# US 2013/0158505 A1 · MEDICAL DEVICES FOR DELIVERY OF siRNA > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0158505 A1 - Document ID: US20130158505A1 - Status: Published application - Kind: A1 - Application number: 13/641,502 - Filed: 2011-04-27 - Published: 2013-06-20 - Earliest claimed: 2010-04-28 - Assignees: Kimberly-Clark Worldwide, Inc. - Inventors: Russell Frederick Ross - Web page: https://patentgrep.com/patent/US20130158505A1 ## CPC - A61M 37/0015: {by using microneedles} - A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body} - A61M 37/00: Other apparatus for introducing media into the body (for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30); Percutany, i.e. introducing medicines into the body by diffusion through the skin (salt baths A61H33/04) - A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics - A61P 35/00: Antineoplastic agents - C12N 15/113: Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; {Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing (when used in plants C12N15/8218)} - C12N 15/89: using microinjection - A61M 2037/0023: {Drug applicators using microneedles} - A61M 2037/0038: {having a channel at the side surface} - A61M 2037/0053: {Methods for producing microneedles} - A61M 2037/0061: {Methods for using microneedles} - C12N 2310/14: interfering nucleic acids [NA] - Y10T 29/49826: Assembling or joining - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract Disclosed are medical devices that incorporate siRNA. In addition to one or more siRNA constructs, devices include nanostructures fabricated on a surface to form a nanotopography. A random or non-random pattern of structures may be fabricated such as a complex pattern including structures of differing sizes and/or shapes. Microneedles may be incorporated on devices. The pattern including nanostructures may be formed on the surface of the microneedles. ## Claims ### Claim 1 A device for delivery of an siRNA construct across a dermal barrier, the device comprising: a microneedle and a plurality of nanostructures fabricated on a surface of the microneedle, the nanostructures being arranged in a predetermined pattern; and an siRNA construct in fluid communication with the microneedle. ### Claim 2 (depends on 1) The device of claim 1, wherein the pattern further includes microstructures, wherein the nanostructures have a cross-sectional dimension smaller than the microstructures. ### Claim 3 (depends on 2) The device of claim 2, further comprising second nanostructures having a cross-sectional dimension less than the cross-sectional dimension of the microstructures and greater than the cross-sectional dimension of the first nanostructures. ### Claim 4 (depends on 1) The medical device of claim 1, wherein at least a portion of the nanostructures have a cross-sectional dimension of less than about 500 nanometers and greater than about 5 nanometers. ### Claim 5 (depends on 1) The medical device of any of claim 1, wherein at least a portion of the nanostructures have a center-to-center spacing of from about 50 nanometers to about 1 micrometer. ### Claim 6 (depends on 1) The medical device of claim 1, where at least a portion of the nanostructures have a height of from about 10 nanometers to about 20 micrometers. ### Claim 7 (depends on 1) The medical device of claim 1, wherein at least a portion of the nanostructures have an aspect ratio of from about 0.15 and about 30. ### Claim 8 (depends on 1) The device of claim 1, wherein the siRNA agent includes a duplexed region of between about 20 and about 30 pairs. ### Claim 9 (depends on 1) The device of claim 1, at least one strand of the siRNA including a 3′ overhang of two or three nucleotides. ### Claim 10 (depends on 1) The device of claim 1, the siRNA agent comprising additional nucleotides or nucleotide analogue. ### Claim 11 (depends on 1) The device of claim 1, wherein the siRNA agent comprises a nucleotide sequence that is identical to a portion of a targeted gene. ### Claim 12 (depends on 1) The device of claim 1, wherein the siRNA agent includes insertions, deletions, or single point mutations compared to a portion of a targeted gene. ### Claim 13 (depends on 1) The device of claim 1, wherein the siRNA agent is a single strand siRNA. ### Claim 14 (depends on 1) The device of claim 1, wherein the siRNA comprises a ligand tethered to the siRNA, for example a therapeutic modifier, a diagnostic compound, a reporter group, a crosslinking agent, a nucleobase, a lipophilic molecule or a protein. ### Claim 15 (depends on 1) The device of claim 1, wherein the siRNA agent is incorporated into a delivery vehicle, for instance a liposome. ### Claim 16 (depends on 1) The device of claim 1, wherein the siRNA construct comprises a vector, for instance a viral vector. ### Claim 17 A method for delivering an siRNA construct across a dermal barrier, the method comprising: penetrating the stratum corneum with a microneedle, the microneedle comprising a plurality of nanostructures formed on a surface of the microneedle and arranged in a pattern, the siRNA construct being in fluid communication with the microneedle, the siRNA construct being transported across the stratum corneum following penetration of the stratum corneum by the microneedle. ### Claim 18 (depends on 17) The method according to claim 17, wherein the siRNA construct is transported across the stratum corneum within an annular bore or a channel of the microneedle. ### Claim 19 (depends on 17) The method according to claim 17, wherein the siRNA construct is transported across the stratum corneum at a steady concentration over a period of time. ### Claim 20 A method for forming a device for delivery of an siRNA construct across a dermal barrier, the method comprising: fabricating an array of microneedles; fabricating a pattern of nanostructures on a surface of at least one of the microneedles; associating an siRNA construct with the microneedles such that the siRNA construct is in fluid communication with the microneedles. ### Claim 21 (depends on 20) The method according to claim 20, the method further comprising retaining the siRNA construct within a reservoir that is in fluid communication with the array of microneedles. ### Claim 22 (depends on 21) The method according to claim 21, wherein the reservoir is attached to a substrate upon which the array of microneedles are located. ### Claim 23 (depends on 21) The method according to claim 21, wherein the reservoir is removably connectable to the array of microneedles.