Patient interface systems

• US 10,456,545 B2
• Filed: 11/21/2018
• Issued: 10/29/2019
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Inventors: Barlow, Adam Francis, Scheiner, Rupert Christian, Formica, Justin John, Davidson, Aaron Samuel, Stuebiger, Kai
• Primary Examiner(s): Dixon, Annette
• Application Number:
  US16/198,492
• Publication Number:
  US 20190091430A1
• Time in Patent Office: 342 Days
• 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 mask system for respiratory therapy involving delivery of pressurized air to a patient, the mask system comprising:

a patient interface shaped to form a seal with both a mouth of the patient and nasal airways of the patient without contacting a nasal bridge of the patient, including;

a flexible cushion shaped to form a seal with (i) the nasal airways using a nasal seal portion of the cushion, and (ii) the mouth of the patient using a mouth seal portion of the cushion, the nasal seal portion of the cushion and the mouth seal portion of the cushion comprising a same flexible material, the nasal seal portion of the cushion shaped to form a seal with the nasal airways at a portion of a nose of the patient that surrounds nares of the patient under the nose of the patient, the flexible cushion defining a plate-receiving aperture that is located at a front portion of the cushion that is opposite from a face-contacting portion of the cushion,

a front plate that has a greater rigidity than the flexible cushion, the front plate being located within the plate-receiving aperture at the front portion of the flexible cushion, the front plate being molded to the flexible cushion at a perimeter of the front plate, the front plate and the cushion defining a breathing chamber, the front plate comprising a transparent window through which the mouth of the patient is visible when the patient interface is worn by the patient,

a first headgear connector that is on a first side of the patient interface and positionable proximate to a first ear of the patient when the patient interface is worn by the patient, the first side being located between a top of the patient interface proximate the nose of the patient when the mask system is worn by the patient and a bottom of the patient interface proximate a chin of the patient when the mask system is worn by the patient, and

a second headgear connector that is on a second side of the patient interface and positionable proximate to a second ear of the patient when the patient interface is worn by the patient, the second side opposing the first side; and

headgear shaped to secure the patient interface on a head of the patient in sealing engagement with the mouth and the nasal airways, the headgear adapted to connect to the first headgear connector and the second headgear connector.

2. The mask system of claim 1, wherein the cushion is adapted to connect with an air delivery conduit and the front plate is free of any direct connection to an air delivery conduit.

3. The mask system of claim 1, wherein:

the transparent window has a maximum width extending in a direction from the left side of the patient interface to the right side of the patient interface when the patient interface is viewed from in front of the patient when the mask system is worn by the patient;

the maximum width of the transparent window is greater than a maximum height of the transparent window; and

the transparent window is wider at a top of the transparent window proximate the nose than a bottom of the transparent window proximate the chin, when the mask system is worn by the patient.

4. The mask system of claim 3, wherein corners at the top of the transparent window are rounded and corners at the bottom of the transparent window are rounded.

5. The mask system of claim 1, wherein the transparent window is convex from the left side of the patient interface to the right side of the patient interface when the patient interface is viewed from in front of the patient when the mask system is worn by the patient.

6. The mask system of claim 5, wherein the transparent window is convex from the top of the patient interface to the bottom of the patient interface when the patient interface is viewed from in front of the patient when the mask system is worn by the patient.

7. The mask system of claim 5, wherein the transparent window is substantially smooth in front of a mouth of the patient to permit visibility to the mouth from in front of the patient when the mask system is worn by the patient.

8. The mask system of claim 1, wherein the patient interface has a width extending from the left side of the patient interface to the right side of the patient interface when the patient interface is viewed from in front of the patient when the mask system is worn by the patient, and the patient interface is wider than the patient interface is tall.

9. The mask system of claim 1, wherein the mouth seal portion of the cushion supports the nasal seal portion of the cushion, wherein the nasal seal portion of the cushion and the mouth seal portion of the cushion are integrally formed in one piece.

10. The mask system of claim 1, wherein the mouth seal portion of the cushion supports the nasal seal portion of the cushion, wherein the nasal seal portion of the cushion and the mouth seal portion of the cushion are integrally formed from silicone.

11. The mask system of claim 10, wherein the cushion and the front plate have widths extending from the left side of the patient interface to the right side of the patient interface when the patient interface is viewed from in front of the patient when the mask system is worn by the patient, and the cushion is wider than the front plate and is taller than the front plate, when the patient interface is viewed from in front of the patient when the mask system is worn by the patient.

12. The mask system of claim 1, wherein the cushion forms a continuous sealing surface that is formed to seal both the nasal airways using the nasal seal portion of the cushion and the mouth of the patient using the mouth seal portion of the cushion.

13. The mask system of claim 1, wherein:

the nasal seal portion of the cushion defines a nasal aperture through which the pressurized air is to be provided to the nasal airways;

the mouth seal portion of the cushion defines a mouth aperture through which the pressurized air is to be provided to the mouth; and

the nasal aperture is spaced apart from the mouth aperture.

14. The mask system of claim 13, wherein:

the cushion includes a cradle wall that separates the nasal aperture from the mouth aperture, the cradle wall being shaped to contact a face of the patient between an upper lip of the patient and the nose of the patient; and

the cradle wall hangs below a top of the front plate and is structured so that a tip of the nose of the patient hangs below the top of the front plate, when the mask system is worn by the patient and the patient interface is viewed from in front of the patient.

15. The mask system of claim 14, wherein the nasal aperture has a shape in which sides of the nasal aperture sweep closer towards an upper lip of the patient than a center portion of the nasal aperture, when the mask system is worn by the patient.

16. The mask system of claim 14, wherein the cushion includes a gusset that partially surrounds the nasal seal portion of the cushion to facilitate movement of the nasal seal portion of the cushion with respect to the mouth seal portion of the cushion.

17. The mask system of claim 14, wherein the cradle wall that separates the nasal aperture from the mouth aperture forms a continuous sealing surface that provides part of the nasal seal portion of the cushion and part of the mouth seal portion of the cushion.

18. The mask system of claim 17, wherein the cradle wall forms the continuous sealing surface by lacking definition between the nasal seal portion of the cushion and the mouth seal portion of the cushion.

19. The mask system of claim 1, wherein the front plate includes a vent to vent gases exhaled into the breathing chamber by the patient.

20. The mask system of claim 19, wherein the vent includes a plurality of vent holes defined in the front plate, the plurality of vent holes being formed in an upper, central region of the front plate.

21. The mask system of claim 1, wherein the first headgear connector and the second headgear connector are attached to the front plate.

22. The mask system of claim 1, wherein the flexible cushion is adapted to form an air-pressure assisted seal.

23. The mask system of claim 1, wherein:

the nasal seal portion of the cushion includes means for forming a seal with the nasal airways;

the mouth seal portion of the cushion includes means for forming a seal with the mouth; and

the cushion includes means for separating the nasal seal portion of the cushion from the mouth seal portion of the cushion.

24. The mask system of claim 23, wherein:

the patient interface includes means for receiving the pressurized air;

the headgear includes means for connecting to the first headgear connector and to the second headgear connector;

the patient interface includes means for venting gases exhaled into the breathing chamber by the patient; and

the patient interface includes means for preventing asphyxia.

25. The mask system of claim 1, wherein the front portion of the flexible cushion comprises a channel that receives the perimeter of the front plate.

26. The mask system of claim 25, wherein the channel in the flexible cushion defines at least part of the plate-receiving aperture.

27. A mask system for respiratory therapy involving delivery of pressurized air to a patient, the mask system comprising:

a patient interface shaped to form a seal with both a mouth of the patient and nasal airways of the patient without contacting a nasal bridge of the patient, including;

a flexible cushion shaped to form a seal with (i) the nasal airways using a nasal seal portion of the cushion, and (ii) the mouth of the patient using a mouth seal portion of the cushion, the nasal seal portion of the cushion and the mouth seal portion of the cushion comprising a same flexible material, the nasal seal portion of the cushion shaped to form a seal with the nasal airways at a portion of a nose of the patient that surrounds nares of the patient under the nose of the patient, the flexible cushion being adapted to connect with an air delivery conduit, the flexible cushion defining a plate-receiving aperture that is located at a front portion of the cushion that is opposite from a face-contacting portion of the cushion, the cushion including a cradle wall that separates a nasal aperture through which the pressurized air is to be provided to the nasal airways from a mouth aperture through which the pressurized air is to be provided to the mouth, the cradle wall being shaped to contact a face of the patient between an upper lip of the patient and the nose of the patient, the cradle wall hanging below a top of the front plate and being structured so that a tip of the nose of the patient hangs below the top of the front plate, when the mask system is worn by the patient and the patient interface is viewed from in front of the patient, the flexible cushion including a single continuous sealing surface that forms part of the nasal seal portion of the cushion and part of the mouth seal portion of the cushion, the single continuous sealing surface of the flexible cushion lacking definition between the nasal seal portion of the cushion and the mouth seal portion of the cushion,

a front plate that has a greater rigidity than the flexible cushion, the front plate being located within the plate-receiving aperture at the front portion of the flexible cushion, the front plate being molded to the flexible cushion at a perimeter of the front plate, the front plate comprising a transparent window through which the mouth of the patient is visible when the patient interface is worn by the patient, the front plate being free of a connection with an air delivery conduit,

a first headgear connector that is on a first side of the patient interface and positionable proximate to a first ear of the patient when the patient interface is worn by the patient, the first side being located between a top of the patient interface proximate the nose of the patient when the mask system is worn by the patient and a bottom of the patient interface proximate a chin of the patient when the mask system is worn by the patient, and

a second headgear connector that is on a second side of the patient interface and positionable proximate to a second ear of the patient when the patient interface is worn by the patient, the second side opposing the first side; and

headgear shaped to secure the patient interface on a head of the patient in sealing engagement with the mouth and the nasal airways, the headgear adapted to connect to the first headgear connector and the second headgear connector.