# US 10,478,344 B2 · Adhesive earplugs useful for sealing the ear canal > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,478,344 B2 - Document ID: US10478344B2 - Status: Granted - Kind: B2 - Application number: 15/154,496 - Filed: 2016-05-13 - Published: 2016-12-15 - Granted: 2019-11-19 - Earliest claimed: 2012-05-30 - Assignees: Tusker Medical, Inc. - Applicants: Tusker Medical, Inc. - Inventors: Rohit Girotra; Bernard H. Andreas; Alfredo Cantu; Nikhil Bhat; Mansour Saleki; Shrirang V. Ranade; Miranda Ray - Web page: https://patentgrep.com/patent/US10478344B2 ## CPC - A61F 11/08: internal, e.g. earplugs - A61N 1/0428: {Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs} - A61F 11/00: Methods or devices for treatment of the ears or hearing sense (implantable prostheses that substitute or replace internal ear parts, e.g. ear-drums, A61F2/18; methods or devices to cause a change in the state of auditory consciousness A61M21/00; electrotherapy applying electrical stimulation of the auditory system, or circuits therefor A61N1/36; radiotherapy using optical stimulation of the auditory system A61N5/06; electro-acoustic hearing aids H04R25/00); Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand (headwear, e.g. caps or helmets, with means for protecting the ears A42B1/0188, A42B3/16) - A61F 11/12: External mounting means - A61M 31/00: Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008}) - A61N 1/306: {Arrangements where at least part of the apparatus is introduced into the body} - A61F 11/085: {including an inner channel} - A61M 2202/048: Anaesthetics - A61N 1/325: {for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body (electrodes for external use A61N1/0428)} - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - 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 Systems and methods are provided for sealing an ear canal for retaining a solution in the ear canal. Adhesive earplugs are provided through which the solution can be delivered, and which, following delivery, retain the fluid in the ear canal. The systems and methods may also be useful for delivering an anesthetizing solution to the ear canal of a human patient and for maintaining the solution therein for use with an iontophoresis system for anesthetizing the tympanic membrane. ## Claims ### Claim 1 An earplug comprising: a dome-shaped portion for insertion into an ear canal, said dome-shaped portion having an outside surface and an inside surface; a pressure sensitive adhesive positioned on the outside surface of the dome-shaped portion and configured to contact a surface of the ear canal to define a space in the ear canal between the dome-shaped portion and a tympanic membrane such that a solution delivered into the space can be retained in the space for a period of time; and a liner in a folded configuration configured to protect the pressure sensitive adhesive when the dome-shaped portion with the pressure sensitive adhesive positioned thereon is inserted into the ear canal, the liner configured to unfold after the dome-shaped portion is positioned in the ear canal such that the pressure sensitive adhesive is exposed for contact with the surface of the ear canal. ### Claim 2 (depends on 1) The earplug of claim 1, further comprising a flange surrounding the dome-shaped portion. ### Claim 3 (depends on 2) The earplug of claim 2, wherein the flange surrounds 180 to 360 degrees of the dome-shaped portion. ### Claim 4 (depends on 2) The earplug of claim 2, wherein the flange includes notches. ### Claim 5 (depends on 1) The earplug of claim 1, wherein the solution includes at least one of: an anesthetizing solution, an antibacterial solution, an antifungal solution, an anti-inflammatory solution, or a ceruminolytic solution. ### Claim 6 (depends on 5) The earplug of claim 5, wherein the solution is an anesthetizing solution including at least one of: lidocaine; a combination of lidocaine and epinephrine; or a combination of lidocaine, epinephrine, and sodium bicarbonate. ### Claim 7 (depends on 1) The earplug of claim 1, further comprising a shaft portion for connection to a fill system through which the solution is delivered into the space in the ear canal, the dome-shaped portion surrounding a portion of the shaft portion. ### Claim 8 (depends on 1) The earplug of claim 1, wherein the pressure sensitive adhesive includes at least one of: a silicone, an acrylic, butyl rubber, ethylene-vinyl acetate, natural rubber, a nitrile, or a styrene block copolymer. ### Claim 9 (depends on 1) The earplug of claim 1, wherein the liner has (1) a first portion that is configured to wrap around a portion of the dome-shaped portion to cover the pressure sensitive adhesive and (2) a second portion that is configured to fold over and onto the first portion. ### Claim 10 (depends on 1) The earplug of claim 1, wherein the liner includes a gripping element configured to be pulled to unfold the liner and remove the liner from the earplug. ### Claim 11 A system, comprising: an earplug for use in retaining a solution in an ear canal of the human patient, the earplug comprising: a dome-shaped portion for insertion into the ear canal, the dome-shaped portion having an outside surface and an inside surface; and a pressure sensitive adhesive positioned on the outside surface of the dome-shaped portion and configured to contact a surface of the ear canal to define a space in the ear canal between the dome-shaped portion and a tympanic membrane such that the solution can be retained in the space for a period of time; a fill system configured to deliver the solution into the space in the ear canal; and a liner including a gripping element, the liner configured to protect the pressure sensitive adhesive when the dome-shaped portion with the pressure sensitive adhesive positioned thereon is inserted into the ear canal to enable the dome-shaped portion to be positioned in the ear canal before the liner is removed by pulling on the gripping element. ### Claim 12 (depends on 11) The system of claim 11, further comprising vent features. ### Claim 13 (depends on 12) The system of claim 12, wherein the vent features include at least one of: a vent hole or a vent slit. ### Claim 14 (depends on 11) The system of claim 11, further comprising a flange surrounding the dome-shaped portion. ### Claim 15 (depends on 11) The system of claim 11, wherein the fill system further includes a fill tip including a plurality of spray holes. ### Claim 16 (depends on 11) The system of claim 11, wherein the solution includes a therapeutic agent, the system further comprising an electrode to supply a current to drive the therapeutic agent, via iontophoretic delivery, into the tympanic membrane. ### Claim 17 A method, comprising: positioning a dome-shaped portion of an earplug in an ear canal of a human patient, the dome-shaped portion configured to fit against a surface of the ear canal and including a pressure sensitive adhesive positioned thereon, the pressure sensitive adhesive covered by a liner; removing, after the dome-shaped portion is positioned in the ear canal, the liner by rolling back a portion of the liner to expose the pressure sensitive adhesive such that the dome-shaped portion adheres to the surface of the ear canal; delivering, via a fill system, a solution including a therapeutic agent into a space between the earplug and a tympanic membrane; and supplying an electric current to the solution to deliver the therapeutic agent to the tympanic membrane. ### Claim 18 (depends on 17) The method of claim 17, wherein the therapeutic agent includes at least one of: lidocaine; a combination of lidocaine and epinephrine; and a combination of lidocaine, epinephrine, and sodium bicarbonate. ### Claim 19 (depends on 17) The method of claim 17, further comprising, prior to delivering the solution into the space, warming the solution to body temperature. ### Claim 20 (depends on 17) The method of claim 17, wherein the liner includes a gripping element, and the removing the liner includes pulling on the gripping element such that the portion of the liner covering the pressure sensitive adhesive is rolled back to expose the pressure sensitive adhesive.