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US-20260124420-A1 - MASK ASSEMBLIES FOR RESPIRATORY THERAPY

US20260124420A1US 20260124420 A1US20260124420 A1US 20260124420A1US-20260124420-A1

Abstract

A mask assembly is provided comprising a cushion with a proximal face contacting portion, a distal inlet aperture, and a side wall between the proximal face contacting portion and the distal inlet aperture, a frame; and an inlet connector configured to connect to a source of pressurised gas. The frame comprises upper and lower headgear connectors both of which are below the cushion uppermost portion. The frame comprises a central connection portion removably connected to the cushion and the inlet connector. The central connection portion is relatively inflexible, whilst the remainder of the frame may be relatively flexible. The inlet connector comprises an inlet port for connection to a gas delivery conduit, and comprises a downwardly directed central axis.

Inventors

  • Mark Richard Tomlinson
  • Christopher Jaye Norman Amadio
  • Craig Robert Prentice
  • Simon MITTERMEIER
  • Andrew Sharp
  • Adam Alexander Tebbutt
  • Paul Mathew Freestone
  • Jeroen Hammer
  • Tony William Spear
  • Matthew Roger Stephenson
  • Katie O'Brien
  • Xueyan Bian
  • Mitesh Patel

Assignees

  • FISHER & PAYKEL HEALTHCARE LIMITED

Dates

Publication Date
20260507
Application Date
20231117

Claims (20)

  1. 1 - 65 . (canceled)
  2. 66 . A mask assembly for respiratory therapy, comprising: a mask frame comprising at least one headgear connector; a cushion; and an inlet connector configured to receive breathable gases from, and be connected to, a gas delivery conduit, the inlet connector being in fluid communication with the cushion; wherein the mask frame and/or the inlet connector comprise one or more engagement features configured to resist relative rotation between the mask frame and inlet connector; wherein the one or more engagement features comprises a tab on one of the mask frame and the inlet connector, and a cut-out on the other of the mask frame and the inlet connector, the tab being received in the cut-out.
  3. 67 . The mask assembly of claim 66 , wherein the tab is provided at a bottom of the mask frame.
  4. 68 . The mask assembly of claim 66 , wherein the cut-out is provided at a bottom of the inlet connector.
  5. 69 . The mask assembly of claim 66 , wherein the tab and the cut-out are oblong.
  6. 70 . The mask assembly of claim 66 , wherein the mask frame comprises a central connection portion and wherein the inlet connector is mounted on the central connection portion.
  7. 71 . The mask assembly of claim 70 , wherein the mask frame comprises a frame clip configured to removably mount the mask frame on the inlet connector; wherein preferably the central connection portion comprises the frame clip.
  8. 72 . The mask assembly of claim 71 wherein the frame clip comprises opposed ends between which is defined a mouth configured to receive the inlet connector to mount the frame clip on the mask assembly.
  9. 73 . The mask assembly of claim 72 wherein the frame clip comprises a front wall, and side walls extending rearwardly from the front wall, each side wall comprising an opposed end, the opposed ends being spaced apart to define the mouth at a rear of the frame clip.
  10. 74 . The mask assembly of claim 73 wherein a lower part of the inlet connector comprises: a skirt that extends downwardly, wherein the skirt comprises a recess configured to received and engage with the frame clip of the mask frame; and a guide flange that projects outwardly from the skirt below the recess.
  11. 75 . The mask assembly of claim 74 wherein a central, forward portion of the guide flange is omitted to define the cut-out.
  12. 76 . The mask assembly of claim 74 wherein the guide flange comprises sides which are inclined upwardly from front to rear, to guide the mask frame upwardly as the mask frame is pushed onto the inlet connector.
  13. 77 . The mask assembly of claim 66 , wherein the cut-out is provided in a lowermost flange of the inlet connector.
  14. 78 . The mask assembly of claim 66 , wherein the inlet connector comprises an inlet port configured to be connected to a source of pressurised gas, the inlet port comprising a central inlet axis.
  15. 79 . The mask assembly of claim 78 wherein the central inlet axis is substantially vertical when the mask assembly is viewed from a front; and/or extends substantially downwardly when viewed from a side; and/or extends substantially downwardly when viewed from the front.
  16. 80 . The mask assembly of claim 78 wherein the mask frame is removably mounted on the inlet connector by moving the mask frame onto the inlet connector in a mounting direction, the mounting direction intersecting the central inlet axis.
  17. 81 . The mask assembly of claim 70 wherein the mask frame comprises lateral portions that extend away from the central connection portion, the lateral portions being relatively flexible.
  18. 82 . The mask assembly of claim 66 , wherein the mask frame comprises: lateral arms, and an upper portion comprising a connecting frame member which extends over an upper portion of the cushion between the lateral arms.
  19. 83 . A mask assembly for respiratory therapy, comprising: a cushion; an inlet connector configured to receive breathable gases from, and be connected to, a gas delivery conduit, the inlet connector being in fluid communication with the cushion and including an inlet connector portion with an outer curved connector surface; and a mask frame comprising at least one headgear connector and a frame connector portion having an inner curved connector portion configured to engage with the outer curved connector surface; wherein the frame connector portion and the inlet connector portion are configured to resist relative rotation between the mask frame and inlet connector.
  20. 84 . The mask assembly of claim 83 , wherein the inner curved connector portion comprises a concave, curved surface and the outer curved connector surface is a convexly curved surface.

Description

This application includes subject matter from our earlier international patent application PCT/NZ 2022/050086 filed 1 Jul. 2022, our earlier U.S. patent application U.S. 63/384332 filed 18 Nov. 2022, our earlier U.S. patent application U.S. 63/476743 filed 22 Dec. 2022, and our earlier U.S. patent application U.S. 63/500515 filed 5 May 2023, the entire contents of each of which are herein incorporated by reference in their entirety. BACKGROUND Field The present disclosure relates to mask assemblies for respiratory therapy. In particular, the present disclosure relates to full-face mask assemblies that cover the mouth and nose of the user. Description of Related Art Obstructive sleep apnea is commonly treated with the application of positive airway pressure (PAP) therapy. PAP therapy involves delivering a flow of gas to a patient at a therapeutic pressure above atmospheric pressure that will reduce the frequency and/or duration of apneas, hypopneas, and/or flow limitations. The therapy is often implemented by using a positive airway pressure device to deliver a pressurized stream of air through a conduit to a patient through a mask assembly positioned on the face of the patient. Typical mask assemblies are configured to provide sealed communication with a user's airway by sealing around parts of the user's nose and/or mouth. These mask assemblies are commonly used to provide therapies such as, but not limited to, non-invasive ventilation (NIV) and continuous positive airway pressure (CPAP). CPAP therapy is commonly used to treat obstructive sleep apnea (OSA) and involves providing a constant supply of pressurized air to a user's airway. Various problems exist in respect of such full-face mask assemblies. One such problem can be that when the user is side sleeping, one or more parts of the mask assembly can contact the bed or pillow, move and deform, and allow inspiratory gas to leak from the mask assembly, reducing the effectiveness of the therapy, and also causing noise and draughts. Further such movement and deformation can be uncomfortable for the patient. Another problem is the noise made by the inspiratory gas flowing into the mask assembly during therapy. Such noise can be annoying to the patient and others around the patient. A general problem in providing a mask assembly is to improve patient adherence in wearing the mask assembly when required, and for as long as required. A need exists to provide mask assembly with improved comfort and/or sealing performance; and/or to improve on any one or more of the problems mentioned above; and/or to provide the public with a useful choice. SUMMARY The mask assemblies described herein have innovative aspects, no single one of which is indispensable or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the advantageous features will now be summarized. According to an aspect of this disclosure there is provided a mask assembly comprising a cushion with a proximal face contacting portion, a distal inlet aperture, and a side wall between the proximal face contacting portion and the distal inlet aperture, anda frame comprising an inlet opening configured to connect to a source of pressurised gas,the distal inlet aperture of the cushion is removably connected to the inlet opening of the frame, andthe frame further comprising a pair of upper and a pair of lower headgear connectors;the cushion comprising an uppermost portion;both pairs of upper and lower headgear connectors being below the cushion uppermost portion. The frame may comprise a central connection portion, configured to be removably connected to the cushion. The inlet opening may be formed in the central connection portion. The frame material at the central connection portion may circumscribe the inlet opening. The cushion may comprise a lower portion adjacent the inlet aperture, and an upper portion defining the top of the cushion. The frame may comprise an elongate frame member extending across the upper portion of the cushion. The elongate member may extend down the side wall. The lower portion of the frame may be wider than the upper portion, the upper and lower portions being spaced apart. The lower portion of the frame may comprise lateral arms which extend laterally outwardly from the inlet opening. The lateral arms may be relatively narrow as compared to the lower portion, the lower portion being relatively wide. The inlet opening may be provided in the relatively wide, lower portion. The lower portion of the frame may extend symmetrically about a central axis of the inlet opening of the frame. The lower portion of the frame may be positioned centrally, when the mask assembly is viewed from the front. The frame inlet opening may comprise a central axis, the central axis extending generally downwardly from the mask assembly. The inlet aperture of the cushion may taper from the bottom of the inlet aperture to the top of the inlet aperture. The inlet ap