High-aspect-ratio microdevices and methods for transdermal delivery and sampling of active substances
Inventors
Assignees
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Publication Number
US-8043250-B2
Publication Date
2011-10-25
Expiration Date
Abstract
A method of usign a high-aspect ratio microdevice for treating, preventing or ameliorating a medical condition is provided.
Core Innovation
The invention relates to high-aspect-ratio microdevices for transdermal delivery and sampling, including an array of microstructures such as microneedles, microblades, and microknives. The microstructures have an aspect ratio of about 10:1 or higher, with embodiments in which the microneedle has a tip in nanoscale dimension and a body in microscale dimension, and the microblade or microknife has an edge in nanoscale dimension and a body in microscale dimension.
The invention addresses delivering and/or sampling through skin by using microstructures to perforate or scratch the skin while addressing the role of the stratum corneum and the viable epidermis. A two-step transdermal workflow is described in which the device is applied to a topical site to perforate the skin and is immediately removed.
After removal, an effective amount of an agent is applied to the topical site to allow the agent to penetrate into the body of a mammal. The document further describes applying an agent via a skin patch over the site after device removal, and includes optional microchannels and microreservoirs, along with agent formulations and agent classes including therapeutic agents and vaccines.
Claims Coverage
The independent claims cover a two-step topical method for treating, preventing, or ameliorating a medical condition using a device with high-aspect-ratio microstructures (about 10:1 or higher) that perforate skin, followed by immediate device removal and application of an agent to allow penetration into the body.
Immediate device removal after skin perforation and agent application
Treating, preventing, or ameliorating a medical condition by treating a topical site with a device, immediately removing the device 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.
High-aspect-ratio microstructure array
The device comprises an array of microstructures wherein the microstructure has an aspect ratio of about 10:1 or higher.
Nanoscale tip microneedle and nanoscale edge microblade or microknife
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.
Across the independent claims, the core coverage is the combination of perforating skin with a device having a high-aspect-ratio microstructure array, immediately removing the device after perforation, and applying an effective amount of an agent to enable penetration into the body.
Stated Advantages
Minimization of pain by perforating or scratching skin without reaching dermis is described.
Increased permeation and enhanced penetration of agents are described.
Faster agent penetration is described, including lidocaine penetration.
Documented Applications
Transdermal delivery for treating, preventing, or ameliorating medical conditions of a mammal using a microstructure array device and immediate removal followed by application of an agent.
Delivery of therapeutic agents such as lidocaine for pain relief, with human pain score improvement described for a microneedle-assisted lidocaine patch.
Delivery of biological therapeutic agents and proteins including BSA, including FITC labeled BSA, with delivery durations up to 60 hours described.
Delivery of vaccines for multiple diseases including influenza, DTaP, MMR, hepatitis B, polio, haemophilus influenzae type b, chickenpox, tuberculosis, anthrax, yellow fever, rabies, AIDS, meningococcus, SARS, and cholera.
Examples of medical conditions listed for pain-relief variants include chronic back pain and cancer.
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