# US 2021/0330951 A1 · Microneedle Assembly > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2021/0330951 A1 - Document ID: US20210330951A1 - Status: Published application - Kind: A1 - Application number: 17/235,976 - Filed: 2021-04-21 - Published: 2021-10-28 - Earliest claimed: 2020-04-28 - Assignees: Ticona LLC - Applicants: Ticona LLC - Inventors: Young Shin Kim - Web page: https://patentgrep.com/patent/US20210330951A1 ## CPC - A61M 37/0015: {by using microneedles} - A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)} - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes} - A61B 5/1486: using enzyme electrodes, e.g. with immobilised oxidase - A61B 5/685: {Microneedles} - A61K 9/0021: {Intradermal administration, e.g. through microneedle arrays or needleless injectors} - A61L 31/04: Macromolecular materials - A61L 31/128: {containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127} - A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials} - A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} - A61B 17/205: {Vaccinating by means of needles or other puncturing devices} - A61B 2562/12: Manufacturing methods specially adapted for producing sensors for in-vivo measurements - A61M 2037/0023: {Drug applicators using microneedles} - A61M 2037/0038: {having a channel at the side surface} - A61M 2037/0046: {Solid microneedles} - A61M 2037/0061: {Methods for using microneedles} - 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)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) ## Abstract A microneedle assembly that is capable of delivering a drug compound (e.g., vaccine) and/or detecting the presence of an analyte is provided. The assembly comprises at least one microneedle extending outwardly from a support. The microneedle includes a polymer composition containing a thermoplastic polymer having a melting temperature of about 250° C. or more. The polymer composition exhibits a melt viscosity of about 100 Pa-s or less and a tensile elongation of about 5% or less. ## Claims ### Claim 1 A microneedle assembly comprising at least one microneedle extending outwardly from a support, wherein the microneedle includes a polymer composition containing a thermoplastic polymer having a melting temperature of about 250° C. or more, wherein the polymer composition exhibits a melt viscosity of about 100 Pa-s or less as determined in accordance with ISO Test No. 11443:2014 at a shear rate at a shear rate of 1,000 seconds−1 and temperature of about 30° C. above the melting temperature, and further wherein the polymer composition exhibits a tensile elongation of about 5% or less as determined at in accordance with ISO Test No. 527:2012 at a temperature of about 23° C. ### Claim 2 (depends on 1) The microneedle assembly of claim 1, wherein the polymer composition exhibits a melt viscosity of about 150 Pa-s or less as determined in accordance with ISO Test No. 11443:2014 at a shear rate at a shear rate of 400 seconds−1 and temperature of about 30° C. above the melting temperature. ### Claim 3 (depends on 1) The microneedle assembly of claim 1, wherein the polymer composition exhibits a deflection temperature under load of about 160° C. or more as determined in accordance with ISO Test No. 75-2:2013 at a load of 1.8 Megapascals. ### Claim 4 (depends on 3) The microneedle assembly of claim 3, wherein the ratio of the deflection temperature under load to the melting temperature is from about 0.5 to about 1.00. ### Claim 5 (depends on 1) The microneedle assembly of claim 1, wherein the polymer composition exhibits a tensile modulus of about 7,000 MPa or more as determined in accordance with ISO Test No. 527:2012 at a temperature of about 23° C. ### Claim 6 (depends on 1) The microneedle assembly of claim 1, wherein the thermoplastic polymer includes a polyarylene sulfide, polyamide, polyaryleneketone, liquid crystalline polymer, or a combination thereof. ### Claim 7 (depends on 1) The microneedle assembly of claim 1, wherein the thermoplastic polymer includes a liquid crystalline polymer. ### Claim 8 (depends on 7) The microneedle assembly of claim 7, wherein the liquid crystalline polymer contains repeating units derived from one or more aromatic dicarboxylic acids, one or more aromatic hydroxycarboxylic acids, or a combination thereof. ### Claim 9 (depends on 8) The microneedle assembly of claim 8, wherein the aromatic hydroxycarboxylic acids include 4-hydroxybenzoic acid, 6-hydroxy-2-naphthoic acid, or a combination thereof. ### Claim 10 (depends on 8) The microneedle assembly of claim 8, wherein the aromatic hydroxycarboxylic acids include terephthalic acid, isophthalic acid, 2,6-naphthalenedicarboxylic acid, or a combination thereof. ### Claim 11 (depends on 8) The microneedle assembly of claim 8, wherein the liquid crystalline polymer further contains repeating units derived from one or more aromatic diols. ### Claim 12 (depends on 11) The microneedle assembly of claim 11, wherein the aromatic diols include hydroquinone, 4,4′-biphenol, or a combination thereof. ### Claim 13 (depends on 7) The microneedle assembly of claim 7, wherein the liquid crystalline polymer is wholly aromatic. ### Claim 14 (depends on 7) The microneedle assembly of claim 7, wherein the liquid crystalline polymer contains repeating units derived from naphthenic hydroxycarboxylic and/or dicarboxylic acids in an amount of about 10 mol. % or more. ### Claim 15 (depends on 7) The microneedle assembly of claim 7, wherein the liquid crystalline polymer contains repeating units derived from 6-hydroxy-2-naphthoic acid in an amount of about 30 mol. % or more. ### Claim 16 (depends on 1) The microneedle assembly of claim 1, wherein thermoplastic polymers constitute from about 30 wt. % to about 99 wt. % of the polymer composition. ### Claim 17 (depends on 1) The microneedle assembly of claim 1, wherein the polymer composition further comprises a mineral filler. ### Claim 18 (depends on 17) The microneedle assembly of claim 17, wherein the mineral filler is in the form of particles. ### Claim 19 (depends on 18) The microneedle assembly of claim 18, wherein the particles have a median size of about 10 micrometers or less. ### Claim 20 (depends on 18) The microneedle assembly of claim 18, wherein the particles have a median size of from about 0.6 to about 2.5 micrometers. ### Claim 21 (depends on 18) The microneedle assembly of claim 18, wherein the particles include talc. ### Claim 22 (depends on 1) The microneedle assembly of claim 1, wherein the polymer composition further comprises a tribological additive material. ### Claim 23 (depends on 22) The microneedle assembly of claim 22, wherein the tribological additive material includes a fluoropolymer. ### Claim 24 (depends on 1) The microneedle assembly of claim 1, wherein the assembly includes a plurality of microneedles arranged in an array on the support. ### Claim 25 (depends on 1) The microneedle assembly of claim 1, wherein the microneedle has a tip and base. ### Claim 26 (depends on 25) The microneedle assembly of claim 25, wherein the tip has a length of from about 5 to about 500 nanometers and a width of from about 0.5 to about 5 micrometers. ### Claim 27 (depends on 25) The microneedle assembly of claim 25, wherein the base has a length of from about 10 to about 1,000 nanometers and a thickness of from about 5 to about 100 micrometers. ### Claim 28 (depends on 1) The microneedle assembly of claim 1, wherein the microneedle has a height of from about 10 to about 1,000 nanometers. ### Claim 29 (depends on 1) The microneedle assembly of claim 1, wherein the assembly is configured to deliver a drug compound. ### Claim 30 (depends on 29) The microneedle assembly of claim 29, wherein the drug compound includes a proteinaceous compound, polynucleotide agent, vaccine, small molecule agent, anti-infection agent, hormone, drug regulating cardiac action or blood flow, or a combination thereof. ### Claim 31 (depends on 29) The microneedle assembly of claim 29, wherein the drug compound has a molecular weight of about 1 kDa or more. ### Claim 32 (depends on 29) The microneedle assembly of claim 29, wherein the drug compound includes a viral vaccine antigen. ### Claim 33 (depends on 32) The microneedle assembly of claim 32, wherein the vaccine antigen is a coronavirus vaccine antigen. ### Claim 34 (depends on 33) The microneedle assembly of claim 33, wherein the vaccine antigen is a viral vector, live attenuated virus, or an inactivated virus. ### Claim 35 (depends on 33) The microneedle assembly of claim 33, wherein the the coronavirus vaccine antigen includes mRNA-1273, BNT162, Ad5-nCoV, ChAdOx1, bacTRL-Spike, BCG, AdCovid, NVX-CoV2373, LV-SMENP, SARS recombinant spike protein plus delta inulin, SARS VLPs S protein and influenza M1 protein, DNA vaccine VRC-SRSDNA015-00-VP, VEEV replicon particles expressing the SARS-CoV S, inactivated SARS-CoV-2 virus or viral vector, live attenuated SARS-CoV-2 virus, or a combination thereof. ### Claim 36 (depends on 32) The microneedle assembly of claim 32, wherein the viral vaccine antigen is derived from and/or used for prophylaxis against adenoviruses, arenaviruses, bunyaviruses, flavirviruses, hantaviruses, hepadnaviruses, herpesviruses, papilomaviruses, paramyxoviruses, parvoviruses, picornaviruses, poxviruses, orthomyxoviruses, retroviruses, reoviruses, rhabdoviruses, rotaviruses, spongiform viruses, togaviruses, or a combination thereof. ### Claim 37 (depends on 29) The microneedle assembly of claim 29, wherein the drug compound is coated onto a surface of the microneedle. ### Claim 38 (depends on 37) The microneedle assembly of claim 37, wherein the microneedle is solid. ### Claim 39 (depends on 29) The microneedle assembly of claim 29, wherein the microneedle contains at least one channel through which the drug compound is capable of flowing. ### Claim 40 (depends on 39) A transdermal delivery device comprising the microneedle assembly of claim 39 and a drug reservoir in fluid communication with the channel, wherein the drug compound is located within a reservoir. ### Claim 41 (depends on 40) The transdermal delivery device of claim 40, further comprising an additional reservoir containing an excipient. ### Claim 42 (depends on 1) A method for delivering a drug compound to a subject, the method comprising: placing the transdermal delivery device of claim 1 adjacent to the skin of a subject; penetrating a stratum corneum of the skin with the microneedle; and transporting the drug compound from the microneedle and across the stratum corneum. ### Claim 43 (depends on 42) The method of claim 42, wherein the drug compound has a molecular weight of about 1 kDa or more. ### Claim 44 (depends on 42) The method of claim 42, wherein the drug compound includes a viral vaccine antigen. ### Claim 45 (depends on 44) The method of claim 44, wherein the viral vaccine antigen includes a coronavirus vaccine antigen. ### Claim 46 (depends on 45) The method of claim 45, wherein the coronavirus vaccine antigen includes mRNA-1273, BNT162, Ad5-nCoV, ChAdOx1, bacTRL-Spike, BCG, AdCovid, NVX-CoV2373, LV-SMENP, SARS recombinant spike protein plus delta inulin, SARS VLPs S protein and influenza M1 protein, DNA vaccine VRC-SRSDNA015-00-VP, VEEV replicon particles expressing the SARS-CoV S, inactivated SARS-CoV-2 virus or viral vector, live attenuated SARS-CoV-2 virus, or a combination thereof. ### Claim 47 (depends on 1) A method for detecting a target analyte in a subject, the method comprising: placing the transdermal delivery device of claim 1 adjacent to the skin of a subject; penetrating a stratum corneum of the skin with the microneedle so that the microneedle contacts a bodily fluid of the subject; and detecting the presence of the analyte within the bodily fluid. ### Claim 48 (depends on 47) The method of claim 47, wherein the bodily fluid is blood. ### Claim 49 (depends on 47) The method of claim 47, wherein the analyte is detected on a surface of the microneedle. ### Claim 50 (depends on 49) The method of claim 49, wherein the microneedle is solid. ### Claim 51 (depends on 47) The method of claim 47, wherein the analyte is glucose. ### Claim 52 (depends on 47) The method of claim 47, wherein the bodily fluid is withdrawn from the subject through the microneedle.