Transdermal integrated actuator device, methods of making and using same

• US 8,706,210 B2
• Filed: 01/27/2009
• Issued: 04/22/2014
• Est. Priority Date: 03/11/2002
• Status: Expired due to Term

• Current Assignee: ​Passport Technologies, Inc.
• Original Assignee: Nitto Denko Corporation
• Inventors: Eppstein, Jonathan, McRae, Stuart
• Primary Examiner(s): Schmidt, Emily
• Assistant Examiner(s): Anderson, Michael J
• Application Number:
  US12/360,698
• Publication Number:
  US 20090264810A1
• Time in Patent Office: 1,911 Days
• Field of Search: 604/19, 604 20- 27, 604/200
• US Class Current: 604/20
• 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 a device for delivering a drug comprising:

• • a. forming one or more micropores in a tissue membrane; and
  • b. applying a patch containing a drug to the one or more micropores formed in the tissue membrane

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

Claims

1. A device comprising:

(a) a poration device comprising

(i) an outer body defining a top of said poration device, said outer body containing a cavity;

(ii) a controller board comprising driving electronics and a battery, said controller board being positioned within said cavity; and

(iii) a tissue interface layer for contacting a tissue membrane of an animal, said tissue interface layer containing at least one probe element, each at least one probe element comprising a heated resistive element configured to conductively deliver thermal energy to cause ablation of said tissue membrane to a desired depth for formation of at least one micropore in said tissue membrane;

(b) a patch comprising a drug, said patch applied to a microporated area of said tissue membrane after poration; and

(c) an extension tab comprising a perforated tear line and releasably connected to a periphery of said tissue interface layer and a periphery of said patch.

2. The integrated poration and patch device according to claim 1, wherein the patch is a permeable solid structure.

3. The integrated poration and patch device according to claim 2, wherein the permeable solid structure is a porous polymer.

4. The integrated poration and patch device according to claim 1, wherein said tissue interface layer comprises a material selected from the group of a woven material, a film, a supporting layer, and a sheet.

5. The integrated poration and patch device according to claim 1, wherein said at least one probe element comprises a plurality of probe elements.

6. The integrated poration and patch device according to claim 4, wherein the plurality of probe elements form an array.

7. The integrated poration and patch device according to claim 1, wherein said tissue interface layer is removably attached to said outer body.

8. The integrated poration device and patch according to claim 1, further comprising a control button for initiating poration of said tissue membrane.

9. The integrated poration device system according to claim 1, wherein said tissue interface layer further comprises an adhesive layer for attachment of said poration device to said tissue membrane.

10. A system for selective formation of a plurality of micropores within a tissue membrane, comprising:

(a) an outer body defining a cavity;

(b) a controller board comprising driving electronics, said controller board being positioned within said cavity;

(c) a thin film configured for contacting the tissue membrane, the thin film comprising a plurality of probe elements configured for selective formation of the plurality of micropores, each probe element of the plurality of probe elements comprising a heated resistive element configured to conductively deliver thermal energy to cause ablation of the tissue membrane to a desired depth for formation of at least one micropore in the tissue membrane, said thin film being in select electrical communication with the controller board;

(d) a patch comprising a drug, said patch applied to the plurality of micropores in the tissue membrane after poration; and

(e) an extension tab comprising a perforated tear line and releasably connected to a periphery of said thin film and a periphery of said patch.

11. The poration and patch system according to claim 10, wherein the patch is a permeable solid structure.

12. The poration and patch system according to claim 11, wherein the permeable solid structure is a porous polymer.

13. The poration and patch system according to claim 10, wherein the plurality of probe elements form an array.

14. The poration and patch system according to claim 10, wherein the thin film is removably attached to said outer body.

15. The poration and patch system according to claim 10, further comprising a control button for initiating poration of the tissue membrane.

16. The poration and patch system according to claim 10, further comprising:

a tissue interface layer; and

an adhesive layer for selectively releasable attachment of the tissue interface layer to the tissue membrane, wherein the thin film is positioned within the tissue interface layer.