Patient interface with a seal-forming structure having varying thickness

• US 10,926,050 B2
• Filed: 09/23/2016
• Issued: 02/23/2021
• Est. Priority Date: 09/23/2015
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Inventors: Eves, Matthew, Nga, Lemmy, Rummery, Gerard Michael, Scheiner, Rupert Christian
• Primary Examiner(s): Boecker, Joseph D.
• Application Number:
  US15/761,168
• Publication Number:
  US 20180272095A1
• Time in Patent Office: 1,614 Days
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0611 with a gusset portion
• CPC Class Codes: A61M 16/0616 with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
• CPC Class Codes: A61M 16/0622 having an underlying cushion
• CPC Class Codes: A61M 16/0633 with forehead support
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/1055 bacterial
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/109 the humidifying liquid or the beneficial agent
• CPC Class Codes: A61M 16/1095 in the connecting tubes
• CPC Class Codes: A61M 16/16 Devices to humidify the respiration air A61M16/1045 takes precedence
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2205/42 Reducing noise
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production

Abstract

A cushion assembly for a patient interface including an elastomeric support portion and an elastomeric seal-forming structure supported by the elastomeric support portion that is more rigid than the elastomeric seal-forming structure. The elastomeric seal-forming structure includes a first compliant region and a second compliant region separated from the first compliant region by a support region that is more rigid than the first and second compliant regions. The more rigid support region extends to and is anchored by the elastomeric support portion. In addition, for every point in the rigid support region, the inner surface has a negative curvature when the outer surface has a positive curvature and the inner surface has a positive curvature when the outer surface has a negative curvature.

Claims

1. A cushion assembly for 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 airways including at least entrance of the patient'"'"'s nares, wherein the patient interface is configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure in use, throughout the patient'"'"'s respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing, the cushion assembly comprising:

an elastomeric support portion;

an elastomeric seal-forming structure supported by the elastomeric support portion and being shaped to be bisected by a sagittal plane that includes a line tangent to the elastomeric seal-forming structure at a superior tangent point and at an inferior tangent point, the elastomeric support portion being more rigid than the elastomeric seal-forming structure; and

a chamber defined by the elastomeric support portion and the elastomeric seal-forming structure,

wherein the elastomeric seal-forming structure comprises an inner surface forming a boundary for the chamber and comprises an outer surface opposite the inner surface,

wherein the elastomeric seal-forming structure comprises a first compliant region that includes the superior tangent point and a second compliant region separated from the first compliant region by a support region that is more rigid than the first and second compliant regions, the support region being bounded by a first transition side adjacent the first compliant region and a second transition side adjacent the second compliant region,

wherein the first and second transition sides oppose each other and form respective transitions from the more rigid support region to the first and second compliant regions,

wherein the more rigid support region extends to and is anchored by the elastomeric support portion,

wherein the elastomeric seal-forming structure forms an aperture configured to receive the patient'"'"'s nose,

wherein the entirety of the more rigid support region is above an inferior rim of the aperture configured to receive the patient'"'"'s nose,

wherein the more rigid support region is configured to resist crinkling and/or creasing of the first compliant region when the first compliant region is subject to a compressive force, and

wherein for every point in the more rigid support region, the inner surface has a negative curvature when the outer surface has a positive curvature and the inner surface has a positive curvature when the outer surface has a negative curvature.

2. The cushion assembly of claim 1, wherein the support region increases in rigidity toward the elastomeric support portion.

3. The cushion assembly of claim 1, wherein the first compliant region extends to the elastomeric support portion.

4. The cushion assembly of claim 1, wherein the second compliant region extends to the elastomeric support portion.

5. The cushion assembly of claim 1, wherein the rigidity of the elastomeric seal-forming structure within the second compliant region increases toward the elastomeric support portion.

6. The cushion assembly of claim 1, wherein the second compliant region transitions into a loop that is anchored to the elastomeric support portion.

7. The cushion assembly of claim 6, wherein an elastomeric wall thickness of the loop increases toward the elastomeric support portion.

8. The cushion assembly of claim 1, wherein the elastomeric seal-forming structure comprises a third compliant region that includes the inferior tangent point.

9. The cushion assembly of claim 8, wherein the first and third compliant regions have the same rigidity.

10. The cushion assembly of claim 9, wherein a rigidity of the elastomeric seal-forming structure is invariable within a continuous portion of the elastomeric seal-forming structure extending from the third compliant region to the first compliant region.

11. The cushion assembly of claim 10, wherein the continuous portion of the elastomeric seal forming structure includes a portion of the second compliant region.

12. The cushion assembly of claim 11, wherein the elastomeric seal-forming structure further comprises an intermediate support region and a side support region positioned between the second and third compliant regions.

13. The cushion assembly of claim 12, wherein the intermediate support region and the side support region are more rigid than the first and third compliant regions.

14. The cushion assembly of claim 13, wherein the third compliant region is curved toward the first compliant region.

15. The cushion assembly of claim 14, wherein a depth of the elastomeric support portion varies so that the depth of the elastomeric support portion is smallest at locations adjacent to the first and second compliant regions.

16. The cushion assembly of claim 1, wherein the elastomeric support portion comprises a pair of pivotable flanges configured to pivot when the elastomeric seal-forming structure is compressed into the elastomeric support portion.

17. The cushion assembly of claim 1, wherein the elastomeric seal-forming structure comprises a single layer of elastomeric material.

18. A patient interface comprising:

the cushion assembly of claim 1;

a rigid shell removably connected to the cushion assembly; and

headgear removably attached to the rigid shell.

19. A CPAP system comprising:

the patient interface according to claim 18;

a flow generator configured to pressurize a flow of gas; and

an air delivery tube configured to deliver the pressurized gas to the patient interface.

20. The cushion assembly of claim 1, wherein at least a portion of the second compliant region is located superior to the inferior rim of the aperture configured to receive the patient'"'"'s nose.

21. A cushion assembly for 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 airways including at least entrance of the patient'"'"'s nares, wherein the patient interface is configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure in use, throughout the patient'"'"'s respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing, the cushion assembly comprising:

an elastomeric support portion; and

an elastomeric seal-forming structure that is supported by the elastomeric support portion and is shaped to be bisected by a sagittal plane that includes a line tangent to the elastomeric seal-forming structure at a superior tangent point and at an inferior tangent point, the elastomeric support portion being more rigid than the elastomeric seal-forming structure,

wherein the elastomeric seal-forming structure comprises a first compliant region that includes the superior tangent point and a second compliant region separated from the first compliant region by a spring region that has a greater elastomeric wall thickness than the first and second compliant regions, the spring region being bounded by a first transition side adjacent the first compliant region and a second transition side adjacent the second compliant region,

wherein the first and second transition sides oppose each other and form respective transitions from the thicker spring region to the first and second compliant regions,

wherein the elastomeric seal-forming structure forms an aperture configured to receive the patient'"'"'s nose,

wherein the spring region is entirely superior to an inferior rim of the aperture configured to receive the patient'"'"'s nose,

wherein the spring region is tapered so that the elastomeric wall thickness increases in a direction toward the elastomeric support portion,

wherein the spring region is biased to resist crinkling and/or creasing of the first compliant region when the first compliant region subject to a compressive force, and

wherein the spring region has a curvature extending from the aperture to the elastomeric support portion.

22. The cushion assembly of claim 21, the spring region is anchored to the support portion at a location that is entirely superior to the aperture.