Applicators for microneedles

• US 8,821,446 B2
• Filed: 01/22/2008
• Issued: 09/02/2014
• Est. Priority Date: 01/22/2007
• Status: Active Grant

• Current Assignee: Corium Pharma Solutions, Inc.
• Original Assignee: Corium International, Inc.
• Inventors: Trautman, Joseph C., Worsham, Robert Wade, Bayramov, Danir F., Bowers, Danny Lee, Klemm, Steven Richard, Singh, Parminder
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US12/009,954
• Publication Number:
  US 20080183144A1
• Time in Patent Office: 2,415 Days
• Field of Search: 604/22, 604/46, 604/47, 604/115, 604/117, 604/173, 604/180, 604/264, 604/272, 604/298, 604/304, 604/307, 604/890.1, 604/305, 604/306
• US Class Current: 604/173
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

A microneedle applicator is provided which has two roughly concentric portions which may be, for example, a solid disk and an annulus surrounding it. On the skin-facing side of the inner portion of the applicator a microneedle array is located. The outer portion of the applicator is placed against the skin, contacting it at a zone. The microneedle array is then pressed towards the skin.

Claims

1. An applicator for a microprojection array, comprising:

an inner portion and an outer portion that is concentric to and integral with the inner portion;

a contact zone on the outer portion for contacting skin at an application site;

a region on the inner portion to which a microprojection array can be attached;

wherein upon application of force to the inner portion, the applicator is deformable from a first configuration to a second configuration in which the applicator stably remains until a further force is applied to the applicator,

wherein the microprojection array contacts the application site when the applicator is in the second configuration; and

wherein the applicator, when placed adjacent skin at the application site in its first configuration, has a shape such that the outer portion slopes towards the skin such that the contact zone is capable of contacting the skin, and the applicator has a shape in its second configuration wherein the outer portion extends away from the skin such that the contact zone is no longer in skin contact.

2. The applicator of claim 1, wherein at least a portion of the contact zone is coated with adhesive.

3. The applicator of claim 1, wherein the inner and outer portions meet at a closed curve.

4. The applicator of claim 3, wherein the curve at which the inner and outer portions meet is approximately circular.

5. The applicator of claim 1, wherein the applicator deforms between the first and second configurations with manual pressure.

6. The applicator of claim 5, wherein the applicator can be deformed between the first and second configurations at least 10 times without damage to the applicator.

7. The applicator of claim 1, wherein the applicator is deformable between the first and second configurations at least 2 times without damage to the applicator.

8. The applicator of claim 1, wherein the inner portion or the outer portion or both comprise a polymer selected from the group consisting of polyethylene terephthalate, glycol-modified polyethylene terephthalate, high-impact polystyrene, polycarbonate, polyvinylchloride, polyurethane, polyethylene, polypropylene, silicone rubber, polymethyl methacrylate, polyvinyl alcohol, acrylonitrile-butadiene-styrene, ethylene vinyl acetate, phenylene oxide, polysulfones, and natural rubber.

9. The applicator of claim 1, wherein the inner portion or the outer portion or both comprise a metal.

10. The applicator of claim 1, further comprising a further structure capable of mating with or attaching to the inner portion, wherein pressure in a direction approximately perpendicular to the inner portion which is applied to the further structure is spread more uniformly to the inner and outer portions of the applicator than pressure applied directly to the inner portion.

11. The applicator of claim 10, wherein the further structure has approximately the shape of the inner and outer portions in the first stable configuration.

12. The applicator of claim 10, wherein as the applicator approaches the second stable configuration, the outer portion of the applicator presses against the further structure and is held in position by the further structure.

13. The applicator of claim 1, wherein the inner portion of the applicator is approximately flat and the outer portion is approximately frustoconical.

14. The applicator of claim 1, wherein the inner portion has a shape which projects towards the skin when the applicator is used.

15. The applicator of claim 1, wherein the portion of the applicator not including the microprojections is symmetric under rotation about an axis which is approximately parallel to a microprojection.

16. The applicator of claim 1, wherein the outer perimeter of the contact zone does not significantly expand when the applicator shifts between the first and second stable configurations.

17. A method for testing for a condition in a patient, comprising:

(a) applying a microprojection array to the skin of the patient employing an applicator as described in claim 1,

(b) collecting biological fluid using microchannels created in the skin by the microprojection array, and

(c) detecting the presence of one or more biomarkers in the collected biological fluid.

18. A method for administering an active agent, comprising:

(a) applying a microprojection array to the skin of the patient employing an applicator as described in claim 1, and

(b) causing the active agent to pass through skin using microchannels created in the skin by the microprojection array.

19. The method of claim 18, wherein the microprojection array is used for one of bolus, sustained, pulsatile, or continuous drug delivery.

20. The method of claim 18, wherein the microprojection array is used for one of acute, intermittent, or chronic drug delivery.

21. The method of claim 18, wherein the active agent has a molecular weight exceeding 500 Daltons.

22. The method of claim 21, wherein the active agent has a molecular weight exceeding 1000 Daltons.

23. The method of claim 18, further comprising the step of applying an adhesive to skin and then contacting the applicator to the adhesive applied to skin.

24. The method of claim 18, wherein an adhesive is applied to the outer portion of the applicator prior to applying the microprojection array to the skin.

25. An applicator for a microprojection array, comprising:

an inner and outer portion wherein

(a) the inner portion comprises a region for attaching a microprojection array,

(b) the outer portion comprises a contact zone designed for contacting skin at an application site, and

(c) the relative positions of the inner and outer portions can be varied by application of force to the inner portion between a first stable configuration and a second configuration in which (i) the applicator remains until a further force is applied to return it to the first stable configuration, and (ii) the outer portion in the second stable configuration is inverted about the contact zone with respect to the first stable configuration, such that the outer portion and the contact zone extend at an angle away from the skin at the application site;

wherein the microprojection array contacts the application site when the applicator is in the second configuration.

26. The applicator of claim 25, wherein the applicator comprises a laminate at least one of whose components contributes energy to the transition of the applicator to the second configuration.

27. The applicator of claim 25, wherein the inner portion comprises an inner contact zone, further comprising an adhesive on the inner contact zone.

28. An applicator for a microprojection array comprising an inner and outer portion wherein

(a) the microprojection array attaches to or is integral with the inner portion,

(b) the outer portion has a contact zone designed for contacting skin at an application site,

(c) the inner and outer portions are integral with each other, and

(d) the relative positions of the inner and outer portions may be varied between a first and a second configuration, wherein the outer portion in the second stable configuration is inverted about the contact zone with respect to the first stable configuration in the absence of an adhesive, such that the outer portion and the contact zone extend at an angle away from the skin at the application site.