Transdermal drug delivery device

• US 10,183,156 B2
• Filed: 02/28/2014
• Issued: 01/22/2019
• Est. Priority Date: 02/28/2013
• Status: Active Grant

• Current Assignee: Sorrento Therapeutics Inc.
• Original Assignee: Sorrento Therapeutics Inc.
• Inventors: Ross, Russell F., Hagan, Luke, Malkin, Alexander, Hatchett, Derek, Marks, Jacob, Lutzow, Thomas
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): Ponton, James D
• Application Number:
  US14/762,844
• Publication Number:
  US 20150367117A1
• Time in Patent Office: 1,789 Days
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/42 having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means

Abstract

A transdermal drug delivery device is disclosed that may comprise a housing including an upper housing portion and a lower housing portion. The lower housing portion may define a bottom surface including skin attachment means for releasably attaching the lower housing portion to skin of a user. The upper housing portion may at least partially surround a central region of the device. The device may also include a microneedle assembly and a reservoir disposed within the central region. The reservoir may be in fluid communication with the microneedle assembly. Additionally, the device may include a pushing element disposed above the microneedle assembly within the central region. The pushing element may be configured to provide a continuous bilateral force having a downward component transmitted through the microneedle assembly and an upward component transmitted through the skin attachment means.

Claims

1. A transdermal drug delivery device comprising:

a housing in hiding an upper housing portion and a lower housing portion, the lower housing portion defining a bottom surface including skin attachment means for releasably attaching the lower housing portion to skin of a user, the upper housing portion at least partially surrounding a central region of the device;

a microneedle assembly disposed within the central region;

a reservoir disposed within the central region, the reservoir being in fluid communication with the microneedle assembly; and

a pushing element disposed above the microneedle assembly within the central region, the pushing element being configured to provide a continuous bilateral force having a downward component transmitted through the microneedle assembly and an upward component transmitted through the skin attachment means,

wherein the microneedle assembly is configured to move independently of the lower housing portion.

2. The transdermal drug delivery device of claim 1, wherein the reservoir is disposed between the microneedle assembly and the pushing element;

the downward component of the continuous bilateral force being transmitted through the reservoir to the microneedle assembly.

3. The transdermal drug delivery device of claim 2, wherein the reservoir is configured as a flexible bladder.

4. The transdermal drug delivery device of claim 3, wherein the downward component of the continuous bilateral force pressurizes a drug formulation contained within the reservoir.

5. The transdermal drug delivery device of claim 2, wherein the reservoir is configured as a rigid member and contains a drug formulation in the form of a fluid.

6. The transdermal drug delivery device of claim 5, wherein the downward component of the continuous bilateral force is transmitted through the microneedle assembly without increasing the pressure of the drug formulation contained within the reservoir.

7. The transdermal drug delivery device of claim 1, wherein an outer region of the device is defined at an interface between the skin attachment means and the bottom surface of the lower housing portion, wherein the central region is defined by a footprint of the microneedle assembly and the pushing element, wherein the downward component of the continuous bilateral force is transmitted through the central region to the microneedle assembly and the upward component of the continuous bilateral force is transmitted through the outer region to the skin attachment means.

8. The transdermal drug delivery device of claim 7, further comprising an intermediate region defined underneath the housing and separating the central and outer regions, wherein neither the downward component nor the upward component of the continuous bilateral force is transmitted through the intermediate region.

9. The transdermal drug delivery device of claim 1, wherein the pushing element comprises a spring compressed between the upper housing portion and the reservoir.

10. The transdermal drug delivery device of claim 9, further comprising a plunger disposed above the reservoir, the spring being compressed between the upper housing portion and the plunger.

11. The transdermal drug delivery device of claim 1, wherein the pushing element comprises an expandable member positioned between the upper housing portion and the reservoir.

12. The transdermal drug delivery device of claim 11, wherein the expandable member comprises an expandable material vacuum sealed within a jacket.

13. A transdermal drug delivers;

device comprising;

an upper housing attached to a lower housing defining a cavity, the lower housing defining a bottom surface including skin attachment means for releasably attaching the lower housing to skin of a user;

the lower housing defining an opening and surrounding a microneedle assembly, the device configured such that the lower housing is dissociated from the microneedle assembly;

a reservoir disposed within the cavity and being in fluid communication with the microneedle assembly; and

a pushing element disposed within the cavity between the microneedle assembly and the upper housing, the pushing element being configured to provide (i) a continuous force having a downward component, dissociated from the upper and lower housings, transmitted via the microneedle assembly towards the skin of a user, (ii) a continuous force having an upward component, dissociated from the microneedle assembly, transmitted to the lower housing.

14. The transdermal drug delivery device of claim 13, wherein the device further includes a rigid member disposed between the upper housing and the pushing element.

15. The transdermal drug delivery device of claim 13, wherein the reservoir comprises a rigid material and is positioned within the cavity between the pushing element and the microneedle assembly.

16. The transdermal drug delivery device of claim 13, wherein the pushing element is actuatable and comprises, prior to actuation, a compressed member.

17. The transdermal drug delivery device of claim 13, further comprising a plunger, wherein a top portion of the plunger extends through an opening defined in the upper housing, the top portion being movable relative to the upper housing, wherein application of a downward force on the top portion transmits a further downwardly force against the microneedle assembly.

18. A method for transdermally delivering a drug formulation, the method comprising:

positioning a transdermal drug delivery device adjacent to skin, wherein the transdermal drug delivery device comprises;

a housing including an upper housing portion and a lower housing portion, the lower housing portion defining a bottom surface including skin attachment means for releasably attaching the lower housing portion to skin of a user, the upper housing portion at least partially surrounding a central region of the device;

a microneedle assembly disposed within the central region, the microneedle assembly being configured to move independently of the lower housing portion;

a reservoir disposed above the microneedle assembly within the central region, the reservoir being in fluid communication with the microneedle assembly; and

a pushing element disposed above the microneedle assembly within the central region; and

attaching the housing to the skin via the skin attachment means;

applying, with the pushing element, a continuous bilateral force through the transdermal drug delivery device having a downward component transmitted through the microneedle assembly and an upward component transmitted through the skin attachment means; and

delivering the drug formulation from through the microneedle assembly and into or through the skin.

19. The method of claim 18, wherein applying the continuous bilateral force comprises applying the continuous bilateral force with a spring compressed between the upper housing portion and the reservoir or applying the continuous bilateral force with an expandable member positioned between the upper housing portion and the reservoir.

20. A transdermal drug delivery device comprising:

a housing including an upper housing portion and a lower housing portion, the lower housing portion defining a bottom surface including skin attachment means for releasably attaching the lower housing portion to skin of a user, the upper housing portion at least partially surrounding a central region of the device;

a microneedle assembly disposed within the central region;

a reservoir disposed within the central region, the reservoir being in fluid communication with the microneedle assembly; and

a pushing element disposed above the microneedle assembly within the central region, the pushing element being configured to provide a continuous bilateral force having a downward component transmitted through the microneedle assembly and an upward component transmitted through the skin attachment means,

wherein the reservoir is disposed between the microneedle assembly and the pushing element, the downward component of the continuous bilateral force being transmitted through the reservoir to the microneedle assembly without increasing the pressure of a drug formulation contained within the reservoir.

21. The transdermal drug delivery device of claim 20, wherein the reservoir is configured as a rigid member and contains the drug formulation in the form of a fluid.

22. A transdermal drug delivery device comprising:

a housing including an upper housing portion and a lower housing portion, the lower housing portion defining a bottom surface including skin attachment means for releasably attaching the lower housing portion to skin of a user, the upper housing portion at least partially surrounding a central region of the device;

a microneedle assembly disposed within the central region;

a reservoir disposed within the central region, the reservoir being in fluid communication with the microneedle assembly; and

a pushing element disposed above the microneedle assembly within the central region, the pushing element being configured to provide a continuous bilateral force having a downward component transmitted through the microneedle assembly and an upward component transmitted through the skin attachment means, the pushing element comprising an expandable member positioned between the upper housing portion and the reservoir, the expandable member comprising an expandable material vacuum sealed within a jacket.