Patient interface
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.
1 . A patient interface for providing a flow of air at a therapeutic pressure above ambient air pressure to a patient throughout the patient's respiratory cycle to treat sleep disordered breathing, the patient interface comprising:
a frame constructed from a first material, the frame having a connection port, and the frame having a first group of vent holes positioned on a first lateral side of the connection port and a second group of vent holes positioned on a second lateral side of the connection port that is opposite the first lateral side;
a seal-forming structure removably connected to the frame to at least partly form a gas chamber, the seal-forming structure being configured to contact and seal against the patient's face to deliver the flow of air to the patient's nares during use, the seal-forming structure being configured to leave the patient's mouth uncovered in use, and the seal-forming structure being constructed from a second material that is more flexible than the first material;
a tube connected to the frame at the connection port without an elbow and configured to direct the flow of air into the gas chamber for breathing by the patient;
a pair of rigidizer arms constructed from a third material that is more flexible than the first material and less flexible than the second material, each of the rigidizer arms being connected to the frame; and
a strap constructed from a textile material, the strap having a pair of length-adjustable side strap portions, each of the length-adjustable side strap portions being removably connected to a corresponding one of the rigidizer arms, the strap having a length-adjustable top strap portion positioned between and connected to each of the length-adjustable side strap portions, the strap having a back strap portion positioned between and connected to each of the length-adjustable side strap portions, and a gap being formed between the length-adjustable top strap portion and the back strap portion.
2 . The patient interface of claim 1 , wherein a pair of mesh portions are positioned on the frame on a corresponding lateral side of the connection port, and the first group of vent holes and the second group of vent holes being formed through corresponding ones of the mesh portions.
3 . The patient interface of claim 1 , wherein the tube is permanently connected to the frame at the connection port.
4 . The patient interface of claim 1 , wherein a cuff is overmolded onto the tube, and
wherein the cuff is joined to the frame at the connection port with an overmolded connection.
5 . The patient interface of claim 1 , wherein the first material and the third material are unable to be integrally bonded.
6 . The patient interface of claim 1 , wherein the seal-forming structure comprises nasal pillows configured to contact and seal against the underside of the patient's nose at corresponding ones of the patient's nares.
7 . The patient interface of claim 1 , wherein the seal-forming structure comprises a nasal cradle.
8 . The patient interface of claim 1 , wherein the seal-forming structure comprises a single orifice configured to direct the flow of air into both of the patient's nares during use.
9 . The patient interface of claim 1 , wherein the rigidizer arms are joined to the frame separately from one another.
10 . The patient interface of claim 1 , wherein the frame includes a channel portion and the seal-forming structure includes a tongue portion configured to be inserted into the channel portion when the seal-forming structure is removably connected to the frame.
11 . The patient interface of claim 1 , wherein the frame is symmetric across a first plane,
wherein each of the rigidizer arms comprises a first curve such that a first portion of each of the rigidizer arms extends away from the first plane at the first curve, and
wherein each of the rigidizer arms comprises a second portion that extends from the first portion, the second portion having a second curve such that a surface of the second portion that faces the first plane is concave and configured to be positioned against a corresponding one of the patient's cheeks in use.
12 . The patient interface of claim 11 , wherein the second portion of each of the rigidizer arms is upwardly curved such that in use a corresponding one of the length-adjustable side strap portions is directed between corresponding ones of the patient's eyes and ears.
13 . The patient interface of claim 1 , wherein the textile material is elastically stretchable.
14 . The patient interface of claim 1 , wherein the length-adjustable side strap portions are dimensioned such that the length-adjustable top strap portion and the back strap portion and the gap are positioned posterior to the patient's ears in use.
15 . The patient interface of claim 1 , wherein the length-adjustable side strap portions, the length-adjustable top strap portion, and the back strap portion are dimensioned such that the length-adjustable top strap portion and the back strap portion split from one another at a location superior to the patient's ears in use.
16 . The patient interface of claim 1 , wherein the length-adjustable top strap portion is configured to engage the patient's head across the parietal bones in use and the back strap portion is configured to engage the patient's head proximal to the occipital bone in use.
17 . The patient interface of claim 1 , wherein each of the rigidizer arms comprises an enclosable section, the frame being overmoulded around the enclosable section of each of the rigidizer arms.
18 . The patient interface of claim 1 , wherein the rigidizer arms and the frame are integrally bonded.
19 . The patient interface of claim 1 , wherein each of the rigidizer arms comprises a main body portion and an extension portion that extends from the main body portion and is joined to the frame, and
wherein the extension portion is narrower than the main body portion.
20 . The patient interface of claim 1 , wherein each of the length-adjustable side strap portions comprises a sleeve portion, each of the rigidizer arms extending into the sleeve portion of a corresponding one of the length-adjustable side strap portions.
21 . The patient interface of claim 1 , wherein the textile material is flexible such that a distance between the length-adjustable top strap portion and the back strap portion is adjustable in use.
22 . The patient interface of claim 1 , wherein the second material is silicone.
23 . The patient interface of claim 22 , wherein the seal-forming structure further comprises a base that is removably connected to the frame.
24 . The patient interface of claim 23 , wherein the base is constructed from silicone having a higher durometer than silicone of the remainder of the seal-forming structure.
25 . The patient interface of claim 24 , wherein the base and the frame are structured to be removably connected with an audible snap fit.
26 . The patient interface of claim 23 , wherein the frame includes a rim that extends away from the frame in a direction opposite the connection port, the rim forming an opening, and
wherein an inner periphery of the base is configured to surround and seal against an outer periphery of the rim when the base is removably connected to the frame.
27 . The patient interface of claim 1 , wherein each of the rigidizer arms is connected to a corresponding lateral side of the frame with an overmolded connection.
28 . The patient interface of claim 1 , wherein the tube comprises a swivel connector positioned on an end of the tube opposite the frame.
29 . The patient interface of claim 1 , wherein a visual indicator is formed on an exterior surface of the seal-forming structure to indicate orientation of the seal-forming structure for assembly to the frame.
30 . The patient interface of claim 1 , wherein:
the tube is permanently connected to the frame at the connection port,
the first material and the third material are unable to be integrally bonded,
the rigidizer arms are joined to the frame separately from one another,
the frame includes a channel portion and the seal-forming structure includes a tongue portion configured to be inserted into the channel portion when the seal-forming structure is removably connected to the frame,
the frame is symmetric across a first plane,
each of the rigidizer arms comprises a first curve such that a first portion of each of the rigidizer arms extends away from the first plane at the first curve,
each of the rigidizer arms comprises a second portion that extends from the first portion, the second portion having a second curve such that a surface of the second portion that faces the first plane is concave and configured to be positioned against a corresponding one of the patient's cheeks in use,
the second portion of each of the rigidizer arms is upwardly curved such that in use a corresponding one of the length-adjustable side strap portions is directed between corresponding ones of the patient's eyes and ears,
the textile material is elastically stretchable,
the length-adjustable side strap portions are dimensioned such that the length-adjustable top strap portion and the back strap portion and the gap are positioned posterior to the patient's ears in use,
the length-adjustable side strap portions, the length-adjustable top strap portion, and the back strap portion are dimensioned such that the length-adjustable top strap portion and the back strap portion split from one another at a location superior to the patient's ears in use,
the length-adjustable top strap portion is configured to engage the patient's head across the parietal bones in use and the back strap portion is configured to engage the patient's head proximal to the occipital bone in use,
each of the rigidizer arms comprises an enclosable section, the frame being overmoulded around the enclosable section of each of the rigidizer arms,
each of the rigidizer arms comprises a main body portion and an extension portion that extends from the main body portion and is joined to the frame,
the extension portion is narrower than the main body portion,
each of the length-adjustable side strap portions comprises a sleeve portion, each of the rigidizer arms extending into the sleeve portion of a corresponding one of the length-adjustable side strap portions,
the textile material is flexible such that a distance between the length-adjustable top strap portion and the back strap portion is adjustable in use,
the second material is silicone,
the seal-forming structure further comprises a base that is removably connected to the frame,
the frame includes a rim that extends away from the frame in a direction opposite the connection port, the rim forming an opening,
an inner periphery of the base is configured to surround and seal against an outer periphery of the rim when the base is removably connected to the frame, and
the tube comprises a swivel connector positioned on an end of the tube opposite the frame.
31 . The patient interface of claim 30 , wherein:
a pair of mesh portions are positioned on the frame on a corresponding lateral side of the connection port, and the first group of vent holes and the second group of vent holes being formed through corresponding ones of the mesh portions,
the seal-forming structure comprises nasal pillows configured to contact and seal against the underside of the patient's nose at corresponding ones of the patient's nares,
the base and the frame are structured to be removably connected with an audible snap fit, and
a visual indicator is formed on an exterior surface of the seal-forming structure to indicate orientation of the seal-forming structure for assembly to the frame.
32 . The patient interface of claim 30 , wherein:
the seal-forming structure comprises a nasal cradle, and
the base is constructed from silicone having a higher durometer than silicone of the remainder of the seal-forming structure.
33 . The patient interface of claim 1 , wherein:
the tube is permanently connected to the frame at the connection port,
the seal-forming structure comprises nasal pillows configured to contact and seal against the underside of the patient's nose at corresponding ones of the patient's nares,
the rigidizer arms are joined to the frame separately from one another,
the frame is symmetric across a first plane,
each of the rigidizer arms comprises a first curve such that a first portion of each of the rigidizer arms extends away from the first plane at the first curve,
each of the rigidizer arms comprises a second portion that extends from the first portion, the second portion having a second curve such that a surface of the second portion that faces the first plane is concave and configured to be positioned against a corresponding one of the patient's cheeks in use,
the second portion of each of the rigidizer arms is upwardly curved such that in use a corresponding one of the length-adjustable side strap portions is directed between corresponding ones of the patient's eyes and ears,
the length-adjustable side strap portions, the length-adjustable top strap portion, and the back strap portion are dimensioned such that the length-adjustable top strap portion and the back strap portion split from one another at a location superior to the patient's ears in use,
the length-adjustable top strap portion is configured to engage the patient's head across the parietal bones in use and the back strap portion is configured to engage the patient's head proximal to the occipital bone in use,
each of the rigidizer arms comprises a main body portion and an extension portion that extends from the main body portion and is joined to the frame,
the extension portion is narrower than the main body portion,
the textile material is flexible such that a distance between the length-adjustable top strap portion and the back strap portion is adjustable in use,
the second material is silicone,
the tube comprises a swivel connector positioned on an end of the tube opposite the frame, and
a visual indicator is formed on an exterior surface of the seal-forming structure to indicate orientation of the seal-forming structure for assembly to the frame.
34 . The patient interface of claim 1 , wherein:
the tube is permanently connected to the frame at the connection port,
the seal-forming structure comprises a nasal cradle,
the seal-forming structure comprises a single orifice configured to direct the flow of air into both of the patient's nares during use,
the rigidizer arms are joined to the frame separately from one another,
the frame is symmetric across a first plane,
each of the rigidizer arms comprises a first curve such that a first portion of each of the rigidizer arms extends away from the first plane at the first curve,
each of the rigidizer arms comprises a second portion that extends from the first portion, the second portion having a second curve such that a surface of the second portion that faces the first plane is concave and configured to be positioned against a corresponding one of the patient's cheeks in use,
the second portion of each of the rigidizer arms is upwardly curved such that in use a corresponding one of the length-adjustable side strap portions is directed between corresponding ones of the patient's eyes and ears,
the length-adjustable side strap portions, the length-adjustable top strap portion, and the back strap portion are dimensioned such that the length-adjustable top strap portion and the back strap portion split from one another at a location superior to the patient's ears in use,
the length-adjustable top strap portion is configured to engage the patient's head across the parietal bones in use and the back strap portion is configured to engage the patient's head proximal to the occipital bone in use,
each of the rigidizer arms comprises a main body portion and an extension portion that extends from the main body portion and is joined to the frame,
the extension portion is narrower than the main body portion,
the textile material is flexible such that a distance between the length-adjustable top strap portion and the back strap portion is adjustable in use,
the second material is silicone,
the tube comprises a swivel connector positioned on an end of the tube opposite the frame, and
a visual indicator is formed on an exterior surface of the seal-forming structure to indicate orientation of the seal-forming structure for assembly to the frame.