High-aspect-ratio microdevices and methods for transdermal delivery and sampling of active substances

• US 8,043,250 B2
• Filed: 08/25/2006
• Issued: 10/25/2011
• Est. Priority Date: 05/18/2005
• Status: Active Grant

• Current Assignee: Nanomed Devices Incorporated
• Original Assignee: Nanomed Devices Incorporated
• Inventors: Xu, Bai
• Primary Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US11/510,078
• Publication Number:
  US 20070060867A1
• Time in Patent Office: 1,887 Days
• Field of Search: 604 20- 22, 604/93.01, 604/239, 604/272, 604/500
• US Class Current: 604/22
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: B82Y 10/00 Nanotechnology for information processing, storage or transmission, e.g. quantum computing or single electron logic
• CPC Class Codes: B82Y 5/00 Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

A method of usign a high-aspect ratio microdevice for treating, preventing or ameliorating a medical condition is provided.

Claims

1. A method of treating, preventing, or ameliorating a medical condition of a mammal, comprising:

treating a topical site of a mammal using a device,

immediately removing the device from the topical site after the device has perforated the skin, and

applying an effective amount of an agent to the topical site to allow the agent to penetrate into the body of the mammal,

wherein the device comprises an array of microstructures, and

wherein the microstructure has an aspect ratio of about 10;

1 or higher.

2. The method of claim 1, wherein the microstructure comprises microneedles, microknives or microblades,

wherein the treating comprises pushing a plurality of microneedles, microblades, or microknives of a microstructure through the outer layer of skin on a preselected site of the skin, and

wherein the applying comprises applying a skin patch containing the agent over the topical site after the device has been removed from the topical site.

3. The method of claim 1, wherein the agent is a therapeutic agent selected from the group consisting of antibiotics, hormones, steroids, anti-inflammatory drugs, protein drugs, DNA drugs, recombinant Erythropoietin (rhEPO), Taxol®

, Interferon-alpha-1b, Interferon beta, Interferon gamma, Emla®

, Fluorouracil, Lidocaine, Salicylic acid, Pureriran, eflornithine hydrochloride, spironolactone, flutamide, insulin, nanoparticle drugs, Epidural, recombinant human parathyroid hormone, growth hormone, thyroid, cortisol, estrogen, progesterone, testosterone and a combination thereof.

4. The method of claim 1, wherein the active agent is a natural or synthetic vaccine selected from the group consisting of vaccines, protein vaccines, peptide vaccines, gene vaccines and DNA vaccines, and

wherein the vaccine is against influenza (flu), diphtheria, tetanus, pertussis (DTaP), measles, mumps, rubella (MMR), hepatitis B, polio, haemophilus influenzae type b, chickenpox, tuberculosis, anthrax, yellow fever, rabies, AIDS, cancers, meningococcus, SARS and cholera.

5. The method of claim 1, wherein the agent is a pain relieving agent.

6. The method of claim 5, wherein the medical condition is chronic back pain.

7. The method of claim 5, wherein the medical condition is a cancer.

8. A method of treating, preventing, or ameliorating a medical condition of a mammal, comprising:

treating a topical site of a mammal using a device,

immediately removing the device from the topical site after the device has perforated the skin, and

applying an effective amount of an agent to the topical site to allow the agent to penetrate into the body of the mammal,

wherein the device comprises an array of microstructures having an aspect ratio of about 10;

1 or higher,

wherein the microstructure is a microneedle, microblade, microknife, or a combination thereof,

wherein the microneedle comprises a tip in nanoscale dimension and a body in microscale dimension, and

wherein the microblade or microknife comprises an edge in nanoscale dimension and a body in microscale dimension.

9. The method of claim 8, wherein the treating comprises pushing a plurality of microneedles, microblades, or microknives of a microstructure through the outer layer of skin on a preselected site of the skin, and

wherein the applying comprises applying a skin patch containing the agent over the topical site after the device has been removed from the topical site.

10. The method of claim 8, wherein the agent is a therapeutic agent selected from the group consisting of antibiotics, hormones, steroids, anti-inflammatory drugs, protein drugs, DNA drugs, recombinant Erythropoietin (rhEPO), Taxol®

, Interferon-alpha-1b, Interferon beta, Interferon gamma, Emla®

, Fluorouracil, Lidocaine, Salicylic acid, Pureriran, eflornithine hydrochloride, spironolactone, flutamide, insulin, nanoparticle drugs, Epidural, recombinant human parathyroid hormone, growth hormone, thyroid, cortisol, estrogen, progesterone, testosterone and a combination thereof.

11. The method of claim 8, wherein the active agent is a natural or synthetic vaccine selected from the group consisting of vaccines, protein vaccines, peptide vaccines, gene vaccines and DNA vaccines, and

wherein the vaccine is against influenza (flu), diphtheria, tetanus, pertussis (DTaP), measles, mumps, rubella (MMR), hepatitis B, polio, haemophilus influenzae type b, chickenpox, tuberculosis, anthrax, yellow fever, rabies, AIDS, cancers, meningococcus, SARS and cholera.

12. The method of claim 8, wherein the agent is a pain relieving agent.

13. The method of claim 12, wherein the medical condition is chronic back pain.

14. The method of claim 12, wherein the medical condition is a cancer.