System and method for manufacturing patient interfaces and their components

Abstract

A system and method for fabricating a customized patient respiratory interface is disclosed. Data indicative of one or more landmark features of a human head is obtained. One or more landmark feature positions of the landmark features are identified based on the data. A set of manufacturing specifications for fabricating patient respiratory interface components is determined based on the one or more landmark feature positions. The patient respiratory interface components are fabricated based on the set of manufacturing specifications.

Claims

1. A method performed by a processor for fabricating a customized patient respiratory interface component, including a headgear strap for positioning and stabilizing the patient interface, Receiving data representing one or more landmark features of a human head and data representing one or more functional requirements associated with the human, wherein the one or more functional requirements include one or more of the following: the properties of a heat-moisture exchanger related to the absorption of heat and / or moisture from a certain amount of air exhaled during exhalation by the patient; the breathability of the patient respiratory interface components; and tactile sensation; Identifying the location of one or more landmark features of the aforementioned landmark features based on the data indicating one or more landmark features using at least one processor; Determining a set of manufacturing specifications for the fabrication of the patient respiratory interface components using the at least one processor based on the location of one or more landmark features and the data indicating one or more functional requirements, wherein the set of manufacturing specifications includes the material, construction technique, and dimensions of the patient respiratory interface components, and the set of manufacturing specifications includes the dimensions of the headgear strap; and This includes having at least one manufacturing machine produce the patient respiratory interface components based on the set of manufacturing specifications, A method for fabricating the patient respiratory interface components, comprising mechanical manipulation of threads for fabricating the components.

2. The method according to claim 1, further comprising the step of capturing at least a portion of the aforementioned data with an image sensor.

3. The method according to claim 1 or 2, wherein the data includes two-dimensional image data.

4. The method according to claim 1 or 2, wherein the data includes three-dimensional image data.

5. The method of any one of claims 1 to 4, further comprising the step of using the at least one processor to identify at least one relationship between two or more of the landmark feature locations, wherein determining the set of manufacturing specifications is at least partially based on the at least one relationship between the two or more of the landmark feature locations.

6. The method of claim 5, wherein identifying at least one relationship between two or more of the aforementioned landmark feature locations includes determining the distance between two or more of the following: the subnasal point, the selion, the auricle point, the posterior point of the head, the anterior point of the head, the lateral point of the orbital rim, the lowest point of the orbital rim, the Frankfurt horizontal plane, and the coronal plane aligned with the auricle point.

7. The method of claim 6, wherein identifying at least one relationship between two or more of the aforementioned landmark feature locations includes determining the distance between the subnasal point and the auricle point in the sagittal plane.

8. The method of claim 6 or 7, wherein identifying at least one relationship between two or more of the aforementioned landmark feature locations includes determining the vertical distance between the subnasal point and the selion in the sagittal plane.

9. Identifying at least one relationship between two or more of the aforementioned landmark feature locations includes determining the distance between the coronal plane aligned with the auricle and the subnasal point, wherein the distance is perpendicular to the coronal plane, according to any one of claims 6 to 8.

10. Identifying at least one relationship between two or more of the aforementioned landmark feature locations includes determining the distance between the coronal plane aligned with the auricle and the outermost point of the orbital rim, wherein the distance is perpendicular to the coronal plane, according to any one of claims 6 to 9.

11. The method according to any one of claims 6 to 10, wherein identifying at least one relationship between two or more of the aforementioned landmark feature locations includes determining the vertical distance between the subnasal point and the foremost point of the head.

12. The method according to any one of claims 6 to 11, wherein identifying at least one relationship between two or more of the aforementioned landmark feature locations includes determining the vertical distance between the foremost point of the head and the Frankfurt horizontal plane.

13. Identifying at least one relationship between two or more of the aforementioned landmark feature locations includes determining the distance between the coronal plane aligned with the ear point and the posterior point of the head, wherein the distance is perpendicular to the coronal plane, according to any one of claims 6 to 12.

14. The method of any one of claims 1 to 13, comprising the step of determining at least one required performance of the patient respiratory interface component based on one or more landmark feature locations using the at least one processor, wherein the at least one required performance includes one or more of the force applied to the patient's head by the component or applied to the component by the patient's head, the elasticity and dimensions of the component, and positioning on the head, and determining the set of manufacturing specifications is at least partially based on the at least one required performance.

15. The method of claim 14, wherein the patient respiratory interface component comprises a plurality of regions, and at least one required performance is determined for each region.

16. The method of claim 14 or 15, wherein the at least one required performance is determined at least in part on the characteristics of another component of the patient interface intended to be used in conjunction with the customized patient respiratory interface component.

17. The method according to any one of claims 1 to 16, wherein the set of manufacturing specifications includes at least one material specification.

18. The method according to any one of claims 1 to 17, wherein the set of manufacturing specifications includes at least one constituent technical specification.

19. The method according to any one of claims 1 to 17, wherein the set of manufacturing specifications includes at least one dimensional specification.

20. The method according to any one of claims 1 to 19, wherein determining the set of manufacturing specifications includes selecting the set of manufacturing specifications from a plurality of existing sets of manufacturing specifications.

21. The method of claim 20, wherein the selection of the plurality of existing manufacturing specifications is based on a comparison between the one or more landmark feature locations determined for the human and the one or more landmark feature locations associated with the plurality of existing manufacturing specifications.

22. The method according to any one of claims 1 to 19, wherein determining the set of manufacturing specifications includes selecting a plurality of manufacturing specifications to form the set of manufacturing specifications from a plurality of existing manufacturing specifications.

23. The method according to any one of claims 1 to 22, further comprising generating manufacturing machine programming instructions for the production of the patient interface or its components based on the set of manufacturing specifications using the at least one processor, wherein the production of the patient respiratory interface components includes programming the at least one manufacturing machine using the manufacturing machine programming instructions and operating the at least one manufacturing machine in accordance with the generated program.

24. The method of claim 23, wherein producing the manufacturing machine programming instructions comprises generating a map representing the set of manufacturing specifications, the map including two-dimensional and / or three-dimensional images of the patient interface or its components, and generating the manufacturing machine programming instructions based on the map.

25. The method of claim 24, wherein producing the manufacturing machine programming instructions comprises generating a two-dimensional model and / or a three-dimensional model of the patient respiratory interface component based on the set of manufacturing specifications, and generating the manufacturing machine programming instructions based on the two-dimensional model and / or the three-dimensional model.

26. The method according to any one of claims 1 to 25, wherein the fabrication of the patient respiratory interface components includes assembling the components.

27. The method of claim 26, wherein organizing the patient respiratory interface components includes one of weft knitting and circular knitting.

28. The method according to any one of claims 1 to 27, wherein the manufacturing specifications of the set include at least one dimension of the rear strap portion of the headgear strap, and the rear strap portion is configured to be positioned at least opposite the rear surface of the head when in use.

29. The method according to any one of claims 1 to 27, wherein the set of manufacturing specifications includes one length for each of a pair of upper strap portions for the headgear strap, and each upper strap portion is configured to be positioned on each side of the head when in use.

30. The method according to any one of claims 1 to 27, wherein the set of manufacturing specifications includes an upper strap position on the rear strap portion for the headgear strap, and one of each of the pair of upper strap portions for the headgear strap extends from the upper strap position.

31. The method according to any one of claims 1 to 27, wherein, in the upper strap direction included in the set of manufacturing specifications, one of the pair of upper strap portions for the headgear strap extends from the rear strap portion for the headgear strap.

32. The method according to any one of claims 1 to 27, wherein the set of manufacturing specifications includes one length for each of a pair of lower strap portions for the headgear strap, and each lower strap portion is configured to be positioned on each side of the head when in use.

33. The method according to any one of claims 1 to 27, wherein the manufacturing specifications of the set include a lower strap position on the rear strap portion for the headgear strap, and one of each of the pair of lower strap portions extends from the lower strap position.

34. The method according to any one of claims 1 to 27, wherein the manufacturing specifications of the set include the length of the ring strap portion for the headgear strap, the ring strap portion having an upper portion configured to rest on the parietal bone of the head when in use, and a lower portion configured to rest on the occipital bone of the head or to be positioned below the occipital bone of the head when in use.

35. The method according to any one of claims 1 to 34, wherein the manufacturing specifications of the set are determined such that a predetermined force is applied from the headgear strap to the seal-forming structure of the patient interface when the patient interface is worn by the person during use.

36. The method of claim 35, wherein the predetermined force is 3N to 5N.

37. The method of claim 36, wherein the predetermined force is approximately 4 N.

38. The method according to any one of claims 1 to 25, wherein the patient respiratory interface component includes the frame of the patient interface.

39. The method of claim 38, wherein the set of manufacturing specifications includes frame dimensions.

40. The method of claim 38, wherein the set of manufacturing specifications includes one length for each of the pair of upper arms of the frame, and each upper arm is configured to connect to each upper strap portion of the positioning and stabilizing structure when in use.

41. The method of claim 38, wherein the set of manufacturing specifications includes a direction in which one of each of the pair of upper arms of the frame extends from the central part of the frame.

42. The method of claim 38, wherein the set of manufacturing specifications includes one length for each of the pair of lower arms of the frame, and each lower arm is configured to connect to each lower strap portion of the positioning and stabilizing structure when in use.

43. The method of claim 38, wherein the set of manufacturing specifications includes a direction in which one of each of the pair of lower arms of the frame extends from the central part of the frame.

44. The method according to any one of claims 1 to 25, wherein the patient respiratory interface component includes a plenum chamber of the patient interface.

45. The method according to any one of claims 1 to 25, wherein the patient respiratory interface component includes a seal-forming structure for the patient interface.

46. The method according to any one of claims 1 to 45, wherein the set of manufacturing specifications specifies the specifications for a headgear strap of a positioning and stabilizing structure for a patient interface, and includes at least one of knit structure, material composition, yarn denier and / or mechanical gauge for the manufacture of the headgear strap, and one or more of the manufacturing specifications defines the stretch properties of the positioning and stabilizing structure.

47. The method according to any one of claims 1 to 46, wherein the method is carried out by a manufacturing system including the at least one processor and the communication circuit.

48. A system for fabricating customized patient respiratory interface components, including a headgear strap for positioning and stabilization of the patient interface, One or more processors that receive data indicating one or more landmark features of a human head and data indicating one or more functional requirements associated with the human, wherein the one or more functional requirements include one or more of the following: the properties of a heat-moisture exchanger related to the absorption of heat and / or moisture from a certain amount of air exhaled during a patient's exhalation, the air permeability of the patient respiratory interface components and tactile sensation. The one or more processors are further configured to identify the location of one or more landmark features based on the data indicating one or more landmark features; The one or more processors are further configured to determine a set of manufacturing specifications for the fabrication of the patient respiratory interface components based on the location of the one or more landmark features and the data indicating the one or more functional requirements, the set of manufacturing specifications including the material, construction technique, and dimensions of the patient respiratory interface components, and the set of manufacturing specifications including the dimensions of the headgear strap; and Includes at least one manufacturing machine configured to produce the patient respiratory interface components based on the set of manufacturing specifications, The fabrication of the patient respiratory interface components includes a system comprising the mechanical manipulation of threads for the fabrication of the components.

49. A method performed by a processor, which is carried out by a processing system including at least one processor and a communication circuit for the fabrication of a patient respiratory interface component, including a headgear strap for positioning and stabilizing structures for a patient interface, Receiving data representing one or more landmark features of a human head and data representing one or more functional requirements associated with the human, wherein the one or more functional requirements include one or more of the following: the properties of a heat-moisture exchanger related to the absorption of heat and / or moisture from a certain amount of air exhaled during exhalation by the patient; the breathability of the patient respiratory interface components; and tactile sensation; Identifying the location of one or more landmark features of the aforementioned landmark features based on the data indicating one or more landmark features using the processing system; Determining a set of manufacturing specifications for the fabrication of the patient respiratory interface components using the processing system based on the location of one or more landmark features and the data indicating one or more functional requirements, wherein the set of manufacturing specifications includes the material, construction technique, and dimensions of the patient respiratory interface components, and the set of manufacturing specifications includes the dimensions of the headgear strap; and This includes communicating the set of manufacturing specifications to a manufacturing system, which includes at least one manufacturing machine configured to manufacture the patient respiratory interface components based on the set of manufacturing specifications, using the communication circuit. A method for fabricating the patient respiratory interface components, comprising mechanical manipulation of threads for fabricating the components.

50. A system for fabricating customized patient respiratory interface components, including a headgear strap for positioning and stabilization of the patient interface, The system includes one or more processors that receive data representing one or more landmark features of a human head and data representing one or more functional requirements associated with the human, wherein the one or more functional requirements include one or more of the following: the properties of a heat-moisture exchanger related to the absorption of heat and / or moisture from a certain amount of air exhaled during a patient's exhalation; the breathability of the patient respiratory interface components; and tactile sensation. The one or more processors are further configured to identify the location of one or more landmark features based on the data indicating one or more landmark features; The one or more processors are further configured to determine a set of manufacturing specifications for the fabrication of the patient respiratory interface components based on the location of the one or more landmark features and the data indicating the one or more functional requirements, the set of manufacturing specifications including the material, construction technique, and dimensions of the patient respiratory interface components, and the set of manufacturing specifications including the dimensions of the headgear strap; The one or more processors are further configured to communicate the set of manufacturing specifications to a manufacturing system which includes at least one manufacturing machine configured to manufacture the patient respiratory interface components based on the set of manufacturing specifications. The fabrication of the patient respiratory interface components includes a system comprising the mechanical manipulation of threads for the fabrication of the components.

51. A method performed by a processor, which is carried out by a processing system including at least one processor and a communication circuit for the fabrication of a patient respiratory interface component, including a headgear strap for positioning and stabilizing structures for a patient interface, The communication circuit receives, wherein the location of one or more landmark features of a human head and data indicating one or more functional requirements associated with the human, the location of the one or more landmark features being identified from the data indicating one or more landmark features of the head, and the functional requirements including one or more of the properties of a heat-moisture exchanger related to the absorption of heat and / or moisture from a certain amount of air exhaled during exhalation by the patient, the breathability of the patient respiratory interface components and tactile sensation; Determining a set of manufacturing specifications for the fabrication of the patient respiratory interface components using the processing system based on the location of one or more landmark features and the data indicating one or more functional requirements, wherein the set of manufacturing specifications includes the material, construction technique, and dimensions of the patient respiratory interface components, and the set of manufacturing specifications includes the dimensions of the headgear strap; and This includes communicating the set of manufacturing specifications to a manufacturing system, which includes at least one manufacturing machine configured to manufacture the patient respiratory interface components based on the set of manufacturing specifications, using the communication circuit. A method for fabricating the patient respiratory interface components, comprising mechanical manipulation of threads for fabricating the components.

52. A system for fabricating customized patient respiratory interface components, including a headgear strap for positioning and stabilization of the patient interface, One or more processors that receive one or more landmark feature locations of landmark features of a human head and data indicating one or more functional requirements associated with the human, wherein the one or more landmark feature locations are identified from data indicating one or more landmark features of the head, and the one or more functional requirements include one or more of the following: the properties of a heat-moisture exchanger related to the absorption of heat and / or moisture from a certain amount of air exhaled during exhalation by a patient, the breathability of the patient respiratory interface components and tactile sensation; The one or more processors are further configured to determine a set of manufacturing specifications for the fabrication of the patient respiratory interface components based on the location of the one or more landmark features and the data indicating the one or more functional requirements, the set of manufacturing specifications including the material, construction technique, and dimensions of the patient respiratory interface components, and the set of manufacturing specifications including the dimensions of the headgear strap; The one or more processors are further configured to communicate the set of manufacturing specifications to a manufacturing system which includes at least one manufacturing machine configured to manufacture the patient respiratory interface components based on the set of manufacturing specifications. The fabrication of the patient respiratory interface components includes a system comprising the mechanical manipulation of threads for the fabrication of the components.

53. A processor-driven method for fabricating patient respiratory interface components, including a headgear strap for positioning and stabilizing structures for a patient interface, Receiving a set of manufacturing specifications for the fabrication of the patient respiratory interface components using a communication circuit, wherein the set of manufacturing specifications is determined based on the location of one or more landmark features identified from data indicating one or more landmark features of a human head and based on data indicating one or more functional requirements associated with the human, the set of manufacturing specifications includes the material, construction technique, and dimensions of the patient respiratory interface components, the set of manufacturing specifications includes the dimensions of the headgear strap, and the one or more functional requirements include one or more of the properties of a heat-moisture exchanger related to the absorption of heat and / or moisture from a certain amount of air exhaled during exhalation by the patient, the breathability and tactile feel of the patient respiratory interface components; and This includes having at least one manufacturing machine produce the patient respiratory interface components based on the set of manufacturing specifications, A method for fabricating the patient respiratory interface components, comprising mechanical manipulation of threads for fabricating the components.

54. A system for fabricating customized patient respiratory interface components, including a headgear strap for positioning and stabilization of the patient interface, One or more processors that receive a set of manufacturing specifications for the fabrication of the patient respiratory interface components, the set of manufacturing specifications being determined based on the location of one or more landmark features identified from data indicating one or more landmark features of a human head and based on data indicating one or more functional requirements associated with the human, the set of manufacturing specifications including the material, construction technique, and dimensions of the patient respiratory interface components, the set of manufacturing specifications including the dimensions of the headgear strap, and the one or more functional requirements including one or more of the properties of a heat-moisture exchanger related to the absorption of heat and / or moisture from a certain amount of air exhaled during exhalation by the patient, the breathability and tactile feel of the patient respiratory interface components; and Includes at least one manufacturing machine configured to produce the patient respiratory interface components based on the set of manufacturing specifications, The fabrication of the patient respiratory interface components includes a system comprising the mechanical manipulation of threads for the fabrication of the components.

55. A processor-driven method for fabricating patient respiratory interface components, including a headgear strap for positioning and stabilizing structures for a patient interface, Obtaining information indicating the location of one or more landmark features of a human head based on data received from a device using a communication circuit; Determining a set of manufacturing specifications for the fabrication of the patient respiratory interface components using at least one processor based on the location of one or more landmark features and data indicating one or more functional requirements associated with the human, wherein the set of manufacturing specifications includes the material, construction technique, and dimensions of the patient respiratory interface components, the set of manufacturing specifications includes the dimensions of the headgear strap, and the one or more functional requirements include one or more of the properties of a heat-moisture exchanger related to the absorption of heat and / or moisture from a certain amount of air exhaled during exhalation by the patient, the breathability and tactile feel of the patient respiratory interface components; and This includes having at least one manufacturing machine produce the patient respiratory interface components based on the set of manufacturing specifications, A method for fabricating the patient respiratory interface components, comprising mechanical manipulation of threads for fabricating the components.

56. A system for fabricating patient respiratory interface components, including a headgear strap for positioning and stabilizing structures for a patient interface, The system includes one or more processors that obtain information indicating the location of one or more landmark features of a human head and one or more functional requirements associated with the human, wherein the one or more functional requirements include one or more of the following: the properties of a heat-moisture exchanger related to the absorption of heat and / or moisture from a certain amount of air exhaled during a patient's exhalation; the air permeability of the patient respiratory interface components; and tactile sensation. The one or more processors are further configured to determine a set of manufacturing specifications for the fabrication of the patient respiratory interface components based on the one or more landmark feature locations and the one or more functional requirements associated with the human, the set of manufacturing specifications including the materials, construction techniques, and dimensions of the patient respiratory interface components, and the set of manufacturing specifications including the dimensions of the headgear strap; The one or more processors are further configured to manufacture the patient respiratory interface components based on the set of manufacturing specifications, The fabrication of the patient respiratory interface components includes a system comprising the mechanical manipulation of threads for the fabrication of the components.

57. Apparatus for fabricating patient respiratory interface components, including a headgear strap for positioning and stabilizing structures for a patient interface, Means for obtaining information indicating one or more landmark feature locations on a human head and one or more functional requirements associated with the human, wherein the one or more functional requirements include one or more of the following: the properties of a heat-moisture exchanger related to the absorption of heat and / or moisture from a certain amount of air exhaled during a patient's exhalation; the breathability of the patient respiratory interface components; and tactile sensation; Means for determining a set of manufacturing specifications for the fabrication of the patient respiratory interface components based on the location of one or more landmark features and based on one or more functional requirements, wherein the set of manufacturing specifications includes the material, construction technique, and dimensions of the patient respiratory interface components, and the set of manufacturing specifications includes the dimensions of the headgear strap; and The means for manufacturing the patient respiratory interface components based on the set of manufacturing specifications includes, The means for fabricating the patient respiratory interface components includes an apparatus for the fabrication of the components, comprising the mechanical manipulation of threads.

58. A method performed by a processor for fabricating a customized component of an apparatus or device for the treatment of respiratory disorders, wherein the customized component includes a headgear strap of a positioning and stabilizing structure for a patient interface, and the method is Receiving data indicating one or more landmark features of a human head and data indicating one or more functional requirements not derived from the location of the landmark features, wherein the one or more functional requirements include one or more of the following: the characteristics of a heat-moisture exchanger related to the absorption of heat and / or moisture from a certain amount of air exhaled during a patient's exhalation; the permeability of a patient respiratory interface component; and tactile sensation. Determining a set of manufacturing specifications for the fabrication of the components using at least one processor, based on the landmark features and one or more functional requirements, wherein the set of manufacturing specifications includes the materials, construction techniques, and dimensions of the patient respiratory interface components, and the set of manufacturing specifications includes the dimensions of the headgear strap; and This includes having one or more manufacturing devices produce the components based on the set of manufacturing specifications, A method for producing the aforementioned components, comprising mechanical manipulation of yarn for the production of the aforementioned components.

59. A method, performed by a processor according to claim 58, for producing the patient respiratory interface component, further comprising: (a) organizing the component; (b) weft knitting the component; (c) circular knitting the component; (d) forming the component from a textile; (e) additive manufacturing of the component; (f) three-dimensional printing of the component; and / or (g) laser cutting of the component.

60. A method, performed by a processor according to claim 58, for manufacturing the components based on the set of manufacturing specifications, comprising generating instructions for one or more manufacturing apparatus configured to manufacture the components, and controlling the one or more manufacturing apparatus based on the generated instructions to manufacture the components.

61. The method described above is performed by a manufacturing system including the at least one processor and the communication circuit, according to any one of claims 58 to 60, and is performed by a processor.

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