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WO-2026094016-A1 - HEADGEAR AND PATIENT INTERFACE ASSEMBLY FOR A RESPIRATORY SUPPORT SYSTEM

WO2026094016A1WO 2026094016 A1WO2026094016 A1WO 2026094016A1WO-2026094016-A1

Abstract

A headgear is provided for use in securing a patient interface in a therapeutic position on the head of a patient for provision of respiratory support. The headgear includes a rear portion configured to engage a rear of the head of the patient, and a pair of side portions configured to engage respective sides of the head of the patient. The rear portion and the pair of side portions may be knitted. One or more inlaid elements are each mechanically inlaid with one or more of the rear portion or the pair of side portions. The inlaid elements may include tensile elements each configured to be coupled with a tensioner configured to control a tension in the headgear, or sleeves configured to receive the tensile elements.

Inventors

  • Fraser, Gordon William
  • HOCKING, Jake Baker
  • FREESTONE, PAUL MATHEW
  • PEREIRA, Priyanka Ferdinand

Assignees

  • FISHER & PAYKEL HEALTHCARE LIMITED

Dates

Publication Date
20260507
Application Date
20251104
Priority Date
20241104

Claims (20)

  1. 1. A headgear for use in securing a patient interface in a therapeutic position on a head of a patient for provision of respiratory support, the headgear comprising : a rear portion configured to engage a rear of the head of the patient, in use; a pair of side portions extending from the rear portion, the pair of side portions configured to engage respective sides of the head of the patient; and an inlaid element, the inlaid element mechanically inlaid with one or more of the rear portion or the pair of side portions.
  2. 2. The headgear of claim 1, the inlaid element comprising a tensile element, the tensile element configured to be coupled with a tensioner configured to control a tension in the headgear.
  3. 3. The headgear of claim 2, wherein the tensile element is knitted.
  4. 4. The headgear of claim 1, the inlaid element comprising a sleeve, the headgear comprising a tensile element received within the sleeve, the tensile element configured to be coupled with a tensioner configured to control a tension in the headgear.
  5. 5. The headgear of claim 4, the sleeve comprising a hollow tubular structure, the tensile element slidably received within the hollow tubular structure.
  6. 6. The headgear of claim 5, wherein the sleeve is knitted.
  7. 7. The headgear of any one of claims 4 to 6, further comprising the tensioner.
  8. 8. The headgear of any one of claims 2 to 7, the tensioner comprising: an automatic tensioner configured to automatically adjust the headgear to an appropriate size and/or tension when the headgear is donned by the patient; a headgear adjustment assembly operable, e.g., rotatable, by the patient to adjust an effective length of the tensile element and/or to control a tension in the headgear; or a resilient member configured to control the tension in the headgear by elastic deformation.
  9. 9. The headgear of any one of claims 1 to 8, comprising a further inlaid element, the further inlaid element comprising: a shaping element; and/or a cushioning element.
  10. 10. The headgear of claim 9, wherein the cushioning element is knitted.
  11. 11. The headgear of any one of claims 1 to 10, the inlaid element comprising a curved path when the headgear is laid flat.
  12. 12. The headgear of any one of claims 1 to 11, the inlaid element emerging from a distal end of one or each of the pair of side portions.
  13. 13. The headgear of any one of claims 1 to 12, wherein movement of the inlaid element with respect to one or more of the rear portion and the pair of side portions is: relatively uninhibited in a longitudinal direction of the inlaid element; and/or relatively inhibited in a lateral direction.
  14. 14. The headgear of any one of claims 1 to 13, wherein the inlaid element is anchored to one or more of the rear portion or the pair of side portions.
  15. 15. The headgear of any one of claims 1 to 13, wherein the inlaid element is configured to move within one or more of the rear portion or the pair of side portions.
  16. 16. The headgear of any one of claims 1 to 15, wherein the inlaid element is: relatively inextensible compared to one or more of the rear portion or the pair of side portions; and/or substantially inextensible when subjected to tensile forces typically encountered during normal use of headgear in a respiratory support system.
  17. 17. The headgear of any one of claims 1 to 16, one or more of the rear portion or the pair of side portions comprising a knit structure, the knit structure preferably comprising : an inner layer configured to engage the head of the patient when the headgear is donned by the patient; and an outer layer configured to face outwardly when the headgear is donned by the patient, wherein an interior space is formed between the inner layer and the outer layer.
  18. 18. The headgear of claim 17, the inlaid element is mechanically inlaid: through the inner layer; through the outer layer; and/or within the interior space.
  19. 19. The headgear of claim 18, wherein the inner layer is joined with the outer layer by a knit structure, e.g., a double knit stitch structure, an interlock stitch structure, or a rib stitch structure.
  20. 20. The headgear of any one of claims 1 to 19, one or more of the rear portion or the pair of side portions comprising a moisture absorbent yarn or a wicking yarn.

Description

HEADGEAR AND PATIENT INTERFACE ASSEMBLY FOR A RESPIRATORY SUPPORT SYSTEM CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This applications claims the benefit of priority from United States Patent Application No. 63/716,138, filed on November 4, 2024, the disclosure of which is hereby incorporated by reference in its entirety. BACKGROUND Field [0002] The disclosure relates to headgear and a patient interface assembly configured for use in a respiratory support system. Particularly, though not exclusively, the disclosure relates to a headgear including a knitted fabric with inlaid elements. Description of Related Art [0003] In respiratory support systems, a flow of respiratory gases is supplied to a patient through a patient interface in gases communication with the patient's airway. [0004] The patient interface is generally secured in position on the patient by headgear. The headgear may apply a sealing force to maintain a seal between the patient interface and the patient for respiratory therapy, e.g., for positive airway pressure (PAP) therapy or non-invasive ventilation (NIV). Together, the patient interface and the headgear may be referred to as a patient interface assembly. [0005] Relevant factors in designing a patient interface assembly for a respiratory support system may include one or more of sealing, comfort, usability, manufacturability, cost, aesthetics, or sustainability, for example. [0006] Obtaining an appropriate fit of the patient interface assembly with the patient may require a balance between sealing and comfort. An excessive sealing force may result in patient discomfort. And, over time, an excessive sealing force may contribute to pressure sores, e.g., where the patient interface engages sensitive parts of the patient's face such as the nasal bridge region. Conversely, an inadequate or misdirected sealing force may result in an uncontrolled leak of respiratory gases from the patient interface. An uncontrolled leak may impact the efficacy of the therapy or cause patient discomfort, e.g., jetting into the patient's eyes. [0007] The optimum sealing force to be applied by the headgear may depend upon a number of different factors including one or more of the patient's facial geometry, the type of patient interface, the type of headgear, the pressure of the flow of respiratory gases, or the therapy period(s), for example. [0008] To account for these factors, the headgear may be adjustable. The headgear may include one or more straps each configured to be adjustably coupled with the patient interface and/or each other. For example, side straps may loop through a slotted connector of the patient interface or a clip removably coupled with the patient interface, and adjustably couple back onto itself using a hook-and-loop fastener. The effective length of the side strap may be shortened to increase tension in the side strap, or lengthened to decrease tension in the side strap, when the patient interface assembly is donned by the patient. [0009] Some patients, or their caregivers, may have difficulty adjusting the headgear precisely. For example, they may have difficulty with one or more of adjusting the tension at all (e.g., due to limited dexterity), adjusting the headgear with limited or no visual cues (e.g., due to poor vision, poor or no lighting, or the patient interface being donned), adjusting the tension symmetrically, or obtaining a suitable sealing force. There may be a tendency to overtighten adjustable headgear, e.g., to ensure an adequate sealing force. But this may come at the cost of long-term comfort. [0010] Breathability of the headgear may also be a factor in patient comfort. [0011] Headgear may be manufactured by cutting the headgear from a sheet of material. The sheet of material may be a composite material including at least a layer of foam, e.g., open-cell foam, sandwiched between two fabric layers (e.g., the Breath-o-prene™ composite material developed by Accu-Med Technologies, Inc). [0012] The headgear may be formed as a single unitary piece from the sheet of material. But this may require compromises in the shape or properties (e.g., elasticity) of the headgear, impacting patient comfort. And it may result in excess waste material. [0013] Alternatively, the headgear may be formed from two or more separate pieces joined to each other at one or more joints, e.g., by stitching or welding. But joining the pieces requires additional manufacturing steps, the joints may cause patient discomfort, and/or there may still be excess waste material. [0014] Patient discomfort may result in a reduction in compliance, i.e., adherence to a prescribed therapy schedule. SUMMARY [0015] In a first aspect, a headgear is provided for use in securing a patient interface in a therapeutic position on a head of a patient for provision of respiratory support. The headgear may include: a rear portion configured to engage a rear of the head of the patient, in use; a pair of side portions extendin