# US 11,298,261 B2 · Mouth piece for cooling of oral tissue of a user during therapeutic treatment > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,298,261 B2 - Document ID: US11298261B2 - Status: Granted - Kind: B2 - Application number: 15/687,969 - Filed: 2017-08-28 - Published: 2017-12-14 - Granted: 2022-04-12 - Earliest claimed: 2016-04-04 - Assignees: Chemomouthpiece, LLC - Applicants: Chemomouthpiece, LLC - Inventors: David Yoskowitz - Web page: https://patentgrep.com/patent/US11298261B2 ## CPC - A61F 7/12: Devices for heating or cooling internal body cavities - A61C 19/06: Implements for therapeutic treatment (radiation therapy A61N5/00) - A61F 7/10: Cooling bags, e.g. ice-bags - A61F 7/123: {using a flexible balloon containing the thermal element} - A61F 2007/0017: {Mouth} - A61F 2007/0056: {for cooling} - A61F 2007/0219: {Gels} - A61F 2007/0287: {Preventing negative effects of chemotherapy} - A61F 2007/108: {Cold packs, i.e. devices to be cooled or frozen in refrigerator or freezing compartment} - 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) - A61C: DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE (non-driven toothbrushes A46B; {tongue scrapers A61B17/24;} preparations for dentistry A61K6/00; preparations for cleaning the teeth or mouth A61K8/00, A61Q11/00) ## Abstract The invention is directed to a mouth piece for cooling of oral tissue of a patient during chemotherapy treatment. The mouth piece includes a cooling medium contained within the top element and the bottom element and able to retain a cooling environment within the mouth sufficient to reduce capillary blood flow to the patient's mouth. In one embodiment, an external chamber extends from the front of the mouth piece to house a cooling medium. The external chamber can be configured so that it is removably attached to the mouth piece. A support device can be utilized to support the external chamber during use. ## Claims ### Claim 1 A mouth piece for cooling of oral tissue of a user during therapeutic treatment comprising: a malleable top element configured to rest adjacent at least major surfaces of the upper gums and teeth of the user's mouth in a close-fitting relationship; a malleable bottom element configured to rest adjacent at least major surfaces of the lower gums and teeth of the user's mouth in a close-fitting relationship; wherein the top element is integral with or connected to the bottom element to permit emplacement in the mouth as a one-piece unit; an aperture positioned in a frontal location of the mouthpiece and configured to permit the user to breathe through the mouth when the mouth piece is emplaced within the mouth in said operative close-fitting relationship; a cooling medium contained within the top element and the bottom element and able to retain a cooling environment within the mouth sufficient to reduce capillary blood flow to the user's mouth; wherein the cooling medium includes a first coolant and a second coolant, the first coolant is positioned within the mouth piece in areas configured to rest in proximity to the teeth creating a first cooling zone, the second coolant is positioned within the mouth piece in areas configured to rest in proximity to the gums creating a second cooling zone; and wherein the first cooling zone has a lower specific heat than the second cooling zone, such that the area in proximity to the teeth is cooled less than the area in proximity to the gums. ### Claim 2 (depends on 1) The mouth piece according to claim 1, wherein the mouth piece has flexible inner and outer walls and is adapted to self-adjust its configuration to the size and shape of the user's mouth. ### Claim 3 (depends on 1) The mouth piece according to claim 1, further comprising a support device for supporting the first chamber of the mouth piece, the support device comprising: a sling having a surface for receiving the first chamber; and at least two support legs extending from the sling, wherein the support legs are configured to rest on a rigid surface for supporting the first chamber during use. ### Claim 4 (depends on 3) The mouth piece according to claim 3, wherein the support legs are configured to telescope and adjust to accommodate various positions. ### Claim 5 (depends on 1) The therapeutic oral device mouth piece of claim 1, wherein the first freezing temperature of the first solution is below 0 degrees Celsius. ### Claim 6 A mouth piece for cooling of oral tissue of a user during therapeutic treatment, the mouthpiece being insertable into the user's mouth and comprising: a malleable top element configured to rest adjacent at least major surfaces of the upper gums and teeth of the user's mouth in a close-fitting relationship; a malleable bottom element configured to rest adjacent at least major surfaces of the lower gums and teeth of the user's mouth in a close-fitting relationship; wherein the top element is integral with or connected to the bottom element to permit emplacement in the mouth as a one-piece unit its an operative close-fitting relationship; a first chamber extending directly from a front of the mouth piece fir storing a cooling medium comprised of a first solution having a first freezing temperature; an aperture positioned in a frontal location and extending through the first chamber that permits the user to breathe through the mouth via the aperture when the mouth piece is emplaced within the mouth in said operative close-fitting relationship; a second chamber positioned inside the first chamber and containing a second solution having a second freezing point above the first freezing point temperature of the first solution to assist in cooling the first solution; and one or more bladders positioned within the top element and the bottom element, wherein the one or more bladders are fluidly connected to the first chamber for receiving the cooling medium which flows throughout the first chamber, the top element and the bottom element to cool the oral tissue in the user's mouth. ### Claim 7 (depends on 6) The mouth piece according to claim 6, in which the first solution is salt water. ### Claim 8 (depends on 6) The mouth piece according to claim 6, in which the second solution is water. ### Claim 9 (depends on 6) The mouth piece according to claim 6, further comprising a separation wall positioned between the first chamber and the second chamber. ### Claim 10 (depends on 6) The mouth piece according to claim 6, in which the second chamber is smaller than the first chamber. ### Claim 11 (depends on 10) The mouth piece according to claim 10, wherein the second chamber is configured to move freely inside of the first chamber. ### Claim 12 (depends on 10) The mouth piece according to claim 10, in which the second chamber is spherically-shaped. ### Claim 13 (depends on 6) The mouth piece according to claim 6, in which the first chamber includes an outer insulation wall. ### Claim 14 (depends on 13) The mouth piece according to claim 13, in which the outer insulation wall provides elasticity to allow a user to squeeze the contents and assist the flow of the cooling medium. ### Claim 15 (depends on 6) The mouth piece according to claim 6, further comprising mating elements which are dimensioned and configured to permit the first chamber to be removably attached to the mouth piece. ### Claim 16 (depends on 15) The mouth piece according to claim 15, wherein the mating elements are positioned at a proximal end of the first chamber and the front of the mouth piece. ### Claim 17 (depends on 15) The mouth piece according to claim 15, wherein the mating elements include tongue and groove mating surfaces to permit a removable snap fit attachment. ### Claim 18 (depends on 15) The mouth piece according to claim 15, wherein the mating elements include threaded mating surfaces to permit a removable screw fit attachment. ### Claim 19 (depends on 6) The mouth piece according to claim 6, further comprising at least one valve positioned between the one or more bladders and the first chamber for controlling the flow of the cooling medium. ### Claim 20 (depends on 19) The mouth piece according to claim 19, wherein the at least one valve is a duck bill valve, including a flexible tunnel that is configured to open when pressure is applied by the flow of the cooling medium. ### Claim 21 (depends on 6) The mouth piece according to claim 6, wherein the first chamber is positioned between the mouth piece and the second chamber. ### Claim 22 (depends on 6) The mouth piece according to claim 6, wherein the first chamber includes a cavity forming a distal opening that is configured and dimensioned to receive the second chamber in a nested arrangement. ### Claim 23 (depends on 22) The mouth piece according to claim 22, wherein each of the first chamber and the second chamber include tapered proximal end portions. ### Claim 24 (depends on 6) The therapeutic oral device mouth piece of claim 6, wherein the first freezing temperature of the first solution is below 0 degrees Celsius. ### Claim 25 A hand-held therapeutic oral device for cooling oral tissue of a user comprising: a mouthpiece including at least one malleable element configured to rest adjacent one or more oral tissue surfaces of the user's mouth in a close-fitting relationship; a first container having a proximal end directly attached to a front portion of the mouth piece, the first container including a first chamber which stores a first coolant having a first freezing temperature, the first coolant being in fluid communication with the at least one malleable element of the mouthpiece, the first container being configured and dimensioned to enable the user to guide the mouthpiece of the hand-held oral device in and out of the user's mouth; and a second chamber positioned within the first chamber which stores a second coolant having a freezing point above the freezing point temperature of the first coolant, wherein the second chamber is positioned within the first chamber such that the second coolant assists in cooling the first solution, and the first coolant assists in cooling of the at least one malleable element for the one or more oral tissue surfaces of the user. ### Claim 26 (depends on 25) The therapeutic oral device of claim 25, wherein the first coolant from the first chamber flows through the at least one malleable element. ### Claim 27 (depends on 25) The therapeutic oral device of claim 25, wherein the first coolant is salt water and the second solution is water. ### Claim 28 (depends on 25) The therapeutic oral device of claim 25, wherein the at least one malleable element includes a malleable top element configured to rest adjacent at least major gum surfaces of the user's mouth in a close-fitting relationship; a malleable bottom element configured to rest adjacent at least major gum surfaces of the user's mouth in a close-fitting relationship; and wherein the top element is integral with or connected to the bottom element to permit emplacement in the mouth as a one-piece unit. ### Claim 29 (depends on 25) The therapeutic oral device mouth piece of claim 25, wherein the first freezing temperature of the first coolant is below 0 degrees Celsius. ### Claim 30 (depends on 25) The therapeutic oral device mouth piece of claim 25, wherein the first coolant is a salt solution and the second coolant is water. ### Claim 31 (depends on 25) The therapeutic oral device mouth piece of claim 25 further comprising an aperture extending through the mouthpiece and the first container that permits the user to breathe through the mouth via the aperture when the mouth piece is emplaced within the user's mouth. ### Claim 32 (depends on 25) The therapeutic oral device mouth piece of claim 25 further comprising at least one valve positioned between the first container and the mouthpiece for controlling the flow of the cooling medium. ### Claim 33 (depends on 25) The therapeutic oral device mouth piece of claim 25, wherein a front portion of the mouthpiece includes a first mating connector, and the first container includes a proximate end with a second mating connector configured to interlock with the first mating connector at the front portion of the mouth piece. ### Claim 34 (depends on 33) The therapeutic oral device mouth piece of claim 33, wherein the first and second mating connectors include a tongue and groove arrangement. ### Claim 35 (depends on 33) The therapeutic oral device mouth piece of claim 33, wherein the first and second mating connectors include threaded mating surfaces.