Non-intrusive nasal mask

Abstract

A patient interface for delivering breathable gas to a patient includes a sealing portion (210) comprising: a nasal tip engagement portion (212) adapted to form a seal with the tip of a patient's nose; an upper lip engagement portion (213) adapted to form a seal with the upper lip of a patient and / or the base of a patient's nostrils; and an external nostril engagement wing portion (214) adapted to form a seal with a patient's nostrils. The nasal tip engagement portion (212), the upper lip engagement portion (213), and the external nostril engagement wing portion (214) are all configured to extend or bend outward from a support wall defining an air path.

Description

[0001] This application is a divisional application of patent application No. 201810257610.8, filed on June 2, 2010, entitled "Non-protruding nose mask". Application No. 201810257610.8 is a divisional application of patent application No. 201510222321.0, filed on June 2, 2010, entitled "Non-protruding nose mask". Application No. 201510222321.0 is a divisional application of patent application No. 201080034250.7 (international application No. PCT / AU2010 / 000684), filed on June 2, 2010, entitled "Non-protruding nose mask".

[0002] Cross-reference to related applications

[0003] This application claims the rights of Australian Provisional Application No. 2009902524, filed June 2, 2009; Australian Provisional Application No. 2009906101, filed December 15, 2009; Australian Provisional Application No. 20100, filed May 28, 2010 (application number not yet obtained, agent information number C10110P); U.S. Provisional Application No. 61 / 222711, filed July 2, 2009; and U.S. Provisional Application No. 61 / 272162, filed August 25, 2009. The interests of U.S. Provisional Application No. 61 / 272250, filed September 4, 2009; the interests of U.S. Provisional Application No. 61 / 263175, filed November 20, 2009; the interests of U.S. Provisional Application No. 61 / 282693, filed March 18, 2010; and the interests of International Application No. PCT / AU2010 / 000657, filed May 28, 2010, the entire contents of each of the above applications are incorporated herein by reference. Technical Field

[0004] This technology relates to a nasal breathing mask used in conjunction with an air delivery system, for example, for the treatment of sleep-disordered breathing (SDB) via continuous positive airway pressure (CPAP) or non-invasive positive airway pressure (NIPPV). Specifically, this technology relates to a non-protruding breathing mask. Background Technology

[0005] Devices that deliver breathable gas to a patient typically include a positive airway pressure (PAP) device, an air delivery tube or tubing, and a patient interface that contacts the patient's face during use to deliver pressurized breathable gas from the PAP device to the patient.

[0006] In practice, the patient interface may appear cumbersome, and its overly prominent nature could discourage patients from receiving treatment. This could lead to decreased treatment compliance and consequently treatment failure.

[0007] Patients using nasal pillows or nasal sprays may dislike the sensation of having a nasal pillow inserted into their nostrils or the feeling of pressurized air being directed into their nostrils (also known as the "air jet" effect).

[0008] Therefore, there is a need in the art to provide alternative patient interfaces that are less prominent and may not include the insertion of a nasal pillow into the nostrils and / or alleviate the sensation of pressurized air being introduced into the nostrils. Summary of the Invention

[0009] One aspect of this technology relates to a patient interface for delivering breathable gas to a patient. Another aspect of this technology is a patient interface that forms a seal on the underside of the patient's nose. Another aspect of this technology is a patient interface that avoids contact with the bridge of the patient's nose. Another aspect of this technology is a patient interface that forms a seal on the underside of the patient's nose in an area surrounding both nostrils. Another aspect of this technology is a patient interface that avoids contact with the nasal septum. Another aspect of this technology is a patient interface that defines a single breathing chamber that provides a positive-pressure air supply to both external nasal openings (nostrils).

[0010] One form of the patient interface according to the present technology includes a sealing portion comprising: a nasal tip engagement adapted to form a seal with the patient's nasal tip; an upper lip engagement adapted to form a seal with the patient's upper lip and / or the base of the patient's nostrils; and an external nostril engagement wing adapted to form a seal with the patient's nostrils. In one embodiment, the nasal tip engagement, the upper lip engagement, and the external nostril engagement wing are all configured to extend or bend outward from a support wall defining an air path.

[0011] According to one aspect of the present technology, a patient interface is provided, wherein different sealing forming mechanisms are used in different areas of the patient interface. Preferably, in the area suitable for sealing with the nasal folds of the face, a portion of the seal is in a compressed state. Preferably, in the area suitable for sealing with the nasal tip area of ​​the face, a portion of the seal is in a tensioned state during use. Preferably, in the nasal alar sidewall area between the folds of the face and the nasal tip area, the seal of the patient interface is configured to form a cantilever. Preferably, in the area between the left and right folds of the face, the seal of the patient interface is constructed and configured to be in a tensioned state during use.

[0012] According to one aspect of the present technology, a patient interface is provided, comprising a nasal tip seal forming portion in the form of a membrane. Preferably, the membrane is constructed and configured to be held in a taut state with its ends relatively fixed and to adhere to the nasal tip during use.

[0013] According to one embodiment of the present technology, a patient interface is provided comprising a sealing forming portion configured with regions of different stiffness. In one embodiment, the sealing forming portion has a relatively high-stiffness region configured to be adjacent to a nasal fold region of the face in use or near the base of the nose adjacent to the junction between the upper lip and one side of the nose. In one embodiment, the sealing forming portion may include corresponding left and right regions of relatively high stiffness. In one embodiment, the sealing forming portion includes a relatively low-stiffness region adapted to form a seal on the underside of a nasal tip region of the face. In one embodiment, the sealing forming portion has a medium-stiffness region configured to be adjacent to the side of the nose in use.

[0014] In one embodiment, the sealing portion of the patient interface according to the present invention defines a front lateral portion and a rear lateral portion on both the left and right sides. In another embodiment, the sealing portion of the patient interface according to the present invention defines a front central portion and a rear central portion. Preferably, the corresponding left lateral portion and right lateral portion are constructed and configured to hinge about the front central portion and the rear central portion during use. See International Patent Application No. PCT / AU2004 / 000207, Publication No. WO2004 / 073778. Figure 19 As shown in Figure 21, according to one embodiment of the present invention, the sealing portion is adapted to hinge about the middle portion to accommodate the angle of the patient's nasal ala. In one form, the sealing portion is adapted to hinge outward to accommodate a wider nose. In another form, the sealing portion is adapted to hinge inward to accommodate a narrower nose.

[0015] In one embodiment of this technology, a patient interface is provided, comprising a headband and a sealing formation. The sealing formation is adapted to bend about its middle portion to define an angle therebetween. The patient interface is constructed and configured such that the angle can be adjusted by changing the tension of the headband. In one embodiment, the patient interface includes a lateral headband connector configured at an angle relative to an orifice through which supplied breathable gas is delivered to the patient. In one embodiment, the patient interface is constructed and configured such that the angle of the headband connector can be adjusted. In a preferred embodiment, adjusting the angle of the headband connector can be used to adjust the angle of the sealing formation. In one embodiment, adjusting the headband can be used to increase or decrease the lateral force or clamping force of the sealing formation. In one embodiment, the headband is connected near the lower side of the sealing formation. Preferably, the patient interface is configured such that bending of the sealing formation about its middle portion can be achieved by changing the tension of the headband. In one embodiment, the upper surface of the headband connector is configured to push against the lower side of the sealing portion (preferably, the rear side of the sealing portion) to increase the lateral force or clamping force.

[0016] In one embodiment, a patient interface is provided, comprising a seal-forming portion adapted to form a seal on the underside of a patient's nose, the patient interface including a flexible body defining a breathing chamber. A headband is attached to each side of the flexible body. The body is constructed and configured to flex in response to varying tension in the headband to alter lateral or clamping forces on the sides of the nose, thereby achieving a seal. In one embodiment, the flexible body is formed of rubber, preferably silicone. In one embodiment, the flexible body is formed of rubber having a Type A indicative hardness of approximately 35 to approximately 45 (preferably approximately 40).

[0017] In one embodiment of this technology, a patient interface is provided, comprising a seal-forming portion, a headband, an air delivery conduit, and an isolation device. The headband is connected to a region of the patient interface adjacent to the seal-forming portion. The air delivery conduit is connected to the isolation portion. The isolation portion is located between the connection point of the headband and the connection point of the air delivery conduit.

[0018] Another aspect of this technology relates to a patient interface for delivering breathable gas to a patient, the patient interface including a seal configured to extend or bend outward from a support wall defining an air path. In one form of this technology, the seal forming portion is configured to have a trumpet-shaped or horn-shaped cross-section. In one form, the seal forming portion has a bell-shaped cross-section. In one form, the seal forming portion is located on the inner surface of a liner. In one form, certain areas of the seal forming portion are trumpet-shaped, horn-shaped, or bell-shaped, while other areas have different shapes. For example, the area of ​​the seal forming portion adapted to form a seal with the underside of the tip of the nose may be trumpet-shaped, horn-shaped, or bell-shaped.

[0019] In one form of this technology, the sealing portion is formed of rubber with low indicative hardness, preferably silicone resin having a type A indicative hardness in the range of 1 to 15.

[0020] In one embodiment of this technology, a patient interface is provided, comprising: a mask body formed of rubber having a Type A hardness in the range of approximately 35 to approximately 45; and a sealing portion formed of rubber having a Type A hardness in the range of 1 to 15. In one embodiment, the patient interface further includes a headband connector formed of a flexible material, preferably rubber having a Type A hardness in the range of approximately 35 to approximately 45. Preferably, the rubber is silicone rubber.

[0021] Another aspect of this technology relates to a patient interface for delivering breathable gas to a patient, the patient interface including a seal configured to bend outward and form at least one hanging membrane.

[0022] Another aspect of this technology relates to a patient interface for delivering breathable gas to a patient. The patient interface includes: a sealing portion comprising a nasal tip engagement portion adapted to form a seal with the tip of the patient's nose, an upper lip engagement portion adapted to form a seal with the patient's upper lip and / or the base of the patient's nostrils, and an external nostril engagement wing adapted to form a seal with the patient's nostrils; and a support portion supporting one or more portions of the sealing portion, wherein the support portion supports different portions of the sealing portion with varying degrees of support. The support portion may include one or more thickened portions, may have hollow portions or recesses, or portions with variable stiffness to provide varying degrees of support.

[0023] Another aspect of this technology relates to a patient interface for delivering breathable gas to a patient, wherein a support supports one or more portions of a seal, wherein the support supports different portions of the seal with varying degrees of support.

[0024] Another aspect of this technology relates to a patient interface for delivering breathable gas to a patient. The patient interface includes: a sealing portion comprising a nasal tip engagement portion adapted to form a seal with the tip of a patient's nose, an upper lip engagement portion adapted to form a seal with the upper lip of a patient and / or the bottom of a patient's nostrils, and an external nostril engagement wing adapted to form a seal with a patient's nostrils; and a support portion supporting the sealing portion, the sealing portion being connected to the support portion at each side of the sealing portion, and the sealing portion being spaced apart from the support portion at the front and rear of the sealing portion.

[0025] Another aspect of this technology relates to a patient interface for delivering breathable gas to a patient. The patient interface includes: a sealing portion comprising a nasal tip engagement adapted to form a seal with the tip of a patient's nose, an upper lip engagement adapted to form a seal with the upper lip of a patient and / or the base of a patient's nostrils, and an external nostril engagement wing adapted to form a seal with a patient's nostrils; and a support portion supporting the sealing portion, the sealing portion being connected to the support portion and the sealing portion being attached to the support portion, wherein the support portion is compliant.

[0026] Another aspect of this technology relates to a patient interface for delivering breathable gas to a patient. The patient interface includes a seal and a support supporting the seal, wherein the seal is connected to the support in some areas and spaced apart from the support in other areas.

[0027] Another aspect of this technology relates to a patient interface for delivering breathable gas to a patient. The patient interface includes: a sealing portion including a nasal tip engagement adapted to engage with the patient's nasal tip; and a support portion supporting the sealing portion, the support portion being connected to the sealing portion at two sides of the sealing portion, and the support portion being spaced apart from the sealing portion at the nasal tip engagement, the nasal tip engagement being adapted to stretch to fit and seal with the patient's nasal tip.

[0028] Another aspect of this technology relates to a patient interface for delivering breathable gas to a patient. The patient interface includes a sealing portion adapted to form a seal with the patient's face during use. The sealing portion includes: a forward stretch portion adapted to form a seal with the tip of the patient's nose; a backward stretch portion adapted to form a seal with the patient's upper lip; a lateral push portion adapted to anchor the seal in a region adjacent to the nasolabial fold of the patient's nose by applying a force normal to the plane of the patient's face; and a lateral wrap portion adapted to form a seal with the patient's nostrils by applying a clamping force normal to the patient's nostrils. The lateral wrap portion and the lateral push portion may have a greater thickness than the forward stretch portion or the backward stretch portion. The forward stretch portion can be stretched during use to seal with the tip of the patient's nose, and the backward stretch portion can be stretched during use to seal with the patient's upper lip.

[0029] Another aspect of this technology relates to a patient interface for delivering pressurized breathable gas to a patient. The patient interface includes a sealing portion adapted to form a seal with the patient's face, the sealing portion having: an opening adapted to receive pressurized breathable gas; an outer sealing edge that seals with the patient's face; and a transition region located between the opening and the outer sealing edge, the size of which gradually increases from the opening to the outer sealing edge.

[0030] Another aspect of this technology relates to a patient interface for delivering breathable gas to a patient. The patient interface includes: a sealing portion adapted to form a seal with the patient's face; a support portion supporting one or more portions of the sealing portion; and a headband connector extending from the support portion, the headband connector being adapted to connect to a headband to secure the patient interface to the patient, wherein the headband causes the headband connector to bend toward the support portion during use, and the bending force from the headband connector is transmitted to the sealing portion as a sealing force. The bending force may be applied as a clamping force to both sides of the patient's nose and / or as an anchoring force to the area of ​​the patient's nose adjacent to the nasolabial folds.

[0031] Another aspect of this technology relates to a patient interface for delivering breathable gas to a patient. The patient interface includes: a seal; and a multi-axis bend assembly operatively coupled between the seal and a flexible tube, wherein the multi-axis bend assembly allows the flexible tube to move in two separate planes while substantially preventing drag forces from the flexible tube from being transmitted to the seal.

[0032] Another aspect of this technology relates to a multi-axis pipe bending assembly that substantially blocks drag forces from the connected pipe while allowing the pipe to move in two independent planes.

[0033] Other solutions, features and advantages of this technology will become apparent from the following detailed description taken in conjunction with the accompanying drawings, which are part of this disclosure and illustrate the principles of the technology by way of example. Attached Figure Description

[0034] The accompanying drawings are helpful for understanding various embodiments of the present technology. In these drawings: Figure 1 A PAP system with a patient interface as in the prior art is shown; Figure 1-1 A patient interface in use according to an embodiment of the present technology is shown; Figure 1-2 for Figure 1-1 Isometric view of the sealing part and the suspension system of the patient interface; Figure 1-3 for Figure 1-2 Another isometric view of the sealing section and the cushioning system; Figure 1-4 for Figure 1-2 A top view of the sealing parts and the buffer system; Figure 1-5 for Figure 1-2 Bottom view of the sealing part and the buffer system; Figure 1-6 for Figure 1-2A front view of the sealing part and the buffer system; Figure 1-7 for Figure 1-2 Rear view of the sealing part and the buffer system; Figure 1-8 for Figure 1-2 Side view of the sealing part and the buffer system; Figure 1-9 for Figure 1-1 The patient interface buffer system and isometric view of the frame; Figure 1-10 for Figure 1-9 A bottom view of the buffer system and frame; Figure 1-11 for Figure 1-9 A top view of the buffer system and frame; Figure 1-12 for Figure 1-9 A front view of the buffer system and frame; Figure 1-1 3 is Figure 1-9 The rear view of the buffer system and frame; Figure 1-1 4 Figure 1-9 Side view of the buffer system and frame; Figure 1-15 for Figure 1-1 Isometric view of the patient interface seal, buffer system, and frame; Figure 1-1 6 Figure 1-15 Rear view of the sealing parts, cushioning system, and frame; Figure 1-1 7 is Figure 1-15 A front view of the sealing parts, cushioning system, and frame; Figure 1-1 8 Figure 1-15 Side view of the sealing parts, cushioning system, and frame; Figure 2-1 A rear view of the sealing part and the frame according to an embodiment of the present technology; Figure 2-2 for Figure 2-1 A front view of the sealing part and the frame; Figure 2-3 for Figure 2-1 Side view of the sealing part and the frame; Figure 2-4 for Figure 2-1 Top view of the sealing part and frame; Figure 2-5 for Figure 2-1 Bottom view of the sealing part and frame; Figure 2-6 for Figure 2-1 Isometric views of the sealing part and the frame; Figure 2-7A and Figure 2-7B A top view illustrating an alternative shape of the sealing portion according to an embodiment of the present technology; Figure 2-8A and Figure 2-8B A side view illustrating an alternative shape of the sealing portion according to an embodiment of the present technology; Figure 2-9A and Figure 2-9B A rear view illustrating an alternative shape of the sealing portion according to an embodiment of the present technology; Figure 2-10 An isometric view of the seal and frame in use according to an embodiment of the present technology; Figure 2-11 A rear view illustrating an alternative shape of a sealing portion according to an embodiment of the present technology; Figure 3-1 A patient interface in use according to another embodiment of the present technology is shown; Figure 3-2 for Figure 3-1 Isometric view of the patient interface seal and buffer system; Figure 3-3 for Figure 3-2 Rear view of the sealing part and the buffer system; Figure 3-4 for Figure 3-2 A top view of the sealing parts and the buffer system; Figure 3-5 for Figure 3-2 Bottom view of the sealing part and the buffer system; Figure 3-6 for Figure 3-2 Side view of the sealing part and the buffer system; Figure 4-1 A patient interface in use according to another embodiment of the present technology is shown; Figure 4-2 for Figure 4-1 Isometric view of the seal of the patient interface Figure 4-3 for Figure 4-2 Another isometric view of the sealing part; Figure 4-4 for Figure 4-2 Rear view of the sealing part; Figure 4-5 for Figure 4-2 A front view of the sealing part; Figure 4-6 for Figure 4-2 Side view of the sealing part; Figure 4-7 for Figure 4-2 A top view of the sealing part; Figure 4-8 and Figure 4-9 It shows Figure 4-2 The optional self-adjusting shape of the sealing part; Figure 5-1 and Figure 5-2 A cross-sectional view of a sealing portion having a gel bead edge according to an embodiment of the present technology is shown. Figure 6-1 and Figure 6-2 A schematic diagram illustrating the external nostril engagement wing portion of a sealing portion according to an embodiment of the present technology is provided. Figure 7-1 , Figure 7-2 and Figure 7-3 A sealing portion having a finger-like portion or a ridge-like portion according to an embodiment of the present technology is shown; Figure 8-1 The illustration shows a face mask with a gel cushioning system according to an embodiment of the present technology; Figure 8-2 and Figure 8-3 A face mask with a gel cushioning system according to another embodiment of the present technology is shown; Figure 9-1 and Figure 9-2 A sealing portion with reinforcing ribs according to an embodiment of the present technology is shown; Figure 10 A sealing portion with a headband connector according to an embodiment of the present technology is shown; Figure 11 A cushioning system with a headband connector according to an embodiment of the present technology is shown; Figure 12 A headband for a face mask according to one embodiment of the present technology is shown; Figure 13-1 , Figure 13-2 , Figure 13-3 , Figure 13-4 and Figure 13-5 A headband according to an embodiment of the present technology is shown; Figure 14-1 , Figure 14-2 , Figure 14-3 and Figure 14-4 A curved tube for a face mask according to an embodiment of the present technology is shown; Figure 15 A sealing portion with an adhesive tape according to an embodiment of the present technology is shown; Figure 16-1 and Figure 16-2 A sealing portion with a flexible tube according to an embodiment of the present technology is shown; Figure 17-1 and Figure 17-2The illustration shows a sealing portion of a gusseted buffer system according to an embodiment of the present technology; Figure 18-1 and Figure 18-2 The illustration shows a sealing portion disposed on an exoskeleton according to an embodiment of the present technology; Figure 19 The figure illustrates a gel sealing portion according to an embodiment of the present technology; Figures 20-1 to 20-7 A cross-section of a sealing portion according to an embodiment of the present technology is shown; Figure 21-1 This is a lower side view of one embodiment of the present technology; Figure 21-2 This is a rear view of the lower part of one embodiment of the present technology; Figure 21-3 This is a front view of the lower part of one embodiment of the present technology; Figure 21-4 This is a top view of the lower part of one embodiment of the present technology; Figure 21-5 This is another top view of the lower part of one embodiment of the present technology; Figure 21-6 This is a bottom view of the lower part of one embodiment of the present technology; Figure 22-1 This is a side view of the upper part of one embodiment of the present technology; Figure 22-2 This is a rear view of the upper part of one embodiment of the present technology; Figure 22-3 This is a front view of the upper part of one embodiment of the present technology; Figure 22-4 This is a top view of the upper part of one embodiment of the present technology; Figure 23-1 This is a side view of one embodiment of the present technology; Figure 23-2 This is a rear view of one embodiment of the present technology; Figure 23-3 This is a front view of one embodiment of the present technology; Figure 23-4 This is a top view of one embodiment of the present technology; Figure 23-5 This is a bottom view of one embodiment of the present technology; Figure 23-6 A cross-section of a side view of one embodiment of this technology; Figure 23-7 This is a cross-section of a front view of one embodiment of the present technology; Figure 24-1 This is a top view of a sealing portion according to an embodiment of the present technology; Figure 24-2 and Figure 24-3 for Figure 24-1 A front view of the sealing part; Figure 24-4 for Figure 24-1 A bottom view of the sealing part; Figure 25-1 , Figure 25-2 and Figure 25-3 This is a cross-section of the sealing portion according to an alternative embodiment of the present technology; Figure 25-4 This is a top view of a sealing portion according to an embodiment of the present technology; Figure 26 This is a side view of an isolation device according to an embodiment of the present technology; Figure 27-1 and Figure 27-2 An isometric view according to an embodiment of the present technology; Figure 28 An isometric view of a sealing portion having a fixed-size option according to an embodiment of the present technology; Figure 29 This is a cross-section of the sealing part in the prior art; Figure 30 This is a cross-section of the sealing part in the prior art; Figure 31 This is a cross-section of a sealing portion according to an embodiment of the present technology; Figure 32-1 A rear view of a headband attached to a sealing portion according to an embodiment of the present technology is shown; Figure 32-2 A front view of a headband attached to a sealing portion according to an embodiment of the present technology is shown; Figure 33-1 and Figure 33-2 This is a top view of the support member of the sealing part according to an alternative embodiment of the present technology; Figure 34-1 and Figure 34-2 A membrane support member for a sealing portion according to an embodiment of the present technology is shown; Figure 35-1 This is a top view of a sealing portion having a flexible part according to an embodiment of the present technology; Figure 35-2 and Figure 35-3 for Figure 35-1 A cross-sectional view of the sealing part; Figure 36 This is a side view of a membrane support according to an embodiment of the present technology; Figure 37-1 and Figure 37-2 The illustration shows a vent element according to an embodiment of the present technology; Figure 38A side view of a bent pipe according to an embodiment of the present technology; Figure 39 An isometric view of the support mechanism of the handle of the sealing part according to an embodiment of the present technology; Figure 40 This is a cross-section of a sealing portion according to an embodiment of the present technology; Figure 41 A side view of a pipe isolation mechanism according to an embodiment of the present technology; Figure 42-1 A top view of a rotating ring with a vent according to an embodiment of the present technology; Figure 42-2 for Figure 42-1 Isometric view of the rotating ring; Figure 42-3 A side view of a rotating ring according to an embodiment of the present technology; Figure 42-4 , Figure 42-5 , Figure 42-6 and Figure 42-7 A top view of a rotating ring including a vent element according to an alternative embodiment of the present technology; Figure 42-8 for Figure 42-7 The cross-section of the rotating ring; Figure 43 A side view of a system including an air chamber according to an embodiment of the present technology; Figures 44 to 46 This illustrates the sealing of a sealing portion with a patient's nose according to an embodiment of the present technology; Figure 47-1 , Figure 47-2 and Figure 47-3 This is an isometric view of a patient interface according to an embodiment of the present technology, the patient interface including a sealing portion and a supporting portion; Figure 48-1 for Figure 47-1 A top view of the sealing and supporting parts; Figure 48-2 for Figure 47-1 A schematic top view of the sealing part; Figure 49 for Figure 47-1 A front view of the sealing part and the support part; Figure 50 for Figure 47-1 Rear view of the sealing and supporting parts; Figure 51-1 for Figure 49 A cross-sectional side view of the sealing part and the support part; Figure 51-2 For having a second membrane Figure 49 A cross-sectional side view of the sealing and supporting parts; Figure 52-1 for Figure 47-1 Side view of the support section; Figure 52-2 for Figure 49 A front view of the cross-section of the sealing part and the support part; Figure 52-3 for Figure 49 A partial cross-sectional front view of the sealing and supporting parts; Figure 52-4 For use on patients Figure 49 A cross-sectional side view of the sealing and supporting parts; Figure 52-5 For use on patients Figure 49 Side view of the sealing part and the support part; Figure 52-6 For use on patients Figure 49 A cross-sectional side view of the sealing and supporting parts; Figure 52-7 For use on patients Figure 49 A front perspective view of the sealing part and the support part; Figure 53 for Figure 47-1 Front view of the support section; Figure 54 for Figure 47-1 A front view of the support section and headband connector; Figure 55 for Figure 54 A top view of the support section and headband connector; Figure 56-1 for Figure 54 Side view of the support and headband connector; Figure 56-2 for Figure 54 Cross-sectional view of the support section; Figure 56-3 for Figure 54 Cross-sectional view of the support section; Figure 57 A front perspective view of a patient interface according to an embodiment of the present technology; Figure 58 A frontal perspective view of a patient interface in a curved position according to an embodiment of the present technology; Figure 59 A perspective view of a multi-axis pipe bending assembly according to an embodiment of the present technology; Figure 60 This is a right-side perspective view of a patient interface at the patient's location during use, according to an embodiment of the present technology. Figure 61 This is a left perspective view of a patient interface at the patient's location during use, according to an embodiment of the present technology; Figure 62 This is a front perspective view of a patient interface at the patient's location during use, according to an embodiment of the present technology. Figure 63 This is a left perspective view of a patient interface at the patient's location during use, according to an embodiment of the present technology; Figure 64 This is a front perspective view of a patient interface at the patient's location during use, according to an embodiment of the present technology. Figure 65 A perspective view of a patient interface with a bellows according to an embodiment of the present technology; Figure 66 A perspective view of a patient interface with a bellows according to an embodiment of the present technology; Figure 67 This is a left perspective view of a patient interface with a headband used on a patient according to an embodiment of the present technology; Figure 68 This is a perspective view of a bellows according to an embodiment of the present technology; Figure 69 For illustration Figure 68 Diagrams of various dimensions of bellows; Figure 70 A perspective view of a patient interface having a ball joint and a socket connector according to an embodiment of the present technology; Figure 71 This is a perspective view of a ball joint and connector according to an embodiment of the present technology; Figure 72 This is a perspective view of a socket connector according to an embodiment of the present technology; Figure 73 A perspective view of a ball joint and a bend with a vent according to an embodiment of the present technology; Figure 74 A cross-sectional view of a ball joint and a bend with a vent according to an embodiment of the present technology; Figure 75 A perspective view of a ball joint and a bend with a removable vent plug according to an embodiment of the present technology; Figure 76 A perspective view of a mesh vent element according to an embodiment of the present technology; Figure 77 A view of a ball joint and a bend with a vent according to an embodiment of the present technology; Figure 78 This is a perspective view of a socket connector with a venting groove according to an embodiment of the present technology; Figure 79 This is a left perspective view of a patient interface with a headband used on a patient according to an embodiment of the present technology; Figure 80 A perspective view of a hybrid bend and ball joint according to an embodiment of the present technology; Figure 81 According to one embodiment of the present technology Figure 80 Cross-sectional view of hybrid bend and ball joint; Figure 82 According to one embodiment of the present technology, it has a function at the patient's site during use. Figure 80 A three-dimensional side view of the patient interface of the hybrid bend and ball joint; Figure 83 According to one embodiment of the present technology, it has a function at the patient's site during use. Figure 80 A three-dimensional side view of the patient interface of the hybrid bend and ball joint; Figure 84 A perspective side view of a patient interface with a membrane and a bend assembly at the patient site during use, according to an embodiment of the present technology; Figure 85 A perspective view of an angled bend and ball joint assembly according to an embodiment of the present technology; Figure 86 This is a left perspective view of a patient interface with a headband used on a patient according to an embodiment of the present technology; Figure 87 A perspective view of a patient interface with a headband used at the patient's location according to an embodiment of the present technology; Figure 88 This is a left perspective view of a patient interface with a headband used on a patient according to an embodiment of the present technology; Figure 89 This is a rear-view perspective view of a headband used on a patient according to an embodiment of the present technology; Figure 90 A perspective view of a patient interface with a headband used at the patient's location according to an embodiment of the present technology; Figure 91 A perspective view of a patient interface with a headband used at the patient's location according to an embodiment of the present technology; Figure 92 A rear-view perspective view of a patient interface with a headband according to an embodiment of the present technology; Figure 92-1 A front perspective view of a patient interface with a headband according to an embodiment of the present technology; Figure 93 This is a left perspective view of a patient interface with a headband used on a patient according to an embodiment of the present technology; Figure 94A perspective view of a patient interface with a headband used at the patient's location according to an embodiment of the present technology; Figure 95 This is a perspective view of a ball joint assembly comprising a ball joint portion, a vent portion, and a rotating ring according to an embodiment of the present technology. Figure 96 This is a perspective view of a rotating ring and ball joint according to an embodiment of the present technology; Figure 97 A front perspective view of a ball joint assembly comprising a ball joint portion, a vent portion and a rotating ring according to an embodiment of the present technology; Figure 98 This is a perspective view of a ball joint assembly comprising a ball joint portion, a vent portion, and a rotating ring according to an embodiment of the present technology. Figure 99 This is a side perspective view of a ball joint assembly incorporating a ball joint and a rotating ring according to an embodiment of the present technology; Figure 100 This is a side perspective view of a ball joint assembly incorporating a ball joint and a rotating ring according to an embodiment of the present technology. Figure 101 This is a cross-sectional side view of a ball joint assembly comprising a ball joint portion, a vent portion, and a swivel ring joint according to an embodiment of the present technology; Figure 102 This is a perspective view of a patient interface with a connecting tube on one side at the patient during use, according to an embodiment of the present technology; Figure 103 A front perspective view of a patient interface with a connecting tube on one side at the patient during use according to an embodiment of the present technology; Figure 104 This is a front perspective view of a patient interface with a connecting tube on one side at the patient during use according to an embodiment of the present technology; Figure 105 A front perspective view of a patient interface having two side connecting tubes according to an embodiment of the present technology; Figure 106 A front perspective view of a patient interface with a frame and headband according to an embodiment of the present technology; Figure 107 A front perspective view of a patient interface with a frame and headband used at the patient site according to an embodiment of the present technology; Figure 108 A perspective view of a patient interface with a headband support according to an embodiment of the present technology; Figure 109 A perspective view of a patient interface with a headband support according to an embodiment of the present technology; Figure 110A perspective view of a headband with hook and loop material and finger rings according to an embodiment of the present technology; Figure 111 A perspective view of a flexible tube and a sphere with an arc-shaped ventilation groove according to an embodiment of the present technology; Figure 112 A perspective view of a flexible tube and a ball with vent holes according to an embodiment of the present technology; Figure 113-1 , Figure 113-2 A perspective view of a bend and a ball having a vent groove and a removable barrier element according to an embodiment of the present technology; Figure 114 A perspective view of a patient interface having a headband connecting bracket and a connecting bend according to an embodiment of the present technology; Figure 115 A perspective view of a rotary connector and a bend with a venting groove according to an embodiment of the present technology; Figure 116 A perspective view of a rotary connector and a bend with a venting groove according to an embodiment of the present technology; Figure 117 This is a front perspective view of the sealing portion of a patient interface according to an embodiment of the present technology; Figure 118-1 , Figure 118-2 and Figure 118-3 This is a perspective view of the sealing portion of a patient interface according to an embodiment of the present technology; Figure 119 This is a top view of the sealing portion of a patient interface according to an embodiment of the present technology; Figure 120 This is a perspective view of the sealing portion of a patient interface according to an embodiment of the present technology; Figure 121 This is a front view of the sealing portion of a patient interface according to an embodiment of the present technology; Figure 122-1 , Figure 122-2 and Figure 122-3 This is a cross-sectional view of the sealing portion of a patient interface according to an embodiment of the present technology; Figure 123 This is a cross-sectional view of the sealing portion of a patient interface according to an embodiment of the present technology; Figure 124 A top view of the sealing portion of a patient interface according to an embodiment of the present technology; and Figure 125 This is a top view of the sealing portion of a patient interface according to an embodiment of the present technology. Detailed Implementation

[0035] The following provides a description of several embodiments that can share common features and characteristics. It should be understood that one or more features of any embodiment can be combined with one or more features of other embodiments. Furthermore, any single feature or combination of features in any embodiment can constitute an additional embodiment.

[0036] In this instruction manual, the word "including" will be understood as "open," that is, as meaning "including...included," and therefore cannot be limited to its "closed" meaning, that is, "consisting only of...". The corresponding words "including," "being included," and "including" also have their corresponding meanings.

[0037] The term "air" should be understood to include breathable gases, such as oxygen-supplemented air. It should also be recognized that the PAP equipment or blower described herein may refer to the pumping of fluids other than air.

[0038] 1. PAP system like Figure 1 As shown, the PAP system 10 typically includes a PAP device 15, an air delivery conduit 20 (also referring to an air delivery tube or fitting), and a patient interface 100. In use, the PAP device 15 generates a supply of pressurized air, which is delivered to the patient via the air delivery conduit 20, which includes one end connected to an outlet of the PAP device 15 and the opposite end connected to the patient interface 100. The patient interface 100 comfortably engages with the patient's face and provides a seal.

[0039] 2. Patient Interface like Figure 1 As shown, the patient interface 100 may include a face mask 200 and a headband 300 configured to secure the face mask in place on the patient's face during use. As illustrated, the face mask 200 may include: a seal 210; a frame 220; a bend 230 (e.g., having a swivel) adapted to connect to an air delivery tube 20; a headband attachment 240 (e.g., a notch or clip on the frame and / or adapted to engage a forehead support with a headband strap); a forehead support 250; and a forehead adjustment 260.

[0040] In existing patient interfaces (e.g.) Figure 1 The Mirage Quattro of ResMed shown TM In this case, the mask appears bulky and conspicuous on the patient's face. The basic rigid frame 220, combined with the headband 300, surrounds most of the patient's face. This configuration can psychologically discourage patients from undergoing treatment and thus negatively impact their adherence.

[0041] Another existing patient interface is ResMed's MirageSwift. TM The nasal pillow or nasal spray mask is sealed inside or around the patient's nostrils. This configuration can cause discomfort due to the contact of the nasal pillow inside or around the nostrils. In addition, the "air jet" effect can cause discomfort because laminar flow is introduced into the nostrils at a higher speed, resulting in higher pressure on a smaller area of ​​the nasal cavity and causing the mucous membranes to dry out.

[0042] The patient interface disclosed in one or more embodiments described below overcomes this problem because it is less conspicuous and more comfortable. This discomfort is overcome because the proposed patient interface does not seal into the nostrils. Furthermore, unlike nasal pillow-type patient interfaces, the proposed patient interface has a single opening or orifice for introducing breathable gas into the patient's airway. This single opening can induce stronger turbulence in the airflow, thereby mitigating the "air jet" effect.

[0043] 3. Face mask Figures 1-1 to 1-18 The illustration shows a face mask 200 according to one embodiment of the present technology, which includes a sealing portion 210, a cushioning system 215, and a frame 220. The face mask 200 can be a full-face mask or a mask for the nose only. The face mask 200 can also be a mask for the mouth only. Although the preferred configuration is below the nose, the present technology can be incorporated into other forms of face masks, such as a mask that surrounds the nose, or a mask that surrounds both the nose and mouth.

[0044] 3.1 Sealing part In use, the sealing portion 210 connects to the patient, allowing breathable gas to be delivered to the patient. In the described embodiment, the sealing portion 210 can form a seal with the patient's nostrils during use. For example, the sealing portion 210 can connect to and seal the exterior of each of the nasal ala or external nasal flanks, the upper lip and / or the base of the nostril, and the tip of the nose. The sealing portion 210 can be made of materials including, but not limited to, silicone, thermoplastic elastomers, gels, foams, or any other suitable conformable material. The material can have an indicated hardness of approximately 1 to 15 Shore A. Preferably, the material can have an indicated hardness of approximately 3 to 10 Shore A. Preferably, the material can have an indicated hardness of approximately 5 to 12 Shore A. Most preferably, the material can have an indicated hardness of approximately 5 Shore A. Therefore, the preferred sealing portion provides a non-invasive configuration that does not extend into the patient's external nasal cavity during use. The preferred sealing portion 210 does not expand and therefore does not require expansion pressure to form a seal. Preferably, although the seal does not rely on pressure, the seal can be improved in this regard. In one form, as disclosed in its entirety by reference in U.S. Patent No. 7,523,754 or International Patent Application WO01 / 97893A1, which is incorporated herein by reference, the sealing portion can use a gusset plate (e.g., having a projection area larger than the area of ​​the sealing portion) to assist in providing a seal.

[0045] In one embodiment, the sealing portion may have a wall thickness of approximately 0.1 mm to 15 mm. Preferably, the sealing portion may have a wall thickness of approximately 2 mm to 10 mm. Preferably, the sealing portion may have a wall thickness of approximately 7 mm to 12 mm. Preferably, the sealing portion may have a wall thickness of approximately 1 mm to 5 mm. Most preferably, the sealing portion may have a wall thickness of approximately 1 mm to 3 mm. Most preferably, the sealing portion may have a wall thickness of approximately 1.5 mm. The wall thickness may vary in different regions of the sealing portion; for example, the wall thickness may be approximately 0.5 mm in thinner regions and range from approximately 2 mm to 10 mm in thicker regions. Optionally, the sealing portion may have a constant wall thickness, for example, approximately 1.2 mm. The wall may be composed of different material layers, each material layer having a different hardness and / or thickness (e.g., two layers of silicone resin, both 1.2 mm thick but with different indicative hardness).

[0046] 3.1.1 Shape In the illustrated embodiment, the sealing portion 210 (also referring to the nasal support) may have a generally saddle-shaped, cup-shaped, or U-shaped form, such that when placed under the patient's nose, it maintains the same angle as or approximately forms that angle with the patient's nostrils (e.g., see...). Figure 1-1See also International Patent Application No. PCT / AU2004 / 000207, Publication No. WO2004 / 073778. Figure 19 (See Figure 21 and its related description).

[0047] Because the generally smooth, curved, or wavy shape of the seal 210 can bend to adapt to different nose shapes and sizes, it can be comfortable. The overall shape of the seal 210 can also mean comfort and non-prominence for the patient, thereby improving compliance.

[0048] Alternatively, the seal 210 may be generally flat, but it can still bend to the desired angle of the patient's nasal ala. This can be achieved by providing a seal 210 with a reduced thickness portion to support bending; and / or by constructing the seal 210 from a flexible material or a composite of flexible materials.

[0049] 3.1.2 Orifice As Figures 1-2 to 1-7 As best shown, the sealing portion 210 may have an opening 211 that allows breathable gas from the air delivery conduit 20 to reach the patient. The opening 211 may be generally circular, rectangular, or any other desired shape (e.g., as shown in the diagram). Figure 1-4 , Figure 1-5 (And the trapezoidal or elliptical shape shown in Figure 48). In one embodiment, the opening 211 may be shaped to indicate the alignment or positioning of the seal 210 with the patient's nose during use, for example, as a trapezoidal or triangular shape.

[0050] The orifice 211 of the sealing part can be larger than that of a nasal pillow or nasal fork mask. This means that the air velocity can be lower when air is expelled from the orifice 211 compared to a nasal fork or nasal pillow mask. The lower velocity of the air expelled from the orifice 211 makes it easier for the patient to exhale against the incoming air and also relieves pain caused by the high-speed airflow in or around the nose.

[0051] like Figure 48-1As shown in the embodiments, the orifice 455 may have the following dimensions: d1 (width), which is used to accommodate the width of a patient's nostrils within a certain range determined by different anthropometric methods; and d2 (height), which is used to accommodate the height of the nasal tip or the distance from the upper lip of a patient within a certain range determined by different anthropometric methods. Preferably, dimension d1 may be approximately 10 mm to 60 mm. Preferably, dimension d1 may be approximately 15 mm to 40 mm. Most preferably, dimension d1 may be approximately 21 mm. Most preferably, dimension d1 may be approximately 38 mm. Most preferably, dimension d1 may be approximately 58 mm. Preferably, dimension d2 may be approximately 1 mm to 20 mm. Most preferably, dimension d2 may be approximately 5 mm to 15 mm. Most preferably, dimension d2 may be approximately 11 mm. Any other values ​​of d1 and d2 may be used to provide sufficient airflow without excessive resistance and to accommodate different nasal sizes. The radius of curvature at the corner 457 may be 5 mm, but different radii of curvature may be used.

[0052] 3.1.3 Joint In the illustrated embodiment, the sealing portion 210 may include a nose tip engagement portion 212 and an upper lip engagement portion 213. For example... Figures 1-2 to 1-4 and Figure 1-8 As shown, the nasal tip engagement 212 is generally flat or planar along its length to provide a sufficiently long sealing surface to accommodate noses of different sizes. The upper lip engagement 213 is generally arcuate along its length to minimize contact with the patient's upper lip during use. Figure 20-1 A top view of another embodiment is shown and indicates that Figures 20-2 to 20-7 The portion shown in the figure. In one embodiment, and as shown... Figure 20-5 As shown, the radius of curvature R4 of the outer side or non-patient contact side of the nasal tip joint 212 is greater than the radius of curvature R2 of the outer side or non-patient contact side of the upper lip joint 213. In one embodiment, the radius of curvature R3 of the inner side or patient contact side of the nasal tip joint 212 is greater than the radius of curvature R1 of the inner side or patient contact side of the upper lip joint 213. The radius of curvature of the non-patient contact side (e.g., R2, R4) may be different from (e.g., greater than or less than) the radius of curvature of the patient contact side (e.g., R1, R3). The radii of curvature R1, R2, R3, and R4 can be from 1 mm to 5 mm, for example, 2 mm, 3 mm, and 4 mm. In the example, R1 can be approximately 3 mm to 3.75 mm, R2 can be approximately 2 mm, R3 can be approximately 3.25 mm to 4.5 mm, and R4 can be approximately 3.25 mm to 4.25 mm. Figure 20-2As shown, the radii of curvature R10 and R11 can be approximately 8 mm to 13 mm, for example, 9 mm and 11.5 mm. In the example, R10 can be approximately 9.5 mm to 11.5 mm and R11 can be approximately 9 mm to 10.5 mm.

[0053] 3.1.4 External nostril joining wing In the illustrated embodiment, the sealing portion 210 may include an external nasal cavity engaging wing 214 configured to align close to or against the patient's external nasal cavity. In use, the wing 214 (e.g., directly at the nasal entrance or along the patient's external nasal cavity) seals the nasal cavity and bends or deflects inward toward the patient's nose to secure or anchor the seal and allow the sealing portion 210 to fit noses of various sizes and shapes.

[0054] like Figure 1-6 As shown, the external nostril connecting wing 214 can be bent into a generally V-shaped orientation, denoted as angle α (which is measured from the center of the orifice 211 and traces a generally straight path along each external nostril connecting wing 214).

[0055] In one embodiment, angle α is in the range of approximately 0° to 180°, for example, approximately 90° to 180°, approximately 90° to 120°, approximately 120° to 180°, approximately 0° to 90°, approximately 0° to 45°, approximately 45° to 90°, approximately 90°, and approximately 75° to 95°. Angle α represents the angle of the engaging wings when not in use or in a relaxed state. When in use (i.e., when a patient places the mask over their nose and their nose applies pressure to the mask), angle α can increase, thus allowing the engaging wings to bend outwards to the use position. This can include angles of approximately 75° to 200°. The radius of curvature, as shown in the area roughly defined by α, can be approximately 5 mm to 8 mm.

[0056] The external nasal cannula joining wings may include optional configurations to enhance the seal. For example, such as... Figure 6-1 As shown, the external nostril engaging wing 214 can be narrower (e.g., at a reduced angle α) so that the wing "clamps" the nose, i.e., the nose causes the wing to bend outward during use. Figure 6-2 As shown, the wing 214 may include a hook-shaped end 214(1) configured to "hook" onto the patient's nostril and seal the patient's nostril during use.

[0057] 3.1.5 Horn-shaped sealing part like Figures 1-2 to 1-8As shown, the nasal tip joint 212, the upper lip joint 213, and the external nasal cavity joint wing 214 are all configured to bend or extend outward from the annular support wall or base 219. That is, the nasal tip joint 212, the upper lip joint 213, and the external nasal cavity joint wing 214 are all suspended or braced from the aforementioned support wall, such that they extend or bend outward from the support wall defining the air path in a continuous, uninterrupted, and smooth manner to the outer edge of the sealing portion 210.

[0058] 3.1.6 Sealing part with malleable wire Figures 4-1 to 4-7 A seal 210 with a malleable wire 270 is shown. As shown, the malleable wire 270 is disposed on the underside of the seal or on a non-facial contact portion and extends around the periphery of the seal (e.g., inwardly spaced from the edge of the seal to avoid any contact with the patient's face during use). However, the malleable wire may be disposed on one or more selected portions of the seal (e.g., only along the wings). The malleable wire allows the patient to deform the seal 210 into their specific nose shape (i.e., a self-adjusting seal geometry) and maintains this deformed seal shape during use. For example, Figure 4-8 The sealing portion 210, deformed into a generally V-shape, is shown, and Figure 4-9 A sealing portion 210, deformed into a generally flat or planar shape, is shown.

[0059] In this embodiment, a sealing portion 210 having malleable wire 270 is disposed on a base 271 adapted to connect to a frame. However, as described below, such a sealing portion can be disposed on a cushioning system or directly on the frame.

[0060] Malleable wire can be attached to or set to the seal in any other suitable manner (e.g., co-formed with the seal, modified, etc.).

[0061] The seal can be deformed in other suitable ways, for example, by making the seal from a thermoformable plastic material to achieve a similar effect.

[0062] 3.1.7 Gel bead edge like Figure 5-1 and Figure 5-2 As shown, the gel bead edge 272 (e.g., teardrop-shaped) may be disposed around the periphery of the seal 210 or one or more portions of the seal (e.g., along the external nasal cannula engagement wing) to support the seal in use, provide compliance, and / or provide tactile visibility. The gel bead edge 272 may be disposed along the edge of the seal ( Figure 5-1 ), along a portion of the edge, and / or within the edge ( Figure 5-2 )position.

[0063] 3.1.8 Finger-like part or ridge-like part In one embodiment, finger-like or ridge-like portions may be provided along the face contact surface of the seal to enhance the seal and prevent leakage during use. Figure 7-2 An embodiment of the finger-like portion 273 is illustrated, and Figure 7-3 An embodiment of the ridge 274 is illustrated. For example... Figure 7-1 As shown, the finger-like portions 273 / ridge-like portions 274 can be arranged in a concentric ring around the sealing portion 210. However, the finger-like portions / ridge-like portions can be configured in other suitable ways, for example, disposed in one or more selected areas of the sealing portion. In each embodiment, the finger-like portions / ridge-like portions extend outward from the facial contact surface of the sealing portion (e.g., at a height of approximately 0.5 mm), and are configured to deform in use and conform to various shapes of the patient's face and nose. Such finger-like portions / ridge-like portions can particularly enhance the seal at awkward locations (e.g., along the junction of the nose and upper lip). Because the finger-like portions / ridge-like portions can form a frictional / stabilizing interface with the patient's skin in use, they can also enhance tactile awareness or maintain positioning.

[0064] 3.1.9 Reinforcing the ribs In one embodiment, reinforcing ribs 275 (e.g., thickened portions integrally formed with the seal) may be provided to one or more portions of the seal 210 (e.g., the external nostril engaging wing 214) to support the seal in use. For example, as Figure 9-1 As shown, the reinforcing ribs 275 can be arranged around the seal in one or more concentric rings to increase the strength around the entire periphery and support the outer edge of the seal 210 to prevent it from collapsing and leaving the patient's nose during use. Figure 9-2 As shown, the reinforcing rib 275 may extend radially along the orifice 211 (e.g., one or more "branches" having ribs) to increase support and reduce buckling in selected areas of the seal (e.g., areas highly susceptible to leakage or deformation). In another embodiment, reinforcing ribs or thickenings may be provided at discrete points of the seal (e.g., points highly susceptible to leakage or deformation). The reinforcing rib 275 may be thicker than the seal 210. Optionally, the reinforcing rib may be made of a material with a different hardness than the seal 210, such as a silicone resin having an indicated hardness higher than that of the seal 210.

[0065] 3.1.10 Gel Sealing Part Figure 19An embodiment of a seal 210 made of gel is illustrated, namely a capsule or membrane filled with gel (e.g., a wall thickness of approximately 0.3 mm to 5 mm, or 0.7 mm). As shown, the membrane or capsule 276 is filled with one or more gel layers, and a cap 277 (e.g., made of polycarbonate, silicone, polypropylene, nylon) is provided to close and seal the opening in the capsule. Furthermore, the cap 277 helps to position and secure the gel-filled capsule to the frame 220. In use, the gel seal enhances comfort and compliance.

[0066] 3.1.11 Color-changing materials In one embodiment, the seal may be made of a material suitable for color change, such as a thermosensitive material. For example, the seal may be made of a thermosensitive color-changing silicone resin, which, for instance, begins as blue (or any first color) at room temperature and changes to white / transparent (or any second color different from the first color) upon heating (e.g., body temperature).

[0067] Patients can use this color-changing material to measure their seal. For example, a patient can be provided with a seal for the largest possible nose size, and when the patient fits the seal against their nose, they will be able to accurately see how much excess material is on the seal. For instance, contact with the patient's face will heat the material and change it from a first color to a second color. The patient can then trim off the excess material to customize the mask to fit their nose.

[0068] Furthermore, color-changing materials can be used for leak indication. For example, if the leaking air is below body temperature, the color-changing material will retain its first or original color wherever there is a leak path.

[0069] Color-changing materials can have other applications, such as for sealing parts and / or other components of patient interfaces or PAP systems.

[0070] For example, color-changing materials can be used for disinfection. If the cleaning agent used (e.g., water) is most effective at cleaning the face mask at a specific temperature, the silicone resin can change color at that temperature to indicate that the required disinfection state has been achieved. For instance, if the best method for disinfecting the face mask is to boil it in hot water, the mask can change from colored to white / transparent at 100 degrees Celsius. Alternatively, if cleaning the face mask with alcohol is preferred, the latent heat reacting with the applied alcohol will cause the silicone resin to change color.

[0071] Color-changing materials can be used as end-of-life indicators. If the color-changing silicone resin will only change color a certain number of times before it fails, this can be used to indicate when to replace the face mask.

[0072] Color-changing materials can be used to enhance invisibility. For example, silicone resin can change color to become transparent, making face masks less noticeable.

[0073] Color-changing materials can be used as positioning elements. For example, the color of silicone resin can be used to locate parts that have been dropped or lost.

[0074] Color-changing materials can be used for mask asymmetry. For example, if a patient has an asymmetrical nose, this can serve as a useful alignment indicator. It can suggest that the patient position the mask off-center to accommodate their asymmetrical nose. The silicone will change color at the point where the patient's nose is currently in contact with the mask, and during use, the patient can adjust the mask's position to ensure that both nostrils can receive a flow of breathable air from the mask.

[0075] Color-changing materials can be used on PAP equipment, humidifiers, and / or fittings (e.g., heated pipes) to indicate that the temperature of the PAP equipment, humidifiers, and / or fittings is at its limit or desired temperature.

[0076] In another embodiment, the seal may be made of a pressure-sensitive color-changing material. In this embodiment, the patient will be able to identify the pressure point and subsequently adjust the mask accordingly.

[0077] An exemplary material could be Chromazone Free Flowing Powder supplied by Thermographic Measurements Ltd, Devon, UK.

[0078] Another exemplary material could be a Thermochromatic and Liquid Crystal product supplied by B&H ColourChange Ltd, London, UK.

[0079] Another exemplary material could be Thermochromatic Inks supplied by Siltech Ltd, Nottingham, UK.

[0080] 3.1.12 Dimensioning indicator Figure 27-1 and Figure 27-2 The diagram shows a sealing portion 210 with a thermochromic dimensional indicator. Figure 27-1 The sealing portion 210 before use is shown, and the sealing portion 210 is the entire colored area 358. Figure 27-2An exemplary seal 210 after use is shown, wherein the area touched by the patient has changed color, as indicated by the colored area 360. The color change indicates the portion of the seal 210 that has been in contact with the patient and allows the patient to remove excess material after use (i.e., Figure 27-2 (The colored area 360° in the image). The color-changing part can also be used by personnel who assemble the seal to the patient, so the color change will indicate the ideal choice among pre-fabricated seals of different sizes.

[0081] 3.1.13 Fixed Size Selection The sealing part 210 can be configured such that a single-size bracket can be manufactured, which can be cut or trimmed to a smaller size. For example, as... Figure 28 As shown, the sizing of the sealing portion for patients' noses of different sizes can relate to the size of the orifice, so that orifice opening 362, orifice opening 364, or orifice opening 366 can be used depending on the size of the patient's nose; that is, orifice opening 366 is used for larger noses and orifice opening 362 is used for smaller noses. Excess membrane material of membrane 348 can also be trimmed by the patient or medical staff. Perforated eyelets or trimming lines can be incorporated into the sealing portion 210 to indicate the sizing range.

[0082] 3.1.14 Protrusion Figures 24-1 to 24-4 A sealing portion 210 (also referred to as a nasal support) is shown, provided with a nozzle or protrusion 320. The nozzle 320 is positioned on the sealing portion 210 for positioning in or near the patient's nostril during use and positioning the sealing portion 210 below the patient's nose 324. The nozzle 320 positions the sealing portion 320 to form an effective seal and provide adequate treatment to the patient.

[0083] The nozzle 320 is provided with an orifice 322 for directing gas into the patient's nose 324. The nozzle 320 does not necessarily need to seal against the patient's nostrils, while the sealing portion 210 can seal against the underside of the patient's nose, for example, as described above. In the illustrated embodiment, the sealing portion 210 is provided with a nasal septum positioning member 326, wherein the patient's nasal septum can be positioned between the nozzles 320. The nasal septum positioning member 326 may include padding material to provide comfort to the patient in this sensitive area of ​​the nose. Optional alignment protrusions or mechanisms may be used to position the sealing portion relative to the patient.

[0084] The nozzle 320 is configured with an arcuate or concave outer surface 321, the width of which gradually increases from the top to the bottom of the nozzle 320 to provide a comfortable fit for noses and nostrils of different sizes. Figure 24-2As shown, a patient with a relatively small nose 324 and nostrils can utilize the curved outer surface of the nozzle 320 by extending the patient's nose towards the lower portion of the curved outer surface 321 to provide a comfortable seal. Figure 24-3 As shown, patients with relatively large noses 324 and nostrils can utilize the curved outer surface of the nozzle 320 by extending the patient's nose further down the curved outer surface 321, thus providing a comfortable seal. Meanwhile, the seal 210 can be resistively bent to accommodate noses of different sizes (e.g., width).

[0085] 3.1.12 Comfort of the sealing part Figures 25-1 to 25-4 A seal 210 is shown, comprising elements configured to provide comfort to the patient. For example, the seal 210 may be provided with a soft, compliant pad to enhance comfort and, consequently, treatment adherence. The pad may be made of a low-indicative-hardness material, such as a material having a Shore A (or Type A) hardness of less than 40. For example, the material may have a Shore A hardness of approximately 5 to 60. Preferably, the material may have a Shore A hardness of less than 20. Most preferably, the material may have a Shore A hardness of less than 10.

[0086] exist Figure 25-1 In this process, a pad 330 or pouch made of a soft material is placed beneath the sealing film 328. The film 328 may be made of silicone or other suitable materials. The pad 330 may be a molded thermoplastic elastomer (TPE), a gel-filled capsule, foam, or other compliant material, or a combination thereof. As shown, the film 328 includes an end that hooks onto or wraps around the outer edge of the pad 330, such that the film 328 positions and secures the pad 330 beneath the film 328. A locking protrusion 332 may also be provided on the handle 334 of the sealing portion 210 to maintain the position of the pad 330 by preventing it from sliding downwards; that is, the locking protrusion 332 provides an obstruction to prevent the pad from moving in a downward direction.

[0087] The sealing portion 210 includes a channel 336 through which breathable gas can be delivered to the patient. The membrane 328 is connected to the patient and preferably prevents the pad 330 from connecting to the patient, thus allowing for fewer restrictions on the selection of the material for the pad 330, taking into account patient safety.

[0088] Figure 25-2 It shows the relationship with Figure 25-1A similar configuration, however, also includes a lower membrane 340 to support the liner; that is, an upper membrane 338 and a lower membrane 340 are provided to support the liner 330 in situ. Because the patient positions the seal 210 during use, the patient will apply a patient force (as indicated by the arrow) to the seal 210 and the liner 330. To provide sufficient reaction force for the liner 330 under appropriate displacement (as indicated by the arrow), the lower membrane 340 supports the liner 330 in situ so as to seal with the patient and provide patient comfort.

[0089] exist Figure 25-3 In this embodiment, the sealing portion includes an upper liner 342 disposed above the lower liner 344. In this embodiment, the sealing portion may or may not include the sealing membrane as described above. The upper liner 342 may have one hardness and the lower liner 344 may have another hardness; for example, the upper liner 342 may have a lower hardness than the lower liner 344. In one example, the upper liner 342 may have a hardness of approximately 5 to 20 Shore A (e.g., approximately 7 to 15 Shore A, preferably approximately 7 Shore A), and the lower liner 344 may have a hardness of approximately 20 to 80 Shore A (e.g., approximately 40 to 70 Shore A, preferably approximately 40 Shore A). However, other suitable hardnesses are also possible. For example, the upper liner 342 and the lower liner 344 may be made of silicone, TPE, gel, foam, nylon, or combinations thereof. The lower liner 344 may support the sealing portion 210 in situ to ensure comfort during use and a seal with the patient. A channel 336 is provided through the upper and lower liner to allow gas to be delivered to the patient.

[0090] exist Figure 25-4 In the middle, the sealing part 210 may have a horseshoe shape 346 (when viewed from above) to facilitate the connection with the nasal tip 352 and the external nasal cavity joining wings. Because the traction line of the molding tool (as indicated by the arrow) is straight and therefore easy to mold, this configuration allows the capsule to be molded as a pad. The capsule may be filled with gel, foam, TPE, or any other suitable material. A membrane 348 may be disposed to the pad 346 and positioned to contact the patient's upper lip during use. The membrane 348 may be stretchable and / or flexible to adapt to different upper lip structures. The membrane may also seal onto the patient's face with less force and is therefore more comfortable at the upper lip position.

[0091] exist Figures 47-1 to 50In the illustrated embodiment, the seal 450 may be formed of a soft material to provide comfort to the patient and easily conform to the patient's face. For example, the seal 450 may be a liquid silicone rubber material or another elastic material, such as TPE. The seal may have a hardness of approximately 5 to 40 Shore A (preferably approximately 5 to 15 Shore A, most preferably approximately 5 Shore A) to provide patient comfort.

[0092] 3.1.15 Membrane Flexibility In such Figure 29 and Figure 30 In the prior art holder shown in the mid-section view, the membrane 368 is rolled inward or bent from the support wall 370. This configuration allows the patient's nose to travel into the liner, and the membrane rolls down or moves to create a seal. The support wall 370 ensures that the membrane 368 is supported and has sufficient space to roll or bend inward. Because excess material may cover the patient's airway, this rolling may cause nasal obstruction.

[0093] On the contrary, in such Figure 31 In the illustrated embodiment of the present technology, the membrane 348 is configured to bend outward from the center of the patient's nose or bend away from the center of the patient's nose during use. Alternatively, this configuration can be described as trumpet-shaped or bell-shaped. The support 372 secures the membrane 348 in its unused position and prevents the membrane 348 from bending outward beyond its intended limits. Because the excess material of the membrane 348 bends outward, the likelihood of material occlusion of the patient's external nasal cavity is reduced. The excess material of the membrane 348 reduces the likelihood of occlusion by removing or reducing the clamping force caused by the collapsible outer wall.

[0094] 3.1.16 Membrane Support The headband can be attached to the membrane to support its outer wall in an upward position, i.e., to prevent the membrane from buckling outwards into a flat position that would block the patient's nostrils or disrupt the seal between the mask and the patient. Figure 32-1 As shown in the rear view, the headband strap 378 can be attached to the sealing portion at the headband attachment point 376. As shown, the headband attachment point 376 is located near the orifice 374, so that the strap 378 can support the length of the sealing portion 210 and support the membrane 348 in an upward position during use. Therefore, the membrane 348 cannot be excessively bent outward, preventing closure of the patient's nostrils or damage to the seal between the mask and the patient. The headband strap 378 can be bent or moved below the sealing portion 210 at the portion of the headband strap 378 not attached via the headband attachment point, so as to have a greater range of fit due to the headband being able to be placed in multiple positions under the membrane.

[0095] like Figure 32-2As shown, the headband 378 can optionally be attached via headband attachment point 376 to a portion further away from the channel 374 and closer to the membrane edge. This gives the membrane greater flexibility to accommodate noses of various shapes (e.g., a pointed nose to a flat nose).

[0096] Figure 33-1 The illustration shows a support member 381 (e.g., a generally rigid member) positioned below, inside, or as part of the seal 210 (support member 381 is shown in dashed lines). The support member 381 is configured to force the membrane of the seal 210 into contact with areas of the patient's face that are difficult to seal. For example, these areas are difficult to seal because patients have a wide range of varying geometries at the corners of the nose and the flared portions of the nostrils. The support member 381 can be more rigid or stiffer than the membrane, thereby anchoring the seal in the upper lip region, the corner of the nose region 382, ​​and the flared portions of the nostrils 384, and also ensuring that the membrane maintains a seal with the patient in these areas. Because the tip of the nose is very sensitive, a support member may not be positioned at the tip of the nose region 352. The support member 381 may extend at least partially into the upper lip region 350.

[0097] The support member 381 may be co-molded with the sealing portion 210 and may include malleable wire or other rigid elements. The support member 381 may include an integrally molded thickened area to provide support.

[0098] Figure 33-2 Another optional support member 381 is illustrated, which does not include the external nasal opening region to allow the membrane 348 to bend in these regions. The support member 381 also extends to the nasal tip region 352 to anchor the seal in place relative to the patient's nostril. The support member 381 may also extend at least partially into the upper lip region 350 and the nasal corner region 382.

[0099] The support member can be molded together with the membrane or attached separately to the membrane. The support member can be made of a material harder than membrane 384. For example, the membrane can be approximately Shore A hardness and the support member can be approximately Shore A hardness. However, other suitable hardnesses are also possible.

[0100] like Figure 34-1 and Figure 34-2As shown, the sealing area may include a material that supports the membrane 348 while providing comfort to sensitive facial areas. For example, a retaining portion 386 may be provided at the corners and tip of the nose. The retaining portion should be rigid enough to maintain the shape of the sealing portion and support the membrane 348 attached to or adjacent to the sealing portion, while providing sufficient flexibility for comfort during use. The retaining area 386 may be made of gel, foam, TPE, silicone, or any other suitable material.

[0101] 3.1.17 Flexible membrane portion Figure 35-1 The diagram shows... Figure 34-1 and Figure 34-2 An optional configuration in which the flexible or cushioning region is located in the upper lip region 350. For example... Figure 35-2 and 35-3 As shown, this flexible or softened area has a lower indicated hardness or less than other areas of the seal (e.g., the nasal tip area 352). Furthermore, the remaining areas of the seal have two layers: a top layer L1 with a lower indicated hardness or less (i.e., the layer in contact with the patient's face); and a bottom layer L2 with a higher indicated hardness or less. The material with the lower indicated hardness can have higher adhesion or tack than the harder bottom layer, thus providing a frictional fit with the patient's face.

[0102] 3.1.18 Membrane support A bracket or protrusion 390 positioned below the outer wing (external nostril joining wing) of the sealing part 210 can be used. Figure 36 The support 390 can be attached to or positioned at the headband connector 376. The support 390 prevents the outer wings 388 of the seal 210 from collapsing away from the patient's face, thereby achieving a more effective seal by maintaining the seal 210 in a sealed position on the patient's face.

[0103] 3.1.20 Diffusion ventilation like Figure 37-1 and Figure 37-2 As shown, the sealing part 210 can be secured in place on the patient's head at an appropriate position using one or more headband straps 390. The sealing part 210 can also be connected to a tube 20 for delivering breathable gas to the patient. The tube 20 can be connected to the sealing part 210 via a ventilation ring 392. Figure 37-2As shown, the ventilation ring 392 includes a tube connector 398 at one end adapted to attach a tube 20, and has a platform or flange 396 to prevent the tube 20 from being positioned on one or more gaswash outvents 394. At its other end, the ventilation ring 392 includes a sealing connector 395 adapted to attach to a seal. The connector 395 provides one or more gaswash outvents 394 aligned with vents or vent tracks along the end of the seal, allowing exhaled gas to escape from the seal 210 through the gaswash outvents to the atmosphere. The gaswash outvents or channels advantageously direct air away from the patient's face. The gaswash outvents or channels also disperse the air surrounding the ventilation ring 392, thereby diffusing exhaled gas and thus preventing a jetting sensation.

[0104] 3.1.21 Handle Support Figure 39 The illustration shows a sealing portion 210 with a handle 404 for allowing breathable gas to flow through a mask to a patient. The handle 404, attached to the tube connector 406, may include one or more ribs 402 or other support mechanisms to support the handle 404 and prevent it from collapsing during use and obstructing the gas flow. The ribs may be thickened areas or separate attachable or embeddable supports to keep the handle 404 in the open position. The ribs 402 may also support the sealing portion 210 so that the seal is held in the open position to prevent obstruction of the passage for delivering breathable gas to the patient.

[0105] 3.1.22 Supported sealing part The sealing portion 210 can be supported by the support portion. The sealing portion can be completely separated from the support portion by a gap, or one or more portions of the sealing portion can contact the support portion, while other portions of the sealing portion can be separated from the support portion by one or more gaps. When such gaps are used, the corresponding portions of the sealing portion 210 can be stretched to conform to the patient's face.

[0106] 3.1.22.1 Separated sealing parts Figure 40 The illustration shows a sealing portion 210 separated from a support portion 409 by spaces or gaps 408(1), 408(2), which allows the sealing portion 210 to bend downwards until it contacts the support portion 409. The support portion 409 prevents the sealing portion 210 from losing its shape or collapsing and thus helps maintain a seal with the patient. The patient contact portion 407 preferably has a lower rigidity than the support portion 409 and may be thinner than the support portion 409. The patient contact portion 407 and the support portion 409 may be formed by multiple molding, gluing, or other suitable methods.

[0107] The upper lip 350 of the sealing portion 210 may have a gap 408(1) between the patient contact portion 407 and the support portion 409 to allow for different anthropometric dimensions of the patient's upper lip. This also allows the patient contact portion 407 to be flexible near the patient's nasal septum (which is a highly sensitive area). The nasal tip region 352 of the sealing portion 210 may also have a gap 408(2) between the patient contact portion 407 and the support portion 409 to allow for different anthropometric dimensions of the patient's nasal tip. The flexibility also allows the patient contact layer 407 to bend around the nasal tip and thus enhances the sealing capability of the sealing portion 210.

[0108] 3.1.22.2 Partially Separated Sealing Section Figure 47-1 A view of a seal 450 supported or positioned by a support 453 is shown. The seal 450 is separated from the support 453 by a front gap at the region of the nose joint 452 between the front anchor points 469, and the seal 450 is connected to the support on each side outside the front anchor points 469.

[0109] Although the nasal tip junction 452 is flexible and can extend downwards upon contact with the patient's nose, its extension distance is limited upon reaching the support portion 453. The length of the nasal tip junction extends from the opening 455 to accommodate nasal tips of different sizes, allowing different patients' nasal tips to engage with the nasal tip junction at different locations. The handle 454 supports the sealing portion 450 and the support portion 453. The handle 454 is also adapted to house an air delivery tube for supplying pressurized breathable gas to the patient.

[0110] The sealing portion 450, handle 454, and support portion 453 can be made of liquid silicone rubber or other materials, such as TPE, gel, or foam. The sealing portion 450 can be formed of a material having different properties than the materials forming the support portion 453 and handle 454. The handle 454 and support portion 453 can be formed together, for example, in a single mold, and the sealing portion 450 can be formed separately and subsequently bonded to the support portion 453, for example, by gluing. Alternatively, the handle 454 and support portion 453 can be formed together, for example, in a single mold, and the sealing portion 450 can then be bonded to the support portion 453 and handle 454 in the mold.

[0111] The sealing portion 450 may have different characteristics from the support portion 453 and the handle 454. For example, the sealing portion 450 may be formed of different (or the same) materials having different geometries and different hardnesses than the support portion 453 and the handle 454.

[0112] Because both the support portion 453 and the handle 454 support the sealing portion 450 and provide a reaction force to secure the sealing portion 450 in the proper position on the patient's face, the support portion 453 and the handle 454 have a higher hardness than the sealing portion 450 (which, as described above, can have an indicated hardness of approximately 5 Shore A). For example, the support portion 453 and the handle 454 have a hardness of approximately 20 to 80 Shore A. Preferably, the support portion 453 and the handle 454 have a hardness of approximately 30 to 65 Shore A. Most preferably, the support portion 453 and the handle 454 have a hardness of approximately 40 Shore A.

[0113] The hardness of the sealing portion 450, the support portion 453, and the handle 454 may differ from the aforementioned hardness grades. However, if so, it may be necessary to change the thickness of the material to ensure a seal with the patient. For example, the nasal tip engagement portion 452 of the sealing portion 450 may have a thickness of 1.2 mm and a hardness expressed as approximately 5 to 20 Shore A (preferably approximately 5-10 Shore A, most preferably approximately 5 Shore A). However, if a harder material is used for the sealing portion 450, the nasal tip engagement portion 452 should have a thickness reduced to, for example, 0.3 mm, in order to apply the same stiffness or reaction force to the patient's face to provide an effective seal.

[0114] Figure 47-2 Another view of the sealing portion 450 is illustrated. The sealing portion 450 is separated from the support portion 453 by a rear gap in the region of the upper lip engagement 462 between the rear anchor points 475, and the sealing portion 450 is connected to the support portion 453 on each side outside the rear anchor points 475. Although the upper lip engagement 462 is flexible and can extend downward upon contact with the patient's upper lip, the distance it can extend is limited when it reaches the support portion 453.

[0115] Figure 49 (and Figure 48-2 The illustration shows a front view of the sealing portion 450. The nasal tip joint 452 is formed as a suspended, flexible membrane. Each side of the sealing portion 450 is connected or joined to the support portion 453; however, an anterior gap exists between the anterior anchoring points 469, at the center of the sealing portion 450, and the support portion 453. By using this suspended, flexible membrane, the nasal tip joint 452 provides a flexible surface that maintains stretchable contact with the nose during patient interface movement and better adapts to different nasal geometries. The use of a wide nasal tip joint 452 provides a comfortable and effective seal for noses of different sizes, allowing the nasal tip to be positioned at various locations between the orifice 455 and the anterior edge of the nasal tip joint 452. The nasal tip joint 452 can be stretched downward toward the support portion according to the size of the patient's nose.

[0116] The sealing portion 450 includes two thickened corner regions 467 positioned on each side of the upper lip engagement 462. The thickened corner regions 467 are adapted to seal against the patient's face in the area adjacent to the nasolabial fold of the patient's nose during use. The two thickened corner regions 467 protrude outwards to provide an effective seal in this area. Each of the two thickened corner regions 467 may have a radius of curvature between approximately 2.4 mm and approximately 6 mm. The radius of curvature of the upper lip engagement may be approximately 5 mm.

[0117] The width d5 ​​of the sealing portion 450 can be approximately 48 mm to accommodate noses up to approximately 45 mm wide. A larger width d5, such as 60 mm, can be used to accommodate noses up to approximately 60 mm wide. The distance d6 between the nasal tip engagement portion 452 and the support portion 453 can be approximately 5 mm to 20 mm, preferably approximately 5 mm to 15 mm, and most preferably approximately 10 mm. While this distance d6 provides an effective seal between the patient interface 451 and patients with nasal alar angles up to approximately 135°, it can also accommodate patients with nasal alar angles up to approximately 200°. The distance d7 can be approximately 38 mm, which is the width of the nasal tip engagement portion (i.e., the distance (width) of the portion of the sealing portion 450 not engaged with the support portion 453), however, for larger noses, it can be other values, such as 48 mm, or up to approximately 60 mm.

[0118] The radius of curvature of the nasal tip junction 452 can be approximately 30 mm to 45 mm, preferably approximately 30 mm to 40 mm, and most preferably approximately 35 mm. However, to accommodate a flatter nose, it can be approximately 35 mm to 50 mm, preferably approximately 40 mm to 50 mm, and most preferably approximately 40 mm. At the protruding edge 476 in Figure 48, a contact radius of at least 1 mm can be used to assist in machining, wherein the protruding edge 476 can be clamped in a tool while forming the sealing portion. The distance (height) d3 of the nasal tip junction is approximately 10 mm to 30 mm, preferably approximately 12 mm to 18 mm, and most preferably approximately 17 mm. The distance d4 of the nose length region is approximately 20 mm to 40 mm, preferably approximately 25 mm to 35 mm, and most preferably approximately 27 mm, covering a nose length of approximately 12 mm to approximately 25 mm. For wider / flatter noses (width greater than 40 mm and length less than 15 mm), the distance d4 can be reduced to approximately 17 mm.

[0119] Figure 48-2A schematic top view of the sealing portion 450 is illustrated. The sealing portion 450 includes an orifice 455, a forward stretching portion 564, a backward stretching portion 562, a lateral pushing or pressing portion 566, and a lateral wrapping or lateral suspension portion 568. The forward stretching portion 564 and the backward stretching portion 562 are flexible portions of the sealing portion, capable of stretching or flexing when these flexible portions come into contact with the patient's nasal tip and upper lip. In these areas, the sealing portion 450 is a thin film that is in a taut state and thus hugs or conforms to the geometry of the patient's nasal tip and upper lip. Preferably, the corresponding forward stretching and backward stretching portions are fixed at their respective ends, while their middle portions are unsupported. Because the upper lip and nasal tip can be sensitive, flexibility minimizes the force required to make a predetermined displacement on the upper lip and nasal tip.

[0120] The side wrap or side suspension 568 is adapted to provide a generally horizontal or lateral force that is generally normal to the plane of the flared portion of the patient's nose. When the flared portion of the patient's nose is filled with pressurized air, it is propelled outward due to air pressure. The side wrap or side suspension 458 provides a reaction force against this outward force on the flared portion, ensuring a good seal in this area. (Compared to tension portions 562, 564) the side wrap or side suspension 568 may need to be reinforced or made more rigid to ensure that the reaction force is sufficient to maintain the seal and prevent bursting or damage to the seal. Reinforcement can be provided by the additional thickness of the sealing portion 450 in these side wraps, for example, by using a more rigid material, or by additional structures (e.g., headband attachments or ribs below the side wrap or side suspension 568).

[0121] The lateral push or lateral pressure portion 566 is adapted to anchor or support the sealing portion 450 in place. In use, the portion 566 can be substantially compressed. The force provided from the lateral push portion 566 can be normal to the plane of the patient's face, generally in a horizontal direction. Because this area of ​​the sealing interface on the patient's face is hyposensitive, tension from the headband is substantially transmitted to the lateral push portion 566. Preferably, this is the most rigid area of ​​the sealing portion 450. The lateral push portion 566 can have a greater thickness than the front stretch portion 562 or the rear stretch portion 564.

[0122] The sealing part 450 has varying stiffness in different sections, namely, the front tension section relative to the rear tension section relative to the side push section relative to the side wrapping section. The stiffness of these sections can be changed by altering the material, the material hardness, the material thickness, or by using a support section.

[0123] Figure 50The illustration shows a rear view of the patient interface 451. A sealing portion 450 is connected to a support portion 453 on both sides of the patient interface 451, and the sealing portion 450 includes an upper lip engagement portion 462 that engages with the patient's upper lip during use. The upper lip engagement portion 462 is formed as a suspended, flexible membrane, with a rear gap formed between the upper lip engagement portion 462 of the sealing portion 450 and the support portion 453. The rear gap is positioned between rear anchoring points 475 that anchor the sealing portion 450 to the support portion 453. The flexible, suspended membrane provides a flexible surface that maintains stretchable contact with the patient's upper lip during movement of the patient interface, and the membrane is stretchable to adapt to different facial geometries by allowing movement of the upper lip engagement portion 462.

[0124] The thickness d8 of the thickened corner region 467 of the sealing portion 450 can be approximately 1 mm to 5 mm, preferably approximately 2 mm to 4 mm, and most preferably approximately 3.5 mm, and has a relatively low Shore A hardness for comfort. The thickness d8 can be increased to approximately 5 mm to 10 mm, preferably 5 mm to 8 mm, and most preferably approximately 5 mm, depending on the thickness of the support portion 453 located below, and can be reduced to the same thickness as the upper lip engagement portion 462, approximately 0.25 mm to 3 mm, preferably less than 2 mm, and most preferably 1.2 mm.

[0125] When not in use, the distance d9 between the support portion 453 and the unbonded area of ​​the sealing portion 450 located at the upper lip joint 462 can be approximately 1 mm to 15 mm, preferably approximately 5 mm to 10 mm, and most preferably approximately 7 mm, and when in use, it can vary between 0 mm and 15 mm, preferably up to 7 mm, depending on the contact sealing force in the patient's philtrum. The distance d10 between the upper edge of the support portion 453 and the sealing portion 450 can be approximately 10 mm to 30 mm, preferably approximately 15 mm to 20 mm, and most preferably approximately 18 mm. The width of the upper lip joint 462 (and the distance (width) d11 between the unbonded portion of the sealing portion 450) can be approximately 10 mm to 30 mm, preferably approximately 15 mm to 25 mm, and most preferably approximately 20 mm; however, this value can vary between approximately 14 mm and approximately 22 mm depending on the width of the nose. When not in use, the radius of curvature at the center of the upper lip junction 462 can be approximately 5 mm to 20 mm, preferably approximately 10 mm to 15 mm, and most preferably approximately 12.5 mm, but decreases when in use as the patient interface 451 flexes inward.

[0126] Therefore, the sealing portion 450 is connected to the support portion 453 on both sides, but is separated from the support portion 453 by a certain gap between the front and rear anchor points 469 and 475. These gaps allow the sealing portion 450 to bend at the tip of the patient's nose and upper lip during use to provide good fit and comfort for the patient.

[0127] Figure 51-1 The illustration shows a cross-sectional side view of the patient interface 451. The front unbonded area 460 of the seal 450 may have a radius of curvature of approximately 8 mm to 15 mm, preferably approximately 10 mm to 13 mm, and most preferably approximately 12.5 mm. The rear corner 464 of the seal 450 may have a radius of curvature of approximately 1 mm to 7 mm, preferably approximately 3 mm to 6 mm, and most preferably approximately 4 mm. The rear unbonded area 463 of the seal 450 may have a radius of curvature of approximately 2 mm to 8 mm, preferably approximately 3 mm to 6 mm, and most preferably approximately 5 mm; however, this value can vary to an almost flat shape at the outer edge.

[0128] The seal 450 may include: an outer sealing edge 534 located above the dotted line for sealing with the patient's face; and a transition region 536 located between the opening 455 and the outer sealing edge, the size of which gradually increases from the opening to the outer sealing edge 534. The opening 455 defines an inner surface in communication with breathable gas, and the outer sealing edge 534 is formed as a continuous extension of the inner surface. The outer edge of the seal 450 is oriented away from the opening 455 and / or away from the direction of breathable gas flow. As seen in its top view, the outer sealing edge 534 is generally convex.

[0129] Figure 51-2 The illustration shows a cross-sectional side view of the patient interface 451. This embodiment includes an intermediate portion 450.1 disposed between the sealing portion 450 and the support portion 450. The intermediate portion 450.1 can be formed as a suspended membrane. The intermediate portion 450.1 can be formed together with the sealing portion 450, together with the support portion 453, or independently of the sealing portion 450 and the support portion 453. The intermediate portion 450.1 can provide support for the sealing portion 450. For example... Figure 51-2 As shown, the entire intermediate portion 450.1 can be separated from the sealing portion 450 by a gap, or a portion of the intermediate portion 450.1 can contact the sealing portion 450 while other portions of the intermediate portion 450.1 can be separated from the sealing portion 450 by a gap.

[0130] Figure 52-1The diagram illustrates a support membrane 465, which may include a support portion 453 and a handle 454. The support portion 453 and the handle 454 may be formed as a single integral element. The support membrane 465 may have a total wall section 466, a front thickened portion 468, and a rear thickened portion 470. The front thickened portion 468 and the rear thickened portion 470 are formed on each side of the support portion 453. The front thickened portion 468 and the rear thickened portion 470 provide different degrees of support to the seal portion 450 after assembly. The support membrane 465 may be made of silicone resin having a hardness of approximately 20 to 90 Shore A, preferably approximately 20 to 60 Shore A, and most preferably approximately 40 Shore A. The support membrane 465 may also be made of polycarbonate, polypropylene, nylon, thermoplastic elastomer (TPE), or hytrel. TM Made from, etc.

[0131] like Figure 47-2 As seen, the front thickened portion 468 is positioned adjacent to the areas of the sealing portion that contact the patient's nose on each side during use, and the front thickened portion 468 converts the load of the headband into clamping forces on each side of the patient's nose to provide an effective seal. The front thickened portion 468 may have a thickness that increases from top to bottom and has a height of approximately 5 mm to 20 mm, preferably approximately 7 mm to 14 mm, and most preferably approximately 11 mm.

[0132] The thickened portion 470 may include a lower portion 471 having a first thickness and an upper portion 473 having a second thickness greater than the first thickness. The height d13 of the upper portion 473 may be approximately 7 mm to 20 mm, preferably approximately 8 mm to 12 mm, most preferably approximately 9.5 mm, however, it can be reduced to approximately 4 mm to reduce load. The thickened portion 470 may have an arcuate portion 472, which may have a radius of curvature of approximately 0.5 mm to 3 mm, preferably approximately 2 mm, however, it can be increased to approximately 4 mm to increase stiffness relative to the patient's upper lip. The thickened portion 470 may include a hollow portion 477 to reduce the volume of silicone and shorten the curing time.

[0133] like Figure 47-3As seen, the rear thickening portion 470 is positioned directly below the thickened corner region 467 of the sealing portion 450. The rear thickening portion 470 transfers the load from the headband connector to the thickened corner region 467 and the lower corners of the patient's nose to assist in providing an effective seal, and increases the load transfer to the lower corners of the patient's nose when the headband is tightened. In use, the bending force from the headband connector 456 is transferred through the rear thickening portion 470 to the thickened corner region 467 of the sealing portion 450 to apply a sealing force as an anchoring force to the area of ​​the patient's nose adjacent to the nasolabial folds. The force transfer from the headband connector 456 to the rear thickening portion 470 can be achieved by the bending force caused by the reinforced headband connector arm when bent, and / or by the actual contact between the headband connector 456 and the rear thickening portion 470.

[0134] Compared to the total wall segment 466, the lateral upper lip portion 474 may also be thickened and have a width d14 varying between 3.5 mm and 1.2 mm to vary the total amount of resistance relative to the patient's upper lip.

[0135] Figure 52-2 The illustration shows a cross-sectional view of the support membrane 465 and the sealing portion 450. The cross-sectional view shows how the support portion 453 supports the sealing portion 450 on each side of the sealing portion and contacts the sealing portion 450.

[0136] Figure 52-3 Another cross-sectional view of the support membrane 465 and the sealing portion 450 is shown. The cross-section shows the thickness difference between the lower portion 471 and the upper portion 473 of the rear thickened portion 470, and also shows the hollow portion 477.

[0137] Figure 52-4 The illustration shows a cross-sectional view of the support membrane 465 and the sealing portion 450 when the sealing portion 450 is connected and sealed to the patient. The nasal tip joint 452 engages and seals with the patient's nasal tip. When the nasal tip joint 452 and the upper lip joint 462 are fitted to the patient's nasal tip and upper lip, the nasal tip joint 452 and the upper lip joint 462 are stretched toward the support portion 453.

[0138] Figure 52-5 The illustration shows a side view of the support membrane 465 and the sealing portion 450 when the sealing portion 450 is connected and sealed to the patient. The sides of the sealing portion 450 and the support portion 453 clamp and seal the sides of the patient's nose. The thickened corner region 467 seals the patient's nose in the area adjacent to the nasolabial folds. A rear thickening portion 470 is positioned adjacent to and below the thickened corner region 467 to provide additional sealing force.

[0139] Figure 52-6The illustration shows another cross-sectional view of the support membrane 465 and the sealing portion 450 when the sealing portion 450 is connected and sealed to the patient. Each side of the sealing portion 450 seals to each side of the patient's nose and is supported in this area by the support portion 453, the front thickening portion 468, and the rear thickening portion 470.

[0140] Figure 52-7 The illustration shows a front view of the support membrane 465 and the sealing portion 450 when the sealing portion 450 is connected and sealed to the patient. The nasal tip joint 452 engages and seals with the patient's nose and stretches toward the support portion 453. Anterior anchoring points anchor the sealing portion 450 to the support portion 453 on both sides of the nasal tip joint 452. Each side of the sealing portion 450 engages and seals with each side of the patient's nose.

[0141] Figure 53 The diagram illustrates a front view of the support membrane 465. The distance d15 between the front thickened portions 468 can be approximately 25 mm to 45 mm, preferably approximately 35 mm to 42 mm, and most preferably approximately 40 mm. The distance d15 can be varied to change the contact stiffness between the headband and the sidewalls of the membrane, thereby increasing the clamping load on each side of the patient's nose. The distance 16 between the rear thickened portions 470 can be approximately 35 mm to 55 mm, preferably approximately 40 mm to 50 mm, and most preferably approximately 46 mm. The variation in d16 changes the point of contact between the headband and the rear thickened portions 470 to increase or decrease the load.

[0142] Figure 54 The illustration shows a front view of a support membrane 465 having a headband connector 456. The headband connector 456 can be formed as a single integral element molded together with the support membrane 465, or it can be formed separately and attached to the support membrane 465. The headband connector 456 may include a headband protrusion 458 for connecting a headband. The distance d21 from the bottom of the headband connector 456 to the top of the support membrane can be approximately 10 mm to 25 mm, preferably approximately 12 mm to 20 mm, and most preferably approximately 17 mm. The distance d20 between the outer ends of the headband connector can be approximately 60 mm to 100 mm, preferably approximately 70 mm to 90 mm, and most preferably approximately 80 mm. The headband connector 456 can be angled upwards at an angle α1, which can be approximately 2° to 15°, preferably approximately 5° to 8°, and most preferably approximately 6.5°. The larger the angle α1, the smaller the torque of the clamping force applied by the patient interface.

[0143] like Figure 55As shown, a headband connector 456 is positioned towards the bottom of the sealing portion 450 to generate torque forces at each sidewall. When a headband force is applied by tightening the headband strap, a load is placed at the headband connector 456 and the protrusion 458, which promotes inward forces at each side of the sealing portion, thereby providing a seal force for each side of the patient's nose. When the headband strap is tightened, the clamping load torque applied to the sealing portion 450 can cause the sealing portion 450 to shift inward, reducing the width of the sealing portion by almost half from its initial width before the headband strap is in place. In use, the bending force from the headband connector 456 is transmitted to the sealing portion 450 as clamping forces on each side of the patient's nose via the support portion 453.

[0144] The stiffness of the sidewalls of the support membrane 465, the stiffness of the headband connector 456, and the connection point of the headband connector 456 all affect the total clamping force transmitted to the seal 450. The headband connector 456 may have a thickness of approximately 2.5 mm to 4.0 mm, while the sidewalls of the support membrane 465 may have a thickness of approximately 1.2 mm to 5.0 mm, and both are made of silicone resin with a hardness of approximately 40 Shore A to 65 Shore A. The sidewalls of the headband connector 456 and the support membrane 465 are not necessarily of constant thickness; however, the thickness may vary along their length and width, or they may have locally thickened areas to control the stiffness in specific areas. Furthermore, additional silicone resin may be present at the connection point between the headband connector 456 and the support membrane 465. Optionally, the headband connector may be made of a material harder than silicone resin, such as nylon, polycarbonate, polypropylene, or other suitable materials. This facilitates the connection between the headband and the headband connector.

[0145] Figure 55The illustration shows a top view of a support membrane 465 with a headband connector 456. The support portion 453 may include a recessed area 478 formed in the upper surface of the support portion 453, thereby reducing the stiffness of the support portion 453 by using a low-stiffness filler material to fill this recess, the filler material having a lower stiffness than the support portion. This recess may be approximately 8 mm by 9 mm inward from the uppermost surface of the support portion 453; however, other sizes of recesses can still be used. The reduced stiffness of the support portion 453 allows for a smaller clamping force applied to the patient's nose (compared to a support portion with higher stiffness), which provides a more comfortable seal. The distance d17 between the center point of the channel 479 and the center of the headband connector 456 can be adjusted to bias the front-to-back load at the patient interface, and d17 may be approximately 2.7 mm; however, values ​​between 0 mm and 4.0 mm can still be used. The headband sweep angle α2 can be changed, and increasing α2 biases the load toward the rear of the patient interface (upper lip area). The headband sweep angle α2 can be approximately 6.6°, however, values ​​between 0° and 10° can still be used.

[0146] Figure 56-1 The illustration shows a side view of the support membrane 465 with headband connector 456. The distance d18 between the top of the headband protrusion 458 and the rear corner load point formed by the rear thickening 470 can be approximately 1 mm to 5 mm, preferably approximately 1 mm to 3 mm, and most preferably approximately 2 mm, to allow for a certain amount of movement before the headband protrusion 458 contacts the patient interface. This helps prevent the seal from closing when the patient initially attaches the seal. The angle α3 can be 90°, which can vary in increments of + / - 5°. If the headband connector 456 is not formed into the support membrane 465, this angle can vary in increments of + / - 10°, and the varying α3 offsets the angle at which the patient interface is located below the patient's nose (nasolabial angle).

[0147] Figure 56-2 and 56-3 The diagrams show the diagrams respectively. Figure 56-1 And a cross-sectional side view of the support membrane 465 shown in Figure 52. The handle 454 can be adapted to connect to a ring for connecting an air tube. The ring may have a socket-type fitting for a ball joint and / or involve ventilation. The diameter at the base of the handle 454 should be sufficient to allow for flow generator compatibility in air paths with flow restrictions, and may have a diameter from 8 mm to 25 mm, preferably less than 20 mm and preferably about 15 mm. However, different diameters, such as 12 mm, can be used.

[0148] The handle 454 may include a thin-walled portion 481, which may have a height d19 of 5.5 mm, however d19 may vary, for example, between 2 mm and 10 mm. The thin-walled portion 481 allows the isolation area of ​​the handle 454 to buckle due to dragging of the tube to which it is connected. The thin-walled portion may have a wall thickness of approximately 0.3 mm to 1.0 mm, depending on buckling and strength requirements. The handle 454 may include reinforcing ribs (located internally or externally) arranged radially or circumferentially, or other reinforcing elements.

[0149] 3.1.23 Sealing with the patient like Figures 44 to 46 As shown, sealing portion 210 provides an effective seal with the patient's nose 324. The nasal flare portion 384 of sealing portion 210 provides a seal with the patient's nasal flare portion 385. Nasal tip portion 352 provides a seal with the patient's nasal tip 353. Upper lip portion 350 provides a seal with the patient's upper lip 351. The nasal flare portion 384, nasal tip 352, and upper lip 350 all contribute to providing an effective and comfortable seal with the patient and help position the orifice 336 adjacent to the patient's nostrils.

[0150] 3.2 Buffer System For example in Figures 1-1 to 1-18 In this context, the sealing portion 210 is attached to or otherwise suitably disposed to the cushioning system 215. The attachment may be permanent (e.g., including but not limited to: single-piece molding, e.g.) Figures 1-2 to 1-8 (as seen in the image), co-molding, insert molding, gluing, or any other suitable method. Optionally, the attachment can use removable components (e.g., including but not limited to: clips, Velcto). TM (Tongue and groove, or any other suitable component). In one embodiment, the attachment of the sealing part 210 to the buffer system 215 can be achieved along the periphery of the orifice 211 on the sealing part 210 and the orifice 216 on the buffer system 215.

[0151] A cushioning system 215 may be provided to the face mask 200 to isolate or absorb forces from the seal 210 and the remaining components of the patient interface 100 (e.g., the air delivery tube 20). The cushioning system 215 may be formed of a generally flexible material, such as silicone, foam, gel, or any other suitable material.

[0152] 3.2.1 Shape like Figure 1-8 and 1-14 As shown, the buffer system 215 may have a generally wedge-shaped or triangular cross-section. In use, this shape can help orient the seal relative to the patient's nose.

[0153] like Figure 1-12and Figure 1-1 As shown in Figure 3, the surface adjacent to the orifice 216 of the buffer system 215 can be generally U-shaped or V-shaped. Such a surface can be defined at an angle θ between approximately 90° and 180°, for example, approximately 110° to 160°. Alternatively, the buffer system 215 can be relatively flat.

[0154] In one embodiment, buffer system 215 may approximate the gusset plate disclosed in U.S. Patent Application Publication No. 2009 / 0044808, published February 19, 2009, the entire contents of which are incorporated herein by reference. In another embodiment, buffer system 215 may approximate the isolation element disclosed in PCT Application No. PCT / AU2009 / 000240, filed February 27, 2009, the entire contents of which are incorporated herein by reference.

[0155] 3.2.2 Connection with the frame exist Figures 1-1 to 1-18 In the illustrated embodiment, the cushioning system 215 includes a connecting ring 217 for hermetically attaching the cushioning system 215 to the frame 220. The connecting ring 217 may engage with a channel 227 disposed along the periphery of the frame to form a static fit. The static fit may be achieved by tongue and groove, snap-fit, or any other suitable means. In another embodiment, the connecting ring 217 may be adapted to attach to a bend 230 and / or an air delivery duct 20. For example, the bend 230 may be statically fitted within, around, or immediately adjacent to the connecting ring 217 to seal the connection between the bend 230 or the air delivery duct 20 and the cushioning system 215.

[0156] Connecting ring 217 defines orifice 218 to allow breathable gas to flow from frame 220 to buffer system 215. Orifice 216 allows breathable gas to flow from buffer system 215 to seal 210.

[0157] 3.2.3 Foam or gel cushioning system The cushioning system 215 may be made of alternative materials to silicone, which may provide better flexibility, resilience, flexurality, comfort, and / or consumer appeal.

[0158] For example, the cushioning system can be made of foam. The foam acts as a spring to support the seal 210 and propels it toward the patient's nostrils during use. The softness of the foam also allows for adjustment of the seal. Figure 3-1Views 3-6 show various views of a foam cushioning system 215 used between a seal 210 and a frame 220. The foam can be open-cell, closed-cell, or a combination of both. The foam can be skinned or unskinned. The foam can be from 1 mm to 50 mm thick, for example, 30 mm thick.

[0159] In one alternative embodiment, the cushioning system may be composed of a gel. The gel may be compliant, flexible, and comfortable. In one embodiment, a gel with multiple indicative stiffness may be used. Figure 8-1 A gel buffer system 215 according to one embodiment of the present technology is illustrated. As illustrated, the gel buffer system 215 is in the form of an encapsulated gel sleeve 278 disposed between a sealing portion 210 (e.g., silicone) and a base 279 (e.g., plastic). In one embodiment, the gel buffer system may alter the geometry of the sealing portion, for example, by buckling a thinner region of the sealing portion (e.g., a nasal tip junction). The gel may be silicone, polyurethane gel, or any other suitable gel. The gel may be the gel disclosed in PCT application No. PCT / AU2008 / 001711, filed November 17, 2008, the entire contents of which are incorporated herein by reference.

[0160] In one embodiment, the seal 210 may overhang the foam or gel cushioning system to reduce weight and enhance the flexibility along the edges of the seal 210 to accommodate a wider range of patient facial geometries. For example, Figure 8-2 and Figure 8-3 The illustration shows a seal 210 (e.g., silicone) that protrudes over the gel cushioning system 215. This protrusion allows the edges of the seal to "sink" or "clamp" depending on orientation to enhance the seal. As shown, the edges of the seal 210 may include teardrop-shaped gel pockets to facilitate sealing gaps and corners of the patient's face during use.

[0161] In yet another embodiment, the cushioning system can be made of thermoplastic elastomer (TPE).

[0162] 3.2.4 Sealing part with flexible tube In one alternative embodiment, the buffer system may be in the form of a flexible tube, which is provided (e.g., co-molded) or otherwise suitablely attached to the bottom of the seal.

[0163] like Figure 16-1 As shown, the flexible tube 280 can be corrugated so that the tube can move in any direction relative to the seal 210, for example, like a drinking straw, such as by compression, expansion, bending, etc.

[0164] like Figure 16-2As shown, the flexible tube 280 is provided with flexible helical ribs, which allow the tube to bend elastically relative to the sealing portion 210.

[0165] In each embodiment, the end of the tube in use can be directly connected to an air delivery tube.

[0166] In each embodiment, the flexible tube 280 may have a constant wall length. Alternatively, the flexible tube 280 may have a varying wall thickness to, for example, change the tensile, elongation, or flexural properties of the tube within a specific region.

[0167] In one embodiment, one or more vent elements may be disposed on the tube (e.g., molded into the tube, inserted, or attached to the tube as a separate insert), and / or one or more vent elements may be disposed on a swivel located at the end of the tube.

[0168] like Figure 26 As shown, the telescopic portion 354 and the hinge portion 356 can be disposed between the sealing portion 210 and the tube 20. In use, when the tube 20 rotates away from the patient's face, the telescopic portion 354 absorbs the movement of the tube 20. That is, when the sealing portion 210 is positioned, the tube 20 cannot bend towards the patient's face because the patient's jaw or other parts of the patient's face will prevent such movement. When the tube 20 bends away from the patient's face during use, the hinge portion 356 transmits the movement of the tube 20 to the telescopic portion 354 and thus prevents the sealing portion 210 from moving, maintaining a seal with the patient. The hinge portion 356 also prevents the telescopic portion 354 from extending, prevents the telescopic portion 354 from losing its structural integrity, and allows the telescopic portion to continuously absorb the movement of the tube 20. Figure 26 The positions of the nose tip 352 and upper lip 351 of the sealing part are also shown.

[0169] 3.2.5 Angle Bracing Plate In one embodiment, such as Figure 17-1 As shown, the buffer system can be in the form of a gusset plate or an isolation chamber 281, which is disposed to (e.g., co-molded) or otherwise suitable and attached to the bottom of the seal 210. In use, the gusset plate 281 can expand / compress / tilt to increase the range of adjustability.

[0170] The thickness of the sidewall of the gusset plate can be constant, for example, about 0.2 mm to 3 mm thick, preferably 0.2 mm to 1 mm thick, and most preferably 0.3 mm thick. Alternatively, the sidewall of the gusset plate can vary in various places; for example, some areas can be thicker than other areas to facilitate the connection between the air supply pipe and the gusset plate, or some areas can have a thinner thickness than other areas to improve flexibility in those areas.

[0171] In this embodiment, the bottom of the gusset plate can be directly connected to the air delivery pipe 20 during use.

[0172] In another embodiment, such as Figure 17-2 As shown, a headband connector 240 can be disposed to a seal 210 for attaching the headband. As illustrated, the headband connector can extend from a trampoline-type base 282, allowing the seal to bend, stretch, and / or wiggle relative to the headband connector, thus relieving pressure on the headband during use. This configuration, together with the gusset plate, enhances adjustability. Preferably, the headband connector 240 is positioned between the seal 210 and the flexible base 282 to isolate the seal 210 from tubular forces.

[0173] In addition, an additional elastic pad configuration 283 can be provided at the bottom of the gusset plate 281 to allow for additional adjustability of the air delivery pipe relative to the gusset plate.

[0174] 3.2.6 Management and isolation facilities The sealing part 210 may be provided with a spring part 413. Figure 41 This is to absorb or absorb the drag force of the tube. The spring portion 413 may have a width 416, which is smaller than the width 418 of the connecting portion 399 of the sealing portion (bracket) and the width 418 of the swivel connecting portion 414. As described in the above embodiment, the swivel connecting portion 414 may be connected to the swivel ring 415. Figure 41 A headband strap 390 is also shown, which is attached to the sealing part 210 to support the mask in the appropriate position on the patient's head.

[0175] 3.2.7 Diffusion ventilation with rotating ring The rotating ring 415 may include one or more gas flushing vents 422. The gas flushing vent 422 may be configured as one or more orifices, holes, notches, or scallops. Figure 42-1 and Figure 42-2 The illustration shows a rotating ring 415, in which one or more gas flushing vents 422 are cut from the inner wall connected to the bend wall 426 (shown in dashed lines) to form one or more ventilation openings or gas flushing vents 422 that allow exhaled gas to pass through and be discharged from the mask to the atmosphere. One or more ventilation openings or gas flushing vents 422 (three are shown) may be present, formed between the support walls 424. The bend wall 426 is connected to the inner wall 423 of the rotating ring 415 and the support walls 424. The support walls 424 prevent accidental separation of the bend.

[0176] Figure 42-3The illustration shows a swivel ring 415 connected to a seal 210 at a bracket flange 430 and to a bend at a bend flange 432. The swivel ring 415 is inserted into an orifice in the seal 210 and secured by a static fit with a flange located on either side of a sealing portion interference web 434. The sealing portion interference web 434 can be U-shaped, however other shapes may also be used. In one example, the swivel ring 415 may be of a similar construction to that shown in PCT / AU2008 / 001557 filed October 22, 2008, the entire contents of which are incorporated herein by reference.

[0177] Figure 42-4 The illustration shows an optional gas flushing vent 422, in which a row of small holes configured as gas flushing vents 422 are present within the rotating ring 415. The gas flushing vents 422 (e.g., 5 to 50, or about 15) can be about 0.5 mm to 1.0 mm in diameter, for example, 0.7 mm.

[0178] Figure 42-5 The illustration shows an optional gas flushing vent 422, in which a single vent is provided in the rotating ring 415 as the gas flushing vent 422. Figure 42-6 Another optional gas flushing vent 422 is illustrated, wherein there are multiple venting notches (e.g., more than 2, or about 5 to 20) in the rotating ring 415 that are configured as gas flushing vents 422.

[0179] Figure 42-7 The illustration shows an array of vent holes arranged around a rotating ring 415 as gas flushing vents 422. As shown, two rows of vent holes are configured as gas flushing vents 422, with the vent holes in each row offset or staggered from each other. The vent holes can be positioned or arranged in other ways.

[0180] Figure 42-8 The diagram shows... Figure 42-7 The diagram shows an example cross-section of a vent hole configured as a gas flushing vent 422. In this embodiment, the diameter of the vent hole varies from the inlet to the outlet; for example, the vent holes gradually taper along their length. The diameter D1 of the vent hole on the side of the rotating ring 415 facing the seal 210 is larger than the diameter D2 on the other side of the rotating ring 415. Diameters D1 and D2 can also be the same, or diameter D2 can be larger than diameter D1. The diameter of the vent hole can be approximately 0.5 mm to 1.0 mm. Preferably, the diameter of the vent hole can be approximately 0.7 mm.

[0181] In all the ventilation examples above, ventilation is directed downwards, thus away from the patient's face and along a bend in the tube or air delivery line. Ventilation port 422 is also positioned only on one half or a portion of the rotating ring 415 to prevent air from being directed towards the patient's chest during use.

[0182] 3.2.8 Vent direction like Figure 43 As shown, the direction of air discharged from the vent 395 can be adjusted by positioning the connection between the bend 397 and the seal 210 using the plenum 438. The plenum 438 can attach the seal 210 in an upward position for engagement with the patient's nose during use. In a position that avoids contact with the patient and directs air away from the patient, the plenum 438 can be attached to the bend 397 via a rotating ring 415. When tube drag force is applied, the plenum 397 can also absorb the tube drag force by twisting or compressing, rather than removing or dislodging the seal 210 from its sealed position.

[0183] 3.3 Framework Figures 1-9 to 1-14 A buffer system 215 connected to the frame 220 is shown (without a sealing portion 210 provided to the buffer system 215), and Figures 1-15 to 1-18 A cushioning system 215 (with a seal 210 disposed thereon) is shown attached to a frame 220. In the illustrated embodiment, the cushioning system 215 includes a connecting ring 217 adapted to press-fit into a channel 227 on the frame 220. Alternatively, the cushioning system 215 can be attached to the frame 220 by other removable components, such as clips, hooks, zipper locks, or any other suitable components. Furthermore, the cushioning system 215 can be permanently attached to the frame 220, including but not limited to insert molding, co-molding, gluing, etc.

[0184] The frame 220 may typically be more rigid than the cushioning system 215 and the seal 210 in order to support and secure the seal 210 and / or the cushioning system 215. The frame 220 may be made of (including but not limited to) silicone, TPE, polycarbonate, polypropylene, foam, gel, nylon, etc.

[0185] like Figure 1-10 As best shown, frame 220 may include aperture 226 adapted for connection to bend 230 or air delivery pipe 20. Frame 220 may be connected to bend 230 or air delivery pipe 20 via snap-fit, tongue and groove mechanisms, or any other removable or non-removable connection. Example connections are disclosed in U.S. Patent Publication No. US2009-0044808, the entire contents of which are incorporated herein by reference.

[0186] 3.3.1 Headband attachments In the illustrated embodiment, as Figure 1-1 As shown in Figures 1-9 to 1-18, frame 220 includes a headband attachment or connector 240 for removably attaching headband 150 and / or headband stiffener 160 to face mask 200. Headband attachment 240 may be made of, for example (including but not limited to), silicone, TPE, polycarbonate, or any other suitable material. The headband attachment may be molded together with frame 200. Optionally, the headband attachment may be disposed at cushioning system 215 and / or sealing portion 210 as described below. Optionally, the headband attachment may be attached to any portion of face mask 200 by, for example (including but not limited to), gluing, push-clip, hook-and-loop engagement, etc.

[0187] like Figures 61 to 64 and Figure 67 As shown, the patient interface 459 can be secured to the patient via a headband 484. In use, the headband 484 can extend from the headband connector 456 between the patient's eyes and ears on each side of the patient's head and connect at the top of the patient's head. The adjustable connector 500 allows the headband to be adjusted to fit the patient. The headband 484 may include a back-of-the-head section 485 that wraps around the back of the patient's head.

[0188] In one embodiment, headband attachments may include those disclosed in U.S. Patent Application Publication No. 2009 / 0044808, published February 19, 2009, the entire contents of which are incorporated herein by reference.

[0189] 3.3.1.1 Orientation In the illustrated embodiment, as Figure 1-12 As shown, for example as β, the headband connector 240 extends approximately perpendicular to the longitudinal axis of the frame 220. Figure 1-1 As shown, the hardened member 160 is rotatably coupled to a corresponding headband connector (as described in U.S. Patent Application Publication No. 2009 / 0044808, which is incorporated herein by reference) to allow adjustment to fit the nasolabial angle of most patients. Furthermore, this configuration allows adjustment of the cushioning system to move it away from the tip of the patient's nose.

[0190] 3.3.1.2 Optional Positioning In an alternative embodiment, the headband connector can be positioned closer to the seal to improve seal stability, as this eliminates or shortens the length of the torque arm. For example, Figure 10 The diagram shows a headband connector 240 that is directly attached to the sealing part 210.

[0191] In another embodiment, the headband connector can be positioned such that the headband strap / hardening member extends below the external nasal cannula engagement wing 214. For example, as Figure 11 As shown, the headband connector 240 can be disposed to the cushioning system 215. In use, the headband strap 190 / hardener 160 can be positioned below the external nasal cannula engaging wing 214, this strap / hardener acting as a stop to prevent further deformation and / or upward thrust of the wing during use. In use, the strap / hardener is positioned to engage a specific area of ​​the wing and allow the remainder of the seal to bend or conform. As shown, a bracket 284 can be positioned below the wing to engage the strap / hardener.

[0192] exist Figure 47-3 In another embodiment shown, the patient interface 459 includes a headband connector 456. The headband connector 456 may include a protrusion 458. The protrusion 458 may provide a connection point for attaching a headband. The headband connector 456 may be formed together with a handle 454. Optionally, the headband connector 456 may be rotatably attached to the handle 454 and / or the support 453. For example, the headband connector 456 may clamp, wrap around, or otherwise suitably attach to the handle 454.

[0193] The headband connector 456 may have a hardness of approximately 20 to 80 Shore A, preferably approximately 20 to 60 Shore A, and most preferably approximately 40 Shore A. The geometry of the support portion 453 can be adjusted to be molded together with the headband connector 456.

[0194] The position of the headband protrusions 458 relative to the sealing portion 450 is crucial. If the headband protrusions 458 are too low (i.e., further away from the sealing portion 450), they cannot provide sufficient stability. The greater the distance between the sealing portion 450 and the headband protrusions 458, the longer the lever arm, and therefore the greater the tendency of the sealing portion 450 to move. If the headband protrusions 458 are too close to the top of the sealing portion 450, the sealing portion 450 will hinge inward beyond what is required for a seal, increasing the force on the patient's nose. This could also lead to the possibility of nasal obstruction. Accordingly, the headband protrusions 458 should be 1 mm to 10 mm from the sealing portion. Preferably, the headband protrusions 458 should be approximately 2 mm to 5 mm from the sealing portion.

[0195] Further details of this headband connector are disclosed in PCT / AU2008 / 001557 filed on 22 October 2008, the entire contents of which are incorporated herein by reference.

[0196] 3.3.2 Sealing Support In one embodiment, such as Figure 18-1 and 18-2 As shown, frame 220 may include an exoskeleton or support device 290 configured to push the nostril engagement wing 214 toward the nostril during use. As illustrated, the fingers 291 provided by the exoskeleton 290 will support and shape the seal when engaged with it. That is, the exoskeleton is made of a more rigid material than the seal so that the fingers can bend / deform, but to a lesser degree than the seal, thereby advancing the seal toward the patient's nose or clamping the seal onto the patient's nose.

[0197] In one embodiment, the bottom of the seal may include a rolling diaphragm 292, which is adapted to fit into the outer frame to provide a certain degree of adjustability (e.g., compression or expansion) of the seal relative to the outer frame.

[0198] In one embodiment, the seal and the outer skeleton can be configured as an integral molded part or can be formed separately and attached to each other.

[0199] 4. Headband like Figure 1-1 As shown, the headband 150 may include side straps 190, top straps 170, back straps 180, and hardening members 160 provided at the corresponding side straps 190 (e.g., sewn to the corresponding side straps).

[0200] In the illustrated embodiment, the hardened member is provided with an end adapted to engage with a corresponding headband connector 240 on the frame (e.g., via a snap-fit), such as Figure 1-1 As shown in the figure. However, the hardened component can be coupled to the corresponding headband connector in other suitable ways, for example, the hardened component includes an opening adapted to receive the corresponding auricle-shaped headband connector.

[0201] In one embodiment, headband 150 may be the headband disclosed in U.S. Patent Application No. 2009 / 0044808, published on February 19, 2009, the entire contents of which are incorporated herein by reference.

[0202] The hardening element can be configured to add support to selected areas of the mask. For example, the hardening element can provide cheek support (similar to those disclosed in U.S. Patent Application Publication No. 2009 / 0044808), and / or the hardening element can be configured to engage the chin or jawline to support / secure the mask in use (see [link to patent application]). Figure 12 ).

[0203] In one alternative embodiment, the headband strap may be made of silicone resin, and the hardened element may be co-molded into the corresponding silicone resin strap.

[0204] In the illustrated embodiment, the headband provides a two-point connection to the face mask. However, other configurations are also possible, such as a three-point connection or more point connections.

[0205] 4.1 One-piece headband Figure 13-1 and Figure 13-2 The illustration shows a headband 150 constructed as a single piece (e.g., cut from material to form a monolithic structure). As shown, the headband 150 includes a central portion 185 and side straps 190 adapted to engage with each other (e.g., via a buckle device). The central portion 185 includes an opening 186 for receiving and supporting a sealing portion 210. Figure 13-3 As shown, the headband may include a contoured portion 187 surrounding the opening 186, which is adapted to support the seal during use.

[0206] In one embodiment, such as Figure 13-4 As shown, the region 188 surrounding the opening 186 can be configured to provide a resilient padding configuration for the seal 210, which allows the seal to bend, stretch, and / or sway relative to the headband 150 to relieve pressure during use. For example, the region surrounding the opening can be thinner than the rest of the headband.

[0207] In another embodiment, such as Figure 13-5 As shown, the headband 150 can be integrated with the sealing part 210.

[0208] In each of the above configurations, the air delivery pipe 20 can be directly connected to the bottom of the sealing part 210.

[0209] 4.2 Adhesive headband like Figure 15 As shown, instead of a headband, an adhesive band 285 can be attached to the corresponding external nasal cavity joining wing 214 to directly adhere the sealing portion 210 to the patient's face. However, for example... Figure 15 As shown by the dashed line, the strip can be disposed at the lower part of the seal. A related example is disclosed in U.S. Patent Application No. 12 / 478,537, filed June 4, 2009, the entire contents of which are incorporated herein by reference.

[0210] 4.3 Other headbands Figure 86 The illustration shows a headband 484 including a strap 527 and a back strap 529. Strap 527 includes a headband connector 456 for attaching a headband. Figure 47-2 The notch 531 and the adjustable connector 500. The strap 527 can be connected to the headband connector 456 via other connection structures (e.g., using hook and loop connectors).

[0211] The strap 527 is configured to extend between the patient's eyes and ears during use and connect to the adjustable connector 500 at the top of the patient's head. The flexible tube 486 can be attached to the strap 527 by a clamp or other fastening member in the area of ​​the adjustable connector 500 of the strap 527 to secure the flexible tube 486 in the appropriate position at the top of the patient's head.

[0212] The posterior bandage 529 is configured to extend around the back of the patient's head during use to assist in holding the bandage 527 in place. The posterior bandage may include a connector 500 for attachment at the back of the patient's head, or optionally it may be a one-piece bandage. Bandage 527 and posterior bandage 529 may be made of silicone or other materials, such as rubber bands or TPE.

[0213] Figures 87 to 89 The diagram illustrates a headband 533, which includes two sides 535 and a rear portion 524 connected to each side 535. Each side 535 includes a first notch for connecting to a headband connector 456. Figure 47-2 The second notch 537 is used to connect the rear portion 524. The rear portion 524 may have an end portion 526 passing through the second notch 537. The end portion 526 may be formed with a hook-like material for connection with the ring-like material 528.

[0214] The side portion 535 can be formed from a silicone material, which can be molded. The silicone material can reduce the visible volume of the side portion 535 by giving it a more streamlined appearance. The rear portion 524 can be formed from a softer material (such as a soft polymer material, like TPE or thermoplastic polyurethane (TPU)) to provide patient comfort.

[0215] The posterior portion 524 may include one or more hardening or reinforcing elements to help maintain the shape of the headband and to fix and position the headband relative to the top of the patient's head and / or occipital bone. The one or more hardening or reinforcing elements may be made of rigid or semi-rigid materials configured to increase the rigidity or stiffness of the headband and anchor it in place during use. While the hardening element is capable of bending or deforming along its length, it is capable of preventing or inhibiting stretching of the headband along the longitudinal direction of the hardening element. The hardening element may be generally non-stretchable. The posterior portion 524 may wrap around the top of the patient's head. The hardening element may be elastic. The posterior portion may be formed by thermoforming and / or ultrasonic cutting, as disclosed, for example, in PCT / AU2009 / 001605, filed December 10, 2009. The headband disclosed in PCT / AU2009 / 001605 may be used in conjunction with the technology disclosed in this application, and therefore the entire contents of PCT / AU2009 / 001605 are incorporated herein by reference.

[0216] Figures 90 to 93 The illustration shows a headband 539 formed as a single unit. The headband 539 covers the front of the patient interface in region 541 and also covers the headband connector 456 for a more streamlined appearance. A hardening element may be included in or on the headband 539 to increase stability.

[0217] Figure 94 A headband 543 similar to headband 539 is illustrated, wherein headband 543 covers the front of the patient interface in region 541. However, headband 543 includes a cutout 545, which makes the headband protrusion 532 visible on the outside of headband 543. This configuration can help align the headband with the patient interface.

[0218] Figure 110 The illustration shows a headband 484, which can be used with any embodiment herein, and includes hook and loop attachments. A loop material 560 can be positioned on a first portion of the headband 484, and a hook material 562 can be positioned on a second portion of the headband 484. Although the hook material 562 and the loop material 560 are secured together when pressed together, a user can pull them apart when a certain force is applied.

[0219] A finger loop 558 may be included at the hook material 562 to assist the user in finding and gripping the end of the hook material 562. A buckle 590 may be attached to the end of the headband 484 with the loop material 560 to assist in alignment and guide the hook material 562 portion of the headband 484 to the appropriate position on the loop material 560. The buckle 590 and the finger loop 558 are interchangeable, i.e., the buckle 590 is located at the end of the hook material 562 of the headband 584, and the finger loop is located on the loop material 560 portion of the headband 584.

[0220] 5. Pipe bend exist Figure 1-1 In this case, the bend 230 (e.g., having a swivel) is generally L-shaped and adapted to connect the mask to the air delivery pipe 20.

[0221] In one alternative embodiment, the bend is flexible or pliable to prevent or reduce pipe drag during use. For example, as... Figure 14-1 and Figure 14-2 As shown, the middle portion of the bend 230 may include a set of folds 286 and a movable hinge 287 so that the ends of the bend can pivot relative to each other during use. This folded bend can be formed as a single piece (e.g., two-part forming, co-forming, insert forming) or as a component (e.g., a 2-part or 3-part component).

[0222] In another embodiment, as shown in 14-3, the flexible region 288 may be incorporated into the bend 230 to allow the ends of the bend to move relative to each other during use. The flexible region may be made of an elastic material (e.g., TPE, soft rubber) to allow the flexible region to compress and expand. Such a bend may be formed by molding (e.g., secondary molding, co-molding, insert molding).

[0223] In another embodiment, the folded regions 289 may be provided between the ends of the bend 230 so that the ends can move relative to each other in any direction, for example, by compression, expansion, bending, etc. Such a bend can be formed by molding (e.g., secondary molding, co-molding, insert molding).

[0224] In another embodiment, such as Figure 38 As shown, a generally L-shaped bend 397 is connected at one end to a seal or mask system and at the other end to a tube. For example, a seal connector 399 is connected to the seal or mask system, and a tube connector 398 is connected to the tube. An air vent 395 can be positioned between the connectors. The bend 397 is configured such that when the patient wears the mask, it moves the tube connector 398 away from the patient's face and above the mask, so that the tube can be positioned above the patient's head during use. The air vent 395 facilitates directing exhaled air away from the patient's face during use. Connectors 398 can be attached to an air delivery tube, and connectors 399 can be attached to a mask, such that the air vent 395 is parallel to the patient and faces away from the patient's airway.

[0225] 6. Sealing parts without a buffer system In an alternative embodiment, the mask 200 may be configured without a cushioning system between the seal 210 and the frame 220, i.e., as Figures 2-1 to 2-6 The sealing part shown is directly attached to the frame.

[0226] In this embodiment, the seal 210 can be removably attached to the frame 220, for example, by means of (but not limited to) snap-fit, tongue and groove, clip, etc. Alternatively, the seal 210 can be permanently attached to the frame 220 by means of (but not limited to) co-molding, insert molding, gluing, etc. In an alternative form, the seal 210 can be integrally formed with the frame 220.

[0227] 6.1 Shape like Figure 2-7B As shown, the sealing portion 210 can be generally rectangular or elliptical when viewed from above. In an alternative embodiment, as... Figure 2-7A As shown, the sealing portion 210 can be approximately triangular or trapezoidal when viewed from the top. Figure 2-7AThe embodiments are configured to reduce the amount of excess material in the seal 210 that could cause discomfort or be less noticeable. This also provides alignment guidance for the patient; that is, because the inherent shape of the nose is closer to a triangle, the patient may be more likely to align the triangular seal 210 accurately, and thus the nasal tip junction 212 and the upper lip junction 213 are more likely to be oriented in their desired positions.

[0228] like Figure 2-8B neutralization Figure 2-9B As shown, the upper lip engagement portion 213 of the rectangular sealing portion is long enough that its free end protrudes beyond at least a portion of the frame, in order to prevent, for example, engagement of the patient's upper lip with the frame during use. Furthermore, the upper lip engagement portion can be long enough to accommodate various nose and upper lip shapes (e.g., Figure 2-8B The embodiments shown may have more than Figure 2-8A The embodiments shown have a wider range of patient cooperation. Figure 2-8A and 2-9A As shown, in the embodiment of the triangular sealing portion, the length of the upper lip engagement portion 213 is shortened or reduced in order to, for example, reduce the amount of excess material. Figure 2-10 The illustration shows an embodiment of a triangular sealing portion that engages with a patient's face during use.

[0229] Figure 2-11 This is a rear view of the sealing part, showing, for example, relative to... Figure 2-8B and Figure 2-9B The sealing portion, the upper lip joint 213, is the part that will be removed (shaded portion). Shaping the material of the upper lip joint can improve comfort and the attractiveness of the mask (i.e., make it more visually non-prominent) and can improve leak-proof performance.

[0230] 7. Optional mask and tube connection Figures 57 to 85 and Figures 95 to 101 The illustration shows various optional mask and tube connections that can be used with this technology.

[0231] 7.1 Film like Figure 57 As shown, the membrane 482 can be disposed between the support membrane 465 and the flexible tube 486. In this embodiment, the headband connector 456 allows the headband 484 to be connected. Figure 58As shown, a membrane 482 provides freedom of movement between the support membrane 465 and the flexible tube 486. The membrane 482 can engage the flexible tube 486 with the patient interface 459 via a rotating ring 480. The membrane 482 can stretch, flex, or otherwise elastically deform to allow movement between the support membrane 465 and the flexible tube 486. The membrane 482 can have a wall thickness less than that of the support membrane 465. The membrane 482 can have a wall thickness of approximately 0.2 mm to 5 mm. Preferably, the membrane 482 can have a wall thickness of approximately 0.5 mm to 2 mm. Most preferably, the membrane 482 can have a wall thickness of 0.5 mm to 1 mm. Movement between the tube 486 and the seal 450 can be restricted by the length of the membrane 482, and the length of the membrane 482 can be adjusted based on the desired amount of movement. The flexible tube serves to prevent any additional movement.

[0232] 7.2 Multi-axis pipe bending assembly Figures 59 to 64 The illustration shows a multi-axis pipe bending assembly 495, for example. Figure 59 As indicated by the arrows, it creates additional degrees of freedom by allowing rotation in two independent planes. The multi-axis bending assembly 495 includes a frame 491 that can be connected to a membrane 482 or a support membrane 465, a bend 488 connected to the frame 491, a rotating assembly 494, a rotating ring 492, and a bend 490.

[0233] The additional degrees of freedom provided by the multi-axis bending assembly 495 have a significant impact on the functionality of the patient interface 459. For example, as Figure 60 and Figure 61 As shown, the multi-axis bending assembly 495 allows the flexible tube 486 to be easily placed on either side of the patient's head, such as... Figure 62 As shown, the multi-axis bending assembly 495 allows the flexible tube 486 to be positioned along the patient's nose and between the patient's eyes, while maintaining a streamlined shape (not bulging outwards) and applying almost zero torque to the patient interface. Furthermore, as... Figure 63 and Figure 64 As shown, the flexible tube 486 can also be positioned in a downward or outward configuration. The multi-axis bend assembly 495 allows the tube 486 to be placed in a number of different locations where the patient can use the tube 486 without applying a large torque to the patient interface caused by the tube dragging, so as to provide an effective and comfortable seal with the patient.

[0234] 7.3 Corrugated short pipe isolation component Figures 65 to 69The diagram illustrates a bellows or telescopic tube isolation element. A series of bellows 502 are connected at one end to the patient interface 459 and at the other end to a tube 506. The tube 506 may have a swivel connector 504 for connection, for example, to a gas supply line. The bellows 502 includes a bore with multiple support rings that helps prevent blockage of the air path even when tightly bent; that is, the bellows may have a wall section thicker than the non-bellows portion of the bore. Optionally, the bellows and the bore may have a constant wall section. The length of the bellows providing isolation can be selected so that the patient interface 459 remains sealed even when the bellows 502 is bent. Thus, the bellows 502 provides freedom of movement between the patient interface 459 and the tube 506.

[0235] The bellows 506 can be molded as an integral structure with the support membrane 465, or it can be a separate, removable element. The bellows 502 can be formed of a material with a hardness of 20 to 80 Shore A, preferably 20 to 60 Shore A, and most preferably about 40 Shore A, to match the support membrane 465 so that the two parts can be molded together. When the bellows 502 is a separate element, it can have a different hardness, for example, about 20 to 40 Shore A, preferably about 20 Shore A. Preferably, when the hardness is 40 Shore A, the thickness is preferably about 0.3 mm.

[0236] The bellows 502 may have an inner bore of 8 mm to 20 mm, preferably 10 mm to 15 mm, and most preferably 12 mm or 15 mm. A thin film may be used between the bellows 502 and the support membrane 465 of the patient interface 459.

[0237] like Figure 67 As shown, the increased flexibility of the bellows 502 allows the fitting 506 to be easily positioned outwards or downwards onto the top of the head with minimal force at the patient interface. The bellows 502 has wide spacing between the rings to ensure sufficient bending of the tube. The bellows 502 prevents blockage of the air path when the tube is extremely bent.

[0238] Figure 69 The diagram shows... Figure 68The bellows rings and sidewalls are shown in various dimensions. Each bellows ring has a height (including the sidewalls) of, for example, 2 mm to 6 mm, preferably 3 mm to 5 mm, most preferably 5 mm, and a width of, for example, about 2 mm to 8 mm, preferably about 3 mm to 6 mm, most preferably about 4 mm. The radius R1 of the arcuate portion between each bellows ring can be about 1 mm to 4 mm, preferably about 2 mm to 3 mm, most preferably about 2.5 mm. The spacing between the rings of the bellows is, for example, about 2 mm to 8 mm, preferably about 4 mm to 6 mm, most preferably about 5 mm, and the thickness of the sidewall of the bellows ring is, for example, 0.2 mm to 2 mm, preferably about 0.5 mm to 1.5 mm, most preferably about 0.3 mm. The radius of the bellows 502, measured from the inner side of the bottom of each arcuate portion between the bellows rings, is, for example, about 4 mm to 12 mm, preferably about 6 mm to 10 mm, most preferably about 7.5 mm. While these values ​​can be altered, it has been found that setting a very soft bellows with a stiffness of approximately 20 to 60 Shore A (preferably approximately 40 Shore A) can provide improved impedance and overall compatibility of the tube / patient interface.

[0239] 7.4 Ball parts and bearing parts Figure 70 The illustration shows a patient interface 459 connected to a flexible tube 486 via a ball-and-socket connection. The ball-and-socket connection includes a ball 508 and a socket connector 510. For example... Figure 71 As shown, the ball 508 can be connected to the flexible tube 486 via the connector 507, and so on. Figure 72 As shown in the diagram, the socket connector 510 can be connected to the patient interface 459. The socket connector 510 can be a known bent tube ring sized to accommodate the ball 508. The socket connector 510 may also include a diffuser vent, which allows for the expulsion of air from the patient.

[0240] The ball-and-socket connection provides isolation for the movement of the flexible tube 486 to eliminate the torque formed at the patient interface 459 due to tube drag. The ball 508 can move freely within the socket connection 510 as the flexible tube 486 moves freely.

[0241] Figure 73 and Figure 74The illustration shows a ball 508 connected to a bend 509. The bend 508 can be connected to a flexible conduit. The bend 509 includes a bend that can be, for example, about 90° to 150°, preferably about 100° to 130°, most preferably about 110°, although other angles may also be used. The bend 509 includes a vent 511, which may include one or more vent holes 513 for discharging exhaled air. The vent holes 513 may be spaced apart in an array. Preferably, the inner diameter of the bend is about 7 mm to 15 mm. Preferably, the bend may have an inner diameter of less than 12 mm. Most preferably, the bend may have an inner diameter of about 8 mm.

[0242] The ball 508 may preferably have an outer diameter in the range of approximately 15 mm to 19 mm. Most preferably, the ball 508 may have an outer diameter of approximately 17 mm.

[0243] The ball 508 may preferably have an inner diameter of about 7 mm to 15 mm. Preferably, the ball 508 may have an inner diameter of less than 12 mm. Most preferably, the ball 508 may have an inner diameter of about 8 mm.

[0244] like Figure 75 As shown, the vent fitting can be in the form of a removable insert 517. The removable insert 517 can be attached to the bend 509 via a structure (e.g., trunnion, tongue, and slot) to lock in place. Figure 76 As shown, the plug-in can be a mesh vent component 515.

[0245] Figure 77An embodiment is illustrated, wherein the ball 508 includes a set of venting grooves 501. The venting grooves 501 may have a length extending to both sides of the socket connector 510 during use, so that exhaled air can be discharged through the venting grooves 501. The venting grooves may have a length of approximately 2 mm to 50 mm. Preferably, the venting grooves 519 may extend along the outer surface of the ball 508 to form a longer exhaust flow path. A longer exhaust flow path can reduce the noise of the exhaust gas because the air velocity is reduced. Preferably, the venting grooves 519 are distributed on the ball 508 to disperse the exhaust gas flow path. Preferably, the venting grooves 519 are formed on the ball 508. Preferably, the grooves 519 have a width of approximately 0.2 mm to 3 mm. Preferably, the grooves 519 have a width of less than 1 mm. The narrower the groove, the slower the airflow, and therefore the quieter the exhaust process. The grooves 519 may be generally straight or may have other different configurations. Because curved or bent channels can increase the length of the exhaust flow path and thus reduce exhaust noise, curved or bent channels are preferred. The walls of the spheres 508 adjacent to the recess 519 can be connected to the connector 510. The connector 510 can be placed on top of the recess 519 and thus form a cover over the recess 519.

[0246] Figure 111 An embodiment is illustrated, wherein the ball 508 includes a set of arcuate vent grooves 564. The arcuate vent grooves 564 may also have a width of approximately 0.2 mm to 3 mm. Preferably, the vent grooves 564 have a width of less than 1 mm. The ball 508 may be connected to a tube 486 or a bend 509 or other components.

[0247] Figure 112 An embodiment is illustrated, wherein the ball is a perforated ball 568 having a set of vents 570. The perforated ball 568 allows air to flow between the connector (e.g., connector 510) and the ball 568. The ball 508 can be connected to a pipe 486 or a bend 509 or other components.

[0248] Figure 113-1 and Figure 113-2 An embodiment is illustrated in which the ball 508 has a venting groove 570, and a flow path barrier 592 can be removably attached to the ball 508. The flow path barrier 592 can be connected to the connector 510 to form a flow path between the barrier 592 and the connector 510.

[0249] Figure 78An optional socket connector 521 is illustrated. The socket connector 521 includes a ventilation groove 523. The ventilation groove 523 allows exhaled air to exit the patient interface. The ventilation groove 523 may extend radially outward (as shown). Optionally, the ventilation groove 523 may extend axially. Optionally, the ventilation groove 523 may extend along the inner surface of the inner wall of the socket connector 521.

[0250] Figure 79 The illustration shows a patient interface 459 utilizing a ball joint 508 and a socket connector. The ball joint 508 can move freely within the socket connector, which provides degrees of freedom of movement, allowing the tube 486 to be placed in various positions.

[0251] 7.5 Hybrid bends and ball joints Figures 80 to 83 The diagram illustrates a hybrid bend and ball joint. The bend assembly 514 includes a swivel connector 512 and a socket connector 518. The ball assembly 516 includes a ball 522 and a swivel connector 520. The ball 522 mates with the socket connector 518.

[0252] The bend assembly 514 can take the form of an angle, for example, from 90° to 150°, preferably from about 100° to 130°, and most preferably about 110°. The combination of the bend assembly 516 with the ball joint provides a variety of degrees of freedom of movement. For example, using a bend without a ball joint will force the connected tube to be closer to the patient's jaw in the downward position of the tube, or further away from the patient's jaw in the upward position of the tube. Using a bend assembly with a ball joint allows the tube to be placed in more desired positions.

[0253] Figure 82 The illustration shows a bend assembly 514 employing a ball component 516, with the flexible tube 486 in a downward position. The ball component 516 allows the flexible tube 486 to be positioned away from the patient's face and not in contact with the patient's face.

[0254] Figure 83 The illustration shows a bend assembly 514 employing a ball component 516, with the flexible tube 486 in an upward position. The ball component 516 allows the flexible tube 486 to be positioned closer to the patient's face to help prevent visual obstruction.

[0255] 7.6 Membranes with bends Figure 84The diagram illustrates a diaphragm 482 used in conjunction with the bend assembly 514 and the swivel connector 512. The seal 450 includes an orifice extending downwards from a horizontal position, making it difficult to achieve both an upward and downward tube position simultaneously. The diaphragm 482 is flexible to allow the extension angle to be adjusted to a more horizontal position. Therefore, the diaphragm 482 allows the flexible tube 486 to hang downwards without applying excessive torque to the seal 450, and also allows the flexible tube 486 to be correctly positioned upwards.

[0256] 7.7 Angle bends and ball joints Figure 85 An angled bend and ball joint assembly 525 is illustrated. The angled bend and ball joint assembly 525 includes a bend 514, a ball 516, and a swivel connector 520 for connecting a flexible tube 486. The angled bend and ball joint assembly 525 can have an angle of, for example, 100° to 160°, preferably about 100° to 130°, and most preferably about 110°. The ball 516 can be connected to, for example... Figure 70 The socket connector shown is illustrated. The ball 516 provides the degree of freedom of movement that allows the flexible tube 486 to be correctly positioned in an upward or downward position.

[0257] 7.8 Ball and Socket Assembly Figures 95 to 101 The illustration shows a ball-and-socket assembly 561 that combines a ball joint and a rotating ring. The rotating ring 550 can be connected to a face mask or support membrane 465. The ball 552 is placed inside the rotating ring (see diagram). Figure 101 This allows the ball joint 548 to rotate 360° axially around the rotating ring 550 and to move in a plane other than the axial direction of the rotating ring 550. Alternatively, the rotating ring 550 can be omitted, and the ball 552 can be connected to the mask.

[0258] The connector 556 is adapted to connect to a flexible gas supply tube so that gas can be supplied in the air passage 560 in the direction of arrow 558. The air passage may have an inner diameter of 11 mm to 15 mm, and the connector 556 may have the same inner diameter. The vent 554 may be incorporated into the ball joint 548 to expel gas exhaled by the patient.

[0259] The swivel ring 550 can be manufactured and shaped in a mold. The swivel ring 550 can then be placed in a machine tool in which a ball joint portion 548 is formed around or within the swivel ring 550. As the material of the ball joint portion 548 cools, the ball joint portion 548 will shrink and detach from the swivel ring 550. A vent 554 can be formed into the ball joint portion 548.

[0260] 7.9 Side connecting pipe Figures 102 to 104 The illustration shows a patient interface 459 with a laterally connected flexible tube 486. In all embodiments, although not specifically illustrated, the patient interface 459 may include a sealing portion 450 and a support membrane 465. Two orifices 538 are located on each side of the patient interface 459, and the two orifices 538 allow the flexible tube 486 to be connected to either side of the patient interface 456 and extend laterally. A plurality of vent holes 544 may also be included for venting exhaled air from the patient.

[0261] The bend 542 can be connected to the end of the flexible tube 486 and is adapted to connect to the orifice 538. The bend may include a swivel connector that allows the flexible tube 486 to be rotated to different positions, for example, as... Figure 103 The position shown is along one side of the patient's face upwards, or as... Figure 102 and Figure 104 The downward position is shown in the diagram. A tube plug 540 can be used at the orifice 538, which is not connected to the flexible tube 486, to seal the orifice 538.

[0262] The side connector has a streamlined appearance and removes the tube body 486 from the patient's face. The side connector also isolates the tube tension from the seal 450. Further details of the side connector interface are disclosed in U.S. Patent Application Serial No. 12 / 377,801, filed February 29, 2008, the entire contents of which are incorporated herein by reference.

[0263] 7.10 Two side connecting pipes Figure 105 The illustration shows a patient interface 459 employing two side-connected flexible tubes 548. A frame 546 can be used to support the patient interface 459. The flexible tubes 548 can have a smaller diameter than when using a single flexible tube. For example, the flexible tube 548 can have half the diameter of a single tube. This can provide better comfort for the patient, especially when the patient rolls over and presses against one of the tubes 548.

[0264] 7.11 Rigid frame above the patient interface Figures 105 to 107 A rigid frame 546 is illustrated, which can be adapted to be mounted on and support the patient interface 459. For example, the rigid frame can be shaped to be mounted on the patient interface 459. The rigid frame 546 may include a headband connector 456 for connecting the headband 484.

[0265] Frame 546 can be formed of a rigid material to provide rigid support. Further details of frame 546 are also disclosed in U.S. application Serial No. 12 / 377,801, the entire contents of which are incorporated herein by reference.

[0266] 7.12 Headband Bracket Figure 108 and Figure 109 The illustration shows a headband bracket portion 552 adapted for connection to a patient interface 459. The headband bracket portion 552 may include openings 554 for connecting the headband bracket portion 552 to the patient interface 459. The headband bracket portion 552 may have openings at each end therefor for receiving a headband 484.

[0267] The headband support portion 552 may also have a tactile end 550 to enhance the patient's grip for easy connection and disconnection of the headband 484. The headband 484 may be connected using hook and loop materials. The headband support portion 552 may also include a comfortable padding 556 inside the headband support portion 552. The compliant padding 556 supports the patient interface 459 and provides isolation between the patient interface 459 and the headband support portion 552. The compliant padding 556 also provides a soft feel to the patient when using the patient interface 459.

[0268] 7.13 Bent tube with trunnion Figure 114 An embodiment is illustrated in which a patient interface 459 is connected to a headband 484 and a bend 582. The patient interface includes a connector 578 having an opening 580. The headband 484 has a headband connector 557, which is configured to connect to the connector 578 by fitting onto the outside of the connector 578. The trunnion 586 of the bend 582 is fitted within the opening 580. The bend 582 is adapted to form an airtight connection with the connector 578. If desired, the headband 484 may have an opening near the headband connector 557 to receive a portion of the bend 582 near the trunnion 586.

[0269] 7.14 Vent bend assembly Figure 115 and Figure 116 The diagram illustrates a ventilation bend assembly. The ventilation bend assembly includes a bend 509, a swivel ring 550, and a connector 556. The swivel ring 550 can be connected to a patient interface 459 or a support membrane 465, and the connector 556 can be connected to a flexible tube supplying gas.

[0270] The bend 509 may include a set of ventilation recesses 558 for expelling the patient's exhaled air. The ventilation recesses 558 may have different lengths and may be arranged parallel to or perpendicular to the direction of airflow through the bend 509.

[0271] 8. Other embodiments Figures 23-1 to 23-7 Another embodiment of this technology is shown. Figure 23-1A patient interface 3000 is shown having an interface portion (also called a sealing portion) 2000 positioned above or on top of a support portion 1000. Figures 21-1 to 21-6 A support portion 1000 is shown. The support portion 1000 may have a nose tip portion 212B, an external nasal nostril portion 214B, and optionally an upper lip portion 213B. A ridge or thickened section may be provided in the area below or on the non-patient contact side to provide additional support for the interface portion 2000 and different levels of support for the sealing portion 210 during assembly. The support portion 1000 may be made of silicone resin having a Shore A hardness of approximately 20 to 90, preferably approximately 40 Shore A. The support portion 1000 can also be made of polycarbonate, polypropylene, nylon, thermoplastic elastomer (TPE), or hydride. TM The support portion 1000 can be approximately 1 mm to 15 mm thick, preferably 1.2 mm. For example... Figure 21-4 As shown in the best example, the upper lip 213B can be excised or removed.

[0272] Figures 22-1 to 22-4 An interface portion 2000 is shown. The interface portion 2000 may have a nose engagement portion 212A, an external nasal nostril engagement portion 214A, and an upper lip engagement portion 213A. In use, the interface portion 2000 can engage with a patient. The interface portion 2000 may be made of silicone resin having a hardness of approximately 7 Shore A. Optionally, the hardness of the interface portion 2000 may be approximately 12 Shore A. The thickness of the interface portion 2000 may be approximately 1.2 mm. The interface portion 2000 may be made of other suitable materials, such as nylon, textile materials, TPE, etc. For tactile feel and to "stick" or adhere to the patient's skin during use, the interface portion may have a polished surface.

[0273] Figures 23-1 to 23-7 An interface portion 2000 is shown attached to or positioned on the top of the support portion 1000. The interface portion 2000 may be co-molded, insert-molded, glued, or attached to the support portion 1000 by other means. The interface portion 2000 may be permanently attached or removably attached.

[0274] like Figure 23-3 and Figure 23-6 As best shown in Figure 23-5, the nasal connector 212A may protrude or support above the nasal portion 212B. This configuration allows the patient's nose to bend into the nasal connector 212A, thus providing a wider range of fit. The nasal portion 212B supports the sidewalls of the interface portion 2000. As best shown in Figure 23-5, the upper lip connector 213A is suspended from the upper lip portion 213B with a gap. This allows for flexibility of the patient interface 3000 in the patient's upper lip region, thus providing a wider range of fit.

[0275] Figure 117 The illustration shows a patient interface 600. The patient interface 600 includes a sealing portion 600 for sealing against the patient's face, a support portion 608, and a connection portion 610 (e.g., a flexible tube) for connecting to a gas supply. An optional gusset plate 604 may also be included.

[0276] A headband can be attached to the patient interface 600 to create a headband vector in an area (e.g., location 606). This can be achieved, for example, by arranging a headband connector below a seal 602 on a support 608. An optional gusset plate 604 may be included between the seal 602 and the support 608.

[0277] Figure 118-1 , Figure 118-2 and Figure 118-3 The patient interface 612 is illustrated. The patient interface 612 includes a sealing part 602, a support part 616, a gusset plate 614 located between the sealing part 602 and the support part 616, a connection part 618 (e.g., a flexible tube) for connecting to a gas supply, and an orifice 620.

[0278] The sealing portion 602 is connected to the patient's face (typically the patient's upper lip and nose) and forms a seal. The sealing portion 602 may include reinforcement portions, such as those portions of the sealing portion 602 that connect to the patient in the area adjacent to the nasolabial folds of the nose. The reinforcement portions of the sealing portion 602 may be formed of an incompressible material, such as gel or other materials (e.g., silicone with a high apparent hardness compared to other portions of the sealing portion 602). Optionally or additionally, structural support may be added, such as… Figure 52-5 In the embodiments, ribs or thickened portions are provided on each side of the sealing portion or on the support portion, and / or the gusset plate 614 may be filled with a rigid material to provide additional support.

[0279] Figure 118-3 The illustration shows a cross-sectional view, in which gel-filled pouches 622 are included in the corner areas of the sealing portion 602, and these gel-filled pouches can be positioned in each corner area. The gel-filled pouches 622 can be used to provide reinforcement and a more effective seal with the patient during use. A gel filling position 623 may be included, allowing the user or patient to add or remove gel as needed.

[0280] Figure 119The illustration shows a top view of the sealing portion 602 of the patient interface. The sealing portion 602 may include a channel 602 for delivering gas to the patient during use. As illustrated, the channel 602 may have a generally trapezoidal shape or a generally triangular shape. These shapes more closely resemble the shape of a patient's nose, making it easier for the patient to wear the patient interface in the correct orientation.

[0281] Figure 120 The illustration shows a patient interface 630, which includes a sealing portion 632, a support portion 636, an optional gusset plate 638, and a connecting portion 640. The sealing portion 632 may be a single-walled sealing portion, and in this embodiment, a second sealing wall 634 may be included below the sealing portion (forming a first sealing wall) to provide additional support.

[0282] Figure 121 The illustration shows a patient interface 642, which includes a seal 644, a support 652, and an optional gusset plate 650. In this embodiment, the front portion 648 (nose joint) of the seal 644 curves downward, making the sealing interface deeper and more curved. This shape allows the sidewalls of the seal to bend more outward for a flatter nose and allows a more pointed nose to be positioned within the curvature provided by this shape.

[0283] Figure 122-1 and Figure 122-3 The illustration shows a cross-sectional view of a patient interface 600 or 642 with an additional soft and compliant support structure. The support structure 604 is disposed below the seal 602. The support structure 604 may be foam or other soft and compliant material, while the seal 602 and support 606 may be silicone or other similar materials as described herein. The support structure 604 may be fitted into a recess formed in the sidewall of the seal 602 or in the support 606. As shown, the support structure 604 may have a variable width or a constant width. The support structure 604 may be annular.

[0284] like Figure 122-3 As shown, the support structure 604 can provide additional contact at the patient's upper lip during use, and because the material of the support structure 604 is soft and compliant, it can provide additional comfort to the patient during use. Furthermore, the support structure 604 can help provide a seal with the patient's upper lip. Figure 122-2 The diagram illustrates a support structure 604 having a sealing portion that curves outward at its outer edge.

[0285] The cross-section of the foam ring can vary in different areas. For example, in the tip of the nose, the foam ring can have a smaller cross-section and can be easily bent to fit noses of different sizes. In the lateral areas of the nose (e.g., to accommodate folds in the face), the foam ring can be thicker.

[0286] Foam rings can combine foams of different densities and change the level of support in different areas.

[0287] Figure 123 The illustration shows a cross-sectional view of the inwardly curved seal 620. The end of the seal 620 has been elongated to seal against the side (outwardly flared portion) of the patient's nose and to provide a side support 622, rather than sealing only on the underside of the nose. This provides a more effective seal.

[0288] Figure 124 and Figure 125 The illustration shows a top view of a patient interface 630 having a sealing portion 636, which includes a nose fork 634 disposed on an upper surface 640 of the sealing portion 636. The nose fork 634 is adapted to form a seal with the patient's nostril during use. A support portion 638 may optionally be included below the sealing portion.

[0289] like Figure 125 As shown, the sealing portion 636 may include a support portion 642 arranged adjacent to the nasal fork 634. The support portion may be foam or other suitable material and is arranged in the area of ​​the sealing portion 636 that connects with the patient's upper lip and the corner of the nose during use, so as to provide support and secure the sealing portion 636 and the nasal fork 634 in place.

[0290] It is understood that the patient interface according to this technology is more adaptable to faces and noses of different sizes and shapes than existing designs. It is understood that the patient interface according to this technology can reduce the need for inventory of different sizes. It is understood that the patient interface according to this technology can provide improved patient comfort and better treatment adherence.

[0291] Although the present technology has been described in conjunction with embodiments currently considered to be the most practical and preferred, it should be understood that the present technology is not limited to the disclosed embodiments, but rather, it is intended to cover various modifications and equivalent arrangements included within the concept and scope of the present technology. Furthermore, the various embodiments described above can be implemented in combination with other embodiments; for example, a solution of one embodiment can be combined with a solution of another embodiment to achieve other embodiments. Additionally, each individual feature or component of any given component can constitute an additional embodiment. Moreover, although the present technology has specific applications for patients with OSA, it should be understood that patients with other conditions (such as congestive heart failure, diabetes, morbid obesity, stroke, and obesity treatment surgery) can also benefit from the above teachings. Moreover, the above teachings are equally applicable to patients and non-patients in non-medical applications.

Claims

1. A patient interface for delivering pressurized breathable gas to a patient, the patient interface comprising: A sealing portion having an elastic sealing surface, the sealing portion comprising: a nasal tip engagement portion adapted to form a seal with the underside of the patient's nasal tip; an upper lip engagement portion adapted to form a seal with the patient's upper lip and / or the bottom of the patient's nostrils; and an external nasal cavity engagement wing portion adapted to form a seal with the patient's nostrils. A support portion that supports the sealing portion and is more rigid than the sealing portion. The stiffness of the sealing portion is greater at the external nasal cavity joining wing portion than at the upper lip joining portion and the nasal tip joining portion. The resilient sealing surface at each of the external nostril joint wings is thicker than the sealing surface at the upper lip joint and the nasal tip joint.

2. The patient interface according to claim 1, wherein the support is an elastic material.

3. The patient interface of claim 1, wherein one or more regions of the support include a ridge or a thickened section to provide rigidity.

4. The patient interface according to claim 1, further comprising a recess formed in the support portion.

5. The patient interface of claim 1, wherein the support includes a handle extending from the seal, a portion of the handle having an increased thickness compared to the other portions of the handle to provide structural support.

6. The patient interface of claim 1, wherein the support terminates at a connecting end having an opening configured to receive a connector for an air delivery tube, the edge of the opening being configured to retain the connector for the air delivery tube.

7. The patient interface of claim 6, wherein the sealing portion and the support portion together form at least a portion of an airflow path configured to deliver the pressurized breathable gas and extend from the connecting end of the support portion to the resilient sealing surface of the sealing portion.

8. The patient interface of claim 1, further comprising a gusset plate between the support and the nasal tip junction, the gusset plate being configured to move at least a portion of the nasal tip junction away from the support.

9. The patient interface of claim 8, wherein the gusset plate is in the form of a groove, the groove forming a channel in the outer surface of the patient interface and extending across the sagittal plane of the patient in use.

10. The patient interface of claim 1, wherein the resilient sealing surface includes an orifice configured to allow pressurized gas to flow into the patient's nasal passage during use.

11. The patient interface according to claim 1, wherein the sealing portion and the supporting portion are integrally formed.

12. The patient interface according to any one of claims 1 to 11, further comprising: A headband configured to support the patient interface on the patient's head.

13. A patient interface for delivering pressurized breathable gas to a patient, the patient interface comprising: A sealing portion having an elastic sealing surface, the sealing portion comprising: The nasal tip junction is adapted to form a seal with the underside of the patient's nasal tip; The upper lip junction is adapted to form a seal with the patient's upper lip and / or the bottom of the patient's nostrils; And the external nasal junction wings, which are adapted to form a seal with the patient's nostrils, and A support portion, which supports the sealing portion and is more rigid than the sealing portion, is integrally formed with the support portion. The support portion terminates at a connecting end configured for connection to a connector for an air delivery pipe. The connecting end has a radially inwardly extending flange configured to retain the connector for the air delivery pipe. The elastic sealing surface at each of the external nasal nostril joint wings is thicker than the elastic sealing surface at the nasal tip joint and the upper lip joint.

14. The patient interface according to claim 13, wherein the side portion of the sealing portion corresponds to the external nasal cavity engagement wing, the front portion of the sealing portion corresponds to the nasal tip engagement portion, and the rear portion of the sealing portion corresponds to the upper lip engagement portion.

15. The patient interface of claim 13, wherein the support includes a wall segment having a front thickened portion and a rear thickened portion formed on each side of the support.

16. The patient interface of claim 15, wherein the front thickened portion and the rear thickened portion provide different degrees of rigidity to the sealing portion.

17. The patient interface according to claim 16, wherein the front thickened portion and the rear thickened portion have different thicknesses.

18. The patient interface according to any one of claims 13 to 17, further comprising: The connector for the air delivery pipe; Air delivery pipe; and A headband configured to support the patient interface on the patient's head.

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