# US 11,998,315 B2 · Custom patient interface and methods for making same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,315 B2 - Document ID: US11998315B2 - Status: Granted - Kind: B2 - Application number: 18/077,633 - Filed: 2022-12-08 - Published: 2023-04-13 - Granted: 2024-06-04 - Earliest claimed: 2014-07-02 - Assignees: ResMed Pty Ltd - Applicants: ResMed Pty Ltd - Inventors: Tzu-Chin Yu; Aaron Samuel Davidson; Robert Henry Frater; Benjamin Peter Johnston; Paul Jan Klasek; Robert Anthony Paterson; Quangang Yang; Gerard Michael Rummery; Priyanshu Gupta; Liam Holley; Gordon Joseph Malouf - Web page: https://patentgrep.com/patent/US11998315B2 ## CPC - A61B 5/107: Measuring physical dimensions, e.g. size of the entire body or parts thereof - A61B 5/1077: {Measuring of profiles} - A61B 5/6819: {Nose} - A61M 16/0066: {Blowers or centrifugal pumps} - A61M 16/06: Respiratory or anaesthetic masks - A61M 16/0683: {Holding devices therefor} - A61M 16/0688: {by means of an adhesive} - A61M 16/107: {in the inspiratory path} - A61M 16/16: Devices to humidify the respiration air {(A61M16/1045 takes precedence)} - G06T 19/00: Manipulating three-dimensional [3D] models or images for computer graphics - G06T 19/20: Editing of three-dimensional [3D] images, e.g. changing shapes or colours, aligning objects or positioning parts - G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture - G16H 40/67: for remote operation - A61M 16/1055: {bacterial} - A61M 16/109: {the humidifying liquid or the beneficial agent} - A61M 16/1095: {in the connecting tubes} - A61M 2016/0033: {electrical} - A61M 2016/0661: {with customised shape} - A61M 2205/3368: Temperature - A61M 2207/00: Methods of manufacture, assembly or production - G06T 2210/41: Medical - G16H 50/50: for simulation or modelling of medical disorders - Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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)} - G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA - Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE ## Abstract A method of manufacturing a patient interface for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to the patient's airways includes collecting anthropometric data of a patient's face. Anticipated considerations are identified from the collected anthropometric data during use of the patient interface. The collected anthropometric data is processed to provide a transformed data set based on the anticipated considerations, the transformed data set corresponding to at least one customised patient interface component. At least one patient interface component is modelled based on the transformed data set. ## Claims ### Claim 1 A patient interface for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to a patient's nares, the patient interface comprising: a mask assembly comprising a frame component having an opening to a delivery tube and having a plurality of vent holes in a row along a surface of the frame component; a sealing element coupleable to the mask assembly and configured to be in contact with the patient's face in use, wherein the frame component and the sealing element form a plenum chamber that defines a cavity by a perimeter of the patient's nares; and a positioning and stabilising structure, coupled to the mask assembly, the positioning and stabilising structure being configured to maintain the sealing element in sealing contact with an area surrounding the entrance to the patient's nares while maintaining a therapeutic pressure at the entrance to the patient's nares; wherein at least one of the mask assembly, the sealing element and the positioning and stabilising structure is configured to compensate for skin movement and deformation. ### Claim 2 (depends on 1) The patient interface of claim 1, wherein the positioning and stabilising structure is configured to compensate for lateral skin sheer of between approximately 1 mm and approximately 30 mm with respect to a longitudinal axis of the patient's face. ### Claim 3 (depends on 1) The patient interface of claim 1, wherein the positioning and stabilising structure is configured to compensate for nare angle deflection of between approximately 1 degree and 30 degrees. ### Claim 4 (depends on 1) The patient interface of claim 1, wherein the mask assembly, the sealing element, and the positioning and stabilising structure is configured to compensate for an upward movement of corners and middle of a nose of a maximum of approximately 9 mm and approximately 4 mm, respectively. ### Claim 5 (depends on 1) The patient interface of claim 1, wherein the positioning and stabilising structure is configured to compensate for an increase in a width of the patient's nose of between approximately 1 mm and approximately 4 mm. ### Claim 6 (depends on 1) The patient interface of claim 1, wherein the positioning and stabilising structure is configured to compensate for a cheek bulge from a first condition to a second condition, the first condition and second condition being spaced by between approximately 1 mm and 10 mm. ### Claim 7 (depends on 1) The patient interface of claim 1, wherein the positioning and stabilising structure includes a first portion and a second portion, the first portion and the second portion being configured to compensate for perturbations such that the sealing element remains in contact with the patient's face when a force of up to 10 Newtons is applied to a portion of the positioning and stabilising structure. ### Claim 8 (depends on 7) The patient interface of claim 7, wherein the first portion is formed of a non-elastic material and the second portion is formed of an elastic material. ### Claim 9 (depends on 1) The patient interface of claim 1, wherein the positioning and stabilising structure includes a first portion and a second portion, at least one of the first portion and the second portion having an elastic material configured to compensate for perturbations such that the sealing element remains in contact with the patient's face when a force of up to 10 Newtons is applied to the positioning and stabilising structure. ### Claim 10 (depends on 1) The patient interface of claim 1, wherein the positioning and stabilising structure includes a first portion, a second portion, and a path portion coupled to the first portion and coextensive with the second portion, the second portion being capable of translation along the path portion. ### Claim 11 (depends on 10) The patient interface of claim 10, wherein the path portion comprises a wireframe. ### Claim 12 (depends on 1) The patient interface of claim 1, wherein at least one of the mask assembly, the sealing element and the positioning and stabilising structure is configured to compensate for longitudinal skin sheer of between approximately 1 mm and approximately 50 mm with respect to a longitudinal axis of the patient's face. ### Claim 13 (depends on 1) The patient interface of claim 1, wherein the frame component further comprises a coupling section attaching the positioning and stabilising structure to the frame component. ### Claim 14 (depends on 13) The patient interface of claim 13, wherein the coupling section comprises a slot with a rigidizer arm. ### Claim 15 (depends on 13) The patient interface of claim 13, wherein the patient interface is configured to compensate for nose twitch.