IP Library Granted Patent US 12,427,280
Granted Patent B2
US 12,427,280 · App. 18/329,008 · Granted Sep 30, 2025

Patient interface with a seal-forming structure having varying thickness

Inventors: Matthew Eves (Sydney, AU); Lemmy Nga (Sydney, AU); Gerard Michael Rummery (Woodford, AU); Rupert Christian Scheiner (Sydney, AU)
Assignee: ResMed Pty Ltd
A61M16/0622A61M16/0066A61M16/0616A61M16/0683A61M16/0875A61M2205/3344A61M2210/0618A61M2210/0625
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Quick Facts
Patent No.
US 12,427,280
App. No.
18/329,008
Granted
Sep 30, 2025
Kind
B2
Abstract

A cushion assembly for a patient interface includes an elastomeric seal-forming portion that includes a dome-shaped superior region and a saddle-shaped inferior region. The elastomeric sealing portion further includes 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 the elastomeric wall thickness of the dome-shaped superior region and the saddle-shaped inferior region. In addition, the seal-forming portion include 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, the elastomeric wall thickness in the second support region increases from the distal side to the proximal side.

Claims (62)

1. 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 patient interface comprising:

a cushion assembly with an elastomeric seal-forming portion terminating at an unsupported edge and forming at least part of a plenum chamber, the elastomeric seal-forming portion having an interior surface inside the plenum chamber and an exterior surface outside the plenum chamber that is configured to form a seal with the patient's face,

wherein a wall thickness of the elastomeric seal-forming portion is varied, wherein a first region of the exterior surface has a first coefficient of friction that is less than a second coefficient of friction in a second region of the exterior surface, and

wherein a transition from the first coefficient of friction to the second coefficient of friction occurs in a region with a relatively greater wall thickness,

wherein the wall thickness of the elastomeric seal-forming portion in the first and second regions is less than the wall thickness of the elastomeric seal-forming portion in a third region, and wherein the transition from the first coefficient of friction to the second coefficient of friction is in the third region.

2. The patient interface of claim 1 , wherein the third region is between the first and second regions.

3. The patient interface of claim 1 , wherein the first region of the exterior surface is on a superior side of the elastomeric seal-forming portion and the second region of the exterior surface is on an inferior side of the elastomeric seal-forming portion.

4. The patient interface of claim 1 , wherein the first region and the second region are configured to be intersected by the patient's sagittal plane in use.

5. The patient interface of claim 1 , wherein the exterior surface in the first region is frosted and the exterior surface in the second region is not frosted.

6. The patient interface of claim 1 , wherein the first region is configured to engage the patient's nasal bridge and the second region is configured to engage the patient's chin.

7. The patient interface of claim 1 , wherein the transition between the first coefficient of friction and the second coefficient of friction is a laterally extending line.

8. The patient interface of claim 7 , wherein the coefficient of friction on a superior side of the transition line is less than the coefficient of friction on an inferior side of the transition line.

9. The patient interface of claim 1 ,

wherein the third region is between the first and second regions,

wherein the first region of the exterior surface is on a superior side of the elastomeric seal-forming portion and the second region of the exterior surface is on an inferior side of the elastomeric seal-forming portion,

wherein the first region and the second region are configured to be intersected by the patient's sagittal plane in use,

wherein the exterior surface in the first region is frosted and the exterior surface in the second region is not frosted,

wherein the first region is configured to engage the patient's nasal bridge and the second region is configured to engage the patient's chin, and

wherein the transition between the first coefficient of friction and the second coefficient of friction is a laterally extending line.

10. The patient interface of claim 1 , further comprising a shell with a central opening, wherein the cushion assembly further comprises an elastomeric support portion configured to support the elastomeric seal-forming portion and connect the elastomeric seal-forming portion to the shell, and wherein the shell is more rigid than the cushion assembly.

11. The patient interface of claim 10 , wherein the central opening in the shell is configured to receive an air delivery tube or a connector for an air delivery tube.

12. A patient interface assembly comprising:

the patient interface of claim 1 ;

a rigid shroud removably connected to the patient interface; and

headgear removably attached to the rigid shroud.

13. A CPAP system comprising:

the patient interface assembly according to claim 12 ;

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 assembly.

14. The patient interface of claim 1 , wherein the region with the relatively greater wall thickness has a first portion with the first coefficient of friction and a second portion with the second coefficient of friction.

15. The patient interface of claim 1 , wherein the transition from the first coefficient of friction to the second coefficient of friction occurs in a region configured to engage the patient's cheek.

16. 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 patient interface comprising:

a cushion assembly with an elastomeric seal-forming portion that is bisected by a sagittal plane that includes a line tangent to the elastomeric seal-forming portion at a superior tangent point and at an inferior tangent point, the elastomeric seal-forming portion terminating at an unsupported edge and forming at least part of a plenum chamber, the elastomeric seal-forming portion having an interior surface inside the plenum chamber and an exterior surface outside the plenum chamber, the elastomeric seal-forming portion comprising:

a superior region that is intersected by the sagittal plane in the vicinity of the superior tangent point;

an inferior region that is intersected by the sagittal plane and includes the inferior tangent point;

a first support region located on one side of the sagittal plane between the inferior region and the superior region; and

a second support region located on an opposite side of the sagittal plane from the first support region between the inferior region and the superior region,

wherein a wall thickness of the elastomeric seal-forming portion in the superior and inferior regions is less than a wall thickness of the elastomeric seal-forming portion in the first and second support regions,

wherein a part of the exterior surface of the elastomeric seal-forming portion in the inferior region is tackier than a part of the exterior surface of the elastomeric seal-forming portion in the superior region,

wherein a transition from the relatively tackier part of the exterior surface of the elastomeric seal-forming portion to the relatively less tacky part of the exterior surface is located in the first and second support regions, and

wherein the transition from the relatively tackier part of the exterior surface of the elastomeric seal-forming portion to the relatively less tacky part of the exterior surface is located in a part of the elastomeric seal-forming portion with the greatest wall thickness.

17. The patient interface of claim 16 , wherein the transition from the relatively tackier part of the exterior surface of the elastomeric seal-forming portion to the relatively less tacky part of the exterior surface of the elastomeric seal-forming portion is located at the unsupported edge of the elastomeric seal-forming portion.

18. The patient interface of claim 16 , wherein the transition between the relatively tackier part of the elastomeric seal-forming portion to the relatively less tacky part of the elastomeric seal-forming portion is a laterally extending line.

19. The patient interface of claim 18 , wherein the tackiness of the elastomeric seal-forming portion on a superior side of the transition line is less than the tackiness of the elastomeric seal-forming portion on an inferior side of the transition line.

20. The patient interface of claim 16 , wherein the exterior surface in the superior region is frosted and the exterior surface in the inferior region is not frosted.

21. The patient interface of claim 16 , wherein the superior region of the elastomeric seal-forming portion is configured to engage the patient's nasal bridge and the inferior region of the elastomeric seal-forming portion is configured to engage the patient's chin.

22. The patient interface of claim 16 , wherein the transition from the relatively tackier part of the exterior surface of the elastomeric seal-forming portion to the relatively less tacky part of the exterior surface of the elastomeric seal-forming portion is located at the unsupported edge of the elastomeric seal-forming portion,

wherein the transition between the relatively tackier part of the elastomeric seal-forming portion to the relatively less tacky part of the elastomeric seal-forming portion is a laterally extending line,

wherein the tackiness of the elastomeric seal-forming portion on a superior side of the transition line is less than the tackiness of the elastomeric seal-forming portion on an inferior side of the transition line,

wherein the exterior surface in the superior region is frosted and the exterior surface in the inferior region is not frosted, and

wherein the superior region of the elastomeric seal-forming portion is configured to engage the patient's nasal bridge and the inferior region of the elastomeric seal-forming portion is configured to engage the patient's chin.

23. The patient interface of claim 16 , further comprising a shell with a central opening, wherein the cushion assembly further comprises an elastomeric support portion configured to support the elastomeric seal-forming portion and connect the elastomeric seal forming portion to the shell, and wherein the shell is more rigid than the cushion assembly.

24. The patient interface of claim 23 , wherein the central opening in the shell is configured to receive an air delivery tube or a connector for an air delivery tube.

25. A patient interface assembly comprising:

the patient interface of claim 16 ;

a rigid shell removably connected to the cushion assembly; and

headgear removably attached to the rigid shell.

26. A CPAP system comprising:

the patient interface assembly according to claim 25 ;

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.

27. The patient interface of claim 16 , wherein each of the first and second support regions has a first portion and a second portion that is relatively tackier than the first portion.

Assignments (2)
CHANGE OF NAME AND CHANGE OF ADDRESS Recorded Jun 30, 2023
From: RESMED LIMITED
To: RESMED PTY LTD
Reel/Frame 064183/0796 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 5, 2023
From: EVES, MATTHEW; NGA, LEMMY; RUMMERY, GERARD MICHAEL; SCHEINER, RUPERT CHRISTIAN
To: RESMED LIMITED
Reel/Frame 063852/0777 →
Continuity (5)
Continuation 17002244 · Aug 25, 2020
Continuation 15759985
Provisional Application 62377217 · Aug 19, 2016
Provisional Application 62222503 · Sep 23, 2015
Related Publication 20230355906A1 · Nov 9, 2023
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Office Action dated Jul. 29, 2024 issued in Japanese Application No. 2023-84810 with English translation (9 pages). [cited by applicant]
Office Action dated Aug. 5, 2024 issued in Japanese Application No. 2023-204787 with English translation (6 pages). [cited by applicant]
Examination Report dated Jul. 12, 2023 issued in New Zealand Application No. 780367 (3 pages). [cited by applicant]
Examination Report dated Jul. 25, 2023 issued in New Zealand Application No. 780370 (3 pages). [cited by applicant]
Examination Report dated Jul. 25, 2023 issued in New Zealand Application No. 780375 (3 pages). [cited by applicant]
Examination Report dated Jul. 26, 2023 issued in New Zealand Application No. 780514 (3 pages). [cited by applicant]
Examination Report dated Jul. 26, 2023 issued in New Zealand Application No. 780366 (3 pages). [cited by applicant]
Notice of Grant dated Aug. 16, 2023 issued in Chinese Application No. 201680066661.1 (4 pages). [cited by applicant]
Examination Report dated Aug. 22, 2023 issued in New Zealand Application No. 780258 (4 pages). [cited by applicant]
Examination Report dated Aug. 22, 2023 issued in New Zealand Application No. 780440 (4 pages). [cited by applicant]
Examination Report dated Aug. 22, 2023 issued in New Zealand Application No. 780446 (3 pages). [cited by applicant]
Examination Report dated Aug. 22, 2023 issued in New Zealand Application No. 780508 (4 pages). [cited by applicant]
Office Action dated Sep. 11, 2023 issued in Japanese Application No. 2022-186547 with English translation (4 pages). [cited by applicant]
Examination Report dated Sep. 20, 2023 issued in New Zealand Application No. 740579 (3 pages). [cited by applicant]
Notice of Allowance dated Dec. 6, 2024 issued in U.S. Appl. No. 18/340,154 citing US 2002/0043265 A1, US 2008/000627 A1, US 2015/0328421 A1, US 2019/0217036 A1, U.S. Pat. No. 11,707,590 B2, and U.S. Pat. No. 11,717,628 … [cited by applicant]
Extended European Search Report dated Dec. 23, 2024 issued in European Application No. 24188721.5 (9 pages). [cited by applicant]
Extended European Search Report dated Nov. 27, 2024 issued in European Application No. 24178607.8 (14 pages). [cited by applicant]
Office Action dated Oct. 28, 2024 issued in Japanese Application No. 2024-027329 with English translation (7 pages). [cited by applicant]
Deadline for Counterstatement dated Nov. 6, 2024 issued in New Zealand Application No. 780421 (2 pages). [cited by applicant]
Notice of Opposition and Statement of Case dated Nov. 5, 2024 filed by Fisher & Paykel Healthcare Limited in New Zealand Application No. 780421 (1 page). [cited by applicant]
Notice of Opposition dated Nov. 5, 2024 filed by Fisher & Paykel Healthcare Limited in New Zealand Application No. 780421 (3 pages). [cited by applicant]
Statement of Case dated Nov. 5, 2024 filed by Fisher & Paykel Healthcare Limited in New Zealand Application No. 780421 (11 pages). [cited by applicant]
Extension of Time to Oppose Granted dated Oct. 9, 2024 issued in New Zealand Application No. 780294 (1 page). [cited by applicant]
Deadline for Counterstatement dated Nov. 6, 2024 issued in New Zealand Application No. 780294 (1 page). [cited by applicant]
Request for Extension of Time to Oppose dated Oct. 4, 2024 filed by Fisher & Paykel Healthcare Limited in New Zealand Application No. 780294 (1 page). [cited by applicant]
Notice of Opposition and Statement of Case dated Nov. 5, 2024 filed by Fisher & Paykel Healthcare Limited in New Zealand Application No. 780294 (1 page). [cited by applicant]
Notice of Opposition dated Nov. 5, 2024 filed by Fisher & Paykel Healthcare Limited in New Zealand Application No. 780294 (3 pages). [cited by applicant]
Statement of Case dated Nov. 5, 2024 filed by Fisher & Paykel Healthcare Limited in New Zealand Application No. 780294 (12 pages). [cited by applicant]
Pre-Appeal Examination Report dated Feb. 12, 2025 issued in Japanese Application No. 2023-84810 with English translation (2 pages). [cited by applicant]
Notice of Allowance dated Feb. 18, 2025 issued in Japanese Application No. 2024-27329 (3 pages). [cited by applicant]
Office Action dated Mar. 25, 2025 issued in Japanese Application No. 2023-204787 with English translation (6 pages). [cited by applicant]