# US 12,721,986 B2 · Systems and methods for microneedle therapeutic delivery with acoustic signals > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,721,986 B2 - Document ID: US12721986B2 - Status: Granted - Kind: B2 - Application number: 18/290,105 - Filed: 2022-05-11 - Published: 2025-10-30 - Granted: 2026-09-01 - Earliest claimed: 2021-05-12 - Assignees: The Trustees of Indiana University - Applicants: The Trustees of Indiana University - Inventors: Feng Guo; Hongwei Cai; Junhua Xu - Web page: https://patentgrep.com/patent/US12721986B2 ## CPC - A61M 37/0092: {using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis} - A61M 37/0015: {by using microneedles} - A61M 2037/0023: {Drug applicators using 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)} ## Abstract Disclosed is a system for therapeutic delivery. The system includes a microneedle patch and an acoustic transducer configured to alter the delivery of the therapeutic from the patch. The acoustic parameters may be determined from a therapeutic release model. The system may also be contained within a housing which may be at least partially removed to deliver the therapeutic. The transducer provides control over the delivery of the therapeutic. ## Claims ### Claim 1 A therapeutic delivery system comprising: a microneedle patch housing; a microneedle patch supported by the microneedle patch housing and comprising a first side and a second side; an array of microneedles is positioned on the first side of the microneedle patch, the array of microneedles containing a volume of a therapeutic; and an acoustic transducer coupled to the second side of the microneedle patch and configured to generate an adjustable acoustic signal with a plurality of acoustic parameters including a frequency, a duty cycle, an energy density, and a signal delivery time; wherein diffusion of the therapeutic from of the microneedle patch is controllable by altering at least one of the acoustic parameters, and at least one of the acoustic parameters is determined by a therapeutic release model configured to: calculate an acoustic field distribution; calculate a streaming field based on the acoustic field distribution; and calculate the at least one diffusion parameter based on the streaming field, wherein the at least one acoustic parameter is determined based on the at least one diffusion parameter. ### Claim 2 (depends on 1) The therapeutic delivery system of claim 1, wherein the at least one diffusion parameter comprises a rate of diffusion. ### Claim 3 (depends on 1) The therapeutic delivery system of claim 1, wherein the therapeutic comprises at least one of hormones, vaccines, analgesics, phenothiazines, antihistamines, antitussives, and sedatives. ### Claim 4 (depends on 1) The therapeutic delivery system of claim 1, wherein the frequency is from 0.1 MHz to 10 GHz, the duty cycle is from 0.1% to 100%, the energy density is from 0.1 mW/cm2 to 10.0 W/cm2, and the signal delivery time is from 1 second to 1 hour. ### Claim 5 (depends on 1) The therapeutic delivery system of claim 1, further comprising a waveform generator operatively coupled to the acoustic transducer and configured to alter the plurality of acoustic parameters. ### Claim 6 (depends on 1) The therapeutic delivery system of claim 1, wherein each microneedle in the array of microneedles has a diameter from 0.1 microns to 50 microns, a length from 1 micron to 2 mm, and contains a volume of therapeutic from 0.1 μL to 2 mL, and the microneedle patch has an area from 1 cm2 to 500 cm2. ### Claim 7 (depends on 1) The therapeutic delivery system of claim 1, wherein the therapeutic model comprises a multiphysics simulation. ### Claim 8 (depends on 1) The therapeutic delivery system of claim 1, wherein the microneedle patch is composed of at least one of a polymer and a metal, and the acoustic transducer comprises a piezoelectric material; the microneedle patch housing is transportable, and the microneedle patch, the acoustic transducer, and a power source operatively coupled to the acoustic transducer are all configured to be contained within the microneedle patch housing; or the microneedle patch housing comprises an actuator configured to at least partially remove the microneedle patch from the microneedle patch housing. ### Claim 9 A method of delivering a therapeutic comprising the steps of: at least partially removing a microneedle patch from a housing; positioning the microneedle patch on a surface such that a plurality of microneedles penetrate at least a portion of the surface; determining at least one acoustic signal parameter based on a therapeutic release model, the therapeutic release model configured to: calculate an acoustic field distribution; calculate a streaming field based on the acoustic field distribution; and calculate the at least one diffusion parameter based on the streaming field, wherein the at least one acoustic signal parameter is determined based on the at least one diffusion parameter; supplying power to an acoustic transducer coupled to the microneedle patch; generating an acoustic signal comprising the at least one acoustic signal parameter; applying the acoustic signal to the microneedle patch; delivering a volume of the therapeutic through the surface over a delivery time at a delivery rate; and controlling the delivery rate by altering the at least one acoustic signal parameter. ### Claim 10 (depends on 9) The method of claim 9, wherein the at least one acoustic signal parameter comprises at least one of a frequency, a duty cycle, and an energy density. ### Claim 11 (depends on 10) The method of claim 10, wherein the frequency is adjustable from 0.1 MHz to 10 GHz, the duty cycle is adjustable from 0.1% to 100%, and the energy density is adjustable from 0.1 mW/cm2 to 10.0 W/cm2. ### Claim 12 (depends on 9) The method of claim 9, wherein the microneedle patch comprises an array of microneedles arranged in a grid, wherein the grid is from 2×2 to 30×30. ### Claim 13 (depends on 12) The method of claim 12, wherein the therapeutic comprises epinephrine and the method further comprises the step of treating anaphylaxis; or the therapeutic is contained within a tip of each of the microneedles in the array of microneedles, and the array of microneedles contains at least 1 μL of the therapeutic. ### Claim 14 (depends on 9) The method of claim 9, wherein the step of at least partially removing the microneedle patch from the hosing is carried out by a mechanical actuator. ### Claim 15 (depends on 9) The method of claim 9, wherein the delivering step delivers at least 1 μL of a therapeutic over a time of at least 10 minutes; the delivery rate is at least two times greater than the delivery rate of a passive microneedle patch without an acoustic signal; or the delivering step increases the concentration of therapeutic in the surface by at least 20 mg/mL when the delivery time is at least 6 minutes.