Transdermal Integrated Actuator Device, Methods of Making and Using Same

• US 20090264810A1
• Filed: 01/27/2009
• Published: 10/22/2009
• Est. Priority Date: 03/11/2002
• Status: Active Grant

• Current Assignee: ​Passport Technologies, Inc.
• Original Assignee: Nitto Denko Corporation
• Inventors: Eppstein, Jonathan A., McRae, Stuart
• Granted Patent: US 8,706,210 B2
• Time in Patent Office: Days
• 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 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. A method for delivering a drug to a patient comprising the steps of:

a. forming one or more micropores in a tissue membrane of said patient with a poration device, the 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 the patient, said tissue interface layer containing at least one probe element, wherein each at least one probe element is a heated resistive element configured to conductively deliver thermal energy to cause ablation of the tissue to a desired depth for formation of the micropore, and wherein said tissue interface layer forms a portion of the bottom of said poration device;

b. removing the poration device; and

c. applying a patch comprising a drug to a microporated area of the tissue membrane after poration.

2. The method of claim 1, wherein the patch further comprises a top layer, a middle layer containing a drug or other permeant composition to be applied to the membrane, and a bottom layer, wherein the bottom layer further comprises an adhesive for attachment of said patch to the microporated area of the tissue membrane.

3. The method of claim 1, wherein the patch is a permeable solid structure.

4. The method of claim 3, wherein the permeable solid structure is a porous polymer.

5. The method according to claim 1 wherein said tissue interface layer comprises a material selected from the group consisting of:

a woven material, a film, a supporting layer and a sheet.

6. The method according to claim 1 wherein said tissue interface layer comprises a plurality of probe elements.

7. The method according to claim 6 wherein the plurality of probe elements forms an array.

8. The method according to claim 1 wherein said tissue interface layer is removably attached to said outer body.

9. The method according to claim 1 further comprising a control button for initiating activation of said poration device.

10. A transdermal drug delivery patch system for delivering a drug across a tissue membrane comprising:

a. an actuator;

b. a porator removably connected to said actuator, said porator comprising at least one microporator which is actuated by said actuator and forms at least one micropore in said tissue membrane;

wherein each at least one microporator is a heated resistive element configured to conductively deliver thermal energy to cause ablation of the tissue membrane to a desired depth for formation of a cavity in the tissue membrane; and

c. a patch comprising a drug, said patch being applied to a microporated area of said tissue membrane after poration.

11. The transdermal drug delivery patch system according to claim 10, wherein the patch is a permeable solid structure.

12. The transdermal drug delivery patch system according to claim 11, wherein the permeable solid structure is a porous polymer.

13. The transdermal drug delivery patch system according to claim 10 further comprising a tissue interface layer that comprises a material selected from the group consisting of:

a woven material, a film, a supporting layer and a sheet.

14. The transdermal drug delivery patch system according to claim 10 wherein said actuator further comprises a control button for initiating poration of said membrane.

15. The transdermal drug delivery patch system according to claim 10 wherein said at least one microporator comprises a plurality of microporators.

16. An integrated poration 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, wherein each at least one probe element is a heated resistive element configured to conductively deliver thermal energy to cause ablation of the tissue to a desired depth for formation of the micropore said tissue interface layer forming the bottom of said poration device; and

b. a patch comprising a drug, said patch being applied to a microporated area of said tissue membrane after poration.

17. The integrated poration device according to claim 16, wherein the patch is a permeable solid structure.

18. The integrated poration device according to claim 17, wherein the permeable solid structure is a porous polymer.

19. The integrated poration device according to claim 16 wherein said tissue interface layer comprises a material selected from the group consisting of a woven material, a film, a supporting layer and a sheet.

20. The integrated poration device according to claim 16 wherein said at least one probe element comprises a plurality of probe elements.

21. The integrated poration device according to claim 20 wherein the plurality of probe elements forms an array.

22. The integrated poration device according to claim 16 wherein said tissue interface layer is removably attached to said outer body.

23. The integrated poration device according to claim 16 further comprising a control button for initiating poration of said membrane.

24. The integrated poration device system according to claim 16 wherein said tissue interface layer further comprises an adhesive layer for attachment of said poration device to said tissue membrane.

25. A method for delivering a drug to a patient comprising the steps of:

a. forming one or more micropores in a tissue membrane of said patient with a poration device, the 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, said controller board being positioned within said cavity; and

iii. a tissue interface layer for contacting a tissue membrane of the patient, said tissue interface layer comprising a thin film defining a plurality of probe elements, wherein each at least one probe element is a heated resistive element configured to conductively deliver thermal energy to cause ablation of the tissue to a desired depth for formation of the micropore(s), and wherein said tissue interface layer forms a portion of the bottom of said poration device;

b. removing the poration device; and

c. applying a patch comprising a drug to a microporated area of the tissue membrane after poration

26. The method according to claim 25, wherein the patch is a permeable solid structure.

27. The method according to claim 26, wherein the permeable solid structure is a porous polymer.

28. The method according to claim 25 wherein said plurality of probe elements forms an array.

29. A method for delivering a drug to a patient comprising the steps of:

a. forming one or more micropores in a tissue membrane of said patient with a poration device, the poration device comprising a tissue interface layer configured for contacting the tissue membrane and selectively forming a plurality of micropores within the tissue membrane, the tissue interface layer comprising a thin film, wherein the thin film comprises a plurality of probe elements that are configured for selective formation of the plurality of micropores, wherein each probe element of the plurality of probe elements is a heated resistive element that is configured to conductively deliver thermal energy to cause ablation of the tissue to a desired depth for formation of one micropore in the tissue membrane; and

b. removing the poration device and

c. applying a patch to a microporated area of the tissue membrane after poration.

30. The method according to claim 29, wherein the patch is a permeable solid structure.

31. The method according to claim 30, wherein the permeable solid structure is a porous polymer.

32. A transdermal drug delivery patch system for delivering a drug across a tissue membrane comprising:

a. an actuator;

b. a porator array removably connected to the actuator, the porator array comprising a plurality of microporators which is actuated by the actuator to form a plurality of micropores in the tissue membrane;

wherein each microporator of the plurality of microporators comprises a heated resistive element configured to conductively deliver thermal energy to cause ablation of the tissue membrane to a desired depth for formation of one micropore in the tissue membrane; and

c. a patch comprising a drug, said patch being applied to a microporated area of said tissue membrane after poration.

33. The transdermal drug delivery patch system according to claim 32, wherein the patch is a permeable solid structure.

34. The transdermal drug delivery patch system according to claim 33, wherein the permeable solid structure is a porous polymer.

35. The transdermal drug delivery patch system according to claim 32 wherein the actuator comprises an interface connection port for receiving the porator array, the interface connection port having an anode and a cathode configured for being selectively placed in electrical communication with respective portions of the porator array.

36. The transdermal drug delivery patch system according to claim 32 further comprising a film, wherein the plurality of microporators of the porator array are formed within a portion of the film.

37. The transdermal drug delivery patch system according to claim 32 further comprising a tissue interface layer that comprises a material selected from the group consisting of:

a woven material, a film, a supporting layer and a sheet.

38. The transdermal drug delivery patch system according to claim 32 wherein said actuator further comprises a control button for initiating poration of said membrane.

39. A poration system for selective formation of a plurality of micropores within a tissue membrane of an animal, 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, wherein the thin film comprises a plurality of probe elements that are configured for selective formation of the plurality of micropores, wherein each probe element of the plurality of probe elements is a heated resistive element that is configured to conductively deliver thermal energy to cause ablation of the tissue to a desired depth for formation of one micropore in the tissue membrane, and wherein the thin film is in select electrical communication with the controller board; and

d. a patch comprising a drug, said patch being applied to a plurality of micropores in the tissue membrane after poration.

40. The poration system according to claim 39, wherein the patch is a permeable solid structure.

41. The poration system according to claim 40, wherein the permeable solid structure is a porous polymer.

42. The poration system according to claim 39 wherein the plurality of probe elements forms an array.

43. The poration system according to claim 39 wherein the thin film is removably attached to the outer body.

44. The poration system according to claim 39 further comprising a control button for initiating poration of the tissue membrane.

45. The poration system according to claim 39 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.

46. A method for delivering a drug to a patient comprising the steps of:

a. forming one or more micropores in a tissue membrane of said patient with a poration device, the 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

a tissue interface layer for contacting a tissue membrane of the patient, said tissue interface layer containing at least one probe element, wherein each at least one probe element is a heated resistive element configured to conductively deliver thermal energy to cause ablation of the tissue to a desired depth for formation of the micropore, and wherein said tissue interface layer forms a portion of the bottom of said poration device;

b. removing the poration device; and

c. applying a patch comprising a drug to a microporated area of the tissue membrane after poration, wherein said patch is a permeable solid structure, wherein said permeable solid structure is a porous polymer.