DRUG DELIVERY DEVICE INCLUDING TISSUE SUPPORT STRUCTURE

• US 20110172637A1
• Filed: 01/08/2010
• Published: 07/14/2011
• Est. Priority Date: 01/08/2010
• Status: Abandoned Application

• Current Assignee: FluGen, Inc., Ratio, Inc.
• Original Assignee: FluGen, Inc., Ratio, Inc.
• Inventors: Chase, Kent, Smith, Garrick D.S., Moga, Benjamin J.
• Application Number:
  US12/684,834
• Publication Number:
  US 20110172637A1
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• 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 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure

Abstract

A drug delivery device for delivering a drug to a subject includes a microneedle configured to facilitate delivery of the drug to the subject. The microneedle includes a tip portion and is moveable from an inactive position to an activated position. When the microneedle is moved to the activated position, the tip portion of the microneedle is configured to penetrate the skin of the subject. The drug delivery device includes a tissue support structure that includes a channel and an engagement element. The channel has a first end and a second end and is in axial alignment with the microneedle. At least the tip portion of the microneedle extends past the second end of the channel in the activated position. The engagement element is positioned adjacent to the channel, and the engagement element is configured to engage with the skin of the subject such that the engagement element resists downward deformation of the skin caused by the microneedle as the microneedle moves from the inactive position to the activated position.

Claims

1. A drug delivery device for delivering a drug to a subject, the device comprising:

a microneedle configured to facilitate delivery of the drug to the subject, the microneedle including a tip portion, the microneedle moveable from an inactive position to an activated position, wherein when the microneedle is moved to the activated position, the tip portion of the microneedle is configured to penetrate the skin of the subject; and

a tissue support structure comprising;

a channel having a first end and a second end, the channel in axial alignment with the microneedle, wherein at least the tip portion of the microneedle extends past the second end of the channel in the activated position; and

an engagement element positioned adjacent to the channel, the engagement element configured to engage with the skin of the subject such that the engagement element resists deformation of the skin caused by the microneedle as the microneedle moves from the inactive position to the activated position.

2. The device of claim 1, wherein the engagement element comprises an adhesive material, wherein the adhesive material is configured to form a nonpermanent bond to the skin of the subject, the bond being of sufficient strength to increase membrane stiffness in a portion of the skin located beneath the microneedle, the increased membrane stiffness resulting in a decrease in compliance of the portion of the skin facilitating piercing of the skin by the microneedle.

3. The device of claim 2, wherein the tissue support structure further comprises a tensile wall having an upper surface and a lower surface, wherein the adhesive material is coupled to the lower surface of the rigid wall.

4. The device of claim 3, wherein the adhesive material includes a first hole and the tensile membrane includes a second hole aligned with the first hole, wherein the first and second holes define the channel.

5. The device of claim 2, wherein the adhesive material encircles a shaft of the microneedle in the activated position.

6. The device of claim 1, wherein the channel is a cylindrical channel and further wherein the diameter of the channel at the first end is substantially same as a diameter of a base of the microneedle.

7. The device of claim 1, wherein the channel has a circular cross section and further wherein the diameter of the channel at the first end is greater than the diameter of the channel at the second end.

8. The device of claim 6, wherein the channel is tapered between the first and second ends.

9. The device of claim 1, wherein the microneedle is a hollow microneedle having a central channel extending through the tip portion of the microneedle, and further wherein the drug is a liquid drug to be delivered to the subject through the central channel and through the tip portion of the microneedle to the skin of the subject.

10. The device of claim 1, further comprising:

a second microneedle configured to facilitate delivery of the drug to the subject, the second microneedle including a tip portion, the second microneedle moveable from an inactive position to an activated position, wherein, when the second microneedle is moved to the activated position, the tip portion of the second microneedle is configured to penetrate the skin of the subject;

wherein the tissue support structure includes a second channel having a first end and a second end, the second channel in axial alignment with the microneedle, wherein at least the tip portion of the second microneedle extends past the second end of the second channel in the activated position; and

a second engagement element positioned adjacent to the channel, the second engagement element configured to engage with the skin of the subject such that the second engagement element resists deformation of the skin caused by the second microneedle as the second microneedle moves from the inactive position to the activated position.

11. The device of claim 10, wherein both the engagement element and the second engagement element are adhesive materials configured to form nonpermanent bonds to the skin of the subject, the bond being of sufficient strength to resist the deformation of the skin as the first and second microneedles move from the inactive position to the activated position, and further wherein the adhesive materials of the first and second engagement elements encircle shaft portions of the first and second microneedles in the activated position.

12. A drug delivery device for delivering a liquid drug into the skin of a subject, the device comprising:

a drug reservoir for storing a dose of the liquid drug;

a microneedle component including a hollow microneedle, the hollow microneedle including a tip portion and a central channel extending through the tip portion of the hollow microneedle, the microneedle component moveable from an inactive position to an activated position, wherein when the microneedle component is moved to the activated position, the tip portion of the hollow microneedle is configured to penetrate the skin of the subject;

a drug channel extending from the drug reservoir and coupled to the microneedle component such that the drug reservoir is in fluid communication with the tip portion of the hollow microneedle;

an engagement element positioned adjacent to the hollow microneedle in the activated position, the engagement element configured to adhere to the skin of the subject such that the engagement element exerts reaction forces on the skin in a direction opposite to the direction of movement of the microneedle component from the inactive position to the activated position.

13. The drug delivery device of claim 12, wherein the engagement element comprises an adhesive material, and the adhesive material is configured to form a nonpermanent bond to the skin of the subject, the bond being of sufficient strength to resist deformation of the skin as the hollow microneedle moves from the inactive position to the activated position.

14. The drug delivery device of claim 13, further comprising a tensile membrane having an upper surface and a lower surface, wherein the adhesive material is coupled to the lower surface of the tensile wall.

15. The drug delivery device of claim 14, wherein the adhesive material includes a first hole and the tensile membrane includes a second hole aligned with the first hole, wherein the first and second holes define a channel, the channel having a first end and a second end, the channel in axial alignment with the hollow microneedle, wherein at least the tip portion of the hollow microneedle extends past the second end of the channel in the activated position.

16. The drug delivery device of claim 13, wherein the tensile membrane is a rigid wall, wherein the engagement element exerts reaction forces on the skin perpendicular to the movement of the microneedle component, and further wherein the microneedle component is a microneedle array including a plurality of hollow microneedles.

17. The drug delivery device of claim 16, further comprising a plurality of channels each corresponding to one of the plurality of hollow microneedles, each of the plurality channels having a first end and a second end, each of the plurality of channels in axial alignment with one of the plurality of hollow microneedles, wherein at least the tip portion of each hollow microneedle extends past the second end of the respective channel in the activated position.

18. The drug delivery device of claim 17, wherein the engagement element comprises an adhesive material surrounding each of the plurality of channels.

19. A method of delivering a drug to the skin of a subject, the method comprising:

providing a drug delivery device, the drug delivery device comprising;

a dose of the drug to be delivered;

a microneedle;

an attachment element; and

a tissue support structure including a skin engagement element;

attaching the drug delivery device to the skin of the subject via the attachment element;

attaching the skin engagement element to the skin of the subject;

moving the microneedle from an inactive position to an activated position in which a tip portion of the microneedle pierces the skin of the subject;

increasing membrane stiffness in a portion of the skin located beneath the microneedle, the increased membrane stiffness resulting in a decrease in compliance of the portion of the skin facilitating piercing of the skin by the microneedle; and

delivering the dose of the drug to the subject via the microneedle.

20. The method of claim 19, wherein the drug delivery device further comprises an adhesive layer, the adhesive layer being both the attachment element and the skin engagement element.

21. A drug delivery device for delivering a drug to a subject, the device comprising:

a microneedle component having a body and a microneedle, the microneedle configured to facilitate delivery of the drug to the subject, the microneedle including a tip portion, the microneedle moveable from an inactive position to an activated position, wherein when the microneedle is moved to the activated position, the tip portion of the microneedle is configured to penetrate the skin of the subject;

a housing having a bottom wall; and

a channel defined in the bottom wall, the channel having a first end and a second end, the channel aligned with the microneedle;

wherein at least the tip portion of the microneedle extends past the second end of the channel in the activated position;

wherein at least a portion of the body of the microneedle component bears against a surface of the bottom wall in the activated position.

22. The drug delivery device of claim 21, wherein a lower surface of the portion of the body of the microneedle component bears against an upper surface of the bottom wall.

23. The drug delivery device of claim 22, wherein the bottom wall is positioned between the skin of the subject and the lower surface of the portion of the body of the microneedle component.