Mask system

• US 10,441,738 B2
• Filed: 11/21/2018
• Issued: 10/15/2019
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Inventors: Formica, Justin John, Romagnoli, Jose Ignacio, Kwok, Philip Rodney, Gibson, Joel Edward, Pidcock, David Anthony, Skipper, Christopher Scott, Gray, Stephen
• Primary Examiner(s): Boecker, Joseph D.
• Application Number:
  US16/198,518
• Publication Number:
  US 20190091431A1
• Time in Patent Office: 328 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 16/0655 in the form of a linear or curvilinear slide
• 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 16/0816 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 2209/06 Packaging for specific medical equipment
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0625 Mouth

Abstract

A mask system for delivery of respiratory therapy to a patient includes a nares portion and a mouth portion and an inlet conduit connected to at least one of the nares portion and the mouth portion to deliver the pressurized, breathable gas. The mask system is adapted to selectively utilize the nares portion and/or the mouth portion in a first mode utilizing both the nares portion and the mouth portion, and in a second mode utilizing the nares portion and not utilizing the mouth portion.

Claims

1. A mask system for delivery of respiratory therapy to a patient, comprising:

a mask shaped to seal entirely below a nasal bridge of the patient and provide pressurized air to a nose of the patient and a mouth of the patient, the mask including;

a mouth sealing portion that defines a mouth aperture through which the pressurized air is to be provided to the mouth of the patient;

a nares sealing portion that defines a nasal aperture through which the pressurized air is to be provided to the nose of the patient, the nasal aperture spaced apart from the mouth aperture, the nares sealing portion including;

(i) a first wall,

(ii) a flexible membrane shaped to seal around nares of the patient through contact with sides of the nose of the patient when the mask is worn by the patient, the flexible membrane extending away from the first wall towards a free edge of the flexible membrane, the flexible membrane including;

a flexible membrane nose tip engagement portion,

a flexible membrane upper lip engagement portion,

a first flexible membrane side portion that is between the flexible membrane nose tip engagement portion and the flexible membrane upper lip engagement portion, and

a second flexible membrane side portion that is between the flexible membrane nose tip engagement portion and the flexible membrane upper lip engagement portion, the first flexible membrane side portion being on an opposite side of the nasal aperture from the second flexible membrane side portion,

(iii) a first supporting thickened portion that is located behind the first flexible membrane side portion to provide support to the first flexible membrane side portion that is between the flexible membrane nose tip engagement portion and the flexible membrane upper lip engagement portion, the first supporting thickened portion extending away from the first wall towards a first free edge of the first supporting thickened portion, the first free edge of the first supporting thickened portion being separated from a free edge of the first flexible membrane side portion, wherein a thickness of the first supporting thickened portion is multiple times thicker than a thickness of the first flexible membrane side portion, and

(iv) a second supporting thickened portion that is located behind the second flexible membrane side portion to provide support to the second flexible membrane side portion that is between the flexible membrane nose tip engagement portion and the flexible membrane upper lip engagement portion, the second supporting thickened portion extending away from the first wall towards a first free edge of the second supporting thickened portion, the first free edge of the second supporting thickened portion being separated from a free edge of the second flexible membrane side portion, wherein a thickness of the second supporting thickened portion is multiple times thicker than a thickness of the second flexible membrane side portion; and

headgear connectors on opposing sides of the mask to connect with headgear that retains the mask in position on a head of the patient when the mask system is worn by the patient.

2. The mask system of claim 1, wherein the nasal aperture is shaped to contemporaneously provide pressured air to both nares of the patient.

3. The mask system of claim 2, wherein the nasal aperture is separated from the mouth aperture by a portion of the mask.

4. The mask system of claim 2, wherein the flexible membrane nose tip engagement portion comprises a hanging, flexible membrane shaped to engage a tip of the nose of the patient.

5. The mask system of claim 1, wherein the flexible membrane, the first supporting thickened portion, the second supporting thickened portion, and the first wall comprise a silicone material.

6. The mask system of claim 1, wherein the flexible membrane, the first supporting thickened portion, the second supporting thickened portion, and the first wall are formed as a unitary structure of a silicone material.

7. The mask system of claim 6, further comprising:

a first air delivery conduit that functions as headgear in addition to being an air delivery conduit; and

a second air delivery conduit that functions as headgear in addition to being an air delivery conduit;

wherein the mask is connectable to the first air delivery conduit and the first air delivery conduit is structured to extend along a first side of the face of the patient when worn as headgear, and

wherein the mask is connectable to the second air delivery conduit and the second air delivery conduit is structured to extend along a second side of the face of the patient when worn as headgear.

8. The mask system of claim 6, wherein the mouth sealing portion of the mask seals with the face of the patient at a front of a chin of the patient through a mouth sealing membrane contacting the front of the chin of the patient when the mask system is worn by the patient.

9. The mask system of claim 8, wherein the mouth sealing membrane is shaped to contact cheeks of the patient and above an upper lip of the patient when the mask system is worn by the patient.

10. The mask system of claim 9, wherein the mouth sealing membrane defines the mouth aperture.

11. The mask system of claim 9, wherein the mask includes means for venting gas exhaled by the patient.

12. The mask system of claim 1, wherein the mouth sealing portion includes means for sealing around the mouth of the patient.

13. The mask system of claim 12, wherein the mask includes a rigid frame that includes means for connecting to the mouth sealing portion and the nares sealing portion.

14. The mask system of claim 11, further comprising means for retaining the mask in position on the head of the patient.

15. The mask system of claim 11, further comprising means for delivering pressurized air to the mask.

16. The mask system of claim 1, wherein:

the thickness of the first supporting thickened portion being multiple times thicker than the thickness of the first flexible membrane side portion comprises a maximum thickness of the first supporting thickened portion being multiple times thicker than a maximum thickness of the first flexible membrane side portion; and

the thickness of the second supporting thickened portion being multiple times thicker than the thickness of the second flexible membrane side portion comprises a maximum thickness of the second supporting thickened portion being multiple times thicker than a maximum thickness of the second flexible membrane side portion.

17. The mask system of claim 1, wherein:

the thickness of the first supporting thickened portion being multiple times thicker than the thickness of the first flexible membrane side portion comprises a thickness of the first free edge of the first supporting thickened portion being multiple times thicker than a thickness of the free edge of the first flexible membrane side portion; and

the thickness of the second supporting thickened portion being multiple times thicker than the thickness of the second flexible membrane side portion comprises a thickness of the first free edge of the second supporting thickened portion being multiple times thicker than a thickness of the free edge of the second flexible membrane side portion.

18. The mask system of claim 1, wherein:

the mask system is structured so that the first supporting thickened portion transfers load applied by the headgear to a first side of the nose of the patient when the mask system is worn by the patient; and

the mask system is structured so that the second supporting thickened portion transfers load applied by the headgear to a second side of the nose of the patient when the mask system is worn by the patient, the second side of the nose of the patient being opposite the first side of the nose of the patient on an underside of the nose of the patient.

19. The mask system of claim 1, wherein:

the first supporting thickened portion extends away from the first wall towards the first free edge of the first supporting thickened portion and a second free edge of the first supporting thickened region, the first free edge of the first supporting thickened portion being separated from the second free edge of the first supporting thickened region by an air gap; and

the second supporting thickened portion extends away from the first wall towards the first free edge of the second supporting thickened portion and a second free edge of the second supporting thickened region, the first free edge of the second supporting thickened portion being separated from the second free edge of the second supporting thickened region by an air gap.

20. The mask system of claim 19, wherein:

a first connecting wall transversely connects the first free edge of the first supporting thickened portion to the second free edge of the first supporting thickened portion; and

a second connecting wall transversely connects the first free edge of the second supporting thickened portion to the second free edge of the second supporting thickened portion.

21. The mask system of claim 1, wherein the nares sealing portion includes:

(v) a third supporting thickened portion that is located behind the first flexible membrane side portion to provide support to the first flexible membrane side portion, the third supporting thickened portion extending away from the first wall towards a first free edge of the third supporting thickened portion, the first free edge of the third supporting thickened portion being separated from the edge of the first flexible membrane side portion, wherein a thickness of the third supporting thickened portion is multiple times thicker than a thickness of the first flexible membrane side portion, and

(vi) a fourth supporting thickened portion that is located behind the second flexible membrane side portion to provide support to the second flexible membrane side portion, the fourth supporting thickened portion extending away from the first wall towards a first free edge of the fourth supporting thickened portion, the first free edge of the fourth supporting thickened portion being separated from the edge of the second flexible membrane side portion, wherein a thickness of the fourth supporting thickened portion is multiple times thicker than a thickness of the second flexible membrane side portion.

22. The mask system of claim 21, wherein:

the first free edge of the first supporting thickened portion is separated from the first free edge of the third supporting thickened portion; and

the first free edge of the second supporting thickened portion is separated from the first free edge of the fourth supporting thickened portion.

23. The mask system of claim 1, wherein:

a width of the first supporting thickened portion terminates before extending beneath the flexible membrane nose tip engagement portion and before extending beneath the flexible membrane upper lip engagement portion, such that the width of the first supporting thickened portion is entirely located beneath the first flexible membrane side portion; and

a width of the second supporting thickened portion terminates before extending beneath the flexible membrane nose tip engagement portion and before extending beneath the flexible membrane upper lip engagement portion, such that the width of the second supporting thickened portion is entirely located beneath the second flexible membrane side portion.

24. The mask system of claim 1, further comprising:

an additional membrane that extends away from the first wall towards a free edge of the additional membrane, the additional membrane being located behind the flexible membrane, a free edge of the additional membrane being separated from the free edge of the flexible membrane, from the first free edge of the first supporting thickened portion, and from the first free edge of the second supporting thickened portion.

25. A mask system for delivery of respiratory therapy to a patient, comprising:

a mask shaped to seal entirely below a nasal bridge of the patient and provide pressurized air to a nose of the patient and a mouth of the patient, the mask including;

a mouth sealing portion that defines a mouth aperture through which the pressurized air is to be provided to the mouth of the patient;

a nares sealing portion that defines a nasal aperture through which the pressurized air is to be provided to the nose of the patient, the nasal aperture shaped to contemporaneously provide pressured air to both nares of the patient, the nasal aperture spaced apart from the mouth aperture, the nares sealing portion including;

(i) a first wall,

(ii) a flexible membrane shaped to seal around nares of the patient through contact with sides of the nose of the patient when the mask is worn by the patient, the flexible membrane extending away from the first wall towards an edge of the flexible membrane, wherein the flexible membrane includes a nose tip engagement portion comprising a hanging, flexible membrane shaped to engage a tip of the nose of the patient, and

(iii) a supporting portion to provide support to the flexible membrane, the supporting portion extending away from the first wall towards an edge of the supporting portion, the edge of the supporting portion being separated from the edge of the flexible membrane, wherein the nose tip engagement portion is adapted to stretch toward the supporting portion when the mask system is worn by the patient with the tip of the nose of the patient placed into contact with the nose tip engagement portion; and

headgear connectors on opposing sides of the mask to connect with headgear that retains the mask in position on a head of the patient when the mask system is worn by the patient.

26. A mask system for delivery of respiratory therapy to a patient, comprising:

a mask shaped to seal entirely below a nasal bridge of the patient and provide pressurized air to a nose of the patient and a mouth of the patient, the mask including;

a mouth sealing portion that defines a mouth aperture through which the pressurized air is to be provided to the mouth of the patient;

a nares sealing portion that defines a nasal aperture through which the pressurized air is to be provided to the nose of the patient, the nasal aperture spaced apart from the mouth aperture, the nares sealing portion including;

(i) a first wall,

(ii) a flexible membrane shaped to seal around nares of the patient through contact with sides of the nose of the patient when the mask is worn by the patient, the flexible membrane extending away from the first wall towards an edge of the flexible membrane, wherein the flexible membrane includes;

a flexible membrane nose tip engagement portion,

a flexible membrane upper lip engagement portion, and

a first flexible membrane side portion that is between the flexible membrane nose tip engagement portion and the flexible membrane upper lip engagement portion,

a second flexible membrane side portion that is between the flexible membrane nose tip engagement portion and the flexible membrane upper lip engagement portion, the first flexible membrane side portion being on an opposite side of the nasal aperture from the second flexible membrane side portion, the first flexible membrane side portion and the second flexible membrane side portion each being thicker than each of the flexible membrane nose tip engagement portion and the flexible membrane upper lip engagement portion, and

(iii) a supporting portion to provide support to the flexible membrane, the supporting portion extending away from the first wall towards an edge of the supporting portion, the edge of the supporting portion being separated from the edge of the flexible membrane; and

headgear connectors on opposing sides of the mask to connect with headgear that retains the mask in position on a head of the patient when the mask system is worn by the patient.

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

a mask shaped to seal entirely below a nasal bridge of the patient and provide pressurized air to a nose of the patient and a mouth of the patient, the mask including;

a mouth sealing portion that defines a mouth aperture through which the pressurized air is to be provided to the mouth of the patient;

a nares sealing portion that defines a nasal aperture through which the pressurized air is to be provided to the nose of the patient, the nasal aperture spaced apart from the mouth aperture, the nares sealing portion including;

(i) a first wall,

(ii) a flexible membrane shaped to seal around nares of the patient through contact with sides of the nose of the patient when the mask is worn by the patient, the flexible membrane extending away from the first wall towards an edge of the flexible membrane, wherein the flexible membrane includes;

a flexible membrane nose tip engagement portion,

a flexible membrane upper lip engagement portion,

a first flexible membrane side portion that is between the flexible membrane nose tip engagement portion and the flexible membrane upper lip engagement portion, and

a second flexible membrane side portion that is between the flexible membrane nose tip engagement portion and the flexible membrane upper lip engagement portion, the first flexible membrane side portion being on an opposite side of the nasal aperture from the second flexible membrane side portion; and

(iii) a supporting portion to provide support to the flexible membrane, the supporting portion extending away from the first wall towards an edge of the supporting portion, the edge of the supporting portion being separated from the edge of the flexible membrane, wherein the supporting portion includes;

a first supporting portion side portion that is located behind the first flexible membrane side portion to provide support for the first flexible membrane side portion, and

a second supporting portion side portion that is located behind the second flexible membrane side portion to provide support for the second flexible membrane side portion, wherein the first supporting portion side portion and the second supporting portion side portion have a maximum thickness that is greater than a maximum thickness of the supporting portion between the first supporting portion side portion and the second supporting portion side portion; and

headgear connectors on opposing sides of the mask to connect with headgear that retains the mask in position on a head of the patient when the mask system is worn by the patient.

28. The mask system of claim 27, wherein the supporting portion between the first supporting portion side portion and the second supporting portion side portion is located proximal either the nose of the patient or the upper lip of the patient when the mask system is worn by the patient.