Patient interface with a seal-forming structure having varying thickness

• US 10,799,661 B2
• Filed: 09/23/2016
• Issued: 10/13/2020
• 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:
  US15/759,985
• Publication Number:
  US 20180272094A1
• Time in Patent Office: 1,481 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 16/0616 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 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/42 Reducing noise
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0625 : Mouth

Abstract

A cushion assembly for a patient interface includes an elastomeric seal-forming portion that includes a dome-shaped superior region (3180A); a saddle-shaped inferior region (3180G); a first support region (3180E) having a consistent wall thickness, preferably 2 mm, that is greater than the wall thickness of the dome-shaped superior and the saddle-shaped inferior regions, preferably 0.3 mm; a second support region (3180D) having a varied wall thickness and is bounded by the first support region (3180E) on a proximal side and having a distal side opposite the proximal side. In claim 1, the wall thickness in the second support region (3180D) increases from the distal side to the proximal side, preferably 2 to 1.3 mm. Preferably, wall thickness of a third support region (3180F) is 1.3 mm, a compliant region (3180C) is 0.85 mm and a flap (3180H) is 0.5 mm. Preferably flap (3180H) moves independently of a loop connection (3110).

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 seal-forming portion shaped to be bisected by a sagittal plane that includes a line tangent to the elastomeric seal-forming portion at a superior tangent point and an inferior tangent point,

wherein the elastomeric seal-forming portion comprises;

a dome-shaped superior region that straddles the sagittal plane in the vicinity of the superior tangent point,

a saddle-shaped inferior region that straddles the sagittal plane and includes the inferior tangent point,

a first support region extending from the saddle-shaped inferior region to the dome-shaped superior region, the first support region having a consistent elastomeric wall thickness that is greater than an elastomeric wall thickness of the dome-shaped superior region and the saddle-shaped inferior region, and

a second support region adjacent the first support region that extends from the saddle-shaped inferior region to the dome-shaped superior region, the second support region being bounded by the first support region on a proximal side and having a distal side opposite the proximal side, an elastomeric wall thickness in the second support region increases from the distal side to the proximal side.

2. The cushion assembly of claim 1, wherein the elastomeric wall thickness of the second support region at the distal side is less than the elastomeric wall thickness of the second support region at the proximal side.

3. The cushion assembly of claim 1, wherein the elastomeric wall thickness of the second support region at the proximal side is the same as the elastomeric wall thickness of the first support region.

4. The cushion assembly of claim 1, wherein the elastomeric seal-forming portion further comprises a third support region adjacent the second support region, the second support region being bounded by the third support region at the distal side.

5. The cushion assembly of claim 4, wherein an elastomeric wall thickness of the third support region is the same as the elastomeric wall thickness at the proximal side of the second support region.

6. The cushion assembly of claim 1, wherein the elastomeric seal-forming portion further comprises a saddle-shaped superior region that straddles the sagittal plane in the vicinity of the superior tangent point.

7. The cushion assembly of claim 6, wherein an elastomeric wall thickness in the saddle-shaped superior region is less than the elastomeric wall thickness in the domes-shaped superior region.

8. The cushion assembly of claim 6, wherein the elastomeric seal-forming portion further comprises a compliant region bounded by the second support region, the saddle-shaped superior region and the dome-shaped superior region.

9. The cushion assembly of claim 8, wherein an elastomeric wall thickness in the compliant region is greater than the elastomeric wall thickness of the saddle-shaped superior region and the elastomeric wall thickness of the dome-shaped superior region.

10. The cushion assembly of claim 8, wherein an elastomeric wall thickness in the compliant region is less than the elastomeric wall thickness of the second support region.

11. The cushion assembly of claim 8, wherein the elastomeric seal-forming portion further comprises a loop connection extending from the compliant region and the second support region.

12. The cushion assembly of claim 11, wherein the elastomeric seal-forming portion further comprises a flap portion extending from the compliant region and the second support region.

13. The cushion assembly of claim 12, wherein the flap portion extends from a location where the loop connection is attached to the compliant region and the second support region.

14. The cushion assembly of claim 12, wherein an elastomeric wall thickness in the flap portion is less than the elastomeric wall thickness in the compliant region and the second support region.

15. The cushion assembly of claim 12, wherein the flap portion is configured to move independently of the loop connection.

16. 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.

17. A CPAP system comprising:

the patient interface according to claim 16;

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.

18. The cushion assembly of claim 1, wherein the elastomeric seal-forming portion is dome-shaped at the superior tangent point.

19. 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 seal-forming structure 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 an inferior tangent point, the elastomeric seal-forming structure comprising;

a posterior central opening and an anterior central opening opposite the posterior central opening, the elastomeric seal-forming structure including a plurality of closed paths concentric to the posterior central opening;

a dome-shaped superior region that straddles the sagittal plane in the vicinity of the superior tangent point, the dome-shaped superior region being positioned on the outermost closed path;

a saddle-shaped superior region that straddles the sagittal plane in the vicinity of the superior tangent point, the saddle-shaped superior region being positioned on the innermost closed path;

a saddle-shaped inferior region that straddles the sagittal plane and includes the inferior tangent point, the saddle-shaped inferior region being on both the innermost closed path and the outermost closed path;

wherein an elastomeric wall thickness of the elastomeric seal-forming structure is invariable along a portion of the outermost closed path extending from the saddle-shaped inferior region to the dome-shaped superior region; and

wherein the elastomeric wall thickness of the elastomeric seal-forming structure varies along a portion of the innermost closed path that extends from the saddle-shaped inferior region to the saddle-shaped superior region.

20. The cushion assembly of claim 19, wherein the portion of the outermost closed path extending from the saddle-shaped inferior region to the dome-shaped superior region includes a saddle-shaped portion.

21. The cushion assembly of claim 19, wherein the portion of the outermost closed path extending from the saddle-shaped inferior region to the dome-shaped superior region includes a dome-shaped portion.

22. The cushion assembly of claim 19, wherein the portion of the innermost closed path extending from the saddle-shaped inferior region to the saddle-shaped superior region includes a saddle-shaped portion.

23. The cushion assembly of claim 19, wherein the portion of the innermost closed path extending from the saddle-shaped inferior region to the saddle-shaped superior region includes a dome-shaped portion.

24. A patient interface comprising:

the cushion assembly of claim 19;

a rigid shell removably connected to the cushion assembly; and

headgear removably attached to the rigid shell.

25. A CPAP system comprising:

the patient interface according to claim 24;

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.

26. 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 seal-forming structure that is shaped to be bisected by a sagittal plane that has a line that is tangent to the elastomeric seal-forming structure at a superior tangent point and at an inferior tangent point,

wherein a first nasal bridge region of the elastomeric seal-forming structure straddles the sagittal plane in the vicinity of the superior tangent point,

wherein a second nasal bridge region of the elastomeric seal-forming structure straddles the sagittal plane in the vicinity of the superior tangent point and is configured to seal against the patient'"'"'s nasal bridge when the cushion is mounted on the patient'"'"'s face, the second nasal bridge region having a thinner elastomeric wall than the first nasal bridge region,

wherein a chin region of the elastomeric seal-forming structure straddles the sagittal plane and includes the inferior tangent point, the chin region being configured to engage the patient'"'"'s chin when the cushion is mounted on the patient'"'"'s face, the chin region having the same elastomeric wall thickness as the first nasal bridge region,

wherein a first support region and a second support region are positioned side by side and both extend from the chin region to the first nasal bridge region, the first support region having a consistent elastomeric wall thickness, and the second support region having a varied elastomeric wall thickness.

27. The cushion assembly of claim 26, wherein the elastomeric wall thickness of the second support region is consistent in the direction from the chin region to the first nasal bridge.

28. The cushion assembly of claim 26, wherein the elastomeric wall thickness in the second support region increases toward the first support region.

29. The cushion assembly of claim 26, wherein the elastomeric seal-forming structure further comprises a compliant region configured to engage a side of the upper portion of the patient'"'"'s nose, an elastomeric wall thickness in the compliant region being less than the second support region and greater than the first nasal bridge region.

30. The cushion assembly of claim 29, wherein the compliant region is bounded by the first nasal bridge region, the second nasal bridge region and the second support region.

31. The cushion assembly of claim 30, wherein the elastomeric seal-forming structure further comprises a loop structure extending from the second support region and the compliant region.

32. The cushion assembly of claim 31, wherein the elastomeric seal-forming structure further comprises a flap portion bounded by the second nasal bridge region, the compliant region and the second support region.

33. The cushion assembly of claim 32, wherein an elastomeric wall thickness of the flap portion is greater than the second nasal bridge region and less than the elastomeric wall thickness of the compliant region.

34. The cushion assembly of claim 32, wherein the flap portion is configured to move independently of the loop structure.

35. The cushion assembly of claim 26, wherein an elastomeric seal-forming structure further comprises a third support region bounded by the chin region, the second support region and the flap portion.

36. The cushion assembly of claim 35, wherein an elastomeric wall thickness of the third support region is greater than the elastomeric wall thickness in the chin region and is less than the elastomeric wall thickness in the first support region.

37. A patient interface comprising:

the cushion assembly of claim 26;

a rigid shell removably connected to the cushion assembly; and

headgear removably attached to the rigid shell.

38. A CPAP system comprising:

the patient interface according to claim 37;

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.