Patient interface

• US 10,543,332 B2
• Filed: 01/16/2014
• Issued: 01/28/2020
• Est. Priority Date: 01/16/2013
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Inventors: Scheiner, Rupert Christian, Hitchcock, William Laurence, Barbara, Anthony Paul, Barlow, Adam Francis, Edwards, Craig David, Goldspink, Lachlan Richard, Haskard, Kirrily Michele, Lee, Murray William, May, Frederick Arlet, Rummery, Gerard Michael, Shanmuga Sundara, Shiva Kumar, Tan, Chia Ik, Wagner, Stewart Joseph, Wells, Alicia Kristianne, Forrester, Martin, Jourdan, Ralph
• Primary Examiner(s): Ho, Tan-Uyen T
• Assistant Examiner(s): Heffner, Ned T
• Application Number:
  US14/760,808
• Publication Number:
  US 20150352306A1
• Time in Patent Office: 2,203 Days
• 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 16/0622 having an underlying cushion
• CPC Class Codes: A61M 16/0672 Nasal cannula assemblies for oxygen therapy
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/10 Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 16/1055 bacterial
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/16 Devices to humidify the respiration air A61M16/1045 takes precedence
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2210/0618 Nose

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

1. A patient interface configured for sealed delivery of a supply of pressurized, breathable gas at a continuously positive pressure with respect to ambient air pressure to a patient'"'"'s nares, the patient interface being configured to maintain a therapeutic 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, said patient interface comprising:

a frame member comprising a gas washout vent configured to allow a flow of patient exhaled CO2 to an exterior of the patient interface to minimise rebreathing of exhaled CO2 by the patient;

a cushion member configured to deliver the supply of pressurized, breathable gas to the patient'"'"'s nares, the cushion member further comprising;

a seal-forming structure and a plenum chamber at least partly forming a gas chamber, the seal-forming structure being configured to seal against the patient'"'"'s face around both nares at an inferior periphery of the patient'"'"'s nose such that the seal-forming structure contacts the patient'"'"'s face below the bridge of the nose, at lateral sides of the patient'"'"'s nose, and at the patient'"'"'s upper lip, the seal-forming structure being configured not to enter the patient'"'"'s nares in use, and the seal-forming structure having no undercushion; and

a retaining structure configured to releasably engage with the frame member to releasably secure the seal-forming structure and the plenum chamber to the frame member; and

a positioning and stabilising structure configured to maintain the seal-forming structure in sealing contact with patient'"'"'s face while maintaining the therapeutic pressure at the patient'"'"'s nares;

wherein the seal-forming structure and the plenum chamber are made from one piece of a first material and the retaining structure is made from a second material, the first material being silicone and the second material being silicone with a higher durometer than the first material, such that the retaining structure is more rigid than the seal-forming structure and the plenum chamber; and

wherein the plenum chamber further comprises a sealing lip, the sealing lip being configured such that an increase in air pressure within the gas chamber increases a sealing force of the plenum chamber against the frame member.

2. The patient interface of claim 1, wherein the plenum chamber is located between the retaining structure and the seal-forming structure.

3. The patient interface of claim 1, further comprising a frame member made from the second material.

4. The patient interface of claim 1, wherein the first material permits the seal-forming structure to readily conform to finger pressure and the second material prevents the retaining structure from readily conforming to finger pressure.

5. The patient interface of claim 1, wherein said seal-forming structure has a varied thickness adjacent the nasal opening at predetermined positions around the perimeter of the nasal opening.

6. The patient interface of claim 1, wherein a lower portion of said seal-forming structure is concave in a relaxed state to seal against the upper lip of the patient and to follow a curvature of the upper lip of the patient.

7. The patient interface of claim 1, wherein the frame member further comprises ribs and the plenum chamber further comprises notches corresponding to the ribs.

8. The patient interface of claim 1, wherein the retaining structure is permanently joined to the plenum chamber with a chemical bond between the first material and the second material.

9. The patient interface of claim 1, wherein said seal-forming structure includes a recessed portion that is configured to receive the tip of the nose of the patient, the recessed portion being located at a region of the seal-forming structure that is thinner than laterally adjacent regions of the seal-forming structure that are configured to contact the patient'"'"'s ala.

10. The patient interface of claim 9, wherein said seal-forming structure comprises a compliant region located above the recessed portion, said compliant region being thin and flexible relative to the remainder of the seal-forming structure.

11. The patient interface of claim 1, wherein said seal-forming structure comprises a pair of protruding ends extending symmetrically about the nasal opening, each protruding end configured to seal against a region of the patient'"'"'s face where the ala of the nose joins to the patient'"'"'s face.

12. The patient interface of claim 11, wherein said seal-forming structure comprises a pair of protruding end support sections corresponding to each protruding end and structured to support each protruding end,

wherein said pair of protruding end support sections extend into the gas chamber.

13. The patient interface of claim 1, wherein the positioning and stabilising structure further comprises a pair of rigidiser arms, each joined to a corresponding lateral side of the frame member.

14. The patient interface of claim 13, wherein the positioning and stabilising structure further comprises a strap having two ends, each end removably connected to a corresponding one of the rigidiser arms.

15. A patient interface configured for sealed delivery of a supply of pressurized, breathable gas at a continuously positive pressure with respect to ambient air pressure to a patient'"'"'s nares, the patient interface being configured to maintain a therapeutic 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, said patient interface comprising:

a frame member comprising a gas washout vent configured to allow a flow of patient exhaled CO2 to an exterior of the patient interface to minimise rebreathing of exhaled CO2 by the patient;

a cushion member configured to deliver the supply of pressurized, breathable gas to the patient'"'"'s nares, the cushion member further comprising;

a seal-forming structure and a plenum chamber at least partly forming a gas chamber, the seal-forming structure being configured to seal against the patient'"'"'s face around both nares at an inferior periphery of the patient'"'"'s nose such that the seal-forming structure contacts the patient'"'"'s face below the bridge of the nose, at lateral sides of the patient'"'"'s nose, and at the patient'"'"'s upper lip, the seal-forming structure being configured not to enter the patient'"'"'s nares in use, and the seal-forming structure having no undercushion; and

a retaining structure configured to releasably engage with the frame member to releasably secure the seal-forming structure and the plenum chamber to the frame member; and

a positioning and stabilising structure configured to maintain the seal-forming structure in sealing contact with patient'"'"'s face while maintaining the therapeutic pressure at the patient'"'"'s nares;

wherein the seal-forming structure and the plenum chamber are made from one piece of a first material and the retaining structure is made from a second material, the first material being silicone and the second material being silicone with a higher durometer than the first material, such that the retaining structure is more rigid than the seal-forming structure and the plenum chamber;

wherein the plenum chamber further comprises a sealing lip, the sealing lip being configured such that an increase in air pressure within the gas chamber increases a sealing force of the plenum chamber against the frame member; and

wherein a retention force between the retaining structure and the frame member is higher than a disengagement force to disengage the retaining structure from the frame member.

16. The patient interface of claim 15, wherein said seal-forming structure has a varied thickness adjacent the nasal opening at predetermined positions around the perimeter of the nasal opening.

17. The patient interface of claim 15, wherein said seal-forming structure comprises a pair of protruding ends extending symmetrically about the nasal opening, each protruding end configured to seal against a region of the patient'"'"'s face where the ala of the nose joins to the patient'"'"'s face.

18. The patient interface of claim 15, wherein said seal-forming structure comprises a pair of protruding end support sections corresponding to each protruding end and structured to support each protruding end,

wherein said pair of protruding end support sections extend into the gas chamber.

19. The patient interface of claim 15, wherein a lower portion of said seal-forming structure is concave in a relaxed state to seal against the upper lip of the patient and to follow a curvature of the upper lip of the patient.

20. The patient interface of claim 15, wherein the frame member further comprises ribs and the plenum chamber further comprises notches corresponding to the ribs.

21. The patient interface of claim 15, wherein the retaining structure is permanently joined to the plenum chamber with a chemical bond between the first material and the second material.

22. The patient interface of claim 15, wherein the positioning and stabilising structure further comprises a pair of rigidiser arms, each joined to a corresponding lateral side of the frame member, and

wherein the positioning and stabilising structure further comprises a strap having two ends, each end removably connected to a corresponding one of the rigidiser arms.

23. The patient interface of claim 15, wherein said seal-forming structure includes a recessed portion that is configured to receive the tip of the nose of the patient, the recessed portion being located at a region of the seal-forming structure that is thinner than laterally adjacent regions of the seal-forming structure that are configured to contact the patient'"'"'s ala.

24. The patient interface of claim 23, wherein said seal-forming structure comprises a compliant region located above the recessed portion, said compliant region being thin and flexible relative to the remainder of the seal-forming structure.

25. A patient interface configured for sealed delivery of a supply of pressurized, breathable gas at a continuously positive pressure with respect to ambient air pressure to a patient'"'"'s nares, the patient interface being configured to maintain a therapeutic 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, said patient interface comprising:

a frame member comprising a gas washout vent configured to allow a flow of patient exhaled CO2 to an exterior of the patient interface to minimise rebreathing of exhaled CO2 by the patient;

a cushion member configured to deliver the supply of pressurized, breathable gas to the patient'"'"'s nares, the cushion member further comprising;

a seal-forming structure and a plenum chamber at least partly forming a gas chamber, the seal-forming structure being configured to seal against the patient'"'"'s face around both nares at an inferior periphery of the patient'"'"'s nose and below the bridge of the nose, at lateral sides of the patient'"'"'s nose, and at the patient'"'"'s upper lip, the seal-forming structure being configured not to enter the patient'"'"'s nares in use, and the seal-forming structure having no undercushion; and

a retaining structure configured to releasably engage with the frame member to releasably secure the seal-forming structure and the plenum chamber to the frame member; and

a positioning and stabilising structure configured to maintain the seal-forming structure in sealing contact with patient'"'"'s face while maintaining the therapeutic pressure at the patient'"'"'s nares;

wherein the seal-forming structure and the plenum chamber are made from one piece of a first material and the retaining structure is made from a second material, the first material being silicone and the second material being silicone with a higher durometer than the first material, such that the retaining structure is more rigid than the seal-forming structure and the plenum chamber; and

wherein the plenum chamber further comprises a sealing lip, the sealing lip being configured such that an increase in air pressure within the gas chamber increases a sealing force of the plenum chamber against the frame member;

wherein said seal-forming structure includes a recessed portion that is configured to receive the tip of the nose of the patient, the recessed portion being located at a region of the seal-forming structure that is thinner than laterally adjacent regions of the seal-forming structure that are configured to contact the patient'"'"'s ala, and

wherein said seal-forming structure comprises a pair of protruding ends extending symmetrically about the nasal opening, each protruding end configured to seal against a region of the patient'"'"'s face where the ala of the nose joins to the patient'"'"'s face.

26. The patient interface of claim 25, wherein said seal-forming structure comprises a compliant region located above the recessed portion, said compliant region being thin and flexible relative to the remainder of the seal-forming structure.

27. The patient interface of claim 25, wherein said seal-forming structure has a varied thickness adjacent the nasal opening at predetermined positions around the perimeter of the nasal opening.

28. The patient interface of claim 25, wherein the seal-forming structure includes an overhang at the nasal opening of the seal-forming structure, said overhang located proximal to the recessed portion.

29. The patient interface of claim 25, wherein said seal-forming structure comprises a pair of protruding end support sections corresponding to each protruding end and structured to support each protruding end,

wherein said pair of protruding end support sections extend into the gas chamber.

30. The patient interface of claim 25, wherein the frame member further comprises ribs and the plenum chamber further comprises notches corresponding to the ribs.

31. The patient interface of claim 25, wherein the retaining structure is permanently joined to the plenum chamber with a chemical bond between the first material and the second material.

32. The patient interface of claim 25, wherein the positioning and stabilising structure further comprises a pair of rigidiser arms, each joined to a corresponding lateral side of the frame member, and

wherein the positioning and stabilising structure further comprises a strap having two ends, each end removably connected to a corresponding one of the rigidiser arms.

33. The patient interface of claim 25, wherein a lower portion of said seal-forming structure is concave in a relaxed state to seal against the upper lip of the patient and to follow a curvature of the upper lip of the patient.

34. The patient interface of claim 33, wherein said lower portion has a reduced material thickness relative to the rest of the seal-forming structure.