Transdermal integrated actuator device, methods of making and using same

• US 8,517,958 B2
• Filed: 11/12/2010
• Issued: 08/27/2013
• Est. Priority Date: 06/08/1999
• Status: Expired due to Fees

• Current Assignee: ​Passport Technologies, Inc.
• Original Assignee: Nitto Denko Corporation
• Inventors: Eppstein, Jonathan, McRae, Stuart
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Anderson, Michael J
• Application Number:
  US12/944,792
• Publication Number:
  US 20110245728A1
• Time in Patent Office: 1,019 Days
• Field of Search: 604/19, 604/20, 604/22, 604/46, 604/47, 604/48, 606/20, 606/45, 600/575
• US Class Current: 600/575
• 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

The invention provides for an integrated device for forming a cavity in a surface of a tissue of an animal comprising:

• • a) a controller board connected to an energy source for actuating at least one porator;
  • b) a fluid reservoir in fluid communication with the tissue; and
  • c) a tissue interface layer, the tissue interface layer containing the at least one porator, the porator in contact with the tissue for forming the cavity.

The invention also provides for methods of making and methods of using the same.

Claims

1. An integrated device for forming one or more micropores in a surface of a tissue of an animal comprising:

a) a controller board connected to an energy source for actuating at least one probe element;

b) a patch; and

c) a tissue interface layer, said tissue interface layer containing at least one probe element, wherein each at least one probe element is a non-invasive heated resistive element that conductively delivers thermal energy to cause ablation of the tissue to a desired depth, thereby forming one or more micropores.

2. The integrated device according to claim 1, wherein said tissue interface layer comprises:

a) a substrate, said at least one probe element being located on or within said substrate; and

b) an adhesive layer for attaching said integrated poration device to said tissue.

3. The integrated device according to claim 2, wherein said substrate is selected from the group consisting of a woven material, a film, a supporting layer and a sheet.

4. The integrated device according to claim 1, wherein said at least one probe element comprises an array of probe elements.

5. The integrated device according to claim 1, further comprising a first control button for initiating poration of said membrane.

6. The integrated device according to claim 5, further comprising a second control button for initiating delivery of a permeant composition to said membrane or extraction of an analyte from said membrane.

14. The integrated device of claim 1, further comprising an outer body, wherein the outer body defines a top of the integrated poration device and wherein the outer body contains a cavity.

15. The integrated device of claim 14, wherein the controller board is positioned within the cavity.

16. The integrated device of claim 1, wherein said at least one probe element is in contact with said tissue for forming said one or more micropores.

7. A poration system comprising:

a) a porator comprising at least one probe element, wherein each at least one probe element is a non-invasive heated resistive element that is configured to conductively deliver thermal energy to cause ablation of a tissue membrane to a desired depth for the formation of a micropore;

b) a body defining a cavity;

c) a controller board comprising an energy source, said controller board being positioned within said cavity; and

d) an interface connection port for selectively receiving said porator.

8. The poration system according to claim 7, further comprising a patch, said patch being applied to said microporated area of said tissue membrane after poration.

9. The poration system according to claim 7, wherein said porator comprises:

a) a top surface, wherein a portion of the top surface contacts an anode and a cathode when the porator is in contact with the interface connection port; and

b) a bottom surface.

10. The poration system according to claim 8, wherein said patch is in proper registration over said microporated area of said tissue.

11. The poration system according to claim 7, a probe element of the at least one probe element is destroyed upon forming the micropore.

12. The poration system according to claim 7, wherein said porator is removably attached to said interface connection port.

13. The poration system according to claim 7, further comprising a control button for initiating poration of said tissue membrane.