Integrated microneedle array delivery system

• US 10,010,707 B2
• Filed: 10/09/2012
• Issued: 07/03/2018
• Est. Priority Date: 10/12/2011
• Status: Active Grant

• Current Assignee: Kindeva Drug Delivery L.P.
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Colburn, David J., Johnson, Erik J., Brandwein, David H., Gysbers, Jerome E., Young, Patrick J., Cantor, Adam S.
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US14/350,156
• Publication Number:
  US 20140257187A1
• Time in Patent Office: 2,093 Days
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

The present disclosure provides a low-profile system and methods for delivering a microneedle array. The delivery system includes a housing that may be secured to and temporarily worn on a patient'"'"'s skin. A carrier assembly coupled to a microneedle array is received in the housing proximate an applicator device. The carrier assembly is at least releasably secured to the housing and it is typically not attached or otherwise fixed to any portion of the applicator device.

Claims

1. An integrated system for delivering a microneedle array, the system comprising:

a housing having a height of at least 2 mm and no greater than 3.0 cm, a cavity therein, and including an applicator device;

a carrier assembly including a solid microneedle array, wherein a portion of the carrier assembly is attached to the housing proximate the cavity and is in contact with a portion of the applicator; and

wherein neither the carrier assembly nor the array are attached to the applicator device;

a stored energy device comprising one or more bifurcating-springs that are capable of undergoing a shape change as a result of a predetermined force normal to a major plane of the stored energy device, wherein at least a portion of the stored energy device is located within the housing; and

wherein the stored energy device can be actuated to apply force on the carrier assembly;

wherein the applicator device further comprises an actuator; and

wherein the actuator is movable within the housing in a certain direction orthogonal to the major plane of the stored energy device and the actuator comprises a screw received in a series of helical threads in the housing.

2. The integrated system of claim 1, wherein the carrier assembly comprises a flexible membrane.

3. The system of claim 2, wherein the membrane comprises a bellowed height greater than 500 microns and less than 1 cm.

4. The system of claim 3, wherein the membrane will not return to the bellowed height upon transfer of an application energy to the carrier assembly.

5. The system of claim 2, wherein the membrane is non-vented.

6. The system of claim 2, wherein the membrane comprises vents or apertures.

7. The system of claim 2, wherein the membrane comprises a polymeric film.

8. The system of claim 2, wherein the membrane comprises a sterilizable material.

9. The system of claim 1, wherein the height of the cavity is at least 550 microns and no greater than 2.0 cm.

10. An integrated system for delivering a microneedle array, the system comprising:

a housing having a cavity therein and including an applicator device, the applicator device comprising an actuator comprising a screw received in a series of helical threads in the housing;

a carrier assembly including a solid microneedle array, wherein a portion of the carrier assembly is attached to the housing proximate the cavity and is in contact with a portion of the applicator; and

wherein neither the carrier assembly nor the array are attached to the applicator device; and

a stored energy device comprising one or more bifurcating springs that are capable of undergoing a shape change as a result of a predetermined force normal to a major plane of the spring, wherein at least a portion of the stored energy device is located within the housing; and

wherein the stored energy device can be actuated to apply force on the carrier assembly;

wherein the actuator is movable within the housing in a certain direction orthogonal to the major plane of the stored energy device.

11. The integrated system of claim 10, wherein the carrier assembly comprises a flexible membrane.

12. The system of claim 11, wherein the membrane comprises a bellowed height greater than 500 microns and less than 1 cm.

13. The system of claim 12, wherein the membrane will not return to the bellowed height upon transfer of an application energy to the carrier assembly.

14. The system of claim 11, wherein the membrane is non-vented.

15. The system of claim 11, wherein the membrane comprises vents or apertures.

16. The system of claim 11, wherein the membrane comprises a polymeric film.

17. The system of claim 11, wherein the membrane comprises a sterilizable material.

18. The system of claim 10, wherein the actuator is slidably coupled to the housing.

19. The system of claim 10, wherein the height of the cavity is at least 550 microns and no greater than 2.0 cm.

20. The system of claim 10, wherein the height of the housing is at least 2 mm and no greater than 3.0 cm.

21. An integrated system for delivering a microneedle array, the system comprising:

a housing having a cavity therein and including an applicator device comprising an actuator;

a carrier assembly including a solid microneedle array, wherein a portion of the carrier assembly is attached to the housing proximate the cavity and is in contact with a portion of the applicator; and

wherein neither the carrier assembly nor the array are attached to the applicator device; and

a stored energy device comprising one or more bifurcating springs that are capable of undergoing a shape change as a result of a predetermined force normal to a major plane of the spring, wherein at least a portion of the stored energy device is located within the housing; and

wherein the stored energy device can be actuated to apply force on the carrier assembly;

wherein the actuator comprises a cam proximate to a surface of the stored energy device and rotatable to direct energy to the stored energy device.

22. The integrated system of claim 21, wherein the carrier assembly comprises a flexible membrane.

23. The system of claim 22, wherein the membrane comprises a bellowed height greater than 500 microns and less than 1 cm.

24. The system of claim 23, wherein the membrane will not return to the bellowed height upon transfer of an application energy to the carrier assembly.

25. The system of claim 22, wherein the membrane is non-vented.

26. The system of claim 22, wherein the membrane comprises vents or apertures.

27. The system of claim 22, wherein the membrane comprises a polymeric film.

28. The system of claim 22, wherein the membrane comprises a sterilizable material.

29. The system of claim 21, wherein the height of the cavity is at least 550 microns and no greater than 2.0 cm.

30. The system of claim 21, wherein the height of the housing is at least 2 mm and no greater than 3.0 cm.

31. An integrated system for delivering a microneedle array, the system comprising:

a housing having a height of at least 2 mm and no greater than 3.0 cm, a cavity therein, and including an applicator device;

a carrier assembly including a solid microneedle array, wherein a portion of the carrier assembly is attached to the housing proximate the cavity and is in contact with a portion of the applicator; and

wherein neither the carrier assembly nor the array are attached to the applicator device;

a stored energy device comprising one or more bifurcating-springs that are capable of undergoing a shape change as a result of a predetermined force normal to a major plane of the stored energy device, wherein at least a portion of the stored energy device is located within the housing; and

wherein the stored energy device can be actuated to apply force on the carrier assembly; and

wherein the actuator is slidably coupled to the housing and comprises a planar surface and one or more elongated posts, wherein at least one of the posts is received in a recess in the housing, and wherein at least one post is operable to contact the stored energy device when an activation force is applied to the planar surface.

32. The integrated system of claim 31, wherein the carrier assembly comprises a flexible membrane.

33. The system of claim 32, wherein the membrane comprises a bellowed height greater than 500 microns and less than 1 cm.

34. The system of claim 33, wherein the membrane will not return to the bellowed height upon transfer of an application energy to the carrier assembly.

35. The system of claim 32, wherein the membrane is non-vented.

36. The system of claim 32, wherein the membrane comprises vents or apertures.

37. The system of claim 32, wherein the membrane comprises a polymeric film.

38. The system of claim 32, wherein the membrane comprises a sterilizable material.

39. The system of claim 31, wherein the applicator device further comprises an actuator.

40. The system of claim 31, wherein the height of the cavity is at least 550microns and no greater than 2.0 cm.