# US 11,298,267 B2 · System for inner ear drug delivery via trans-round window membrane injection > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,298,267 B2 - Document ID: US11298267B2 - Status: Granted - Kind: B2 - Application number: 16/272,395 - Filed: 2019-02-11 - Published: 2019-06-06 - Granted: 2022-04-12 - Earliest claimed: 2016-06-22 - Assignees: The Charles Stark Draper Laboratory, Inc. - Applicants: The Charles Stark Draper Laboratory, Inc.; Massachusetts Eye and Ear Infirmary - Inventors: Ernest S. Kim; Michael McKenna; Ruwan Kiringoda - Web page: https://patentgrep.com/patent/US11298267B2 ## CPC - 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) - A61M 5/142: Pressure infusion, e.g. using pumps - 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}) - A61M 2210/0662: Ears - 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) - 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 The present disclosure discussed a handpiece for trans-canal delivery of a therapeutic substance to the inner ear. The handpiece can be inserted into the middle ear via a surgical tympanotomy approach. The handpiece can enable a controlled injection of a therapeutic substance directly through the round window membrane and into the inner ear. The direct delivery of the therapeutic substance to the inner ear can enable the delivery of a precise amount of therapeutic substance into the inner ear. Because the therapeutic substance is delivery directly to the inner ear the delivery of the therapeutic substance is not subject to limitations on molecule size and inconsistent diffusion rates that are present when therapeutic substances are diffused across the round window membrane. ## Claims ### Claim 1 A handpiece to deliver a fluid to an ear, comprising: a tool shaft comprising a first distal end, a first proximal end, a first fluidic channel; a tip portion coupled with the tool shaft and comprising an outlet and a second fluidic channel in communication with the first fluidic channel; an angled portion between the tool shaft and the tip portion and configured to rotate with respect to the tool shaft; and a collar coupled with the tip portion a predetermined distance from the outlet, the collar configured to seat with a round window and control a distance the tip portion projects into a cochlea. ### Claim 2 (depends on 1) The handpiece of claim 1, wherein the angled portion comprises a second distal end, a second proximal end coupled with the first distal end, a third fluidic channel in communication with the first fluidic channel, and a first longitudinal axis defining an angle with a second longitudinal axis of the tool shaft configured for trans-canal positing of the tip portion at the round window. ### Claim 3 (depends on 2) The handpiece of claim 2, wherein the angle is between about 140° and about 170°. ### Claim 4 (depends on 2) The handpiece of claim 2, wherein the tip portion projects from the angled portion at an angle between about 75° and about 130°. ### Claim 5 (depends on 2) The handpiece of claim 2, wherein the tip portion projects from the angled portion at an angle between about 110° and about 120°. ### Claim 6 (depends on 1) The handpiece of claim 1, further comprising a fluid reservoir in communication with the outlet via the first fluidic channel and the second fluidic channel. ### Claim 7 (depends on 6) The handpiece of claim 6, the fluid reservoir further comprising a pierceable septum configured to enable filling of the fluid reservoir. ### Claim 8 (depends on 1) The handpiece of claim 1, further comprising: a fluid reservoir; and a self-contained pumping system coupled with the tool shaft and configured to pump a fluid from the fluid reservoir to the outlet. ### Claim 9 (depends on 1) The handpiece of claim 1, wherein the first fluidic channel and the second fluidic channel form a fluid channel. ### Claim 10 (depends on 1) The handpiece of claim 1, wherein the tip portion is configured to rotate with respect to the tool shaft. ### Claim 11 (depends on 1) The handpiece of claim 1, wherein the collar is substantially dome shaped. ### Claim 12 (depends on 1) The handpiece of claim 1, wherein the first fluidic channel is encased within the tool shaft and the second fluidic channel is encased within the tip portion. ### Claim 13 (depends on 1) The handpiece of claim 1, wherein each of the first fluidic channel and the second fluidic channel are encased in a sterilizable plastic. ### Claim 14 A handpiece to deliver a fluid to an ear, comprising: a tool shaft comprising a first distal end, a first proximal end, a first fluidic channel; a tip portion coupled with the tool shaft and comprising an outlet and a second fluidic channel in communication with the first fluidic channel, the tip portion is configured to detach from the tool shaft; and a collar coupled with the tip portion a predetermined distance from the outlet, the collar configured to seat with a round window and control a distance the tip portion projects into a cochlea. ### Claim 15 A method comprising: providing a handpiece comprising: a tool shaft comprising a first distal end, a first proximal end, a first fluidic channel; a tip portion coupled with the tool shaft and comprising an outlet and a second fluidic channel in communication with the first fluidic channel; and a collar coupled with the tip portion a predetermined distance from the outlet, the collar configured to seat with a round window and control a distance the tip portion projects into a cochlea; piercing a round window membrane covering the round window with the tip portion; setting a rotational offset between the tip portion and an angled portion of the handpiece; and flowing a fluid through the outlet and into the cochlea via the first fluidic channel and the second fluidic channel. ### Claim 16 (depends on 15) The method of claim 15, further comprising forming a ventilation hole in a stapes footplate. ### Claim 17 (depends on 15) The method of claim 15, further comprising flowing, by a self-contained pumping system coupled with the tool shaft, the fluid from a reservoir. ### Claim 18 (depends on 15) The method of claim 15, further comprising seating the collar in the round window.