Unobtrusive nasal mask

Abstract

To provide a patient interface that is less obtrusive, dispenses with placement of pillows along the nares and may reduce the sensation of pressurized air being directed upward along the nares.SOLUTION: The patient interface for delivering breathable gas to a patient includes a sealing portion (210) including a nose tip engagement portion (212) adapted to form a seal with the patient's nose tip, an upper lip engagement portion (213) adapted to form a seal with the patient's upper lip and / or the base of the patient's nares, and nostril engagement flaps (214) adapted to form a seal with the patient's nares. The nose tip engagement portion (212), the upper lip engagement portion (213), and the nostril engagement flaps (214) are all structured to extend or curve outwardly from a supporting wall defining an air path.SELECTED DRAWING: Figure 1-1

Description

[Technical field]

[0001] [CROSS REFERENCE TO RELATED APPLICATIONS] This application is a continuation of Australian Provisional Patent Application No. 2009902524, filed June 2, 2009, Australian Provisional Patent Application No. 2009906101, filed December 15, 2009, Australian Provisional Patent Application No. 20099062101, filed May 28, 2010 (not yet assigned attorney docket number C10110P), U.S. Provisional Patent Application No. 61 / 222711, filed July 2, 2009, U.S. Provisional Patent Application No. 61 / 222711, filed August 25, 2009, This application claims priority to U.S. Provisional Patent Application No. 72162, filed Sep. 4, 2009, U.S. Provisional Patent Application No. 61 / 272250, filed Nov. 20, 2009, U.S. Provisional Patent Application No. 61 / 263175, filed Nov. 18, 2010, U.S. Provisional Patent Application No. 61 / 282693, filed Mar. 18, 2010, and PCT Application No. PCT / AU2010 / 000657, filed May 28, 2010, which are incorporated herein by reference in their entireties.

[0002] The present technology relates to a nasal breathing mask for use with an air delivery system for the treatment of Sleep Disordered Breathing (SDB), for example, with Continuous Positive Airway Pressure (CPAP) or Non-Invasive Positive Pressure Ventilation (NIPPV). In particular, the present technology relates to an unobtrusive breathing mask. [Background technology]

[0003] Apparatus for delivering breathable gas to a patient typically comprises a positive airway pressure (PAP) device, an air delivery conduit or tube, and a patient interface which, in use, contacts the patient's face to deliver pressurized breathable gas from the PAP device to the patient.

[0004] When in use, the patient interface may feel bulky and therefore may be quite intrusive and prevent the patient from receiving treatment, which may in turn reduce compliance with treatment and lead to treatment failure.

[0005] Patients who use nasal pillows or nasal puffs may dislike placing the nasal pillows in their nostrils and / or the perception of pressurized air directed upward along their nostrils (also known as the "air jetting" effect). [Prior art documents] [Patent documents]

[0006] [Patent Document 1] International Patent Application No. PCT / AU2004 / 000207 [Patent Document 2] International Patent Application Publication No. 2004 / 073778 [Patent Document 3] U.S. Patent No. 7,523,754 [Patent Document 4] International Patent Application Publication No. 01 / 97893 Brochure [Patent Document 5] US Patent Application Publication No. 2009 / 0044808 [Patent Document 6] International Patent Application No. PCT / AU2009 / 000240 [Patent Document 7] International Patent Application No. PCT / AU2008 / 001711 [Patent Document 8] International Patent Application No. PCT / AU2008 / 001557 [Patent Document 9] U.S. Patent Application Serial No. 12 / 478,537 [Patent Document 10] International Patent Application No. PCT / AU2009 / 001605 [Patent Document 11] U.S. Patent Application Serial No. 12 / 377,801 Summary of the Invention [Problem to be solved by the invention]

[0007] Thus, there is a growing need in the art to provide alternative patient interfaces that are less intrusive, do not require placement of pillows along the nares, and / or may reduce the perception of pressurized air directed upwardly along the nares. [Means for solving the problem]

[0008] One aspect of the present technology relates to a patient interface for supplying breathable gas to a patient. Another aspect of the present technology is a patient interface that forms a seal under the patient's nose. Another aspect of the present technology is a patient interface that avoids contacting the bridge region of the patient's nose. Another aspect of the present technology is a patient interface that forms a seal under the patient's nose in an area surrounding both nostrils. Another aspect of the present technology is a patient interface that avoids contacting the nasal septum. Another aspect of the present technology is a patient interface that defines a single breathing chamber that provides for the supply of air at positive pressure to both nares.

[0009] One form of a patient interface according to the present technology has a sealing portion including a nose tip engagement portion adapted to form a seal with the patient's nose tip, an upper lip engagement portion adapted to form a seal with the patient's upper lip and / or the base of the patient's nares, and a nostril engagement flap adapted to form a seal with the patient's nares. In one form, the nose tip engagement portion, the upper lip engagement portion, and the nostril engagement flap are all configured to extend or curve outwardly from a support wall that defines an airway.

[0010] According to one form of the present technology, there is provided a patient interface that uses different seal forming mechanisms in different regions of the patient interface. Preferably, in a region adapted to form a seal with a nasal crease region of the face, a portion of the seal operates in compression. Preferably, in a region adapted to form a seal with a tip of the nasal region of the face, a portion of the seal operates in tension in use. Preferably, in an alar sidewall region intermediate the crease region of the face and the tip of the nasal region of the face, a sealing portion of the patient interface is arranged to form a cantilever. Preferably, in a region intermediate the left and right crease regions of the face, a sealing portion of the patient interface is constructed and arranged to be in tension in use.

[0011] In accordance with one form of the present technology, there is provided a patient interface that includes a nasal tip seal-forming portion in the form of a membrane, preferably constructed and arranged such that an end of the membrane is held somewhat fixed and is pulled against the tip of the nose in use.

[0012] According to one form of the present technology, a patient interface is provided having a seal-forming portion constructed and arranged to have multiple regions of differing stiffness. In one form, the seal-forming portion has a relatively stiff region that is arranged in use adjacent the nasal crease region of the face or adjacent the base of the nose near the junction between the top lip and the side of the nose. In one form, the seal-forming portion may have left and right regions, respectively, that are relatively stiff. In one form, the seal-forming portion has a relatively low stiffness region that is adapted to form a seal under the tip of the nasal region of the face. In one form, the seal-forming portion has a medium stiffness region that is arranged in use adjacent the lateral portions of the nose.

[0013] In one form, the seal-forming portion of the patient interface of the present technology defines an anterior outer portion and a posterior outer portion on both the left and right sides. In one form, the seal-forming portion of the patient interface of the present technology defines an anterior medial portion and a posterior medial portion. Preferably, the right and left lateral portions are constructed and arranged to hinge about the anterior and posterior medial portions, respectively, in use. With reference to Figures 19-21 of U.S. Patent Publication 2007 / 0133991, published as U.S. Patent Publication 2007 / 0133991, a seal-forming portion according to one aspect of the present technology is adapted to hinge about the medial portion to accommodate the patient's alar angle. In one form, the seal portion is adapted to hinge outwardly to accommodate a wide nose. In one form, the seal portion is adapted to hinge inwardly to accommodate a narrow nose.

[0014] In one form of the present technology, a patient interface is provided having a headgear and a seal-forming portion. The seal-forming portion is arranged to bend about a medial portion thereof to define an angle therebetween. The patient interface is constructed and arranged such that the angle can be adjusted by varying tension in the headgear. In one form, the patient interface has an outer headgear connector arranged at an angle relative to an orifice through which a supply of breathable gas is delivered to the patient. In one form, the patient interface is constructed and arranged such that the angle of the headgear connector is adjustable. In a preferred form, adjustment of the angle of the headgear connector can be used to adjust the angle of the seal-forming portion. In one form, adjustment of the headgear is used to increase or decrease the outward or clamping force of the seal-forming portion. In one form, the headgear is coupled to an underside of the seal-forming portion in a tight fit. Preferably, the patient interface is arranged such that bending of the seal-forming portion about an inner portion thereof can be achieved by varying tension in the headgear. In one form, the upper surface of the headgear connector is configured to press against the underside, preferably the rear outer portion, of the seal-forming portion to increase the outward or clamping force.

[0015] In one form, a patient interface is provided having a seal-forming portion adapted to form a seal under a patient's nose, the patient interface having a flexible body defining a breathing chamber. Headgear is coupled to a side of the flexible body. The body is constructed and arranged to flex in response to varying headgear tension to vary the outward or pinching force on the side of the nose that affects the seal. In one form, the flexible body is formed from rubber, preferably silicone. In one form, the flexible body is formed from rubber having a Type A durometer of about 35 to about 45, preferably about 40.

[0016] In one form of the present technology, there is provided a patient interface having a seal-forming portion, headgear, an air delivery conduit, and a separation arrangement, the headgear is coupled to a region of the patient interface adjacent the seal-forming portion, the air delivery conduit is coupled to the separation portion, the separation portion is located between a connection point of the headgear and a connection point of the air delivery conduit.

[0017] Another aspect of the present technology relates to a patient interface for delivering breathable gas to a patient, the patient interface having a seal portion configured to extend or curve outwardly from a support wall defining an air path. In one form of the present technology, the seal-forming portion is arranged 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 an interior surface of a cushion. In one form, certain regions of the seal-forming portion have a trumpet-, horn-, or bell-shape, while remaining regions have a different shape. For example, a region of the seal-forming portion adapted to form a seal with the underside of the tip of the nose may have a trumpet-, horn-, or bell-shape.

[0018] In one form of the present technology, the seal-forming portion is formed from a low durometer rubber, preferably a silicone having a Type A durometer in the range of 1-15.

[0019] In one form of the present technology, there is provided a patient interface having a mask body formed from a rubber having a Type A durometer in the range of about 35 to about 45, and a seal forming portion formed from a rubber having a Type A durometer in the range of about 1 to 15. In one form, the patient interface further includes a headgear connector formed from a flexible material, preferably from a rubber having a Type A durometer in the range of about 35 to about 45. Preferably, the rubber is a silicone rubber.

[0020] Another aspect of the present technology relates to a patient interface for delivering breathable gas to a patient, the patient interface having a sealing portion that is configured to curve outwardly to form at least one suspended membrane.

[0021] Another aspect of the present technology relates to a patient interface for delivering breathable gas to a patient. The patient interface has a sealing portion including a nasal tip engagement portion adapted to form a seal with the patient's nasal tip, 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, a nostril engagement flap adapted to form a seal with the patient's nares, and a support portion for supporting one or more portions of the sealing portion, where the support portion supports different portions of the sealing portion with different degrees of support. The support portion may have one or more thick portions with perforated or recessed portions, or portions with different hardnesses to provide different degrees of support.

[0022] Another aspect of the present technology relates to a patient interface for supplying breathable gas to a patient, in which a support portion supports one or more portions of a sealing portion, where the support portion supports different portions of the sealing portion with different degrees of support.

[0023] Another aspect of the present technology relates to a patient interface for supplying breathable gas to a patient, the patient interface having a sealing portion having a nasal tip engagement portion adapted to form a seal with the patient's nasal tip, an upper lip engagement portion adapted to form a seal with the patient's upper lip and / or the base of the patient's nares, nostril engagement flaps adapted to form a seal with the patient's nares, and a support portion supporting the sealing portion, the sealing portion coupled to the support portion at side portions of the sealing portion and the sealing portion separated from the support portion at anterior and posterior portions of the sealing portion.

[0024] Another aspect of the present technology relates to a patient interface for supplying breathable gas to a patient, the patient interface having a sealing portion having a nasal tip engagement portion adapted to form a seal with the patient's nasal tip, an upper lip engagement portion adapted to form a seal with the patient's upper lip and / or the base of the patient's nares, nostril engagement flaps adapted to form a seal with the patient's nares, and a support portion supporting the sealing portion, the sealing portion being coupled to and attached to the support portion, where the support portion is conformable.

[0025] Another aspect of the present technology relates to a patient interface for delivering breathable gas to a patient, the patient interface having a sealing portion and a support portion supporting the sealing portion, the sealing portion being coupled to the support portion in some regions and separated from the support portion in other regions.

[0026] Another aspect of the present technology relates to a patient interface for delivering breathable gas to a patient, the patient interface having a sealing portion having a nasal tip engagement portion adapted to engage a nasal tip of a patient, and a support portion supporting the sealing portion, the support portion being coupled to the sealing portion at two side portions of the sealing portion and the support portion being separated from the sealing portion by a gap at the nasal tip engagement portion, the nasal tip engagement portion being adapted to extend to conform to and form a seal with the patient's nasal tip.

[0027] Another aspect of the present technology relates to a patient interface for delivering breathable gas to a patient. The patient interface has a sealing portion adapted to form a seal with a patient's face in use, the sealing portion having a forward stretch portion adapted to form a seal with the patient's nose tip, a rearward stretch portion adapted to form a seal with the patient's upper lip, a side pressing portion adapted to secure the sealing portion at an area of ​​the patient's nose adjacent the nose-lip crease by applying a force perpendicular to the plane of the patient's face, and a side wrap portion adapted to form a seal with the patient's nares by applying a clamping force perpendicular to the patient's nares. The side wrap portion and the side pressing portion may be thicker than the forward stretch portion or the rearward stretch portion. The forward stretch portion can stretch to form a seal with the patient's nose tip in use, and the rearward stretch portion can stretch to form a seal with the patient's upper lip in use.

[0028] Another aspect of the present technology relates to a patient interface for delivering pressurized breathable gas to a patient, the patient interface having a sealing portion adapted to form a seal with a patient's face, the sealing portion having an opening adapted to receive the pressurized breathable gas, an outer sealing perimeter for making a seal with the patient's face, and a transition region between the opening and the outer sealing perimeter that gradually increases in size from the opening to the outer sealing perimeter.

[0029] Another aspect of the present technology relates to a patient interface for delivering breathable gas to a patient. The patient interface has a sealing portion adapted to form a seal with a patient's face, a support portion supporting one or more portions of the sealing portion, and a headgear connector extending from the support portion, the headgear connector adapted to be coupled to a headgear to secure the patient interface to the patient, and in use, the headgear causes the headgear connector to bend towards the support portion, and a bending force from the headgear connector is transferred to the sealing portion as a sealing force. The bending force may be applied to the sides of the patient's nose as a clamping force and / or to the patient's nasal region adjacent the naso-labial crease as a securing force.

[0030] Another aspect of the present technology relates to a patient interface for delivering breathable gas to a patient, the patient interface having a sealing portion and a polyaxial elbow assembly operatively coupled between the sealing portion and a flexible tube, the polyaxial elbow assembly allowing movement of the flexible tube in two separate planes while substantially isolating the transfer of traction forces from the flexible tube to the sealing portion.

[0031] Another aspect of the present technology relates to a multi-axis elbow assembly that allows movement of a connecting tube in two separated planes while simultaneously substantially isolating traction forces from the tube.

[0032] Other aspects, features, and advantages of the present technology will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which are a part of this disclosure and illustrate, by way of example, the principles of the technology.

[0033] The accompanying drawings facilitate an understanding of various embodiments of the present technology. [Brief description of the drawings]

[0034] [Figure 1] FIG. 1 illustrates a PAP system with a prior art patient interface. [Figure 1-1]14 shows a patient interface in use according to an embodiment of the present technology. [Figure 1-2] FIG. 1-2 is a perspective view of the sealing portion and suspension system of the patient interface of FIG. 1-1. [Figure 1-3] FIG. 3 is another perspective view of the sealing portion and suspension system of FIG. 1-2. [Figure 1-4] FIG. 3 is a top view of the seal portion and suspension system of FIG. 1-2. [Figure 1-5] FIG. 3 is a bottom view of the seal portion and suspension system of FIG. 1-2. [Figure 1-6] FIG. 3 is a front view of the seal portion and suspension system of FIG. 1-2. [Figure 1-7] FIG. 3 is a rear view of the seal portion and suspension system of FIG. 1-2. [Figure 1-8] FIG. 3 is a side view of the seal portion and suspension system of FIG. 1-2. [Figure 1-9] FIG. 2 is a perspective view showing the suspension system and frame of the patient interface of FIG. 1-1. [Figure 1-10] FIG. 10 is a bottom view of the suspension system and frame of FIG. 1-9. [Figure 1-11] FIG. 10 is a top view of the suspension system and frame of FIG. 1-9. [Figure 1-12] FIG. 1-9 is a front view of the suspension system and frame. [Figure 1-13] FIG. 10 is a rear view of the suspension system and frame of FIG. 1-9. [Figure 1-14] FIG. 10 is a side view of the suspension system and frame of FIG. 1-9. [Figure 1-15] FIG. 1-2 is a perspective view showing the sealing portion, suspension system, and frame of the patient interface of FIG. 1-1. [Figure 1-16] FIG. 1-15 is a rear view of the seal portion, suspension system, and frame of FIG. [Figure 1-17]FIG. 1-15 is a front view showing the seal portion, suspension system, and frame of FIG. [Figure 1-18] FIG. 1-15 is a side view of the seal portion, suspension system, and frame of FIG. [Figure 2-1] FIG. 13 is a rear view of a sealing portion and frame according to an embodiment of the present technology. [Figure 2-2] FIG. 2-2 is a front view showing the seal portion and the frame of FIG. 2-1. [Figure 2-3] FIG. 2-2 is a side view showing the seal portion and the frame of FIG. 2-1. [Figure 2-4] FIG. 2-2 is a top view showing the seal portion and the frame of FIG. 2-1. [Figure 2-5] FIG. 2-2 is a bottom view showing the sealing portion and the frame of FIG. 2-1. [Figure 2-6] FIG. 2-2 is a perspective view showing the seal portion and the frame of FIG. 2-1. [Figure 2-7A] 13A-13C are top views illustrating alternatively shaped sealing portions in accordance with embodiments of the present technology; [Figure 2-7B] 13A-13C are top views illustrating alternatively shaped sealing portions in accordance with embodiments of the present technology; [Figure 2-8A] 13A-13C are side views illustrating alternatively shaped sealing portions in accordance with embodiments of the present technology; [Figure 2-8B] 13A-13C are side views illustrating alternatively shaped sealing portions in accordance with embodiments of the present technology; [Figure 2-9A] 13A-13C are rear and top views of alternatively shaped sealing portions in accordance with embodiments of the present technology; [Figure 2-9B] 13A-13C are rear and top views of alternatively shaped sealing portions in accordance with embodiments of the present technology; [Figure 2-10] FIG. 13 is a perspective view of a sealing portion and frame in use according to an embodiment of the present technology; [Figure 2-11] FIG. 13 is a rear view of an alternatively shaped sealing portion according to an embodiment of the present technology. [Figure 3-1] 14 shows a patient interface in use according to another aspect of the present technology. [Figure 3-2]FIG. 3-2 is a perspective view of the sealing portion and suspension system of the patient interface of FIG. 3-1. [Figure 3-3] FIG. 3-3 is a rear view of the seal portion and suspension system of FIG. 3-2. [Diagram 3-4] FIG. 3-3 is a top view of the seal portion and suspension system of FIG. 3-2. [Figure 3-5] FIG. 3-3 is a bottom view of the seal portion and suspension system of FIG. 3-2. [Diagram 3-6] FIG. 3-3 is a side view of the seal portion and suspension system of FIG. 3-2. [Figure 4-1] 14 shows a patient interface in use according to another aspect of the present technology. [Figure 4-2] FIG. 4-2 is a perspective view of a sealing portion of the patient interface of FIG. 4-1. [Figure 4-3] FIG. 4-3 is another perspective view showing the sealing portion of FIG. 4-2. [Figure 4-4] FIG. 4-3 is a rear view showing the sealing portion of FIG. 4-2. [Figure 4-5] FIG. 4-3 is a front view showing the sealing portion of FIG. [Figure 4-6] FIG. 4-3 is a side view showing the sealing portion of FIG. 4-2. [Diagram 4-7] FIG. 4-3 is a top view showing the sealing portion of FIG. 4-2. [Figure 4-8] 4-3 shows an alternative self-adjusting shape of the sealing portion of FIG. 4-2. [Figure 4-9] 4-3 shows an alternative self-adjusting shape of the sealing portion of FIG. 4-2. [Figure 5-1] 13A-13C are cross-sectional views illustrating a sealing portion with beading of gel in accordance with an embodiment of the present technology. [Figure 5-2] 13A-13C are cross-sectional views illustrating a sealing portion with beading of gel in accordance with an embodiment of the present technology. [Figure 6-1] 13 is a schematic diagram illustrating a nostril engagement flap for a sealing portion in accordance with an embodiment of the present technology. [Figure 6-2]13 is a schematic diagram illustrating a nostril engagement flap for a sealing portion in accordance with an embodiment of the present technology. [Figure 7-1] 13A-13C show a sealing portion with fingers or ridges according to an embodiment of the present technology; [Figure 7-2] 13A-13C show a sealing portion with fingers or ridges according to an embodiment of the present technology; [Figure 7-3] 13A-13C show a sealing portion with fingers or ridges according to an embodiment of the present technology; [Figure 8-1] 14 shows a mask with a gel suspension system according to an embodiment of the present technology. [Figure 8-2] 14 shows a mask with a gel suspension system according to another embodiment of the present technology. [Figure 8-3] 14 shows a mask with a gel suspension system according to another embodiment of the present technology. [Figure 9-1] 13 illustrates a sealing portion with reinforcing ribs in accordance with an embodiment of the present technology; [Figure 9-2] 13 illustrates a sealing portion with reinforcing ribs in accordance with an embodiment of the present technology; [Figure 10] 13 shows a sealing portion with a headgear connector according to an embodiment of the present technology. [Figure 11] FIG. 13 shows a suspension system with headgear connectors according to an embodiment of the present technology. [Figure 12] FIG. 13 shows head gear for a mask in accordance with an embodiment of the present technology. [Figure 13-1] 14 shows a headgear according to an embodiment of the present technology. [Figure 13-2] 14 shows a headgear according to an embodiment of the present technology. [Figure 13-3] 14 shows a headgear according to an embodiment of the present technology. [Figure 13-4] 14 shows a headgear according to an embodiment of the present technology. [Figure 13-5]14 shows a headgear according to an embodiment of the present technology. [Figure 14-1] 14 illustrates an elbow for a mask in accordance with an embodiment of the present technology. [Figure 14-2] 14 illustrates an elbow for a mask in accordance with an embodiment of the present technology. [Figure 14-3] 14 illustrates an elbow for a mask in accordance with an embodiment of the present technology. [Figure 14-4] 14 illustrates an elbow for a mask in accordance with an embodiment of the present technology. [Figure 15] 13 shows a sealing portion with an adhesive strip according to an embodiment of the present technology. [Figure 16-1] 13 illustrates a sealing portion comprising flexible tubing in accordance with an embodiment of the present technology; [Figure 16-2] 13 illustrates a sealing portion comprising flexible tubing in accordance with an embodiment of the present technology; [Figure 17-1] 13 illustrates a sealing portion with a gusset-type suspension system in accordance with an embodiment of the present technology. [Figure 17-2] 13 illustrates a sealing portion with a gusset-type suspension system in accordance with an embodiment of the present technology. [Figure 18-1] 13 shows a sealing portion attached to an exoskeleton according to an embodiment of the present technology. [Figure 18-2] 13 shows a sealing portion attached to an exoskeleton according to an embodiment of the present technology. [Figure 19] 13 shows a gel seal portion according to an embodiment of the present technology. [Figure 20-1] 13 is a cross-sectional view of a sealing portion according to an embodiment of the present technology; [Figure 20-2] 13 is a cross-sectional view of a sealing portion according to an embodiment of the present technology; [Figure 20-3] 13 is a cross-sectional view of a sealing portion according to an embodiment of the present technology; [Figure 20-4] 13 is a cross-sectional view of a sealing portion according to an embodiment of the present technology; [Figure 20-5] 13 is a cross-sectional view of a sealing portion according to an embodiment of the present technology; [Figure 20-6] 13 is a cross-sectional view of a sealing portion according to an embodiment of the present technology; [Figure 20-7] 13 is a cross-sectional view of a sealing portion according to an embodiment of the present technology; [Figure 21-1] FIG. 13 is a side view of the lower portion of an embodiment of the present technology. [Figure 21-2] FIG. 13 is a rear view of the lower portion of an embodiment of the present technology. [Figure 21-3] FIG. 13 is a front view of the lower portion of an embodiment of the present technology. [Figure 21-4] FIG. 13 shows a top view of the lower portion of an embodiment of the present technology. [Figure 21-5] FIG. 13 is another top view of the lower portion of an embodiment of the present technology. [Figure 21-6] FIG. 13 is a bottom view of the lower portion of an embodiment of the present technology. [Figure 22-1] FIG. 13 shows a side view of the upper portion of an embodiment of the present technology. [Figure 22-2] FIG. 13 is a rear view of the upper portion of an embodiment of the present technology. [Figure 22-3] FIG. 13 shows a front view of the upper portion of an embodiment of the present technology. [Figure 22-4] FIG. 13 shows a top view of the upper portion of an embodiment of the present technology. [Figure 23-1] FIG. 13 is a side view of an embodiment of the present technology. [Figure 23-2] FIG. 13 is a rear view of an embodiment of the present technology. [Figure 23-3] FIG. 1 is a front view of an embodiment of the present technology; [Figure 23-4] FIG. 1 illustrates a top view of an embodiment of the present technology; [Figure 23-5] FIG. 13 shows a bottom view of an embodiment of the present technology. [Figure 23-6] FIG. 13 is a side cross-sectional view illustrating an embodiment of the present technology. [Figure 23-7] FIG. 13 is a front cross-sectional view illustrating an embodiment of the present technology; [Figure 24-1]FIG. 13 is a top view of a sealing portion according to an embodiment of the present technology. [Figure 24-2] FIG. 24-2 is a front view showing the sealing portion of FIG. 24-1. [Figure 24-3] FIG. 24-2 is a front view showing the sealing portion of FIG. 24-1. [Figure 24-4] FIG. 24-2 is a bottom view showing the sealing portion of FIG. 24-1. [Figure 25-1] 13 is a cross-sectional view of a sealing portion according to an alternative embodiment of the present technology; [Figure 25-2] 13 is a cross-sectional view of a sealing portion according to an alternative embodiment of the present technology; [Figure 25-3] 13 is a cross-sectional view of a sealing portion according to an alternative embodiment of the present technology; [Figure 25-4] FIG. 13 is a top view of a sealing portion according to an embodiment of the present technology. [Figure 26] FIG. 13 is a side view illustrating a separation configuration according to an embodiment of the present technology. [Figure 27-1] FIG. 1 is a perspective view illustrating an embodiment of the present technology; [Figure 27-2] FIG. 1 is a perspective view illustrating an embodiment of the present technology; [Figure 28] 13 is a perspective view of a sealing portion with sizing options according to an embodiment of the present technology; [Figure 29] FIG. 1 is a cross-sectional view showing a sealing portion of the prior art. [Diagram 30] FIG. 1 is a cross-sectional view showing a sealing portion of the prior art. [Diagram 31] 13 is a cross-sectional view of a sealing portion according to an embodiment of the present technology; [Figure 32-1] FIG. 13 is a rear view showing attachment of a headgear to a sealing portion according to an embodiment of the present technology. [Figure 32-2] FIG. 13 is a front view showing attachment of headgear to a sealing portion according to another embodiment of the present technology. [Figure 33-1] 13 is a top view of a support member for a sealing portion according to an alternative embodiment of the present technology; [Figure 33-2] 13 is a top view of a support member for a sealing portion according to an alternative embodiment of the present technology; [Figure 34-1] 13 shows a membrane support for a sealing portion according to an embodiment of the present technology. [Figure 34-2] 13 shows a membrane support for a sealing portion according to an embodiment of the present technology. [Figure 35-1] FIG. 13 shows a top view of a sealing portion with a flexible portion according to an embodiment of the present technology. [Figure 35-2] FIG. 35-2 is a cross-sectional view showing the sealing portion of FIG. 35-1. [Figure 35-3] FIG. 35-2 is a cross-sectional view showing the sealing portion of FIG. 35-1. [Diagram 36] FIG. 1 illustrates a side view of a membrane implementation according to an embodiment of the present technology. [Figure 37-1] FIG. 13 shows a vent according to an embodiment of the present technology. [Figure 37-2] FIG. 13 shows a vent according to an embodiment of the present technology. [Figure 38] FIG. 13 is a side view of an elbow in accordance with an embodiment of the present technology. [Figure 39] 13 is a perspective view showing a support mechanism for a stem of a sealing portion according to an embodiment of the present technology; [Diagram 40] 13 is a cross-sectional view of a sealing portion according to an embodiment of the present technology; [Diagram 41] FIG. 13 is a side view of a tube separation mechanism according to an embodiment of the present technology. [Figure 42-1] FIG. 13 is a top view of a swivel ring with vent holes according to an embodiment of the present technology. [Figure 42-2] FIG. 42-2 is a perspective view showing the swivel ring of FIG. 42-1. [Figure 42-3] FIG. 13 is a side view of a swivel ring according to an embodiment of the present technology. [Figure 42-4] FIG. 13 is a top view of a swivel ring with vent holes according to an alternative embodiment of the present technology. [Figure 42-5] FIG. 13 is a top view of a swivel ring with vent holes according to an alternative embodiment of the present technology. [Figure 42-6]FIG. 13 is a top view of a swivel ring with vent holes according to an alternative embodiment of the present technology. [Figure 42-7] FIG. 13 is a top view of a swivel ring with vent holes according to an alternative embodiment of the present technology. [Figure 42-8] A cross-sectional view showing the swivel ring of Figure 42-7. [Diagram 43] FIG. 1 illustrates a side view of a system having a plenum in accordance with an embodiment of the present technology. [Diagram 44] 13 illustrates a seal between the sealing portion and a patient's nose in accordance with an embodiment of the present technology. [Diagram 45] 13 illustrates a seal between the sealing portion and a patient's nose in accordance with an embodiment of the present technology. [Figure 46] 13 illustrates a seal between the sealing portion and a patient's nose in accordance with an embodiment of the present technology. [Figure 47-1] FIG. 13 is a perspective view of a patient interface in accordance with the present technology including a sealing portion and a support portion. [Figure 47-2] FIG. 13 is a perspective view of a patient interface in accordance with the present technology including a sealing portion and a support portion. [Figure 47-3] FIG. 13 is a perspective view of a patient interface in accordance with the present technology including a sealing portion and a support portion. [Figure 48-1] FIG. 47-2 is a top view showing the sealing portion and the supporting portion of FIG. 47-1. [Figure 48-2] FIG. 47-2 is a schematic top view showing the sealing portion of FIG. 47-1. [Figure 49] FIG. 47-2 is a front view showing the sealing portion and the supporting portion of FIG. 47-1. [Figure 50] FIG. 47-2 is a rear view showing the sealing portion and the support portion of FIG. 47-1. [Figure 51-1] FIG. 50 is a side cross-sectional view of the sealing portion and the support portion of FIG. 49. [Figure 51-2] FIG. 50 is a side cross-sectional view of the sealing portion and support portion of FIG. 49 with a second membrane. [Figure 52-1] FIG. 47-2 is a side view showing the support portion of FIG. 47-1. [Figure 52-2]FIG. 50 is a front cross-sectional view of the sealing portion and the support portion of FIG. 49. [Figure 52-3] FIG. 50 is a partial front cross-sectional view of the sealing portion and the support portion of FIG. 49. [Figure 52-4] FIG. 50 is a side cross-sectional view showing the sealing portion and support portion of FIG. 49 in use on a patient. [Figure 52-5] FIG. 50 is a side view showing the sealing portion and support portion of FIG. 49 in use on a patient. [Figure 52-6] FIG. 50 is a side cross-sectional view showing the sealing portion and support portion of FIG. 49 in use on a patient. [Figure 52-7] FIG. 50 is a front perspective view showing the sealing portion and support portion of FIG. 49 in use on a patient. [Diagram 53] FIG. 47-2 is a front view showing the support portion of FIG. 47-1. [Figure 54] FIG. 47-2 is a front view showing the support portion and headgear connector of FIG. 47-1. [Figure 55] FIG. 55 is a top view showing the support portion and headgear connector of FIG. 54. [Figure 56-1] FIG. 55 is a side view showing the support portion and headgear connector of FIG. 54. [Figure 56-2] FIG. 55 is a cross-sectional view showing the support portion of FIG. 54. [Figure 56-3] FIG. 55 is a cross-sectional view showing the support portion of FIG. 54. [Figure 57] FIG. 13 is a front perspective view of a patient interface according to an embodiment of the present technology. [Figure 58] FIG. 13 is a front perspective view of a patient interface in a bent position in accordance with an embodiment of the present technology; [Figure 59] FIG. 13 shows a perspective view of a polyaxial elbow assembly in accordance with an embodiment of the present technology; [Figure 60] FIG. 13 is a right perspective view showing a patient interface on a patient in use according to an embodiment of the present technology; [Figure 61] FIG. 13 is a left perspective view showing a patient interface on a patient in use according to an embodiment of the present technology; [Figure 62] FIG. 13 is a front perspective view of a patient interface on a patient in use according to an embodiment of the present technology; [Figure 63] FIG. 13 is a left perspective view showing a patient interface on a patient in use according to an embodiment of the present technology; [Figure 64] FIG. 13 is a front perspective view of a patient interface on a patient in use according to an embodiment of the present technology; [Figure 65] FIG. 13 is a perspective view of a patient interface with a bellows in accordance with an embodiment of the present technology. [Figure 66] FIG. 13 is a perspective view of a patient interface with a bellows in accordance with an embodiment of the present technology. [Figure 67] FIG. 13 is a left perspective view of a patient interface with headgear on the patient, in use, in accordance with an embodiment of the present technology; [Figure 68] FIG. 13 is a perspective view of a bellows according to an embodiment of the present technology. [Figure 69] 7 is a graph showing various dimensions of the bellows of FIG. [Figure 70] FIG. 13 is a perspective view of a patient interface with a ball joint and socket connector according to an embodiment of the present technology. [Figure 71] FIG. 13 is a perspective view of a ball joint and connector according to an embodiment of the present technology. [Figure 72] FIG. 1 shows a perspective view of a socket connector according to an embodiment of the present technology; [Figure 73] FIG. 13 is a perspective view of a ball joint and elbow with vent holes according to an embodiment of the present technology. [Figure 74] FIG. 13 is a cross section showing a ball joint and elbow with vent holes according to an embodiment of the present technology. [Figure 75] FIG. 13 is a perspective view of a ball joint and elbow with a removable vent insert according to an embodiment of the present technology. [Figure 76] FIG. 13 is a perspective view of a mesh vent according to an embodiment of the present technology. [Figure 77] FIG. 13 shows a ball joint and elbow with vent holes according to an embodiment of the present technology. [Figure 78] FIG. 13 shows a perspective view of a socket connector with ventilation grooves according to an embodiment of the present technology; [Figure 79] FIG. 13 is a left perspective view showing a patient interface with headgear on a patient in use according to an embodiment of the present technology. [Figure 80] FIG. 13 is a perspective view of a hybrid elbow and ball joint in accordance with an embodiment of the present technology. [Figure 81] FIG. 81 is a cross-sectional view of the combined elbow and ball joint of FIG. 80 in accordance with an embodiment of the present technology. [Figure 82] FIG. 81 is a side perspective view showing a patient interface with the hybrid elbow and ball joint of FIG. 80 in use on a patient according to an embodiment of the present technology. [Figure 83] FIG. 81 is a side perspective view showing a patient interface with the hybrid elbow and ball joint of FIG. 80 in use on a patient according to an embodiment of the present technology. [Figure 84] FIG. 13 is a side perspective view showing a patient interface with a membrane and elbow assembly in use on a patient according to an embodiment of the present technology. [Figure 85] FIG. 13 is a perspective view of an angled elbow ball joint assembly according to an embodiment of the present technology. [Figure 86] FIG. 13 is a left perspective view showing a patient interface with headgear on a patient in use according to an embodiment of the present technology. [Figure 87] FIG. 13 is a perspective view showing a patient interface with headgear on a patient in use according to an embodiment of the present technology; [Figure 88] FIG. 13 is a left perspective view showing a patient interface with headgear on a patient in use according to an embodiment of the present technology. [Figure 89]FIG. 13 is a rear perspective view showing headgear on a patient in use according to an embodiment of the present technology; [Figure 90] FIG. 13 is a perspective view showing a patient interface with headgear on a patient in use according to an embodiment of the present technology; [Figure 91] FIG. 13 is a perspective view showing a patient interface with headgear on a patient in use according to an embodiment of the present technology; [Figure 92] FIG. 13 is a rear perspective view of a patient interface with headgear according to an embodiment of the present technology. [Figure 92-1] FIG. 13 is a front perspective view of a patient interface with headgear in accordance with an embodiment of the present technology; [Figure 93] FIG. 13 is a left perspective view showing a patient interface with headgear on a patient in use according to an embodiment of the present technology. [Figure 94] FIG. 13 is a perspective view showing a patient interface with headgear on a patient in use according to an embodiment of the present technology; [Figure 95] FIG. 13 is a perspective view showing a ball and socket assembly combined with a ball joint portion, vent and swivel ring according to an embodiment of the present technology. [Figure 96] FIG. 13 is a perspective view of a swivel ring and ball joint according to an embodiment of the present technology. [Figure 97] FIG. 13 is a front perspective view showing a ball and socket assembly combined with a ball joint portion, vent and swivel ring according to an embodiment of the present technology. [Figure 98] FIG. 13 is a perspective view showing a ball and socket assembly combined with a ball joint portion, vent and swivel ring according to an embodiment of the present technology. [Figure 99] FIG. 13 is a side perspective view showing a ball and socket assembly combined with a ball joint portion and a swivel ring according to an embodiment of the present technology. [Figure 100]FIG. 13 is a side perspective view of a ball and socket assembly combined with a ball joint portion and a swivel ring according to an embodiment of the present technology. [Figure 101] FIG. 13 is a side cross-sectional view showing a ball and socket assembly combined with a ball joint portion, vent and swivel ring joint according to an embodiment of the present technology. [Figure 102] FIG. 13 is a perspective view showing a patient interface with a side connection tube on a patient in use according to an embodiment of the present technology. [Figure 103] FIG. 13 is a front perspective view showing a patient interface with a side connection tube on a patient in use according to an embodiment of the present technology. [Figure 104] FIG. 13 is a front perspective view showing a patient interface with a side connection tube on a patient in use according to an embodiment of the present technology. [Figure 105] FIG. 13 is a front perspective view of a patient interface with a double sided connecting tube according to an embodiment of the present technology. [Fig. 106] FIG. 13 is a front perspective view of a patient interface including a frame and headgear according to an embodiment of the present technology. [Figure 107] FIG. 13 is a front perspective view showing a patient interface with a frame and headgear on a patient in use according to an embodiment of the present technology. [Figure 108] FIG. 13 is a perspective view of a patient interface with a headgear cradle according to an embodiment of the present technology. [Fig. 109] FIG. 13 is a perspective view of a patient interface with a headgear cradle according to an embodiment of the present technology. [Figure 110] FIG. 13 is a perspective view showing headgear with hook and loop material as well as finger loops according to one embodiment of the present technology. [Figure 111] FIG. 13 is a perspective view of a flexible tube and ball with curved vent grooves according to an embodiment of the present technology; [Figure 112]FIG. 13 is a perspective view of a flexible tube and ball with vent holes according to an embodiment of the present technology; [Figure 113-1] FIG. 13 is a perspective view of an elbow ball with ventilation grooves according to an embodiment of the present technology. [Figure 113-2] FIG. 13 is a perspective view of an elbow ball with vent grooves and a removable barrier according to an embodiment of the present technology. [Fig. 114] FIG. 13 is a perspective view of a patient interface comprising a headgear coupled to a cradle and further coupled to an elbow according to an embodiment of the present technology. [Figure 115] FIG. 13 is a perspective view showing an elbow and swivel connector with vent grooves according to an embodiment of the present technology; [Fig. 116] FIG. 13 is a perspective view showing an elbow and swivel connector with vent grooves according to an embodiment of the present technology; [Figure 117] FIG. 13 is a front perspective view showing a sealing portion of a patient interface according to an embodiment of the present technology. [Figure 118-1] 13 is a perspective view of a sealing portion of a patient interface according to an embodiment of the present technology. [Figure 118-2] 13 is a perspective view of a sealing portion of a patient interface according to an embodiment of the present technology. [Figure 118-3] 13 is a perspective view of a sealing portion of a patient interface according to an embodiment of the present technology. [Figure 119] FIG. 13 is a top view of a sealing portion of a patient interface according to an embodiment of the present technology. [Figure 120] 13 is a perspective view of a sealing portion of a patient interface according to an embodiment of the present technology. [Figure 121] FIG. 13 is a front view showing a sealing portion of a patient interface according to an embodiment of the present technology. [Figure 122-1] 13 is a cross section showing a sealing portion of a patient interface according to an embodiment of the present technology. [Figure 122-2] 13 is a cross section showing a sealing portion of a patient interface according to an embodiment of the present technology. [Figure 122-3] 13 is a cross section showing a sealing portion of a patient interface according to an embodiment of the present technology. [Figure 123] 13 is a cross section showing a sealing portion of a patient interface according to an embodiment of the present technology. [Figure 124] FIG. 13 is a top view of a sealing portion of a patient interface according to an embodiment of the present technology. [Fig. 125] FIG. 13 is a top view of a sealing portion of a patient interface according to an embodiment of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] The following description is provided in relation to several embodiments that may share common properties and characteristics. It should be understood that one or more features of any one embodiment may be combinable with one or more features of other embodiments. Furthermore, any single feature or combination of features of any embodiment may constitute additional embodiments.

[0036] As used herein, the words "having" and "comprising" are to be understood in the non-exclusive sense or in the sense of "including", and not limited to the exclusive sense or the sense of "consisting only of".

[0037] The term "air" is intended to include any breathable gas, such as air with supplemental oxygen. It should also be understood that the PAP devices or blowers described herein may be designed to pump fluids other than air.

[0038] 1. PAP System 1, a PAP system 10 generally includes a PAP device 15, an air delivery conduit 20 (also referred to as an air delivery tube or air delivery tubing), and a patient interface 100. In use, the PAP device 15 produces a supply of pressurized air that is delivered to a patient via the air delivery conduit 20, which includes one end that is coupled to an outlet of the PAP device 15 and an opposite end that is coupled to the patient interface 100. The patient interface 100 is comfortably engaged with the patient's face to form a seal.

[0039] 2. Patient Interface The patient interface 100 may include a mask 200 and headgear 300 configured to maintain the mask in place on the patient's face during use as shown in Figure 1. As shown, the mask 200 may include a sealing portion 210, a frame 220, an elbow 230 (e.g., with a swivel) adapted to be coupled to an air delivery tube 20, a headgear attachment 240 (e.g., a slot or clip on the frame and / or on the forehead support provided to engage a headgear strap), a forehead support 250, and a forehead adjustment device 260.

[0040] In prior art patient interfaces, such as ResMed's Mirage Quattro™ (as shown in FIG. 1), the mask on the patient's face is bulky and cumbersome. The substantially rigid frame 220 combined with the headgear 300 encases a large portion of the patient's face. Such a configuration can psychologically interfere with the patient's treatment and therefore adversely affect their compliance.

[0041] Another prior art patient interface is ResMed's Mirage Swift™, a nasal pillows or puff mask that seals in or around the patient's nares. Such a configuration can cause discomfort due to the nasal pillows contacting in or around the nares. Additionally, discomfort can be caused by an "air jetting" effect due to high velocity laminar airflow directed upward into the nares, which increases pressure in small areas within the nasal passages and dries out the mucous membranes.

[0042] The patient interface disclosed in one or more embodiments of the following description overcomes this by being less intrusive and more comfortable. The proposed patient interface does not seal in the nares, thus eliminating this discomfort. Also, unlike nasal pillows patient interfaces, the proposed patient interface has a single opening or aperture that directs breathable gas into the patient's airway. A single opening allows for more turbulence in the airflow, thereby reducing the "air jetting" effect.

[0043] 3. Mask 1-1 through 1-18 show a mask 200 having a sealing portion 210, a suspension system 215, and a frame 220 in accordance with one embodiment of the present technology. The mask 200 may be either a full face mask or a nasal only mask. The mask 200 may also be a mouth only mask. While the preferred mask is below the nasal structure, aspects of the present technology may be incorporated into other forms of masks, such as a mask that surrounds the nose or a mask that surrounds both the nose and mouth.

[0044] 3.1 Seal part In use, the sealing portion 210 interfaces with the patient and allows for the delivery of breathable gas to the patient. In the embodiment shown, the sealing portion 210 can form a seal with the patient's nares in use. For example, the sealing portion 210 can interface with and seal with the outer portions of each of the alar or nostril flaps, the upper lip and / or the base of the nostrils, and the tip of the nose. The sealing portion 210 can be made from a material including, but not limited to, silicone, thermoplastic elastomer, gel, foam material, or any other suitable conformable material. The material can have a durometer of about 1 Shore A to 15 Shore A. Preferably, the material can have a durometer of about 3 Shore A to 10 Shore A. Preferably, the material can have a durometer of about 5 Shore A to 12 Shore A. Most preferably, the material can have a durometer of about 5 Shore A. Thus, the preferred sealing portion achieves an atraumatic configuration that does not extend into the patient's nostrils during use. The preferred sealing portion 210 does not inflate and therefore does not require inflation pressure to form a seal. Preferably, the seal is not pressure assisted, but may be modified to be pressure assisted. In one form, the sealing portion may use gussets (e.g., having a projected area larger than the area of ​​the sealing portion) to aid in forming a seal, as disclosed in U.S. Patent No. 5,399,623 or U.S. Patent No. 5,399,623, the entireties of which are incorporated herein by reference.

[0045] In one embodiment, the sealing portion may have a wall thickness of about 0.1-15 mm. Preferably, the sealing portion may have a wall thickness of about 2 mm to 10 mm. Preferably, the sealing portion may have a wall thickness of about 7 mm to 12 mm. Preferably, the sealing portion may have a wall thickness of about 1-5 mm. Most preferably, the sealing portion may have a wall thickness of about 1-3 mm. Most preferably, the sealing portion may have a wall thickness of about 1.5 mm. The wall thickness may vary in various regions of the sealing portion, for example ranging from about 0.5 mm thick in the thin regions to up to about 2-10 mm in the thick regions. Alternatively, the sealing portion may have a constant wall thickness, for example about 1.2 mm. The wall may be composed of various layers of material, each layer having a different hardness and / or thickness (for example, two layers each 1.2 mm thick but with silicone of different durometers).

[0046] 3.1.1 Shape In the embodiment shown, the sealing portion 210 (also referred to as the nasal cradle) may have a generally cradle, cup or U-shape so that when placed under the patient's nose it conforms to or is shaped to generally match the patient's alar angle (see, e.g., FIG. 1-1 and also see FIGS. 19-21 and associated description of U.S. Patent No. 5,399,323, published as U.S. Patent No. 5,399,323).

[0047] The generally smooth curves, or wavy shape, of sealing portion 210 may be conformable, since it may bend to accommodate a variety of nose shapes and sizes. The general shape of sealing portion 210 may also provide comfort to the patient and be unobtrusive, thereby increasing compliance.

[0048] Alternatively, sealing portion 210 may be generally flat and still bendable to accommodate the patient's desired alar angle, which may be accomplished by providing sealing portion 210 with sections of reduced thickness to facilitate bending and / or by constructing sealing portion 210 from or incorporating sections of flexible material.

[0049] 3.1.2 Aperture As best shown in Figures 1-2 through 1-7, the sealing portion 210 may have an aperture 211 that allows for the passage of breathable gas from the air delivery conduit 20 to the patient. The aperture 211 may be generally circular, rectangular, or any other desired shape (e.g., a trapezoidal or elliptical shape as shown in Figures 1-4, 1-5 and 48). In one embodiment, the aperture 211 may be shaped to indicate the alignment or orientation of the sealing portion 210 relative to the patient's nose in use, such as, for example, a trapezoidal or triangular shape.

[0050] The apertures 211 in the seal portion may be larger compared to the apertures in a nasal pillows or prongs mask, which means that the velocity of the air exiting the apertures 211 may be lower compared to a nasal prongs or pillows mask. The lower velocity of the air exiting the apertures 211 makes it easier for the patient to exhale against the incoming air and also reduces discomfort from high velocity airflow in and around the nose.

[0051] As shown in the embodiment of FIG. 48-1, the aperture 455 can have a dimension d1 (width) corresponding to the width of the nose of various patients having various measurements, and a dimension d2 (height) corresponding to the nose tip height or distance from the upper lip of various patients having various measurements. Preferably, the dimension d1 can be about 10-60 mm. Preferably, the dimension d1 can be about 15-40 mm. Most preferably, the dimension d1 can be about 21 mm. Most preferably, the dimension d1 can be about 38 mm. Most preferably, the dimension d1 can be about 58 mm. Preferably, the dimension d2 can be about 1-20 mm. Most preferably, the dimension d2 can be about 5-15 mm. Most preferably, the dimension d2 can be about 11 mm. Any other values ​​of d1 and d2 may be used to provide sufficient gas flow without excessively high impedance and to accommodate different sized noses. The radius of curvature of the corner portion 457 may be 5 mm, although different radii of curvature may be used.

[0052] 3.1.3 Engagement part In the embodiment shown, the sealing portion 210 may have a nose tip engaging portion 212 and an upper lip engaging portion 213. As shown in Figs. 1-2 to 1-4 and 1-8, the nose tip engaging portion 212 is generally flat or planar along its length to provide a sufficient length of sealing surface to accommodate various sizes of noses. The upper lip engaging portion 213 is generally curved along its length to minimize contact with the patient's upper lip during use. Fig. 20-1 shows a top view of another embodiment, illustrating the portions shown in Figs. 20-2 to 20-7. In one embodiment, as shown in Fig. 20-5, the radius of curvature R4 of the outer or non-patient contacting side of the nose tip engaging portion 212 is greater than the radius of curvature R2 of the outer or non-patient contacting side of the upper lip engaging portion 213. In one embodiment, the radius of curvature R3 of the inner or patient-contacting side of the nose tip engaging portion 212 is greater than the radius of curvature R1 of the inner or patient-contacting side of the upper lip engaging portion 213. The radii of curvature of the non-patient-contacting side (e.g., R2, R4) may be different (e.g., larger or smaller) than the radii of curvature of the patient-contacting side (e.g., R1, R3). The radii of curvature of R1, R2, R3 and R4 may be 1-5 mm, e.g., 2 mm, 3 mm, 4 mm. In one embodiment, R1 may be about 3-3.75 mm, R2 may be about 2 mm, R3 may be about 3.25-4.5 mm, and R4 may be about 3.25-4.25 mm. As shown in FIG. 20-2, the radii of curvature R10 and R11 may be about 8-13 mm, e.g., 9 mm, 11.5 mm. In one embodiment, R10 may be approximately 9.5 to 11.5 mm, and R11 may be approximately 9 to 10.5 mm.

[0053] 3.1.4 Nostril Engagement Flaps In the embodiment shown, the sealing portion 210 may have a nostril-engaging flap 214 that is structured to be aligned near or facing the patient's nares. In use, the flap 214 creates a seal with the nostril (e.g., directly at the entrance to the nostril or along the patient's nares) and is bent or biased inwardly toward the patient's nose to stabilize and secure the seal, as well as to allow the sealing portion 210 to conform to a variety of nose sizes and shapes.

[0054] As demonstrated in FIGS. 1-6 , the nostril engagement flaps 214 may be angled as indicated by angle α (measured from the center of the aperture 211 and forming a generally straight path along each nostril engagement flap 214) so ​​as to be generally V-shaped.

[0055] In one embodiment, the angle α is in the range of about 0-180°, e.g., about 90-180°, about 90-120°, about 120-180°, about 0-90°, about 0-45°, about 45-90°, about 90°, about 75°-95°, etc. The angle α represents the angle of the engagement flaps in a non-use or relaxed configuration. The angle α increases in use or when the patient places the mask over the nose and exerts a force on the mask by the nose, thereby bending the engagement flaps outward to the use position. This may include angles of about 75°-200°. The radius of curvature represented by the schematic area bounded by α may be about 5-8 mm.

[0056] The nostril engagement flap can have alternative configurations to enhance the seal. For example, as shown in FIG. 6-1, the nostril flap 214 can be narrower (e.g., angle α can be smaller) so that it "pins" against the nose or is bent outward by the nose in use. As shown in FIG. 6-2, the flap 214 can have a hook-shaped end portion 214(1) that is structured to "hook" over the patient's nostril in use to seal across the patient's nostril.

[0057] 3.1.5 Protruding seal area 1-2 through 1-8, nose tip engaging portion 212, upper lip engaging portion 213 and nostril engaging flap 214 are all structures that curve or extend outwardly from a tubular support wall or base 219. That is, nose tip engaging portion 212, upper lip engaging portion 213 and nostril engaging flap 214 overhang or cantilever from the support wall such that they extend or curve outwardly from the support wall defining an air path to the outer edge of sealing portion 210 in a continuous and uninterrupted smooth manner.

[0058] 3.1.6 Seal parts with malleable wire 4-1 through 4-7 show the sealing portion 210 with a malleable wire 270. As shown, the malleable wire 270 is provided on the underside or non-face-contacting portion of the sealing portion and extends along the periphery of the sealing portion (e.g., spaced inward from the edge of the sealing portion to avoid any contact with the patient's face during use). However, the malleable wire may be provided on one or more selected portions of the sealing portion (e.g., along only the flaps). The malleable wire allows the patient to deform the sealing portion 210 to fit their particular nose shape (i.e., to adjust the geometry of the sealing portion themselves) and also allows the deformed shape of the sealing portion to be maintained during use. For example, FIG. 4-8 shows the sealing portion 210 deformed into a generally V-shape, and FIG. 4-9 shows the sealing portion 210 deformed into a generally flat or planar shape.

[0059] In this embodiment, the sealing portion 210 comprising the malleable wire 270 is provided on a base 271 adapted to be attached to a frame, however such a sealing portion may also be provided on a suspension system or directly on a frame, as will be explained below.

[0060] The malleable wire may be attached to the seal portion in any manner or may otherwise be provided to the sealing wire in any manner, for example, co-molded with the seal portion or retrofitted.

[0061] The sealing portion may be deformable in another suitable manner, for example the same effect may be achieved by constructing the sealing portion of a thermoformable plastics material.

[0062] 3.1.7 Gel beads As shown in Figures 5-1 and 5-2, a bead of gel 272 (e.g., teardrop shaped) may be provided around the periphery of the sealing portion 210 or around one or more portions of the sealing portion (e.g., along the nostril engagement flaps) to support the sealing portion, provide conformability, and / or be palpable during use. The bead of gel 272 may be located along the edge of the sealing portion (Figure 5-1), along a portion of the edge, and / or within the edge (Figure 5-2).

[0063] 3.1.8 Fingers or Ridges In one embodiment, fingers or ridges may be provided along the face-contacting surface of the sealing portion to enhance the seal and prevent leakage during use. FIG. 7-2 shows one embodiment of fingers 273, and FIG. 7-3 shows one embodiment of ridges 724. As shown in FIG. 7-1, the fingers 273 / ridges 274 may be provided in the form of concentric rings around the sealing portion 210. However, the fingers / ridges may be arranged in another suitable manner, for example, in one or more selected areas of the sealing portion. In each embodiment, the fingers / ridges extend outwardly from the face-contacting surface of the sealing portion (e.g., at a height of about 0.5 mm) and are configured to deform during use to conform to the various contours of the patient's face. Such fingers / ridges may improve the seal, particularly in unfavorable locations, for example, from the base of the nose along the upper lip. Such fingers / ridges may also provide a friction / stabilizing interface with the patient's skin during use, thereby improving tactility and maintaining position.

[0064] 3.1.9 Reinforcing ribs In one embodiment, reinforcing ribs 275 (e.g., thickened portions formed integrally with the sealing portion) may be provided on one or more portions of the sealing portion 210 (e.g., the nostril engagement flap 214) to support the sealing portion during use. For example, as shown in FIG. 9-1, the reinforcing ribs 275 may be provided in the form of one or more concentric rings around the sealing portion to provide increased strength around the entire perimeter and support the outer edge of the sealing portion 210 against collapse away from the patient's nose during use. As shown in FIG. 9-2, the reinforcing ribs 275 may extend radially from the aperture 211 (e.g., with one or more "branches" of the rib) to provide increased support and reduce bending in selected areas of the sealing portion, e.g., areas most likely to leak or deform. In another embodiment, the reinforcing ribs or thickened portions may be provided at spaced locations on the sealing portion, e.g., areas most likely to leak or deform. The reinforcing ribs 275 may be thicker than the sealing portion 210. Alternatively, the reinforcing ribs may be made from a material of different hardness than the sealing portion 210 , for example the durometer of the silicone may be higher than the durometer of the silicone of the sealing portion 210 .

[0065] 3.1.10 Gel seal part FIG. 19 shows one embodiment of the sealing portion 210 constructed of gel, i.e., a gel-filled sack or gel-filled membrane (e.g., approximately 0.3-5 mm, illustratively 0.7 mm, wall thickness). As shown, the membrane or sack 276 is filled with one or more layers of gel, and a cap 277 (e.g., constructed of polycarbonate, silicone, polypropylene, nylon) is provided to close and seal the opening into the sack. The cap 277 also helps to position and maintain the gel-filled sack in the frame 220. This gel sealing portion improves comfort and conformability during use.

[0066] 3.1.11 Color-changing materials In one embodiment, the sealing portion may be comprised of a material adapted to change color, such as a heat sensitive material. For example, the sealing portion may be comprised of a heat sensitive color changing silicone, e.g., starting out blue (or any first color) at room temperature and changing to white / clear (or any second color different from the first color) upon the application of heat, e.g., body heat.

[0067] This color changing material can be used by a user to size the seal portion. For example, a patient may be provided with the seal portion for the largest size nose, and as the patient fits the seal portion to their nose, the patient can see exactly how much excess material is on the seal portion, for example, by changing from a first color to a second color when the thermal substance contacts the patient's face. The patient can then trim off the excess material to custom fit the mask to their nose.

[0068] The color changing material can also be used for leak indication, for example, if the leaking air is cooler than body temperature, the color changing material will maintain its first or original color where any leak path exists.

[0069] This color changing material may have other uses, for example, for sealing portions and / or other portions of a patient interface or PAP system.

[0070] For example, the color-changing material may be used for sterilization. If the cleaning substance used (e.g., water) is most effective at cleaning the mask at a certain temperature, the silicone may change color at that particular temperature to indicate that the required sterilization conditions have been met, for example, if the best way to sterilize the mask is to boil it in hot water, the mask may change from colored to white / clear at 100 degrees Celsius. Alternatively, if it is preferred to clean the mask with alcohol, the latent heat reaction from the added alcohol will cause the silicone to change color.

[0071] The color changing material can be used as a service life indicator: if the color changing silicone only changes color a predetermined number of times before it fails, it can be used to indicate that it is time for a new mask.

[0072] Color changing materials can be used to improve invisibility, for example silicone that changes color to clear silicone to make the mask less intrusive.

[0073] Color changing materials can be used as locators, for example the color of silicone can be useful for locating a dropped or lost part.

[0074] The color-changing material can be used to make the mask asymmetric. For example, if the patient has an asymmetric nose, the color-changing material can be a useful indicator of alignment. It is conceivable that the patient may need to position the mask off-center to accommodate their asymmetric nose. The silicone will change color where the nose is currently contacting the mask, allowing the patient to adjust the position of the mask during use to ensure that both nostrils receive a flow of breathable gas from the mask.

[0075] Color changing materials may be used on the PAP device, humidifier and / or tubing (e.g., heated tubing) to indicate that the temperature of the PAP device, humidifier and / or tubing is at a limit or desired temperature.

[0076] In another embodiment, the sealing portion may be constructed of a pressure-sensitive color-changing material. In such an embodiment, the patient can identify pressure points and modify the mask accordingly.

[0077] An exemplary material may be Chromazone® Free Flowing Powder, available from Thermographic Measurements Ltd., Devon, UK.

[0078] Another exemplary material may be Thermochromatic and Liquid Crystal products available from B&H Colour Change Ltd., London, UK.

[0079] Another exemplary material may be Thermochromatic Inks available from Siltech Ltd., Nottingham, UK.

[0080] 3.1.12 Sizing Indicators 27-1 and 27-2 show a sealing portion 210 with a thermo-chromic sizing indicator. FIG. 27-1 shows the sealing portion 210 before use, with the entire sealing portion 210 being colored region 358. FIG. 27-2 shows the exemplary sealing portion 210 after use, with the area contacted by the patient changing color as indicated by colored region 360. The color change indicates the area of ​​the sealing portion 210 that the patient contacted and allows the patient to remove excess material (i.e., colored region 360 in FIG. 27-2) after use. The color change can also be used by the person applying the sealing portion to the patient, thus indicating an ideal choice between pre-made sealing portions of various sizes.

[0081] 3.1.13 Sizing Options The sealing portion 210 can be configured such that a single size cradle can be made that can be trimmed or scaled down to smaller sizes. For example, as shown in FIG. 28, sizing the sealing portion for multiple patients of different sizes can be related to the size of the orifice such that orifice opening 362, orifice opening 364, or orifice opening 366 can be used depending on the size of the patient's nose, i.e., for larger noses, orifice opening 366 is used and for smaller noses, orifice opening 362 is used. Also, excess membrane material of membrane 348 can be trimmed off by the patient or clinician. Perforations or cut lines can be incorporated into the sealing portion 210 to indicate the sizing range.

[0082] 3.1.14 Protrusion 24-1 to 24-4 show the sealing portion 210 (also referred to as a nasal cradle) with a nozzle or protrusion 320. The nozzle 320 is disposed on the sealing portion 210 to be located in or near the patient's nares, and in use positions the sealing portion under the patient's nose 324. The nozzle 320 positions the sealing portion 320 to enable an effective seal to be formed to enable delivery of appropriate treatment to the patient.

[0083] The nozzle 320 includes an orifice 322 that can be used to release gas into the patient's nose 324. The nozzle 320 does not necessarily have to form a seal with the patient's nares, instead the sealing portion 210 can form a seal with the underside of the patient's nose, for example, in the manner described above. In the embodiment shown, the sealing portion 210 includes a septum locator 326 to allow the patient's septum to be located between the nozzle 320. The septum locator 326 may have a cushioning material to provide comfort to the patient in this sensitive area of ​​the nose. Alternative alignment protrusions or mechanisms may be used to position the sealing portion relative to the patient.

[0084] The nozzle 320 is configured to have a curved or concave outer surface 321 that gradually increases in width from the top of the nozzle 320 to the bottom of the nozzle 320 to comfortably fit different sized noses and nostrils. As shown in FIG. 24-2, a patient with a relatively small nose 324 and nostrils can use the curved surface of the nozzle 320 such that the patient's nose extends along a portion of the curved outer surface 321 to form a comfortable seal. As shown in FIG. 24-3, a patient with a relatively large nose 342 and nostrils can use the curved surface of the nozzle 320 such that the patient's nose extends further down the curved outer surface 321 to also form a comfortable seal. Additionally, the sealing portion 210 can be resistively bent to accommodate noses having different sizes, e.g., different widths.

[0085] 3.1.12 Sealing comfort 25-1 through 25-4 illustrate the sealing portion 210 including elements of construction to provide patient comfort. For example, the sealing portion 210 may include a soft, comfortable cushion to improve comfort and improve compliance with treatment. The cushion may be constructed of a low durometer material, such as a material having a hardness of less than 40 Shore A (or Type A). For example, the material may have a hardness of about 5 to 60 Shore A. Preferably, the material may have a hardness of less than 20 Shore A. Most preferably, the material may have a hardness of less than 10 Shore A.

[0086] In FIG. 25-1, a cushion 330 or pocket of soft material is disposed under the sealing membrane 328. The membrane 328 may be constructed of silicone or another suitable material. The cushion 330 may be a molded thermoplastic elastomer (TPE), a gel-filled bladder, a foam material, or another conformable material, or a combination thereof. As shown, the membrane 328 has end portions that hook or wrap over the outer edges of the cushion 330, thus positioning the cushion 330 below the membrane 328 and holding it in place. Also, a latching ridge 332 on the stem 334 of the sealing portion 210 may be provided to hold the cushion 330 by preventing it from sliding downward. That is, the latching ridge 332 provides an obstruction to prevent the cushion from moving downward.

[0087] The sealing portion 210 has an orifice 336 through which breathable gas can be delivered to the patient. The membrane 328 interfaces with the patient and preferably prevents the cushion 330 from interfacing with the patient, thereby placing fewer constraints on material selection for the cushion 330 due to patient safety.

[0088] FIG. 25-2 shows a similar configuration to FIG. 25-1, but further includes a lower membrane 340 for supporting the cushion. Alternatively, an upper membrane 338 and a lower membrane 340 are provided to support the cushion 330 in place. When the patient positions the sealing portion 210 in use, the patient exerts a force (indicated by the arrow) on the sealing portion 210 and the cushion 330. The lower membrane 340 supports the cushion 330 in place so that the cushion 330 generates a sufficient reaction force at the appropriate displacement (as indicated by the arrow), thereby allowing the cushion 330 to form a seal with the patient and also provide comfort to the patient.

[0089] In FIG. 25-3, the sealing portion includes an upper cushion 342 disposed on a lower cushion 344. In this embodiment, the sealing portion may or may not include a sealing membrane as described above. The upper cushion 342 may have one hardness and the lower cushion 344 may have another hardness, for example, the upper cushion 342 may have a lower hardness than the lower cushion 344. In one embodiment, the upper cushion 342 may have a hardness of about 5-20 Shore A (e.g., about 7-15 Shore A, preferably about 7 Shore A) and the lower cushion 344 may have a hardness of about 20-80 Shore A (e.g., about 40-70 Shore A, preferably about 40 Shore A). However, other suitable hardnesses are possible. The upper cushion 342 and the lower cushion 344 may be made of, for example, silicone, TPE, gel, foam material, nylon, or a combination thereof. The lower cushion 344 can support the sealing portion 210 in a fixed position for comfort during use and to allow for a seal to be formed with the patient. An orifice 336 is provided through the upper and lower cushions to allow for the delivery of gas to the patient.

[0090] In FIG. 25-4, the sealing portion 210 may have a horseshoe shape 346 (when viewed from above) to cushion the nose tip portion 352 and the nostril engagement flap. This configuration allows the bladder to be formed as a cushion since the drawing line (indicated by the arrow) of the molding tool is straight and therefore easier to mold. The bladder may be filled with gel, foam, TPE or any other suitable material. The cushion 346 may be provided with a membrane 348, which is positioned to contact the patient's upper lip in use. The membrane 348 may be stretchable and / or flexible to accommodate various upper lip structures. The membrane may also reduce the force acting on the patient's face to create a seal, thus improving comfort at the upper lip position.

[0091] In the embodiment shown in Figures 47-1 through 50, the sealing portion 450 may be formed from a material and may be flexible to provide patient comfort and easily conform to the patient's face. For example, the sealing portion 450 may be a liquid silicone rubber material or another elastomeric material such as TPE. The sealing portion may have a durometer of about 5-40 Shore A (preferably about 5-15 Shore A, most preferably about 5 Shore A) to provide patient comfort.

[0092] 3.1.15 Membrane bending In prior art cradles such as those shown in cross-section in Figures 29 and 30, the membrane 368 is rolled or curved inward from the support wall 370. This configuration allows the patient's nose to move into the cushion and allows the membrane to roll or move downward to form a seal. The support wall 370 ensures that the membrane 368 is supported and also ensures that the membrane 368 has sufficient space to roll or bend inward. This rolling can cause blockage of the patient's nares as excess material can cover the patient's airways.

[0093] In contrast, in an embodiment of the technology as shown in FIG. 31, the membrane 348 is configured to bend outward or away from the center of the patient's nose when in use. Alternatively, this configuration may be described as a trumpet or bell shape. A support wall 372 maintains the membrane 348 in a non-use position and prevents the membrane 348 from bending outward beyond its pre-determined limit. Because the excess material of the membrane 348 bends outward, it reduces the chance of the material blocking the patient's nostrils. The excess material of the membrane 348 reduces the chance of blockage by eliminating or reducing the pinching force created by the flexible outer wall.

[0094] 3.1.16 Membrane support Headgear may be attached to the membrane to support the outer wall of the membrane in an upward position, i.e., to prevent the membrane from bending outward and becoming in a downward position that may block the patient's nares or break the seal between the mask and the patient. As shown in the rear view of FIG. 32-1, headgear straps 378 may be attached to the sealing portion at headgear attachment points 376. As shown, the headgear attachment points 376 are located in close proximity to the orifice 374, so that the straps 378 can support the entire length of the sealing portion 210 and also support the membrane 348 in an upward position during use. Thus, the membrane 348 cannot bend outward too much, thus preventing the patient's nares from being blocked or the seal between the mask and the patient from being broken. The headgear straps 378 can flex and move under the sealing portion 210 that is not attached via a headgear attachment, thereby providing a greater fit by allowing the headgear to rest in multiple positions under the membrane.

[0095] As shown in Fig. 32-2, the headgear 378 may alternatively be attached via headgear attachment points 376 further away from the orifice 374 and closer to the edge of the membrane, allowing for greater flexibility of the membrane to accommodate various nose shapes (e.g., pointy and flat noses).

[0096] FIG. 33-1 shows a support member 381 (e.g., a substantially rigid member) disposed under, within, or as part of the sealing portion 210 (support member 381 is shown in dotted lines). Support member 381 is structured to urge the membrane of sealing portion 210 into contact with areas of the patient's face that are difficult to seal. For example, the corners of the nose and the bulging of the nostrils are difficult to seal at because patients have varying geometries at the corners of the nose and the bulging of the nostrils. Support member 381 may have a stiffer or harderness than the membrane to secure the sealing portion at the upper lip area, corners of the nose area 382, ​​and the bulging of the nostrils area 384, and further to hold the membrane in sealing engagement with the patient in these areas. No support member is disposed in nose tip area 352 because the tip of the nose is very sensitive. The support member 381 may extend at least partially within the upper lip region 350 .

[0097] The support member 381 may be co-molded with the seal portion 210 and may include a malleable wire or another rigid element. The support member 381 may have co-molded thickened regions to provide support.

[0098] 33-2 shows an alternative support member 381 that does not have a nostril bulge region to allow the membrane 348 to flex in the area of ​​the nostril. The support member 381 extends further into the nasal tip region 352 to secure the sealing portion in position against the patient's nares. The support member 381 may also extend at least partially into the upper lip region 350 and nasal corner region 382.

[0099] The support member may be co-molded or may be separate and attached to the membrane. The support member may be made of a material having a higher hardness than the membrane 384. For example, the membrane may be about 10 Shore A and the support member may be about 40 Shore A. However, other suitable hardnesses are possible.

[0100] As shown in Figs. 34-1 and 34-2, multiple regions of the sealing portion may have materials that can support the membrane 348 and also provide comfort to sensitive areas of the face. For example, stabilizing regions 386 may be provided at the corners of the nose and the tip of the nose. The stabilizing regions must be sufficiently stiff to maintain the shape of the sealing portion and support the membrane 348 attached to or adjacent to the sealing portion, while at the same time being sufficiently flexible to provide comfort during use. The stabilizing regions 386 may be composed of gel, foam, TPE, silicone, or any other suitable material.

[0101] 3.1.17 Flexible membrane parts FIG. 35-1 shows an alternative configuration to FIGS. 34-1 and 34-2, where a flexible or cushioning region is in the upper lip region 350. As shown in FIGS. 35-2 and 35-3, this flexible or cushioning region has a lower durometer or hardness than other regions of the sealing portion, such as the nose tip region 352. Additionally, the remaining regions of the sealing portion have two layers, a top layer L1 (i.e., the layer that contacts the patient's face) of low durometer or hardness and a bottom layer L2 of high durometer or hardness. The low durometer material may have a higher adhesion or tack than the bottom harder layer, and therefore may be able to frictionally adhere to the patient's face.

[0102] 3.1.18 Membrane support The membrane 348 may be supported by struts or tabs 390 ( FIG. 36 ) disposed under an outer flap 388 (nostril-engaging flap) of the sealing portion 210. The struts 390 may be attached to or positioned with the headgear connector 376. The struts 390 prevent the outer flap 388 of the sealing portion 210 from folding away from the patient's face, thereby maintaining the sealing position of the sealing portion 210 on the patient's face and allowing a more effective seal to be formed.

[0103] 3.1.20 Dispersion ventilation function As shown in Figs. 37-1 and 37-2, the sealing portion 210 may be secured in place on the patient's head with one or more headgear straps 390. The sealing portion 210 may also be connected to a tube 20 for supplying breathable gas to the patient. The tube 20 may be connected to the sealing portion 210 by a vent ring 392. As shown in Fig. 37-2, the vent ring 392 has a tube connector 398 adapted to be attached to the tube 20 at one end with a step or flange 396 to prevent the tube 20 from being positioned over one or more gas washout vents 394. The vent ring 392 has a sealing portion connector 395 adapted to be connected to the sealing portion at the other end. The connector 395 forms one or more gas washout vents 394 that align with a vent section or track along the end of the sealing portion, thereby allowing gas to be exhaled from the sealing portion 210 through the gas washout vents to the atmosphere. The gas exit vents or passages advantageously direct air away from the patient's face. The gas exit vents or passages also distribute air around the periphery of the vent ring 392, thereby diffusing exhaled gases and preventing them from escaping.

[0104] 3.1.21 Stem Support 39 shows a seal portion 210 having a stem 404 to allow breathable gas to flow through the mask to the patient. The stem 404, which is attached to a tube connection 406, may have one or more ribs 402 or another support mechanism to support the stem 404 and prevent it from potentially collapsing during use and blocking the flow of gas. The ribs may be thickened areas or may be separately attachable or may be built-in struts to hold the stem 404 in an open position. The ribs 402 may also support the seal portion 210, thereby holding it in an open position and preventing the orifice that provides breathable gas to the patient from becoming blocked.

[0105] 3.1.22 Supported Seal Parts The sealing portion 210 may be supported by the support portion. The sealing portion may be entirely separated from the support portion by a gap, or one or more portions of the sealing portion may contact the support portion and other portions of the sealing portion may be separated from the support portion by one or more gaps. When such gaps are used, the corresponding portions of the sealing portion 210 may stretch to fit the patient's face.

[0106] 3.1.22.1 Separated Seal Parts 40 shows sealing portion 210 separated from support portion 409 by a space, or gap, 408(1), 408(2), which allows sealing portion 210 to bend downward until it reaches support portion 409. Support portion 409 prevents sealing portion 210 from losing its shape or folding, thereby helping to maintain a seal against the patient. Patient contacting portion 407 preferably has a lower hardness than support portion 409 and may also be thinner than support portion 409. Patient contacting portion 407 and support portion 409 may be formed by multi-shot molding, adhesive bonding, or any other suitable method.

[0107] The upper lip portion 350 of the sealing portion 210 may have a gap 408(1) between the patient contacting portion 407 and the support portion 409 to accommodate varying measurements of a patient's upper lip. This allows flexibility for the patient contacting portion 407 adjacent the patient's septum, which is a very sensitive area. Additionally, the nasal tip region 352 of the sealing portion 210 may have a gap 408(2) between the patient contacting portion 407 and the support portion 409 to accommodate varying measurements of the patient's nose tip. This flexibility further allows the patient contacting layer 407 to flex around the nasal tip, thereby improving the seal of the sealing portion 210.

[0108] 3.1.22.2 Partially separated seal parts 47-1 shows a view of the sealing portion 450 supported or positioned by a support portion 453. The sealing portion 450 is separated from the support portion 453 by a forward gap in the area of ​​the nose tip engagement portion 452 between the forward fastening points 469, and the sealing portion 450 is coupled to the support portion on the side of the sealing portion 450 outside the forward fastening points 469.

[0109] The nasal tip engaging portion 452 is flexible and can extend downwardly when in contact with the patient's nose, but how far it can extend is limited by whether it reaches the support portion 453. The nasal tip engaging portion extends longitudinally from an aperture 455 to accommodate different sized nasal tips, thereby allowing the nasal tips of various patients to engage the nasal tip engaging portion at different positions. A stem 454 supports the support portion 453 and the sealing portion 450. The stem 454 is also adapted to receive an air delivery tube for supplying pressurized breathable gas to the patient.

[0110] The sealing portion 450, stem 454 and support portion 453 may be a liquid silicone rubber material or another material, such as, for example, a TPE, gel or foam material. The sealing portion 450 may be formed from a material having different properties than the material forming the support portion 453 and stem 454. The stem 454 and support portion 453 may be integrally formed, such as in a mold, and the sealing portion 450 may be formed separately and then integrally joined to the support portion 453, such as by gluing. Alternatively, the stem 454 and support portion 453 may be integrally formed, such as in a mold, and then the sealing portion 450 may be glued to the support portion 453 and stem 454 in the mold.

[0111] The sealing portion 450 may have different properties than the support portion 453 and the stem 454. For example, the sealing portion 450 may be formed from a different (or the same) material as the support portion 453 and the stem 454 and may have a different geometry and hardness than the support portion 453 and the stem 454.

[0112] The support portion 453 and stem 454 have a higher hardness than the sealing portion 450 (which may have a hardness of about 5 Shore A durometer as described above) because both the support portion 453 and stem 454 support the sealing portion 450 and also provide a reaction force to stabilize the sealing portion 450 in position on the patient's face. For example, the support portion 453 and stem 454 have a hardness of about 20-80 Shore A durometer. Preferably, the support portion 453 and stem 454 have a hardness of about 30-65 Shore A durometer. Most preferably, the support portion 453 and stem 454 have a hardness of about 40 Shore A.

[0113] The hardness of the sealing portion 450, support portion 453 and stem 454 may be different from the hardness levels described, in which case the thickness of the material may need to be altered to ensure a seal is formed with the patient. For example, the nose tip engaging portion 452 of the sealing portion 450 may have a durometer hardness of about 5-20 Shore A (preferably about 5-10 Shore A, most preferably about 5 Shore A) and a thickness of 1.2 mm, but if a harder material is used for the sealing portion 450, the nose tip engaging portion 452 should have a reduced thickness, for example to 0.3 mm, so that it exerts the same stiffness or reaction force on the patient's face to form an effective seal.

[0114] 47-2 shows another view of sealing portion 450. Sealing portion 450 is separated from support portion 453 by a rear gap in the area of ​​upper lip engaging portion 462 between rear fixation points 475, and sealing portion 450 is connected to support portion 453 on the side of sealing portion 450 outside rear fixation points 475. Upper lip engaging portion 462 is flexible and can stretch downward when in contact with the patient's upper lip, but how far it can stretch is limited by whether it reaches support portion 453.

[0115] FIG. 49 (and 48-2) shows a front view of the sealing portion 450. The nose tip engaging portion 452 is formed as a suspended flexible membrane. The sides of the sealing portion 450 are connected or bonded to the support portion 453, while a front gap exists between the central portion of the sealing portion 450 and the support portion 453 between the front fastening points 469. The use of this suspended flexible membrane allows the nose tip engaging portion 452 to remain in tensioned contact with the nose during movement of the patient interface, forming a flexible surface that conforms well to various nasal geometries. A wide nose tip engaging portion 452 can be used to provide comfort or effectively seal against various nose sizes, allowing the nose tip to be positioned at various positions between the aperture 455 and the front edge of the nose tip engaging portion 452. The nose tip engaging portion 452 can extend downwardly towards the support portion depending on the size of the patient's nose.

[0116] The sealing portion 450 has thickened corner regions 467 located on either side of the upper lip engaging portion 462. The thickened corner regions 467 are adapted to form a seal with the patient's face in the area of ​​the patient's nose adjacent the nasal and lip creases in use. The two thickened corner regions 467 protrude outwardly to form an effective seal in this area. The two thickened corner regions 467 may each have a radius of curvature between about 2.4 mm and about 6 mm. The radius of curvature of the upper lip engaging portion is about 5 mm.

[0117] The width d5 ​​of the sealing portion 450 may be about 48 mm to accommodate noses up to 45 mm wide. A larger width d5 ​​such as 60 mm may be used to accommodate noses up to 60 mm wide. The distance d6 between the nasal tip engagement portion 452 and the support portion 453 may be about 5-20 mm, preferably 5-15 mm, and most preferably about 10 mm. This distance d6 allows the patient interface 451 to effectively seal with patients having a nasal alar angle of up to about 135°, but may also accommodate patients having a nasal alar angle of up to about 200°. The distance d7, which is the width of the nasal tip engagement portion (and the distance (width) of the portion of the sealing portion 450 not adhered to the support portion 453), may be about 38 mm, but may be another value for larger noses, such as about 48 mm, or up to about 60 mm.

[0118] The radius of curvature of the nose tip engaging portion 452 may be about 30-45 mm, preferably about 30-40 mm, and most preferably about 35 mm, but may be about 35-50 mm, preferably about 40-50 mm, and most preferably about 40 mm, to accommodate flatter noses. At the protruding edge 476 of FIG. 48, a bond contact radius of at least 1 mm may be used to assist the tool, where the protruding edge 476 may be clamped by the tool while the seal portion is being molded. The distance (height) d3 of the nose tip engaging portion is about 10 mm to 30 mm, preferably about 12-18 mm, and most preferably about 17 mm. The distance d4 of the nose longitudinal region is about 20-40 mm, preferably about 25-35 mm, and most preferably about 27 mm, which corresponds to a nose length of about 12 mm to about 25 mm. Distance d4 may be reduced to about 17 mm for wide / short noses (width greater than 40 mm and length less than 15 mm).

[0119] FIG. 48-2 shows a schematic top view of the sealing portion 450. The sealing portion 450 has an aperture 455, a front stretch portion 564, a rear stretch portion 562, a side pressing or compressing portion 566, and a side wrapping or cantilever portion 568. The front stretch portion 564 and the rear stretch portion 562 are flexible portions of the sealing portion that can stretch or bend when contacting the patient's nose tip and upper lip. In these regions, the sealing portion 450 is a thin membrane in tension, so that it fits or conforms to the geometry of the patient's nose tip and upper lip. Preferably, the front stretch portion and the rear stretch portion are held at their ends, respectively, and their central portions are unsupported. This flexibility minimizes the force required to achieve a given displacement on the potentially sensitive upper lip and nose tip.

[0120] The side wrap or cantilever portions 568 are adapted to provide a substantially horizontal or lateral force that is substantially perpendicular to the plane of the patient's nasal bulges. When the patient's nasal bulges are filled with pressurized air, the bulges are forced outward by the air pressure. The side wrap or cantilever portions 458 provide a counter force to the outward force of the bulges, thereby forming a good seal in this area. To obtain sufficient counter force to maintain the seal and prevent seal rupture or seal failure, it may be necessary to reinforce the side wrap or cantilever portions 568 or increase their stiffness (compared to the stretch portions 562, 564). Reinforcement may be achieved by increasing the thickness of the seal portions 450 at these side wrap portions, such as by using a high stiffness material, or by additional structures such as headgear attachments or ribs located under the side wrap or cantilever portions 568.

[0121] The lateral pressure or compression portion 566 is adapted to fix or support the sealing portion 450 in position. In use, the lateral pressure or compression portion 566 may be mostly in compression. The force provided by the lateral pressure portion 566 may be perpendicular to the plane of the patient's face or may be substantially horizontal. Since this area of ​​the patient's face that is in sealing contact is the least sensitive, tension from the headgear is substantially transferred to the lateral pressure portion 566. Preferably, this is the stiffest area of ​​the sealing portion 450. The lateral pressure portion 566 may be thicker than the front stretch portion 562 or the rear stretch portion 564.

[0122] The sealing portion 450 has different stiffness in different regions, i.e., the front stretch portion, the rear stretch portion, the side pressure portion, and the side wrap portion, and the stiffness of these portions can be varied by using different materials, different hardness of materials, different thickness of materials, or by using support portions.

[0123] 50 shows a rear view of the patient interface 451. The sealing portion 450 is connected to the support portion 453 on either side of the patient interface 451 and has an upper lip engaging portion 462 which engages the patient's upper lip in use. The upper lip engaging portion 462 is formed as a suspended flexible membrane such that there is a rear gap between the upper lip engaging portion 462 of the sealing portion 450 and the support portion 453. The rear gap is located between rear fixation points 475 which secure the sealing portion 450 to the support portion 453. The suspended flexible membrane provides a flexible surface which is tensioned to maintain contact with the patient's upper lip during movement of the patient interface and which can stretch to accommodate a variety of facial geometries due to the movement of the upper lip engaging portion 462.

[0124] The thickness d8 of the thickened corner region 467 of the sealing portion 450 may be about 1 mm to 5 mm, preferably about 2 mm to 4 mm, and most preferably about 3.5 mm, with a relatively low durometer Shore A hardness for comfort. The thickness d8 may be increased to about 5 mm to 10 mm, preferably about 5 mm to 8 mm, and most preferably about 5 mm, depending on the thickness of the underlying support portion 453, and may be decreased to the same thickness as the upper lip engagement portion 462, which is about 0.25 to 3 mm, preferably less than 2 mm, and most preferably about 1.2 mm.

[0125] The distance d9 between the unbonded portion of the sealing portion 450 and the support layer 453 at the upper lip engaging portion 462 may be about 1 mm to 15 mm, preferably about 5 mm to 10 mm, most preferably about 7 mm when not in use, and may vary between 0 mm to 15 mm, preferably up to 7 mm, when in use, based on the contact seal force against the patient's philtrum. The distance d10 between the top of the sealing portion 450 and the support portion 453 may be about 10 mm to 30 mm, preferably about 15 mm to 20 mm, most preferably about 18 mm. The width of the upper lip engaging portion 462 (and the distance (width) d11 of the unbonded portion of the sealing portion 450) may be about 10 mm to 30 mm, preferably about 15 mm to 25 mm, most preferably about 20 mm, but this may vary between about 14 mm to about 22 mm depending on the width of the nose. The radius of curvature of the center of the upper lip engagement portion 462 may be approximately 5 mm to 20 mm, preferably 10 mm to 15 mm, and most preferably approximately 12.5 mm when not in use, but is reduced when in use by bending the patient interface 451 inward.

[0126] As such, the sealing portion 450 is connected to the support portion 453 on either side, but separated by gaps from the support portion 453 between the anterior fixation point 469 and the posterior fixation point 475. These gaps allow the sealing portion 450 to flex in use at the patient's nose tip and upper lip areas, thereby providing a good seal and comfort to the patient.

[0127] FIG. 51-1 shows a side cross-sectional view of the patient interface 451. The anterior non-bonded region 460 of the sealing portion 450 may have a radius of curvature of about 8 mm to 15 mm, preferably about 10 mm to 13 mm, and most preferably about 12.5 mm. The rear corner portion 464 of the sealing portion 450 may have a radius of curvature of about 1 mm to 7 mm, preferably about 3 mm to 6 mm, and most preferably about 4 mm. The rear non-bonded region 463 of the sealing portion 450 may have a radius of curvature of about 2 mm to 8 mm, preferably about 3 mm to 6 mm, and most preferably about 5 mm, although this value may vary to be approximately flat at the outer edges.

[0128] The sealing portion 450 may have an outer sealing perimeter 534 on the dotted line to create a seal with the patient's face, and may have a transition region 536 between the opening 455 and the outer sealing perimeter, the transition region 536 gradually increasing in size from the opening to the outer sealing perimeter 534. The opening 455 defines an interior surface in communication with breathable gas, and the outer sealing perimeter 534 is formed as a continuous extension of this interior surface. An outer edge of the sealing portion 450 is oriented away from the opening 455 and / or in the direction of flow of breathable gas. The outer sealing perimeter 534 is substantially concave when viewed from above.

[0129] FIG. 51-2 shows a side cross-sectional view of the patient interface 451. This embodiment has an intermediate portion 450.1 disposed between the sealing portion 450 and the support portion 453. The intermediate portion 450.1 may be formed as a suspended membrane. The intermediate portion 450.1 may be integrally molded with the sealing portion 450, integrally molded with the support portion 453, or molded separately from the sealing portion 450 and the support portion 453. The intermediate portion 450.1 may support the sealing portion 450. The intermediate portion 450.1 may be entirely separated from the sealing portion 450 by a gap, as shown in FIG. 51-2, or portions of the intermediate portion 450.1 may contact the sealing portion 450 and other portions of the intermediate portion 450.1 may be separated from the sealing portion 450 by a gap.

[0130] FIG. 52-1 illustrates a support membrane 465 that may have a support portion 453 and a stem 454. The support portion 453 and the stem 454 may be formed as a single integral element. The support membrane 465 may have an entire wall section 466, a forward thickened portion 468, and a rearward thickened portion 470. The forward thickened portion 468 and the rearward thickened portion 470 are formed on each side of the support portion 453. The forward thickened portion 468 and the rearward thickened portion 470 provide different degrees of support to the sealing portion 450 upon assembly. The support membrane 465 may be constructed of silicone having a hardness of about 20 to 90 Shore A, preferably about 20 to 60 Shore A, and most preferably about 40 Shore A. The support membrane 465 may be made of polycarbonate, polypropylene, nylon, thermoplastic elastomer (TPE), Hytrel®, and the like.

[0131] The thickened front portion 468 is located adjacent to the area of ​​the sealing portion that contacts the side of the patient's nose in use, as shown in Fig. 47-2, and translates the load of the headgear into a clamping force on the side of the patient's nose to form an effective seal. The thickened front portion 468 may have an increasing thickness from top to bottom and may have a height d12 of about 5mm to 20mm, preferably 7mm to 14mm, most preferably about 11mm.

[0132] The posterior thickened portion 470 may have 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 about 7 mm to 20 mm, preferably about 8 mm to 12 mm, most preferably about 9.5 mm, but may be reduced to about 4 mm to reduce loading. The posterior thickened portion 470 may have a curved portion 472 that may have a radius of curvature of about 0.5 mm to 3 mm, preferably about 2 mm, but may be increased to about 4 mm to improve rigidity against the patient's upper lip. The posterior thickened portion 470 may have a perforated portion 477 to reduce the volume of silicone and reduce curing time.

[0133] The rear thickened portion 470 is located directly under the thickened corner area 467 of the sealing portion 450 seen in FIG. 47-3. The rear thickened portion 470 transfers load from the headgear connector to the thickened corner area 467 and further to the lower corner of the patient's nose to help form an effective seal, and as the headgear is pulled, the load transferred to the lower corner of the patient's nose increases. In use, bending forces from the headgear connector 456 are transferred by the rear thickened portion 470 to the thickened corner area 467 of the sealing portion 450, thereby applying a sealing force as a fixing force to the area of ​​the patient's nose adjacent the nose and lip crease. The transfer of force from the headgear connector 456 to the rear thickened portion 470 can be caused by reinforced headgear connector arms that generate a bending force when bent and / or by the headgear connector 456 actually contacting the rear thickened portion 470.

[0134] Additionally, the lateral upper lip portion 474 may be thicker than the entire wall section 466, and has a width d14 that varies from approximately 3.5 mm to 1.2 mm to vary the amount of reaction force against the patient's upper lip.

[0135] 52-2 shows a cross-sectional view of the support membrane 465 and the sealing portion 450. This cross-sectional view illustrates how the support portion 453 supports and contacts the sealing portion 450 on the sides of the sealing portion.

[0136] 52-3 shows another cross-sectional view of the support membrane 465 and sealing portion 450. This cross-sectional view illustrates the difference in thickness between the lower portion 471 and the upper portion 473 of the rear thickened portion 470, and further shows the perforated portion 477.

[0137] FIG. 52-4 shows a cross-sectional view of the support membrane 465 and sealing portion 450 when mated with a patient to form a seal with the patient. The nose tip engaging portion 452 engages the patient's nose tip to form a seal with the patient's nose tip. The nose tip engaging portion 452 and upper lip engaging portion 462 extend toward the support portion 453 when they are in contact with the patient's nose tip and upper lip.

[0138] FIG. 52-5 shows a side view of the support membrane 465 and sealing portion 450 when mated with a patient to create a seal with the patient. The sides of the sealing portion 450 and support portion 453 clamp against the sides of the patient's nose to create a seal with the sides of the patient's nose. A thickened corner area 467 creates a seal with the patient in the area of ​​the patient's nose adjacent the nasal and lip creases. A rear thickened portion 470 is located adjacent and below the thickened corner area 467 to provide additional sealing force.

[0139] 52-6 shows another cross-sectional view of the support membrane 465 and sealing portion 450 when mated and forming a seal with the patient. The sides of sealing portion 450 form a seal with the sides of the patient's nose and are supported in this area by support portion 453, anterior thickened portion 468 and posterior thickened portion 470.

[0140] 52-7 shows a front view of the support membrane 465 and sealing portion 450 when mated with the patient's face. The nose tip engaging portion 452 engages and creates a seal with the patient's nose and extends towards the support portion 453. Anterior fastening points secure the sealing portion 450 to the support portion 453 on either side of the nose tip engaging portion 452. The sides of the sealing portion 450 engage and create a seal with the sides of the patient's nose.

[0141] FIG. 53 shows a front view of the support membrane 465. The distance d15 between the front thickened portions 468 may be about 25 mm to 45 mm, preferably about 35 mm to 42 mm, and most preferably about 40 mm. The distance d15 may be varied to change the stiffness of the contact between the headgear and the side walls of the membrane to increase the clamping load on the sides of the patient's nose. The distance d16 between the rear thickened portions 470 may be about 35 mm to 55 mm, preferably about 40 mm to 50 mm, and most preferably about 46 mm. Varying d16 changes the location where the headgear contacts the rear thickened portions 470, increasing or decreasing the load.

[0142] FIG. 54 shows a front view of the support membrane 465 with the headgear connectors 456. The headgear connectors 456 may be formed as a single integral element molded with the support membrane 465 or may be formed separately and attached to the support membrane 465. The headgear connectors 456 may have headgear tabs 458 for connecting the headgear. The distance d21 from the bottom of the headgear connectors 456 to the top of the support membrane may be about 10 mm to 25 mm, preferably about 12 mm to 20 mm, and most preferably about 17 mm. The distance d20 between the outer ends of the headgear connectors may be about 60 mm to 100 mm, preferably about 70 mm to 90 mm, and most preferably about 80 mm. The headgear connectors 456 may be angled upward at an angle α1, which may be about 2° to 15°, preferably about 5° to 8°, and most preferably about 6.5°. The larger the angle α1, the smaller the moment of the clamping force exerted by the patient interface.

[0143] As shown in FIG. 55, the headgear connectors 456 are positioned towards the base of the sealing portion 450 to generate a moment force on the side walls. When a headgear force is applied by tightening the headgear straps, a predetermined load is placed on the headgear connectors 456 and tabs 458, increasing the inward force on the sides of the sealing portion 450 and applying a sealing force against the sides of the patient's nose. When the headgear straps are tightened, the moment force of the tightening load applied to the sealing portion 450 can displace the sealing portion 450 inward, thereby reducing the width of the sealing portion by approximately half of its original width without the headgear straps in place. The bending force from the headgear connectors 456 is transferred by the support portion 453 to the sealing portion 450 as a tightening force against the sides of the patient's nose in use.

[0144] The stiffness of the sidewalls of the support membrane 465, the stiffness of the headgear connector 456, and the connection point of the headgear connector 456 all affect the amount of clamping force transferred to the sealing portion 450. The headgear connector 456 may have a thickness of about 2.5 mm to 4.0 mm, and the sidewalls of the support membrane 465 may have a thickness of about 1.2 mm to 5.0 mm, both using silicone having a hardness of about 40 Shore A to 65 Shore A durometer. The sidewalls of the headgear connector 456 and the support membrane 465 need not have a constant thickness, but may vary in thickness along their length and width, or may have localized thickened areas to adjust stiffness in certain areas. There may also be additional silicone where the headgear connector 456 connects to the support membrane 465. The headgear connector may alternatively be constructed of a material with a stiffness higher than silicone, such as nylon, polycarbonate, polypropylene, or another suitable material. This may assist in connecting the headgear to the headgear connector.

[0145] FIG. 55 shows a top view of the support membrane 465 with the headgear connector 456. The support portion 453 may have a recessed area 478 formed in the upper surface of the support portion 453, and the recess may be filled with a low hardness filler material having a lower hardness than the support portion to reduce the stiffness of the support portion 453. The recess may be approximately 8 mm by 9 mm inward from the top surface of the support portion 453, although other sizes of recesses may be used. Reducing the stiffness of the support portion 453 may reduce the pinching force applied to the patient's nose (compared to a support portion having a higher stiffness) and a more comfortable seal may be formed. The distance d17 between the center point of the orifice 479 and the center of the headgear connector 456 may be adjusted to bias the load on the patient interface from front to back, and d17 may be approximately 2.7 mm, although values ​​between 0 mm and 4.0 mm may be used. The headgear sweep angle α2 may be varied, with increasing α2 biasing the load towards the rear of the patient interface (upper lip area). The headgear sweep angle α2 may be approximately 6.6°, although values ​​between 0° and 10° may be used.

[0146] FIG. 56-1 shows a side view of the support membrane 465 with the headgear connector 456. The distance d18 between the top of the headgear tab 458 and the load-bearing point of the rear corner formed by the rear thickened portion 470 may be about 1-5 mm, preferably about 1-3 mm, and most preferably about 2 mm, allowing the headgear tab 458 to move a predetermined amount before contacting the patient interface. This helps to prevent the seal from closing when initially fitted by the patient. The angle α3 may be 90°, which may be varied by + / - 5°. If the headgear connector 456 is not molded as the support membrane 465, this angle may be varied by + / - 10°, varying α3 to affect the angle (nose, lip angle) when the patient interface is placed under the patient's nose.

[0147] Figures 56-2 and 56-3 show side cross-sectional views of the support membrane 465 shown in Figures 56-1 and 52, respectively. The stem 454 may be adapted to be connected to a ring for connection to an air tube. The ring may have a socket type fitting for a ball joint and / or may be with a venting feature. The diameter of the base of the stem 454 should be large enough to allow air to pass at a limited flow rate for compatibility with the flow generator and may have a diameter of 8 mm to 25 mm, preferably less than 20 mm, preferably about 15 mm. However, other diameters may be used, such as, for example, 12 mm.

[0148] The stem 454 may have a thin walled section 481 that may have a height d19 of 5.5 mm, but d19 may vary between 2 mm and 10 mm, for example. The thin walled section 481 allows the stem 454 to bend at a separate region by pulling on a tube connected to the stem 454. The thin walled section may have a wall thickness of about 0.3 mm to 1.0 mm, depending on the amount and strength of bending required. The stem 454 may include radial or circumferential reinforcing ribs or other reinforcing elements on either the interior or exterior.

[0149] 3.1.23 Patient seal The sealing portion 210 forms an effective seal with the patient's nose 324, as shown in Figures 44-46. The nostril bulge portion 348 of the sealing portion 210 forms a seal with the patient's nostril bulge portion 385. The nasal tip portion 352 forms a seal with the patient's nasal tip 353. The upper lip portion 350 forms a seal with the patient's upper lip 351. The nostril bulge portion 384, the nasal tip portion 352 and the upper lip portion 350 all aid in forming an effective and comfortable seal with the patient and further aid in positioning the orifice 336 adjacent the patient's nasal cavity.

[0150] 3.2 Suspension system 1-1 through 1-18, for example, the sealing portion 210 is attached to or otherwise disposed on the suspension system 215. The attachment may be permanent (including, but not limited to, for example, a single component molding (see, for example, FIGS. 1-2 through 1-8), co-molding, insert molding, adhesive, or any other means). Alternatively, the attachment may be by removable means (including, but not limited to, for example, clips, Velcro®, tongue and groove, or any other suitable means). In one embodiment, the attachment of the sealing portion 210 to the suspension system 215 may be along the periphery of an aperture 211 on the sealing portion 210 and an aperture 216 on the suspension system 215.

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

[0152] 3.2.1 Shape The suspension system 215 may have a generally wedge-shaped or triangular-shaped cross-section, as shown in Figures 1-8 and 1-14. Such a shape may assist in orienting the sealing portion relative to the patient's nose in use.

[0153] The surface of the suspension system 215 adjacent the aperture 216 may be generally U-shaped or V-shaped, as shown in Figures 1-12 and 1-13. Such a surface may define an angle θ between 90 and 180°, such as between about 110 and 160°. Alternatively, the suspension system 215 may be relatively flat.

[0154] In one embodiment, the suspension system 215 may be similar to the gussets disclosed in U.S. Patent Application Publication No. 2009 / 0239916, published on February 19, 2009, which is incorporated by reference in its entirety. In one embodiment, the suspension system 215 may be similar to the isolation elements disclosed in U.S. Patent Application Publication No. 2009 / 0239916, filed on February 27, 2009, which is incorporated by reference in its entirety.

[0155] 3.2.2 Linking to a frame In the embodiment shown in FIGS. 1-1 through 1-18, the suspension system 215 has a connection ring 217 for attaching the suspension system 215 to the frame 220 in a sealed condition. The connection ring 217 can mate with a channel 227 provided along the frame perimeter, thereby forming an interference fit. The interference fit can be achieved by tongue and groove, snap fit, or any other suitable means. In another embodiment, the connection ring 217 can be adapted to attach to the elbow 230 and / or the air supply conduit 20. For example, the elbow 230 can be interference-fitted within, around, or against the connection ring 217 to seal the connection between the elbow 230 or air supply conduit 20 and the suspension system 215.

[0156] The connecting ring 217 defines an aperture 218 for allowing breathable gas from the frame 220 to pass into the suspension system 215. The aperture 216 allows breathable gas to pass from the suspension system 215 to the seal portion 210.

[0157] 3.2.3 Foam or Gel Suspension Systems The suspension system 215 may be constructed of alternative materials to silicone that may provide improved conformability, resilience, flexibility, comfort, and / or consumer appeal.

[0158] For example, the suspension system may be made of a foam material. The foam material acts as a spring to support the sealing portion 210 during use and to bias the sealing portion 210 towards the patient's nostrils. The foam material's conformability also allows for adjustment of the sealing position. Figures 3-1 to 3-6 show various views of a foam material suspension system 215 used between the sealing portion 210 and the frame 220. The foam material may be an open-cell foam material or a closed-cell foam material, or a foam material having a combination of open and closed cells. The foam material may or may not have a skin. The foam material may be 1 to 50 mm thick, for example 30 mm thick.

[0159] In an alternative embodiment, the suspension system may be comprised of a gel. The gel may be conformable, compliant, and comfortable. In one embodiment, gels having multiple durometers may be used. FIG. 8-1 illustrates a gel suspension system 215 according to one embodiment of the present technology. As shown, the gel suspension system 215 is in the form of an encapsulating gel jacket 278 disposed between the sealing portion 210 (e.g., silicone) and the base 279 (e.g., plastic). In one embodiment, the gel suspension system may change the geometry of the sealing portion, for example, bending the thin areas of the sealing portion (e.g., nose tip engaging portion). The gel may be a silicone gel, a polyurethane gel, or any other suitable gel. The gel may be a gel as disclosed in U.S. Patent Application Publication No. 2008 / 0133994, filed Nov. 17, 2008, which is incorporated herein by reference in its entirety.

[0160] In one embodiment, the sealing portion 210 may have a flared foam or gel suspension system to reduce weight and improve compliance along the edges of the sealing portion 210, thereby accommodating a wider range of patient facial geometries. For example, Figs. 8-2 and 8-3 show the sealing portion 210 (e.g., silicone) flared over the gel suspension system 215. Such flaring may allow the edges of the sealing portion to "flex" or "pin" depending on the orientation, enhancing the seal. As shown, the edges of the sealing portion 210 may have deerdrop-shaped gel pockets to help seal gaps and corners of the patient's face during use.

[0161] In another embodiment, the suspension system may be constructed from a thermoplastic elastomer (TPE).

[0162] 3.2.4 Sealing parts with flexible tubes In an alternative embodiment, the suspension system may be in the form of a flexible tube that is provided (eg, co-molded) or otherwise attached to the base of the sealing portion.

[0163] As shown in FIG. 16-1, the flexible tube 280 may be corrugated, e.g., like a drinking straw, to allow the tube to be moved relative to the sealing portion 210 in any direction, e.g., compressed, stretched, bent, etc.

[0164] As shown in FIG. 16-2, the flexible tube 280 includes flexible spiral ribbing that allows the tube to bend resiliently relative to the sealing portion 210 .

[0165] In each embodiment, the end of the tube may be directly coupled to the air delivery conduit in use.

[0166] In each embodiment, the flexible tube 280 may have constant wall sections, or alternatively, the flexible tube 280 may have varying wall thicknesses, for example to change the stretch, elongation, or flex characteristics of the tube in certain regions.

[0167] In one embodiment, one or more vents may be provided in the tube (e.g., molded into the tube, insert molded into the tube, or attached to the tube as a separate insert) and / or one or more vents may be provided in a swivel on the end of the tube.

[0168] As shown in FIG. 26, a collapsible section 354 and a hinge section 356 may be provided between the sealing section 210 and the tube 20. The collapsible section 354 absorbs the movement of the tube 20 when it is rotated away from the patient's face in use, or when the sealing section 210 is positioned, the tube 20 is not bent towards the patient's face because the patient's jaw or other parts of the patient's face would prevent such movement. When the tube 20 is bent away from the patient's face in use, the hinge section 356 transfers the movement of the tube 20 to the collapsible section 354, thus preventing the sealing section 210 from moving and maintaining a seal with the patient. The hinge section 356 may also prevent the collapsible section 354 from stretching, thereby preventing the collapsible section 354 from losing structural integrity and allowing the collapsible section to continue to absorb the movement of the tube 20. FIG. 26 also shows the location of the nose tip portion 352 and upper lip portion 351 of the sealing portion.

[0169] 3.2.5 Gussets In one embodiment, as shown in FIG. 17-1, the suspension system may be in the form of a gusset or separate chamber 281 provided (e.g., co-molded) or otherwise attached to the base of the sealing portion 210. In use, the gusset 281 may be stretched / compressed / tilted to increase the range of adjustment.

[0170] The thickness of the gusset side walls may be constant, for example 0.2 to 3 mm thick, preferably 0.2 to 1 mm thick, and most preferably 0.3 mm thick. Alternatively, the gusset side walls may vary throughout, for example some areas may be thicker than others to aid in connecting the air supply conduit to the gusset, or some areas may be thinner than others to improve flexibility in those areas.

[0171] In this embodiment, the base of the gusset may be directly coupled to the air delivery tube 20 in use.

[0172] In another embodiment, as shown in FIG. 17-2, a headgear connector 240 may be provided on the sealing portion 210 for attaching headgear. As shown, the headgear connector may extend from a trampoline-type base 282, allowing the sealing portion to bend, stretch, and / or bounce relative to the headgear connector, thus allowing the headgear to relieve pressure during use. Such an arrangement allows for increased adjustability with the gusset. Preferably, the headgear connector 240 may be between the sealing portion 210 and the flexible base 282, allowing for tube forces to be isolated from the sealing portion 210.

[0173] Additionally, an additional trampoline type formation 283 may be provided at the base of the gusset 281 to provide additional adjustability of the air delivery tube relative to the gusset.

[0174] 3.2.6 Tube separation mechanism The sealing portion 210 may include a spring portion 413 (FIG. 41) to absorb or relieve tube pulling forces. The spring portion 413 may have a width 416 that is less than a width 418 of the sealing portion (cradle) connecting portion 399 and the swivel connecting portion 414. The swivel connecting portion 414 may be connected to a swivel ring 415 such as the embodiments described above. FIG. 41 also shows headgear straps 390 attached to the sealing portion 210 to support the mask in place on the patient's head.

[0175] 3.2.7 Swivel Ring Distributed Ventilation Function The swivel ring 415 may have one or more gas vents 422. The gas vents 422 may be provided as one or more apertures, holes, slots or scallops. FIGS. 42-1 and 42-2 show a swivel ring 415 with one or more gas vents 422 cut out of an interior wall that joins with an elbow wall 426 (shown in dashed lines) to form one or more vent slots or gas vents 422 that allow exhaled gases to pass through the mask and out of the mask to the atmosphere. There may be one or more vent slots or gas vents 422 (three shown) that are formed between support walls 424. The elbow wall 426 joins with the interior wall 423 and support wall 424 of the swivel ring 415. The support wall 424 prevents the elbow from being accidentally removed.

[0176] FIG. 42-3 shows that the swivel ring 415 is connected to the seal portion 210 at a cradle flange 430 and further connected to the elbow at an elbow flange 432. The swivel ring 415 is inserted into an aperture in the seal portion 210 and is retained by an interference fit with the flanges on either side of the seal portion interference webs 434. The seal portion interference webs 434 may be U-shaped, although other shapes may be used. In one embodiment, the swivel ring 415 may be of a similar structure to the swivel ring shown in U.S. Patent Application Publication No. 2008 / 0133991, filed on Oct. 22, 2008, which is incorporated by reference in its entirety.

[0177] FIG. 42-4 shows an alternative gas vent 422 where there is a row of small holes provided as gas vents 422 in the swivel ring 415. The gas vents 422 (e.g., 5 to 50, or about 15) may be about 0.5-1.0 mm in diameter, e.g., 0.7 mm.

[0178] FIG. 42-5 illustrates an alternative gas exit vent 422 where there is a single vent slot provided as the gas exit vent 422 in the swivel ring 415. FIG. 42-6 illustrates another alternative gas exit vent 422 where there are multiple vent slots provided as the gas exit vent 422 in the swivel ring 415 (e.g., 3 or more, or about 5-20).

[0179] FIG. 42-7 illustrates a row of vent portions provided as gas vent 422 disposed about swivel ring 415. As shown, two rows of vent portions are provided as gas vent 422, with the vents in each row offset from one another or staggered from one another. These vent portions may be positioned or arranged in other configurations.

[0180] FIG. 42-8 shows an example cross section of a vent hole portion provided as the gas outlet vent hole 422 shown in FIG. 42-7. In this embodiment, the diameter of the vent hole portion changes from the inlet to the outlet, for example, the vent hole portion is tapered along its length. The diameter D1 of the vent hole portion on the side of the swivel ring 415 facing the sealing portion 210 is larger than the diameter D2 on the other side of the swivel ring 415. The diameters D1 and D2 may be the same, or the diameter D2 may be larger than the diameter D1. The diameter of the vent hole portion may be about 0.5 to 1.0 mm. Preferably, the diameter of the vent hole portion may be about 0.7 mm.

[0181] In all of the above venting embodiments, the air is directed downwards and thus away from the patient's face, along the elbow or air delivery tube, and the vent portion 422 may be located on only half or a portion of the swivel ring 415 to avoid directing air towards the patient's chest in use.

[0182] 3.2.8 Airflow direction 43, the direction of air emitted from the vent 395 may be modified by positioning the attachment of the elbow 397 to the sealing portion 210 using a plenum 438. The plenum 438 may attach the sealing portion 210 in an upward position to engage the patient's nose in use. The plenum 438 may be attached to the elbow 397 via a swivel ring 415 in a position to avoid contacting the patient and also direct air away from the patient in use. The plenum 438 may also absorb tube pulling forces by shortening or compressing when tube pulling forces are applied without dislodging or moving the sealing portion 210 from its sealed position.

[0183] 3.3 Frames 1-9 to 1-14 show the suspension system 215 coupled to the frame 220 (sealing portion 210 on the suspension system 215 is not shown) and 1-15 to 1-18 show the suspension system 215 coupled to the frame 220 (sealing portion 210 on the suspension system 215 is also shown). In the embodiment shown, the suspension system 215 has a coupling ring 217 adapted to be press fitted into a channel 227 on the frame 220. Alternatively, the suspension system 215 may be coupled to the frame 220 by other removable means such as, for example, clips, hooks, Ziploc®, or any other suitable means. The suspension system 215 may also be attached to the frame 220 by permanent means including, for example, but not limited to, insert molding, co-molding, adhesives, etc.

[0184] The frame 220 may generally be more rigid than the suspension system 215 and the sealing portion 210 to support and stabilize the sealing portion 210 and / or the suspension system 215. The frame 220 may be made from materials including, but not limited to, silicone, TPE, polycarbonate, polypropylene, foam materials, gel, nylon, and the like.

[0185] 1-10, the frame 220 may have an aperture 226 adapted to be coupled to the elbow 230 or the air delivery tube 20. The frame 220 may be coupled to the elbow 230 or the air delivery conduit 20 by a snap fit, tongue and groove mechanism, or any other removable or non-removable connection. An example connection is disclosed in U.S. Patent Application Publication No. 2005 / 0139994, which is incorporated herein by reference in its entirety.

[0186] 3.3.1 Headgear attachments In the illustrated embodiment, as shown in Figs. 1-1 and 1-9 through 1-18, the frame 220 has a headgear attachment or connector 240 for removably attaching the headgear 150 and / or headgear rigidizer 160 to the mask 200. The headgear attachment 240 may be made from, for example, but not limited to, silicone, TPE, polycarbonate, or any other suitable material. The headgear attachment may be molded with the frame 220. Alternatively, the headgear attachment may be provided to the suspension system 215 and / or the sealing portion 210, as described below. Alternatively, the headgear attachment may be attached to any portion of the mask 200 by means including, for example, but not limited to, adhesive, push clips, snap-fit, etc.

[0187] As shown in Figures 61 to 64-2 and 67, the patient interface 459 may be secured to the patient using headgear 484. In use, the headgear 484 may extend from the headgear connectors 456 on either side of the patient's head between the patient's eyes and ears and connect at the crown of the patient's head. An adjustable connector 500 allows the headgear to be adjusted to fit the patient. The headgear 484 may have a rear head portion 485 that wraps around the rear of the patient's head.

[0188] In one embodiment, the headgear attachment may include the headgear attachment disclosed in US Pat. No. 6,399,233, published Feb. 19, 2009, which is incorporated herein by reference in its entirety.

[0189] 3.3.1.1 Orientation In the embodiment shown, the headgear connectors 240 extend generally perpendicular to the longitudinal axis of the frame 220, as shown in FIG. 1-12, for example as indicated at β. As shown in FIG. 1-1, the rigidizers 160 are rotatably coupled to their respective headgear connectors (as described in U.S. Patent Application Publication No. 2005 / 0133991, which is incorporated herein by reference), allowing adjustment to fit the nasolabial angle for a wide range of patients. Additionally, this configuration allows the suspension system to be adjusted to move the suspension system away from the patient's upper lip.

[0190] 3.3.1.2 Alternative Positioning In one embodiment, the headgear connector may be located closer to the sealing portion to eliminate or reduce the length of the moment arm and improve the stability of the seal. For example, FIG. 10 shows a headgear connector 240 located directly on the sealing portion 210.

[0191] In another embodiment, the headgear connectors may be positioned such that the headgear straps / rigidizers extend under the nostril engagement flaps 214 in use. For example, as shown in FIG. 11, the headgear connectors 240 may be provided to the suspension system 215. In use, the headgear straps 190 / rigidizers 160 may be positioned under the nostril engagement flaps 214, and these straps / rigidizers act as stops to prevent the flaps from further deforming and / or to bias the flaps upward in use. The straps / rigidizers are positioned to engage certain areas of the flaps in use to allow the remainder of the seal portion to bend or conform. As shown, struts 284 may be positioned under the flaps to engage the straps / rigidizers.

[0192] In another embodiment shown in FIG. 47-3, the patient interface 459 has a headgear connector 456. The headgear connector 456 may have tabs 458. The tabs 458 may form connection points for connecting the headgear. The headgear connector 456 may be integrally molded with the stem 454. Alternatively, the headgear connector 456 may be removably attachable to the stem 454 and / or the support portion 453. For example, the headgear connector 456 may be clipped, wrapped around, or otherwise connected to the stem 454.

[0193] The headgear connectors 456 may have a durometer of about 20 to 80 Shore A, preferably about 20 to 60 Shore A, and most preferably about 40 Shore A. The geometry of the support portion 453 may be adjusted to be molded with the headgear connectors 456.

[0194] The location of the headgear tabs 458 relative to the sealing portion 450 is important. If the headgear tabs 458 are too low, i.e., far from the sealing portion 450, they cannot provide sufficient stability. The greater the distance from the sealing portion 450 to the headgear tabs 458, the longer the lever arm and the greater the tendency of the sealing portion 450 to move. If the headgear tabs 458 are too close to the top of the sealing portion 450, the sealing portion 450 may hinge inward more than is necessary for sealing, thereby increasing the force on the patient's nose. This may also result in the patient's nares becoming blocked. Therefore, the headgear tabs 458 should be 1 to 10 mm from the sealing portion. Preferably, the headgear tabs 458 should be approximately 2 to 5 mm from the sealing portion.

[0195] Such headgear connectors and tabs are disclosed in further detail in US Pat. No. 6,399,433, filed Oct. 22, 2008, which is incorporated herein by reference in its entirety.

[0196] 3.3.2 Seal Support 18-1 and 18-2, the frame 220 may have an exoskeleton or support structure 290 configured to bias the nostril engagement flap 214 toward the nostril in use. As shown, fingers 291 formed by the exoskeleton 290 support and shape the sealing portion when engaging the sealing portion. That is, the exoskeleton is composed of a stiffer material than the sealing portion, and thus the fingers may bend / deform but to a lesser extent than the sealing portion, thereby biasing or pinching the sealing portion over the patient's nose.

[0197] In one embodiment, the base of the sealing portion may have a pivoting membrane 292 adapted to fit into the exoskeleton to provide the sealing portion with some adjustability (e.g., compressed or stretched) relative to the exoskeleton.

[0198] In one embodiment, the sealing portion and the exoskeleton may be formed as a one-piece molding, or may be formed separately and attached to one another.

[0199] 4. Headgear As best shown in FIG. 1-1, the headgear 150 may have side straps 190, a top strap 170, a rear strap 180, and a rigidizer 160 attached to the straps 190 on each side (e.g., sewn to the straps on each side).

[0200] In the embodiment shown, the rigidizers have end portions adapted to engage with respective headgear connectors 240 on the frame, for example by a snap fit, as shown in Fig. 1-1, but the rigidizers may be coupled to the respective headgear connectors in another suitable manner, for example the rigidizers have openings adapted to receive the respective headgear connectors in the form of lugs.

[0201] In one embodiment, headgear 150 may include the headgear disclosed in US Pat. No. 6,399,233, published Feb. 19, 2009, which is incorporated herein by reference in its entirety.

[0202] The rigidizers may be configured to apply support to selected areas of the mask, for example, they may form cheek supports (as disclosed in U.S. Patent No. 5,399,433) and / or they may be configured to engage the lower cheek / chin portions to support / position the mask during use (see FIG. 12).

[0203] In an alternative embodiment, the headgear straps may be constructed of silicone and the rigidizers may be co-molded to the respective silicone straps.

[0204] In the embodiment shown, the headgear forms two connections to the mask, however other configurations are possible, for example three or more.

[0205] 4.1 One-piece headgear 13-1 and 13-2 show headgear 150 that is constructed in one piece, e.g., machined from a material as a one-piece construction. As shown, headgear 150 has a central portion 185 and side straps 190 that are adapted to engage one another, e.g., via a buckle arrangement. Central portion 185 has an opening 186 for receiving and supporting sealing portion 210. As shown in FIG. 13-3, headgear has a contoured portion 187 that surrounds opening 186, which may be adapted to support the sealing portion during use.

[0206] 13-4, the area 188 surrounding the opening 186 may be configured to provide a trampoline-type configuration to the sealing portion 210, allowing the sealing portion to flex, stretch, and / or bounce against the headgear 150 to relieve pressure during use. For example, the area surrounding the opening may be thinner than other portions of the headgear.

[0207] In another embodiment, as shown in FIG. 13-5, the headgear 150 may be formed in one piece with the sealing portion 210.

[0208] In each of the above configurations, the air delivery tube 20 may be directly connected to the base of the sealing portion 210 . 4.2 Adhesive Headgear As shown in Figure 15, instead of headgear, an adhesive strip 285 may be provided on each nostril engagement flap 214 to adhere the sealing portion 210 directly to the patient's face. However, the strip may also be provided on the lower portion of the sealing portion, for example, as shown by the dashed line in Figure 15. Some examples are disclosed in U.S. Patent Application Publication No. 2009 / 0139994, filed on June 4, 2009, which is incorporated herein by reference in its entirety.

[0209] 4.3 Alternative headgear FIG. 86 shows headgear 484 having straps 527 and rear straps 529. Straps 527 have slots 531 for attachment to headgear connectors 456 (FIG. 47-2) and adjustable connectors 500. Straps 527 can be connected to headgear connectors 456 by other connection structures, such as using a hook-and-loop type connector.

[0210] The strap 527 is configured to extend between the patient's eyes and ears in use and to be connected at the top of the patient's head with the adjustable connector 500. In the region of the adjustable connector 500 of the strap 527, a flexible tube 486 may be attached to the strap 527 by a tube clip or another retention means, which holds the flexible tube 486 in place on the top of the patient's head.

[0211] Rear strap 529 is configured to extend around the back of the patient's head to help keep strap 527 in place during use. The rear strap may have a connector 500 to connect at the back of the patient's head or may alternatively be a one-piece strap. Strap 527 and rear strap 529 may be silicone or another suitable material such as an elastic material or TPE.

[0212] 87-89 show headgear 533 having two side portions 535 and a rear portion 524 connected to each of the side portions 535. Each of the side portions 535 includes a first slot for connecting to a headgear connector 456 (FIG. 47-2) and a second slot 537 for connecting to the rear portion 524. The rear portion 524 can have an end portion 526 that is threaded through the second slot 537. The end portion 526 can be formed with a hook type material for connecting to a loop type material 528.

[0213] The lateral portions 535 may be formed from a moldable silicone material that can reduce the visual bulk of the lateral portions 535 by providing a more streamlined appearance. The posterior portion 524 may be formed from a softer material, such as a soft polymeric material such as TPE or thermoplastic urethane (TPU), to provide comfort to the patient.

[0214] The rear portion 524 may have one or more rigidizers or stiffeners to help maintain the shape of the headgear and also secure and position the headgear against the top and / or back of the patient's head. The one or more rigidizers may be constructed of a rigid or semi-rigid material that is structured to add stiffness or hardness to the headgear and secure the headgear in place during use. The rigidizer may be bent or deformed along its length, but resists or prevents the headgear from stretching in the length of the rigidizer. The rigidizer may be substantially non-elastic. The rear portion 524 may wrap around the top of the patient's head. The rigidizer may be elastic. The rear portion may be thermoformed and / or ultrasonically die cut as disclosed in U.S. Patent Application Publication No. 2009 / 0239914, filed Dec. 10, 2009. The headgear disclosed in U.S. Patent Application Publication No. 2009 / 0239914 may be used with the technology disclosed herein, and U.S. Patent Application Publication No. 2009 / 0239914 is incorporated herein by reference in its entirety.

[0215] 90-93 show headgear 539 formed in one piece. The headgear 539 covers the front portion of the patient interface in area 541 and also covers the headgear connectors 456 for a more streamlined appearance. Rigidizers may be included in or on the headgear 539 to improve stability.

[0216] 94 shows headgear 543 that is similar to headgear 539 or covers a front portion of the patient interface in region 541. However, the headgear 543 has cut-out portions 545 to allow the headgear tabs 532 to be visible on the outside of the headgear 543. This configuration can aid in aligning the headgear relative to the patient interface.

[0217] 110 shows headgear 484 having hook and loop attachment that may be used with any of the embodiments herein. Loop material 560 may be located on a first portion of headgear 484 and hook material 562 may be located on a second portion of headgear 484. The hook material 562 and loop material 560 fasten together when pressed together, but can be pulled apart by a user by applying a certain amount of force.

[0218] A finger loop 558 may be included on the hook material 562 to assist a user in grasping or locating the end portion of the hook material 562. A buckle 590 may be attached to the end of the portion of headgear 484 having loop material 560 to assist in aligning and guiding the portion of hook material 562 of headgear 484 into position over the loop material 560. The buckle 590 and finger loop 558 may be interchanged, i.e., there may be a buckle 590 on the end of the hook material 562 and a finger loop on the portion of loop material 560 of headgear 584.

[0219] 5. Elbow In FIG. 1-1, an elbow 230 (eg, with a swivel) is generally L-shaped and is provided for connecting the mask to the air delivery tube 20.

[0220] In alternative embodiments, the elbow may be bendable or flexible to prevent or reduce tube traction forces during use. For example, as shown in Figures 14-1 and 14-2, the middle portion of the elbow 230 may have a series of corrugations 286 and a living hinge 287 to allow the ends of the elbow to pivot relative to one another during use. Such corrugated elbows may be molded in one piece (e.g., two-shot molding, co-molding, insert molding) or may be assembled (e.g., two- or three-part assemblies).

[0221] In another embodiment, as shown in FIG. 14-3, a flexible region 288 may be incorporated into the elbow 230 to allow the end portions of the elbow to move relative to one another during use. The flexible region may be constructed of a flexible material (e.g., TPE, soft rubber) to allow the flexible region to be compressed and stretched. Such elbows may be formed by molding, for example, two-shot molding, co-molding, insert molding.

[0222] In another embodiment, a corrugated region 289 may be provided between the end portions of the elbow 230 to allow the end portions to move relative to one another in any direction, e.g., undergo compression, extension, bending, etc. Such elbows may be formed by molding, e.g., two-shot molding, co-molding, insert molding. In another embodiment, as shown in FIG. 38, a generally L-shaped elbow 397 is connected at one end to a sealing portion or mask system and at the other end to a tube, e.g., a sealing portion connector 399 is connected to the sealing portion or mask and a tube connector 398 is connected to the tube. An air vent 395 may be located between these connectors. The elbow 397 is configured such that when the patient wears the mask, the elbow 397 moves the tube connector 398 upward on the mask and away from the patient's face, thereby allowing the tube to be located above the patient's head in use. The air vent 395 advantageously directs exhaled air away from the patient in use. Connector 398 may be attached to the air delivery tube and connector 399 may be attached to the mask so that the air vent 395 is parallel to the patient and faces directly away from the patient's airways.

[0223] 6. Sealing parts without suspension system In an alternative embodiment, a mask 200 may be provided without a suspension system between the sealing portion 210 and the frame 220, ie, the sealing portion is attached directly to the frame, as shown in FIGS. 2-1 through 2-6.

[0224] In such embodiments, the sealing portion 210 may be removably coupled to the frame 220 in a manner including, but not limited to, for example, a snap fit, tongue and groove, clips, etc. Alternatively, the sealing portion 210 may be permanently coupled to the frame 220 in a manner including, but not limited to, for example, co-molding, insert molding, adhesives, etc. In an alternative form, the sealing portion 210 may be configured to be one piece with the frame 220.

[0225] 6.1 Shape The sealing portion 210 may be generally rectangular or oval in top view, as shown in FIG. 2-7B. In an alternative embodiment, the sealing portion 210 may be generally triangular or trapezoidal in top view, as shown in FIG. 2-7A. The embodiment of FIG. 2-7A is a less obtrusive or less intrusive structure that reduces excess material in the sealing portion 210 that may cause discomfort. This embodiment may also provide alignment guidance to the patient, i.e., the patient may be more likely to correctly align the triangular shaped sealing portion 210, since the natural shape of the nose is more triangular and therefore the nose tip engaging portion 212 and the upper lip engaging portion 213 are more likely to be oriented in their desired positions.

[0226] As shown in Figures 2-8B and 2-9B, the upper lip engaging portion 213 of the rectangular shaped sealing portion is long enough that its free end overhangs at least a portion of the frame, e.g., to prevent the patient's upper lip from engaging the frame in use. The upper lip engaging portion may also be long enough to accommodate a variety of nose and upper lip shapes (e.g., the embodiment shown in Figure 2-8B may accommodate a larger range of patients than the embodiment shown in Figure 2-8A). As shown in Figures 2-8A and 2-9A, in the embodiment of the triangular shaped sealing portion, the length of the upper lip engaging portion 213 is reduced or shortened, e.g., to reduce excess material. Figure 2-10 shows an embodiment of a triangular shaped sealing portion that engages the patient's face in use.

[0227] Figure 2-11 is a rear view of the sealing portion showing a portion (shaded section) of the upper lip engaging portion 213 that is removed relative to the sealing portion of Figures 2-8B and 2-9B, for example. Reducing material in the upper lip engaging portion can improve comfort and appearance of the mask (i.e., less intrusive appearance) and can improve leak performance.

[0228] 7. Alternative Mask-Tube Connection Figures 57 through 85 and 95 through 101 show various alternative mask-tube connections that may be used with the present technology.

[0229] 7.1 Thin Films As shown in FIG. 57, a membrane 482 may be disposed between the support membrane 465 and the flexible tube 486. In this embodiment, a headgear 484 may be connected by a headgear connector 456. As shown in FIG. 58, the membrane 482 provides a degree of freedom of movement between the support membrane 465 and the flexible tube 486, which may be joined to the patient interface 459 via a swivel ring 480. The membrane 482 may stretch, bend, or otherwise elastically deform to allow movement between the support membrane 465 and the flexible tube 486. The membrane 482 may have a thinner wall thickness than the support membrane 465. The membrane 482 may have a wall thickness of about 0.2 mm to 5 mm. Preferably, the membrane 482 may have a wall thickness of about 0.5 mm to 2 mm. Most preferably, the membrane 482 may have a wall thickness of 0.5 mm to 1 mm. The movement between the tube 486 and the sealing portion 450 may be limited by the length of the membrane 482, which may be adjusted based on the amount of movement desired. Any additional movement is due to the flexible tubing.

[0230] 7.2 Multi-axis elbow assembly Figures 59 through 64 show a multi-axis elbow assembly 495 that provides an additional degree of freedom by allowing rotation in two separate planes, for example as shown by the arrows in Figure 59. The multi-axis elbow assembly 495 has a frame 491, which may be coupled to the membrane 482 or the support membrane 465, an elbow 488 coupled to the frame 491, a swivel assembly 494, a swivel ring 492, and an elbow 490.

[0231] The additional degrees of freedom provided by the multi-axial elbow assembly 495 have a significant impact on the functionality of the patient interface 459. For example, the multi-axial elbow assembly 495 allows the flexible tube 486 to be easily positioned on either side of the patient's head as shown in FIGS. 60 and 61, or along the nose and between the patient's eyes as shown in FIG. 62, while being streamlined (does not hang outward) and applying near zero moment to the patient interface. Additionally, the flexible tube 486 may also be positioned in a downward or outward orientation, as shown in FIGS. 63 and 64, respectively. The multi-axial elbow assembly 495 allows the tube 486 to be positioned in many different positions that may be used by the patient, while at the same time not applying significant moment to the patient interface due to tube traction forces, thereby creating an effective and comfortable seal with the patient.

[0232] 7.3 Bellows-type short tube separator A bellows-type or collapsible tube separation device is shown in Figs. 65-69. A series of bellows 502 is 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 that may be used to connect to a gas supply tube, for example. The bellows 502 have a hole with a number of support rings that help prevent the air path from being blocked in tight bends. That is, the bellows may have a thicker wall section than the portion of the hole that does not have the bellows section. Alternatively, the bellows and the hole may have a constant wall section. The length of the bellows may be selected to have a separation function to maintain the seal of the patient interface 459 even when the bellows 502 is bent. In that case, the bellows 502 has a degree of freedom of movement between the patient interface 459 and the tube 506.

[0233] Bellows 506 may be molded as a unitary structure with support membrane 465 or may be a separate, removably attachable element. Bellows 502 may be formed from a material having a hardness of about 20 to 80 Shore A, preferably 20 to 60 Shore A, most preferably 40 Shore A durometer, to fit over support membrane 465 so that both parts may be molded together, or may have another hardness of about 20-40 Shore A, preferably about 20 Shore A durometer, if bellows 502 is a separate element. Preferably, when the Shore A durometer is 40, the preferred thickness is about 0.3 mm.

[0234] The bellows 502 may have an internal bore of 8 to 20 mm, preferably 10 to 15 mm, and most preferably 12 to 15 mm. A thin membrane may be used between the bellows 502 and the support membrane 465 of the patient interface 459.

[0235] This added versatility of bellows 502 allows tubing 506 to be easily positioned over the head, outward or downward to the side of the head as shown in FIG 67, with minimal force applied to patient interface 459. Bellows 502 has a wide separation between the rings to allow for ample bending with the tubing. Bellows 502 prevents the air path from becoming blocked when the tubing is bent too tightly.

[0236] Fig. 69 shows various dimensions of the bellows rings and side walls shown in Fig. 68. Each bellows ring, including the side walls, has a height of, for example, 2 mm to 6 mm, preferably 3 mm to 5 mm, and most preferably 5 mm, and a width of, for example, about 2 mm to 8 mm, preferably about 3 mm to 6 mm, and most preferably about 4 mm. The radius R1 of the curved portion between each bellows ring may be about 1 mm to 4 mm, preferably about 2 mm to 3 mm, and most preferably about 2.5 mm, the separation between the rings of the bellows is, for example, about 2 mm to 8 mm, preferably about 4 mm to 6 mm, and most preferably about 5 mm, and the thickness of the side walls of the bellows ring is, for example, about 0.2 mm to 2 mm, preferably about 0.5 mm to 1.5 mm, and most preferably about 0.3 mm. The radius of the bellows 502, measured from the inside of the bottom of each curved portion between the bellows rings, is, for example, about 4 mm to 12 mm, preferably about 6 mm to 10 mm, and most preferably about 7.5 mm. These values ​​may be varied, but have been found to improve impedance and overall tube / patient interface compliance while at the same time producing a highly flexible bellows at a durometer of about 20 Shore A to 60 Shore A, preferably about 40 Shore A.

[0237] 7.4 Ball and Socket Figure 70 shows a patient interface 459 that is 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. The ball 508, also shown in Figure 71, may be connected to the flexible tube 486 by a connector 507, also shown in Figure 72. The socket connector 510 may be connected to the patient interface 459. The socket connector 510 may be a conventional elbow ring sized to receive the ball 508. The socket connector 510 may further include a diffusion vent to allow exhaled air from the patient to be vented.

[0238] The ball and socket connection can isolate the movement of the flexible tube 486 to release the moment applied to the patient interface 459 created by tube traction forces. When the flexible tube 486 moves flexibly, the ball 508 can move flexibly within the socket connector 510.

[0239] 73 and 74 show a ball 508 connected to an elbow 509. The elbow 508 may be connected to a flexible tube. The elbow 509 may have a curved portion that may be, for example, about 90° to 150°, preferably about 100° to 130°, and most preferably about 110°, although other angles may be used. The elbow 509 may have a vent 511 that may have one or more vent portions 513 for venting exhaled air. The vent portion 513 may be a row of spaced apart vent portions. Preferably, the inner diameter of the curved portion is about 7 mm to 15 mm. Preferably, the curved portion may have an inner diameter of less than 12 mm. Most preferably, the curved portion may have an inner diameter of about 8 mm.

[0240] Ball 508 may preferably have an outer diameter in the range of about 15 mm to 19 mm. Most preferably, ball 508 may have an outer diameter of about 17 mm.

[0241] Ball 508 may preferably have an inner diameter of about 7 mm to 15 mm. Preferably, ball 508 may have an inner diameter of less than 12 mm. Most preferably, ball 508 may have an inner diameter of about 8 mm.

[0242] As shown in Fig. 75, the vent may be in the form of a removable insert 517. The removable insert 517 may be attached to the elbow 509 with lugs, tongues, grooves, or other structures that lock the removable insert 517 in place. The insert may be a mesh vent 515 shown in Fig. 76.

[0243] FIG. 77 shows an embodiment in which the ball 508 has a series of vent grooves 501. The vent grooves 501 may have a length that extends to both sides of the socket connector 510 in use so that exhaled air can exit through the vent grooves 501. The vent grooves may have a length of about 2mm to 50mm. Preferably, the vent grooves 519 may extend along the outer surface of the ball 508 to form a long vent flow path. A long vent flow path can reduce the speed of the air and therefore reduce the noise of the exiting gases. Preferably, the vent grooves 519 are distributed around the ball 508 to diffuse the flow path of the exiting air. Preferably, the vent grooves 519 are molded onto the ball 508. Preferably, the grooves 519 have a width of about 0.2mm to 3mm. Preferably, the grooves 519 have a width of less than 1mm. The narrower the grooves, the slower the air flows and the quieter the vent. The groove 519 may be generally straight or may have a variety of other configurations. A curved or tortuous path is preferred because it can increase the length of the vent flow path and reduce vent noise. The wall of the ball 508 adjacent the groove 519 may interface with a connector 510. The connector 510 may be positioned over the top of the groove 519 to form a cover over the groove 519.

[0244] 111 shows an embodiment in which the ball 508 has a series of curved vent grooves 564. The curved vent grooves 564 may also have a width of about 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 the tube 486 or elbow 509, or to another element.

[0245] 112 shows one embodiment, where the ball is a perforated ball 568 with a series of vent holes 570. The perforated ball 568 allows air to flow between a connector (such as connector 510) and the ball 568. The ball 508 may be connected to the tube 486 or elbow 509, or to another element.

[0246] 113-1 and 113-2 show an embodiment comprising a ball 508 having vent grooves 570, where a flowpath barrier 592 may be removably attachable to the ball 508. The flowpath barrier 592 may be mated with the connector 510 to form a flow path between the barrier 592 and the connector 510.

[0247] 78 shows an alternative socket connector 521. The socket connector 521 has a vent groove 523. The vent groove 523 allows exhaled air to exit the patient interface. The vent groove 523 may extend radially outward (as shown). Alternatively, the vent groove 523 may extend axially. Alternatively, the vent groove 523 may extend along the inner surface of the inner wall of the socket connector 521.

[0248] 79 shows a patient interface 459 that uses a ball 508 and socket connector. The ball 508 is free to move within the socket connector, which allows one degree of movement and allows the tab 486 to be positioned in a variety of positions.

[0249] 7.5 Composite Elbow Ball Joint 80 to 83 show a combination elbow and ball joint. The elbow assembly 514 has a swivel connector 512 and a socket connector 518. The ball assembly 516 has a ball 522 and a swivel connector 520. The ball 522 mates with the socket connector 518.

[0250] The elbow assembly 514 may use an angle of, for example, 90° to 150°, preferably about 100° to 130°, and most preferably about 110°. The combination of the elbow assembly 516 and ball joint allows for multiple degrees of freedom of movement. For example, using an elbow without a ball joint may result in the connecting tube being too close to the patient's chin in the downward position or too far away in the upward position. Using an elbow assembly with a ball joint allows the tube to be positioned in a more desired position.

[0251] 82 shows an elbow assembly 514 that uses a ball assembly 516 where the flexible tubing 486 is positioned downwards. The ball 516 allows the flexible tube 486 to be positioned away from the patient's face and out of contact with the patient's face.

[0252] 83 shows an elbow assembly 514 that uses a ball assembly 516 where the flexible tubing 486 is positioned upwards. The ball 516 allows the flexible tube 486 to be positioned closer to the patient's face to help prevent vision being blocked.

[0253] 7.6 Membranes with elbows 84 shows a membrane 482 used with elbow assembly 514 and swivel connector 512. Sealing portion 450 has an opening that exits at a downward angle from horizontal, making it difficult to achieve both a tube-up position and a tube-down position. Membrane 482 has flexibility such that the exit angle can be adjusted to a more horizontal position. Thus, membrane 482 allows flexible tube 486 to hang downward without applying excessive moment to sealing portion 450, and also allows flexible tube 486 to be properly positioned in the upward position.

[0254] 7.7 Angled Elbow Ball Joint FIG. 85 shows an angled elbow and ball joint assembly 525. The angled elbow and ball joint assembly 525 has an elbow 514, a ball 516, and a swivel connector 520 for connecting to the flexible tube 486. The angled elbow and ball joint assembly 525 may have an angle of, for example, 100° to 160°, preferably about 100° to 130°, and most preferably about 110°. The ball 516 may be connected to a socket connector as shown in FIG. 70. The ball 516 allows free movement, thereby allowing the flexible tube 486 to be properly positioned in an up or down position.

[0255] 7.8 Ball and Socket Assembly 95-101 show a ball and socket assembly 561 combined with a ball joint portion and a swivel ring. The swivel ring 550 can be attached to the mask or support membrane 465. A ball 552 is disposed within the swivel (see FIG. 101) to allow 360° rotation of the ball joint portion 548 about the swivel ring 550, and for movement in a plane not about the swivel ring 550. Alternatively, the swivel ring 550 can be omitted and the ball 552 can be attached to the mask.

[0256] Connector 556 is adapted to be connected to a flexible gas supply tube so that gas may be supplied in the direction of arrow 558 within air passage 560. The air passage may have an inner diameter of 11-15 mm, and connector 556 may have the same inner diameter. A vent 554 may be incorporated into ball joint portion 548 to vent exhaled gases from the patient.

[0257] The swivel ring 550 may be manufactured and solidified in a mold. The swivel ring 550 may then be placed in a tool and the ball joint portion 548 is molded around or within the swivel ring 550. When the material of the ball joint portion 548 cools, the ball joint portion 548 shrinks and disengages from the swivel ring 550. Air vents 554 may be molded into the ball joint portion 548.

[0258] 7.9 Side connection tube 102-104 show a patient interface 459 with a side connecting flexible tube 486. Unless specifically shown, in all embodiments, the patient interface 459 may have a sealing portion 450 and a support membrane 465. Two apertures 538 are located on each side of the patient interface 459 to allow connection of the flexible tube 486 on either side of the patient interface 456 and to allow the flexible tube 486 to extend laterally (sideways). Additionally, a number of vent portions 544 may be included to vent exhaled gases from the patient.

[0259] An elbow 542 may be coupled to the end of the flexible tube 486 and may be adapted to be coupled to the aperture 538. The elbow may have a swivel connector to allow the flexible tube 486 to swivel into different positions, such as an upward position along the side of the patient's face as shown in FIG. 103 or a downward position as shown in FIGS. 102 and 104. A plug 540, to which the flexible tube 486 is not coupled, may be used over the aperture 538 to seal the aperture 538.

[0260] The side connection tube has a streamlined appearance and moves the tube 486 away from the patient's face. The side connection tube also isolates the tube's traction forces from the seal portion 450. The side connection interface is disclosed in more detail in U.S. Patent Application Publication No. 2007 / 0139994, filed February 29, 2008, which is incorporated herein by reference in its entirety.

[0261] 7.10 Two side connecting tubes 105 shows a patient interface 459 that uses two side connecting flexible tubes 548. A frame 546 may be used to support the patient interface 459. The flexible tubes 548 may have a smaller diameter than if one flexible tube were used. For example, the flexible tubes 548 may have half the diameter than if one flexible tube were used. This may provide more comfort to the patient, especially if the patient turns over and is on one side of the tubes 548.

[0262] 7.11 Rigid frame above the patient interface 105 to 107 show a rigid frame 546 that may be provided to fit over and support the patient interface 459. For example, the rigid frame may be shaped to fit over the patient interface 459. The rigid frame 546 may have a headgear connector 456 for connecting to the headgear 484.

[0263] The frame 546 may be formed from a rigid material to provide firm support and is also disclosed in more detail in US Pat. No. 6,399,633, which is incorporated herein by reference in its entirety.

[0264] 7.12 Headgear Cradle 108 and 109 show a headgear cradle portion 552 adapted to be coupled to a patient interface 459. The headgear cradle portion 552 can have an aperture 554 for coupling the headgear cradle portion 552 to the patient interface 459. The headgear cradle portion 552 can have an aperture at its end for receiving the headgear 484.

[0265] The headgear cradle portion 552 may also have tactile ends 550 for increasing the grip of the patient to facilitate connecting and disconnecting the headgear 484. The headgear 484 may use a hook and loop material for connection. The headgear cradle portion 552 may also have a conformable pad 556 on the interior of the headgear cradle portion 552. The conformable pad 556 supports the patient interface 459 and facilitates disconnection of the patient interface 459 and the headgear cradle portion 552. The conformable pad 556 also provides a soft feel to the patient when using the patient interface 459.

[0266] 7.13 Elbows with lugs FIG. 114 illustrates an embodiment in which the patient interface 459 is coupled to headgear 484 and elbow 582. The patient interface includes a connector 578 having an aperture 580. The headgear 484 has a headgear connector 557 shaped to mate with the connector 578 by fitting over the outside of the connector 578. A lug 586 of the elbow 582 fits into the aperture 580. The elbow 582 is adapted to form an airtight connection with the connector 578. The headgear 484 can have an opening near the headgear connector 557 to receive a portion of the elbow 582 near the lug 586, if desired.

[0267] 7.14 Vented Elbow Assemblies 115 and 116 show a vented elbow assembly having an elbow 509, a swivel ring 550 and a connector 556. The swivel ring 550 may be connected to a patient interface 459 or a support membrane 465 and the connector 556 may be connected to a flexible tube that supplies gas.

[0268] The elbow 509 may have a series of vent channels 558 for venting gases exhaled by the patient. The vent channels 558 may be of various lengths and may be positioned parallel or perpendicular to the direction of gas flow through the elbow 509.

[0269] 8. Additional Embodiments Figures 23-1 through 23-7 show additional embodiments of the present technology. Figure 23-1 shows a patient interface 3000 with an interface portion (also known as a sealing portion) 2000 located above or on top of the support portion 1000. The support portion 1000 is shown in Figures 21-1 through 21-6. The support portion 1000 can have a nose tip portion 212B, a nostril portion 214B, and optionally an upper lip portion 213B. To provide additional support to the interface portion 2000 upon assembly, and to provide different degrees of support to the sealing portion 210, multiple areas below or above the non-patient contacting side may have ridges or thickened sections. The support portion 1000 may be constructed of silicone having a hardness of about 20 to 90 Shore A, preferably about 40 Shore A. The support portion 1000 may be made from polycarbonate, polypropylene, nylon, thermoplastic elastomer (TPE), Hytrel®, etc. The support portion 1000 may be about 1-15 mm thick, preferably about 1.2 mm thick. As best shown in FIG. 21-4, the upper lip portion 213B may be cut or removed.

[0270] 22-1 through 22-4 show an interface portion 2000. The interface portion 2000 may have a nose engaging portion 212A, a nostril engaging portion 214A, and an upper lip engaging portion 213A. The interface portion 2000 may be engaged by a patient during use. The interface portion 2000 may be made from silicone having a hardness of about 7 durometers on the Shore A scale. Alternatively, the hardness of the interface 2000 may be about 12 durometers on the Shore A scale. The thickness of the interface portion 2000 may be about 1.2 mm. The interface portion 2000 may be made from another suitable material such as nylon, fabric, TPE, etc. The interface portion may have an abrasive surface finish for tactility and to "stick" or adhere to the patient's skin during use.

[0271] 23-1 through 23-7 show an interface portion 2000 attached or placed on top of a support portion 1000. The interface portion 2000 may be co-molded, insert molded, glued, or otherwise attached to the support portion 1000. The interface portion 2000 may be permanently or removably attached.

[0272] As best shown in Figs. 23-3 and 23-6, the nose engaging portion 212A may be raised or supported above the nose portion 212B. This arrangement is advantageous in allowing the patient's nose to bend into the nose engaging portion 212A, thereby increasing the range of fit. The nose portion 212B supports the side walls of the interface portion 2000. As best shown in Fig. 23-5, the upper lip engaging portion 213A is suspended above a gap in the upper lip portion 213B. This provides flexibility to the patient interface 3000 in the patient's upper lip area, thereby increasing the range of fit.

[0273] 117 shows a patient interface 600. The patient interface 600 has a sealing portion 600 for creating a seal with the patient's face, a support portion 608, and a connection portion 610 for connecting to a supply of gases, such as a flexible tube. An optional gusset 604 may be included.

[0274] The headgear may be attached to the patient interface 600 to allow movement in areas such as location 606. This may be accomplished, for example, by locating the headgear connectors below the sealing portion 602 on the support portion 608. Optionally, a gusset 604 may be included between the sealing portion 602 and the support portion 608.

[0275] 118-1, 118-2 and 118-3 show a patient interface 612. The patient interface 612 has a sealing portion 602, a support portion 616, a gusset 614 between the sealing portion 602 and the support portion 616, and a connection portion 618 for a supply of gas, such as a flexible tube, as well as an aperture 620.

[0276] The sealing portion 602 typically interfaces with the patient's upper lip and nose to create a seal with the patient's face. The sealing portion 602 may have reinforced portions, such as portions of the sealing portion 602 that interface with the patient at the nose, in the area of ​​the patient's nose adjacent the lip crease. The reinforced portions of the sealing portion 602 may be formed from a non-compressible material, such as a gel, or a material, such as silicone, that is of a higher durometer compared to other portions of the sealing portion 602. Alternatively or additionally, structural support, such as ribs or thickening, may be added to the sides or support portions of the sealing portion, and / or the gussets 614 may be filled with a stiffer material to provide additional support, as in the embodiment of FIG. 52-5.

[0277] FIG. 118-3 shows a cross-sectional view including gel-filled pockets 622 at the corner regions of the sealing portion 602, and such gel-filled pockets may be located at each corner region. The gel-filled pockets 622 may be used to provide reinforcement to form a more effective seal with the patient in use. Gel-filled points 623 may be included to allow the user or patient to add or remove gel as needed.

[0278] 119 shows a top view of the sealing portion 602 of the patient interface. The sealing portion 602 may have an orifice 602 for supplying gas to the patient in use. The orifice 602 may have a substantially trapezoidal shape as shown, or may be substantially triangular in shape. These shapes approximate the shape of a patient's nose, which allows the patient interface to be easily worn in the correct orientation by the patient.

[0279] 120 shows a patient interface 630 having a sealing portion 632, a support portion 636, an optional gusset 638, and a connecting portion 640. The sealing portion 632 may be a single walled sealing portion, which in this embodiment may have a second sealing wall 634 below the sealing portion (forming the first sealing wall) to provide additional support.

[0280] 121 shows a patient interface 642 having a sealing portion 644, a support portion 652, and an optional gusset 650. In this embodiment, the front portion 648 (nose engaging portion) of the sealing portion 644 curves downward to provide a deeper, more curved seal interface. This shape allows the side walls of the sealing portion to bend outward for a flatter nose, and also allows a pointed nose to sit within the curve created by this shape.

[0281] 122-1 and 122-3 show cross-sectional views of a patient interface 600 or 642 with the addition of a soft, conformable support structure. The support structure 604 is provided below the sealing portion 602. The support structure 604 may be a foam material or another soft, conformable material, while the sealing portion 602 and the support portion 606 are silicone or another similar material as described herein. The support structure 604 may be fitted into a recess formed in the sidewall of the sealing portion 602 or in the support portion 606. The support structure 604 may have a varying width as shown, or may have a constant width. The support structure 604 may be ring-shaped.

[0282] As shown in Fig. 122-3, the support structure 604 may provide additional contact with the patient's upper lip during use due to the soft and conformable material of the support structure 604, which may provide additional comfort to the patient during use. Additionally, the support structure 604 may assist in forming a seal with the patient's upper lip. Fig. 122-2 shows the support structure 604 with the sealing portion curved outward at its outer edge.

[0283] The cross section of the foam ring may be different in different regions, for example in the nose tip region the foam ring may have a smaller cross section and may be easily bent to accommodate different sized noses, for example in the nose side regions adapted to be located adjacent to the facial wrinkle regions the foam ring may be thicker.

[0284] The foam ring may incorporate different densities of foam and may provide different degrees of support in different areas.

[0285] 123 shows a cross-section of the inwardly curved sealing portion 620. The ends of the sealing portion 620 are elongated in order to seal against the sides (bulges) of the patient's nose as well as against the underside of the nose, forming lateral supports 622. This creates a more effective seal.

[0286] 124 and 125 show a top view of a patient interface 630 having a sealing portion 636 including nasal prongs 634 disposed on an upper surface 640 of the sealing portion 636. The nasal prongs 634 are adapted to form a seal with the patient's nares in use. Optionally, a support portion 638 may be included below the sealing portion.

[0287] 125, the sealing portion 636 may have a support portion 642 positioned adjacent the nasal prongs 634. The support portion may be a foam material or another suitable material and is positioned in the area of ​​the sealing portion 636 that interfaces with the patient's upper lip and corners of the nose in use to support and secure the sealing portion 636 and nasal prongs 634 in place.

[0288] It is believed that the patient interface of the present technology can accommodate a greater variety of face and nose sizes and shapes than previous designs. It is believed that the patient interface of the present technology can reduce the need for a wide range of sizes. It is believed that the patient interface of the present technology can provide greater comfort to patients and improve compliance with their treatment.

[0289] Although the present technology has been described in connection with what are presently considered to be the most practical and preferred embodiments, it should be understood that the present technology is not limited to the disclosed embodiments, but rather is intended to encompass various modifications and equivalent arrangements within the spirit and scope of the present technology. Also, the various embodiments described above may be implemented in conjunction with other embodiments, for example, aspects of one embodiment may be combined with aspects of another embodiment to achieve yet another embodiment. Furthermore, each independent feature and component of any given assembly may constitute another embodiment. Also, it should be understood that while the present technology has particular application to patients suffering from OSA, patients suffering from other illnesses (e.g., congestive heart failure, diabetes, morbid obesity, stroke, bariatric surgery, etc.) may also benefit from the above teachings. Moreover, the above teachings have application in non-medical applications to patients and non-patients alike. [Explanation of symbols]

[0290] 10 PAP System 15 PAP Device 20 Air supply duct 100, 451, 459, 600, 642, 3000 Patient Interface 150, 300, 484, 533, 539, 543 Headgear 160 Headgear Rigidizer 170 Top Strap 180, 529 Rear strap 185 Central part 186 Opening 187 Contour 188 Area surrounding the opening 186 190 Side Straps 200 Mask 210, 450, 602, 632, 644 Seal part 211, 216, 455, 538, 620 Aperture 212, 452 Nose tip engagement part 212A Nose engagement part 212B, 352 Nose tip 213, 213A, 462 Upper lip engaging part 213B Upper lip part 214 Nostril Engagement Flap 214A Nostril engagement part 214B External nostril part 215 Suspension System 217 Connecting Ring 219 Tubular supporting wall or base 220, 491, 546 frames 227 Channel 230, 397, 488, 490, 509, 542, 582 Elbow 240 Headgear Attachment 250 forehead support 260 Forehead adjustment device 270 Malleable Wire 271 Base 272 Gel Beads 273, 291 Finger 274 Ridge 275 Reinforcing rib 276 Membrane or pouch 277 Cap 278 Encapsulating Gel Jacket 280, 486, 548 Flexible Tube 281 Gusset or separation chamber 282 Trampoline-type base 283 Trampoline Tampu Configuration 284 Strut 285 Adhesive Strips 286 Waveform Series 287 Living Hinge 288 Flexible area 289 Waveform area 290 Dermal Skeleton 292 Swivel Membrane 320 Nozzle or protrusion 321 Curved outer surface 322, 336, 374, 479 Orifice 324 Patient's Nose 326 bulkhead locator 328, 348, 368 membrane 330 Cushion 332 Latching ridge 334, 404, 454 stem 338 Upper membrane 340 Inferior membrane 342 Upper cushion 344 Lower cushion 346 Horseshoe Shape 350 upper lip area, upper lip area 351 Patient's upper lip 353 Patient's nose tip 354 Folding section 356 Hinge part 358, 360 color range 362, 346, 366 Orifice opening 370, 372, 424 supporting wall 376 Headgear attachment point, headgear connector 378 Headgear Straps 381 Supporting member 382 Corners of the nasal region 384 Nostril bulge 386 Stabilization region 388 Outer flap (nostril engagement flap) 390 Strut or Tab 392 Ventilation Ring 394, 422 Gas outlet vent 395 Seal Part Connector 396 Step or Flange 398 Tube Connector 399 Seal part (cradle) connection part 402 Rib 406 Tube connection part 407 Patient contact parts 408(1), 408(2) Gap 409, 453, 608, 616, 636, 652, 1000 Support part 413 Spring part 414 Swivel connection part 415, 492, 550 Swivel Ring 416 Width 418 Width of swivel joint 414 426 Elbow Wall 434 Sealing part tightening web 438 Plenum 450.1 Middle part 456 Headgear Connector 458, 568 Side lap or side cantilever 465 Support membrane 466 Whole Wall Section 467 Thick corner area 468 Front thick part 469 Front fixing point 470 Thick rear part 471 Lower part of rear thick part 470 473 Upper part of rear thick part 474 Lateral upper lip area 475 Rear fixing point 476 Protruding Edge 477 Holed part 478 Concave Area 481 Thin wall section 482 Thin Film 485 Head 486 Flexible tubing 494 Swivel Assembly 495 Multi-axis Elbow Assembly 500 Adjustable Connector 502 series of bellows 506 Tube 507, 578 Connectors 508, 522, 552, 568 balls 510, 521 Socket Connectors 511, 554 Ventilation holes 512, 520 Swivel Connector 513, 544, 570 Vent area 514 Elbow Assembly 515 Mesh Vent 516 Ball Assembly 517 Removable Inserts 519, 523, 564 Ventilation groove 524 Rear part 525 Angled Elbow Ball Joint Assembly 526 end portion passing through second slot 537 527 Strap 528 Loop type material 531 Slots 532 Headgear Tab 534 Outside sealing periphery 535 Lateral part 536 Transition area 537 Second Slot 540 Plug 541 area 545 Cutout part 546 Rigid Frame 548 Ball joint part 550 Tactile End 552 Headgear cradle part 556 Conformable Pad 558 Finger Loop 560 Loop Material 561 Ball and socket assembly 562 Hook material 564 Front stretch area 562 Rear stretch area 566 Lateral pressing or compressing part 586 Rug 590 Buckle 592 Flow Path Barrier 604 Support structures 606 position 610, 618, 640 connection part 614, 638, 650 Gusset 622 Gel-filled pocket 623 Gel filling point 634 Sealing Wall 640 Upper surface 2000 Joint part

Claims

1. 1. A patient interface for delivering breathable gas to a patient, the patient interface comprising: a sealing portion having a nasal tip engagement portion adapted to form a seal with the patient's nasal tip, 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 a nostril engagement flap adapted to form a seal with the patient's nares, A patient interface, wherein the nasal tip engagement portion, the upper lip engagement portion and the nostril engagement flap are all configured to extend or curve outwardly from a support wall that defines an air pathway.

2. The patient interface of claim 1 , wherein the sealing portion is constructed of silicone.

3. 3. A patient interface according to claim 1, further comprising a suspension system for supporting the sealing portion and isolating and / or absorbing forces from the sealing portion and other components of the patient interface.

4. The patient interface of claim 3 , wherein the suspension system is constructed from silicone, a foam material, or a gel.

5. 5. A patient interface according to claim 1, wherein the nostril engagement flaps are provided in a V-shape.

6. A patient interface according to claim 1 , wherein the nasal tip engagement portion is generally flat or planar along its length.

7. A patient interface according to any one of claims 1 to 6, wherein the upper lip engaging portion is generally curved along its length.

8. A patient interface according to any one of the preceding claims, wherein the sealing portion has a wall thickness of about 0.1 to 15 mm.

9. 9. A patient interface according to any one of the preceding claims, wherein a non-patient contacting side of the nose tip engaging portion has a radius of curvature that is greater than a radius of curvature of a non-patient contacting side of the upper lip engaging portion.

10. 10. A patient interface according to claim 9, wherein the radius of curvature of the non-patient contacting side of the nasal tip engagement portion is between about 3.25 and 4.25 mm.

11. 11. A patient interface according to any one of claims 9 to 10, wherein the radius of curvature of the non-patient contacting side of the upper lip engaging portion is approximately 2 mm.

12. 12. A patient interface according to any one of the preceding claims, wherein a patient contacting side of the nose tip engaging portion has a radius of curvature that is greater than a radius of curvature of a patient contacting side of the upper lip engaging portion.

13. 13. A patient interface according to claim 12, wherein the radius of curvature of the patient contacting side of the nasal tip engaging portion is between about 3.25 and 4.5 mm.

14. A patient interface according to any one of claims 12 to 13, wherein the radius of curvature of the patient contacting side of the upper lip engaging portion is between about 3 and 3.75 mm.

15. 15. A patient interface according to any one of the preceding claims, wherein the non-patient contacting side of each nostril engagement flap has a radius of curvature of approximately 9 to 10.5 mm.

16. 16. A patient interface according to any one of the preceding claims, wherein the patient contacting side of each nostril engagement flap has a radius of curvature of approximately 9.5 to 11.5 mm.

17. A patient interface according to any one of claims 1 to 16, wherein the nostril engagement flaps define an angle between them of approximately 75° to 95° in a relaxed state.

18. 18. A patient interface according to any one of the preceding claims, further comprising a malleable wire provided in one or more portions of the sealing portion.

19. The patient interface of claim 1 , wherein the sealing portion comprises a gel material.

20. 10. The patient interface of claim 1, wherein the sealing portion is configured to extend or curve outwardly from the support wall defining an air path to an outer edge of the sealing portion in a continuous and uninterrupted smooth manner.

21. 10. A patient interface according to claim 1, further comprising a support portion supporting the sealing portion, the support portion having a nasal tip portion configured to support the nasal tip engagement portion of the sealing portion and / or a nostril portion configured to support a nostril engagement flap of the sealing portion.

22. 22. A patient interface according to claim 21, wherein the support portion further comprises an upper lip portion configured to support the upper lip engaging portion of the sealing portion.

23. 22. A patient interface according to claim 21, wherein one or more areas of the support portion have raised portions or thicker sections to provide additional support.

24. 1. A patient interface for delivering breathable gas to a patient, the patient interface comprising: a sealing portion having a nasal tip engagement portion adapted to form a seal with the patient's nasal tip, 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 a nostril engagement flap adapted to form a seal with the patient's nares; A patient interface comprising a support portion supporting one or more portions of the sealing portion, the support portion supporting different portions of the sealing portion with differing degrees of support.

25. 25. A patient interface according to claim 24, wherein the support portion is an elastomeric material.

26. 26. A patient interface according to any one of claims 24 to 25, wherein one or more regions of the support portion have raised portions or thickened sections to provide different degrees of support.

27. 27. A patient interface according to any one of claims 24 to 26, wherein the support portion comprises a nasal tip portion structured to support the nasal tip engagement portion of the sealing portion, and a nostril portion structured to support the nostril engagement flap of the sealing portion.

28. 28. A patient interface according to claim 27, wherein the support portion further comprises an upper lip portion configured to support the upper lip engaging portion of the sealing portion.

29. 28. A patient interface according to claim 27, wherein the support portion further comprises a nasal corner portion.

30. 30. A patient interface according to any one of claims 24 to 29, wherein the sealing portion has an orifice defining an air path and a septum locator disposed within the orifice.

31. 1. A patient interface for delivering breathable gas to a patient, the patient interface comprising:

1. A patient interface having a sealing portion having a nasal tip engagement portion adapted to form a seal with the patient's nasal tip, an upper lip engagement portion adapted to form a seal with the patient's upper lip and / or the base of the patient's nares, and a nostril engagement flap adapted to form a seal with the patient's nares, and a support portion supporting the sealing portion, wherein the sealing portion is connected to the support portion at side portions of the sealing portion and the sealing portion is separated from the support portion at anterior and posterior portions of the sealing portion.

32. 32. A patient interface according to claim 31 , wherein side portions of the sealing portion correspond to the nostril engagement flaps, the anterior portion of the sealing portion corresponds to the nose tip engagement portion, and the posterior portion of the sealing portion corresponds to the upper lip engagement portion.

33. 32. A patient interface according to claim 31 , wherein the tip engagement portion is spaced from the support portion by a first gap and the upper lip engagement portion is spaced from the sealing portion by a second gap, the first gap and the second gap having different gap lengths.

34. 34. A patient interface according to claim 33, wherein the first gap, when not in use, is approximately 10 mm.

35. 34. A patient interface according to claim 33, wherein the first gap, when not in use, is approximately 7 mm.

36. 1. A patient interface for delivering breathable gas to a patient, the patient interface comprising: a sealing portion having a nose tip engaging portion adapted to be engaged with a patient's nose tip; a support portion supporting the sealing portion, the support portion being connected to the sealing portion at two side portions of the sealing portion, the support portion being spaced from the sealing portion by a gap at the nose tip engagement portion, the nose tip engagement portion being adapted to stretch to conform to the patient's nose tip and form a seal with the patient's nose tip; A patient interface comprising:

37. 37. A patient interface according to claim 36, wherein the gap is approximately 10 mm when not in use.

38. 1. A patient interface for delivering breathable gas to a patient, the patient interface comprising: a sealing portion adapted to form a seal with a patient's face in use, said sealing portion comprising: a forward stretch portion adapted to form a seal with the patient's nose tip; a posterior stretch portion adapted to form a seal with the patient's upper lip; a lateral pressing portion adapted to secure said sealing portion at an area of ​​the patient's nose adjacent the naso-lip crease by applying a force substantially perpendicular to the plane of the patient's face; A seal portion including: a side wrap portion adapted to form a seal with the patient's nares by applying a clamping force perpendicular to the patient's nares; A patient interface comprising:

39. 39. A patient interface according to claim 38, wherein the side wrap portions and side pressure portions have a greater thickness than the anterior stretch portions or the posterior stretch portions.

40. 39. A patient interface according to claim 38, wherein the front stretch portion extends to form a seal with the tip of the patient's nose in use and the rear stretch portion extends to form a seal with the patient's upper lip in use.

41. 41. A patient interface according to any one of the preceding claims, further comprising a pair of nozzles located on the sealing portion and adapted to engage the patient's nares in use.

42. 42. A patient interface according to claim 41, wherein each nozzle has a curved outer surface that gradually increases in width from the top of the nozzle to the bottom of the nozzle.

43. 41. A patient interface according to any one of claims 1 to 40, wherein the sealing portion comprises a cushion and a membrane on an upper surface of the cushion.

44. 44. A patient interface according to claim 43, wherein the membrane hooks over an outer edge of the cushion.

45. 44. A patient interface according to claim 43, further comprising a stem on the sealing portion, the stem having one or more latching ridges for supporting a bottom surface of the cushion.

46. 46. ​​A patient interface according to any one of claims 43 or 45, further comprising a lower membrane on a lower surface of the cushion.

47. 47. A patient interface according to any one of claims 1 to 46, further comprising a tube for supplying air to a patient, and a foldable section and a hinge section provided between the tube and the sealing portion, the foldable section and the hinge section configured to allow the tube to be moved without moving the sealing portion.

48. 48. A patient interface according to any one of claims 1 to 47, wherein the sealing portion has a thermochromic sizing indicator configured to change color upon contact with a patient, allowing the patient interface to be sized to fit the patient.

49. 49. A patient interface according to any one of claims 1 to 48, further comprising one or more perforations or cut lines formed in the sealing portion to allow sizing of the sealing portion to a patient.

50. 38. A patient interface according to any one of claims 1 to 37, further comprising at least one stabilising portion formed in the sealing portion, the stabilising portion being disposed within the nasal tip engagement portion and within a corner of the nasal portion.

51. 51. A patient interface according to claim 50, wherein the at least one stabilizing portion has a higher stiffness compared to other portions of the sealing portion.

52. 52. A patient interface according to claim 51, wherein the at least one stabilizing portion comprises one of a gel, a foam material, a TPE and / or a silicone.

53. 31. A patient interface according to any one of claims 1 to 30, wherein the support wall defining the air pathway defines an aperture having a height of about 21 mm and a width of about 11 mm.

54. 38. A patient interface according to any one of claims 21 to 37, wherein the sealing portion and the support portion are one of silicone, a foam material, a gel, or TPE.

55. 55. A patient interface according to any one of claims 21-37 and 54, wherein the support portion has a harderness that is greater than a harderness of the sealing portion.

56. 56. A patient interface according to claim 55, wherein the sealing portion has a hardness of approximately 5 Shore A durometer and the support portion has a hardness of approximately 40 Shore A durometer.

57. 57. A patient interface according to any one of the preceding claims, wherein the sealing portion has a thickness of from about 0.3 mm to about 1.2 mm in the nasal tip region.

58. 38. A patient interface according to any one of claims 1 to 37, wherein the nasal tip engagement portion is a flexible suspended membrane.

59. 38. A patient interface according to any one of claims 1 to 37, wherein the upper lip engagement portion is a flexible suspended membrane.

60. 38. A patient interface according to any one of claims 1 to 37, further comprising two thickened corner regions formed on the sealing portion, one on each side of the upper lip engaging portion, the thickened corner regions adapted to create a seal with a patient in the area of ​​the patient's nose adjacent the nose and lip creases.

61. 61. A patient interface according to claim 60, wherein the radius of curvature of the thickened corner region is between about 2.4 mm and about 6 mm.

62. 61. A patient interface according to any one of claims 1-60, wherein the sealing portion has a width of about 48 mm to about 60 mm.

63. 38. A patient interface according to any one of the preceding claims, wherein the width of the nasal tip engagement portion is between about 38 mm and about 48 mm.

64. 38. A patient interface according to any one of the preceding claims, wherein the radius of curvature of the nasal tip engagement portion is between about 35 mm and about 40 mm.

65. 38. A patient interface according to any one of the preceding claims, wherein the width of the upper lip engagement portion is between about 14 mm and about 22 mm.

66. 38. A patient interface according to any one of the preceding claims, wherein the radius of curvature of the centre of the upper lip engagement portion is approximately 12.5 mm when not in use.

67. 38. A patient interface according to any one of the preceding claims, wherein the height of the nasal tip engagement portion is approximately 16.8 mm.

68. 57. A patient interface according to any one of claims 21-37 and 54-56, wherein the support portion has a wall section having an anterior thickened portion and a posterior thickened portion formed on each side of the support portion.

69. 69. A patient interface according to claim 68, wherein the anterior and posterior thickened portions provide differing degrees of support to the sealing portion.

70. 70. A patient interface according to any one of claims 68 to 69, wherein the anterior and posterior thickened portions vary in thickness.

71. 71. A patient interface according to any one of claims 68 to 70, wherein the front thickened portion is adapted to translate headgear loads into a clamping force on the sides of the patient's nose.

72. 72. A patient interface according to any one of claims 68-71, wherein the front thickened portion has a height of approximately 11 mm.

73. 73. A patient interface according to any one of claims 68 to 72, wherein the posterior thickened portion has a lower portion having a first thickness and an upper portion having a second thickness that is greater than the first thickness.

74. 74. A patient interface according to claim 73, wherein the upper portion of the posterior thickened portion has a height of between about 4 mm and about 9.5 mm.

75. 75. A patient interface according to any one of claims 73 to 74, wherein the upper portion of the posterior thickened portion has a perforated portion.

76. 76. A patient interface according to any one of claims 73 to 75, wherein the upper portion of the posterior thickened portion has a curved portion with a radius of curvature of between about 2 mm and about 4 mm.

77. 77. A patient interface according to any one of claims 68 to 76, wherein the rear thickened portion is adapted to translate headgear loads into clamping forces on the thickened corner areas of the sealing portion.

78. 78. A patient interface according to any one of claims 68 to 77, wherein the posterior thickened portion has lateral upper lip portions, the lateral upper lip portions having a width that varies from about 1.2 mm to about 3.5 mm.

79. 79. A patient interface according to any one of claims 68 to 78, wherein the distance between the anterior thickened portions is between about 25 mm and about 45 mm.

80. 80. A patient interface according to any one of claims 68 to 79, wherein the distance between the posterior thickened portions is between about 38 mm and about 60 mm.

81. 69. A patient interface according to any one of claims 21-37, 54-56 and 68, wherein the side wall of the support portion has a thickness of between about 1.2 mm and about 5.0 mm.

82. 82. A patient interface according to any one of claims 21-37, 54-56, 68 and 81, further comprising a recess formed in the support portion.

83. 83. A patient interface according to claim 82, wherein the recessed portion has dimensions of approximately 8 mm by approximately 9 mm.

84. 84. A patient interface according to any one of claims 82 to 83, further comprising a filling material filling the recessed portion, the filling material having a lower hardness than the support portion.

85. 38. A patient interface according to any one of the preceding claims, wherein the upper lip engaging portion of the sealing portion has a lower hardness than another portion of the sealing portion.

86. 86. A patient interface according to claim 85, wherein a portion of the sealing portion other than the upper lip engaging portion has a top layer of lower hardness and a bottom layer of higher hardness.

87. 87. A patient interface according to claim 86, wherein the lower durometer top layer and upper lip engaging portion have a greater stiffness than a higher durometer bottom layer adapted for frictional contact with the patient's face in use.

88. 88. A patient interface according to any one of claims 1 to 87, further comprising a headgear connector provided to the sealing portion.

89. 85. A patient interface according to any one of claims 21 to 37, 54 to 56, 68 and 81 to 84, further comprising a headgear connector provided on the sealing portion, wherein a hardness of the support portion and a hardness of the headgear connector are between about 40 Shore A durometer and about 65 Shore A durometer.

90. 54. A patient interface according to claim 53, further comprising a headgear connector provided to the sealing portion, wherein the distance between the center of the aperture and the center of the headgear connector is approximately 2.7 mm.

91. 91. A patient interface according to any one of claims 88 to 90, wherein the headgear connectors curve backwards at an angle of approximately 6.6°.

92. 36. A patient interface according to any one of claims 1 to 35, further comprising a headgear connector provided to the sealing portion and a strut extending from the headgear connector to support the nostril engagement flap of the sealing portion.

93. 93. A patient interface according to any one of claims 88 to 92, further comprising a headgear tab disposed on each of the headgear connectors, the headgear tabs adapted to be coupled to a headgear.

94. 94. A patient interface according to claim 93, wherein the distance between the top portion of the headgear tab and the rear thickened portion of the support portion is approximately 2 mm.

95. 93. A patient interface according to any one of claims 88 to 92, wherein the distance from the bottom of the headgear connector to the top of the sealing portion is approximately 17 mm.

96. 93. A patient interface according to any one of claims 88 to 92, wherein the distance between outer ends of the headgear connectors is approximately 80 mm.

97. 93. A patient interface according to any one of claims 88-92, wherein the headgear connectors are angled upwardly at an angle of approximately 6.6°.

98. 93. A patient interface according to any one of claims 88-92, wherein the headgear connectors have a thickness of between about 2.5 mm and about 4.0 mm.

99. 93. A patient interface according to any one of claims 88 to 92, further comprising headgear adapted to be coupled to the headgear connector, the headgear adapted to secure the patient interface to a patient's head.

100. 100. A patient interface according to claim 99, wherein the headgear has straps that, in use, pass between the patient's eyes and ears and extend to the top of the patient's head.

101. 101. A patient interface according to claim 100, wherein the headgear has rear straps that, in use, connect to the straps and extend to the rear of the patient's head.

102. 101. A patient interface according to claim 100, wherein the headgear has side and rear portions, the side portions having a first slot for attachment to the headgear connector and a second slot for attachment to the rear portion.

103. 103. A patient interface according to claim 102, wherein the posterior portion wraps around the top of the patient's head.

104. 104. A patient interface according to any one of claims 102-103, wherein the posterior portion is thermoformed or ultrasonically cut.

105. 105. A patient interface according to any one of claims 100 to 104, wherein the headgear is one-piece headgear.

106. 105. A patient interface according to any one of claims 100 to 104, wherein the headgear covers the headgear connector and a front portion of the patient interface.

107. 105. A patient interface according to any one of claims 100 to 104, wherein the headgear has hook and loop material and a finger loop located at an end portion of the headgear adjacent one of the hook material or the loop material.

108. 108. A patient interface according to any one of claims 1 to 107, further comprising a vent ring provided in the sealing portion, the vent ring having at least one vent portion for venting air exhaled by the patient.

109. 109. A patient interface according to claim 108, wherein the vent ring has a flange to prevent a tube from being placed over the at least one vent portion.

110. 110. A patient interface according to any one of claims 1 to 109, further comprising an L-shaped elbow connected to the sealing portion, the elbow having an air vent positioned in use to direct exhaled air away from the patient's face.

111. 85. A patient interface according to any one of claims 21-37, 54-56, 68, 81-84, wherein the support portion has a stem extending from the sealing portion, the stem having at least one rib having an increased thickness compared to other portions of the stem to provide structural support.

112. 112. A patient interface according to any one of claims 21-37, 54-56, 68, 81-84, 89 and 111, wherein at least a portion of the sealing portion is separated from the support portion by a gap.

113. 113. A patient interface according to claim 112, wherein the sealing portion has a lower hardness than the support portion.

114. 114. A patient interface according to any one of claims 111 to 113, wherein the gap between the sealing portion and the support portion is located adjacent the upper lip engagement portion.

115. 115. A patient interface according to any one of claims 111 to 114, wherein the gap between the sealing portion and the support portion is located adjacent the nasal tip engagement portion.

116. 116. A patient interface according to any one of claims 1 to 115, further comprising a seal portion connecting portion connected to the seal portion, a swivel connecting portion for connecting to a swivel ring, and a spring portion disposed between the seal portion connecting portion and the swivel connecting portion.

117. 117. A patient interface according to claim 116, wherein the spring portion has a width narrower than a width of the sealing portion connecting portion and narrower than a width of the swivel connecting portion.

118. 118. A patient interface according to any one of claims 1 to 117, further comprising a swivel ring coupled to a swivel connection portion of the patient interface, the swivel ring having at least one vent for gas escape.

119. 119. A patient interface as described in claim 118, wherein the at least one gas exit vent has at least one slot cut therein and has an internal wall with support walls between the slots, each of the slots forming the at least one gas exit vent when the swivel ring is joined with the elbow in use.

120. 119. A patient interface according to claim 118, wherein the at least one gas exit vent comprises at least one vent portion disposed about a portion of the circumference of the swivel ring.

121. 121. A patient interface according to claim 120, wherein each of the vent portions has a diameter of about 0.5 to 1.0 mm.

122. 121. A patient interface according to claim 120, wherein each of the vent portions has a diameter that varies from a vent portion inlet to a vent portion outlet.

123. 119. A patient interface according to claim 118, wherein the at least one gas exit vent comprises at least one vent slot.

124. 119. A patient interface according to claim 118, wherein the at least one vent slot comprises a plurality of vent slots disposed around a portion of a circumference of the swivel ring.

125. 119. A patient interface according to claim 118, wherein the swivel ring further comprises a sealing portion flange connected to the sealing portion and an elbow flange connected to the elbow.

126. 126. A patient interface according to claim 125, wherein the swivel ring has a seal portion interference web formed between the seal portion flange and the elbow flange, the seal portion interference web being U-shaped.

127. a plenum connected between the sealing portion and a swivel ring, the swivel ring being connected to an elbow having a vent for exhaled air; 25. A patient interface according to any one of claims 1 and 24, wherein the plenum positions the elbow such that, in use, air exhaled through the vent is directed away from a patient.

128. 94. A patient interface according to any one of claims 21-37, 54-56, 68, 81-84, 89 and 93, further comprising a support membrane, the support membrane having a support portion and a stem.

129. 129. A patient interface as described in claim 128, further comprising a flexible tube for supplying air to a patient, and a thin flexible membrane connected between the support portion and the flexible tube.

130. 130. A patient interface as described in claim 129, further comprising a polyaxial elbow assembly connected between the support membrane and the flexible tube, the polyaxial elbow assembly allowing the flexible tube to move in two separate planes.

131. 131. A patient interface as described in claim 130, wherein the polyaxial elbow assembly comprises a frame coupled to the thin flexible membrane, a first elbow coupled to the frame, a swivel assembly coupled to the first elbow, a swivel ring coupled to the swivel assembly, and a second elbow coupled between the swivel ring and the flexible tube.

132. 132. A patient interface as described in claim 131 , wherein the first elbow is adapted to rotate within the frame in a first plane and the second elbow is adapted to rotate within the swivel assembly in a second plane different from the first plane.

133. 129. A patient interface as described in claim 128, further comprising a bellows connected to the support membrane and a short tube connected to the bellows.

134. 134. A patient interface according to claim 133, wherein the bellows is a unitary structure comprising the supporting membrane.

135. 135. A patient interface according to any one of claims 133-134, wherein the bellows has a hardness of 40 Shore A durometer.

136. 136. A patient interface according to any one of claims 133 to 135, wherein the bellows has an internal bore of 15 mm.

137. 137. A patient interface according to any one of claims 133 to 136, wherein the bellows comprises a plurality of bellows rings.

138. 138. A patient interface according to claim 137, wherein each of the bellows rings has a height of about 5 mm and a width of about 4 mm.

139. 139. A patient interface according to any one of claims 137 to 138, wherein the radius of the curved portion between each of the bellows rings is approximately 2.55 mm.

140. 140. A patient interface according to any one of claims 137 to 139, wherein the separation between the bellows rings is approximately 5.1 mm.

141. 141. A patient interface according to any one of claims 137 to 140, wherein the side walls of each of the bellows rings have a thickness of approximately 0.3 mm and are constructed from a material having a hardness of 40 Shore A.

142. 142. A patient interface according to any one of claims 137 to 141, wherein the radius of the bellows measured from the inside of the bottom of each curved portion between the bellows rings is approximately 7.5 mm.

143. 129. A patient interface as described in claim 128, further comprising a ball and socket connector connected between the support membrane and a flexible tube for supplying air to the patient.

144. 144. A patient interface according to claim 143, further comprising a plurality of curved ventilation grooves on the ball.

145. 144. A patient interface according to claim 143, further comprising a plurality of vent portions on the ball.

146. 144. A patient interface according to claim 143, further comprising a removable barrier positioned over the ball, the removable barrier having a plurality of ventilation channels.

147. 147. A patient interface as described in claim 146, further comprising an elbow connected between the ball and the flexible tube, the elbow having a vent having a plurality of vent portions adapted to vent air exhaled by a patient.

148. 148. A patient interface according to claim 147, wherein the vent is a removable insert from the elbow.

149. 148. A patient interface according to claim 147, wherein the vent is a mesh vent insert that is removable from the elbow.

150. 148. A patient interface according to claim 147, wherein the ball has a number of vent channels adapted to vent exhaled air from the patient.

151. 148. A patient interface according to claim 147, wherein the socket connector has a plurality of vent channels adapted to vent exhaled air from the patient.

152. a combined elbow and ball joint connected between the support membrane and a flexible tube for supplying air to a patient; the hybrid elbow and ball joint comprising: an elbow assembly having a swivel connector and a socket connector adapted to be coupled to the support membrane; and a ball assembly; 129. A patient interface according to claim 128, wherein the ball assembly includes a ball adapted to fit snugly into the socket connector and a swivel connector adapted to be coupled to the flexible tube.

153. 129. A patient interface as described in claim 128, further comprising a membrane connected between the support membrane and an elbow assembly, a swivel connector connected to the elbow assembly, and a flexible tube connected to the swivel connector for supplying air to a patient.

154. 129. A patient interface as described in claim 128, further comprising an angled elbow ball joint assembly adapted to be coupled to the support membrane, the angled elbow ball joint assembly comprising a ball, an angled elbow coupled to the ball, and a swivel connector coupled to the angled elbow.

155. 129. A patient interface as described in claim 128, further comprising a ball and socket assembly adapted to be connected between the support membrane and a flexible tube for supplying air to a patient, the ball and socket assembly comprising a swivel ring adapted to be connected to the support membrane, a ball adapted to be connected to the swivel ring and to rotate within the swivel ring, a ball joint portion connected to the ball, and a connector adapted to be connected to the flexible tube.

156. 156. A patient interface as described in claim 155, further comprising a vent incorporated into the ball joint portion, the vent adapted to vent exhaled gases from the patient.

157. 129. A patient interface as described in claim 128, further comprising an interface adapted to be coupled between the support membrane and a flexible tube for supplying air to a patient, the interface having a first aperture and a second aperture extending in substantially opposite directions, the flexible tube being coupled to one of the apertures and a plug being coupled to the other of the apertures.

158. 158. A patient interface according to claim 157, further comprising a plurality of vent portions disposed between the first aperture and the second aperture.

159. 129. A patient interface as described in claim 128, further comprising an interface adapted to be connected between the support membrane and a pair of flexible tubes for supplying air to a patient, and a rigid frame connected to the interface, the interface having a first aperture and a second aperture extending in substantially opposite directions, the first tube of the flexible tubes being connected to one of the apertures and the second tube of the flexible tubes being connected to the other of the apertures.

160. 160. The patient interface of claim 159, further comprising a plurality of vent portions disposed between the first aperture and the second aperture.

161. 129. A patient interface according to claim 128, further comprising a rigid frame adapted to be coupled to the support membrane, the rigid frame having a headgear connector adapted to be coupled to a headgear.

162. 129. A patient interface as described in claim 128, further comprising a headgear cradle portion adapted to connect a headgear to the support membrane, the headgear cradle portion having tactile end portions adapted to increase a user's grip.

163. 163. A patient interface according to claim 162, further comprising a conformable pad adapted to provide support to the support membrane.

164. 129. A patient interface as described in claim 128, further comprising a connector on the support membrane, the connector having a pair of apertures, a headgear connection cradle adapted to connect the headgear to the connector, and an elbow having a pair of lugs adapted to connect to the pair of apertures on the connector.

165. 129. A patient interface as described in claim 128, further comprising an elbow assembly adapted to be connected between the support membrane and a flexible tube for supplying gas to a patient, the elbow assembly comprising a swivel ring adapted to be connected to the support membrane, an elbow connected to the swivel ring, a connector adapted to be connected to the flexible tube, and a plurality of ventilation grooves in the elbow, the ventilation grooves having a plurality of different lengths.

166. 166. A patient interface according to claim 165, wherein the plurality of ventilation channels are arranged in a direction substantially parallel or substantially perpendicular to the direction of gas flow through the elbow.

167. 1. A patient interface for delivering pressurized breathable gas to a patient, the patient interface having a sealing portion adapted to form a seal with a patient's face, the sealing portion having an opening adapted to receive the pressurized breathable gas, an outer sealing perimeter for creating a seal with the patient's face, and a transition area between the opening and the outer sealing perimeter that gradually increases in size from the opening to the outer sealing perimeter.

168. 168. A patient interface according to claim 167, wherein the opening defines an interior surface in communication with the breathable gas, and the outer sealing perimeter is formed as a continuous extension of the interior surface.

169. 169. A patient interface according to any one of claims 167 to 168, wherein an outer edge of the sealing portion is oriented away from the opening and / or in the direction of flow of the breathable gas.

170. 168. A patient interface according to claim 167, wherein the outer sealing periphery is substantially concave when viewed from above.

171. 1. A patient interface for delivering breathable gas to a patient, the patient interface comprising: a sealing portion adapted to form a seal with a patient's face; a support portion supporting one or more portions of the sealing portion; a head connector extending from the support portion adapted to be coupled to a headgear to secure the patient interface to a patient; and having A patient interface wherein, in use, the headgear causes the headgear connector to bend towards the support portion and the bending force from the headgear connector is transmitted to the seal portion as a sealing force.

172. 172. A patient interface as described in claim 171, wherein the bending force from the headgear connector is transferred by the support portion to the sealing portion as a clamping force on the side of the patient's nose, in use.

173. 172. A patient interface as described in claim 171, wherein the sealing portion has a thickened corner region and the support portion has a rear thickened portion, and wherein the bending force from the headgear connector is transferred by the rear thickened portion to the thickened corner region of the sealing portion in use, thereby applying the sealing force as a fixing force to the area of ​​the patient's nose adjacent the nose and lip creases.

174. 172. A patient interface as described in claim 171, wherein the bending force from the headgear connector is transferred to the posterior thickened portion by the stiffness of the headgear connector and / or by contact of the headgear with the posterior thickened portion.

175. 1. A patient interface for delivering breathable gas to a patient, the patient interface comprising: The seal part, a polyaxial elbow assembly operatively coupled between the seal portion and a flexible tube, the polyaxial elbow assembly permitting movement of the flexible tube in two separate planes while substantially isolating the transmission of traction forces from the flexible tube to the seal portion; A patient interface comprising:

176. 176. A patient interface as described in claim 175, wherein the polyaxial elbow assembly comprises a frame, a first elbow coupled to the frame, a swivel assembly coupled to the first elbow, a swivel ring coupled to the swivel assembly, and a second elbow coupled between the swivel ring and the flexible tube.

177. 176. A patient interface as described in claim 175, wherein the first elbow is adapted to rotate within the frame in a first plane and the second elbow is adapted to rotate within the swivel assembly in a second plane different from the first plane.

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