patient interface

专利摘要:
patient interface and its aspects a patient interface includes a seal including a pair of nasal locators extending from a flexible bottom. each nasal locator includes a tip. the nasal locator becomes narrower by moving from the bottom to the tip. an opening is at the tip of the nasal locator. the nasal locator includes a dome portion adjacent to the bottom and a tubular portion extending from an apex of the dome portion.
公开号:BR112012011420B1
申请号:R112012011420
申请日:2010-11-12
公开日:2020-01-21
发明作者:Edwin Mcauley Alastair；Paul Maxwell Salmon Andrew；San Jose Gardiola Arvin；Robert Prentice Craig；Mclaren Mark；Marie Allan Olivia；Sao Jin Siew Silas；Dong Huang Wen
申请人:Fisher & Paykel Healthcare Ltd；
IPC主号:

专利说明:

Invention Patent Descriptive Report for PATIENT INTERFACE.
FIELD OF THE INVENTION [0001] The present invention relates to patient interfaces for delivering breathing gases to a patient and aspects of patient interfaces.
SUMMARY OF PREVIOUS TECHNIQUE [0002] The present invention relates to patient interfaces for delivering breathing gases to a patient. The invention will be particularly described with reference to patient interfaces for delivering PAP therapy to a patient, for example, a patient suffering from obstructive sleep apnea (OSA). However, the patient interface could be used for other treatments. In addition, aspects of the patient interface could be combined with aspects of other patient interfaces for use in PAP therapy or for use in other therapy.
[0003] Desirable traits for patient interfaces used in PAP therapy include light weight sealing, comfortable, intuitive to use and stable and safe during use.
[0004] In this specification, where reference was made to patent specification reports, other external documents or other sources of information, this is generally for the purpose of providing a context for discussing the characteristics of the invention. Unless specifically stated to the contrary, reference to such external documents should not be construed as an admission that documents or other sources of information, in any jurisdiction, are prior art or part of the form of general common knowledge in the art. .
SUMMARY OF THE INVENTION [0005] An objective of the present invention is to provide an interface
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2/88 for patient or aspects of a patient interface that will at least provide the public with a useful choice.
[0006] In one aspect, it can be said, broadly, that the present invention consists of a patient interface that comprises: a nasal seal that includes a side that makes contact with the face, the nasal seal being formed from a soft flexible material, which includes a central part to extend through the base of the nose, and a lateral part that extends from each end of the central part, with each lateral part extending through one side of the nose, being that a side that makes contact with the face of the seal is malleable to fit under internal pressure to the surfaces of the nose of a carrier, which includes, on the sides of the seal, up to the surfaces outside the sides of the nose, one side external that includes much harder regions than the malleable inner side, with the regions extending to the sides of the seal.
[0007] According to an additional aspect, wherein the sides of the seal are substantially parallel to each other and are substantially normal to the central part of the seal.
[0008] According to an additional aspect, the external walls of the sides of the fence are aligned to have an angle between their orientations between 0 degrees and 30 degrees.
[0009] According to an additional aspect, the seal includes a pair of nasal locators on the side that makes contact with the face, and the seal is tougher in the immediately adjacent region and that includes the nasal locators than in a surrounding region this region, on the side that makes contact with the seal face.
[00010] According to an additional aspect, a peripheral part of the seal, which joins the side that makes contact with the face to the outer side, is malleable and allows the inner side of the seal to
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3/88 shift with respect to the external side.
[00011] According to an additional aspect, the external side of the central part of the seal includes an opening to pass gases into and from the seal.
[00012] According to an additional aspect, the malleable parts of the seal comprise a silicone material with a thickness between 0.05 mm and 0.5 mm.
[00013] According to an additional aspect, the malleable parts of the seal comprise an elastomer with a thickness between 0.1 mm and 0.2 mm.
[00014] According to an additional aspect, the rigid parts of the seal comprise a silicone material with a thickness between 2 mm and 5 mm.
[00015] According to an additional aspect, the rigid parts of the seal comprise an elastomer with a thickness between 2 mm and 3 mm.
[00016] According to an additional aspect, the region immediately adjacent and which includes the nasal locators comprises a silicone material with a thickness between 0.5 mm and 2 mm.
[00017] According to an additional aspect. The seal has an overall width from the surface on the outside of one side to the surface on the outside of the other side between 30 mm and 60 mm.
[00018] According to an additional aspect, the seal has a general depth, from the external surface of the central part to the line that joins the extreme ends of each lateral part, between 40 mm and 65 mm.
[00019] According to an additional aspect, the patient interface includes a body assembled with the nasal seal, the body being formed of a more rigid material than the nasal seal, and
Petition 870190090866, of 12/09/2019, p. 9/102
4/88 together with the nasal seal forms an enclosure provided with an entrance cavity and an exit cavity for the patient, with a movable elbow connected to the entrance cavity.
[00020] According to an additional aspect, the connection of the mobile elbow to the body provides the rotation of the mobile elbow with respect to the body and the articulation of the mobile elbow with respect to the body around at least one transverse geometric axis.
[00021] According to an additional aspect, the connection comprises a spherical joint.
[00022] According to an additional aspect, the elbow includes a first end and a second end and a flow path between the first end and the second end, the flow path aligned in the first direction at the first end and in the second direction at second end, and the first direction and the second direction include an angle between 120 ° and 180 °.
[00023] According to an additional aspect, the angle is between 120 ° and 150 °.
[00024] According to an additional aspect, the angle is between 130 ° and 140 °.
[00025] According to an additional aspect, the elbow includes a gas eliminating vent.
[00026] According to an additional aspect, the gas elimination ventilation is aligned with a gas flow path in the elbow from the nasal seal and the body assembly.
[00027] According to an additional aspect, the gas elimination ventilation comprises a plurality of holes through an elbow wall.
[00028] According to an additional aspect, the patient interface includes a body mounted with the seal, and a strip that
Petition 870190090866, of 12/09/2019, p. 10/102
5/88 extends from the assembled body and the nasal seal in a loop, the strip coming out of a first part of the assembled body and the nasal seal at one end and a second part of the assembled body and the nasal seal at its other end.
[00029] According to an additional aspect, the strip comprises a single undivided strip along the length of the strip that engages the wearer's head.
[00030] According to an additional aspect, the strap engages the body at either end.
[00031] According to an additional aspect, the body is formed of a rigid material, the strip is relatively flexible compared to the body and includes a soft part, a part of the strip that engages the body formed of a more flexible material than the body material and less flexible than the strip material, such that when attached to the body, the soft part forms a soft extension of the body.
[00032] According to an additional aspect, the soft part extends from 5 mm to 60 mm along the strip.
[00033] According to an additional aspect, the strip engages the body with a removable connector on either end.
[00034] According to an additional aspect, the strip includes a soft covering part that extends from the removable connector for a distance of 5 mm to 60 mm along the strip, the soft covering part being formed from a softer material than the body.
[00035] According to an additional aspect, the strip is narrow, preferably less than 10 mm in width.
[00036] According to an additional aspect, the strip is less than 6 mm wide.
[00037] According to an additional aspect, the strip has a hardness less than 2N per 100 mm in length from a
Petition 870190090866, of 12/09/2019, p. 10/112
6/88 relaxed condition.
[00038] According to an additional aspect, the strip is formed by filaments that incorporate a knitted or braided thread of a material with high elasticity and filaments of material of much higher hardness.
[00039] According to an additional aspect, the strip includes soft end parts which are more rigid than the strip between the end parts, but softer than the body, with the soft end parts acting as parts of soft body extension.
[00040] According to an additional aspect, the patient interface includes a tube that hangs from the seal and the body, and a tube support, connected to the tube and connectable to a patient's neck or garment.
[00041] According to an additional aspect, the tube support includes a fixable collar around the neck of a carrier.
[00042] According to an additional aspect, the collar has a first end part and a second end part, the first end part and the second end part include a fixing arrangement that allows the end parts to be fixed with a selected amount of overlap.
[00043] According to an additional aspect, the collar includes a third end part and a fourth end part and a connector that connects the third end part to the fourth end part.
[00044] According to an additional aspect, the connector is configured to release the third end part of the fourth end part in applying voltage through the connector greater than a release voltage, where the release voltage
Petition 870190090866, of 12/09/2019, p. 10/122
7/88 is less than 10N.
[00045] According to an additional aspect, the necklace is between 30 mm and 60 mm wide.
[00046] According to an additional aspect, the necklace has a core material and a coating material that surrounds the core material.
[00047] According to an additional aspect, the core material is a breathable and stable mesh in dimension.
[00048] According to an additional aspect, the covering material is a natural fiber braided or knitted.
[00049] According to an additional aspect, the tube support includes a tie that extends from the collar, with a connector at one end attached or capable of being attached to the tube.
[00050] According to an additional aspect, the tie includes a connector at the outer end, with the collar passing through the second connector.
[00051] According to an additional aspect, the tie includes a first end and a second end and a connector that connects the first end and the second end, the connector being configured to release under tension above tension release, where the release voltage is less than 10N.
[00052] According to an additional aspect, the strip connector includes a first part and a second part, and in the fit condition, the first part can be articulated with respect to the second part.
[00053] According to an additional aspect, the connector for engaging with the tube comprises a ring.
[00054] According to an additional aspect, the patient interface includes a body connected to the seal, and in which the body includes
Petition 870190090866, of 12/09/2019, p. 10/13
8/88 a nasal seal fitting part which engages one side towards out of the seal, an inlet cavity and at least one strip fitting part from which a looped strip extends to secure the interface to the patient.
[00055] According to an additional aspect, the patient interface includes a soft intermediate part where the loop strip extends from the engaging part of the strip, the soft intermediate part being more rigid than the strip, but it is formed softer material than the body material.
[00056] According to an additional aspect, the body includes two parts of the strip, each part of the strip extends laterally out of the entrance cavity, on the opposite sides of the entrance cavity.
[00057] According to an additional aspect, each fitting part of the strip extends out of the entry cavity in a region where the fitting part of the strip overlaps with the outer wall of the seal.
[00058] According to an additional aspect, a central part of the body defines a convex shape generally compatible with a convex shape of the outer wall of the body, with the fitting parts of the strip extending from the lateral ends of the central part, with the engaging parts of the strip extend away from the central part at an externally aligned angle to the general convex shape.
[00059] According to an additional aspect, the fitting parts of the strip extend away from the outer wall of the seal with an included angle between them greater than 30 degrees.
[00060] According to an additional aspect, the fitting part of the strip from the point where it diverges from the outer wall of the seal is between 50% and 150% of the length of the equivalent length of the wall
Petition 870190090866, of 12/09/2019, p. 10/142
9/88 external seal.
[00061] According to an additional aspect, the patient interface includes a body engaged with the nasal seal, the body being more rigid than the nasal seal, in which a lip support hangs from the body, and extends plus a margin of the fence.
[00062] According to an additional aspect, the lip support includes one or more cushions to engage against a part of the wearer's upper lip.
[00063] According to an additional aspect, the lip support includes two dependent legs, spaced apart on any lateral region of the seal, with each leg extending beyond a lateral part of the lower edge of the seal.
[00064] According to an additional aspect, each loss carries a cushion part oriented to present a face against the upper lip.
[00065] According to an additional aspect, the legs are shaped to have less hardness around a geometric axis parallel to the part of the wearer's lips which they will make contact with, than around a geometric axis normal to the plane of the lips.
[00066] In an additional aspect, it can be said, broadly, that the present invention consists of a head accessory for a patient interface, the head accessory comprises the elastic band with a width between 3 mm and 6 mm, a hardness that provides an extension of 150 mm with a force less than 2N, a first end connected or connectable to a first side of a mask, and a second end connected or connectable to a second side of a mask.
[00067] According to an additional aspect, the strip is between 300 mm and 400 mm in length in its relaxed length.
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10/88 [00068] According to an additional aspect, the strip is between 60 mm and 110 mm longer when applying an extension force of 1N.
[00069] According to an additional aspect, the strip is constructed of a knitted or braided thread, where the thread includes filaments from a first material and filaments from a second material of high elasticity, but much less hardness than the first material.
[00070] According to an additional aspect, the strip comprises a braided yarn and the yarn comprises an elastane filament with a spun wrap.
[00071] In an additional aspect, the strip comprises a plurality of bundles of braided fillets, and each fillet package comprises at least two fillets, and each fillet comprises an elastane core and spun wrap.
[00072] According to an additional aspect, the first end of the strip, the second end of the strip or both include a soft coating part, which extends from 5 mm to 60 mm along the strip, the coating part being soft is more rigid than the strip.
[00073] According to an additional aspect, the coating part is made of a softer material than the side of the mask to which it is intended to connect.
[00074] According to an additional aspect, the head accessory includes a first connector at the first end and a second connector at the second end.
[00075] According to an additional aspect, the connector includes an elastically deformable spring closure engaged with a body of the closure.
[00076] According to an additional aspect, the connector includes a surrounding coating and that at least substantially
Petition 870190090866, of 12/09/2019, p. 10/162
11/88 encapsulates the closure body and part of the strip, the lining being more rigid than the strip and formed of a softer material than the material of the closure body.
[00077] In a further aspect, the invention may consist of a patient interface that includes a strip according to any one or more of the above paragraphs.
[00078] In an additional aspect, it can be said, broadly, that the present invention consists of a patient interface that comprises a nasal seal that includes a side that makes contact with the face, the nasal seal is formed of a soft material flexible, a body assembled with the nasal seal, the body being made of a more rigid material than the nasal seal, and together with the nasal seal forming a housing provided with an entrance cavity and an exit cavity for the patient , and a lip support hangs from the body and extends beyond a margin of the seal.
[00079] According to an additional aspect, the lip support includes one or more cushions to engage against a part of the wearer's upper lip.
[00080] According to an additional aspect, the lip support includes two dependent legs, spaced apart in any lateral region of the seal, with each leg extending beyond a lateral part of the lower edge of the seal.
[00081] According to an additional aspect, each leg carries a cushion part oriented to present a face against the upper lip.
[00082] According to an additional aspect, the legs are shaped to have less hardness around a geometric axis parallel to the part of the wearer's lips, which they will make contact with, than around a normal geometric axis to the plane From
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12/88 lips.
[00083] According to an additional aspect, the patient interface includes a gas supply tube that hangs from the body and a strip that extends from the mounted frame and the nasal seal in a loop, the strip hanging from a first part of the assembled body and the nasal seal at one end and a second part of the assembled body and the nasal seal at its other end.
[00084] In an additional aspect, it can be said, broadly, that the present invention consists of a patient interface that comprises: a mask, a tube that hangs from the mask, and a tube holder, connected to the tube and that includes a fixable collar around a wearer's neck.
[00085] In an additional aspect, the collar has a first end part and a second end part, the first end part and the second end part including a fastening arrangement that allows the end parts are fixed with a selected amount of overlap.
[00086] According to an additional aspect, the collar includes a third end part and a fourth end part and a connector that connects the third end part to the fourth end part.
[00087] According to an additional aspect, the connector is configured to release the third end part of the fourth end part in applying voltage through the connector greater than a release voltage, where the release voltage is less than that 10N.
[00088] According to an additional aspect, the necklace is between 30 mm and 60 mm wide.
Petition 870190090866, of 12/09/2019, p. 10/182
13/88 [00089] According to an additional aspect, the necklace has a core material and a coating material that surrounds the core material.
[00090] According to an additional aspect, the core material is a breathable and stable mesh in size.
[00091] According to an additional aspect, the covering material is a natural fiber braided or knitted.
[00092] According to an additional aspect, the tube support includes a tie that extends from the collar, with a connector at one end attached or capable of being attached to the tube.
[00093] According to an additional aspect, the tie includes a connector at the outer end, with the collar passing through the second connector.
[00094] According to an additional aspect, the tie includes a first end and a second end and a connector that connects the first end and the second end, the connector being configured to release upon the application of a tension above a tension release, where the release voltage is less than 10N.
[00095] According to an additional aspect, the tie connector includes a first part and a second part, and in the fit condition, the first part can be articulated with respect to the second part.
[00096] In an additional aspect, it can be said, broadly, that the present invention consists of a patient interface that comprises: a nasal seal that includes a side that makes contact with the face, the nasal seal being formed of a soft flexible material, which includes a central part to extend through the base of the nose, and a lateral part that extends from each end of the central part, each lateral part extends through
Petition 870190090866, of 12/09/2019, p. 10/192
14/88 one side of the nose, a body connected to the seal, which includes a nasal seal fitting part that engages one side towards the seal, an inlet cavity and at least two fitting parts of the strip, each engaging portion of the strip extends laterally away from the entry cavity, from opposite sides of the entrance cavity, and a strip extends between the engaging parts of the strip; and in which a central part of the body defines a convex shape generally compatible with a convex shape of the outer wall of the body, with the groove parts of the strip extending from the lateral ends of the central part, with the groove parts of the strip extend away from the central part at an outward-aligned angle to the general convex shape.
[00097] According to an additional aspect, the fitting parts of the strip extend away from the outer wall of the seal with an included angle between them greater than 30 degrees.
[00098] According to an additional aspect, the fitting part of the strip from the point where it diverges from the outer wall of the seal is between 50% and 150% of the length of the equivalent length of the outer wall of the seal.
[00099] According to an additional aspect, the patient interface includes a soft intermediate part where the loop strip extends from the fitting part of the strip, the soft intermediate part being more rigid than the strip, but it is formed softer material than the body material.
[000100] In an additional aspect, it can be said that the present invention largely consists of a patient interface comprising: a single loop headband, a mask to cover at least the user's nostrils, the only strip being headband extends from the mask at any
Petition 870190090866, of 12/09/2019, p. 10/20
15/88 end, a supply line less than 200 mm in length coupled to the mask for free rotating movement that includes substantial rotation around multiple orthogonal geometric axes.
[000101] According to an additional aspect, the supply tube is flexible to the extent that the tube passes the test described herein with reference to figure 64.
[000102] In a further aspect, it can be said that the present invention largely consists of a patient interface comprising: a mask to cover at least the user's nostrils, a supply port on the mask to receive a supply of gases, bias flow ventilation in the mask that extends from the inside of the mask to an outside part of the mask, and the bias flow ventilation directs the flow in a direction of less than 45 ° to the coronal plane of the head of a hypothetical carrier and in a direction usually towards the forehead.
[000103] According to an additional aspect, the bias flow ventilation comprises at least one bias flow opening in a mask wall, the part of the wall having the bias flow opening aligned more than 45 ° with the coronal plane of the cover.
[000104] According to an additional aspect, the part of the wall that has the bias flow holes is located in a front wall of the mask, and the part forms a protrusion with respect to a surrounding part of the front wall.
[000105] According to an additional aspect, a plurality of bias flow holes are distributed in a curve around the upper front part of the interface.
[000106] According to an additional aspect, the mask has a
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16/88 U-shape or general V-shape to wrap around the user's nose, and bias flow ventilation is located at the base of the U or V.
[000107] According to an additional aspect, the seal does not cover the nasal bridge of the wearer.
[000108] In a further aspect, it can be said that the present invention largely consists of a patient interface comprising: a frame and a seal, the seal including a side facing the patient with at least one cavity for the patient and one side facing the frame with at least one cavity facing the frame, the seal engaging with the frame on a flange defined by the perimeter of the cavity facing the frame, the frame including a first part of the component and a second part of the component, the first part of the component including a first part of a channel for engaging the lip of the seal, the second part of the component including a second part of the channel for engaging the lip of the seal, wherein the seal is interlocking and disengaging with the channel with the first and second component parts connected to form the channel.
[000109] In a further aspect, it can be said that the present invention largely consists of a patient interface comprising: a frame and a seal, the frame including a first component part and a second component part engaged together , the first part of the component including a part forming a socket with the surfaces to make contact with the moving parts of a freely rotating connector, the second part comprising an external coating, with a cavity in the location of the socket of the first part, and the patient interface includes
Petition 870190090866, of 12/09/2019, p. 10/22
17/88 additionally a connector with a junction part that protrudes beyond the casing into the socket of the first part to be engaged in the socket of the first part for free rotating movement.
[000110] According to an additional aspect, the first component is formed from a material other than the coating, and the coating and the connector are formed from the same material.
[000111] According to an additional aspect, the patient interface includes a seal that includes a pair of nasal locators that extend from a supply bottom, with each nasal locator including a tip, the nasal locator being it becomes narrower by moving from the bottom to the tip, and a cavity at the tip of the nasal locator, the cavity and the profile in cross section of the tip part of the nasal locator being oval or elliptical and having a ratio of the length of the largest geometric axis with the length of the smallest geometric axis greater than 1.5.
[000112] According to an additional aspect, the ratio of the length of the longest axis to the length of the shortest axis is between 1.5 and 3.
[000113] According to an additional aspect, the tip part of the nasal locator includes a ridge adjacent to the tip cavity, the ridge being thickened with respect to the adjacent parts of the tubular part.
[000114] According to an additional aspect, the nasal locator includes a vaulted part adjacent to the bottom and a tubular part that extends from an apex of the rounded part.
[000115] According to an additional aspect, the rounded part extends at least 60% of the path around the nasal locator. [000116] According to an additional aspect, the rounded part
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18/88 extends completely around the nasal locator.
[000117] According to an additional aspect, the tubular part is tapered, extending from the rounded part to the tip part.
[000118] According to an additional aspect, the cross section of the nasal locator in planes parallel to the planes of the tip cavity is oval or elliptical throughout the tubular part and the upper parts of the rounded part.
[000119] According to an additional aspect, the relationship between the length of the largest geometric axis of the oval cross section and the length of the smallest geometric axis of the oval cross section gradually decreases, extending from the tip of the tubular part to the base of the part rounded.
[000120] According to an additional aspect, the geometric axes that project the flows of the nasal locators converge at a location between 10 mm or 40 mm from the tips of the nasal locators.
[000121] According to an additional aspect, the central geometric axis of the nasal locator, projected beyond the tips of the locators, converges to become the closest in a location of 10 mm to 20 mm beyond the tips of the nasal locators.
[000122] According to an additional aspect, if the tip cavities of the nasal locators are projected onto the coronal plane of a hypothetical carrier, the oval shapes of the tip cavities are aligned, such that the larger geometric axes converge at an angle between 60 degrees and 120 degrees.
[000123] In an additional aspect, it can be said that the present invention largely consists of a patient interface comprising: a frame and a seal, the seal being
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19/88 includes a side facing the patient with at least one patient cavity and a side facing the frame with at least one cavity facing the frame, the seal engaging with the frame at a rim defined by the perimeter of the cavity facing the frame, the frame including a part of the front face in the region of a swivel connection to a supply duct, the part of the front face being inclined with respect to the coronal plane of the hypothetical interface bearer, such that the bottom edge of the part is closer to the coronal plane than the top edge of the part, and the connector changes the flow from an inlet to the connector to an outlet of the connector through an angle between 30 degrees and 70 degrees, with the connector and the part of the face tilted out of the joint mask frame allow the free rotary movement of the conduit, the conduit adopts a position more or less parallel to the coronal plane of the hip carrier optical, and the connector remains close to the wearer's face.
[000124] According to an additional aspect, the connector does not include bias flow ventilation.
[000125] In a further aspect, it can be said that the present invention largely consists of a patient interface comprising: a frame and a seal, the seal including a side facing the patient with at least one patient cavity and one side facing the frame with at least one cavity facing the frame, the seal engaging with the frame on a rim defined by the perimeter of the cavity facing the frame, the frame including a supply cavity through a front wall of the frame, a ring portion that extends from the front wall to define a passage that projects from the surface inside the front wall of the frame, and a projection wall that passes around the
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20/88 internally open end of the ring part and which engages the seal rim, the front wall of the frame and the ring part together with other parts of the frame, defining a pressure chamber, with a bias flow vent through a pressure chamber wall, and an open area between the ring portion and the channel structure that provide a flow path between the interior of the seal and the pressure chamber.
[000126] According to an additional aspect, the bias flow holes are arranged through the frame wall in an area of the upper part of the pressure chamber.
[000127] According to an additional aspect, the ring part is formed as part of a first component of the frame, and the front wall of the frame is formed as part of a second component, the two components being attached together to define the pressure chamber.
[000128] According to an additional aspect, the projection wall comprises a channel, the channel receiving the edge of the seal.
[000129] According to an additional aspect, the channel follows a closed curved path of the total width greater than the height, such that the pressure chamber is predominantly formed to either side of the ring part.
[000130] According to an additional aspect, the ring part connects the upper and lower central parts of the projection wall and the flow path of the seal with the pressure chamber passes on either side of the ring part.
[000131] According to an additional aspect, the projection wall is formed as part of the same component as the ring part.
[000132] According to an additional aspect, the bias flow ventilation is formed through the front wall of the second component.
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21/88 [000133] According to an additional aspect, the first component includes parts of the housing that project laterally, the internal surfaces of the parts of the housing fit against the external surfaces of an external wall of the seal to restrict the deflection out of the seal.
[000134] According to an additional aspect, the second component includes stabilizers that hang downwardly and laterally to stabilize the upper edge region of a carrier.
[000135] According to an additional aspect, the first frame component comprises a skeletal frame, with at least part of the component stabilizer parts comprising a soft overmoulded material.
[000136] In an additional aspect, it can be said that the present invention largely consists of a patient interface that includes a soft elastic seal, a rigid frame, head accessory that connects to the frame, rigid projections in the connection of the accessory of head with the frame, the head accessory being very flexible at 60 mm from the frame, and between this location and the projections, a soft part, more rigid than the flexible part of the head accessory, but it is made of a softer material than the rigid frame.
[000137] According to an additional aspect, the projections are similar to long, thin pins.
[000138] According to an additional aspect, the soft part extends from the general path of the pins.
[000139] According to an additional aspect, the projection is made from a combination of a part of the mask frame and a part of the closure of the head accessory.
[000140] According to an additional aspect, the soft part is the
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22/88 part of the head accessory.
[000141] According to an additional aspect, the head accessory is a single strip of simple lace.
[000142] According to an additional aspect, the projections project laterally beyond the width of the seal.
[000143] In an additional aspect, it can be said that the present invention largely consists of a patient interface that includes a seal that includes a pair of nasal locators extending from a malleable bottom, with each locator including a tip, the nasal locator becomes narrower by moving from the bottom to the tip, and from a cavity at the tip of the nasal locator, the nasal locator additionally including a rounded part adjacent to the bottom and a tubular part extending from an apex of the rounded part.
[000144] According to an additional aspect, the rounded part extends at least 60% of the path around the nasal locator. [000145] According to an additional aspect, the rounded part extends completely around the nasal locator.
[000146] According to an additional aspect, the cross section of the nasal locator in planes parallel to the plane of the tip cavity is oval or elliptical throughout the tubular part and the upper parts of the rounded part.
[000147] According to an additional aspect, the relationship between the length of the largest geometric axis of the oval cross section and the length of the smallest geometric axis of the oval cross section gradually reduces, extending from the tip of the tubular part to the base of the part rounded.
[000148] According to an additional aspect, the geometric axes that project the flow of the two nasal locators converge at a location between 10 mm or 40 mm from the tips of the
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23/88 nasal locators.
[000149] According to an additional aspect, the central geometric axis of the nasal locator, projected beyond the tips of the locators, converges to be the closest in a location of 10 mm to 20 mm beyond the tips of the nasal locators.
[000150] According to an additional aspect, the tip cavity and the cross-sectional profile of the tip part of the nasal locator that is oval or elliptical and has a relationship between the length of the largest geometric axis and the length of the smallest major geometric axis than 1.5.
[000151] According to an additional aspect, the ratio of the length of the largest geometric axis to the length of the smallest axis is between 1.5 and 3.
[000152] According to an additional aspect, the tip part of the nasal locator includes a ridge adjacent to the tip cavity, the ridge being thickened with respect to the adjacent parts of the tubular part.
[000153] According to an additional aspect, if the tip cavities of the nasal locators are projected onto the coronal plane of a hypothetical carrier, the oval shapes of the tip cavities are aligned, such that the larger geometric axes converge at an angle between 60 degrees and 120 degrees.
[000154] In accordance with an additional aspect, the invention can consist of an interface according to any plurality of the preceding paragraphs.
[000155] The term "that comprises" is used in the specification and in the claims, it means "that it consists at least in part of". When a statement is interpreted in this specification and in these claims that includes “that you understand”, the characteristics
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24/88 in addition to these or those prefaced by the term can also be presented. Related terms, such as "understand" and "understand" must be interpreted in the same way.
[000156] In this specification where reference was made to patent specification reports, in other external documents, or other sources of information, this is generally for the purpose of providing a context for discussing the characteristics of the invention. Unless specifically stated to the contrary, reference to such external documents should not be construed as an admission to such documents, or such sources of information, in any jurisdiction, is the prior art, or form part of the common knowledge of the art.
BRIEF DESCRIPTION OF THE DRAWINGS [000157] The preferred forms of the present invention will be described with reference to the accompanying drawings.
[000158] Figure 1 is a perspective view of a person using a patient interface.
[000159] Figure 2 is a perspective view of the patient interface of figure 1 without the patient.
[000160] Figure 3 is an exploded view that illustrates the components that make up the interface of figure 2.
[000161] Figures 4A to 4C illustrate, from different angles, a sealing component of the patient interface of figure 2. Figure 4A shows the sealing component on one side facing out, Figure 4B shows the sealing on one side facing the patient and figure 4C shows a side view of the seal.
[000162] Figure 5A is an exploded view of the mask seal and frame showing how they can be joined together to be assembled.
[000163] Figure 5B is a side view of the interface of figure 2,
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25/88 partially disassembled to show the connection of an elbow to the mask frame.
[000164] Figure 5C is a front perspective view of the interface of figure 2 illustrating the assembly of the elbow with the mask frame, with a gas elimination vent present in the elbow.
[000165] Figure 6 is a front view of the assembled seal and mask frame.
[000166] Figure 7A is a top view of the assembled seal and mask frame.
[000167] Figure 7B is a side view of the seal and frame of figure 7A, not sectioned.
[000168] Figure 7C is a patient side view of the seal in figures 4A and 4C.
[000169] Figure 7D is a side elevation of the fence in figure 7C, sectioned through the EE line.
[000170] Figure 8 is a side view of the seal and mask frame of figure 7A taken through the DD line.
[000171] Figure 9A is a top view of the fence in figure 7C, sectioned through the line FF in figure 7D.
[000172] Figure 9B is a top view of the fence in figure 7C, sectioned through the line GG in figure 7D.
[000173] Figures 10A to 10C are seen in perspective that illustrate a patient interface that incorporates numerous inventions described in this specification. Figure 10A is a front view, Figure 10B is a profile view and Figure 10c is a rear view.
[000174] Figures 11A to 11H are seen from the soft sealing component of the interface of figures 10A to 10C. Figure 11A is a top view. Figure 11B is a front view. Figure 11C is a
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26/88 rear view taken from a position facing directly to the open end of a nasal locator. Figure 11D is a cross section through the CC section in figure 11C. Figure 11E is a cross section through the DD line in figure 11C. Figure 11F is a cross section through the EE line in figure 11E. Figure 11G is a cross section through the line GG in figure 11E. Figure 11H is a cross section through the HH line in figure 11E.
[000175] Figures 12A to 12H are seen from an assembly of the interface frame of figures 10A to 10C. Figure 12A is a front perspective view of the frame assembly. Figure 12 B is a rear perspective view of the frame assembly. Figure 12 C is a side profile of the frame assembly. Figure 12D is an assembly view of the two components of the frame assembly. Figure 12E is a rear view of the frame assembly. Figure 12F is a front view of the frame assembly. Figure 12G is a side view in cross section taken through line AA in figure 12F. Figure 12H is a top view in cross section taken through line BB in figure 12F.
[000176] Figure 12I is a rear view of an alternative frame assembly provided with a different channel path to secure the seal edge.
[000177] Figure 13 shows an additional modality of an interface with an inflatable seal. The interface includes a sealing body, frame, tubing and head strap.
[000178] Figure 14 shows the sealing body of the interface of figure 13.
[000179] Figure 15 is a perspective view of the frame and sealing body of the interface of figure 13.
[000180] Figure 16 is a front view of the frame and sealing body of the interface of figure 13.
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27/88 [000181] Figure 17 is a side view of the frame and sealing body of the interface of figure 13.
[000182] Figure 18 is a cross section of the frame and sealing body through BB in figure 17.
[000183] Figure 19 is an alternative cross-sectional view of the seal body.
[000184] Figure 20 is a cross section of the sealing body through AA in figure 16.
[000185] Figure 21 is an alternative embodiment of an interface sealing body of the present invention.
[000186] Figure 22 is a further embodiment of an interface sealing body of the present invention.
[000187] Figure 23 is another embodiment of an interface sealing body of the present invention.
[000188] Figure 24 shows a first embodiment of a headband that can be used with an interface of the present invention.
[000189] Figures 24a and 24b show two alternative cross sections of the headband of figure 24.
[000190] Figure 25 shows a second embodiment of a headband that can be used with an interface of the present invention.
[000191] Figures 25a and 25b show two alternative cross sections of the headband of figure 25.
[000192] Figure 26 shows a third embodiment of a headband that can be used with an interface of the present invention.
[000193] Figure 27 shows a fourth embodiment of a headband that can be used with an interface of the present invention.
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28/88 [000194] Figure 27a shows the part capable of being extended from the strap to the head of figure 27 in the extended and contracted conditions.
[000195] Figure 28 shows a fifth embodiment of a headband that can be used with an interface of the present invention.
[000196] Figure 29 shows a sixth embodiment of a headband that can be used with an interface of the present invention.
[000197] Figure 30 shows a first embodiment of the connection between a sealing body and the frame of the interface of the present invention.
[000198] Figure 31 shows a second embodiment of the connection between a sealing body and the frame of the interface of the present invention.
[000199] Figure 32 shows a third embodiment of the connection between a sealing body and the frame of the interface of the present invention.
[000200] Figure 33 shows an embodiment of the connection between a sealing body and the frame of the interface of the present invention.
[000201] Figure 34 shows a first type of clamp that can be used with the interface of the present invention to fix the tubing connected to the user interface.
[000202] Figure 35 shows a second embodiment of a clamp that can be used with the interface of the present invention to fix the tubing connected to the user interface.
[000203] Figure 36 shows a third embodiment of a clamp that can be used with the interface of the present invention to fix the piping connected to the user interface.
[000204] Figure 37 shows a fourth modality of a
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29/88 clamp that can be used with the interface of the present invention to secure the piping connected to the user interface.
[000205] Figure 38 shows a fifth form of a clamp that can be used with the interface of the present invention to fix the piping connected to the user interface.
[000206] Figure 39 shows a sixth modality of a clamp that can be used with the interface of the present invention to fix the piping connected to the user interface.
[000207] Figure 40 shows a seventh modality of a clamp that can be used with the interface of the present invention to fix the piping connected to the user interface.
[000208] Figure 41 is a perspective view of a support collar.
[000209] Figure 42 is a perspective view of a patient wearing the support collar of figure 41.
[000210] Figure 43 is a perspective view of the collar of Figure 41 from a different angle.
[000211] Figure 44 is a front view of a patient using the collar of figure 41.
[000212] Figure 45 is a top view of the necklace in Figure 41.
[000213] Figure 46 is a top view of a part of the collar of Figure 41 that illustrates a domed fastener connector.
[000214] Figure 47 is a top view of a part of the necklace that includes an alternative fastener.
[000215] Figure 48 is a top view of a part of the necklace that includes an alternative fastener.
[000216] Figure 49 is a top view of a part of the necklace that includes an additional alternative fastener.
[000217] Figure 50A is a side view of a part of the collar that includes a fastening clasp in an engaged configuration.
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30/88 [000218] Figure 50B is a side view of the collar part of figure 50A in an undocking condition.
[000219] Figure 51A is a side view of a part of the collar that includes a fastening clasp according to an alternative embodiment in a disengagement condition.
[000220] Figure 51B is a side view of the collar part of figure 51A in a fit condition.
[000221] Figure 52 is a perspective view of a tie that hangs from a part of the collar, with the tie including a quick disconnect connector.
[000222] Figure 53 is a perspective view that illustrates a tie that hangs from the collar, and the tie includes a quick disconnect connector that can also be articulated.
[000223] Figure 54A is a top view of a mooring similar to the mooring of figure 51B, but of minimum length.
[000224] Figure 54B is a top view of the mooring in figure 54A with the quick release connector disengaged.
[000225] Figure 54C is a side view of the mooring in figure 54A.
[000226] Figure 55 is an exploded view illustrating the connection of a tie ring from the support collar to a conduit.
[000227] Figure 56 is a perspective view of an interface that includes an alternative arrangement to support the patient's conduit.
[000228] Figure 57 is a perspective view of a patient using an interface that includes an even more alternative arrangement to support the conduit in the patient.
[000229] Figure 58 is a side elevation of a frame and seal, the frame incorporating pendant lip stabilizers according to an additional invention in the present.
[000230] Figure 59 is a top view of the frame and seal of the
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31/88 figure 58.
[000231] Figure 60 is a front view of the frame and seal of figure 58.
[000232] Figure 61 is a perspective view of an interface that incorporates the frame and seal of figure 58.
[000233] Figure 62 is a graph of extension forces tested against the material extension of the sample strip.
[000234] Figures 63A to 63C illustrate aspects of an interface head accessory of figures 10A to 10C. Fig. 63A is a perspective view of a part of a headgear that includes an end of a headgear and a connector. Figure 63B is a top view of the strip and the connector. Figure 63C is a view showing both (in cross section) the connector and the socket of the frame assembly that receives the connector in use.
[000235] Figures 63D to 63I illustrate another preferred head accessory. Figure 63D shows a part of the head accessory, the connector and a part of the frame assembly to which it connects. Figure 63E is a top view of the assembly of Figure 63D. Figure 63F is a sectional view through line AA of figure 63E. Figure 63G is a side elevation of the strip and connector part of figure 63G. Figure 63H is a cross section through the BB line of the connector and the strip part of figure 63G. Figure 63I is an assembly drawing of an exploded view of the strip and connector part of figure 63G. Figure 63J is a perspective view of the strip and connector part of Figure 63G.
[000236] Figure 64 is a graph of the extension force tested against the extension of another sample strip material.
[000237] Figure 65 is a diagram illustrating a test device for measuring the flexibility of a breathing tube.
DETAILED DESCRIPTION
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[000238] The inventions in the present relate, in particular, but not exclusively, to an interface that includes an inflatable nasal seal with a malleable wall structure. The inflatable seal has a pair of location protrusions that engage the user's nostrils. The location protrusions provide the gas flow to the user from inside the seal. The patient side of the seal is so malleable, and of sufficient size and shape, that when the inflated seal is pressed against a user's face, with the location protuberances engaged in the user's nostrils, the seal adapts to the face surfaces (particularly the sides of the nose and upper lip) and provides a seal. An outward-facing seal wall is more rigid, and holds the inner seal wall in a curled position around the wearer's nose.
[000239] The seal is formed of a material with sufficient elasticity and resistance that the combination makes the envelope malleable. The malleable part is capable of repeated drastic deformations without failure. Possible materials include latex, vinyl, silicone and polyurethane. Typically, the wall thickness of the malleable parts of the seal would be below 0.5 mm and could be less than 0.2 mm.
[000240] The sealing body includes a pair of nasal locators that protrude from the wall facing the patient. Preferably, nasal locators are formed integral with the seal. Each nasal locator includes an outlet opening to deliver gas from the envelope to a user using the interface.
[000241] The sealing body includes an entry cavity, approximately opposite to the nasal locators.
[000242] A substantial extension of the sealing body or envelope is malleable. An adjacent region that includes
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33/88 nasal locators and an adjacent region that includes the entry cavity are much harder. These areas maintain the general shape of the seal and can be of any suitable hardness. These areas can be formed from a harder material, or formed thicker in the same material as the rest of the envelope.
[000243] The seal is supported by a body or mask frame. The inlet cavity of the seal is fitted to the frame, or directly to a conduit that extends through the frame.
[000244] The frame preferably has a minimal design to provide minimal visual obstruction, allowing for a clear field of view and allowing the user to wear glasses while using the interface.
[000245] The frame can be formed by means of injection molding, for example, of an elastomeric material, such as silicone or polyurethane. Alternatively, more rigid materials, such as polycarbonate or polyester, polystyrene or nylon can be used.
[000246] The preferred frame includes connection points for connecting the strips to the frame. The points of attachment to the strip provide anchorage to the strips.
[000247] In other forms, the nasal seal body may include attachment points to the integral strips. These fixings can be connecting elements on the surface of the envelope. However, they could be strips or integral flaps formed on the envelope that extend outward from either side of the envelope.
[000248] The interface is designed to be supported by a single strip that passes around the back side of the head. The strip can be formed of an elastic or elastomeric material. For example, suitable strip materials can include a woven elastic strip or a narrow foam and fabric strip, such as Breathoprene ^TM . The strip that extends around the back of the head provides pressure on the mask and helps to maintain the seal against the user's face.
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34/88 [000249] A preferred strip according to one or more of the present inventions is described later in this specification.
[000250] A flexible tube extends from the frame. The flexible tube delivers breathable gas. The distal end of the flexible tube connects to the main CPAP delivery tube.
[000251] A connector can connect the tube and the frame. The connection mechanism can be any suitable connection. This could include a quick fit, silicone hooks, minimally invasive inserts, overmoulding, insert molding, screw fixings or glue or any combination.
[000252] The connector can include a limited flow output (or prone flow output) to provide gas dissipation from the interface. The outlet can be in the form of a collection of small openings in the connector. Internally, the connector can include a funnel or extension that takes the ventilation into the mouth of the envelope. Alternatively, the connector may not include a bias flow vent.
[000253] Figures 1 and 2 illustrate an exemplary patient interface that incorporates the inventions disclosed in this application. For the sake of clarity, the patient interface is shown separately from the patient in figure 2 and as being used by a patient in figure
1.
[000254] Patient interface 101 broadly includes a mask 103, a strip 104 for attaching the mask to the patient, a flexible delivery conduit 107 that connects to mask 103 and a conduit support structure 109 that attaches to a patient and supports the weight of the conduit part 107 and any connected conduit that supplies gases to the inlet end 111 of the conduit part 107.
[000255] The particular aspects of this patient interface, and
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35/88 the variations of each aspect, will be discussed with reference to the other figures. An interface can incorporate some aspects, but not other aspects. For example, an interface can incorporate aspects of the mask while using a different layout to attach the mask to the user. An interface can include a different mask while using the inventive aspects of the strip to attach that mask to the user. An interface can incorporate aspects of the mask, but not make use of a similar structure or any structure that supports the weight of the patient's body duct. All of these variations are considered to be within the scope of this order.
[000256] Referring to figure 1, mask 103 fits into the patient's nostrils and includes the side parts that curve around either side of the nose. These side parts determine the formation of a perimeter seal on surfaces facing outward from the flanks of the nose. Strip 105 passes around the user's head in a simple loop above the user's ears.
[000257] The conduit part 107 hangs from a central connection 113 in front of the mask 103. The central connection 113 is preferably a movable elbow so that the path of the conduit with respect to the positioning of the mask on the patient's face can adapt to the position of the patient's sleep. The mobile elbow can be in the form of a spherical joint so that the elbow can articulate around the geometric axes parallel and perpendicular to its connection with the mask.
[000258] The illustrated flue support 109 comprises a collar 115 connected around the user's neck. A tie 117 connects between the collar and conduit 107.
[000259] The component parts of this example interface are illustrated in figure 3. Mask 103 includes a seal 301 and
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36/88 a body or frame 303. The seal and the body are illustrated in more detail in figure 5A. Its engagement will be described in more detail with reference to figure 5A and figure 8.
[000260] The body 303 includes a socket 305 and the connector parts 307. The socket 305 receives an engagement part 311 from the elbow 313. The elbow 313 is connected to the end of a length of flexible tubing 315. The other end of the tubing flexible 315 is terminated with a sleeve 317. The connector parts 307 of the mask body 303 are for engagement with the connector parts 321 of the headband 105. The headband 105 includes a single length 323 of stretch material . Connector parts 321 are provided at either end of length 323.
[000261] The collar 115 includes a band 325 of a material intended to be comfortable when used during periods of sleep. The strip includes a first adjustable connection 327 and a second non-adjustable connection 329. In the adjustable connection 327, the free ends of the strip overlap, and the degree of this overlap can be varied to a desired quantity and fixed in this desired quantity. In the 329 non-adjustable connection, the free ends of the band can simply be secured or released. Once the adjustable connection 327 has been adjusted, the collar can be opened for fitting the patient or removing the client and attached after fitting the client, when disconnecting or connecting the non-adjustable connection 329. The non-adjustable connection 329 can be a quick release connector that disconnects with the voltage applied in the predetermined range. This ensures that the collar will release without hurting the patient if any adverse situation arises.
[000262] Strap 109 includes a first part 331 attached to the collar and a second part 333 which attaches to the conduit. These parts are preferably connected releasably by another connector
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37/88 quick release, which preferably disconnects when applying a voltage in a predetermined range.
[000263] The mooring part 333 connects to the conduit 315. The mooring part 333 includes a part of the quick release connector and a fitting 337 that engages the conduit. The socket 337 can be an open fastener to engage a corrugation of the conduit, or a recess of the sleeve 317 or to engage around the general cylindrical shape of the conduit or to a cylindrical part of the sleeve. Alternatively, and as illustrated, part 337 may comprise a ring that fits around a part of the conduit or a part of the sleeve. In the illustrated embodiment, the ring 337 is captive between the sleeve 317 and a connector part of a joint 335. The ring fits in a part 339 of the sleeve 317 and is held captive by a part of the end 341 of the joint 335, which has a diameter larger than the inner diameter of the ring.
[000264] The external shape of a preferred seal is illustrated in figures 4A to 4C. The seal 301 includes a patient-facing side, extensively illustrated in figure 4B, and an outward-facing side, extensively illustrated in figure 4A. A pair of 401 nasal locators protrude from the side facing the patient. Generally speaking, the wall of the seal that forms the side facing the patient is very malleable with the exception of the nasal locators, the area immediately adjacent to the nasal locators, or both. Variations in flexibility will be described in more detail with reference to the cross sections illustrated in figure 7D, figure 8 and figure 9A and 9B.
[000265] In general, the seal has a central part that includes nasal locators on the side facing the patient and a cavity 403 on the side facing out. The extent of this central part 407 is widely indicated by the broken line 409 in figures 4C and 4A.
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For clarity, the broken line 409 is also included in figure 7A which comprises a top view of the mask part of the interface.
[000266] The side or side parts 411 extend from the central part 407. Each side part includes an outward face 413 and an inward face 415 and a peripheral edge part 417 that joins the inward part of the face and the inward part face out. The peripheral margin part 417 extends around an upper margin 419, an end margin 423 and a lower margin 420. In this way, viewed from the inside of the seal, the side parts 411 look like a pocket.
[000267] Each side is vast. Preferably, the lateral part extends more than 10 mm (more preferably, more than 20 mm) or at least a distance of 70% of the distance that separates the centers of the nostril locators 401 beyond the base of each nostril locator.
[000268] At least the inner wall 415 and the perimeter wall 417 of each side are very malleable, so that they can adapt to the contours of the user's face, and in particular, to the contours outside the sides of the user's nose. At least the outward-facing parts of the wall 413 of the side are also malleable, but can be progressively less malleable by moving towards the central part 407.
[000269] The central part 407 of the seal includes cavity 403 for passing a flow of gases to and from the mask body 303. Cavity 403 may include features such as lips and / or channels to engage with features, such as as channels and / or lips on the body 303. The cavity 403 can be formed with the closure parts, or the closure parts can be attached or overmoulded to the perimeter of the cavity 403 to facilitate engagement with the frame 303.
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Typically, cavity 403 will be substantially thicker and more rigid than the malleable sealing parts of seal 301. Cavity 403 should be at least the size of the inner cross section of the supply conduit 315. Preferably, and as illustrated, the cavity 403 is commensurate with the extension of the mask body 303, this extension being commensurate with the general width of the interface and approximately the width of the intended carrier nose.
[000270] In the preferred form, the interface is intended to be small in size and body part 303 of the mask curves to approximately follow the contour of the wearer's upper lip, and the seal is formed such that cavity 403 follows this curve approximate, in the plane.
[000271] The central part 407 of the seal extends above and below the cavity 403. Above the cavity 403 and nostril locators 401, the central part includes a wall facing the outside 431 and the wall facing the inside 433 and a part of the perimeter 435. At least the part of the wall facing inward 433 and the part facing outward 435 are preferably thin and malleable.
[000272] Below the cavity 403, the central part 407 includes a part of the outer wall 441, a part of the inner wall 443 and a peripheral part 445. At least the inner part 443 and the peripheral part 445 are preferably thin and malleable.
[000273] In use, the malleable inner wall parts above, below and on each side of the nasal locators are inflated by the pressure inside the seal (from the gas flow supplied to the patient interface) to press against the wearer's skin and suit the contours of the surfaces on the outside of the wearer's nose and the surfaces of the lower face of the wearer's nose and the surfaces of the wearer's upper lip immediately below the
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40/88 nose. The movement of the mask body does not break this seal, as the malleable perimeter or periphery of the seal allows the mask body to move in the direction of movement to at least a small extent. The malleable perimeter decouples the position of the nostril locators from the position of the mask body, allowing the mask body to move both laterally and vertically (with respect to the geometric axes of the patient's face). The side parts 411 engage the sides of the patient's nose and form some additional seal against them and support the location of the mask.
[000274] The mask body and the seal are illustrated in the Larger format in figure 5A and in figures 5B and 5C. As previously described, the seal includes cavity 403, with arrangements for attaching the seal to the mask body. The mask body includes a socket 502 to connect with the supply conduit and a seal cavity 501 to engage with cavity 403 of the seal. The seal cavity 501 and the cavity 403 of the seal are provided with the complementary features for engaging them together. In the illustrated form, the seal cavity 403 includes the lip and channel arrangement 507 and the periphery of the seal cavity 501 of the mask body includes a complementary arrangement 505 of channels and lips. The arrangement of channels and lips is designed to ensure that the seal is properly fitted to the mask body, and is supplied with gases under pressure, there are no leaks in this joint. Many other ways can be planned to connect the seal and the mask body and this arrangement is illustrative only.
[000275] In the mask body, the outlet cavity 501 for the seal is directly opposite the socket cavity 502, so that the cavity 502 is centrally located. Either side of the socket
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502 extends a central side part 509. The central side part 509 can be a flat facing wall, which surrounds a part of cavity 403 of the seal. The central side parts 509 may include small openings as part of a gas eliminating vent.
[000276] In the preferred embodiment illustrated, the side arms 511 extend beyond the extension of the seal cavity 501, best illustrated in figure 7A, the side arms 511 preferably extend beyond the extreme width of the seal. Each side arm 511 includes a connector part 513 for connecting to the connector part 321 of the strip. In the illustrated embodiment, the connector parts comprise a fastening column with a reduced perimeter. The strip has a small loop formed at each end that stretches over the fixation column and engages the cut. This connector shape is simple and intuitive, but other connector shapes can be provided, for example, each side arm 511 could be provided with a part (for example, a male or female part) of a lock.
[000277] As best illustrated in figure 7A, the side arms 511 diverge from the wall outside the seal, for example, at an angle 713 between 30 ° and 80 °. A strip attached to column 513 leaves the side arm in a manner as illustrated by line 715 in figure 7A, at a location spaced from the seal and spaced from the face of the carrier. This is illustrated by the relative locations of the tip 717 of the side arm 511 compared to the center line 719 of the interface. The distance 721 from the center line to the tip of the side arm is preferably between 25 mm and 50 mm, and more preferably, about 45 mm. This compares with the distance 723 between the central line 719 and the central geometric axis of the nasal locator, which is preferably between 5 mm and 10 mm, and more preferably about
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42/88 mm. This also compares with the approximate location of the inner wall surface on the side of the fence, where it leaves the central part of the fence. This location is illustrated by the broken line 725 in figure 7A. Preferably, this separation 727 is between 10 mm and 20 mm, and more preferably about 15 mm. For further comparison, the outermost extension of the lateral part is illustrated by the broken line 729. The offset 731 of the broken line 729 from the central line 719 is preferably between 15 mm and 30 mm, and more preferably about 25 mm.
[000278] In the front to back direction, the tips 717 are preferably towards the back of the base of the nasal locators, so that the bases of the nasal locators are between the central part of the mask body and a line connecting the tips 717. [ 000279] With additional reference to figure 7A, in general, the seal of the mask can have the widest external extension 741 between 30 mm and 60 mm and more preferably about 50 mm. The seal and frame of the mask can be an overall depth of 743, preferably between 40 mm and 65 mm and more preferably about 55 mm. With this depth, the interior space defined by the seal, which wraps around the user's nose in use, can have a depth of 745 which is preferably between 20 mm and 40 mm and more preferably about 30 mm.
[000280] As can be seen from figure 7A, in general, the seal curves through a significant arc, such that the sides are generally parallel to each other and opposite through the space that will accommodate the nose. The orientation planes of the lateral parts can together form an angle between 0 ° and 45 ° and preferably between 0 ° and 25 °. Preferably, this applies to both the inner and outer wall, as shown in figures 9A and 9B. Preferably, this is also true for substantially
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43/88 all levels displaced vertically in the fence, as illustrated by the different levels shown in figures 9A and 9B.
[000281] The general flat shape of the seal, as shown in figure 7A, could be considered parabolic, elliptical, half oval or U-shaped. Generally seen, the central part of the seal defines the width of the seal, with the sides of the seal extending away from the lateral ends of the central part in a direction substantially parallel to each other and substantially perpendicular to its width dimension.
[000282] Figures 5B and 5C also show the connection of the movable elbow 313 to the mask body 303. The movable elbow 313 includes a spherical part 515 and cavity 517. The outer surface of the spherical part 515 is preferably a spherical but it could be formed with the variation and still achieve a substantial seal with socket 502. Similarly, socket 502 is preferably a spherical friction surface with a slightly penetrating edge. This is best illustrated in figure 8, where the bead 802 penetrates slightly with respect to the remaining spherical frustal surface 804.
[000283] The movable elbow 313 preferably defines an angle between the flow in the conduit and the flow through the connection to the mask between 0 ° and 90 °, preferably between 30 ° and 60 °, and more preferably about 45 °. The elbow may incorporate 519 openings that form part or all of a gas eliminating vent for the patient interface. The openings are preferably located outside the curvature of the elbow, substantially on the line of the flow path of gases exiting the mask.
[000284] Figures 5B and 5C also illustrate the parts of the strip connector 321 engaged over columns 513 of the mask body.
[000285] Figures 7A to 7D provide context for the sections
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44/88 transversal illustrated in figures 8, 7D, 9A and 9B.
[000286] Figure 7D is a cross section through the EE line of the seal in Figure 7C. Figure 7D illustrates the thickness of the seal parts in the vertical central plane of the seal. This shows a thickening of the seal in the region 731 immediately adjacent to and between the nostril locators. The cross section also illustrates a thickening of the seal on the outer wall part 431 of the central part of the seal above outlet 403 and the thickening of the outer wall part 441 of the central part below cavity 403. These thick sections are preferably gradually thickening from of the thin malleable perimeter parts 435 and 445 respectively to a thickness of approximately 2 mm to 4 mm. The malleable wall parts, which are the peripheral parts 435 and 445 and the lower inner wall 443 and upper inner wall 433 preferably have a wall thickness between 0.05 mm and 0.5 mm and more preferably between 0 , 1 mm and 0.2 mm.
[000287] The part 731 between the nasal locators preferably has a thickness between 2 mm and 0.5 mm and preferably between 0.8 mm and 1 mm.
[000288] These dimensions are given relevance to a silicone material with a Shore A hardness scale of about 40. If the seal is formed from other materials commensurate changes in size may be possible while retaining the flexibility of the envelope in the regions preferred malleable and retain sufficient hardness to shape the envelope in the regions intended to provide the shape.
[000289] Figure 8 is a section through DD of the mask seal and the body of figure 7A. This illustrates the cross section of the central part of the seal on the outward side as
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45/88 illustrated and described already with reference to figure 7D, but illustrates the connection of the seal cavity to the cavity of the mask body. However, the section of figure 8 also illustrates a preferred cross-sectional shape of a nasal locator. In particular, the thickness of the wall material 806 of the nasal locator is preferably between 0.5 mm and 2 mm and more preferably between 0.8 mm and 1 mm.
[000290] The nasal locator includes a base part 808 and a mouthpiece part 810 with a central cavity 812. The part including cavity 812 fits within the user's nostril. The base part 808 provides the primary location at the entrance to the nostril.
[000291] Figure 9A is a section through the GG line of figure 7D of the seal. This is a cross section of the seal approximately in the horizontal central plane that passes through the nostril locators. This section shows that the parts of the wall 806 of the nostril locators, the region immediately adjacent 902 outside the perimeter of the nostril locators and the central part 731 between the nostril locators, all provided with a thickened wall in relation to the malleable wall parts 415 and 423 of the sides of the seal. In particular, the regions immediately adjacent and which include the nasal locators preferably have a thickness between 0.5 mm and 2 mm and more preferably between 0.8 mm and 1 mm.
[000292] The parts of the outer wall 413 of the sides of the seal are substantially thicker again than the parts adjacent to the nostril locators. These parts preferably have a thickness between 2 mm and 5 mm and more preferably between 3 mm and 5 mm. These parts gradually taper in thickness to reach the malleable thickness where they become the peripheral part 423.
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46/88 [000293] The thickened portion of the wall on the outer side 413 of the side parts preferably extends within 10 mm of the outermost tip of the side.
[000294] The thickening and hardness of these 413 outer side parts provide substantial shape to the seal and stability with the seal in place. The sidewall resists flexing outward from the sides of the seal when the seal is inflated under pressure from the supply while the wall parts 413 will flex outward under pressure and have sufficient reaction force to retain the seal wound around of the wearer's nose.
[000295] The stiffness produced by the thickest regions of the seal could be provided by a composite material or combination of parts. For example, the hardness could be provided by reinforcement in silicone or by a flexible insert of hard material. The hard material insert could be integrated into the mask body. Preferably, the construction is such that the sides of the seal provide resistance to flex with an effective hardness of at least 1N of force at the end of the hardened region to flex the side through an angle of about 60 °.
[000296] Figure 9B illustrates an additional plane, substantially horizontal above the cross section of figure 9A. This cross section is taken through the FF line in figure 7D. Again, this illustrates the thickness of the outer wall parts 413 of the seal side parts with respect to the inner wall parts 415 and the perimeter parts 423 and with respect to the thickness of the upper inner wall part 433.
[000297] Again, the side parts 413 preferably have a thickness between 2 mm and 5 mm, more preferably between 5 mm and 3 mm. The malleable parts 415, 423 and 433 have a thickness between 0.05 mm and 0.5 mm, and more preferably between 0.1 mm and 0.2 mm.
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47/88 [000298] Figures 10A to 10C are viewed in perspective that illustrate a patient interface that incorporates numerous inventions described in this specification. Figure 10A is a front view, Figure 10B is a profile view and Figure 10C is a rear view.
[000299] The interface 1000 is similar to the interface described with reference to figures 1 to 3. The seal 1010 includes many similarities with the seal in figure 4. The frame assembly 1008 has some of the same characteristics as the frame 303 in figure 5. Like the interface of figures 1 to 3, interface 1000 has a dependent short circuit coupled to the assembly of frame 1008 by a ball joint or swivel connection. Also like the interface of figures 1 to 3, the interface is preferably attached to the wearer's head by a single loop of loop. This ribbon can be made of materials described later in this specification. The frame assembly may include rim stabilizers as described with reference to figures 58 to 61.
[000300] Referring to figures 10A to 10C, the interface 1000 has a general configuration that includes a frame assembly 1008 and a seal 1010 on the inside of the frame assembly. A supply line 1004 depends on the frame assembly and supplies gases to the frame assembly and from there to the seal. Head accessory 1002 connects to the frame assembly to secure the interface to a user's head.
[000301] The frame assembly includes 1016 side parts. Like the assembly in figure 5, the side parts can extend away from the outer wall of the seal (and therefore away from the face of the wearer when in use). At least one, and preferably both, side part 1016 provides the connection of a connector 1014 of the head fitting 1002.
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48/88 [000302] Connector 1014 is connected to terminate one end of strip 1012. Preferably, each end of strip 1012 includes a connector and each side part 1016 includes a compatible cooperating connection.
[000303] The supply preferably includes a short flexible tube 1026, a supply connector 1022 and an interface connector 1006.
[000304] Tube 1026 can take many forms. For example, tube 1026 may be a stretching conduit, an elastic conduit that is usually short in the relaxed condition, an extruded corrugated pipe or a ribbon tube wound with a spiral rib. The tube would be resistant to breakage and allow extensive lateral flexion and rotation. The tube is preferably between 50 mm and 150 mm in length.
[000305] The interface connector may include a bias flow vent. However, at the illustrated interface, no bias flow ventilation is provided at the connector. The connector 1006 preferably includes parts of a swivel joint to the frame assembly 1008. The connector preferably includes a part of a ball joint or swivel joint, and more preferably includes a hollow extending plug part that extends into a socket of the assembly of frame.
[000306] Referring to figure 10b, the connector preferably changes the supply flow through an angle between 25 degrees and 75 degrees. More preferably, the connector changes the flow through an angle between 40 degrees and 60 degrees. This angle matches the angle of the front face of the frame assembly at the immediate periphery of the 1020 joint (for example, in relation to the carrier's coronal plane) so that the 1026 tube is easily supported below the interface (when the user is vertical) , remains close to the user when the user is lying down, keep joint 1020 close to the patient.
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49/88 [000307] Supply connector 1022 preferably includes a swivel.
[000308] Frame assembly 1008 preferably includes bias flow ventilation 1018. Bias flow ventilation 1018 may include at least the flow path from the interior of the interface to the surroundings in the environment. An interface can be provided for use with a return flow type fan that does not include bias flow ventilation.
[000309] Where a bias flow vent is included, the bias flow vent may include at least one opening that extends through the wall that defines the frame assembly. In the illustrated interface the bias flow ventilation 1018 includes a plurality of openings. The openings are arranged to direct the outflow of gases that are predominantly ascending with respect to the wearer's head. By predominantly ascending, it means that the gases are directed in a direction that is more parallel to the plane of the face (or the coronal plane) than perpendicular to the plane of the face, and generally, in the direction towards the forehead.
[000310] As best seen in figure 10C, the frame assembly may include 1024 dependent support parts that extend below the 1010 seal. The dependent support parts include 1030 pads that are intended to provide support in the upper lip region of the wearer , in the vicinity of the nasolabial folds. In some users, 1030 cushions may extend into the lower cheek area immediately adjacent to the nasolabial folds. The pads are intended to make contact with the face only when required to support the seal. This aspect of the interface is covered in more detail with reference to figures 18 to 61.
[000311] Also in figure 10C, the seal can be seen to include a pair of 1036 nasal locators. Each nasal locator
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50/88 includes a cavity, which in use is arranged in a nostril of the wearer. The nasal locators extend from a portion of the malleable inner wall 1042 of the seal.
[000312] At the illustrated interface, each nasal locator includes a tubular mouthpiece part 1040 and a convex base part 1038. The generally tubular mouthpiece part 1040 can be somewhat tapered towards the open end. The convex base part can be considered a rounded shape.
[000313] In some embodiments, the convex base part extends all the way around the locator and surrounds the tubular mouthpiece part. In other embodiments, the convex base part may extend most of the way around, but not completely around the locator. For example, the base part can continuously extend 60% or more of the path around the locator.
[000314] Both the nozzle part and the base parts of each locator are preferably oval or elliptical in cross section. This is illustrated in more detail in figures 11E to 11H.
[000315] Figures 11A to 11H are seen from the soft sealing component of the interface of figures 10A to 10C. Figure 11A is a top view. Figure 11B is a front view. Figure 11C is a rear view taken from a position directly facing the open end of a nasal locator. Figure 11D is a cross section through the CC section in figure 11C.
[000316] From these figures many similarities can be seen for the fence in figure 4. The usefulness and function of similar characteristics will not be repeated in detail.
[000317] In general terms, the fence includes a part of the wall facing inwards and a part of wall facing outwards. The inward-facing part of the wall forms the seal against the surfaces
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51/88 of the wearer's face. The outward facing part of the wall connects the fence to the frame assembly and supports the overall shape of the fence. Like the seal in Figure 4, the overall shape of the seal is either a U-shape or a V-shape, with sides extending in the rear direction from a central cross-section. [000318] The outward-facing part includes 1032 side parts, which are larger in cross-section than the inward-facing wall. The inward facing wall includes nasal locators supported on a generally pliable bottom 1052. A pliable periphery 1034, 1044 connects the outward facing wall to the inward facing wall around the perimeter.
[000319] With particular reference to figure 11a and figure 11D, each nasal locator preferably comprises a tubular part 1042 and a rounded part 1038. Furthermore, each tubular part ends at an edge 1042 defining the cavity 1050.
[000320] The tubular part tapers towards cavity 1050. The taper is preferably a linear taper. The taper can alternatively be a curved taper. The surfaces of the rounded part and the tubular part are at an included obtuse angle, for example, between 120 degrees and 160 degrees.
[000321] The cross section of figure 11D suggests that the tubular part 1042 is approximately frustoconical, and that the rounded part 1038 is approximately frusto-spherical. However, in each case, the alternative cross section (figures 11F to 11H) is oval rather than circular. In this way, the shape of the dome can be related as an ellipsoid. The shape of the tubular part can be related as an elliptical cone. However, in each case, the shape need not be a true ellipse, and can instead comprise less regular oval shapes, just as the shape of the vault can be related to an oval or oval vault, and the
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52/88 tube shape, an ovoid or ovoid cone or a tapered ovoid or ovoid tube.
[000322] The tubular parts of the nasal locators are spaced, but aligned, such that their geometric axes are generally convergent. Preferably, the converging distance is between 10 mm and 40 mm from the nasal locator cavities.
[000323] The rounded parts of the nasal locators come together, around or joined in a 1046 slot in the center line of the seal. Preferably, the slot 1046 is formed to allow some freedom of movement of the vault of one nasal locator with respect to the vault of the other nasal locator.
[000324] With particular reference to figures 11E to 11H, the oval cross section of each nasal locator is shown in more detail. In particular, three cross sections of the nasal locator are shown. Three cross sections are taken in planes parallel to the plane of the cavity of the open end of the nasal locator.
[000325] What can be seen from these cross sections is the oval shape. In particular, the oval or ellipse shape of cavity 1050 has an aspect ratio of approximately 1.8 to 1. The major geometric axis of the oval or ellipse is greater than twice the minor geometric axis, and preferably between 1.5 and 3 times the minor geometric axis.
[000326] The oval shape is retained throughout the tubular part and the rounded parts of the nasal locator. However, in the illustrated seal, the absolute difference in the major and minor geometric axes is retained, instead of the relationship. Therefore, the ratio decreases by moving from the shape of the cavity 1050 to the first cross section 1050 spaced towards the base of the tubular part. The ratio further reduces by moving from cross section 1054 to cross section 1056 in
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53/88 an intermediate position in the rounded part. The ratio further reduces by moving from cross section 1056 to cross section 1058 at the base of the rounded part.
[000327] By way of example, as for the tip cavity, the dimension of the major geometrical axis can be about 9 mm and the minor geometrical axis about 5 mm. As for the cross section of the EE tubular part, the dimension of the major geometry axis may be about 13 mm and the dimension of the minor geometry axis about 9 mm.
[000328] As for the rounded part in GG, the dimension of the major geometry axis can be about 18 mm and the dimension of the minor geometry axis about 15 mm.
[000329] As for the rounded part in HH, the dimension of the major geometry axis can be about 22 mm and the dimension of the minor geometry axis of about 18 mm.
[000330] As is best illustrated in figure 10C, the oval shapes of the nasal locators are preferably not aligned parallel when viewed from the rear of the interface. In particular, the upper ends of the oval shapes are closer together than the lower ends. When projected later on a coronal plane of a hypothetical carrier, the major geometric axes of the oval shapes are at an angle of between 60 and 120 degrees.
[000331] Each nasal locator is preferably provided with an edge 1042 on the open end 1050. The material on the edge 1042 is preferably thicker than the material of the rest of the tubular part or the material of the region of the tubular part in the vicinity of the edge. The thickened rim provides some positive shape to the end of the locator when it locates the locator in the carrier's nostril. This can be useful for the wearer to better feel the end of the locator when fitting the interface.
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54/88 [000332] Figures 11B and 11E also illustrate the characteristics of the seal involved in securing the seal to the frame assembly. As seen in figure 11B, the part facing out of the seal includes a larger cavity to secure with the frame assembly. The larger cavity includes a rim 1048 that runs the perimeter of the cavity. The cavity may consist of the thicker regions of the outer wall of the seal. For example, the bottom of the rim is shown in the cross section in figure 11E.
[000333] In one location or in multiple locations, on the rim, markers or features can be provided to ensure correct mounting of the seal with respect to the frame assembly. The seal illustrated and described is sensitive to incorrect assembly. In this embodiment, the seal is arranged to be detachable from the frame.
[000334] For easier positioning, the lip is preferably provided with a protuberance, which engages in a chamfer of the frame when the seal is in the correct position. The flange can be provided with a 1046 protrusion that extends in either or both directions inward or outward. In the illustrated embodiment, two 1046 protrusions are provided, which engage with the chamfers 1074 and 1092 of the frame.
[000335] The edge of the seal takes the general shape of a flexed oval. Therefore, it means an oval that has been flexed so that the ends of the oval are curved away from a tangential plane to the central parts of the oval. This can be seen in a general sense in the form of the part of the outer wall of the seal, in figure 11A.
[000336] Figures 12A to 12H are seen from an assembly of the interface frame of figures 10A to 10C. Figure 12A is a view
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55/88 in front perspective of the frame assembly. Figure 12B is a rear perspective view of the frame assembly. Figure 12C is a side profile of the frame assembly. Figure 12D is an assembly view of two components of the frame assembly. Figure 12E is a rear view of the frame assembly.
[000337] Figure 12I is a rear view of a frame assembly that is a slightly different configuration, with the parts of the stabilizer not being shown. This illustrates an alternative configuration of the channel to secure the seal. The frame assembly may otherwise be formed and assembled in substantially the same manner as the frame assembly of figures 12A to 12H.
[000338] The assembly of frame 1008 comprises two larger components, a first component 1070 and a coating 1060.
[000339] The two components of the frame assembly combine to provide a 1096 channel to secure the 1048 edge of the seal.
[000340] The first component 1070 can include a first part of the channel, while the coating 1060 provides a second part of the channel. Component 1070 can provide an inside flange part 1072, and the liner provides an outside flange part 1094. A base part for the channel can be provided extending from the flange part of any part. For example, the base part 1088 can be provided from the flange part 1072.
[000341] The flange part 1072 may include a chamfer 1074 to receive a location characteristic of the seal edge 1048. The flange portion 1094 may include a chamfer 1092 to receive an additional location characteristic of the seal lip.
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56/88 [000342] According to the preferred shape of the seal and the channel, the channel has a general outer spike, so that the parts of the channel on opposite sides of the main cavity deviate from each other when processing from from the base of the channel to the open margin of the channel. In this way, the lip of the seal stretches to pass over the inner flange part 1072 and the seal is retained in the channel by the elastic tension of the lip.
[000343] When assembling the frame of figures 12A to 12H, the channel forms a general flexed ellipse. In the example in figure 12I, the channel follows a path more like an oblong or trapezoidal rounded flexion. In particular, the general channel path is not as wide as the channel path in the form of figures 12A to 12H. In addition, the channel comparatively includes straight side parts 1220. The side parts 1220 converge slightly extending towards the bottom 1226 and diverge slightly extending towards the upper part 1217. Although this assembly maintains the general flexed oval shape, the straightened side parts are to improve the ease of assembly compared to the sharply curved end parts of the flexed ellipse of figures 12A to 12H.
[000344] The alignment of the chamfer and the protrusion is preferably provided adjacent to the upper or lower part of the channel, more preferably adjacent to the upper part of the channel. Thus, the edge 1048 can be seated in the channel with the correct location, and the rest of the edge then stretched over the inner flange part 1072.
[000345] The first 1070 component may include extensions to load the 1030 support pads. For example, a lower housing portion may extend in a curve below the interface supply cavity. The lower housing part may include
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57/88 side parts. The 1030 cushions are provided on the lower inner surface of the sides.
[000346] An internal surface 1078 of an upper part of the housing can wrap around the sides of the interface and be located outside and adjacent to the external wall of the seal. The upper parts of the housing can assist in maintaining the shape of the seal under internal gas pressures by restricting deflection outwards from the outside of the seal envelope.
[000347] The first component can carry a portion of the 1020 swivel connection. Preferably, the first component 1070 includes a ring portion 1080, open forwards and backwards. The ring portion preferably includes surfaces for engaging with the surfaces of the supply pipe connector.
[000348] Preferably, the ring portion 1080 includes a substantially spherical inward facing surface 1084. The inward facing surface 1084 may engage a complementary outward facing surface of a spherical portion of the supply tube connector. The spherical part of the supply tube connector may have guide gases from the supply tube through the ring part 1080 in the internal passage.
[000349] An advantage of this provision is improved material choices available. The supply tube connector is preferably made of a different base polymer material for the 1080 ring part of the 1070 component. Different polymer materials that work against each other tend to exhibit less friction and noise than the polymers of the 1070 component. same base material. In addition, the outer sheath 1060 can be formed from the same material as the supply pipe connector, and then present an aesthetically pleasing exterior.
[000350] For example, the ring part of component 1070 can be
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58/88 formed of a material chosen from its strength and resistance, such as a polycarbonate plastic, and the 1060 coating and the supply tube connector are formed from a plastic chosen primarily for surface finish and appearance, such as an acetal plastic. The acetal plastic can include a lubricating copolymer, such as PTFE (polytetrafluoroethylene). [000351] The ring portion 1080 can also provide characteristics for securing the two components 1060 and 1070.
[000352] For example, the outer surface of the ring portion 1080 can be provided with outward-facing features, such as depressions or a channel 1082, to cooperate with the inward-facing fasteners or an inward-facing annular ridge 1087 from the perimeter 1066 cavity 1068 of the coating 1060. This is best illustrated in the cross section in figure 12G.
[000353] The outer periphery of the coating 1060 can mix in the surfaces of the component 1070 in some parts. For example, the lower curved edge of coating 1060 can rest on the upper curved edge of the lower housing of component 1070. This is indicated in 1081 in figure 12G. A similar borderline on the sides is indicated in 1081 in figure 12H.
[000354] Components 1060 and 1070 can form an outlet air duct adjacent to the 1018 bias flow vent. This is best understood when considering the exploded view of figure 12D and the rear view of figure 12B and the cross sections of the figures 12G and 12H. The air duct 1079 is defined between a part of the flexed oval frame 1072, of the component 1070, and the surface inside the coating 1060 in the vicinity of the opening 1068.
[000355] The cavities 1086 in the air duct 1079 are defined by the rear edge of the ring part 1080 and the part of the oval frame
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1073. Gases flowing from the seal for bias flow ventilation pass through these cavities. The inner surface 1098 of the flange 1072 of the oval frame 1073 preferably converges moving towards the air duct, defining a surface that directs the flow that acts as a funnel.
[000356] Bias flow ventilation holes 1018 guide from air duct 1079.
[000357] The ring portion 1080 opens essentially centrally through the oval frame part 1073. This divides the flow in the seal and the flow out of the seal essentially in a location directly adjacent to the open end of the seal.
[000358] The ring part can be supported in this position by one or more support struts 1076, or by regions at the top and bottom where the ring part and the oval frame come together.
[000359] The bias flow holes 1097 are arranged in a curve around the upper part 1089 of the pressure chamber 1079. This upper part is well confined in the location shown in figure 12G, just above the ring part 1080, but more open to any side.
[000360] To provide an upward outflow (generally parallel to the carrier's coronal plane), the bias flow holes can be arranged in a base part 1099 of the wall of the casing 1060.
[000361] The bottom housing part of component 1060 may include a soft coating 1085, such as a supermoulded layer of a soft biocompatible material, on a more rigid skeleton or frame 1083. A preferred coating would be, for example, a thermoplastic elastomer, a polyurethane foam or a silicone elastomer. The skeleton or frame 1083 of component 1060 can be formed from a copolymer that includes a
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60/88 amount of a plastic material that bonds strongly with the coating material. For example, frame 1083 can be formed from a polycarbonate siloxane copolymer. Siloxane contributes to chemical resistance and improves the agglutination of the overmoulded silicone coating.
[000362] The extreme sides 1016 of the casing 1060 diverge from the outer surfaces of the housing of the component 1070. The sides 1016 end in sockets 1062 to receive the headband strip connectors.
[000363] Figures 13 to 20 show an additional modality of an interface with a wrap around the inflating seal. Interface 1100 includes a seal body 1101 and frame 1102.
[000364] Attached to frame 1102 is tubing 1112, which is attached to a gas supply device. The tubing supplies the gases to the mask frame and seal. The 1112 tubing can be tied to the user (using the 1100 interface) by a 1113 security cord. In use, the 1113 security cord extends around the user's neck. The security cord 1113 is attached to the tube by known methods, however, shown in a c-shaped closure 1114 attached to the security cord 1113 which closes around the tubing.
[000365] The 1100 interface is held in place over the user's nose by means of a head strap 1114. The strip is preferably made of a flexible type material, such as silicone or a laminated material well known in the strip technique for head accessory. Each end of strip 1114 is preferably fitted with a closure 1116 which attaches to a corresponding gap 1117 formed inside or attached to the sealing body 1101. The strip can be a flat molded silicone strip, a small hollow silicone tube or appropriate configurations. as they are
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61/88 known in the art.
[000366] The frame 1102 may have formed therein a plurality of inclined flow orifices 1115 to allow exhaust gases from the user to escape from the interface. Alternatively, the inclined flow holes can be formed in the seal body 1101 to allow gases to escape.
[000367] The sealing body 1101 is, again, a seal of the malleable or inflatable type. The sealing body 1101 is curved in shape to be compatible with the contours of a human face and to extend around the user's nose, surrounding the user's nose. The sealing body 1101 preferably extends completely over the side of the user's nose and can also extend partially over the user's cheeks. The seal 1101 comprises an inner wall with an inner wall 1103 and an outer one with an outer surface 1104. Projecting from the inner surface 1103 are nasal locators 1105, 1106, each with outlets 1107, 1108.
[000368] According to the embodiment of figures 10 to 12, the sealing body 1101 includes an inlet cavity 1109 which is opposite to the nasal locators 1105, 1106 and receives the frame 1102.
[000369] The seal 1101 has a variable thickness of the wall, such that there is stiffness around the parts of the seal that protrude outward and has the flexibility between the nasal locators 1105, 1106 and a periphery 1110 of the inlet cavity 1109 of the seal . This means that there is a decoupling effect between the nasal locators 1105, 1106 and the entrance periphery 1110, and subsequently for the mask frame 1102. This will mean that some movement of the mask frame will be possible without interrupting the sealing of the nasal locators. 1105, 1106 in the user's nostrils.
[000370] As can be seen in figure 18, the entrance periphery
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1110, which defines the gas inlet 1105 for the seal, has a substantially thick cross section. This provides rigidity to the entry periphery 1110. Similarly, nasal locators 1105, 1106 have a substantially thick cross section. However, the thickness of the nasal locators may not necessarily be as thick as or thicker than the entrance periphery 1110. In the preferred form, the thickness of the nasal locators is less than that of the entrance periphery.
[000371] The areas between the entrance periphery 1110 and the nasal locators 1105, 1106 are preferably thinner in cross section than both nasal locations and the entrance periphery. For example, in figure 18, the length of the seal 1101 between X and Y is formed to be substantially thinner in cross section than either at the entrance periphery or at the nasal locators. This means that this length is more flexible, effectively allowing more movement of nasal locators 1105, 1106. Furthermore, as the length between X and Y, which includes an outer periphery 1111, is thinner in the cross section, the seal will inflate more easily to assist in sealing around the user's nose.
[000372] As shown in figure 18, preferably a region 1118 of the envelope adjacent to or at the root of each nasal locator has a thickened cross section. As shown, it is preferable that the length or region 1119 of the seal between region 1118 and the thickened inlet periphery 1110 is formed to be substantially thinner in cross section than either in the inlet periphery 1110 or in nasal locators 1105 1106 or in the region 1118.
[000373] In an alternative embodiment, the envelope includes a thickened region 1118 adjacent to the root of the nasal locators and the
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63/88 the thickness of the cross section of the nasal locators is not thickened. For example, the thickness of the cross section of the nasal locators may be similar to the thickness of the region of the envelope 1119 that extends between the region 1118 adjacent to the nasal locators and the periphery of entry 1110. The thickened region 1118 adjacent to the root of the nasal locators prevents that the base of the nasal locators deforms or swells excessively without the typical CPAP pressure. However, the thinner wall of nasal locators 1105, 1106, in this embodiment, may swell under CPAP pressure.
[000374] Preferably, seal 1101 is formed of silicone with a Shore A scale hardness of about 40. Alternatively, other materials with similar properties can be used. For silicone with a Shore A hardness scale of 40 or other material with similar properties, the thickness of the 1119 envelope region that extends between the nasal locators and the inlet periphery is less than approximately 0.5 mm. Preferably, this region 1119 has a thickness of 0.1 mm to 0.2 mm. Alternatively, this region 1119 of the envelope may have a thickness of less than 0.1 mm, for example, 0.05 mm.
[000375] The thickness of the region 1118 adjacent to the base of the nasal locators preferably has a thickness of less than 2 mm. Preferably, the thickness of the region 1118 adjacent to the base of the nasal locators is approximately 0.8 mm to 1.0 mm. Alternatively, the thickness of the 1118 region adjacent to the base of the nasal locators may be less than 0.8 mm, for example, 0.5 mm.
[000376] The thickness of the region adjacent to the input periphery is approximately 3 mm to 5 mm, but it could be thinner, for example, 2 mm.
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64/88 [000377] Nasal locators have a thickness of less than 2 mm. In the preferred embodiment, the nasal locators have a thickness of approximately 0.8 mm to 1.0 mm. Alternatively, the thickness of the nasal locators can be less than 0.8 mm, for example, 0.5 mm.
[000378] In the alternative modality described above, the thickness of the nasal locators is similar to the thickness of the region of the 1119 envelope that extends between the nasal locators and the entrance periphery. In this embodiment, the nasal locators have a preferred thickness of approximately 0.1 mm to 0.2 mm. Alternatively, the thickness of the nasal locators can be less than 0.2 mm, for example, 0.05 mm.
[000379] Preferably, the change in thickness from one region of the seal to another occurs gradually. For example, the thickness of the seal gradually changes from the thickened part 1118 to the thinner part1119. Similarly, the thickness of the seal gradually changes from the thickened part 1110 to the thinner part1119.
[000380] Referring now to figure 20, which shows the seal 1101 in cross section through the AA of figure 16. The figure shows an alternative view of the seal 1101 showing the varying thicknesses of the seal parts. In particular, the entrance periphery 1110 and the nasal locators 1106, 1108 are thick in cross section compared to the external periphery 1111. At least in the lateral direction, the thickened region 1110 adjacent to the entrance extends at least half the distance from the entrance to the outer peripheral margin 1121. In the upward direction, the thickened region extends at least half the distance from the entrance to the peripheral margin of the top 1123. In the downward direction, the thickened region extends at least half the distance to part of the bottom side 1125.
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65/88
The areas of the seal between nasal locators 1106, 1107, generally indicated as 1112, are also thicker in cross section to provide additional stability in these areas for nasal locators.
[000381] In figure 21, an alternative form of sealing is shown. In this alternative embodiment, the areas between the nasal locators, indicated as 1113, are substantially thinner in the cross section than those of the entrance periphery 1110 and the nasal locators 1106, 1108. This configuration would provide additional flexibility between the nasal locators 1106, 1108 .
[000382] Yet an additional embodiment of a seal of the present invention is shown in figure 22. At present, the seal is an inflatable type, but the seal extends downwards to occlude the user's mouth in use. This seal 1200 has nasal locators 1201, 1202 and is received in a frame similar to that described in any of the modalities detailed above. The 1200 seal has an extension 1203 that goes over the user's mouth creating a seal and reducing mouth leaks.
[000383] Another embodiment of a seal of the present invention is shown in figure 23. This seal 1300 is the same as that in figure 22, with nasal locators 1301, 1302 and an extension that covers the mouth 1203, but includes a outlet 1304 directed to the user's mouth, allowing gases to be released simultaneously to the user's mouth as well as the user's nasal passages through nasal locators 1301, 1302.
[000384] Figures 24 to 29 show several head straps that can be used with any of the interface modes described in the present.
Petition 870190090866, of 12/09/2019, p. 71/102
66/88 [000385] Figure 24 shows a single headband 1402 attached to interface 1400, particularly, to the flexible and inflatable seal 1401 by any appropriate means as known in the interface and headband technique. The strip 1402 can be a hollow tube 1402 as shown in figure 24a or a solid tube 1402 'as known in figure 24b. The hollow tube could, for example, be an extended silicone tube, with a diameter between 3 mm and 6 mm and a wall thickness of 0.2 mm to 1 mm.
[000386] Figure 25 shows a single headband 1410 attached to the interface 1400, particularly to the flexible and inflatable seal 1401 by any appropriate means as known in the art of interfaces and headbands. The strip 1410 can be a hollow elongated tube 1410 as shown in figure 25a or a solid elongated tube 1410 'as shown in figure 25b. The strip is preferably thinner in width at its ends 1411, 1412 which attach to seal 1401 and thicker in width at its midpoint which rests on the back of the user's head in use.
[000387] Figure 26 shows a double head strap 1420 attached to the interface 1400. Strap 1420 extends around the user's ears and has two attachment points on each side of seal 1401 where the strap attaches to seal 1401 .
[000388] Figures 27 and 27a show an extensible head strap 1430 attached to the interface 1400. The strap 1430 has an area 1431 that can be extended and contracted to better fit the strap to the user's head.
[000389] Figure 28 shows an alternative headband 1440 attached to interface 1400, particularly to seal 1401. Headband 1440 preferably includes side strips 1441 with stiffness areas 1442, 1443, to provide additional stability to
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67/88 side strips 1441. The head strap 1440 also preferably includes a top strap 1444 and a back strap 1445 which each extend on the head or behind the head respectively. This headband is further detailed in Patent Application No. US 12/307993 by Fisher and Paykel Healthcare, the contents of which are hereby incorporated by reference.
[000390] Figures 29 and 29a also show a headband
1450 even more alternative attached to interface 1400, particularly to seal 1401. The headband 1450 is curved and has divisions
1451 that provide additional support or stiffness to the strip.
[000391] The head straps detailed above can be formed from any suitable material, such as flexible plastic, silicone, laminated fabrics or other suitable materials.
[000392] Figures 30 to 33 show various ways in which an interface frame can be attached to an inflatable seal body. In figure 30, the sealing body 1500 includes rigid, overmolded or bonded plastic burrs 1502. Burrs 1502 close in correspondingly sized recesses 1503 formed in the frame 1501 and retained in the sealing body 1500 in a sealing engagement with the frame 1501.
[000393] In a similar manner, in figure 31, the sealing body 1500 has a periphery 1512 that is formed with a supermolded or bonded rigid plastic loop closure 1513 that closes to the frame 1501. More details of such closing mechanism are described in Patent Application No. US 12/502528 to Fisher and Paykel Healthcare, the contents of which are hereby incorporated by reference.
[000394] Alternatively, as shown in figure 32, the sealing body 1500 may have an inlet 1522 that has a stretch interference fit around the frame 1501. The frame
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68/88 preferably has a groove 1523 and raised margin 1524 that allows the inlet 1522 to engage with the frame.
[000395] In a more alternative form, as shown in figure 33, a sealing body 1500 can be permanently attached to the frame 1501 by means of overmoulding or connection.
[000396] Figures 34 to 40 illustrate various ways in which the tubing (1112, see figure 13) extending from the 1100 interface can be attached to a user. The advantage of fixing the tubing to the user is that it takes the weight of the tubing from the interface, reducing the possibility of the interface being pulled from the user's face. Each of the clamps described below is preferably made of fabric strips. It is preferred that the fabric is a material of the breathable type, but other suitable fabrics can be used. In all the forms detailed in the present, the tubing is fixed to the clamp by means of a lock or pin.
[000397] In figure 34, a cuff 1600 is shown that is made of a strip with a fabric loop that, in use, is placed around the user's head and shoulder.
[000398] In figure 35, an alternative cuff 1610 is shown. This cuff is also preferably made of fabric that is formed in a central cross across the user's chest and is secured around each of the user's arms.
[000399] In figure 36, a more alternative clamp 1620 is shown. At present, clamp 1620 has a central cross of straps across the user's chest, but is secured through the user's neck and back.
[000400] Alternatively, as shown in figure 37, a clamp 1630 could be used to secure the tubing to the user where a clamp is formed from the looped strip that is extended around the user's chest and under his arms.
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69/88 [000401] As shown in figures 38 or 39, a cuff 1640 may additionally include two shoulder straps 1641, 1642 or simply a shoulder strap 1643.
[000402] Alternatively, as shown in figure 40, a simple clamp 1650 can be used with the interface of the present invention that simply fits, in use, around the user's shoulder or upper arm.
[000403] The additional tube support arrangements will be described with reference to figures 41 to 57. Figures 41 to 51 describe a support collar intended to be worn around the user's neck and to which the tube can be supported by a tie. Figures 52 to 55 describe aspects of a tie that can be used with such a collar or can be used with other arrangements to secure one end of the tie to the patient. Figures 56 and 57 illustrate two such arrangements for attaching a tie to the patient. Figures 34 to 40 illustrate other arrangements for securing such a tie to the patient.
[000404] Figures 41 to 45 illustrate, in more detail, the collar previously described in broad terms with respect to figures 1 to 3. The collar includes an adjustable connection 327 and a secondary connection 329. The adjustable connection operates between a first end of the 4100 collar and a second end 4102. The adjustable connection 327 allows the user to establish the amount of overlap of the ends 4100 and 4102 to be established. Figures 41 to 45 illustrate an adjustable connection 327 in the form of a rounded fastener system. A part of fastener 4104 is attached to the first end of strip 4100. Numerous complementary parts of fastener 4106 are provided spaced along the second end of strip 4102. Engaging fastener 4104 with one of the series of fastener parts 4106 defines the end overlap
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4100 with respect to end 4102. Fastener parts 4106 can be spaced at intervals between 2 cm and 5 cm, preferably between 3 cm and 4 cm. This provides a degree of variation in the circumference of the collar in increments between 3 cm and 4 cm.
[000405] Preferably, the outer overlapping end 4100 includes a single portion of the connector and the end of the inner strip includes a series of outwardly facing parts of the second connector. According to this provision, no part of the connector is aimed at the patient's neck. In this way, the internal surface of the necklace is free of distracting projections.
[000406] The connector parts can be parts of, for example, a rounded fastener of the known type.
[000407] The extreme end of the inner end 4102 may include an outwardly extending loop that engages over the overlapping portion of the collar strip. This loop 4302, shown only in figure 43, would align the free end of the subheading end 4102 with the overlapping part of the collar when the collar is defined in tighter sizes.
[000408] Alternative connectors for the adjustable connection are illustrated in figures 46 to 49. The connection of the rounded fastener is illustrated in more detail in figure 46.
[000409] An alternative fastener using the latching magnets is illustrated in figure 47. The outer strip end 4702 includes an inwardly facing magnet part 4704. The inner strip end 4706 includes an outward facing magnet part 4708. The inwardly facing magnet part 4704 is preferably magnetized to a first inwardly facing polarity. The outwardly facing magnet part 4708 is preferably magnetized with a complementary outward facing polarity. A series of 4708 outward facing magnets would be spaced along the outer surface of the strip part
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71/88 internal 4706.
[000410] The magnet parts can be attached to a 4710 base part which, in turn, can be attached to the strip. For example, magnets can be glued to a substrate material that can be sewn onto the strip. Alternatively, the magnets can be shaped to include holes to allow the magnets to be directly sewn onto the strip.
[000411] The 4704 magnet could be replaced by a magnetic material that would be attached by 4708 magnets, but it would not be a magnet itself. Alternatively, 4708 magnets could be replaced with parts of a material that is magnetic, but not a magnet itself. For example, magnets can be ferrite or rare earth, while magnetic materials can be small sections of steel. Ferrite powder bonded with a flexible polymer can allow magnets to be flexible while maintaining sufficient strength to hold the necklace.
[000412] Figure 48 illustrates the adjustable connection that is made by a hook and loop fastener system. For example, the outer end portion 4802 may include a short section 4804 of a material with protruding hooks. The end of the inner strip 4806 may include an outward facing section 4808 covered with loops, to which the hooks can engage or disengage. The fastener material with hooks and suitable loop is sold under the Velcro brand.
[000413] The outward loop material can be sewn to the collar strap or the collar strap may be formed of a material that fully includes the loops. The length of the loop part 4808 is much greater than the length of the hook part 4804 and preferably extends a length equivalent to the adjustment required to be available for the necklace. For example,
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72/88 loop fastener would have a length of about 15 cm along the strip of the collar.
[000414] Figure 49 illustrates an alternative mechanical fastener similar to the round fastener. This type of round fastener includes an opening for smaller 4902 reception on the female part and smaller projection pins 4904 on the male part.
[000415] Referring again to Figures 43 to 45, the collar preferably includes a second releasable connection 329 between a third end 4302 and a fourth end 4304. Thus, the general ring of the collar is divided into two separate strip sections. Each strip section includes at one end of the adjustable connections 327 and the other end of the second connection 329.
[000416] Preferably, this second connection is not adjustable. This second connection 329 is intended to be engaged and disengaged with each use of the collar. The adjustable fitting can be adjusted to the correct length and configuration and the second fitting 329 can be used to secure and release the collar.
[000417] This second connection 329 can be formed by any suitable means, including the examples illustrated in figures 46 to 49 or that includes a flat release release fastener, as illustrated in figures 50A and 50B (50A in the connected condition and 50B in the condition) or a quick disconnect connector that releases by applying voltage in a predetermined range.
[000418] Connection 329 illustrated in figure 45 includes a quick disconnect connector provided with a first body part 4502 attached to the end of strip 4302 and a second part of body 4504 attached to the fourth end of strip 4304. The first and second body parts each include a protruding spike and a socket. The spike protruding from a body is complementary with the socket of the
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73/88 another body. The protruding spike and the socket preferably have an interference fit. The amount of interference and the force required to pull the socket spike define the release force for the quick disconnect lock.
[000419] This preferred quick disconnect latch is illustrated in more detail in figures 51A and 51B. In figure 51A, the closure is shown in the open configuration where a spike 5102 protrudes from each part of the closure body and each spike 5102 includes a small side projection 5104. The socket on each part of the closure body includes a side opening 5106. When the spike 5102 is pushed into the socket, the projection 5104 extends into the opening 5106. The interference fit is provided by engaging the projection 5104 in the opening 5106. This connector is shown in its fit condition in the figure 51B.
[000420] Referring again to figures 41 to 45, a tie extends from the collar. The 4112 tie is connected with the collar at one end and a 4114 latch at its free end. The 4114 latch is for connection to the supply line for the patient interface. Coupling lock 4114 is illustrated in more detail in figure 55, where an enlarged view of its fit with the duct sleeve is illustrated. The preferred connector includes an open ring that fits over a sleeve portion of the sleeve and is held in place between a flange 5502 of the sleeve and a flange 5504 of a pivot duct connected to the sleeve.
[000421] The preferred tie includes a quick-disconnect clasp in some position along its length between the collar connection and the conduit connector. The quick disconnect connector can be as described above with reference to figures 51A and 51B. That shape of the quick disconnect connector is illustrated in figures 52, 54A and 54B.
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74/88 [000422] Alternatively, the quick disconnect connector may also include a joint, such that the collar does not need to be correctly oriented with respect to the conduit before placing the patient interface. In this case, the quick disconnect connector may include a socket part 5302 and a male part 5304, with the male part 5304 being symmetrically rotationally. For example, the male part 5304 may include a protruding protrusion 5306 with an enlarged end 5308. Socket 5302 would include protruding parts or a protruding annular part around the inner circumference adjacent to the open end. Socket 5302 may be required to be made of two pieces subsequently fastened together to produce this projecting edge or edges. The socket part 5302 can be opened at its other end 5310 so that the connector part 5302 can be formed in one piece. This end can accommodate one end of part of the strap 5312 of the tie.
[000423] Alternatively, a joint can be included in another location along the mooring.
[000424] Preferably, the tie is formed with a 5202 sliding connector at one end for connection to the collar. Sliding connector 5202 preferably comprises a molded loop that includes straight sections on either side of the collar blanket and joined by cross sections above and below the collar edge. The loop preferably has a moderately tight fit on the collar so that, once moved to a position, it tends to stay in that position, but can be moved along the collar by applying sufficient force. The 5202 loop essentially reflects the profile of the collar blanket. A part of the tie may extend from loop 5202, preferably being integrally formed with loop 5202. Preferably, the tie part and loop are formed
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75/88 of a flexible elastic material, such as silicone.
[000425] Another part of the mooring extends from the quick release connector to the duct in hitch. Again, it can be formed from any suitable material, preferably flexible and preferably a silicone material.
[000426] The tie can be fixed and adjustable in length. Preferably, the tie can be provided in multiple lengths for selection by a patient. The mooring can be between 3 cm and 15 cm long. A strap of approximately 3 cm is illustrated in figures 54A to 54B, the strap which includes limited parts of the strap, if any. This tie is mainly made by its loop connector on the collar, the quick release connector and its connection to the conduit connector.
[000427] A longer tie is shown in figure 52 and figure 53, including a part of the substantial strip between the connecting loop 5202 and the quick release connector and another part of the substantial strip between the quick release connector and the conduit connector. These parts of the mooring could be interchanged, so that, for example, the part of the mooring strap could be provided entirely on one side or the other of the quick disconnect connector.
[000428] Figure 56 illustrates an alternative support arrangement for wearing a necklace. The 5602 tie ends with a 5604 clasp instead of ending with a connector for the necklace. Clasp 5604, preferably in the form of a type of handle, alligator clip or other arrangement equipped with clamping clips, is intended for attachment to the neckline or other convenient part of the clothing worn by the patient. Alternatively, the tie can be terminated at a connector to connect the cuff structures to be used by the patient as described above.
[000429] The tie may or may not include a disconnect connector
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76/88 fast.
[000430] Figure 57 illustrates another alternative for connecting to the 5702 garment on the patient. This illustrates the 5704 snap closure connected to the garment collar line and includes a 5706 quick disconnect connector.
[000431] The preferred necklace is constructed from materials that are comfortable for the wearer. In the simplest form, the collar can be, for example, a strip of a soft, flexible material endowed with sufficient hardness to maintain the overall shape of the collar, sufficient strength to resist any substantial extension or stretching, and a comfortable inside surface facing the patient. A suitable material can be, for example, a laminated foam material, such as Breathoprene, which has a foam blanket, turned to any side with a mesh fabric.
[000432] However, the preferred collar is more resistant to stretching than Breathoprene material, and more breathable than Breathoprene material. For the comfort of the skin, the necklace is preferably covered with a woven, knitted or braided natural fiber fabric. For example, a braided tube or woven with cotton woven bamboo yarn. To shape the necklace, the braided or woven tube surrounds a flexible skeleton. The flexible skeleton may comprise a series of hingedly connected frames or a molded flexible strip formed with an open housing. Preferably, it comprises a narrow strip of plastic mesh. An example of a suitable mesh is 3MESH, manufactured by the Mullter Texti Group in Germany. The open shell or mesh form allows moisture and heat to pass quickly through the collar, reducing the discomfort of the patient wearing the collar for long periods.
[000433] The strip of the necklace is preferably 3 cm to 6 cm wide and
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77/88 between 3 mm and 8 mm thick.
[000434] A preferred single headband is illustrated in figures 1 to 3. It includes a single, non-forked strip terminated with a connector at either end. The strip could be permanently attached to either end of the frame, but preferably the connectors are configured to be removable from the mask body. Another example of a preferred headband is shown in figures 10A to 10C, and a preferred connection closure is shown in figures 63A to 63D.
[000435] The single non-forked strip preferably accommodates a substantial variation in head size without adjustment. The preferred strip has a very low hardness, with the extension of a 400 mm main strip from an unstretched condition, but completely extended to a condition of 1.3 times its original length requires a force that does not exceed 4N, and preferably, does not exceeds 2N. Fig. 62 is a graph that illustrates the strength characteristics versus the extension characteristics of four materials of the sample strip. The preferred material comprises a nylon thread of the braided tube or with a mesh weave that incorporates Lycra filaments. The nylon thread is formed in a sufficiently detached manner that it is able to extend beyond the required range without becoming tight. The amount of Lycra filaments in the yarn can be varied to vary the hardness of the strip. An overall diameter or width of the strip is preferably less than 10 mm and more preferably less than 6 mm.
[000436] The strip end connectors can be attached to the strip in any suitable way. Preferably, the end connectors are overmoulded to the ends of the strips. The test results for a range of alternative strip materials are shown in figure 62. All test results are for
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78/88 extensions of a length of the tested material with a length "at rest" of about 400 mm.
[000437] Line 6202 shows the results of the extension test for a knitted nylon thread that incorporates Lycra filaments, the tube with mesh weave has a nominal diameter of 5 mm. This is also harder than desirable.
[000438] Line 6206 illustrates a more desirable hypothetical response determined by the inventors.
[000439] Line 6209 illustrates the response of a hollow extended silicone tube with a wall thickness of 0.25 mm and an outside diameter of 3 mm.
[000440] Line 6207 illustrates the response of an extended hollow silicone tube with a wall thickness of 0.25 mm and an outside diameter of 6 mm.
[000441] Both silicone extensions show satisfactory characteristics.
[000442] Line 6205 illustrates the response of the preferred nylon knitted yarn that incorporates Lycra filaments. This mesh woven tube had a nominal diameter of 4 mm.
[000443] Line 6208 illustrates the response of a 3 mm length of woven elastic blanket. This product exhibited characteristics similar to the preferred knitted yarn, however, the elastic blanket has a tendency to grab hair and lose elasticity.
HEAD STRIP [000444] The most preferred head strap comprises a stretched braided band. The lengths of the stretch thread are wound on a plurality of spools. The thread spools are then used in a braiding machine to produce a continuous braided tube. The tube is passed over a roll or a plurality of rollers, or between the rollers, to flatten the tube into a strip.
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79/88 [000445] The preferred headband has a cross-sectional dimension of approximately 6 mm wide and 1.5 mm thick.
[000446] According to the most preferred modality, the fillet comprises a Lycra filament (elastane or sprandex) with a spun wrap. The elastane filament may be, for example, Lycra (elastane or spandex) of 900 denier filament.
[000447] The spun wrap can comprise at least one nylon thread or filament. The wrap may comprise a wire from the primary wrap and a wire from the secondary wrap. Each yarn may comprise a spun yarn comprising a plurality of nylon filaments.
[000448] For example, each wrap can comprise a nylon filament yarn.
[000449] Nylon filaments contribute to the coloring of the stretch filament. For example, for a white headband, the nylon wrap must comprise white nylon filaments.
[000450] In preparing a stretchable thread spool, preferably multiple stretches (preferably three threads) of stretchable thread are wound on the spool in parallel, so that each element in the braiding process comprises, in fact, a package of three parallel threads.
[000451] Preferably, the locking is carried out on a 16-reel braiding machine, such as a Ratera 16/80 braiding machine available from Talleres Ratera SA of Barcelona, Spain. Each spool of thread for locking is prepared with three parallel threads, as described above.
[000452] The braiding machine is configured (for example, when defining tensions, speeds or both) to produce a suitable braid. The exemplary definitions for the control of
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80/88 speed of the Ratera 16 braiding machine is A: 45, B: 20, C: 30 and D: 35.
[000453] A headband produced according to this description was tested through the gradual extension, with the strength in each registered extension. The results of the force against extension to a length of 300mm from the prototype strip material are shown in figure 64.
[000454] Figures 63A to 63C illustrate characteristics of a strip of the preferred headgear. In particular, they illustrate preferred arrangements for attaching a connector to an end of a suitable stretch strip material. They also illustrate a preferred connector for connecting the strip to the interface frame.
[000455] Figures 63D to 63I illustrate another similar headgear strip that shares many of the characteristics of the headgear strip of Figures 63A to 63C. Except where noted, the description below refers to both modalities and the numerical references are shared.
[000456] At least one end of strip 6304 is terminated, and preferably both ends are terminated, with a connector 6302. Once the complete interface is assembled, connectors 6302 engage the side parts 1016 of the frame.
[000457] To form the connector, the flat tube 6306 is encapsulated by a plastic body 6308 or 6350, for example, through overmoulding.
[000458] In the embodiment of figures 63D to 63J, the strip is encapsulated by a comparatively soft material, such as a thermoplastic elastomer.
[000459] The plastic body 6308 may have characteristics of grip on its external surfaces, such as projections or ridges 6324 or recesses 6352.
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81/88 [000460] The 6308 body ends at its other end on a face of the end that is preferably dimensioned and shaped to be compatible with the end face of the 1016 side parts. The connector and socket are preferably formed to provide a connection rigid between the connector and the frame, such that when engaged the connector is a rigid extension of the side of the frame. Accordingly, the connectors contribute their length to the frame to define the location where the soft strips separate from the frame.
[000461] The preferred connection comprises a metal plug portion extending from the end face of the connector 6302, to engage the socket 1062 formed on the end face of the frame. The metal plug part (preferably steel or titanium or similar material) has high rigidity and strength while maintaining a compact shape.
[000462] The plug part may advantageously be formed of a 6310 metal cable. For example, the plug part may be formed of a length of stainless steel cable.
[000463] The cable can be flexed behind itself and have both ends wrapped by connector 6302, the cable then forms a loop that protrudes from the face of the connector end. To cooperate with this loop, the socket may be in the form of a slot with a general shape to be compatible with the essentially flat nozzle shaped by the loop.
[000464] The loop may include a 6316 member that includes a protruding thread or elevation. The protruding thread 6322 is adapted to engage a shallow chamfer 6334 in socket 1062. Chamfer 6334 can be formed along a surface of the slit margin.
[000465] The loop can be provided with an end part
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82/88 protruding 6318 furthest from connector 6302. The slot can be provided with margin surfaces that are closely compatible at least with the side profile of the end part 6318, so as to close the end part with the loop engaged in the slot. This prevents the connector from rotating in the loop plane.
[000466] The thickness of the slit is preferably closely compatible with the thickness of the cable. This prevents the connector from rotating across the plane of the loop.
[000467] The loop may have a straight 6320 member, and the slit a complementary straight edge face. These straight faces provide a sliding reference surface for aligning the connector with the socket during and after engagement.
[000468] Where one of the cable tie members is screwed and the other straight, and the complementary surfaces are provided in the slot, the connectors can be formed to have shapes that guarantee the correct orientation of the connectors with respect to the socket. For example, connectors can have a shape that is an obvious continuation of the shape of the frame.
[000469] Where a connector and socket are provided at both ends of the strip, the connectors (and the sockets) can be inverted orientation. For example, one socket may have depression 6334 on the face of the lower margin and the other socket may have depression on the face of the upper margin.
[000470] Alternatively, the connectors can have a shape or indication that guarantees the correct selection of the desired socket, as well as the orientation with respect to the selected socket.
[000471] As seen in figures 63A and 63C, one of the main members of the cable loop may be free to move within a cavity 6314 of the connector body 6308. Preferably, the
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83/88 free end 6340 is the end of member 6316 which has a protruding thread. The small freedom to move in cavity 6314 allows the loop of the cable to deflect more than if the end were restricted. This deflection reduces the peak forces required (and generated in the socket) during connection and disconnection of the connector.
[000472] The cavity 6314 comprises a slot that opens in the connector body 6308 from the end face of the connector body.
[000473] The other end of the cable loop can be formed to have a part that fits into the material of the connector body. For example, a part of the cable can be flexed in a curve and overmolded with plastic material from the connector body. This part can overlap inside the connector body with the encapsulated end of the 6304 strip.
[000474] To form this connector, the cable tie and the strip can be mounted with a sleeve, and the assembly can be overmolded. For example, the sleeve (which may be plastic), may have a blind cavity that receives the 6340 end of the cable loop, and an open end cavity that receives the other end of the cable loop (through one end of the cavity) and the end of the strip (through the other end of the cavity). The sleeve can then be overmolded or at least the open-ended cavity that holds the strip and the desired fixed end of the loop can be filled. Alternatively, the sleeve can be formed in two halves, closed together over the loop of the cable. The two halves can, for example, be articulated together. The halves can also close together at the end of strip 6306 and can roughly catch the end of the strip before overmoulding. For example, the 6360 handle protrusions can engage the
Petition 870190090866, of 12/09/2019, p. 89/102
84/88 end 6362 of the strip.
[000475] According to the modality of figures 63D to 63J, the soft coating material 6350 is provided by overmolding the connector with a soft material, such as a thermoplastic elastomer, along a length of the flexible soft strip 6306 in addition to the sleeve . This leads to a flexible part 6370 that passes between a rigid part 6372 of the connector and the very malleable strip. Preferably, this flexible part is progressively more flexible by moving away from the rigid part 6372. For example, the part of the overmolded liner may taper away from the sleeve, indentations may be formed in the liner (such as the depressions 6352 ) or both.
[000476] In masks where the head accessory strip will connect in a rigidly protruding manner (as in some of the masks described in the present), the soft part extending from the connector provides a soft buffer against the impact of the part hard protruding or beak.
[000477] Preferably, the soft part extends from 5mm to 60mm along the strip or strip, more preferably, from 10mm to 20mm. The soft material can be chosen from a wide range of soft plastics with consideration given to bonding with the strip material and the glove material.
[000478] With this connector, one of the surfaces of the edge of socket 1062 may include a first part 6332 that is compatible with the end part 6318 in the loop, a depression or chamfer 6334 that is compatible with the protruding thread 6322, a protrusion 6366 which holds the 6322 screw in the chamfer 6334, and a recessed guide in the 6338 region, which allows the loop to pass well into the slot before requiring the greatest connection force to push the 6322 screw past the protrusion
Petition 870190090866, of 12/09/2019, p. 90/102
85/88
6366.
[000479] The connector described is compact, acts as an extension of the interface frame, and has a simple and intuitive method of connection and disconnection.
[000480] Figures 58 to 61 illustrate another patient interface that incorporates a seal substantially as described above, and as figures 10 to 12 include features that can eliminate or reduce the need for added support for the conduit. According to this embodiment, the mask body includes 6102 pendant stabilizers. A pendant stabilizer is provided on each side of the mask body. Each pendant stabilizer extends beyond the perimeter of the mask seal and includes a 6104 foot to engage against the wearer's upper lip. Preferably, the stabilizer does not extend beyond the inside surface of the seal, but is spaced forward from the inside surface of the seal, with feet 6104 located in such a position that the mask is worn and symmetrically worn on the patient, the 6104 feet of the hanging stabilizers do not make contact with the wearer. Each 6104 foot may include a 6106 soft material pad, such as a soft polymer or elastomer foam or a hollow silicone extrusion section. The stabilizers can be integrated with the seal instead of the frame, for example, being integrally formed as a molded silicone body that extends adjacent to the central cavity to project beyond the bottom edge of the seal. In this case, the features in the mask body could guarantee the position of the edge edges of the stabilizers.
[000481] Each stabilizer extends in a downward direction to a region below the seal, and is intended to engage the patient's upper lip area in the area tied by the
Petition 870190090866, of 12/09/2019, p. 91/102
Mouth, nose and nasolabial folds and, preferably, not against the patient's cheeks. In this way, the feet are profiled and positioned to fit this area. Each stabilizer 6102 and arm 6108 extend from the lateral central part 6110 of the mask body. The shape of this arm and the material of this arm can be such that the arm is rigid or that the arm has a desired degree of flexibility. This arm should generally be rigid.
[000482] The purpose of the stabilizers is to reside spaced close to the part of the upper lip of the user when the interface is correctly placed and to make contact with the region of the upper lip of the user when the interface is rocked to one side or the other with relation to the user's nose, for example, under the influence of the supply line. Light pressure on the 6104 foot of the stabilizer, which is laterally spaced from the center line of the mask, preferably towards the extreme edges of the mask, hold the mask against these lateral duct forces, interrupting the mask's swinging too far on the face and breaking the seal.
[000483] In addition, the stabilizers hang below the mask and support the mask if the weight of the duct tends to rotate the mask forward. In this case, the 6104 feet of both stabilizers will make contact with the user's upper lip and support the mask position.
[000484] The stabilizers are illustrated in the preferred form as a substantially rigid construction, but with 6106 flexible or soft cushions. However, to justify variations in the patient's geometry, these stabilizers could be a selectable appendix, with a connection arrangement with the mask that allows the replacement by stabilizers in a different way. Alternatively, stabilizers could be made to be
Petition 870190090866, of 12/09/2019, p. 92/102
87/88 adjusted, such as when providing hinge parts capable of multiple fixed positions along the length of the stabilizer or at the junction of the arms and feet or both. Alternatively, the arms could be formed from a malleable material that is capable of substantial performance. Accordingly, the arms could be flexed to a desired position by the yield of the material and remain in this position.
[000485] In the mode with the hinges of the arms or feet, a connection arrangement could be provided to connect the movement of each of the stabilizers or the stabilizers can be individually or collectively supported in position by a spring or springs or another elastic member.
[000486] With the addition of stabilizers, the mask can be sufficiently attached and placed on the patient without any desire for added support of the conduit. This, in turn, may allow a shorter length of the flexible coupling tube 6120. In this way, the flexible coupling tube 6210 (which would typically be much more flexible than the main supply line) can be reduced in length between 5cm and 15cm, and preferably about 10cm. In systems that include a humidified gas supply line and a heated main supply line, this short flexible coupling tube is normally cooled down. When the coupling tube needs to be supported by a safety cord or collar, there is a minimum length that generally exceeds 15 cm. If the requirement for the safety cord on the collar is eliminated, the shorter coupling tube is only provided for flexibility, to decouple the relatively rigid supply line from the mask and facilitate freedom of movement for the wearer head. As the coupling tube is typically cooled down, the moisture in the gases
Petition 870190090866, of 12/09/2019, p. 93/102
88/88 loaded in the tube can drain on the surface of the cooling wall creating collections of water that can ultimately be blown into the user's nostrils creating discomfort. Providing a shorter tube, as allowed by the flange stabilizers, reduces the likely flow in the duct.
[000487] The configuration of the interface that incorporates a single malleable head strip, a nasal seal, a low profile frame that can stabilize on the upper lip, all in a size that fits the entire package (preferably, both the strip head and seal) can be highlighted where the short coupling tube is especially malleable. Because the tube is malleable, it is understood that it flexes easily under applied forces. For example, suitable tubes can meet the test criteria explained below with reference to figure 65.
[000488] According to the test in figure 65, a length of 150 mm of the tube is clamped at each end to a cylindrical support at each end extending into the hole in the tube. This leaves approximately 130 mm of the pipe suspended or bridging freely between the supported ends. This part of the bridge should be in a relaxed state, neither contracted nor extended. A lateral force of 5N in the center of the tube should lead to a deflection greater than 13mm.

权利要求:
Claims (16)
[1]
1. Patient interface (101) characterized by the fact that it comprises:
an inflatable nasal seal (301) comprising a side that makes contact with the face and an outside, the nasal seal (301) being formed of a soft flexible material and comprising a central part (407) to extend through the base of the the carrier's nose, and a lateral part (411) extending from each end of the central part (407), each lateral part (411) extending through one side of the nose, a side that makes contact with the face of the seal (301) being malleable to fit under internal pressure to the surface of a wearer's nose, which includes, on the sides (411) of the seal (301), to the surfaces outside the sides of the nose, the seal (301 ) including a pair of nasal locators (401) on the side that makes contact with the face;
a body (303) connected to the nasal seal (301), the body (303) being formed of a more rigid material than the nasal seal (301) and comprising an engagement portion of the nasal seal that engages with the outside of the seal (301), and an inlet opening;
a lip stabilizer (6102) for engaging against a portion of the wearer's upper lip; and an extensible headband (105) extending from the body (303) to hold the carrier interface (101), the headband (105) having a hardness that provides an extension of 150 mm with a force less than than 2N from a relaxed condition.
[2]
2. Patient interface according to claim 1, characterized by the fact that the sides (411) of the seal
Petition 870190090866, of 12/09/2019, p. 95/102
2/4 (301) are substantially parallel to each other and substantially normal to the central part (407) of the seal (301).
[3]
3. Patient interface according to claim 1 or 2, characterized by the fact that the seal (301) is more rigid in the region immediately adjacent and includes the nasal locators (401) more in a region that surrounds this region, in the side making contact with the seal face (301).
[4]
4. Patient interface according to any one of claims 1 to 3, characterized by the fact that the pair of nasal locators (401) extends from a malleable bottom, each nasal locator (401) including a tip, the nasal locator (401) becoming narrower moving from the bottom to the tip, and an opening in the tip of the nasal locator (401), the opening and the cross section of the tip part of the nasal locator (401) being oval or elliptical and having a ratio of the length of the longest axis to the length of the shortest axis greater than 1.5.
[5]
5. Patient interface according to claim 4, characterized in that the tip part of the nasal locator (401) includes a ridge adjacent to the tip opening, the ridge being thickened with respect to the adjacent parts of the tubular part.
[6]
6. Patient interface according to claim 4 or 5, characterized by the fact that the nasal locator (401) comprises a convex base portion (1038) adjacent to the bottom and a tubular portion (1040) extending from an apex of the convex base portion (1038), and wherein the convex base portion (1038) extends at least 60% of the path around the nasal locator (401).
[7]
7. Patient interface according to any one of claims 1 to 6, characterized by the fact that the outside
Petition 870190090866, of 12/09/2019, p. 96/102
3/4 of the seal (301) comprises regions more rigid than the side that makes contact with the malleable face, the regions extending into the side portions (411) of the seal (301).
[8]
8. Patient interface according to any one of claims 1 to 7, characterized by the fact that it still comprises a freely rotating elbow connector (313) and connected to the body entrance opening (303).
[9]
Patient interface according to any one of claims 1 to 8, characterized in that the lip stabilizer (6102) comprises one or more pads (6106) for engaging against a portion of the wearer's upper lip.
[10]
10. Patient interface according to any one of claims 1 to 9, characterized in that the lip stabilizer (6102) includes two dependent legs (6108), spaced apart in the lateral region of the seal (301).
[11]
11. Patient interface according to any one of claims 1 to 10, characterized in that the lip stabilizer (6102) depends on the body (303), and extends beyond a lower edge of the seal (301).
[12]
12. Patient interface according to any one of claims 1 to 10, characterized in that the lip stabilizer (6102) is integrally formed with the seal (301).
[13]
13. Patient interface according to any one of claims 1 to 12, characterized in that the head band (105) is a single-loop, non-forked head band.
[14]
14. Patient interface according to any one of claims 1 to 13, characterized in that the head band (105) engages the body (303) with a release connector (321) on either side.
Petition 870190090866, of 12/09/2019, p. 97/102
4/4
[15]
15. Patient interface according to any one of claims 1 to 14, characterized by the fact that it also comprises a flexible gas supply tube (315) coupled to an opening in the body entrance (303) for free rotating movement, the tube (315) having a length of less than 200mm.
[16]
16. Patient interface according to any one of claims 1 to 15, characterized by the fact that it still comprises a mouth cover extension (1203) having an outlet (1304) directed towards the user's mouth so that the patient interface (101) enable, in use, gases to be distributed simultaneously to the user's mouth via the outlet (1304) and nasal passages through the nasal seal (301).

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EP2498853B1|2018-06-20|

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JP2019030691A|2019-02-28|

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CA3010066A1|2011-05-19|

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JP6416300B2|2018-10-31|

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法律状态:
2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

---

2019-07-16| B06T| Formal requirements before examination [chapter 6.20 patent gazette]|

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2019-11-26| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-01-21| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 12/11/2010, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

---

US26059009P| true| 2009-11-12|2009-11-12|

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PCT/IB2010/052061|WO2010131189A1|2009-05-12|2010-05-10|Patient interface and aspects thereof|

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US37606710P| true| 2010-08-23|2010-08-23|

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PCT/NZ2010/000225|WO2011059346A1|2009-11-12|2010-11-12|Patient interface and aspects thereof|

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