Transdermal drug delivery device, method of making same and method of using same

• US 7,141,034 B2
• Filed: 03/11/2003
• Issued: 11/28/2006
• Est. Priority Date: 06/08/2000
• Status: Expired due to Term

• Current Assignee: Smart Technologies Incorporated (Hon Hai Precision Industry Co., Ltd.), MidCap Funding III, LLC, ​Passport Technologies, Inc.
• Original Assignee: Altea Therapeutics Corporation (Nitto Denko Corporation)
• Inventors: Papp, Joseph, McRae, Stuart, Eppstein, Jonathan
• Primary Examiner(s): Rodriguez, Cris L.
• Assistant Examiner(s): Han, Mark K
• Application Number:
  US10/384,795
• Publication Number:
  US 20040039343A1
• Time in Patent Office: 1,358 Days
• Field of Search: 604/19, 604/20, 604/21, 604/22, 604/27, 604/28, 604/46, 604/48, 604/289, 604/290, 600/309, 600/310, 600/316, 600/345, 600/365, 600/372, 600/373, 600/377, 600/378, 600/381, 600/573, 600/583, 606/9, 606/32, 606/41, 606/42, 606/43, 606/44, 606/45, 606/48, 606/131, 607/2, 607/96, 607/98, 607/99, 607/100, 607/103, 607/104, 607/108
• US Class Current: 604/22
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2210/04 Skin
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61N 1/0424 Shape of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation

Abstract

A transdermal drug delivery device for forming a micropore in a tissue membrane of an animal comprising a substrate and a porator that is located on or within the substrate. The porator is constructed of a material that is destroyed upon forming the micropore. The transdermal drug delivery device also comprises at least one reservoir and a controller for controlling the formation of said micropore by the porator and destroying the porator after the formation of the micropore.

Claims

1. A transderrnal drug delivery device for forming a micropore in a tissue membrane of an animal, comprising:

a) a tissue interface layer comprising;

i) a substrate; and

ii) at least one porator, wherein said porator is located on or within said substrate and said porator is constructed of a material in which said porator is destroyed upon forming said micropore;

b) at least one reservoir in communication with said tissue interface layer; and

c) a controller for controlling the formation of said micropore by said at least one porator, wherein the controller is configured to destroy said porator substantially following the formation of said micropore.

2. The transdermal drug delivery device according to claim 1, further comprising a permeant composition stored within said reservoir.

3. The transdermal drug delivery device according to claim 2, wherein said permeant composition is a drug or therapeutically active ingredient.

4. The transdermal drug delivery device according to claim 1, wherein said reservoir contains an analyte obtained from said animal by way of said micropore.

5. The transdermal drug delivery device according to claim 1, wherein said substrate is selected from the group consisting of a woven material, a film, a supporting layer and a sheet.

6. The transdermal drug delivery device according to claim 1, wherein said porator is selected from the group consisting of a wire conductor, a deposited conductive material, a machined conductive material, a laser cut conductive material, an adhesive foil, an electroplated material, a screen-printed material and an etched conductive material.

7. The transdermal drug delivery device according to claim 1, wherein said controller applies a stimulus to said porator, said stimulus initiating formation of said pore by said porator and then destroying said porator following formation of said micropore.

8. The transdermal drug delivery device according to claim 7, wherein said stimulus is a thermal pulse.

9. The transdermal drug delivery device according to claim 7, wherein said stimulus is an electrical pulse.

10. The transdermal drug delivery device according to claim 1, wherein said substrate is constructed of a material which undergoes thermal shrinking when exposed to an elevated temperature due to activation of said porator, whereby said thermal shrinking results in a tear in said substrate and destruction of said porator.

11. The transdermal drug delivery device according to claim 10, wherein said material is a heat-shrinkable polymer.

12. The transdermal drug delivery device according to claim 11, wherein said heat-shrinkable polymer is a polyvinyl.

13. The transdermal drug delivery device according to claim 10, wherein said substrate is formed with a flaw from which said tear would form.

14. The transdermal drug delivery device according to claim 10, wherein said tear forms said communication between said reservoir and said tissue interface layer.

15. The transdermal drug delivery device according to claim 1, wherein said substrate further comprises an adhesive layer to bond said poration device to said biological membrane.

16. A method of forming at least one micropore in a tissue membrane of an animal composing:

a) providing a poration device, said poration device including;

i) a tissue interface layer comprising;

A) a substrate; and

B) at least one porator, wherein said porator is located on or within said substrate and said porator is constructed of a material in which said porator is destroyed upon forming said micropore;

ii) at least one reservoir in communication with said tissue interface layer; and

iii) a controller for controlling the formation of said micropore by said at least one porator;

b) contacting said poration device with said tissue membrane;

c) providing a thermal or electrical pulse to said at least one porator by way of said controller, thereby forming said at least one micropore in said tissue membrane; and

d) destroying said at least one porator after forming said at least one micropore by sustaining said thermal or electrical pulse for a duration sufficient to destroy said at least one porator.

17. The method according to claim 16, further comprising the step of applying a permeant composition to said at least one micropore, said permeant composition being stored in said reservoir.

18. The method according to claim 17, wherein said permeant composition is a drug or therapeutically active ingredient.

19. The method according to claim 16, wherein said reservoir contains an analyte obtained from said animal by way of said micropore.

20. The method according to claim 16, wherein said substrate is selected from the group consisting of a woven material, a film, a supporting layer and a sheet.

21. The method according to claim 16, wherein said porator is selected from the group consisting of a wire conductor, a deposited conductive material, a machined conductive material, a laser cut conductive material, an adhesive foil, an electroplated material, a screen-printed material and an etched conductive material.

22. The method according to claim 16, wherein said substrate is constructed of a material which undergoes thermal shrinking when exposed to an elevated temperature due to activation of said at least one porator, whereby said thermal shrinking results in tearing said substrate and destruction of said porator.

23. The method according to claim 22, wherein said material is a heat-shrinkable polymer.

24. The method according to claim 23, wherein said heat-shrinkable polymer is a polyvinyl.

25. The method according to claim 22, wherein said substrate is formed with a flaw from which said tear would form.

26. The method according to claim 22, wherein said tear forms said communication between said reservoir and said tissue interface layer.