Unobtrusive nose 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. 2009906101, 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 September 4, 2009, U.S. Provisional Patent Application No. 61 / 272250, filed November 20, 2009, U.S. Provisional Patent Application No. 61 / 263175, filed November 18, 2010, U.S. Provisional Patent Application No. 61 / 282693, filed March 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, using 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 includes a positive airway pressure (PAP) device, an air delivery conduit or tube, and a patient interface that, 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 be very intrusive, which may 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 sensation of pressurized air being 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 Pamphlet [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] Therefore, there is a growing need in the art to provide alternative patient interfaces that are less intrusive, do not involve placing pillows along the nostrils, and / or may reduce the perception of pressurized air directed upward along the nostrils. [Means for solving the problem]

[0008] One aspect of the present technology relates to a patient interface for delivering 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 contact with 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 contact with the nasal septum. Another aspect of the present technology is a patient interface that defines a single breathing chamber that provides for the delivery 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 nostrils, and nostril engagement flaps adapted to form a seal with the patient's nares. In one form, the nose tip engagement portion, upper lip engagement portion, and nostril engagement flaps are all configured to extend or curve outward from a support wall that defines an airway.

[0010] In accordance with one form of the present technology, there is provided a patient interface that utilizes different seal-forming mechanisms in different regions of the patient interface. Preferably, in a region configured to form a seal with a nasal crease region of the face, a portion of the seal operates in compression. Preferably, in a region configured to form a seal with the 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, the 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, the 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 so that the membrane is held somewhat fixed at its ends and is pulled toward the tip of the nose in use.

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

[0013] In one form, the seal-forming portion of a patient interface according to 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 a patient interface according to the present technology defines an anterior inner portion and a posterior inner portion. Preferably, the right and left outer portions are constructed and arranged to hinge about the anterior inner portion and the posterior inner portion, respectively, during use. Referring to Figures 19 to 21 of U.S. Patent Publication No. 2007 / 0129994, published as U.S. Patent Publication No. 2007 / 0129994, a seal-forming portion according to one aspect of the present technology is adapted to hinge about the inner portion to accommodate the patient's alar angle. In one form, the seal portion is adapted to hinge outward to accommodate a wide nose. In one form, the seal portion is adapted to hinge inward to accommodate a narrow nose.

[0014] In one form of the present technology, there is provided a patient interface having a headgear and a seal-forming portion. The seal-forming portion is adapted 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 the tension of the headgear. In one form, the patient interface has an outer headgear connector that is arranged at a predetermined 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 can be 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 so that it fits snugly. Preferably, the patient interface is arranged such that bending of the seal-forming portion about an inner portion thereof can be achieved by varying the tension of 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 embodiment, 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 the sides of the flexible body. The body is constructed and arranged to flex in response to varying headgear tension to vary the outward or clamping force on the sides of the nose affecting the seal. In one embodiment, the flexible body is formed from rubber, preferably silicone. In one embodiment, 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, and 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 sealing portion configured to extend or curve outward from a support wall defining an airway. 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 the interior surface of the cushion. In one form, a particular region of the seal-forming portion has a trumpet-, horn-, or bell-shape, while the remaining region has a different shape. For example, the region of the seal-forming portion configured 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 rubber having a Type A durometer in the range of about 35 to about 45, and a seal-forming portion formed from 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 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 hanging 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, nostril engagement flaps 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 delivering breathable gas to a patient, wherein 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 delivering 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 connected to the support portion at side portions of the sealing portion and 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 delivering 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 nostrils, 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, wherein 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 including a sealing portion having a nasal tip engagement portion adapted to engage the patient's nasal tip, and a support portion supporting the sealing portion, the support portion being connected to the sealing portion at two side portions of the sealing portion and 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 the patient's face in use, the sealing portion having a front stretch portion adapted to form a seal with the patient's nose tip, a rear stretch portion adapted to form a seal with the patient's upper lip, side pressure portions adapted to secure the sealing portion in areas of the patient's nose adjacent the naso-lip crease by applying a force perpendicular to the plane of the patient's face, and side wrap portions adapted to form a seal with the patient's nares by applying a clamping force perpendicular to the patient's nares. The side wrap portions and side pressure portions may be thicker than the front stretch portion or the rear stretch portion. The front stretch portion can stretch to form a seal with the patient's nose tip in use, and the rear 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 the 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, wherein in use, the headgear bends the headgear connector toward the support portion, and a bending force from the headgear connector is transmitted 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 nasal-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 seal portion from transmitting traction forces from the flexible tube.

[0031] Another aspect of the present technology relates to a polyaxial 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 explanation 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 sealing portion and suspension system of FIG. 1-2. [Figure 1-5] FIG. 3 is a bottom view of the sealing portion and suspension system of FIG. 1-2. [Figure 1-6] FIG. 3 is a front view of the sealing portion and suspension system of FIG. 1-2. [Figure 1-7] FIG. 3 is a rear view of the sealing portion and suspension system of FIG. 1-2. [Figure 1-8] FIG. 3 is a side view of the sealing portion and suspension system of FIG. 1-2. [Figure 1-9] FIG. 1-2 is a perspective view of 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 FIGS. 1-9. [Figure 1-11] FIG. 10 is a top view of the suspension system and frame of FIGS. 1-9. [Figure 1-12] FIG. 10 is a front view of the suspension system and frame of FIG. 1-9. [Figure 1-13] FIG. 10 is a rear view of the suspension system and frame of FIGS. 1-9. [Figure 1-14] FIG. 10 is a side view of the suspension system and frame of FIGS. 1-9. [Figure 1-15] FIG. 1-2 is a perspective view of the sealing portion, suspension system, and frame of the patient interface of FIG. 1-1. [Figure 1-16] FIG. 1-16 is a rear view showing the seal portion, suspension system, and frame of FIG. 1-15. [Figure 1-17]FIG. 1-16 is a front view showing the seal portion, suspension system, and frame of FIG. 1-15. [Figure 1-18] FIG. 1-16 is a side view showing the seal portion, suspension system, and frame of FIG. 1-15. [Figure 2-1] FIG. 136 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 sealing 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 views illustrating alternatively shaped sealing portions in accordance with embodiments of the present technology; [Figure 2-9B] 13A-13C are rear views illustrating alternatively shaped sealing portions in accordance with embodiments of the present technology; [Figure 2-10] FIG. 136 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 illustrating an alternatively shaped sealing portion according to an embodiment of the present technology; [Figure 3-1] FIG. 13 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 sealing portion and suspension system of FIG. 3-2. [Figure 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 sealing portion and suspension system of FIG. 3-2. [Figure 3-6] FIG. 3-3 is a side view of the sealing portion and suspension system of FIG. 3-2. [Figure 4-1] FIG. 13 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. 4-2. [Figure 4-6] FIG. 4-3 is a side view showing the sealing portion of FIG. 4-2. [Figure 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 for the sealing portion of FIG. 4-2. [Figure 4-9] 4-3 shows an alternative self-adjusting shape for the sealing portion of FIG. 4-2. [Figure 5-1] 13 is a cross-sectional view illustrating a sealing portion with a beading of gel in accordance with an embodiment of the present technology; [Figure 5-2] 13 is a cross-sectional view illustrating a sealing portion with a 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] 14A-14D show a sealing portion with fingers or ridges according to an embodiment of the present technology; [Figure 7-2] 14A-14D show a sealing portion with fingers or ridges according to an embodiment of the present technology; [Figure 7-3] 14A-14D 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] 13A-13C show a sealing portion with reinforcing ribs in accordance with an embodiment of the present technology; [Figure 9-2] 13A-13C show 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] 14 shows a suspension system with headgear connectors according to an embodiment of the present technology. [Figure 12] 14 shows headgear 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 shows an elbow for a mask in accordance with an embodiment of the present technology; [Figure 14-2] 14 shows an elbow for a mask in accordance with an embodiment of the present technology; [Figure 14-3] 14 shows an elbow for a mask in accordance with an embodiment of the present technology; [Figure 14-4] 14 shows 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] 13A-13C show a sealing portion comprising flexible tubing in accordance with an embodiment of the present technology; [Figure 16-2] 13A-13C show a sealing portion comprising flexible tubing in accordance with an embodiment of the present technology; [Figure 17-1] 14 illustrates a sealing portion with a gusset-type suspension system in accordance with an embodiment of the present technology; [Figure 17-2] 14 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]

[0047] FIG. 104 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. 10 is a side view of an 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]

[0037] FIG. 10 is a front view of an 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. 14 is a side view illustrating an embodiment of the present technology. [Figure 23-2]

[0033] FIG. 14 is a rear view of an embodiment of the present technology. [Figure 23-3] FIG. 14 is a front view illustrating 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. 14 is a bottom view of an embodiment of the present technology. [Figure 23-6] FIG. 10 is a side cross-sectional view illustrating an embodiment of the present technology; [Figure 23-7] FIG. 10 is a front cross-sectional view illustrating an embodiment of the present technology; [Figure 24-1]FIG. 136 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. 136 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 in accordance with 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] FIG. 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. [Figure 30] FIG. 1 is a cross-sectional view showing a sealing portion of the prior art. [Figure 31] 13 is a cross-sectional view of a sealing portion according to an embodiment of the present technology; [Figure 32-1] FIG. 134 is a rear view showing attachment of headgear to a sealing portion according to an embodiment of the present technology. [Figure 32-2] FIG. 134 is a front view showing attachment of headgear to a sealing portion according to another embodiment of the present technology. [Figure 33-1] FIG. 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] FIG. 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 is 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. [Figure 36] FIG. 1 is a side view of a membrane implementation according to an embodiment of the present technology; [Figure 37-1]

[0033] Fig. 11 shows a vent according to an embodiment of the present technology. [Figure 37-2]

[0033] Fig. 11 shows a vent according to an embodiment of the present technology. [Figure 38]

[0033] FIG. 144 is a side view of an elbow in accordance with an embodiment of the present technology; [Figure 39] FIG. 134 is a perspective view showing a support mechanism for a stem of a sealing portion according to an embodiment of the present technology; [Figure 40] 13 is a cross-sectional view of a sealing portion according to an embodiment of the present technology; [Figure 41] FIG. 13 is a side view of a tube separation mechanism in accordance with 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]

[0033] FIG. 144 is a side view of a swivel ring in accordance with 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] FIG. 42-7 is a cross-sectional view showing the swivel ring of FIG. [Figure 43] FIG. 10 is a side view of a system having a plenum in accordance with an embodiment of the present technology; [Figure 44] 13 illustrates a seal between the sealing portion and the patient's nose in accordance with an embodiment of the present technology. [Figure 45] 13 illustrates a seal between the sealing portion and the patient's nose in accordance with an embodiment of the present technology. [Figure 46] 13 illustrates a seal between the sealing portion and the patient's nose in accordance with an embodiment of the present technology. [Figure 47-1] FIG. 10 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. 10 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. 10 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 support 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. [Figure 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 of 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. 10 is a front perspective view of a patient interface according to an embodiment of the present technology; [Figure 58] FIG. 10 is a front perspective view of a patient interface in a bent position in accordance with an embodiment of the present technology; [Figure 59]

[0033] FIG. 10 shows a perspective view of a polyaxial elbow assembly in accordance with an embodiment of the present technology; [Figure 60] FIG. 10 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. 10 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. 10 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. 10 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. 10 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. 10 is a perspective view of a patient interface with a bellows in accordance with an embodiment of the present technology; [Figure 66] FIG. 10 is a perspective view of a patient interface with a bellows in accordance with an embodiment of the present technology; [Figure 67] FIG. 10 is a left perspective view of a patient interface in use with headgear on the patient in accordance with an embodiment of the present technology; [Figure 68] FIG. 14 is a perspective view of a bellows according to an embodiment of the present technology; [Figure 69] 69 is a graph showing various dimensions of the bellows of FIG. 68. [Figure 70] FIG. 10 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]

[0033] FIG. 10 is a perspective view of a ball joint and connector according to an embodiment of the present technology. [Figure 72] FIG. 13 is 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 vents according to an embodiment of the present technology; [Figure 74] FIG. 13 is a cross section view of a ball joint and elbow with vent holes according to an embodiment of the present technology; [Figure 75] FIG. 134 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] 13 shows a ball joint and elbow with vents according to an embodiment of the present technology. [Figure 78] FIG. 13 is a perspective view of a socket connector with ventilation grooves according to an embodiment of the present technology; [Figure 79] FIG. 10 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. 10 is a perspective view of a combined 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 combined elbow and ball joint of FIG. 80 on a patient in use according to an embodiment of the present technology. [Figure 83] FIG. 81 is a side perspective view showing a patient interface with the combined elbow and ball joint of FIG. 80 on a patient in use according to an embodiment of the present technology. [Figure 84] FIG. 10 is a side perspective view showing a patient interface with a membrane and elbow assembly on a patient in use according to an embodiment of the present technology. [Figure 85] FIG. 14 is a perspective view of an angled elbow ball joint assembly according to an embodiment of the present technology. [Figure 86] FIG. 10 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. 10 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. 10 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. 10 is a rear perspective view showing headgear on a patient in use according to an embodiment of the present technology; [Figure 90] FIG. 10 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. 10 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. 10 is a rear perspective view of a patient interface with headgear according to an embodiment of the present technology. [Figure 92-1] FIG. 10 is a front perspective view of a patient interface with headgear according to an embodiment of the present technology; [Figure 93] FIG. 10 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. 10 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. 136 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 swivel ring according to an embodiment of the present technology. [Figure 100]FIG. 144 is a side perspective view of a ball and socket assembly combined with a ball joint portion and 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. 10 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. 10 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. 10 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. 102 is a front perspective view of a patient interface with a double-sided connecting tube according to an embodiment of the present technology. [Figure 106] FIG. 10 is a front perspective view of a patient interface comprising a frame and headgear according to an embodiment of the present technology; [Figure 107] FIG. 10 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. 10 is a perspective view of a patient interface with a headgear cradle according to an embodiment of the present technology. [Figure 109] FIG. 10 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 an 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 venting according to an embodiment of the present technology; [Figure 113-1] FIG. 10 is a perspective view of an elbow ball with ventilation grooves according to an embodiment of the present technology; [Figure 113-2] FIG. 10 is a perspective view of an elbow bowl with ventilation grooves and a removable barrier according to an embodiment of the present technology; [Figure 114] FIG. 102 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. 10 is a perspective view showing an elbow and swivel connector with vent grooves according to an embodiment of the present technology; [Figure 116] FIG. 10 is a perspective view showing an elbow and swivel connector with vent grooves according to an embodiment of the present technology; [Figure 117] FIG. 134 is a front perspective view showing a sealing portion of a patient interface in accordance with an embodiment of the present technology. [Figure 118-1] FIG. 102 is a perspective view of a sealing portion of a patient interface according to an embodiment of the present technology. [Figure 118-2] FIG. 102 is a perspective view of a sealing portion of a patient interface according to an embodiment of the present technology. [Figure 118-3] FIG. 102 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 in accordance with an embodiment of the present technology. [Figure 120] FIG. 102 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 in accordance with an embodiment of the present technology. [Figure 122-1] 14 is a cross-sectional view showing a sealing portion of a patient interface in accordance with an embodiment of the present technology. [Figure 122-2] 14 is a cross-sectional view showing a sealing portion of a patient interface in accordance with an embodiment of the present technology. [Figure 122-3] 14 is a cross-sectional view showing a sealing portion of a patient interface in accordance with an embodiment of the present technology. [Figure 123] 14 is a cross-sectional view showing a sealing portion of a patient interface in accordance with an embodiment of the present technology. [Figure 124] FIG. 13 is a top view of a sealing portion of a patient interface in accordance with an embodiment of the present technology. [Figure 125] FIG. 13 is a top view of a sealing portion of a patient interface in accordance with an embodiment of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0035] The following description is provided in connection with 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 an additional embodiment.

[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 are not limited to the sense of "exclusively" or "consisting only of".

[0037] The term "air" is intended to include breathable gases such as, for example, air containing 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 has one end coupled to an outlet of the PAP device 15 and an opposite end 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, elbows 230 (e.g., with swivels) adapted to be connected to the air delivery tubes 20, headgear attachments 240 (e.g., slots or clips on the frame and / or forehead support that are provided to engage headgear straps), 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 pillow or puff mask that seals in or around the patient's nostrils. In this configuration, the nasal pillows can cause discomfort due to contact with the nostrils. Additionally, the "air jetting" effect caused by high-velocity laminar airflow directed upward into the nostrils can cause discomfort, increasing pressure in small areas within the nasal passages and drying 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 within the nares, thereby eliminating this discomfort. Also, unlike nasal pillow patient interfaces, the proposed patient interface has a single opening or aperture that directs breathable gas into the patient's airway. The 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 under the nasal structures, aspects of the present technology may be incorporated into other forms of masks, such as masks that surround the nose or masks that surround both the nose and mouth.

[0044] 3.1 Seal part In use, the sealing portion 210 interfaces with the patient, enabling the delivery of breathable gas to the patient. In the illustrated embodiment, 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, a thermoplastic elastomer, a gel, a foam material, or any other suitable conformable material. The material can have a durometer of approximately 1 Shore A to 15 Shore A. Preferably, the material can have a durometer of approximately 3 Shore A to 10 Shore A. Preferably, the material can have a durometer of approximately 5 Shore A to 12 Shore A. Most preferably, the material can have a durometer of approximately 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, although it may be modified to be pressure-assisted. In one form, the sealing portion may use a gusset (e.g., having a projected area larger than the area of ​​the sealing portion) to assist in forming the seal, as disclosed in U.S. Patent No. 6,229,999 or U.S. Patent No. 6,229,999, the entire contents of which are incorporated herein by reference.

[0045] In one embodiment, the sealing portion may have a wall thickness of about 0.1 to 15 mm. Preferably, the sealing portion may have a wall thickness of about 2 to 10 mm. Preferably, the sealing portion may have a wall thickness of about 7 to 12 mm. Preferably, the sealing portion may have a wall thickness of about 1 to 5 mm. Most preferably, the sealing portion may have a wall thickness of about 1 to 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, from about 0.5 mm thick in the thin regions to a maximum of about 2 to 10 mm thick 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 having a different hardness and / or thickness (e.g., two layers each 1.2 mm thick but with silicones of different durometers).

[0046] 3.1.1 Shape In the illustrated embodiment, 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 related description of U.S. Patent No. 5,729,492, published as U.S. Patent No. 5,729,492).

[0047] The generally smooth curves or wavy shape of sealing portion 210 can be conformable, as it can bend to accommodate various nose shapes and sizes. The general shape of sealing portion 210 can also provide comfort and less obstruction to the patient, increasing compliance.

[0048] Alternatively, sealing portion 210 may be generally flat and still bendable to fit the patient's desired alar angle, which may be accomplished by providing sealing portion 210 with reduced thickness sections 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, sealing portion 210 may have an aperture 211 that allows breathable gas to pass from air delivery conduit 20 to the patient. Aperture 211 may be generally circular, rectangular, or any other desired shape (e.g., a trapezoidal or oval shape as shown in Figures 1-4, 1-5, and 48). In one embodiment, aperture 211 may be shaped to indicate the alignment or orientation of sealing portion 210 relative to the patient's nose in use, such as a trapezoidal or triangular shape.

[0050] The aperture 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 aperture 211 may be lower compared to a nasal prongs or pillows mask. The lower velocity of the air exiting the aperture 211 makes it easier for the patient to exhale air against the incoming air and reduces discomfort from high velocity airflow in and around the nose.

[0051] As shown in the embodiment of FIG. 48-1, aperture 455 can have a dimension d1 (width) corresponding to the width of the nose of various patients with various measurements, and a dimension d2 (height) corresponding to the height of the nose tip, or distance from the upper lip, of various patients with various measurements. Preferably, dimension d1 can be approximately 10-60 mm. Preferably, dimension d1 can be approximately 15-40 mm. Most preferably, dimension d1 can be approximately 21 mm. Most preferably, dimension d1 can be approximately 38 mm. Most preferably, dimension d1 can be approximately 58 mm. Preferably, dimension d2 can be approximately 1-20 mm. Most preferably, dimension d2 can be approximately 5-15 mm. Most preferably, dimension d2 can be approximately 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 corner portion 457 may be 5 mm, although different radii of curvature may be used.

[0052] 3.1.3 Engagement part In the illustrated embodiment, 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 through 1-4 and 1-8, the nose tip engaging portion 212 is generally flat or planar along its length to provide a sealing surface of sufficient length 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 through 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, or 4 mm. In one example, R1 may be approximately 3-3.75 mm, R2 may be approximately 2 mm, R3 may be approximately 3.25-4.5 mm, and R4 may be approximately 3.25-4.25 mm. As shown in FIG. 20-2, the radii of curvature R10 and R11 may be approximately 8-13 mm, e.g., 9 mm or 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 Engaging Flap In the embodiment shown, sealing portion 210 may have nostril-engaging flaps 214 that are configured to be aligned near or facing the patient's nostrils. In use, flaps 214 create a seal with the nostrils (e.g., directly at the entrance to the nostril or along the patient's nostril) and are bent or biased inward toward the patient's nose to stabilize and secure the seal and also to allow sealing portion 210 to conform to a variety of nose sizes and shapes.

[0054] As demonstrated in Figures 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) to form a generally V-shape.

[0055] In one embodiment, 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°, or about 75-95°. Angle α represents the angle of the engagement flaps in a non-use or relaxed configuration. Angle α increases during use, or when a patient places the mask over their nose and exerts a force on the mask, causing the engagement flaps to bend outward to the use position. This may include angles between about 75° and 200°. The radius of curvature depicted in the general area bounded by α may be about 5-8 mm.

[0056] The nostril-engaging flaps can have alternative configurations to enhance the seal. For example, as shown in FIG. 6-1, the nostril flaps 214 can be narrower (e.g., have a smaller angle α) so that they "pin" or are bent outward by the nose when in use. As shown in FIG. 6-2, the flaps 214 can have hook-shaped end portions 214(1) that are configured to "hook" over the patient's nostrils when in use to seal across the patient's nostrils.

[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 flaps 214 are all structures that curve or extend outwardly from tubular support wall or base 219. That is, nose tip engaging portion 212, upper lip engaging portion 213, and nostril engaging flaps 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, uninterrupted, smooth manner.

[0058] 3.1.6 Seal parts with malleable wire FIGS. 4-1 through 4-7 illustrate a sealing portion 210 including a malleable wire 270. As shown, the malleable wire 270 is located 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 also be located in 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) and maintain the deformed shape of the sealing portion during use. For example, FIG. 4-8 illustrates the sealing portion 210 deformed into a generally V-shape, and FIG. 4-9 illustrates 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 in a base 271 adapted to be attached to a frame, however, such a sealing portion may also be provided in a suspension system or directly to the 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 on the sealing wire in any manner, for example, co-molded with the seal portion or may be a post-installation.

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

[0062] 3.1.7 Gel beads 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 (FIG. 5-1), along a portion of the edge, and / or within the edge (FIG. 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 illustrates one embodiment of fingers 273, and FIG. 7-3 illustrates 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 outward from the face-contacting surface of the sealing portion (e.g., to a height of about 0.5 mm) and are configured to deform during use to conform to the various contours of a patient's face. Such fingers / ridges may particularly improve the seal in unfavorable locations, such as from the base of the nose to the upper lip. Such fingers / ridges may also form 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 integrally formed 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 increase strength around the entire perimeter and support the outer edge of the sealing portion 210 to prevent it from collapsing 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., comprising one or more "branches" of the rib) to increase support and reduce bending in selected areas of the sealing portion, such as areas most susceptible to leakage or deformation. In another embodiment, the reinforcing ribs or thickened portions may be provided at spaced locations on the sealing portion, for example, in areas most susceptible to leakage or deformation. The reinforcing ribs 275 may be thicker than the sealing portion 210. Alternatively, the reinforcing ribs may be made from a material of a 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 illustrates one embodiment of the sealing portion 210 constructed from gel, i.e., a gel-filled sack or membrane (e.g., approximately 0.3-5 mm, e.g., 0.7 mm, wall thickness). As shown, membrane or sack 276 is filled with one or more layers of gel, and cap 277 (constructed from, e.g., polycarbonate, silicone, polypropylene, or nylon) is provided to close and seal the opening into the sack. Cap 277 also helps to position and maintain the gel-filled sack in 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 composed of a material adapted to change color, such as a heat-sensitive material. For example, the sealing portion may be composed of a heat-sensitive color-changing silicone, which starts out blue (or any first color) at room temperature and changes to white / clear (or any second color different from the first color) upon the application of heat, such as 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 nose size, 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 customize the mask to fit 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 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 preferable 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 failing, 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, making the mask less obtrusive.

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

[0074] The color-changing material can be used to make the mask asymmetrical. For example, if a patient has an asymmetrical 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 asymmetrical 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 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 FIGS. 27-1 and 27-2 illustrate a sealing portion 210 with a thermochromic sizing indicator. FIG. 27-1 shows the sealing portion 210 before use, with the entire sealing portion 210 being colored by a color 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 color 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., color 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, providing an ideal choice between pre-made sealing portions of various sizes.

[0081] 3.1.13 Sizing Options The sealing portion 210 can be configured to create a single-size cradle 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 orifice size, such that orifice opening 362, orifice opening 364, or orifice opening 366 can be used depending on the patient's nose size, i.e., orifice opening 366 for larger noses and orifice opening 362 for smaller noses. Additionally, 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 sizing ranges.

[0082] 3.1.14 Protrusion 24-1 through 24-4 show the sealing portion 210 (also referred to as a nasal cradle) with a nozzle or protrusion 320. The nozzle 320 is positioned on the sealing portion 210 to be located in or near the patient's nares, and in use positions the sealing portion below the patient's nose 324. The nozzle 320 positions the sealing portion 320 to allow for an effective seal to be formed and for proper treatment to be administered to the patient.

[0083] Nozzle 320 includes an orifice 322 that can be used to release gas into the patient's nose 324. Nozzle 320 does not necessarily have to form a seal with the patient's nares; instead, 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, sealing portion 210 includes a septum locator 326 to allow the patient's septum to be located between nozzle 320. Septum locator 326 may include cushioning to provide patient comfort 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 with 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 noses and nostrils of different sizes. 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 flexed to accommodate noses of different sizes, e.g., different widths.

[0085] 3.1.12 Sealing comfort 25-1 through 25-4 illustrate the sealing portion 210, which includes structural elements for patient comfort. For example, the sealing portion 210 may include a soft, comfortable cushion to enhance comfort and improve treatment compliance. 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 approximately 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 positioned beneath the sealing membrane 328. The membrane 328 may be constructed of silicone or another suitable material. The cushion 330 may be 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 over or wrap over the outer edges of the cushion 330, thereby positioning and holding the cushion 330 beneath the membrane 328. Additionally, a retaining ridge 332 on the stem 334 of the sealing portion 210 may be provided to retain the cushion 330 by preventing it from sliding downward. That is, the retaining ridge 332 provides an obstruction to prevent the cushion from moving downward.

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

[0088] FIG. 25-2 shows a configuration similar 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 a fixed position. In use, when a patient positions the sealing portion 210, the patient applies a force (indicated by the arrow) to the sealing portion 210 and the cushion 330. The lower membrane 340 supports the cushion 330 in a fixed position so that the cushion 330 generates a sufficient counterforce (as indicated by the arrow) at an appropriate displacement, thereby enabling a seal to be formed with the patient and providing 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 the sealing membrane 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 approximately 5 to 20 Shore A (e.g., approximately 7 to 15 Shore A, preferably approximately 7 Shore A), and the lower cushion 344 may have a hardness of approximately 20 to 80 Shore A (e.g., approximately 40 to 70 Shore A, preferably approximately 40 Shore A). However, other suitable hardnesses are possible. The upper cushion 342 and the lower cushion 344 may be made of, for example, silicone, TPE, gel, foam, 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 nasal tip portion 352 and the nostril-engaging flaps. This configuration allows the draw lines (indicated by the arrows) of the molding tool to be straight, thus facilitating molding, and thus allowing for the formation of a bladder as a cushion. 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 during use. The membrane 348 may be stretchable and / or flexible to accommodate various upper lip anatomy. The membrane may also reduce the force exerted on the patient's face to create a seal, thereby improving comfort at the upper lip.

[0091] In the embodiment shown in Figures 47-1 through 50, the sealing portion 450 may be formed from a single 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 approximately 5 to 40 Shore A (preferably approximately 5 to 15 Shore A, most preferably approximately 5 Shore A) to provide patient comfort.

[0092] 3.1.15 Membrane 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 also 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 curve inward. This rolling can cause blockage of the patient's nares, as excess material can cover the patient's airways.

[0093] In contrast, in the embodiment of the present technology shown in FIG. 31 , the membrane 348 is configured to bend outward, or away from the center of the patient's nose, during use. Alternatively, this configuration may be described as trumpet-shaped or bell-shaped. A support wall 372 maintains the membrane 348 in the non-use position and prevents the membrane 348 from bending outward beyond its predetermined limit. Because the excess material of the membrane 348 bends outward, it reduces the likelihood of the material occluding the patient's nostrils. The excess material of the membrane 348 reduces the likelihood of occlusion 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 falling into a downward position that could occlude 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, headgear attachment points 376 are located proximate to orifice 374, thereby allowing straps 378 to support the entire length of sealing portion 210 and to support membrane 348 in an upward position during use. Thus, membrane 348 is prevented from bending outward excessively, thereby preventing occlusion of the patient's nares or breaking the seal between the mask and the patient. The headgear straps 378 can flex and move under the sealing portion 210 that is not attached via the headgear attachment, thereby allowing the headgear to rest in multiple positions under the membrane, thereby providing a greater fit.

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

[0096] FIG. 33-1 illustrates a support member 381 (e.g., a substantially rigid member) positioned below, within, or as part of the sealing portion 210 (the support member 381 is shown in dotted lines). The support member 381 is configured to urge the membrane of the 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 nostrils are difficult to seal at because patients have varying geometries at the corners of the nose and the bulging nostrils. The support member 381 may have a stiffer or harder structure than the membrane, which secures the sealing portion at the upper lip area, corners of the nose 382, ​​and bulging nostril areas 384, and further helps to hold the membrane in sealing engagement with the patient in these areas. Because the tip of the nose is very sensitive, no support member is positioned in the nasal tip area 352. 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 nostril region. The support member 381 extends further into the nasal tip region 352 to secure the sealing portion in place against the patient's nares. The support member 381 may also extend at least partially into the upper lip region 350 and the nasal corner region 382.

[0099] The support member 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 comprise 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 rigid 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 FIG. 35-1 illustrates an alternative configuration to FIGS. 34-1 and 34-2, in which a flexible or cushioning region is located 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 region of the sealing portion has two layers: a low durometer or hardness top layer L1 (i.e., the layer that contacts the patient's face) and a high durometer or hardness bottom layer L2. The low durometer material may have a higher adhesion or tack than the bottom, harder layer, and therefore may be able to form a frictional seal with the patient's face.

[0102] 3.1.18 Membrane support The membrane 348 may be supported by struts or tabs 390 ( FIG. 36 ) positioned under the 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, maintaining the sealing portion 210 in a sealed position on the patient's face and allowing for a more effective seal.

[0103] 3.1.20 Distributed 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 using one or more headgear straps 390. The sealing portion 210 may also be connected to tubing 20 for supplying breathable gas to the patient. The tubing 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 attach 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 connect to the sealing portion at the other end. The connector 395 forms one or more gas washout vents 394 that align with vent sections or tracks along the edge 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 escape vents or passages advantageously direct air away from the patient's face and also distribute air around the periphery of the vent ring 392, thereby diffusing exhaled gases and preventing them from expelling.

[0104] 3.1.21 Stem Support 39 shows a sealing portion 210 having a stem 404 for allowing breathable gas to flow through the mask to the patient. The stem 404, which is attached to a tubing 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 gas flow. 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 sealing 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 can be supported by the support portion. The sealing portion can be entirely separated from the support portion by a gap, or one or more portions of the sealing portion can contact the support portion while other portions of the sealing portion are separated from the support portion by one or more gaps. When such gaps are used, the corresponding portions of the sealing portion 210 can stretch to fit the patient's face.

[0106] 3.1.22.1 Separated Seal Sections 40 shows sealing portion 210 separated from support portion 409 by a space, or gap, 408(1), 408(2), allowing 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 a 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 seals 47-1 shows a view of the sealing portion 450 supported or positioned by the support portion 453. The sealing portion 450 is separated from the support portion 453 by a forward gap in the region of the nose tip engagement portion 452 between the forward fastening points 469, and the sealing portion 450 is connected 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 downward when in contact with the patient's nose, but the extent to which it can extend is limited by whether it reaches the support portion 453. The nasal tip engaging portion extends longitudinally from the aperture 455 to accommodate different sized nasal tips, thereby allowing the nasal tips of various patients to engage the nasal tip engaging portion in 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 providing 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 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, or 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 the sealing portion 450 may then be adhered 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 hardness greater than that of the sealing portion 450 (which, as described above, may have a hardness of approximately 5 Shore A durometer). This is because both the support portion 453 and the stem 454 support the sealing portion 450 and also provide a counterforce to stabilize the sealing portion 450 in position on the patient's face. For example, the support portion 453 and the stem 454 have a hardness of approximately 20 to 80 Shore A durometer. Preferably, the support portion 453 and the stem 454 have a hardness of approximately 30 to 65 Shore A durometer. Most preferably, the support portion 453 and the stem 454 have a hardness of approximately 40 Shore A.

[0113] The hardness of sealing portion 450, support portion 453, and stem 454 may be different from the hardness levels described, which may require varying the thickness of the material to ensure a reliable seal with the patient. For example, nose tip engaging portion 452 of 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; however, if a harder material is used for sealing portion 450, nose tip engaging portion 452 should have a reduced thickness, for example, to 0.3 mm, to exert 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 posterior gap in the region of upper lip engaging portion 462 between posterior fixation points 475, and sealing portion 450 is connected to support portion 453 on the side of sealing portion 450 outside posterior 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 glued to the support portion 453, while a front gap exists between the center 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 maintain tensioned contact with the nose during movement of the patient interface, providing a flexible surface that better accommodates various nasal geometries. A wider 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 downward toward 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 during use. The two thickened corner regions 467 protrude outward 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 approximately 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 approximately 5 to 20 mm, preferably 5 to 15 mm, and most preferably approximately 10 mm. This distance d6 allows the patient interface 451 to form an effective seal with patients with nasal alar angles of up to approximately 135°, but may also accommodate patients with nasal alar angles of up to approximately 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 approximately 38 mm, but may be another value, such as approximately 48 mm, or up to approximately 60 mm, for larger noses.

[0118] The radius of curvature of the nose tip engagement portion 452 may be approximately 30-45 mm, preferably 30-40 mm, and most preferably approximately 35 mm, but may be approximately 35-50 mm, preferably approximately 40-50 mm, and most preferably approximately 40 mm, to accommodate flatter noses. A bond contact radius of at least 1 mm may be used for the protruding edge 476 of FIG. 48 to assist tooling, allowing the protruding edge 476 to be clamped by the tool while the seal is being formed. The distance (height) d3 of the nose tip engagement portion is approximately 10 mm to 30 mm, preferably approximately 12-18 mm, and most preferably approximately 17 mm. The distance d4 of the nose longitudinal region is approximately 20-40 mm, preferably approximately 25-35 mm, and most preferably approximately 27 mm, corresponding to a nose length of approximately 12 mm to approximately 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 under tension, thus conforming to or conforming to the geometry of the patient's nose tip and upper lip. Preferably, the front stretch portion and the rear stretch portion, respectively, are held at their ends and their centers 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 air pressure urges the bulges outward. The side wrap or cantilever portions 458 provide a counterforce to this outward force, thereby forming a good seal in this area. To obtain sufficient counterforce to maintain this 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 (relative to the stretch portions 562, 564). Reinforcement can be achieved by increasing the thickness of the sealing portion 450 in these side wrap portions, such as by using a higher stiffness material, or by additional structure, such as headgear attachments or ribs, positioned below the side wrap or cantilever portions 568.

[0121] The lateral pressure or compression portions 566 are adapted to secure or support the sealing portion 450 in place. In use, the lateral pressure or compression portions 566 may be mostly in compression. The force provided by the lateral pressure portions 566 may be perpendicular to the plane of the patient's face or may be substantially horizontal. This area of ​​the patient's face that is in sealing contact is least sensitive, so tension from the headgear is substantially transferred to the lateral pressure portions 566. Preferably, this is the stiffest area of ​​the sealing portion 450. The lateral pressure portions 566 may be thicker than the front stretch portions 562 or the rear stretch portions 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, which can be varied by using different materials, different hardnesses of materials, different thicknesses 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 the sealing portion 450 has an upper lip engaging portion 462 that engages the patient's upper lip in use. The upper lip engaging portion 462 is formed as a suspended flexible membrane, and a rear gap exists 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 that secure the sealing portion 450 to the support portion 453. The suspended flexible membrane is tensioned to maintain contact with the patient's upper lip during movement of the patient interface, and the movable upper lip engaging portion 462 provides a flexible surface that can stretch to accommodate a variety of facial geometries.

[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. Depending on the thickness of the underlying support portion 453, 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, or may be decreased to the same thickness as the upper lip engaging 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 approximately 1 mm to 15 mm, preferably approximately 5 mm to 10 mm, and most preferably approximately 7 mm when not in use, and may vary between 0 mm and 15 mm, preferably up to 7 mm, based on the contact seal force against the patient's philtrum when in use. The distance d10 between the top of the sealing portion 450 and the support portion 453 may be approximately 10 mm to 30 mm, preferably approximately 15 mm to 20 mm, and most preferably approximately 18 mm. The width of the upper lip engaging portion 462 (and the distance (width) d11 of the unbonded portion of the sealing portion 450) may be approximately 10 mm to 30 mm, preferably approximately 15 mm to 25 mm, and most preferably approximately 20 mm, but this may vary between approximately 14 mm and approximately 22 mm depending on the width of the nose. The radius of curvature of the center of the upper lip engaging 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] In this manner, the sealing portion 450 is connected to the support portion 453 on either side, but is separated from the support portion 453 by gaps between the anterior fixation point 469 and the posterior fixation point 475. These gaps allow the sealing portion 450 to flex in use in the patient's nose tip and upper lip areas, thereby achieving a good seal and providing comfort to the patient.

[0127] FIG. 51-1 shows a side cross-sectional view of the patient interface 451. The anterior non-adhesive 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-adhesive 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 so as to be generally flat at the outer edges.

[0128] The sealing portion 450 may have an outer sealing perimeter 534 on the dotted line to form 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 that is in communication with breathable gas, and the outer sealing perimeter 534 is formed as a continuous extension of this interior surface. The outer edge of the sealing portion 450 is oriented away from the opening 455 and / or in the direction of the 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 entire intermediate portion 450.1 may be 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 rear thickened portion 470. The forward thickened portion 468 and the rear thickened portion 470 are formed on either side of the support portion 453. The forward thickened portion 468 and the rear 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 approximately 20 to 90 Shore A, preferably approximately 20 to 60 Shore A, and most preferably approximately 40 Shore A. The support membrane 465 may be made from polycarbonate, polypropylene, nylon, thermoplastic elastomer (TPE), Hytrel®, or 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 a thickness that increases from top to bottom, and may have a height d12 of about 5 mm to 20 mm, preferably 7 mm to 14 mm, and most preferably about 11 mm.

[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 approximately 7 mm to 20 mm, preferably approximately 8 mm to 12 mm, and most preferably approximately 9.5 mm, but may be reduced to approximately 4 mm to reduce load. The posterior thickened portion 470 may have a curved portion 472 that may have a radius of curvature of approximately 0.5 mm to 3 mm, preferably approximately 2 mm, but this radius of curvature may be increased to approximately 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 shorten the curing time.

[0133] The thickened rear portion 470 is positioned directly below the thickened corner region 467 of the sealing portion 450, as seen in FIG. 47-3. The thickened rear portion 470 transfers load from the headgear connector to the thickened corner region 467 and further to the lower corner of the patient's nose to help form an effective seal; 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 thickened rear portion 470 to the thickened corner region 467 of the sealing portion 450, thereby applying a sealing force as a fixation 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 thickened rear 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 thickened rear 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] 52-4 shows a cross-sectional view of the support membrane 465 and sealing portion 450 when mated with and forming a seal with a patient. The nose tip engaging portion 452 engages and forms a seal with the patient's nose tip. When the nose tip engaging portion 452 and upper lip engaging portion 462 are in close contact with the patient's nose tip and upper lip, the nose tip engaging portion 452 and upper lip engaging portion 462 extend toward the support portion 453.

[0138] FIG. 52-5 shows a side view of the support membrane 465 and sealing portion 450 when mated and forming a seal with the patient. The sides of the sealing portion 450 and the support portion 453 clamp against the sides of the patient's nose, forming a seal with the sides of the patient's nose. A thickened corner region 467 forms a seal with the patient in the area of ​​the patient's nose adjacent the nasal and lip creases. A posterior thickened portion 470 is located adjacent and below the thickened corner region 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] Figure 52-7 shows a front view of the support membrane 465 and sealing portion 450 when in contact with the patient's face. The nose tip engaging portion 452 engages and forms a seal with the patient's nose and extends toward the support portion 453. Forward fixation 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 form 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 approximately 25 mm to 45 mm, preferably approximately 35 mm to 42 mm, and most preferably approximately 40 mm. Distance d15 may be varied to change the stiffness of the contact between the headgear and the side walls of the membrane, thereby increasing the clamping load on the sides of the patient's nose. The distance d16 between the rear thickened portions 470 may be approximately 35 mm to 55 mm, preferably approximately 40 mm to 50 mm, and most preferably approximately 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 a support membrane 465 with 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 approximately 10 mm to 25 mm, preferably approximately 12 mm to 20 mm, and most preferably approximately 17 mm. The distance d20 between the outer ends of the headgear connectors may be approximately 60 mm to 100 mm, preferably approximately 70 mm to 90 mm, and most preferably approximately 80 mm. The headgear connectors 456 may be angled upward at an angle α1, which may be approximately 2° to 15°, preferably approximately 5° to 8°, and most preferably approximately 6.5°. The larger the angle α1, the smaller the clamping force moment exerted by the patient interface.

[0143] As shown in FIG. 55 , headgear connectors 456 are positioned toward the base of sealing portion 450 to generate a moment force on the sidewall. When a headgear force is applied by tightening the headgear straps, a predetermined load is placed on headgear connectors 456 and tabs 458, increasing the inward force on the sides of 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 sealing portion 450 can displace 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 headgear connectors 456 is transferred by support portion 453 to sealing portion 450 in use as a clamping force against the sides of the patient's nose.

[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 transmitted to the sealing portion 450. The headgear connector 456 may have a thickness of approximately 2.5 mm to 4.0 mm, and the sidewalls of the support membrane 465 may have a thickness of approximately 1.2 mm to 5.0 mm, both using silicone with a durometer hardness of approximately 40 to 65 Shore A. The sidewalls of the headgear connector 456 and the support membrane 465 need not have a constant thickness; their thickness may vary along their length and width, or they may have localized thicker regions to adjust the stiffness in certain areas. Additional silicone may also be present where the headgear connector 456 connects to the support membrane 465. The headgear connector may alternatively be constructed of a material with a stiffness greater 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 its upper surface, which can 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), resulting in a more comfortable seal. 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 anterior to posterior; 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 approximately 1-5 mm, preferably approximately 1-3 mm, and most preferably approximately 2 mm, to allow the headgear tab 458 to move a predetermined amount before contacting the patient interface. This helps 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 into the support membrane 465, this angle may be varied by + / - 10°, varying α3 to affect the angle (nose-lip angle) at which the patient interface is positioned under the patient's nose.

[0147] FIGS. 56-2 and 56-3 show cross-sectional side views of the support membrane 465 shown in FIGS. 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-and-socket joint and / or may include venting features. The diameter of the base of the stem 454 should be large enough to allow air to pass through at a limited flow rate for compatibility with the flow generator, and may be 8 mm to 25 mm, preferably less than 20 mm, and preferably about 15 mm in diameter. However, other diameters, such as 12 mm, may be used.

[0148] Stem 454 may have a thin-walled portion 481 that may have a height d19 of 5.5 mm, although d19 may vary, for example, between 2 mm and 10 mm. This thin-walled portion 481 allows a separate region of stem 454 to bend as a tube connected to stem 454 is pulled. This thin-walled portion may have a wall thickness of approximately 0.3 mm to 1.0 mm, depending on the amount of bend and strength required. 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 nares.

[0150] 3.2 Suspension system 1-1 through 1-18, for example, sealing portion 210 is attached to or otherwise provided with suspension system 215. Attachment may be permanent (including, but not limited to, for example, single-component molding (see, e.g., FIGS. 1-2 through 1-8), co-molding, insert molding, adhesive bonding, or any other means). Alternatively, 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, attachment of sealing portion 210 to suspension system 215 may be along the periphery of aperture 211 on sealing portion 210 and aperture 216 in suspension system 215.

[0151] A suspension system 215 may be provided on 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, which may assist in orienting the sealing portion relative to the patient's nose during 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 degrees, for example, between about 110 and 160 degrees. 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 / 0129999, published February 19, 2009, which is incorporated herein 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 / 0129999, filed February 27, 2009, which is incorporated herein by reference in its entirety.

[0155] 3.2.2 Linking to a frame 1-1 through 1-18, the suspension system 215 includes a connecting ring 217 for sealingly attaching the suspension system 215 to the frame 220. The connecting ring 217 can mate with a channel 227 along the periphery of the frame, thereby forming an interference fit. This interference fit can be achieved by tongue and groove, snap fit, or any other suitable means. In another embodiment, the connecting ring 217 can be adapted to attach to the elbow 230 and / or the air delivery conduit 20. For example, the elbow 230 can be interference-fit within, around, or against the connecting ring 217 to seal the connection between the elbow 230 or air delivery conduit 20 and the suspension system 215.

[0156] The connecting ring 217 defines an aperture 218 to allow 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 sealing 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 compliance, resilience, flexibility, comfort, and / or consumer appeal.

[0158] For example, the suspension system may be constructed 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 toward the patient's nostrils. The foam's conformability also allows for adjustment of the sealing position. Figures 3-1 through 3-6 show various views of a foam suspension system 215 used between the sealing portion 210 and the frame 220. The foam material may be an open-cell foam material, a closed-cell foam material, or a foam material with a combination of open and closed cells. The foam material may have a skin or no 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, a gel with multiple durometers may be used. FIG. 8-1 illustrates a gel suspension system 215 in accordance with 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 can change the geometry of the sealing portion, for example, allowing thin regions of the sealing portion (e.g., the nose tip engaging portion) to flex. The gel may be a silicone gel, a polyurethane gel, or any other suitable gel. The gel may be the gel disclosed in U.S. Patent Application Publication No. 2008 / 0129999, filed November 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, which reduces weight and improves 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 allows the sealing portion edges to "flex" or "pinch" depending on their orientation, enhancing the seal. As shown, the edges of the sealing portion 210 may have deerdrop-shaped gel pockets to help seal around gaps and corners on 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 Seal section with flexible tube 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 against 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, flexible tube 280 may have a constant wall section, or alternatively, flexible tube 280 may have a varying wall thickness, for example, to vary the stretch, elongation, or flexure 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 portion 354 and a hinge portion 356 may be provided between the sealing portion 210 and the tube 20. The collapsible portion 354 absorbs movement of the tube 20 when the tube 20 is rotated away from the patient's face during use. Alternatively, when the sealing portion 210 is positioned, the tube 20 cannot be bent toward 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 during use, the hinge portion 356 transfers the movement of the tube 20 to the collapsible portion 354, thus preventing the sealing portion 210 from moving and maintaining a seal with the patient. The hinge portion 356 may also prevent the collapsible portion 354 from stretching, thereby preventing the collapsible portion 354 from losing its structural integrity and allowing the collapsible section to continue to absorb 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 separation 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 an air delivery 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, the sealing portion 210 may be provided with a headgear connector 240 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, thereby allowing the headgear to relieve pressure during use. This arrangement provides increased adjustability with the gusset. Preferably, the headgear connector 240 may be between the sealing portion 210 and the flexible base 282, thereby isolating the forces of the tube 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 pulling forces on the tube. The spring portion 413 may have a width 416 that is smaller than the width 418 of the sealing portion (cradle) connection portion 399 and the swivel connection portion 414. The swivel connection portion 414 may be connected to a swivel ring 415 such as in 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 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), forming 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), which 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 accidentally being 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 also be used. In one embodiment, the swivel ring 415 may be similar in structure to the swivel ring shown in U.S. Patent Application Publication No. 2008 / 0129998, filed October 22, 2008, which is incorporated herein 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 vent 422 in which there is a single vent slot provided as the gas vent 422 in the swivel ring 415. FIG. 42-6 illustrates another alternative gas vent 422 in which there are multiple vent slots provided as the gas vent 422 in the swivel ring 415 (e.g., three or more, or about 5-20).

[0179] FIG. 42-7 shows rows of vent holes provided as gas vents 422 arranged around the swivel ring 415. As shown, two rows of vent holes are provided as gas vents 422, with the holes in each row offset or staggered relative to one another. These vent holes may be positioned or arranged in other configurations.

[0180] FIG. 42-8 shows an exemplary cross section of a vent provided as the gas outlet vent 422 shown in FIG. 42-7. In this embodiment, the diameter of the vent varies from the inlet to the outlet, e.g., the vent tapers along its length. The diameter D1 of the vent 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 may be approximately 0.5 to 1.0 mm. Preferably, the diameter of the vent may be approximately 0.7 mm.

[0181] In all of the above venting embodiments, the ventilation is directed downwards, and therefore 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 during use.

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

[0183] 3.3 Frames FIGS. 1-9 through 1-14 show a suspension system 215 coupled to a frame 220 (sealing portion 210 provided on suspension system 215 is not shown), and FIGS. 1-15 through 1-18 show a suspension system 215 coupled to a frame 220 (sealing portion 210 provided on suspension system 215 is also shown). In the embodiment shown, suspension system 215 has a coupling ring 217 adapted to be press-fit into a channel 227 on frame 220. Alternatively, suspension system 215 may be coupled to frame 220 by other detachable means, such as, for example, clips, hooks, Ziploc®, or any other suitable means. Suspension system 215 may also be attached to frame 220 by permanent means, including, for example, but not limited to, insert molding, co-molding, adhesive bonding, 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 connected to the elbow 230 or the air delivery tube 20. The frame 220 may be connected 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 exemplary connection is disclosed in U.S. Patent Application Publication No. 2007 / 0129994, 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 headgear attachments or connectors 240 for removably attaching the headgear 150 and / or headgear rigidizer 160 to the mask 200. The headgear attachments 240 may be made from, for example, but not limited to, silicone, TPE, polycarbonate, or any other suitable material. The headgear attachments may be molded with the frame 220. Alternatively, the headgear attachments may be provided on the suspension system 215 and / or the sealing portion 210, as described below. Alternatively, the headgear attachments may be attached to any portion of the mask 200 by means including, for example, but not limited to, adhesive, push clips, snap fits, 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 Patent Application Publication No. 2009 / 0129999, published February 19, 2009, which is incorporated herein by reference in its entirety.

[0189] 3.3.1.1 Orientation In the illustrated embodiment, the headgear connectors 240 extend generally perpendicular to the longitudinal axis of the frame 220, as shown in Figures 1-12, e.g., as indicated by β. As shown in Figure 1-1, rigidizers 160 are rotatably coupled to their respective headgear connectors (as described in U.S. Patent Application Publication No. 2009 / 0129994, incorporated herein by reference), thereby allowing adjustment to fit the nasolabial angle for a wide range of patients. Additionally, this configuration allows adjustment of the suspension system to move it 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, Figure 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 during use. For example, as shown in FIG. 11 , the headgear connectors 240 may be provided with a suspension system 215. During use, the headgear straps 190 / rigidizers 160 may be positioned under the nostril engagement flaps 214, with the straps / rigidizers acting as stops to prevent further deformation of the flaps and / or to bias the flaps upward during use. The straps / rigidizers are positioned to engage specific areas of the flaps during use, allowing the remainder of the seal portion to flex 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 can 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., too far from the sealing portion 450, they will not provide sufficient stability. The greater the distance from the sealing portion 450 to the headgear tabs 458, the longer the lever arm, increasing 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 necessary for sealing, thereby increasing the force on the patient's nose. This, in turn, can potentially occlude the patient's nostrils. 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 U.S. Patent Application Publication No. 2008 / 0129999, filed October 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 flaps 214 toward the nostrils during use. As shown, fingers 291 formed by the exoskeleton 290 support and shape the sealing portion when they engage the sealing portion. That is, the exoskeleton is composed of a stiffer material than the sealing portion, and therefore the fingers can bend / deform but to a lesser extent than the sealing portion, thereby biasing or clamping 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., compression or stretching) relative to the exoskeleton.

[0198] In one embodiment, the sealing portion and 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 each side strap 190 (e.g., sewn to each side strap).

[0200] In the embodiment shown, the rigidizers have end portions adapted to engage with respective headgear connectors 240 on the frame, for example by snap-fitting, as shown in Fig. 1-1. However, 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 lug-like headgear connectors.

[0201] In one embodiment, headgear 150 may include the headgear disclosed in US Patent Application Publication No. 2009 / 0129999, published February 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, the rigidizers may form cheek supports (as disclosed in U.S. Patent No. 6,299,323) and / or 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, but other configurations are possible, for example three or more.

[0205] 4.1 One-piece headgear 13-1 and 13-2 illustrate headgear 150, which is constructed in one piece, e.g., machined from material as a one-piece construction. As shown, headgear 150 has a central portion 185 and side straps 190 adapted to engage with 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 surrounding opening 186, which can be adapted to support the sealing portion during use.

[0206] 13-4, the region 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 region surrounding the opening may be thinner than other portions of the headgear.

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

[0208] In each of the above configurations, the air delivery tube 20 may be connected directly 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 / 0129999, filed 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. Strap 527 has slots 531 for attachment to headgear connector 456 (FIG. 47-2) and adjustable connector 500. Strap 527 can be connected to headgear connector 456 by other connecting 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. A flexible tube 486 may be attached to the strap 527 in the region of the adjustable connector 500 of the strap 527 by a tube clip or another retention means, which holds the flexible tube 486 in place at 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 connector 500 to connect at the back of the patient's head, or alternatively may 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 may have an end portion 526 that is threaded through the second slot 537. The end portion 526 may be formed using 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, which 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 reinforcements to maintain the shape of the headgear and further help secure and position the headgear against the crown and / or occipital region of the patient's head. The one or more rigidizers may be comprised of a rigid or semi-rigid material configured to add stiffness or rigidity to the headgear and secure it in place during use. The rigidizer may be bendable or deformable along its length, but resist or prevent the headgear from stretching in the direction of the rigidizer. The rigidizer may be substantially non-stretchable. The rear portion 524 may wrap around the crown 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 / 0129994, filed December 10, 2009. The headgear disclosed in U.S. Patent Application Publication No. 2009 / 0129994 may be used with the technology disclosed herein, and U.S. Patent Application Publication No. 2009 / 0129994 is incorporated herein by reference in its entirety.

[0215] 90-93 show a one-piece headgear 539. The headgear 539 covers the front portion of the patient interface in area 541 and also covers the headgear connector 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 the front portion of the patient interface in region 541. However, headgear 543 has cutout portions 545 that allow headgear tabs 532 to be visible on the outside of headgear 543. This configuration can aid in aligning the headgear relative to the patient interface.

[0217] 110 shows headgear 484 having hook and loop attachments that can be used with any of the embodiments herein. Loop material 560 can be located on a first portion of headgear 484, and hook material 562 can 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] Finger loops 558 may be included on the hook material 562 to assist the user in grasping or locating the end portion of the hook material 562. Buckles 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 buckles 590 and finger loops 558 may be interchanged, i.e., the buckles 590 may be on the end of the hook material 562 and the finger loops may be 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 to connect 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 a corrugated elbow may be molded in one piece (e.g., two-shot molding, co-molding, insert molding) or may be assembled (e.g., a two- or three-piece assembly).

[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, or 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, flexion, etc. Such an elbow may be formed by molding, e.g., two-shot molding, co-molding, or 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 tubing, e.g., a sealing portion connector 399 is connected to the sealing portion or mask and a tubing connector 398 is connected to the tubing. An air vent 395 may be located between these connectors. The elbow 397 is configured to move the tubing connector 398 upward on the mask and away from the patient's face when the mask is worn by a patient, thereby allowing the tubing to be positioned above the patient's head during use. The air vent 395 advantageously directs exhaled air away from the patient during use. Connector 398 may be attached to the air delivery tube and connector 399 may be attached to the mask so that vent 395 is parallel to the patient and faces directly away from the patient's airway.

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

[0224] In such embodiments, sealing portion 210 may be removably coupled to frame 220 in a manner including, but not limited to, by snap fit, tongue and groove, clips, etc. Alternatively, sealing portion 210 may be permanently coupled to frame 220 in a manner including, but not limited to, by co-molding, insert molding, adhesive, etc. In an alternative form, sealing portion 210 may be configured to be one piece with 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 alternative embodiments, 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 reduces excess material in the sealing portion 210, which may cause discomfort, or is less obtrusive. This embodiment may also provide alignment guidance to the patient, making it easier for the patient to accurately align the triangular-shaped sealing portion 210. This is because the natural shape of the nose is more triangular, and therefore, it is easier to orient the nose tip engaging portion 212 and upper lip engaging portion 213 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 so 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 during 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). In the triangular-shaped sealing portion embodiment shown in Figures 2-8A and 2-9A, 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 during use.

[0227] Figure 2-11 is a rear view of the seal portion showing a portion (shaded section) of the upper lip engaging portion 213 that is removed relative to the seal 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., a less obtrusive appearance), and can also 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 connector 456 allows for connection of a headgear 484. 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, allowing the flexible tube 486 to 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 approximately 0.2 mm to 5 mm. Preferably, the membrane 482 may have a wall thickness of approximately 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 polyaxial 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 polyaxial elbow assembly 495 has a frame 491 that may be coupled to the thin film 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 positioned along the nose and between the patient's eyes, as shown in FIG. 62 , while still providing a streamlined shape (no hanging outward) and near-zero moment on the patient interface. Furthermore, the flexible tube 486 can 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 can 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 tubing 506. The tubing 506 may have a swivel connector 504, which may be used to connect, for example, to a gas supply tube. The bellows 502 have a hole with multiple support rings that help prevent the air path from becoming blocked under tight bends. That is, the bellows may have a thicker wall section than the portion of the hole without the bellow. Alternatively, the bellows and the hole may have a fixed wall section. The length of the bellows may be selected to provide a separation function to maintain the seal of the patient interface 459 even when the bellows 502 are bent. In this case, the bellows 502 has freedom of movement between the patient interface 459 and the tubing 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 if bellows 502 is a separate element, may have a different hardness of about 20-40 Shore A, preferably about 20 Shore A durometer. Preferably, for a Shore A durometer of 40, the preferred thickness is about 0.3 mm.

[0234] The bellows 502 may have an internal bore of 8 mm to 20 mm, preferably 10 mm to 15 mm, and most preferably 12 mm 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 wide separation between the rings to allow for ample bending with tubing. Bellows 502 prevents the air path from becoming blocked when tubing is bent too tightly.

[0236] Figure 69 shows various dimensions of the bellows rings and side walls shown in Figure 68. Each bellows ring, including the side wall, 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 can 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, 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 bellows 502, measured from the inside of the bottom of each curved section 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 also 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 flexible tubing 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 tubing 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 decouple the movement of the flexible tube 486 to release moments applied to the patient interface 459 created by tube traction forces. When the flexible tube 486 moves variably, the ball 508 can move variably 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 has a curve 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 sections 513 for venting exhaled air. The vent section 513 may be a row of spaced vent sections. Preferably, the inner diameter of the curve is about 7 mm to 15 mm. Preferably, the curve may have an inner diameter of less than 12 mm. Most preferably, the curve 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 by 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 ventilation grooves 501. The ventilation 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 ventilation grooves 501. The ventilation grooves may have a length of approximately 2 mm to 50 mm. Preferably, the ventilation grooves 519 may extend along the outer surface of the ball 508 to form a long ventilation flow path. A long ventilation flow path can reduce the air velocity and therefore the noise of the exiting gases. Preferably, the ventilation grooves 519 are distributed around the ball 508 to diffuse the flow path of the exiting air. Preferably, the ventilation grooves 519 are molded onto the ball 508. Preferably, the grooves 519 have a width of approximately 0.2 mm to 3 mm. Preferably, the grooves 519 have a width of less than 1 mm. Narrower grooves slow the air flow and result in a quieter vent. 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 ball 508 adjacent groove 519 may mate with connector 510. Connector 510 may be positioned on top of groove 519 to form a cover over 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 illustrate an embodiment comprising a ball 508 with vent grooves 570, in which a flow path barrier 592 may be removably attachable to the ball 508. The flow path 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, providing one degree of movement and allowing the tab 486 to be positioned in a variety of positions.

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

[0250] The elbow assembly 514 can 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 a 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 more preferably.

[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 tubing 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 with the flexible tubing 486 facing upward. The ball 516 allows the flexible tubing 486 to be positioned closer to the patient's face to help prevent vision obstruction.

[0253] 7.6 Membranes with elbows FIG. 84 shows a membrane 482 used with elbow assembly 514 and swivel connector 512. The 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. The membrane 482 is flexible enough to allow the exit angle to be adjusted to a more horizontal position. Thus, the membrane 482 allows the flexible tube 486 to hang downward without applying excessive moment to the sealing portion 450, and also allows the flexible tube 486 to be properly positioned in the upward position.

[0254] 7.7 Angled Elbow Ball Joint FIG. 85 shows an angled elbow ball joint assembly 525. The angled elbow ball joint assembly 525 includes an elbow 514, a ball 516, and a swivel connector 520 for connecting to the flexible tube 486. The angled elbow 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 planes other than 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 can be supplied in the direction of arrow 558 into air passage 560. The air passage may have an inner diameter of 11-15 mm, and connector 556 may also 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 molded around or within the swivel ring 550. As the material of the ball joint portion 548 cools, the ball joint portion 548 shrinks and releases from the swivel ring 550. Vents 554 may be molded into the ball joint portion 548.

[0258] 7.9 Side connecting tube 102-104 show a patient interface 459 with a side connection 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 plurality 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 couple 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 does not couple, may be used over the aperture 538 to seal the aperture 538.

[0260] The side connector tubes have a streamlined appearance and move the tube 486 away from the patient's face. The side connector tubes also isolate the tube traction forces from the seal portion 450. The side connector interface is disclosed in more detail in U.S. Patent Application Publication No. 2008 / 0129999, 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-connected 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 of if one flexible tube were used. This may provide more comfort to the patient, especially if the patient turns over and one of the tubes 548 is on the bottom.

[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. The frame 546 is also disclosed in more detail in U.S. Patent Application Publication No. 2007 / 0129994, 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 an end thereof for receiving the headgear 484.

[0265] The headgear cradle portion 552 may also have tactile ends 550 to increase the patient's grip and make it easier to connect and disconnect 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 inside the headgear cradle portion 552. The conformable pad 556 supports the patient interface 459 and facilitates separation between 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 Elbow with lug FIG. 114 shows 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 configured to form an airtight connection with the connector 578. The headgear 484 can optionally have an opening near the headgear connector 557 to receive the portion of the elbow 582 near the lug 586.

[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 including an interface portion (also known as a sealing portion) 2000 located above or on top of a support portion 1000. The support portion 1000 is shown in Figures 21-1 through 21-6. The support portion 1000 can have a nasal tip portion 212B, a nostril portion 214B, and optionally an upper lip portion 213B. Multiple areas below or above the non-patient-contacting side can have raised or thickened sections to provide additional support to the interface portion 2000 upon assembly, and to provide different degrees of support to the sealing portion 210. The support portion 1000 can be constructed of silicone having a hardness of approximately 20 to 90 Shore A, preferably approximately 40 Shore A. Support portion 1000 may be made from polycarbonate, polypropylene, nylon, thermoplastic elastomer (TPE), Hytrel®, etc. Support portion 1000 may be approximately 1-15 mm thick, preferably approximately 1.2 mm thick. As best shown in FIG. 21-4, upper lip portion 213B may be excised or removed.

[0270] 22-1 through 22-4 illustrate 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 with a patient during use. The interface portion 2000 may be made from silicone having a hardness of approximately 7 durometers on the Shore A scale. Alternatively, the hardness of the interface portion 2000 may be approximately 12 durometers on the Shore A scale. The thickness of the interface portion 2000 may be approximately 1.2 mm. The interface portion 2000 may be made from another suitable material, such as nylon, fabric, TPE, or the like. 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 the 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 attached 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 flexible tubing. 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 achieved, for example, by placing a headgear connector 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 includes a sealing portion 602, a support portion 616, a gusset 614 between the sealing portion 602 and the support portion 616, a connection portion 618 for a gas supply, such as a flexible tube, and an aperture 620.

[0276] The sealing portion 602 typically interfaces with the patient's upper lip and nose to form a seal with the patient's face. The sealing portion 602 may have reinforced portions, such as multiple 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 has a higher durometer compared to the rest of the sealing portion 602. Alternatively, or in addition, structural support, such as ribs or thickened sections, may be added to the sides or support portions of the sealing portion, as in the embodiment of FIG. 52-5, and / or the gusset 614 may be filled with a stiffer material to provide additional support.

[0277] FIG. 118-3 shows a cross-sectional view including gel-filled pockets 622 in the corner regions of the sealing portion 602; 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 during 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 to easily wear the patient interface in the correct orientation.

[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 create a deeper, more curved seal. This shape allows the side walls of the sealing portion to bend outward for flatter noses and also allows a pointed nose to fit within the curve created by this shape.

[0281] 122-1 and 122-3 show cross-sectional views of the 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 described herein. The support structure 604 may fit 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 be easily bent to accommodate different sized noses. For example, in the nose side regions, which are designed to be located adjacent to the facial wrinkle regions, the foam ring may be thicker.

[0284] The foam ring may incorporate foam of different densities 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 to form lateral supports 622 that seal against the sides (bulges) of the patient's nose, rather than just the underside of the nose, thereby creating 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. This 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 patient interfaces incorporating the present technology can accommodate a greater variety of face and nose sizes and shapes than conventional designs. It is believed that patient interfaces incorporating the present technology can reduce the need for a wide range of sizes. It is believed that patient interfaces incorporating the present technology can provide greater patient comfort and improve compliance with their treatment regimen.

[0289] While 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 falling within the spirit and scope of the present technology. Additionally, the various embodiments described above may be practiced in conjunction with other embodiments, e.g., 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 a separate embodiment. It should also 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. Furthermore, the above teachings have application to patients and non-patients alike in non-medical applications. [Explanation of symbols]

[0290] 10 PAP System 15 PAP devices 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 Outline 188 Area surrounding opening 186 190 Side Straps 200 masks 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 channels 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 Tamp Configuration 284 Strut 285 Adhesive Strips 286 Waveform Series 287 Living Hinge 288 Flexible area 289 Waveform area 290 Dermal Skeleton 292 Rotating 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 area 362, 346, 366 Orifice opening 370, 372, 424 supporting wall 376 Headgear attachment point, headgear connector 378 Headgear Strap 381 Supporting member 382 Corners of the nasal region 384 External nostril bulge 386 Stabilization region 388 Lateral flap (nostril engaging flap) 390 Strut or Tab 392 Ventilation Ring 394, 422 Gas vent 395 Seal Connector 396 Step or Flange 398 Tube Connector 399 Seal part (cradle) connecting part 402 Ribs 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 connection part 414 426 Elbow Wall 434 Sealing part tightening margin web 438 Plenum 450.1 Middle part 456 Headgear Connector 458, 568 Lateral lap or cantilever section 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 Perforated area 478 Recessed Area 481 Thin wall section 482 Thin Film 485 Head part 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 Connector 511, 554 Ventilation holes 512, 520 Swivel Connector 513, 544, 570 Vent area 514 Elbow Assembly 515 Mesh ventilation holes 516 Ball Assembly 517 Removable Insert 519, 523, 564 Ventilation grooves 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 lateral compression 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 flexible sealing portion configured to sealingly engage an exterior of the patient's nose, the flexible sealing portion comprising a pair of resilient, flexible lateral sides and a central portion between the pair of resilient, flexible lateral sides, the central portion of the flexible sealing portion comprising a septum locator configured to engage the patient's nasal septum, the pair of resilient, flexible lateral sides of the flexible sealing portion configured to be bent outward by the patient's nose; a pair of nozzles projecting from the flexible sealing portion and configured to be inserted into the patient's nares in use, each nozzle having a central longitudinal axis, a base end at the flexible sealing portion, and a discharge end opposite the base end; Equipped with Each nozzle tapers from the base end to the discharge end; the bulkhead locator is positioned between the pair of nozzles; the pair of resiliently flexible lateral sides of the flexible sealing portion are configured to pivot at the septum locator when bent outward by the patient's nose; a patient interface configured such that the discharge ends of the pair of nozzles move away from each other when the pair of resilient, flexible lateral sides of the flexible sealing portion are bent outward by the patient's nose.

2. The patient interface of claim 1 , wherein the pair of nozzles are configured not to seal with the interior of the patient's nares.

3. 3. A patient interface according to claim 1 or 2, wherein an outer surface of each nozzle is concave.

4. A patient interface according to any preceding claim, wherein the pair of nozzles are oriented such that the central longitudinal axes of the pair of nozzles intersect one another.

5. 5. A patient interface according to claim 1, wherein each nozzle is configured such that a corresponding central longitudinal axis pivots when the pair of resiliently flexible lateral sides of the flexible sealing portion are bent outward by the patient's nose.

6. A patient interface according to any preceding claim, wherein each nozzle comprises an opening at the discharge end configured to deliver pressurised gas directly into a respective nostril of the patient.

7. A patient interface according to any preceding claim, wherein the pair of nozzles are configured to align the flexible sealing portion with the patient's nose to enable an effective seal.

8. A patient interface according to any preceding claim, further comprising a stem configured to be connected to an air delivery tube.

9. The patient interface of claim 8 , wherein the stem is connected to the central portion of the flexible sealing portion.

10. A patient interface according to claim 8 or 9, wherein the pair of resiliently flexible lateral sides of the flexible sealing portion suspend the stem.

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