# US 9,750,935 B2 · Patch and patch assembly for iontophoretic transdermal delivery of active agents for therapeutic and medicinal purposes > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,750,935 B2 - Document ID: US9750935B2 - Status: Granted - Kind: B2 - Application number: 14/524,891 - Filed: 2014-10-27 - Published: 2015-02-12 - Granted: 2017-09-05 - Earliest claimed: 2009-08-06 - Assignees: InCube Labs, LLC - Applicants: InCube Labs, LLC - Inventors: Mir A. Imran - Web page: https://patentgrep.com/patent/US9750935B2 ## CPC - A61N 1/30: Apparatus for iontophoresis, {i.e. transfer of media in ionic state by an electromotoric force into the body}, or cataphoresis - 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) - A61M 2037/0007: {having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - 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 Embodiments of the invention provide patch assemblies for iontophoretic transdermal delivery of therapeutic agents. An embodiment provides a patch assembly comprising a conformable patch for delivery of the agent and having a tissue contacting side including an adhesive. The housing has a bottom surface for engaging a non-tissue contacting side of the patch, a current source such as a battery and a controller for controlling the delivery of the agent. The housing has sufficient flexibility such that when it is engaged with the patch to form the patch assembly and the patch is adhered to a target site on the patient's skin, the assembly has sufficient flexibility to deform with movement of the patient's skin to remain sufficiently adhered to the skin over an extended period of time to transdermally deliver a desired dose of the agent. Embodiments of the assembly may used to deliver a variety of therapeutic agents. ## Claims ### Claim 1 A patch assembly for iontophoretic transdermal delivery of a therapeutic agent to a patient, the assembly comprising: a conformable patch having two electrodes, the patch having a tissue contacting side including an adhesive and a non-tissue contacting side, each of the electrodes including a porous layer to allow for the iontophoretic transdermal delivery of the therapeutic agent to the patient through the tissue contacting side, each of the electrodes configured to hold a medium to contain the therapeutic agent; a housing having a top surface and a bottom surface, the bottom surface configured to engage the non tissue contacting side of the conformable patch; a current source positioned in or on the housing, the current source configured to deliver direct current; a power inverter coupled to the current source, the power inverter configured to convert direct current from the current source to alternating current; and a controller positioned in or on the housing and configured to receive an alternating current and cause dispersion of the therapeutic agent to alternate between electrodes; wherein the housing has sufficient flexibility such that when the housing is engaged with the conformable patch to form the patch assembly, adhering the conformable patch to a target site on the patient's skin, the patch assembly has sufficient flexibility to deform with movement of the patient's skin so as to remain sufficiently adhered to the patient's skin over an extended period of time to transdermally deliver the agent. ### Claim 2 (depends on 1) The assembly of claim 1, where in the extended period of time is at least at day. ### Claim 3 (depends on 2) The assembly of claim 2, where in the extended period of time is at least three days. ### Claim 4 (depends on 3) The assembly of claim 3, where in the extended period of time is at least seven days. ### Claim 5 (depends on 1) The assembly of claim 1, further comprising at least one contact element positioned on the bottom surface of the housing for engaging and making electrical contact with the non tissue contacting side of the patch. ### Claim 6 (depends on 5) The assembly of claim 5, wherein, the contact element is operatively coupled to the controller. ### Claim 7 (depends on 1) The assembly of claim 1, wherein the housing includes at least one detachment element for mechanically disengaging the housing from the conformable patch. ### Claim 8 (depends on 7) The assembly of claim 7, wherein the detachment element is spring loaded. ### Claim 9 (depends on 1) The assembly of claim 1, wherein the controller comprises a first controller for controlling the delivery of the therapeutic agent and a second controller for controlling the delivery of current to the skin, where the first controller is configured to receive the alternating current and control the iontophoretic delivery of the therapeutic agent. ### Claim 10 (depends on 9) The assembly of claim 9, further comprising a current switching device operatively coupled to at least one of the first controller, the second controller or the current source. ### Claim 11 (depends on 10) The assembly of claim 10, wherein the current switching device comprises an H-bridge. ### Claim 12 (depends on 1) The assembly of claim 1, wherein the current source comprises an electrochemical battery, an alkaline battery, a lithium battery or a lithium-ion battery. ### Claim 13 (depends on 1) The assembly of claim 1, wherein the bottom surface of the housing has a curved contour. ### Claim 14 (depends on 13) The assembly of claim 13, wherein the curved contour corresponds to the contour of an arm, a leg or an abdomen. ### Claim 15 (depends on 1) The assembly of claim 1, wherein the housing has a profile shaped and sized to allow the patch assembly to be worn underneath the patient's clothing without substantially detaching from the patient's skin from movement of the patient's clothing or skin. ### Claim 16 (depends on 1) The assembly of claim 1, wherein the housing is conformable to a flexing contour of the patient's skin to allow the patch assembly to remain adhered to patient's skin over the extended period of time. ### Claim 17 (depends on 16) The assembly of claim 16, wherein the housing is conformable to a flexing contour of the patient's abdomen. ### Claim 18 (depends on 1) The assembly of claim 1, wherein the housing comprises a resilient polymer or an elastomer. ### Claim 19 (depends on 1) The assembly of claim 1, further comprising an input mechanism operatively coupled to the current source, the input mechanism configured to enable the patient to turn the current source on and off. ### Claim 20 (depends on 1) The assembly of claim 1, further comprising a bio-sensor coupled to the controller, the bio-sensor configured to detect a medical characteristic of the patient, wherein the controller controls the iontophoretic delivery of the therapeutic agent based on the medical characteristic. ### Claim 21 (depends on 1) The assembly of claim 1, wherein the housing has a flexibility to allow the patch assembly to deform with movement of the patient's skin. ### Claim 22 (depends on 1) The assembly of claim 1, wherein the housing includes one or more zones of increased flexibility which approximately align with at least one of the electrodes of the conformable patch. ### Claim 23 (depends on 1) The assembly of claim 1, wherein the housing is configured to allow the patch assembly to deform with movement of the patient's skin so as to not substantially affect the delivery of the therapeutic agent from the at least one electrode which is configured to hold the medium to contain the therapeutic agent as a result of forces from movement of the skin. ### Claim 24 (depends on 23) The assembly of claim 23, wherein the housing has a flexibility configured to allow the patch assembly to deform with movement of the patient's skin so as to not substantially affect the rate or total amount of delivery of the therapeutic agent from the at least one electrode which is configured to hold the medium to contain the therapeutic agent as a result of forces from movement of the skin. ### Claim 25 (depends on 1) The assembly of claim 1, wherein the therapeutic agent comprises elemental iron for treatment of iron deficient anemia. ### Claim 26 (depends on 25) The assembly of claim 25, wherein the patch assembly remains sufficiently adhered to the patient's skin for a sufficient period of time so as to transdermally deliver a therapeutic dose of elemental iron for the treatment of iron deficient anemia. ### Claim 27 (depends on 26) The assembly of claim 26, wherein the therapeutic dose of elemental iron is in the range of about 1 to about 100 mg. ### Claim 28 (depends on 1) The assembly of claim 1, wherein causing dispersion of the therapeutic agent to alternate between electrodes enables continuous transdermal delivery of the therapeutic agent using alternating points of the patient's skin to avoid skin irritation or saturation.