RESPIRATORY SYSTEM AND MASK INTERFACE BACKGROUND

Abstract

A mask interface for a respiratory mask, in which the mask interface comprises a resilient mask housing at least partially formed from a textile and being configured to deform under pressure from an external force, such as when being pressed against a pillow, and to substantially return to its original shape either automatically or by manipulation by a user.

Claims

1-34. (canceled)

35. A mask interface configured to deliver breathing gas to a user, the mask interface comprising: a seal comprising a gas inlet configured to seal against a face of the user; and a 3-dimensional mask housing directly or indirectly attached to the seal, wherein the 3-dimensional mask housing comprises: at least one gas inlet, at least one fabric portion, and a flexible, resilient support structure configured to at least partially retain a shape of the 3-dimensional mask housing, the flexible, resilient support structure comprising a plurality of support members.

36. The mask interface of claim 35, wherein the plurality of support members is integrally formed with the at least one fabric portion.

37. The mask interface of claim 35, wherein each of the plurality of support members interconnects with each other.

38. The mask interface of claim 35, wherein the flexible, resilient support structure comprises a skeleton structure comprising the plurality of support members.

39. The mask interface of claim 35, wherein each of the plurality of support members comprises a first end and a second end, wherein a width of the first end is greater than a width of the second end.

40. The mask interface of claim 39, wherein the second end of each of the plurality of support members is a free end.

41. The mask interface of claim 39, wherein each of the plurality of support members curves inwardly such that the second end of each of the plurality of support members is inwardly disposed relative to the first end.

42. The mask interface of claim 39, wherein each of the plurality of support members has a squared-off end at the second end.

43. The mask interface of claim 35, wherein each of the plurality of support members extends partially across the 3-dimensional mask housing.

44. The mask interface of claim 35, further comprising a frame comprising a gas inlet and being configured to attach to the seal and the 3-dimensional mask housing so that the gas inlet of the frame substantially forms a fluid flow path with the gas inlet of the seal and the at least one gas inlet of the 3-dimensional mask housing.

45. The mask interface of claim 44, wherein the frame extends around a perimeter of the 3-dimensional mask housing and each of the plurality of support members is joined to the frame.

46. The mask interface of claim 44, wherein the plurality of support members is formed from a first material and the frame is formed from the first material.

47. The mask interface of claim 44, wherein the frame connects the 3-dimensional mask housing to the seal.

48. The mask interface of claim 35, wherein the seal is formed of silicone.

49. The mask interface of claim 35, wherein an airtight coating or layer is provided on an internal surface of the at least one fabric portion of the 3-dimensional mask housing.

50. The mask interface of claim 35, wherein the flexible, resilient support structure of the 3-dimensional mask housing is configured to at least partially deform under a sufficient deforming external force and to substantially return to its original shape after the sufficient deforming external force is removed.

51. The mask interface of claim 35, wherein the flexible, resilient support structure is located on an interior surface of the at least one fabric portion of the 3-dimensional mask housing.

52. The mask interface of claim 35, wherein the flexible, resilient support structure comprises a resilient support layer applied to interior and/or exterior surfaces of the at least one fabric portion of the 3-dimensional mask housing to increase a thickness of one or more regions of the 3-dimensional mask housing.

53. The mask interface of claim 52, wherein the resilient support layer is applied near outer edges of the 3-dimensional mask housing and/or along sides of the 3-dimensional mask housing to increase the thickness of these regions of the 3-dimensional mask housing.

54. The mask interface of claim 52, wherein the resilient support layer comprises an elastomer.

55. The mask interface of claim 52, wherein the resilient support layer comprises a vinyl or silicone lining.

56. The mask interface of claim 35, wherein the flexible, resilient support structure comprises a ridge that is provided in the at least one fabric portion of the 3-dimensional mask housing.

57. The mask interface of claim 56, wherein the ridge comprises at least one fold line or seam.

58. The mask interface of claim 56, wherein the ridge extends from a substantially central point at a central region of the 3-dimensional mask housing to a substantially central point near an upper edge of the 3-dimensional mask housing.

59. A respiratory system comprising: a respiratory mask according to claim 35; a gas delivery tube comprising a first end configured to connect to the mask interface and a second end configured to connect to a gas source; and a CPAP machine.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Preferred forms of the invention will now be described in relation to the accompanying drawings in which:

[0048] FIG. 1 is a perspective view of one form of mask interface according to the present invention;

[0049] FIG. 2 is a side view of the mask interface of FIG. 1;

[0050] FIG. 3 is a front view of the mask interface of FIG. 1;

[0051] FIG. 4 is a perspective top view of the mask interface of FIG. 1 in a collapsed or deformed state;

[0052] FIG. 5 is a rear view of one form of mask interface showing a support structure for a mask housing that includes a substantially resilient layer of material;

[0053] FIG. 6 is a partial cut-away side view of one form of mask showing a gas inlet at the side of the mask;

[0054] FIG. 7 is a partial cut-away side perspective view of another form of mask showing a support structure for a mask housing that includes support members in the form of filaments;

[0055] FIG. 8 is a rear view of the mask of FIG. 7; and

[0056] FIG. 9 is a partial cut-away side perspective view of another form of mask having a frame and a support structure comprising support fingers that extend from the frame to support the 3-dimensional shape of the mask housing.

DETAILED DESCRIPTION

[0057] Referring to FIGS. 1 to 9, the invention relates to a mask interface 1000, a respiratory mask 2000 comprising such a mask interface 1000, and a respiratory system for the delivery of breathing gas to a user. The respiratory mask 2000 is configured to be worn by a user to deliver breathing gas to the user. The respiratory mask 2000 comprises a mask interface 1000, comprising a seal 100 and mask housing 200, and a headgear assembly 300. Optionally, the mask interface 1000 also comprises a frame 400 that supports the seal 100 and mask housing 200. The respiratory mask 2000 may be a full face mask, a nasal mask or a pillows mask.

[0058] The mask interface 1000 may comprise a connection system to attach to the headgear assembly 300. The headgear assembly 300 is used to hold the mask interface 1000 to the user's face. The headgear is typically attached to the mask interface 1000 and wraps around the rear of the user's head to seal the mask interface 1000 against the user's face. Various forms of connection systems may be used to attach the headgear assembly 300 to the mask interface 1000. Similarly, the mask interface 1000 may be coupled to at least one and possibly multiple different types of headgear assemblies 300.

[0059] The seal 100 of the mask interface may comprise a front or distal surface and a rear surface or proximal surface. The rear surface of the seal 100 may be configured to substantially seal against a user's face during use. The seal 100 may be configured to fit over a user's mouth, nose, or both for sealing around and/or underneath a user's mouth and/or nose.

[0060] In one form, as shown particularly in FIGS. 1 to 5, the seal 100 forms a mask cushion configured to contact a user's face and to form a seal between the user's face and the mask interface 1000. For example, the seal 100 may be configured to substantially seal around a user's nose and mouth. Optionally, the seal 100 is resiliently deformable to fit and seal against a range of facial geometries. In one form, the seal 100 may comprise a rolling bridge 110 that fits over a user's nose and provides the seal 100 with a degree of customization to better fit and seal with a user's face. The seal 100 may be formed of any suitable material, such as silicone for example.

[0061] The seal 100 may comprise a gas inlet opening for receiving a breathing gas.

[0062] The mask housing 200 may be at least partially formed, and preferably fully formed, from a fabric/textile formed into a 3-dimensional shape. The fabric mask housing 200 may be substantially deformable under a sufficient external force. The mask housing 200 may also be configured to resume its original 3-dimensional shape either automatically after removal of the external force, or by manipulation of the mask housing 200 by a user. For example, the fabric mask housing 200 may comprise a first support structure/structural support 250 that is substantially flexible, to allow the mask housing to at least partially deform under a sufficient external force, and that is substantially resilient, to allow the mask housing 200 to substantially revert to its original 3-dimensional shape after removal of the external force.

[0063] In embodiments, such as those shown in FIGS. 6 and 7, where the mask interface 1000 comprises a frame 400, the seal 100 is configured to be attached to the frame 400. Optionally, the seal 100 comprises one or more attachment features to help locate and/or attach the seal 100 to the frame 400. In one form, the seal 100 may be over-moulded to the frame 400.

[0064] The frame 400 may be configured to provide additional structure to the seal 100. For example, the frame 400 may comprise a substantially resilient structure to prevent the seal 100 from collapsing unintentionally. The frame 400 may also provide additional structure to the deformable fabric mask housing 200. For example, the frame 400 may provide a support structure/structural support 450 to the mask housing 200. Where the mask housing 200 includes a first support structure 250, the frame 400 may optionally provide a second support structure. Alternatively, the frame 400 may provide the only support structure for the mask housing 200. In yet another form, only the mask housing 200 may comprise a support structure to support its 3-dimensional shape.

[0065] The frame 400 may comprise a body comprising a first surface or front surface and a substantially opposing second surface or rear surface. The body of the frame 400 may comprise an outer edge that defines the outer periphery of the frame 400. The frame 400 also comprises a gas inlet that may be located substantially centrally within the frame. The gas inlet is defined by an inner edge of the frame 400 and may be relatively large so that the body of the frame 400 forms a substantially thin boundary structure around the gas inlet. For example, the frame 400 may comprise a ring-like support structure for supporting the seal 100 and mask housing 200. The ring-like support structure of the frame 400 may be of any suitable regular or irregular shape, such as a substantially circular or elliptical shape, an oval shape, a triangular shape or a quadrilateral shape for example.

[0066] The frame 400 and seal 100 may be configured to be attached together so that the gas inlet openings of each part substantially align with each other. In one form, the frame 400 may comprise a gas inlet opening defined by a substantially continuous edge provided by a seal flange projecting from the rear surface of the frame 400. The gas inlet opening 120 of the seal 100 may comprise a substantially continuous lip configured to attach to the seal flange of the frame 400.

[0067] The frame 400 is typically located at or near an outer peripheral edge of the mask housing 200 and is configured to provide a substantially rigid connection by which the mask housing 200 may be connected to the seal 100. For this reason, the frame 400 is preferably made from a material that has greater rigidity than the seal 100 and mask housing 200 so that the frame 400 is capable of providing sufficient support to the seal 100 and housing 200. In one form, the frame 400 is made from polycarbonate, but in alternative forms, the frame may be made from any suitable rigid or semi-rigid material, such as nylon, polypropylene, other rigid or semi-rigid plastics, or even metal. In another embodiment, the frame 400 may comprise a thickened rim of material, such as silicone, on the outer perimeter of the seal 100. The resilient configuration of the frame 400 may provide the mask interface 1000 with a support structure to support the seal and/or mask housing.

[0068] In one form, the frame may be over-moulded to the mask housing 200. In another form, the mask interface 1000 may comprise a clipping structure that connects the seal 100, frame 400 and housing 200 together. However, it should be appreciated that any other suitable attachment system may be used to attach the seal 100, housing 200 and frame 400 together.

[0069] The mask housing 200 may be configured to provide at least one gas inlet 210 that substantially forms a fluid flow path with the gas inlets of the seal 100 and frame 400 to provide the mask interface 1000 with a gas inlet. Optionally, the mask housing 200 comprises a pair of gas inlets 210 configured to form a fluid flow path with the gas inlets of the seal 100 and frame 400 and to connect to a pair of gas supply conduits 350 (350a and 350b). The gas inlet(s) 210 may be located at one or both sides of the mask housing 200, as shown in FIG. 6, or at the front of the mask housing 200, as shown in FIG. 7.

[0070] The mask housing 200 may be at least partially or entirely formed of fabric and may be configured to provide an appearance of softness and comfort. The fabric may be any suitable form of woven or knitted textile/fabric and may comprise natural fibres (such as cotton, wool, or bamboo fibres, for example), synthetic fibres (such as nylon, polypropylene, or acrylic fibres, for example) or a combination of both. Preferably, at least an outer surface of the mask housing 200 comprises a soft, non-scratchy fabric.

[0071] The mask housing 200 may be configured to provide a flexible but substantially resilient enclosure that directly or indirectly attaches to the seal 100 to form an airtight breathing chamber.

[0072] To ensure that the mask housing 200 is airtight, the fabric used in the housing 200 should be airtight or should be used in combination with an airtight material, such as vinyl for example. In one form, at least the fabric portion of an inner surface of the housing 200 may comprise a layer or coating of airtight material. In another form, the fabric portion of the housing 200 may be impregnated with a substance such as plastic or resin that provides the fabric/textile with airtight properties.

[0073] In one form, the mask housing 200 may be configured to be sufficiently flexible to at least partially collapse under an external force, such as when pressed against a pillow for example. FIG. 4 illustrates one form of respiratory mask 2000 in which the mask housing 200 has been deformed. In this embodiment, the collapsing mask housing 200 reduces mask pull when the mask interface 1000 presses against the pillow or bed so that a user may sleep comfortably on his or her side while wearing the respiratory mask 2000. The mask housing 200 may also be configured so that the seal against a user's face is substantially retained even when the mask housing 200 partially collapses or when the user wears the mask interface 1000 while sleeping on his or her side.

[0074] The mask housing 200 of the present invention may be configured to be substantially resilient. For example, the mask housing 200 may be configured to have a shape memory so that a user can manipulate a collapsed mask to substantially return the mask to its original non-collapsed 3-dimensional shape. In some forms, the mask housing 200 may be configured to provide a shape memory that biases the mask housing 200 to a non-collapsed 3-dimensional shape. In this embodiment, after removing the external force that has caused the mask housing 200 to collapse, the mask housing 200 may automatically return to or substantially return to its non-collapsed shape without interference from a user.

[0075] In one form, the mask housing 200 may be configured to be sufficiently resilient to return to a substantially non-collapsed 3-dimensional shape by using a first support structure 250. The first support structure 250 may interact with at least the fabric portion of the mask housing 200 to encourage the housing 200 to return to its original shape after the housing 200 has been deformed under an external force.

[0076] In one form, as shown in FIGS. 5 and 6, the mask housing 200 may comprise the support structure 250 in the form of a support layer 251 configured to provide additional structure to the mask interface 1000. In one form, the support layer 251 may be a resilient layer comprising an elastomer, such as silicone for example, that is applied to the interior and/or exterior of at least one fabric portion 205 of the mask housing 200. The resilient support layer may be applied to one or more regions of the mask housing 200 to increase the thickness of those regions. In one form, as shown in FIG. 6, the support layer 251 may be an interior lining or coating. For example, the support layer 251 may be a vinyl or silicone lining. The interior lining may be configured to be thicker in areas of the mask housing 200 where additional structure is required. For example, the interior lining may be thicker near outer edges of the mask housing 200 and/or along sides of the mask housing 200.

[0077] In another form, the mask housing 200 may comprise a fabric/textile portion, such as a fabric/textile layer, and a first support structure 250 in the form of a skeleton structure comprising a plurality of resilient support members 252 configured to at least partially support the 3-dimensional shape of the fabric portion. In this arrangement, the mask housing 200 may be sufficiently flexible to at least partially deform when a user wearing the mask sleeps on his or her side and may also be sufficiently resilient to substantially return to its original shape either automatically or by manipulation by a user.

[0078] The support members 252 may or may not interconnect with each other. By interconnecting the support members 252, a more resilient support structure 250 is provided to the mask housing. The geometry of the support members 252 may provide flexibility to allow the support members 252 to deform together with the mask housing 200.

[0079] In one form, as shown in FIG. 7, the support members 252 comprise resilient or semi-resilient filaments, such as plastic filaments or metal wires for example. The filaments 252a may be configured to at least partially deform under force, such as under an external pressure force that occurs when the mask housing 200 presses against a pillow. The resilient nature of the filaments 252a means that the filaments 252a may be configured to automatically return to an original desired shape or to return to the original shape under manipulation by a user.

[0080] In one form, as shown in FIG. 8, the support members 252 may be located on an interior surface of the fabric/textile layer of the mask housing to form an internal skeleton support structure 250 that may or may not be connected to the fabric layer. In another form, the support members 252 may be integrally formed with a fabric layer to form the mask housing 200. For example, the support members 252 may comprise a plastic or silicone material and may be co-moulded with fabric to form the mask housing 200. In yet another form, the support members 252 may be located on an exterior surface of the mask housing 200 and may be attached to the mask housing 200 to provide structural support.

[0081] In another form, as shown in FIG. 9, the support members 252 comprise fingers 252b that extend from the frame 400 of the mask interface 1000, forming a support structure 450 of the frame 400. Optionally, the fingers 252b may be made from the same material as the frame 400. In one form, the fingers 252b are integral with the mask housing 200. For example, the fingers 252b may be co-moulded with the mask housing 200.

[0082] In another form, as shown in FIG. 3, the mask housing 200 may comprise a support structure 250 in the form of a ridge 252c that is provided in a fabric/textile portion of the housing 200. The ridge 252c may form a fold line along which the mask housing 200 will naturally fold when squashed. The ridge 252c may be configured to provide the mask housing 200 with sufficient support to hold a three-dimensional shape and to at least partially collapse under force. The ridge 252c may be a fold (such as a pleat for example) or seam formed in the mask housing 200. Optionally, the ridge 252c extends from a substantially central point at a central region of the mask housing 200 to a substantially central point near an upper edge of the mask housing 200. In this configuration, the ridge 252c may form a substantially vertical line.

[0083] In one form, as shown best in FIG. 3, the mask housing 200 is formed from a single sheet of fabric/textile that is formed into a 3-dimensional shape by at least one seam that forms a ridge 252c along which the housing will naturally fold when squashed. The seam or ridge 252c forms a support structure 250 that provides additional structure and some resilience to the housing 200. In another form, the 3-dimensional shape of the resilient mask housing 200 may be formed from multiple pieces of fabric joined by one or more seams to form one or more fold lines or ridges 252c to form a support structure. In both of these configurations, the seams in the fabric layer may provide the mask housing with an element of structural resilience and may help a user to manipulate a collapsed mask interface 1000 so as to return the mask interface 1000 to a substantially non-collapsed state.

[0084] An additional or alternative way of configuring the mask housing 200 to provide a shape memory may be by selecting a fabric that encourages the mask housing 200 to at least partially collapse under force and to substantially return to a non-collapsed form either automatically or by manipulation from a user.

[0085] In one form, the mask interface 1000 may comprise a seal 100, as described above, and a mask housing 200, as described above. In other words, it is not essential for the mask interface 1000 to comprise a frame 400. In this form, the seal 100 and mask housing 200 may be configured to connect to each other by any suitable attachment system. For example, the seal 100 and housing 200 may comprise complimentary attachment features, such as male and female attachment members or a clipping structure, as described above. In another form, the seal 100 and housing 200 may be adhered together or the seal 100 may be over-moulded to the housing 200. In yet another form, the seal 100 may comprise a lip or channel that engages with an edge of the mask housing 200 to attach the housing 200 to the seal 100.

[0086] The respiratory mask 2000 is configured to connect to a supply of breathable gas to deliver breathable gas to a user via the mask interface 1000. In one form, the respiratory mask 2000 comprises a pair of collapsible gas supply conduits 350 that form part of a headgear assembly 300. The gas supply conduits 350 may be formed of any suitable material. For example, the gas supply conduits 350 may be at least partially or fully formed from fabric. In one form, the gas supply conduits 350 are formed from an airtight fabric/textile material. The gas supply conduits 350 are configured to extend across each side of a user's face, in use, as shown in FIGS. 1 to 3.

[0087] Optionally, the gas supply conduits 350 are configured to connect to a gas delivery tube of a respiratory system via a connection 500 at the top of the headgear assembly 300 so that in use, the connection 500 will be located at the top of the user's head. In this configuration, the effect of hose pull (from the gas delivery tube pulling on the respiratory mask) is reduced. In another form, the gas supply conduits 350 may be connected to the mask housing via traditional direct connections or elbow connections for example.

[0088] In one form, the respiratory mask 2000 or mask interface 1000 may be configured for use with a CPAP machine.

[0089] In one form, the respiratory mask 2000 may form part of a respiratory system that also comprises a gas delivery tube comprising a first end configured to connect to the mask interface 1000 and a second end configured to connect to a gas source.

[0090] The respiratory mask 2000, mask interface 1000 and respiratory system of the invention may provide several advantages. For example, the resilient mask housing 200 of the mask interface 1000 may be sufficiently compliant to suit the user's sleeping position without compromising sealing performance

[0091] By using a silicone seal 100 with the mask interface 1000, a substantially reliable sealing structure may be provided that is also easy to fit.

[0092] In some forms, the fabric/component of the mask housing 200 may make the respiratory mask 2000 feel and/or look soft and warm to touch, which may provide the respiratory mask 2000 with a less clinical appearance and may be more comforting to a user.