Thermopile powered transdermal drug delivery device

• US 5,733,255 A
• Filed: 10/15/1996
• Issued: 03/31/1998
• Est. Priority Date: 10/18/1995
• Status: Expired due to Fees

• Current Assignee: Novartis Finance Corporation (Novartis Ag)
• Original Assignee: Novartis Finance Corporation (Novartis Ag)
• Inventors: Wouters, Sietse E., Sclafani, Joseph R. Jr., Dinh, Steven M.
• Primary Examiner(s): BROUILLETTE, D GABRIELLE
• Application Number:
  US08/729,969
• Time in Patent Office: 532 Days
• Field of Search: 604/20, 607/75, 607/2, 424/448, 424/449
• US Class Current: 604/20
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

A transdermal drug delivery device has a drug containing element containing a drug which is preferably charged and first and second electrodes for conducting a current flow through the drug containing element. The current flow causes the drug to be released from the drug containing element and to permeate through the skin of a user to which the device has been fixed. A power source is connected to the first and second electrodes for providing the energy necessary to generate the current flow. The power source comprises a thermocouple or thermopile having two different poles which are connected to the first and/or second electrodes, whereby a self-contained drug delivery device is formed which provides the energy necessary for generating the current flow by means of a difference in temperature of the skin of the user and the ambient air (environment), thus providing a device free of batteries, accumulators or other external energy sources.

Claims

1. A transdermal drug delivery device comprising:

a drug containing element selected from the group consisting of a reservoir, matrix, gel and nonwoven layer, said drug containing element comprising a drug;

first and second electrodes for conducting a current flow through the drug containing element, the current flow causing the drug to be released from the drug containing element and to permeate through the skin of a user to which the device has been fixed;

a power source connected to the first and second electrodes for providing the energy necessary to generate the current flow;

wherein the power source comprises a thermocouple or thermopile comprising two poles which are connected to the first and second electrodes, the first pole being in contact with the user'"'"'s skin and the second pole being in contact with the environment whereby a self-contained drug delivery device is formed which provides the energy necessary for generating the current flow by means of a difference in temperature of the skin of the user and the environment.

2. The device according to claim 1, wherein the power source is a thermopile comprising a series connection of two thermocouple elements arranged to form a column, the column of the elements being arranged between two rigid thermally conductive but electrically non-conductive plates.

3. The device according to claim 2, wherein one plate is arranged to come into contact with the skin of the user when the device is applied while the other plate is arranged to contact the environment, and wherein one pole of the thermopile is connected to the first electrode which is located in electrical contact with the drug containing element, while the other pole of the thermopile is connected to the second electrode.

4. The device according to claim 3, wherein two drug containing elements are provided, one of them being provided with the first electrode and the other being provided with the second electrode, and wherein one pole of the thermopile is connected to the first electrode while the other is connected to the second electrode.

5. The device according to claim 2, wherein the first electrode comprises an electrically as well as thermally conductive material, and wherein the first electrode is located on top of the thermally conductive drug containing element, wherein further one plate of the thermopile is arranged to be in contact with the first electrode, while the other plate is arranged to be in contact with the environment.

6. The device according to claim 2, further comprising a second drug containing element and wherein one plate of the thermopile is arranged to come into contact with one drug containing element, which comprises a thermally conductive material while the other plate is arranged to contact the environment, and wherein one pole of the thermopile is connected to the first electrode which is arranged to be in electrical contact with one of the two drug containing elements, while the other pole of the thermopile is connected to the second electrode which is arranged to be in electrical contact with the other of the two drug containing elements.

7. The device according to claim 6, wherein the first electrode is provided either on top of or in one of the two drug containing elements while the second electrode is provided either on top of or in the other of the two drug containing elements.

8. The device according to claim 1, wherein the power source is a thermopile which comprises an alternating series connection of two thermocouple elements which are arranged in a snake manner on the surface of a flexible plate made of an electrically non-conductive material.

9. The device according to claim 8, wherein the first electrode is arranged to be in electrical contact with the drug containing element, and wherein the flexible plate is arranged such that a first side of the flexible plate where one of the poles is located is arranged on top of the drug containing element, which is made of a thermally non-conductive material, said pole being connected to the first electrode, while a second side of the flexible plate where the other pole is located is bent down to be in contact with the skin, said other pole being connected to the second electrode.

10. The device according to claim 9, wherein the first electrode is arranged either on top of or in the drug containing element.

11. The device according to claim 8, further comprising a second drug containing element, and wherein the first electrode is arranged on top of or in one of the two drug containing elements while the second electrode is arranged on top of or in the other of the two drug containing elements.

12. The device according to claim 8, wherein a supporting member is provided in close proximity to the drug containing element, on top of which the first side of the flexible plate, where one of the poles is located, is arranged.

13. The device according to claim 12, further comprising a second drug containing element, wherein further the first electrode is arranged on top of or in one of the two drug containing elements while the second electrode is arranged on top of or in the other of the two drug containing elements, and wherein one pole of the flexible plate is connected to the first electrode while the other is connected to the second electrode.

14. The device according to claim 12, wherein the supporting member is made of a thermally conductive material, and wherein further the flexible plate is arranged such that the first side of the flexible plate, where one of the poles is located, is arranged on top of one of the drug containing elements which comprises a thermally non-conductive material, this pole being connected to the first electrode, and the second side of the plate, where the other pole is located, is arranged on top of the thermally conductive supporting member, thereby eliminating the need of bending the flexible plate.

15. The device according to claim 12, wherein the supporting member is made of a thermally non-conductive material, and wherein further the flexible plate is arranged such that the first side of the flexible plate, where one of the poles is located, is arranged on top of one of the drug containing elements which comprises a thermally conductive material, this pole being connected to the first electrode, and the second side of the plate, where the other pole is located, is arranged on top of the thermally non-conductive supporting member, thereby eliminating the need of bending the flexible plate, or the first side of the plate is bent down to be in contact with the skin.

16. The device according to claim 8, wherein the plate containing the snake thermopile is made of a non-flexible material and comprises a rim at a first edge portion thereof and a cantilever having a tip extending to the opposite side portion, the cantilever being mechanically connected to said first edge portion of the rim, wherein further a gap is provided between the cantilever tip and the other three edge portions of the rim, the thermocouples having one edge located on the rim and the other edge located near the tip of the cantilever.

17. The device according to claim 16, wherein the tip of the cantilever is connected via a thermally conductive piece to a thermally conductive sheet arranged above the plate, the rim of the plate being arranged to be in contact with the skin while the thermally conductive sheet is arranged to be in contact with the environment.

18. The device according to claim 16, wherein two plates are arranged such that the rim of the first plate is arranged to be in contact with the skin while the cantilever of the first plate is connected via a thermally conductive piece to the cantilever of the second plate, which is arranged above the first plate and wherein the rim of the second plate is connected to a thermally conductive sheet which is arranged above the second plate, the thermally conductive sheet being in contact with the environment.

19. A process of increasing drug flux from the device according to claim 1 comprising applying an endothermic process or reaction to cool down the pole which is in contact with the environment.

20. A process of increasing drug flux from the device according to claim 1 comprising applying an exothermic process or reaction to heat up the part of the pole which is in contact with the environment.