Multi-reservoir device for transdermal drug delivery and sensing

• US 20060024358A1
• Filed: 08/01/2005
• Published: 02/02/2006
• Est. Priority Date: 07/30/2004
• Status: Active Grant

• Current Assignee: Microchips Biotech, Inc. (Keratin Biosciences, Inc.)
• Original Assignee: MicroCHIPS Inc.
• Inventors: Santini, John T. Jr., Herman, Stephen J., Staples, Mark A.
• Granted Patent: US 7,537,590 B2
• Time in Patent Office: Days
• US Class Current: 424/448
• CPC Class Codes: A61F 2013/00642 soluble, e.g. in water
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
• CPC Class Codes: A61K 9/7092 Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• 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

Devices and methods are provided for transdermal administration of a pharmaceutical agent to a patient in need thereof. The device includes a substrate, a plurality of discrete reservoirs in the substrate, one or more pharmaceutical agents stored in the reservoirs, discrete reservoir caps that prevent the pharmaceutical agent from passing out from the reservoirs until desired, control means for actuating release of the one or more pharmaceutical agents from one or more of the reservoirs by disintegrating or permeabilizing the reservoir caps, means for securing the device to the skin of the patient, and means for transporting the pharmaceutical agent to the skin following release from the one or more of the reservoirs. In another embodiment, the device is adapted for diagnostic sensing instead of or in addition to drug delivery.

Claims

1. A medical device for transdermal administration of one or more pharmaceutical agents to a patient in need thereof comprising:

a substrate;

a plurality of discrete reservoirs in the substrate;

one or more pharmaceutical agents stored in the reservoirs;

discrete reservoir caps which prevent the one or more pharmaceutical agents from passing out from the reservoirs;

control means for actuating release of the one or more pharmaceutical agents from one or more of the reservoirs by disintegrating or permeabilizing the reservoir caps;

means for securing the device to the skin of the patient; and

means for transporting the one or more pharmaceutical agents to the skin following release from the one or more of the reservoir.

2. The device of claim 1, wherein the reservoir cap is formed of an electrically conductive material and the control means comprises an electrical input lead connected to said reservoir cap, an electrical output lead connected to said reservoir cap, wherein the reservoir cap is ruptured by application of an electrical current through the reservoir cap via the input lead and output lead.

3. The device of claim 2, further comprising a source of electric power for applying the electrical current.

4. The device of claim 1, wherein the reservoir cap comprises a metal film.

5. The device of claim 1, wherein the means for securing comprises a pressure sensitive adhesive.

6. The device of claim 1, wherein the means for securing comprises an adhesive layer which is permeable to the one or more pharmaceutical agents.

7. The device of claim 1, wherein the means for transporting comprises a transport medium disposed between the reservoir caps and the skin.

8. The device of claim 7, wherein the transport medium comprises a permeable body through which the one or more pharmaceutical agents released from the reservoirs can diffuse.

9. The device of claim 7, wherein the transport medium comprises a reservoir containing a liquid, gel, or semi-solid permeation material.

10. The device of claim 1, further comprising a housing which contains the substrate, control means, and a power source.

11. The device of claim 1, further comprising a removably attachable electronics portion which comprises the power source and at least a portion of the control means.

12. The device of claim 1, wherein the means for transporting comprises a plurality of microneedles.

13. The device of claim 1, wherein the means for transporting comprises one or more chemical penetration enhancers.

14. The device of claim 1, wherein the means for transporting comprises an ultrasound generator.

15. The device of claim 1, wherein the means for transporting comprises means for effecting iontophoresis, electroosmosis, or electroporation.

16. The device of claim 1, wherein the means for transporting comprises a heating element.

17. The device of claim 1, wherein the reservoirs are microreservoirs.

18. The device of claim 1, wherein the one or more pharmaceutical agents comprises a drug selected from the group consisting of androgen, estrogen, non-steroidal anti-inflammatory agents, anti-hypertensive agents, analgesic agents, anti-depressants, antibiotics, anti-cancer agents, local anesthetics, antiemetics, anti-infectants, contraceptives, anti-diabetic agents, steroids, anti-allergy agents, anti-migraine agents, agents for smoking cessation, anti-obesity agents, nicotine, testosterone, estradiol, nitroglycerin, clonidine, dexamethasone, wintergreen oil, tetracaine, lidocaine, fentanyl, sufentanil, progestrone, insulin, Vitamin A, Vitamin C, Vitamin E, prilocaine, bupivacaine, sumatriptan, dihydroergotamine, and combinations thereof.

19. The device of claim 1, wherein the means for transporting comprises a flexible or rigid member having media-filled holes with spacing corresponding to reservoir membrane openings, which allows release of reservoir contents without dilution.

20. A medical device for transdermal administration of one or more pharmaceutical agents to a patient in need thereof comprising:

a substrate;

a plurality of discrete reservoirs in the substrate;

one or more pharmaceutical agents stored in the reservoirs;

discrete reservoir caps which prevent the one or more pharmaceutical agents from passing out from the reservoirs;

control means for actuating release of the one or more pharmaceutical agents from one or more of the reservoirs by disintegrating or permeabilizing the reservoir caps;

an adhesive or strap material for securing the device to the skin of the patient; and

a body defining a transport medium reservoir disposed between the reservoir caps and the skin of the patient, the body and reservoir facilitating transport of the one or more pharmaceutical agents to the skin following their release from the one or more of the reservoir.

21. The device of claim 20, wherein the transport medium reservoir contains a liquid, gel, or semi-solid permeation material.

22. The device of claim 20, wherein the transport medium reservoir comprises a single pool of a biocompatible transport fluid into which the one or more pharmaceutical agents are diluted prior to delivery to the skin.

23. The device of claim 20, wherein the transport medium reservoir comprises individual channels for delivery of the one or more pharmaceutical agents with no or minimal dilution prior to delivery to the skin.

24. A device for sensing an analyte in a human or other animal comprising:

a substrate;

a plurality of discrete reservoirs in the substrate, the reservoirs having at least one opening;

one or more sensors or diagnostic agents stored in the reservoirs;

discrete reservoir caps which cover said at least one opening;

control means for disintegrating or permeabilizing the reservoir caps;

means for securing the device to the skin of the patient; and

means for transporting an analyte from the skin to the one or more sensors or for transporting the one or more diagnostic agents to the skin following release of said diagnostic agents from the one or more of the reservoir.