US 12,138,415 B2
Increased bioavailability of transdermally delivered agents
Russell F. Ross, Jacksonville Beach, FL (US)
Assigned to VIVASOR, INC., San Diego, CA (US)
Filed by VIVASOR, INC., San Diego, CA (US)
Filed on Aug. 13, 2020, as Appl. No. 16/992,776.
Application 16/992,776 is a continuation of application No. 15/890,570, filed on Feb. 7, 2018, granted, now 10,773,065.
Application 15/890,570 is a continuation of application No. 13/658,864, filed on Oct. 24, 2012, abandoned.
Claims priority of provisional application 61/552,046, filed on Oct. 27, 2011.
Prior Publication US 2020/0384255 A1, Dec. 10, 2020
This patent is subject to a terminal disclaimer.
Int. Cl. A61M 37/00 (2006.01); A61K 9/00 (2006.01)
CPC A61M 37/0015 (2013.01) [A61K 9/0021 (2013.01); A61M 2037/0023 (2013.01); A61M 2037/0061 (2013.01)] 32 Claims
OG exemplary drawing
 
1. A method of delivering a bioactive agent to a subject, the method comprising:
penetrating a stratum corneum of the subject with a microneedle having a channel in fluid communication with the bioactive agent, a plurality of nanostructures and a plurality of microstructures formed on an external surface of the microneedle, wherein at least a portion of the microstructures have a cross-sectional dimension of greater than about 500 nanometers and less than about 10 micrometers and a height of from about 20 nanometers to about 1 micrometer, wherein at least a portion of the microstructures have a cross-sectional dimension greater than a height of the microstructures, the plurality of nanostructures having a fractal and/or a fractal-like geometry;
transporting the bioactive agent through the channel of the microneedle; and
delivering the bioactive agent to the subject with a comparative bioavailability as compared to subcutaneous delivery of greater than about 20%;
wherein the stratum corneum comprises tight junctions between cells, the nanostructures rearranging tight junctions between the cells, thereby increasing porosity; and
wherein the rearrangement of the tight junctions leads to an increase in the porosity of a second tissue type that is not in direct contact with the microneedle.