# US 6,895,965 B2 · Customizable seal, mask with customizable seal and method of using such a seal > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 6,895,965 B2 - Document ID: US6895965B2 - Status: Granted - Kind: B2 - Application number: 10/106,658 - Filed: 2002-03-26 - Published: 2002-08-01 - Granted: 2005-05-24 - Earliest claimed: 1995-09-08 - Assignees: Respironics, Inc. - Inventors: Eugene N. Scarberry; Ronald E. White; Benedict R. McElroy - Web page: https://patentgrep.com/patent/US6895965B2 ## CPC - A62B 18/00: Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes {or incorporating a pump or compressor for reducing the inhalation effort}(A62B17/00 takes precedence; anaesthetic masks A61M16/06) - A61M 16/06: Respiratory or anaesthetic masks - A61M 16/0605: {Means for improving the adaptation of the mask to the patient} - A61M 16/0616: {with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure} - A61M 16/0633: {with forehead support} - A61M 16/0825: {with ball-sockets} - A62B 18/025: {Halfmasks (A62B23/02 takes precedence; surgical face masks A41D13/11)} - A62B 18/08: Component parts for gas-masks or gas-helmets, e.g. windows, straps, speech transmitters, signal-devices (eye-pieces for protective goggles A61F9/02; composition of materials for the windows or other transparent parts A62D7/00) - A61M 16/0683: {Holding devices therefor} - A61M 2016/0661: {with customised shape} - A61M 2205/0238: the material being a coating or protective layer - A61M 2210/0618: Nose - A62B: DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING (valves specially adapted for medical use A61M39/00; life-saving devices, apparatus or methods specially adapted for use in water B63C9/00; divers' equipment B63C11/00; specially adopted for use with aircraft, e.g. parachutes, ejector seats, {B64D17/00, B64D25/10}; rescue devices peculiar to mining E21F11/00) - 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 A seal and a mask having a seal adapted for confronting engagement with a surface of a user to form an interface therewith. The seal includes a first portion defined by a gel substance and a second portion associated with the first portion. The second portion includes a selectively formable substance adapted to be molded from a first pattern into a second pattern and to retain the second pattern responsive to being so molded. The seal and mask having the seal is tailored to patient by causing the formable portion of the seal to be placed in a malleable state, applying the seal to the patient while the formable portion is in the malleable state, and causing the formable portion to be placed in a fixed state to retain a shape generally conforming to the portion of the patient underlying the seal. ## Claims ### Claim 1 A method of interfacing a patient with an external device, comprising: providing an external device to be interfaced with a patient; providing a seal having a first surface operatively coupled to the external device and a second surface adapted for confronting engagement with an external surface of a patient to form an interface therewith, wherein the seal includes a selectively formable portion having a first pattern that is adapted to be molded into a second pattern and to retain the second pattern responsive to being so molded, and wherein the selectively formable portion includes a combination of a gel substance and a selectively formable stiffening agent; and applying the seal to such an external surface of a patient by applying a compressive force on the formable portion of the seal so that the formable portion takes on the second pattern generally conforming to contours of a portion of such a patient underlying the seal, wherein the formable portion retains the second pattern even after the compressive force is removed from the formable portion. ### Claim 2 (depends on 1) A method according to claim 1, wherein the seal further comprises a first portion defined by a gel substance substantially integrally associated with said selectively formable portion, said first portion being arranged relative to the selectively formable portion such that said first portion is disposed between a patient and the selectively formable portion responsive to said external device being dispose on such a patient. ### Claim 3 (depends on 1) A method according to claim 1, wherein the selectively formable stiffening agent is a thermally activated material, and further comprising enabling the formable portion of the seal to be molded from the first pattern to the second pattern by heating the formable portion to a temperature sufficient to activate the thermally activated material. ### Claim 4 (depends on 3) A method according to claim 3, wherein heating the formable portion of the seal includes placing said seal in a heated fluid for a first predetermined period of time and, thereafter, quenching said seal in a reduced temperature fluid for second predetermined period of time so that an exterior surface of said seal has a temperature suitable to be applied to a human without substantial discomfort. ### Claim 5 (depends on 1) A method according to claim 1, further comprising retaining the seal on such a patient while the formable portion from the first pattern to the second pattern. ### Claim 6 (depends on 1) A method according to claim 1, further comprising providing a retaining member proximate to said seal to prevent movement of the seal.