# US 5,350,580 A · Device and method for extended delivery of pharmacologically active agents to the ear > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 5,350,580 A - Document ID: US5350580A - Status: Granted - Kind: A - Application number: 08/024,191 - Filed: 1993-02-26 - Granted: 1994-09-27 - Earliest claimed: 1990-03-05 - Assignees: Minnesota Mining and Manufacturing Company - Inventors: David C. Muchow; Larry M. Sirvio - Web page: https://patentgrep.com/patent/US5350580A ## CPC - A61K 9/0046: {Ear} - A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence)} - 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) - 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) - 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) ## Abstract A device useful for the treatment of infections of the middle ear in a prophylactic manner. A preferred device involves the use of a biodegradable support incorporating a therapeutically active agent, such as a drug. The device can be surgically inserted into the middle ear and there expand in order to substantially contact the walls of the middle ear. As it biodegrades, the expanded device provides prolonged, responsive release of active agent to the middle ear. ## Claims ### Claim 1 A method of treating otitis media comprising inserting into the middle ear a biodegradable, substantially permeable support device incorporating a therapeutically effective releasable amount of at least one pharmacologically active agent selected from the group consisting of antibacterials, antivirals, antifungals, fluorides, salts, glycerine and antiinflammatory medications, the characteristics of the device being that (1) the device is a cylindrical sheet or coiled filament retained or retainable in an insertable shape of initial dimensions that allow it to be surgically inserted into the middle ear; (2) upon insertion into the middle ear, the device is capable of expanding towards its original shape in order to provide a surface that substantially contacts the walls of the middle ear without substantially occluding the middle ear space; and (3) once expanded, the device is capable of providing extended release of the active agent to the middle ear. ### Claim 2 (depends on 1) The method according to claim 1 wherein the insertable shape is a cylindrical sheet having initial dimensions of a diameter of less than about 2 mm, a length of about 1 cm, and wherein the sheet unrolls in the middle ear to form a tube of on the order of 1 cm circumference and about 0.4 cm to about 0.6 cm diameter. ### Claim 3 (depends on 1) The method according to claim 1 wherein the support device biodegrades within about 2-18 months. ### Claim 4 A method of delivering pharmacologically active agents to the middle ear comprising inserting into the middle ear a biodegradable, substantially permeable support device incorporating a therapeutically effective releasable amount of at least one pharmacologically active agent, the characteristics of the device being such that (1) the device is provided retained or retainable in an insertable shape of initial dimensions that allow it to be surgically inserted into the middle ear; (2) upon insertion into the middle ear, the device is capable of expanding towards its original shape in order to provide a surface that substantially contacts the walls of the middle ear without substantially occluding the middle ear space; and (3) once expanded, the device is capable of providing extended release of the active agent to the middle ear; wherein the insertable shape is a cylindrical sheet having initial dimensions of a diameter of less than about 2 mm, a length of about 1 cm, and wherein the sheet unrolls in the middle ear to form a tube of on the order of 1 cm circumference and about 0.4 cm to about 0.6 cm diameter; wherein the support is made of a material selected from the group consisting of polyesteramides, polyglycolic acid, polylactic acid, copolymers of glycolide and lactide, polyvinyl alcohol, copolymers of polyethylene oxide and polylactic acid, and chemically modified coilagent compounds; and wherein the pharmacologically active agent is selected from the group consisting of antibacterials, antivirals, antifungals, osmotic agents, fluorides and antiinflammatory medications. ### Claim 5 A device to deliver pharmacologically active agents to the middle ear consisting essentially of biodegradable, substantially permeable support, incorporating a therapeutically effective releasable amount of at least one pharmacologically active agent selected from the group consisting of antibacterials, antivirals, antifungals, fluorides, salts, glycerine and antiinflammatory medications, the characteristics of the device being that (1) the device is retained or retainable as coiled filament having initial dimensions that allow it to be surgically inserted into the middle ear; (2) upon insertion into the middle ear, the device is capable of expanding towards its original shape in order to provide a surface that substantially contacts the walls of the middle ear without substantially occluding the middle ear space; (3) once expanded, the device is capable of providing extended release of the active agent to the middle ear; and (4) the support degrades within about 2-18 months when inserted into the middle ear.