IP Library › Granted Patent US 11,583,651

Granted Patent B2

US 11,583,651 · App. 16/552,310 · Granted Feb 21, 2023

Patient interface

Inventors: Alicia Kristianne Wells (Sydney, AU); Craig David Edwards (Sydney, AU); Shiva Kumar Shanmuga Sundara (Sydney, AU); Murray William Lee (Sydney, AU); Kirrily Michele Haskard (Sydney, AU); Anthony Paul Barbara (Sydney, AU); Stewart Joseph Wagner (Hawkesbury, AU); Chia Ik Tan (Sydney, AU); Frederick Arlet May (Sydney, AU); Lachlan Richard Goldspink (Sydney, AU); Martin Forrester (Trenton, CA); Ralph Jourdan (Morfelden, DE)

Assignee: ResMed Pty Ltd

A61M16/0672 A61M16/06 A61M16/0622 A61M16/0683 A61M16/00 A61M16/0633 A61M16/0825 A61M16/107 A61M16/1055 A61M2205/0216 A61M2210/0618

View Patent ↗

Loading inventors, assignments & file history…

Monitor This Case

Get email alerts when status or documents change.

Order Certified Copies

Most orders are placed with the USPTO same day — all within 24 business hours.

Order via The Patent Place →

Pre-filled with this patent's details

Quick Facts

Patent No.: US 11,583,651
App. No.: 16/552,310
Granted: Feb 21, 2023
Kind: B2

External Links

USPTO Patent Center↗ Full Patent PDF↗

Abstract

A patient interface for delivery of a supply of pressurised air or breathable gas to an entrance of a patient's airways comprising: a cushion member that includes a retaining structure and a seal-forming structure permanently connected to the retaining structure; a frame member attachable to the retaining structure; and a positioning and stabilising structure attachable to the frame member.

Claims (96)

1. A patient interface comprising:

a frame comprising:

a connection port sized and structured to receive a flow of air at a therapeutic pressure of at least 4 cmH2O above ambient air pressure for breathing by a patient;

a channel portion; and

a vent structure comprising a plurality of vent holes;

a cushion assembly comprising:

a plenum chamber pressurisable to the therapeutic pressure;

a seal-forming structure constructed and arranged to seal against the patient's face around the patient's nares, the seal-forming structure having a hole configured to deliver the flow of air at the therapeutic pressure to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use, and the seal-forming structure and the plenum chamber being moulded as a single, unitary component;

a retaining structure integrally moulded to the plenum chamber and configured to removably connect the cushion assembly to the frame, the retaining structure comprising a tongue portion configured to extend into the channel portion when the cushion assembly is removably connected to the frame; and

a sealing lip configured to engage the frame such that an increase in air pressure within the plenum chamber causes a sealing force between the sealing lip and the frame to increase; and

a positioning and stabilising structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's face, the positioning and stabilising structure having a pair of rigidiser arms connected to the frame and a strap removably connected to the pair of rigidiser arms, the strap being length-extensible, and the strap being constructed and arranged so that at least a portion overlies a corresponding lateral region of the patient's head superior to the patient's otobasion superior in use; and

a gas delivery tube connected to the frame at the connection port, the gas delivery tube configured to direct the flow of air at the therapeutic pressure to the plenum chamber;

wherein the patient interface is configured to leave the patient's mouth uncovered;

wherein the plurality of vent holes are configured to allow a continuous flow of gases exhaled by the patient to pass from within the plenum chamber to ambient, the vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use;

wherein the seal-forming structure and the plenum chamber are moulded from a first silicone material and the retaining structure is moulded from a second silicone material with a higher durometer than the first silicone material such that the retaining structure is more rigid than the seal-forming structure and the plenum chamber; and

wherein the frame is overmoulded to the rigidiser arms to permanently connect the frame and the rigidiser arms.

2. The patient interface of claim 1 , wherein the patient interface does not include a forehead support.

3. The patient interface of claim 1 , wherein the frame is constructed from a plastic material.

4. The patient interface of claim 3 , wherein the plastic material is polypropylene.

5. The patient interface of claim 3 , wherein the rigidiser arms are constructed from a flexible material that cannot be integrally bonded to the plastic material of the frame.

6. The patient interface of claim 5 , wherein the flexible material is a thermoplastic elastomer.

7. The patient interface of claim 1 , wherein the seal-forming structure is configured not to enter the patient's nares during use.

8. The patient interface of claim 1 , wherein the plurality of vent holes comprise a first group of vent holes positioned on the frame at a first lateral side of the connection port and a second group of vent holes positioned on the frame at a second lateral side of the connection port that is opposite the first lateral side.

9. The patient interface of claim 1 , wherein the frame is moulded onto the gas delivery tube to permanently connect the frame and the gas delivery tube.

10. The patient interface of claim 1 , wherein the strap is constructed from a textile material.

11. The patient interface of claim 10 , wherein the textile material further comprises an elastomeric material such that the strap is elastically stretchable.

12. The patient interface of claim 10 , wherein the textile material is warp knitted such that the strap is elastically stretchable.

13. The patient interface of claim 10 , wherein the strap further comprises a pair of side strap portions, each of the side strap portions being configured to be positioned along a corresponding lateral side of the patient's head in use.

14. The patient interface of claim 13 , wherein each of the side strap portions has a tubular construction and a hole at a corresponding free end thereof, and

wherein each of the rigidiser arms is inserted into a corresponding one of the side strap portions.

15. The patient interface of claim 14 , wherein the free end of each of the side strap portions engages a corresponding one of the rigidiser arms to connect each of the side strap portions to the corresponding rigidiser arm such that each of the rigidiser arms substantially imparts its curvature upon the corresponding side strap portion, and

wherein each of the side strap portions is stretchable relative to the corresponding rigidiser arm.

16. The patient interface of claim 14 , wherein the free end of each of the side strap portions encloses and abuts a portion of the corresponding rigidiser arm to limit movement of the strap relative to the corresponding rigidiser arm.

17. The patient interface of claim 1 , wherein:

the patient interface does not include a forehead support,

the seal-forming structure is configured not to enter the patient's nares during use,

the plurality of vent holes comprise a first group of vent holes positioned on the frame at a first lateral side of the connection port and a second group of vent holes positioned on the frame at a second lateral side of the connection port that is opposite the first lateral side,

the frame is moulded onto the gas delivery tube to permanently connect the frame and the gas delivery tube,

the strap is constructed from a textile material,

the strap further comprises a pair of side strap portions, each of the side strap portions being configured to be positioned along a corresponding lateral side of the patient's head in use,

each of the side strap portions has a tubular construction and a hole at a corresponding free end thereof,

each of the rigidiser arms is inserted into a corresponding one of the side strap portions,

the free end of each of the side strap portions engages a corresponding one of the rigidiser arms to connect each of the side strap portions to the corresponding rigidiser arm such that each of the rigidiser arms substantially imparts its curvature upon the corresponding side strap portion,

each of the side strap portions is stretchable relative to the corresponding rigidiser arm, and

the free end of each of the side strap portions encloses and abuts a portion of the corresponding rigidiser arm to limit movement of the strap relative to the corresponding rigidiser arm.

18. The patient interface of claim 1 , wherein the sealing lip is cantilevered inwardly from the plenum chamber to overlap the frame when the cushion assembly is removably connected to the frame.

19. The patient interface of claim 18 , wherein the frame comprises an annular rim that partly forms the channel portion, and

wherein the sealing lip is configured to overlap the annular rim when the cushion assembly is removably connected to the frame.

20. A patient interface comprising:

a frame comprising:

a connection port sized and structured to receive a flow of air at a therapeutic pressure of at least 4 cmH2O above ambient air pressure for breathing by a patient;

a channel portion; and

a vent structure comprising a plurality of vent holes;

a cushion assembly comprising:

a plenum chamber pressurisable to the therapeutic pressure; a seal-forming structure constructed and arranged to seal against the patient's face around the patient's nares, the seal-forming structure having a hole configured to deliver the flow of air at the therapeutic pressure to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use, and the seal-forming structure and the plenum chamber being moulded as a single, unitary component;

a sealing lip configured to engage the frame such that an increase in air pressure within the plenum chamber causes a sealing force between the sealing lip and the frame to increase; and

a gas delivery tube connected to the frame at the connection port, the gas delivery tube configured to direct the flow of air at the therapeutic pressure to the plenum chamber;

wherein the patient interface is configured to leave the patient's mouth uncovered;

wherein the frame is moulded onto the gas delivery tube to permanently connect the frame and the gas delivery tube.

21. The patient interface of claim 20 , wherein the patient interface does not include a forehead support.

22. The patient interface of claim 20 , wherein the frame is constructed from a plastic material.

23. The patient interface of claim 22 , wherein the plastic material is polypropylene.

24. The patient interface of claim 22 , wherein the rigidiser arms are constructed from a flexible material that cannot be integrally bonded to the plastic material of the frame.

25. The patient interface of claim 24 , wherein the plastic material of the frame is overmoulded to the flexible material of the rigidiser arms to permanently connect the frame and the rigidiser arms.

26. The patient interface of claim 24 , wherein the flexible material is a thermoplastic elastomer.

27. The patient interface of claim 20 , wherein the frame is overmoulded to the rigidiser arms to permanently connect the frame and the rigidiser arms.

28. The patient interface of claim 20 , wherein the seal-forming structure is configured not to enter the patient's nares during use.

29. The patient interface of claim 20 , wherein the plurality of vent holes comprise a first group of vent holes positioned on the frame at a first lateral side of the connection port and a second group of vent holes positioned on the frame at a second lateral side of the connection port that is opposite the first lateral side.

30. The patient interface of claim 20 , wherein the strap is constructed from a textile material.

31. The patient interface of claim 30 , wherein the textile material further comprises an elastomeric material such that the strap is elastically stretchable.

32. The patient interface of claim 30 , wherein the textile material is warp knitted such that the strap is elastically stretchable.

33. The patient interface of claim 30 , wherein the strap further comprises a pair of side strap portions, each of the side strap portions being configured to be positioned along a corresponding lateral side of the patient's head in use.

34. The patient interface of claim 33 , wherein each of the side strap portions has a tubular construction and a hole at a corresponding free end thereof, and

wherein each of the rigidiser arms is inserted into a corresponding one of the side strap portions.

35. The patient interface of claim 34 , wherein the free end of each of the side strap portions engages a corresponding one of the rigidiser arms to connect each of the side strap portions to the corresponding rigidiser arm such that each of the rigidiser arms substantially imparts its curvature upon the corresponding side strap portion, and

wherein each of the side strap portions is stretchable relative to the corresponding rigidiser arm.

36. The patient interface of claim 34 , wherein the free end of each of the side strap portions encloses and abuts a portion of the corresponding rigidiser arm to limit movement of the strap relative to the corresponding rigidiser arm.

37. The patient interface of claim 20 , wherein the sealing lip is cantilevered inwardly from the plenum chamber to overlap the frame when the cushion assembly is removably connected to the frame.

38. The patient interface of claim 37 , wherein the frame comprises an annular rim that partly forms the channel portion, and