended position in which at least a portion of the microneedle array is positioned to contact the skin surface via the opening when the apparatus is positioned on the skin surface and the microneedle array is coupled to the microneedle array holder;

a

a cover configured to be positioned to cover the opening in the base of the housing, the cover including

a first portion configured to cover at least a portion of the base of the housing adjacent the opening, and

a second portion configured to be received in the cavity of the housing and further configured to cover the plurality of microneedles on the microneedle array when the microneedle array holder is in the retracted position; and

wherein the microneedle applicator further includes an actuator movable with respect to the housing between a first position and a second position to cause the microneedle array holder to move from the retracted position to the extended position, wherein, at least when the actuator is in the first position, at least a portion of the actuator protrudes from the opening in the base of the housing and defines a base configured to be coupled to the skin surface, and wherein the cover is configured to cover at least the base of the actuator, wherein the cover is removable from the remainder of the apparatus, and wherein when the cover is coupled to the apparatus, the cover is positioned to prevent the actuator from being moved to its second position;

the method comprising actuating the actuator to move the actuator from the first position to the second position and to move the microneedle array holder from the retracted position to the extended position.

2. The method of claim 1, wherein the cover is configured to be coupled to the housing.

3. The method of claim 1, wherein at least a portion of the base of the housing adjacent the opening includes a skin-contact adhesive, and wherein the cover is configured to cover at least the portion of the base including the skin-contact adhesive.

4. The method of claim 1, wherein at least a portion the base of the housing adjacent the opening includes a skin-contact adhesive and further comprising a release liner coupled to the skin-contact adhesive on the base of the housing, the cover configured to cover at least the portion of the base of the housing including the release liner.

5. The method of claim 1, wherein the second portion of the cover is configured to extend through the opening in the base of the housing and into the cavity of the housing.

6. The method of claim 1, wherein the first portion of the cover includes a recess dimensioned to receive at least a portion of the base of the housing.

7. The method of claim 1, wherein the second portion of the cover includes a recess dimensioned to receive the plurality of microneedles protruding from a first surface on the first side of the microneedle array.

8. The method of claim 1, wherein the recess in the second portion of the cover is defined by an inner surface, and wherein the inner surface of the cover and the first side of the microneedle array together define a chamber for housing the plurality of microneedles prior to use.

9. The method of claim 8, wherein the chamber is a sterile chamber.

10. The method of claim 1, wherein the second portion of the cover includes a microneedle-facing recess, and wherein the first side of the microneedle array includes a cover-facing recess, and further comprising a sealing member dimensioned to be received in the microneedle-facing recess and the cover-facing recess.

11. The method of claim 10, wherein the sealing member configured to be coupled to at least one of the microneedle array and the microneedle array holder to define a chamber for housing the plurality of microneedles prior to use.

12. The method of claim 1, wherein the first portion of the cover is configured to protect at least the portion of the base of the housing configured to be coupled to the skin surface.

13. The method of claim 1, wherein the second portion of the cover is configured to be coupled to at least one of the microneedle array and the microneedle array holder.

14. The method of claim 1, wherein the housing includes a protrusion that defines the base of the housing, and wherein the first portion of the cover includes a recess dimensioned to receive the protrusion of the housing.

15. The method of claim 1, wherein at least one of the plurality of microneedles comprises an active agent.

16. The method of claim 15, wherein the at least one of the plurality of microneedles comprises a lumen and the active agent is disposed in the lumen.

17. The method of claim 15, wherein the method comprises placing a portion of the apparatus adjacent to the skin prior to actuating the actuator.

18. The method of claim 17, wherein movement of the microneedle array holder from the retracted position to the extended position causes at least one of the plurality of microneedles to pierce the skin.

19. The method of claim 3, wherein a drug reservoir is present with the skin-contact adhesive.

20. The method of claim 4, wherein a drug reservoir is present with the skin-contact adhesive.