Patient interface systems

• US 9,010,330 B2
• Filed: 09/30/2011
• Issued: 04/21/2015
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Barlow, Adam Francis, Scheiner, Rupert Christian, Formica, Justin John, Davidson, Aaron Samuel, Stuebiger, Kai
• Primary Examiner(s): Ho, Tan-Uyen T.
• Assistant Examiner(s): Han, Mark K
• Application Number:
  US13/876,624
• Publication Number:
  US 20130213400A1
• Time in Patent Office: 1,299 Days
• Field of Search: 128/201.18, 128/201.22, 128/201.23, 128/201.28, 128/204.18, 128/205.25, 128/206.21, 128/206.24, 128/206.26, 128/206.28, 128/207.11, 128/207.12, 128/207.18
• US Class Current: 128/205.25
• CPC Class Codes: A61M 16/0057 Pumps therefor
• 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 16/0666 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 16/0694 Chin straps
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2202/0085 product washed out
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• 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
• CPC Class Codes: A61M 2210/0625 Mouth

Abstract

A patient interface structure for delivery of respiratory therapy to a patient includes a front plate configured to conform to the shape of the patient'"'"'s face; a mouth cushion defining a breathing chamber and provided to the front plate and configured to seal around the patient'"'"'s mouth; and a nasal cushion configured to seal the patient'"'"'s nasal airways. The nasal cushion is supported by the mouth cushion, does not contact a bridge of the patient'"'"'s nose in use, and extends at least partially into the breathing chamber. A patient interface system includes a patient interface structure and a patient interface structure positioning system configured to position, stabilize and secure the patient interface structure in sealing engagement with the patient'"'"'s face.

Claims

1. A patient interface structure for delivery of respiratory therapy to a patient, comprising:

a front plate configured to conform to the shape of the patient'"'"'s face;

a mouth cushion defining a breathing chamber and provided to the front plate and configured to seal around the patient'"'"'s mouth, a patient-facing side of the mouth cushion defining at least a portion of an aperture; and

a nasal cushion positioned at an upper side of the mouth cushion and configured to seal the patient'"'"'s nasal airways, wherein the nasal cushion is supported by the mouth cushion, has a dual wall construction including a sealing wall and a supporting wall positioned substantially in parallel with each other, does not contact a bridge of the patient'"'"'s nose when the patient interface structure is mounted on the patient'"'"'s face, and extends below an upper portion of the aperture defined by the mouth cushion and at least partially into the breathing chamber.

2. A patient interface structure according to claim 1, wherein the front plate is flexible.

3. A patient interface structure according to claim 1, wherein the front plate is formed of clear material.

4. A patient interface structure according to claim 3, wherein the front plate is formed of nylon or polycarbonate.

5. A patient interface structure according to claim 1, wherein the front plate is formed of nearly clear material.

6. A patient interface structure according to claim 5, wherein the front plate is formed of polypropylene.

7. A patient interface structure according to claim 1, wherein the front plate is shaded.

8. A patient interface structure according to claim 7, wherein the front plate has a graded shading, a patterned shading, or a random shading.

9. A patient interface structure according to claim 1, wherein the front plate has colour changing properties.

10. A patient interface structure according to claim 1, wherein at least a portion of the front plate is surface treated.

11. A patient interface structure according to claim 10, wherein at least a portion of the front plate is frosted.

12. A patient interface structure according to claim 1, wherein the front plate is provided with a skin or adhesive layer.

13. A patient interface structure according to claim 1, wherein the front plate is die cut, drape formed, vacuum formed, moulded, cast, or ultrasonically cut.

14. A patient interface structure according to claim 1, wherein the front plate comprises a vent.

15. A patient interface structure according to claim 14, wherein the vent comprises a plurality of vent holes in the front plate.

16. A patient interface structure according to claim 15, wherein the vent holes are provided around a perimeter of the front plate.

17. A patient interface structure according to claim 15, wherein the vent holes comprise micro-perforated holes provided over an entire surface of the front plate.

18. A patient interface structure according to claim 1, wherein the front plate comprises a strengthening rib.

19. A patient interface structure according to claim 1, wherein the front plate comprises a guide for aligning the mouth cushion.

20. A patient interface structure according to claim 1, wherein the front plate comprises connectors configured to connect to a patient interface structure positioning system configured to position, stabilize and secure the patient interface structure in sealing engagement with the patient'"'"'s mouth and nasal passageways.

21. A patient interface structure according to claim 20, wherein each connector comprises at least one slot configured to receive at least one strap of the patient interface structure positioning system.

22. A patient interface structure according to claim 21, wherein the at least one slot comprises two slots, wherein a first slot is configured to aid sealing of the mouth cushion and a second slot is configured to aid sealing of the nasal cushion when the patient interface structure is in use and connected to the patient interface structure positioning system.

23. A patient interface structure according to claim 1, further comprising a tube connector connected to the front plate.

24. A patient interface structure according to claim 23, wherein the tube connector is connected to a front surface of the front plate.

25. A patient interface structure according to claim 24, wherein the tube connector is an elbow.

26. A patient interface structure according to claim 25, wherein the elbow is a swivel elbow or a ball joint elbow.

27. A patient interface structure according to claim 25, wherein the elbow is connected to a rear surface of the front plate.

28. A patient interface structure according to 27, wherein the front plate comprises connectors configured to connect to a patient interface structure positioning system configured to position, stabilize and secure the patient interface structure in sealing engagement with the patient'"'"'s mouth and nasal passageways and the elbow is behind or adjacent one of the connectors.

29. A patient interface structure according to claim 27, wherein the elbow is formed in one piece with the front plate.

30. A patient interface structure according to claim 23, further comprising an anti-asphyxia valve provided in the tube connector or the front plate.

31. A patient interface structure according to claim 30, wherein the anti-asphyxia valve comprises a flap configured to cover an aperture in the tube connector or front plate in use when a flow of breathable gases is delivered to the patient interface structure.

32. A patient interface structure according to claim 31, wherein the flap comprises a vent.

33. A patient interface structure according to claim 32, wherein the vent comprises a plurality of vent holes in the flap.

34. A patient interface structure according to claim 33, wherein the vent holes are elongated with respect to the flap.

35. A patient interface structure according claim 23, wherein the tube connector has a curvature that corresponds to a curvature of the front plate.

36. A patient interface structure according to claim 1, wherein the mouth cushion is connected to the front plate at a front portion of the mouth cushion by adhesive or welding.

37. A patient interface structure according to claim 36, wherein an upper portion of the mouth cushion has a greater width than a lower portion of the mouth cushion.

38. A patient interface structure according to claim 36, wherein opposite side walls of the mouth cushion each comprise a slot through which a respective connector of the front plate extends.

39. A patient interface structure according to claim 36, wherein the mouth cushion comprises gusseted side walls.

40. A patient interface structure according to claim 36, wherein a rear portion of the mouth cushion comprises at least one flap or membrane configured to seal against the patient'"'"'s face.

41. A patient interface structure according to claim 40, wherein the front portion of the mouth cushion has a Shore A durometer of about 30-50 and the at least one flap or membrane has a Shore A durometer of about 5-10.

42. A patient interface structure according to claim 41, wherein the nasal cushion has a Shore A durometer of about 30-50.

43. A patient interface structure according to claim 41, wherein the nasal cushion has a Shore A durometer of about 5-10.

44. A patient interface structure according to claim 41, wherein the front portion of the mouth cushion has a Shore A durometer of about 40 and the at least one flap or membrane has a Shore A durometer of about 7.

45. A patient interface structure according to claim 44, wherein the nasal cushion has a Shore A durometer of about 40.

46. A patient interface structure according to claim 44, wherein the nasal cushion has a Shore A durometer of about 7.

47. A patient interface structure according to claim 36, wherein the mouth cushion comprises a nasal cushion support portion configured to position and stabilize the nasal cushion in use in engagement with corners of the patient'"'"'s nose.

48. A patient interface structure according to claim 47, wherein the nasal cushion support portion comprises raised portions configured to position the nasal cushion in use against the flares of the patient'"'"'s nostrils.

49. A patient interface structure according to claim 47, wherein the mouth cushion comprises a channel around the nasal cushion support portion to allow the nasal cushion support portion to flex.

50. A patient interface structure according to claim 47, wherein the nasal cushion support portion comprises at least one indent configured to receive at least one lug of the nasal cushion.

51. A patient interface structure according to claim 47, wherein the nasal cushion support portion does not support a central portion of the nasal cushion.

52. A patient interface structure according to claim 36, wherein the mouth cushion is formed of TPE, TPU, silicone, skinned foam, unskinned foam, gel or any combination thereof.

53. A patient interface structure according to claim 36, wherein the nasal cushion is formed of TPE, TPU, silicone, skinned foam, unskinned foam, gel or any combination thereof.

54. A patient interface structure according to claim 36, further comprising a tube cuff provided to a side wall of the mouth cushion, the tube cuff being configured to connect to a tube that delivers a flow of breathable gas.

55. A patient interface structure according to claim 54, wherein the tube cuff is integrally formed with the mouth cushion or the front plate.

56. A patient interface structure according to claim 54, wherein the tube cuff is adhered to the mouth cushion or the front plate.

57. A patient interface structure according to claim 54, wherein the tube cuff is flexible.

58. A patient interface structure according to claim 1, wherein the mouth cushion is releasably connected to the front plate at a front portion of the mouth cushion.

59. A patient interface structure according to claim 58, wherein the mouth cushion is connected to the front plate by a cushion clip.

60. A patient interface structure according to claim 58, wherein the front portion of the mouth cushion comprises a channel that receives the front plate.

61. A patient interface system, comprising:

a patient interface structure according to claim 1; and

a patient interface structure positioning system configured to position, stabilize and secure the patient interface structure in sealing engagement with the patient'"'"'s face.

62. A patient interface system according to claim 61, wherein the patient interface structure positioning system comprises a crown strap configured to cup the crown of the patient'"'"'s head, a pair of upper side straps connected to the crown strap and configured to extend from the crown strap above the patient'"'"'s ears and connect to the front plate, and a pair of lower side straps connected to the front plate and configured to extend below the patient'"'"'s ears.

63. A patient interface system according to claim 62, wherein at least one of the lower side straps extends through a loop on the crown strap.

64. A patient interface system according to claim 62, wherein the pair of upper side straps have a greater width adjacent to the crown strap.

65. A patient interface according to claim 1, wherein the nasal cushion is configured so that when the patient interface structure is mounted on the patient'"'"'s face, a portion of the patient'"'"'s nose rests on the nasal cushion between an uppermost portion of the mouth cushion and the breathing chamber.