Patient Interface

Abstract

A mask system is provided for delivering air at positive pressure from an air source to a patient for the treatment of sleep-disordered breathing. [Solution] The mask system comprises an interface structure adapted to deliver supply air to at least both of the patient's nostrils and configured to engage an entrance to the patient's airways, an inlet conduit removably connectable to the interface structure and adapted to deliver supply air and adapted to extend from the top of the patient's head or in front of the top of the patient's head, between the patient's eyes and ears, along both sides of the patient's face, to the interface structure, and an end portion that is more rigid than the inlet conduit for facilitating connection to the interface structure, wherein the inlet conduit is a one-piece structure molded from a silicone material.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 60 / 833,841, filed Jul. 28, 2006; No. 60 / 874,968, filed Dec. 15, 2006; No. 60 / 924,241, filed May 4, 2007; and No. 60 / 929,393, filed Jun. 25, 2007, the entire disclosure of each of which is incorporated herein by reference.

[0002] The present invention relates to the provision of respiratory therapy to a patient. Examples of such therapy include Continuous Positive Airway Pressure (CPAP), Non - Invasive Positive Pressure Ventilation (NIPPV), and Variable Positive Airway Pressure (VPAP). Such therapies are used to treat various respiratory conditions, including Sleep Disordered Breathing (SDB), and more particularly, obstructive sleep apnea (OSA).

Background Art

[0003] Typically, respiratory therapy is provided in the form of a mask system disposed between a patient and a device that supplies compressed air or breathing gas. Mask systems in the field of the present invention are specifically different from mask systems used in other applications, such as aviation and safety, in that comfort is emphasized. Since the patient must wear the mask for hours, and in some cases every night for life, a high level of comfort is desired. Further, compliance with the treatment can be improved if the person sleeping with the patient is not adversely affected by the patient's treatment and generally by the wearing of the mask.

[0004] Mask systems are typically highly clinically aesthetic, making it obvious from their appearance that they are undergoing treatment (as described below). This can cause patients to feel embarrassed about their treatment, because such an appearance can overtly remind them that they are ill, and therefore risk leaving a negative impression of the patient in the minds of those who see them.

[0005] A mask system typically comprises (i) a rigid or semi-rigid part, often referred to as a shell or frame; (ii) a flexible part that comes into contact with the patient, often referred to as a cushion; and (iii) several forms of headgear that hold the frame and cushion in place. If the mask system actually contains multiple components, it may require at least some assembly and adjustment, which may be difficult for patients lacking dexterity. Furthermore, the mask system often includes a mechanism for connecting an air delivery conduit, which is usually connected to a blower or flow generator.

[0006] The parts that come into contact with the patient, such as cushions, are typically constructed from silicone materials, but parts that come into contact with the patient, including foam, are known. For example, Patent Document 1 describes a lining for a mask made of foamed polyurethane covered with an outer shell (e.g., latex or silicone). However, the covered foam may not allow the part that comes into contact with the face to breathe, thereby causing skin irritation, and the sealed part may wrinkle easily, causing discomfort or leakage. Depending on the thickness and support structure, the outer shell may be too rigid for some patients. The outer shell may also not be able to deform significantly locally and may easily transmit tension across the surface, so the mask may shift on the face, compromising the seal / comfort.

[0007] The range of mask systems is known to include nasal masks, nasal and mouth masks, full-face masks, and nasal prongs, pillows, nozzles, and cannules. A mask typically covers the face beyond the nasal prongs, pillow, nozzle, and cannule. Nasal prongs, nasal pillows, nozzles, and cannules are all collectively referred to as nasal prongs. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] U.S. Patent No. 5,429,683 [Patent Document 2] U.S. Patent Application Publication No. 2003 / 0154980 [Patent Document 3] International Publication No. 03 / 090827 [Patent Document 4] U.S. Patent Application Publication No. 2004 / 0226566 [Patent Document 5] Australian Patent No. 2005100738 [Patent Document 6] U.S. Patent No. 6907882 [Patent Document 7] Special Publication No. 10-508786 [Patent Document 8] Japanese Patent Publication No. 2005-13492 [Patent Document 9] European Patent Application Publication No. 00427474 [Patent Document 10] Special Publication No. 2006-505373 [Patent Document 11] Special Publication No. 2003-501220 [Patent Document 12] International Publication No. 2005 / 076874 [Patent Document 13] U.S. Patent Application Publication No. 2005 / 0199242 Specification [Patent Document 14] International Publication No. 2005 / 099801 [Patent Document 15] Special Publication No. 2005-503869 [Overview of the Initiative] [Problems that the invention aims to solve]

[0009] In this field, there is a constant need to provide mask systems that offer a high level of comfort and ease of operation, and there is a newly recognized need to provide mask systems with improved appearance (i.e., invisible and less bulky during treatment). [Means for solving the problem]

[0010] One aspect of the present invention is to provide a patient interface that enhances treatment compliance.

[0011] Another aspect of the present invention is to provide a comfortable interface with the patient.

[0012] Another aspect of the present invention is to provide a patient interface that is not medical in appearance. In one embodiment, this can be achieved by creating a flexible, comfortable, and pliable patient interface that is one of the garments in appearance.

[0013] Another aspect of the present invention relates to a comfortable, discreet, easy-to-use, and stable system for delivering positively pressurized air to the entrance of a patient's airway, which can be used in nasal CPAP therapy for sleep-disordered breathing. Such a system is compatible with a range of interfaces and / or sealing structures, including nasal masks, nasal cushions, mouth masks, etc. Specifically, the system has been designed to allow the patient to sleep comfortably in a range of different positions, including turning over and lying face down, while maintaining appropriate treatment without an unpleasant experience. The system offers several improved forms of the prior art.

[0014] Another aspect of the present invention relates to an interface structure that improves comfort, enhances interface performance, and is more user-friendly than conventional sealing structures. Some aspects of the improved interface structure do not require as precise a fit as conventional sealing structures, are more comfortable, and are necessary when evenly distributing pressure on the patient's face. The interface structure is characterized in that it feels more natural against the skin than conventional sealing structures and has controlled breathability that allows for skin respiration. Other aspects of the improved interface structure do not tend to separate due to movement as much as conventional sealing structures.

[0015] Another aspect of the present invention relates to an air delivery system for supplying air at positive pressure from an air source to an interface structure disposed at the entrance of a patient's airway. The air delivery system includes a manifold adapted to be connected to a supply of positive pressure air and at least one tube connected to the manifold, and is adapted to deliver supply air to the interface structure. Each tube is configured to be able to transition between (1) an open phase in which the tube allows air to pass through and (2) a collapsed phase in which the tube is crushed. Each tube is configured such that the weight of a typical patient's head on bedding (e.g., a pillow) is sufficient to crush the tube from the open phase to the collapsed phase.

[0016] Another aspect of the present invention relates to an air conduit or tube that is comfortable to lie on laterally. It is comfortable to lie on laterally because when lying on the conduit laterally, the portion lying on it collapses flat or substantially flat, the conduit is overall thin enough to be able to lie on it laterally, and / or the conduit is already comfortable enough that it does not need to be flattened.

[0017] Another aspect of the present invention relates to an air conduit system having sufficient redundancy such that the system maintains a sufficient airflow at therapeutic pressure when some or one of the conduits becomes blocked.

[0018] Another aspect of the present invention relates to an air delivery system adapted to supply pressurized therapeutic air when a patient is lying on a part of the body.

[0019] Another aspect of the present invention relates to an air delivery system for supplying positive-pressure air from an air source to an interface structure located at the entrance of a patient's airway. The air delivery system includes a manifold adapted to connect to a positive-pressure air supply unit, and at least one tube connected to the manifold, the tube adapted to deliver the supply air to the interface structure. The manifold is adapted to be positioned on or in front of the patient's head when in use.

[0020] Another aspect of the present invention relates to an air delivery and stabilization system for supplying positive-pressure air from an air source to an interface structure located at the entrance of a patient's airway. The air delivery and stabilization system includes a manifold adapted to connect to a positive-pressure air supply unit, a pair of tubes connected to the manifold and adapted to deliver the supply air to the interface structure, a stiffening element provided on each tube to add rigidity to the tubes, and a back strap provided on the tubes and / or stiffening elements and adapted to engage with the back of the patient's head. Each tube is adapted to extend from both sides of the manifold at or in front of the patient's head, along the sides of the patient's face, between the patient's eyes and ears, and to the area below the patient's nose.

[0021] Another aspect of the present invention relates to an interface structure positioned at the entrance of a patient's airway, the interface structure comprising a support structure adapted to connect to an air delivery system that supplies air at positive pressure from an air source, and an interface provided to the support structure. The interface is constructed from a flexible, viscoelastic foam and adapted to contact the surface of the patient's face and nose during use.

[0022] Another aspect of the present invention relates to a patient interface comprising a first loop and a second loop connected to the first loop. The first loop is fitted to run along the underside of the patient's nose, along the cheek area, over the ears, and to the top of the patient's head, so as to define a sealing force against the underside of the patient's nose when in use. The second loop generally runs over the occipital bone so as to define the vector of the headgear at an angle of 40 to 80 degrees relative to the first loop.

[0023] Another aspect of the present invention relates to an interface structure positioned at the entrance of a patient's airway. The interface structure includes an interface adapted to contact the skin surface on the underside of the patient's nose when in use, and the thickness of the interface is approximately 5 to 50 mm.

[0024] Another aspect of the present invention relates to an interface structure positioned at the entrance of a patient's airway. The interface structure includes an interface adapted to contact the skin surface below the patient's nose during use, and the interface includes an uncovered surface for the interface to be in contact with or border the patient's skin during use.

[0025] Another aspect of the present invention relates to an interface structure positioned at the entrance of a patient's airway. The interface structure includes an interface adapted to contact the skin surface below the patient's nose when in use, and the interface has sufficient flexibility and compliance in a direction perpendicular to the patient's face so as to conform to the anatomical structure of the face with which it borders.

[0026] Another aspect of the present invention relates to an interface structure positioned at the entrance of a patient's airway. The interface structure includes an interface adapted to contact the skin surface below the patient's nose when in use, and the interface is constructed from a breathable or permeable material.

[0027] Another aspect of the present invention relates to an interface structure positioned at the entrance of a patient's airway. The interface structure includes an interface constructed from foam, adapted to contact the skin surface below the patient's nose during use, and the interface is adapted to provide compressive force to seal against the patient's skin during use.

[0028] Another aspect of the present invention relates to an interface structure positioned at the entrance of a patient's airway. The interface structure includes an interface adapted to contact the skin surface below the patient's nose when in use, and the interface has a textured surface.

[0029] Another aspect of the present invention relates to an interface structure positioned at the entrance of a patient's airway. The interface structure includes an interface adapted to contact the skin surface below the patient's nose during use, and the interface has a recovery speed slower than about 5 cm / second.

[0030] Another aspect of the present invention relates to an air delivery system for supplying air to a patient at positive pressure from an air source. The air delivery system includes an interface structure positioned at the entrance of the patient's airway and a pair of tubes extending along both sides of the patient's face and adapted to deliver supply air to the interface structure. Each tube includes at least one portion configured to allow transition between (1) an open phase in which the tube allows airflow without excessive resistance and (2) a partially compressed phase in which the tube is at least partially compressed to restrict or prevent airflow. Each tube is configured to be comfortable to lie on.

[0031] Another embodiment relates to a gas delivery system for supplying gas at positive pressure from a gas source to an interface structure located at the entrance of a patient's airway. The gas delivery system includes at least two gas passages adapted to communicate with a gas source for delivering the supply gas to the interface structure. The at least two gas passages are configured and constructed to cooperate in delivering the appropriate supply gas to the interface structure, even if one of the gas passages exhibits a collapsed configuration that prevents or substantially obstructs the airflow.

[0032] Other aspects, characteristics, and advantages of the present invention will become apparent from the following detailed description, together with the accompanying drawings, which are part of this disclosure and illustrate the principles of the present invention by example. [Brief explanation of the drawing]

[0033] [Figure 1-1] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 1-2] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 1-3] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 1-4] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 1-5] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 1-6] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 1-7] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 1-8] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 1-9] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 1-10] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 1-11] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 1-12] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 1-13] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 1-14] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 1-15] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 1-16] This figure shows the interface with the patient according to an embodiment of the present invention. [Figure 2-1] This is a schematic diagram showing the assembly of the patient interface according to an embodiment of the present invention. [Figure 2-2] This is a schematic diagram showing the assembly of the patient interface according to an embodiment of the present invention. [Figure 2-3] This is a schematic diagram showing the attachment of a patient interface to a PAP device according to an embodiment of the present invention. [Figure 2-4a] This figure shows the attachment of a patient interface to a PAP device according to another embodiment of the present invention. [Figure 2-4b] This figure shows the attachment of a patient interface to a PAP device according to another embodiment of the present invention. [Figure 3-1] This figure shows a tube for the interface with the patient during the activation phase, according to an embodiment of the present invention. [Figure 3-2a] This figure shows a tube for the interface with the patient during the collapse phase, according to an embodiment of the present invention. [Figure 3-2b] This figure shows a tube for the interface with the patient during the collapse phase, according to an embodiment of the present invention. [Figure 3-3] This is a schematic diagram of a patient interface tube and rigidifying element according to an embodiment of the present invention. [Figure 3-4]This figure shows a cross-section of a tube along its length according to an embodiment of the present invention. [Figure 3-4a] This figure shows a cross-section of a tube along its length according to an embodiment of the present invention. [Figure 3-4b] This figure shows a cross-section of a tube along its length according to an embodiment of the present invention. [Figure 3-4c] This figure shows a cross-section of a tube along its length according to an embodiment of the present invention. [Figure 3-4d] This figure shows a cross-section of a tube along its length according to an embodiment of the present invention. [Figure 3-4e] This figure shows a cross-section of a tube along its length according to an embodiment of the present invention. [Figure 3-4f] This figure shows a cross-section of a tube along its length according to an embodiment of the present invention. [Figure 3-5a] This is a schematic diagram of a tube interface with the patient during the opening phase and the collapse phase or partial collapse phase, according to another embodiment of the present invention. [Figure 3-5b] This is a schematic diagram of a tube interface with the patient during the opening phase and the collapse phase or partial collapse phase, according to another embodiment of the present invention. [Figure 3-5c] This is a schematic diagram of a tube interface with the patient during the opening phase and the collapse phase or partial collapse phase, according to another embodiment of the present invention. [Figure 3-6a] This figure shows a tube having a bellows structure according to another embodiment of the present invention. [Figure 3-6b] This figure shows a tube having a bellows structure according to another embodiment of the present invention. [Figure 4-1] This figure shows piping for an interface with a patient according to an embodiment of the present invention. [Figure 4-2] This figure shows piping for an interface with a patient according to an embodiment of the present invention. [Figure 4-3] This figure shows piping for an interface with a patient according to an embodiment of the present invention. [Figure 4-4] This figure shows piping for an interface with a patient according to an embodiment of the present invention. [Figure 4-5] This figure shows piping for an interface with a patient according to an embodiment of the present invention. [Figure 4-6] This figure shows a tube and a rigidifying element according to an embodiment of the present invention. [Figure 4-7] This figure shows a tube and a rigidifying element according to an embodiment of the present invention. [Figure 4-8] This figure shows a tube and a rigidifying element according to an embodiment of the present invention. [Figure 4-9] This figure shows a tube and a rigidifying element according to an embodiment of the present invention. [Figure 5-1] This figure shows a tube for the patient interface according to an alternative embodiment of the present invention. [Figure 5-2] This figure shows a tube for the patient interface according to an alternative embodiment of the present invention. [Figure 5-3] This figure shows a tube for the patient interface according to an alternative embodiment of the present invention. [Figure 6-1] This figure shows a backstrap for the patient interface according to an embodiment of the present invention. [Figure 6-2] This figure shows a backstrap for the patient interface according to an embodiment of the present invention. [Figure 6-3] This figure shows a backstrap for the patient interface according to an embodiment of the present invention. [Figure 6-4] This figure shows a backstrap for the patient interface according to an embodiment of the present invention. [Figure 6-5] This figure shows a backstrap for the patient interface according to another embodiment of the present invention. [Figure 7-1] This figure shows a manifold of an interface with a patient according to an alternative embodiment of the present invention. [Figure 7-2] This figure shows a manifold of an interface with a patient according to an alternative embodiment of the present invention. [Figure 8-1] This figure shows the configuration of a tube according to an embodiment of the present invention. [Figure 8-2] This figure shows the configuration of a tube according to an embodiment of the present invention. [Figure 8-3] This figure shows the configuration of a tube according to an embodiment of the present invention. [Figure 8-4] This figure shows the configuration of a tube according to an embodiment of the present invention. [Figure 8-5] This figure shows the configuration of a tube according to an embodiment of the present invention. [Figure 8-6] This is a schematic diagram showing an area through which piping may pass, according to an embodiment of the present invention. [Figure 8-7] This figure shows the configuration of an adjustable tube according to another embodiment of the present invention. [Figure 9-1] This figure shows a method for attaching a patient interface according to an embodiment of the present invention. [Figure 9-2] This figure shows a method for attaching a patient interface according to an embodiment of the present invention. [Figure 9-3] This figure shows a method for attaching a patient interface according to an embodiment of the present invention. [Figure 10-1] This is a diagram of a patient interface, including a cover, according to an embodiment of the present invention. [Figure 10-2] This is a diagram of a patient interface, including a cover, according to an embodiment of the present invention. [Figure 10-3] This is a diagram of a patient interface, including a cover, according to an embodiment of the present invention. [Figure 10-4] This is a diagram of a patient interface, including a cover, according to an embodiment of the present invention. [Figure 10-5] This is a diagram of a patient interface, including a cover, according to an embodiment of the present invention. [Figure 10-6] This is a diagram of a patient interface, including a cover, according to an embodiment of the present invention. [Figure 11-1]This figure shows a valve for the interface with the patient according to an embodiment of the present invention. [Figure 12-1] This figure shows a clip for the patient interface according to an alternative embodiment of the present invention. [Figure 12-2] This figure shows a clip for the patient interface according to an alternative embodiment of the present invention. [Figure 12-3] This figure shows a clip for the patient interface according to an alternative embodiment of the present invention. [Figure 13-1] This is a diagram of a foam interface and support according to an embodiment of the present invention. [Figure 13-2] This is a diagram of a foam interface and support according to an embodiment of the present invention. [Figure 13-3] This is a top view of a foam interface having an uncoated cross-section according to an embodiment of the present invention. [Figure 13-4] This is a side view of a foam interface having an uncoated cross-section according to an embodiment of the present invention. [Figure 13-5] This is a top view of a foam interface having a covered surface according to an embodiment of the present invention. [Figure 13-6] Figure 13-5 is an enlarged schematic cross-sectional view of a portion of the foam interface shown. [Figure 13-7a] This figure shows a foam according to an alternative embodiment of the present invention. [Figure 13-7b] This figure shows a foam according to an alternative embodiment of the present invention. [Figure 13-7c] This figure shows a foam according to an alternative embodiment of the present invention. [Figure 13-8] This is a schematic cross-sectional view of a portion of a foam interface having a covered surface and vents according to an embodiment of the present invention. [Figure 14-1] This is a table showing the mechanical properties of the foam interface according to embodiments of the present invention. [Figure 14-2] This graph shows the characteristics of the foam interface according to an embodiment of the present invention. [Figure 14-3]This is a schematic diagram of a dispenser adapted to dispense individual packages including a foam interface according to an embodiment of the present invention. [Figure 15-1] This is a front cross-sectional view of a foam interface according to an embodiment of the present invention. [Figure 15-2] This is a side cross-sectional view of a foam interface according to an embodiment of the present invention. [Figure 16-1] This is a schematic diagram of the interface with the patient according to an embodiment of the present invention. [Figure 16-2] This is a schematic diagram of the frame and force vectors according to an embodiment of the present invention. [Figure 16-3] This is a schematic diagram of the frame and force vectors according to an embodiment of the present invention. [Figure 17-1] This figure schematically shows the layers of the interface structure according to an embodiment of the present invention. [Figure 17-2] This figure shows a method for joining an interface to a frame according to an embodiment of the present invention. [Figure 17-3A] This figure shows a mechanical interference-type mounting mechanism for detachably attaching an interface structure according to an embodiment of the present invention to a patient interface. [Figure 17-3B] This figure shows a mechanical interference-type mounting mechanism for detachably attaching an interface structure according to an embodiment of the present invention to a patient interface. [Figure 17-3C] This figure shows a mechanical interference-type mounting mechanism for detachably attaching an interface structure according to an embodiment of the present invention to a patient interface. [Figure 17-4A] This figure shows a hook and loop type attachment mechanism for detachably attaching an interface structure according to an embodiment of the present invention to a patient interface. [Figure 17-4B] This figure shows a hook and loop type attachment mechanism for detachably attaching an interface structure according to an embodiment of the present invention to a patient interface. [Figure 17-4C]This figure shows a hook and loop type attachment mechanism for detachably attaching an interface structure according to an embodiment of the present invention to a patient interface. [Figure 18-1] This figure shows a method for joining the interface with the area below the nose to the frame according to an embodiment of the present invention. [Figure 18-2] This figure shows a method for joining the interface with the area below the nose to the frame according to an embodiment of the present invention. [Figure 18-3] This figure shows a method for joining the interface with the area below the nose to the frame according to an embodiment of the present invention. [Figure 19-1] This figure shows the manufacturing process for applying a pressure-sensitive adhesive to the back of the interface with the area under the nose according to an embodiment of the present invention. [Figure 19-2] This figure shows the manufacturing process for applying a pressure-sensitive adhesive to the back of the interface with the area under the nose according to an embodiment of the present invention. [Figure 19-3] This figure shows the manufacturing process for applying a pressure-sensitive adhesive to the back of the interface with the area under the nose according to an embodiment of the present invention. [Figure 20-1] This figure shows a method for joining the interface with the area below the nose to the frame according to an embodiment of the present invention. [Figure 20-2] This figure shows a method for joining the interface with the area below the nose to the frame according to an embodiment of the present invention. [Figure 20-3] This figure shows a method for joining the interface with the area below the nose to the frame according to an embodiment of the present invention. [Figure 20-4] This figure shows the manufacturing process for forming a composite interface with the subnasal area according to an embodiment of the present invention. [Figure 20-5] This figure shows the manufacturing process for forming a composite interface with the subnasal area according to an embodiment of the present invention. [Figure 20-6] This figure shows the manufacturing process for forming a composite interface with the subnasal area according to an embodiment of the present invention. [Figure 20-7]This figure shows the manufacturing process for forming a composite interface with the subnasal area according to an embodiment of the present invention. [Figure 21-1] This figure shows a flexible frame according to an embodiment of the present invention. [Figure 21-2] This figure shows a flexible frame according to an embodiment of the present invention. [Figure 21-3] This figure shows a flexible frame according to an embodiment of the present invention. [Figure 22-1] This figure shows a flexible frame according to another embodiment of the present invention. [Figure 23-1] This figure shows a flexible frame having a spring element according to an embodiment of the present invention. [Figure 23-2] This is a graph of a variable spring element in which the k value according to an embodiment of the present invention changes over its length. [Figure 23-3] This figure shows a flexible frame having a spring element according to another embodiment of the present invention. [Figure 24-1] This figure shows a foam interface including an exhaust rigidizer according to an embodiment of the present invention. [Figure 25-1] This figure shows an interface with a patient, including an interface with the area below the nose and an interface with the mouth, according to an embodiment of the present invention. [Figure 26-1] This is a perspective view of a known mask sold by Respironics under the name ComfortCurve™. [Figure 26-2] This figure shows an improved and / or alternative configuration of Respironics' ComfortCurve® mask according to an embodiment of the present invention. [Figure 26-3] This figure shows an improved and / or alternative configuration of Respironics' ComfortCurve® mask according to an embodiment of the present invention. [Figure 26-4] This figure shows an improved and / or alternative configuration of Respironics' ComfortCurve® mask according to an embodiment of the present invention. [Figure 26-5]This figure shows an improved and / or alternative configuration of Respironics' ComfortCurve® mask according to an embodiment of the present invention. [Figure 26-6] This figure shows an improved and / or alternative configuration of Respironics' ComfortCurve® mask according to an embodiment of the present invention. [Figure 26-7] This figure shows an improved and / or alternative configuration of Respironics' ComfortCurve® mask according to an embodiment of the present invention. [Figure 26-8] This figure shows an improved and / or alternative configuration of Respironics' ComfortCurve® mask according to an embodiment of the present invention. [Figure 26-9] This figure shows an improved and / or alternative configuration of Respironics' ComfortCurve® mask according to an embodiment of the present invention. [Figure 26-10] This figure shows an improved and / or alternative configuration of Respironics' ComfortCurve® mask according to an embodiment of the present invention. [Figure 27-1] This is a perspective view of a known mask sold by Respironics under the name OptiLife (trademark). [Figure 27-2] This figure shows improved and / or alternative configurations of Respironics' OptiLife® mask according to several embodiments of the present invention. [Figure 27-3] This figure shows improved and / or alternative configurations of Respironics' OptiLife® mask according to several embodiments of the present invention. [Figure 27-4] This figure shows improved and / or alternative configurations of Respironics' OptiLife® mask according to several embodiments of the present invention. [Figure 27-5] This figure shows improved and / or alternative configurations of Respironics' OptiLife® mask according to several embodiments of the present invention. [Figure 27-6] This figure shows improved and / or alternative configurations of Respironics' OptiLife® mask according to several embodiments of the present invention. [Figure 27-7] This figure shows improved and / or alternative configurations of Respironics' OptiLife® mask according to several embodiments of the present invention. [Figure 28-1A] This is a perspective view of a known mask sold by Respironics under the name ComfortLite (trademark). [Figure 28-1B] This is a perspective view of a known mask sold by Respironics under the name ComfortLite® 2. [Figure 28-2A] This figure shows an improved and / or alternative configuration of Respironics' ComfortLite® mask according to an embodiment of the present invention. [Figure 28-2B] This figure shows an improved and / or alternative configuration of Respironics' ComfortLite® 2 mask according to an embodiment of the present invention. [Figure 29-1] This is a diagram showing a known mask sold by Fisher & Paykel under the name Opus (trademark). [Figure 29-2] This is a diagram showing a known mask sold by Fisher & Paykel under the name Opus (trademark). [Figure 29-3] This figure shows an improved and / or alternative configuration of Fisher & Paykel's Opus® mask according to an embodiment of the present invention. [Figure 29-4] This figure shows an improved and / or alternative configuration of Fisher & Paykel's Opus® mask according to an embodiment of the present invention. [Figure 29-5] This figure shows an improved and / or alternative configuration of Fisher & Paykel's Opus® mask according to an embodiment of the present invention. [Figure 29-6]This figure shows an improved and / or alternative configuration of Fisher & Paykel's Opus® mask according to an embodiment of the present invention. [Figure 29-7] This figure shows an improved and / or alternative configuration of Fisher & Paykel's Opus® mask according to an embodiment of the present invention. [Figure 29-8] This figure shows an improved and / or alternative configuration of Fisher & Paykel's Opus® mask according to an embodiment of the present invention. [Figure 29-9] This figure shows an improved and / or alternative configuration of Fisher & Paykel's Opus® mask according to an embodiment of the present invention. [Figure 30-1] This is a perspective view of a known mask sold by Puritan Bennett under the names Breeze®, SleepGear®, and DreamSeal®. [Figure 30-2] This is a perspective view of a known mask sold by Puritan Bennett under the names Breeze®, SleepGear®, and DreamSeal®. [Figure 30-3] This figure shows improved and / or alternative configurations of Puritan Bennett's Breeze®, SleepGear®, and DreamSeal® masks according to several embodiments of the present invention. [Figure 30-4] This figure shows improved and / or alternative configurations of Puritan Bennett's Breeze®, SleepGear®, and DreamSeal® masks according to several embodiments of the present invention. [Figure 30-5] This figure shows improved and / or alternative configurations of Puritan Bennett's Breeze®, SleepGear®, and DreamSeal® masks according to several embodiments of the present invention. [Figure 31-1]This is a diagram showing a known mask sold by InnoMed Technologies under the name Nasal-Aire (trademark). [Figure 31-2] This is a diagram showing a known mask sold by InnoMed Technologies under the name Nasal-Aire (trademark). [Figure 31-3] This figure shows improved and / or alternative configurations of InnoMed Technologies' Nasal-Aire® mask according to several embodiments of the present invention. [Figure 31-4] This figure shows improved and / or alternative configurations of InnoMed Technologies' Nasal-Aire® mask according to several embodiments of the present invention. [Modes for carrying out the invention]

[0034] The attached drawings facilitate understanding of various embodiments of the present invention.

[0035] The following description relates to several embodiments that may share features and characteristics. It should be understood that one or more characteristics of any one embodiment can be combined with one or more characteristics of other embodiments. Furthermore, any single characteristic or combination of characteristics of any embodiment may constitute additional embodiments.

[0036] The following patient interfaces are intended to include subnasal interfaces, but patient interfaces can be adapted for use with other suitable interface types. That is, the interface types are merely illustrative, and some aspects of the present invention can be adapted to include other interface types, such as nasal cushions, nasal prongs, full-face masks, and mouth masks.

[0037] Some embodiments of the present invention aim to advance from uncomfortable, unattractive mask systems to smooth, elegant patient interfaces that are flexible, comfortable, lightweight, functional, therapeutic, fashionable, easy and intuitive to put on and adjust with little or no adjustment, maintain shape, have less impact, low profile, a continuous form, are tailored or customized to the individual, and / or are more attractive and far less uncomfortable for the patient and / or those sleeping with them. The target patient interface is not a large, mechanical extension attached to the patient that may look unsightly or unattractive, but rather something that is less intrusive, less conspicuous, anatomically consistent, looks like an organic extension, and / or harmonizes with the patient. This can help the patient and those sleeping with them to relax and / or sleep more easily during treatment. Furthermore, the patient interface can improve the overall perception of the patient, making them feel as if they are simply wearing clothing such as a nightcap or sleepwear, rather than undergoing treatment for a respiratory illness. This improved awareness can help increase the likelihood that patients will actually wear the interface with the patient and follow or better follow treatment, thus increasing the chances of effective treatment for the device user. It may also be possible that the person sleeping with the patient will be more likely to accept the treatment and participate in the treatment by encouraging the use of the sleep-promoting device, which has an interface that is easy to use / adjust and is more attractive and / or interesting.

[0038] Patient Interface Figures 1-1 to 1-16 show a patient interface or mask system 10 according to an embodiment of the present invention. As shown, the patient interface 10 includes an interface structure 20 (also referred to as a buffer structure or adaptable structure) adapted to provide an effective interface with the patient's face, and an air delivery and stabilization system 30 (also referred to as a conduit headgear or inlet conduit configuration) adapted to deliver breathable gas to the interface structure 20 and support the patient interface 10 at a desired position on the patient's head. A cover (also referred to as a sock or covering) may optionally be provided to substantially enclose one or more portions of the interface structure 20 and / or the air delivery and stabilization system 30.

[0039] 1. Air delivery and stabilization system 1.1 Background and Overview Known patient interfaces typically involve separate headgear and air delivery components, which are used to position the mask and supply it with breathable gas. Known headgear typically include an assembly of elastic (or non-elastic) straps, buckles, locks, and / or clips. Known air delivery components typically include spiral reinforcement piping and swivel connectors with a diameter of 15–22 mm. These known configurations of headgear and air delivery components can be difficult for clumsy and / or unfamiliar individuals to handle. These known configurations of headgear and air delivery components can also be uncomfortable or impractical to lie on.

[0040] One aspect of the present invention relates to the stability of an air delivery and interface structure provided by a single combined system. In the illustrated embodiment, the air delivery and stabilization system 30 includes four main components: piping 40, a rigidizer 50, a backstrap 60, and a manifold 70 (see, for example, Figure 1-6). When in use, the air supply is directed, for example, to the manifold 70 located above or in front of the patient's head. The air supply is directed from the manifold 70 towards the patient's nose and / or mouth through piping 50, for example, at least one, preferably two tubes. Piping 40 has the property of being collapsible when laid on it, but is sufficiently rigid in other directions to maintain sufficient stability of the interface.

[0041] 1.2 Piping In the illustrated embodiment, the piping 40 includes two tubes or inlet conduits 42 (also referred to as gas flow paths or gas conduits), which communicate with the interface structure 20 to deliver breathable gas to the interface structure 20 (see, for example, Figure 1-6). In one embodiment, a single tube can be used. However, it is preferable to use two tubes so that, for example, when one tube 42 is completely compressed, the interface structure 20 can still be supplied with sufficient breathable gas. That is, using two tubes 42 allows one or both tubes 42 to be opened during use. In an alternative embodiment, two or more tubes, for example, three or more tubes, can be used. For example, the piping can provide a four-tube configuration including two upper tubes along the upper side of the patient's face and two lower tubes along the lower side of the patient's face.

[0042] Each tube 42 includes a first end 42.1 fitted to engage with each end of the frame 22 of the interface structure 20, and a second end 42.2 fitted to engage with each end of the manifold 70, as shown in Figures 2-1 and 2-2. In one embodiment, the frame 22 and the manifold 70 may each include tube portions 25, which are fitted to engage with each end of the tube 42, for example, by friction fitting. When in use, the tube 42 is supplied with pressurized breathable gas from the manifold 70, and the pressurized breathable gas is delivered to both ends of the interface structure 20.

[0043] In the illustrated embodiment, the frame 22 and the tubular sections 25 of the manifold 70 (see, for example, Figures 2-1 and 2-2) each have a stepped configuration, resulting in a smooth and virtually seamless shape at the connection point when each tube is attached to the tubular section 25, for example, the step becomes invisible in the overall shape. For example, the boundary between each tubular section 25 and the frame or manifold body can have a step height that is substantially equal to the wall thickness of each end 42.1, 42.2 of the tube, and by joining the tubular sections to each end of the tube, the connection point becomes smooth and virtually seamless. Such a smooth connection point improves the appearance and can have a functional benefit in that it reduces the resistance to snagging on pillows, bedding, etc. when a patient rolls around on the bed during use.

[0044] In an alternative embodiment, the two tubes can be independently connected to the gas supply unit (e.g., a positive airway pressure (PAP) device or flow generator). For example, as schematically shown in Figure 2-3, one tube 42 can extend from one end of the interface structure 20 to the first outlet O1 of the PAP device, and the other tube 42 can extend from the other end of the interface structure 20 to the second outlet O2 of the PAP device. In such a configuration, the manifold can be eliminated or incorporated into the PAP device itself.

[0045] In other embodiments, two tubes can be joined together at an outlet of the PAP device (for example, both tubes are adapted to connect to a single outlet of the PAP device), and then those tubes can branch out toward an interface structure (i.e., split or divide into separate tubes). For example, as shown in Figure 2-4a, tube 42(1) can be connected to a single outlet O of the PAP device, and then split toward each end of the interface structure 20 to form separate tubes 42(2). As shown in Figure 2-4b, tube 42(1) may include an internal partition W to split the tube into two conduits, one of each of tube 42(2) and associated with it.

[0046] 1.2.1 It must be crushable and thin. In the illustrated embodiment, each tube 42 is constructed to transition between two phases: a first open phase in which the tube 42 allows air to pass through (see, e.g., Figure 3-1) and a second collapse phase in which the tube 42 is completely collapsed and comfortable to lie on (see, e.g., Figure 3-2b). Each tube 42 is constructed such that the weight of the head of any patient (e.g., adult or infant / child) resting on the tube 42 is sufficient to collapse the tube 42, so that the patient can lie on their side comfortably (see, e.g., Figures 1-3, 1-5, and 1-14). However, since the tubes have a consistency similar to that of a tubular balloon inflated under low pressure, each tube 42 can be collapsed with a weight much lighter than that of a typical patient's head.

[0047] In the opening phase, the tube is open or at least partially open, so that the tube allows enough air to pass through to perform treatment, for example, without excessive resistance to the flow. In the collapse phase, the tube is collapsed so that air passage or conductivity is substantially obstructed.

[0048] It should be understood that each tube does not need to be completely or entirely compressed to improve comfort. For example, each tube can be configured to transition between a first open phase in which tube 42 allows air to pass through and a second partially or substantially compressed phase in which tube 42 is at least partially or substantially compressed to restrict and / or at least partially obstruct air passage (see, for example, Figure 3-2a).

[0049] In the partially or substantially crushed phase, the opposing walls of the tube can engage with each other at one or more points or surfaces along its length, and as a result, conductivity in the partially or substantially crushed tube can be minimized, or even reduced to a negligible amount. Also, in the partially or substantially crushed phase, the tube can be opened enough to maintain a small degree of conductivity for pressurized gas. A small degree of openness can be achieved by utilizing one or more short, crush-resistant ribs provided on the inner surface of the tube and / or a standard wall thickness (where the opposing walls do not or do not come into contact with each other when the loads typically encountered during treatment are applied).

[0050] Each tube 42 is configured to be sufficiently airtight and to deliver air from the top of the patient's head to the patient's nose without causing discomfort to the patient (see, for example, Figures 1-4 and 4-2). The resistance provided by the tubes is suitable for the blower in use, regardless of whether one or both tubes are in the open phase. That is, the tubes 42 provide a wide, open cross-section with low resistance in the open phase and a low profile in the collapse phase. Furthermore, the tubes provide a linear piping system with parallel lines that can be switched on or off (i.e., open phase or collapse phase), and switching either of the parallel lines off has only a slight effect on the total resistance of the piping system. In other words, the resistance "felt" by the PAP device is substantially independent of whether one or both tubes are open. The tubes can also be adapted to control pressure fluctuations, such as the patient's deep breaths.

[0051] In one embodiment, each tube 42 may have sufficient strength to remain open or open and unblocked without being compressed. That is, the tubes 42 may be constructed so that they are only crushed when "actively" compressed, and otherwise remain in the open phase. In an alternative embodiment, a supply of gas may be used to assist in the expansion of each tube.

[0052] Each tube 42 can be compressed at any point along its length, and can be compressed into a substantially flat structure, so that the tube 42 is substantially flat against the patient's face for comfort. However, the tube 42 can be constructed to be compressed along a selected portion, for example, only the middle section or only the center section.

[0053] In other embodiments, at least one tube may have the characteristic of bulging laterally at at least one point. In such tubes (also referred to as “bubble” tubes), a portion of the tube is crushed or partially crushed, and a portion of the tube opens up, for example, the tube is “pinched” in the middle, resulting in an overall shape resembling the number 8. In other embodiments, at least one tube may have a relatively wide, flat shape to provide a stretched tube adapted to cover more of the patient’s cheek. For example, Figure 3-5a is a schematic diagram of the initial configuration of tube 142, Figure 3-5b shows tube 142 when the end portions 144, 146 are crushed or partially crushed to a flat configuration, and Figure 3-5c shows tube 142 when the middle portion 145 is crushed or partially crushed to a flat configuration. In other modified forms, the tube can be pre-formed to have one or more relatively flat portions 144, 145, 146 and one or more circular conduit portions 147, as shown in Figures 3-5b and 3-5c.

[0054] It should be understood that the interface with the patient is preferably not crushed in the area of ​​the manifold and the front of the patient's nose, for example, in the interface structure 20. That is, the manifold can be constructed from a substantially rigid material, and the interface structure 20 can include a substantially rigid frame (for example, the frame 22 shown in Figure 2-1) that prevents crushing during use. Such a configuration ensures that there is a passage for airflow from at least one tube 42 to the patient's nose.

[0055] In one embodiment, each tube 42 can be molded from a silicone material, such as liquid silicone rubber (LSR), having a thin wall thickness of about 0.5 mm. However, each tube can have a wall thickness of about 0.3 mm to 5 mm. The tubes can be of various colors, and the tubes can be formed in a mold with a polished surface to give the tubes a smooth outer surface. However, each tube can be constructed from other flexible and pliable materials, such as dipped and knitted textiles, including thermoplastic elastomers (e.g., Santoprene®), foams, foam laminates, closed-cell impermeable foams, cotton, or silk. In one embodiment, each tube can be constructed from two material sheets, such as a laminated product, attached to each other, for example, by heat welding. In an alternative embodiment, each tube can be constructed from a plurality of elements, such as relatively rigid elements, configured in a bellows structure so that the tubes can transition between an open phase and a collapsed phase. In one embodiment, each tube may have a bellows structure that allows each tube to be compressed from one volume to another smaller volume. For example, Figure 3-6a shows a cross-section of a first-phase bellows-type tube 542 yielding a first volume, and Figure 3-6b shows a second-phase bellows-type tube 542 yielding a second volume smaller than the first volume. In this example, one end 543 of the tube 542 is positioned adjacent to the patient's face.

[0056] The tubing configuration according to embodiments of the present invention differs from conventional configurations, such as InnoMed's NasalAire and other shapes of nasal cannulas. These conventional configurations are designed to withstand crushing (i.e., to always deliver breathable gas through both tubes), and therefore present an uncomfortable structure when the patient lies on it. Furthermore, unlike conventional configurations, the tubing configurations according to some embodiments of the present invention are capable of providing sufficient compressed gas even when one of the pair of tubes is completely crushed. Because the pair of tubes according to embodiments of the present invention has a specific configuration, both tubes will not be crushed simultaneously during normal use. This allows the patient to assume any sleeping position (e.g., a completely free sleeping position) without leakage of the compressed gas supply (see, for example, Figures 1-1, 1-3, 1-5, 1-7, 1-8, and 1-14). In other words, the tubing configuration according to embodiments of the present invention provides two or more tubes that cooperate to maintain sufficient gas conductivity (e.g., sufficient gas flow at therapeutic pressure) and patient comfort without introducing unnecessarily high resistance. For example, when a two-tube configuration is provided, each tube has sufficiently low resistance (e.g., sufficiently large hydraulic diameter) to facilitate sufficient gas supply when one of the tubes is blocked, for example by lying on top of it.

[0057] 1.2.2 Cross-sectional profile In the illustrated embodiment, each tube 42 has a non-cylindrical cross-sectional shape, and its cross-section provides a harmonious contour to harmonize with the patient's face (see, for example, Figures 3-1 and 4-1 to 4-5). That is, each tube 42 provides a harmonious contour or free form with little to no sharp edges or straight lines. The harmonious contour is smooth, streamlined, and rounded, harmonizing or tapering the tube 42 to or from the contour of the patient's head, for example, making it anatomically consistent, less conspicuous, and more aesthetically pleasing. Furthermore, the harmonious contour does not have sharp edges that could cause discomfort, such as skin irritation or abrasion.

[0058] The contour or cross-section of each tube 42 can be varied along its length, and can be unevenly varied, for example, with respect to its position around the patient's head. In one embodiment, each tube may have a substantially constant hydraulic diameter, and its cross-sectional area may vary along its length. For example, each tube 42 can provide a flatter area in a certain region, for example, the area of ​​the tube on which the patient rests while sleeping. In this way, the tubes can be said to be organic extensions of the contour of the patient's face.

[0059] Figure 3-1 shows an exemplary cross-section of the tube 42. As shown, the tube 42 has a generally D-shaped cross-section and includes an inner surface or inward-facing surface 44 and an outer surface or outward-facing surface 45.

[0060] The inner surface 44 is relatively flat and is adapted to be substantially flush with the patient's face during use. The inner surface 44 may have a tapered configuration from the inner edge to the outer edge to ensure a comfortable fit for a wide range of patients. The inner surface 44 provides a relatively large surface area for more even load distribution. Such a configuration makes it less likely to create pressure points during use. The inner surface 44 may also have a handle-like attachment to help stabilize the interface with the patient's face. To add rigidity to the tube, a stiffening element can be provided on the inner surface, as described below.

[0061] The outer surface 45 has a smooth contour that harmonizes with the patient's face. That is, the outer surface 45 has a profile or organic shape with edges that harmonize with the patient's face in the tangential direction, for example, to prevent the edges from getting caught on bedding, pillows, etc. during sleep (for example, when the patient turns over in bed).

[0062] As described above, the generally D-shaped cross-section can be varied along its length, for example, a thicker, narrower D-shaped cross-section near the patient's nose, and a wider, shallower D-shaped cross-section along the cheeks and near the top of the patient's head. For example, Figures 3-4 and 3-4a to 3-4f show various cross-sections of the tube 42 along its length according to embodiments of the present invention. Specifically, Figure 3-4a shows a cross-section of tube 42 at the end adapted to engage with manifold 70, Figure 3-4b shows a cross-section of tube 42 at 20% of the length from the manifold end, Figure 3-4c shows a cross-section of tube 42 at 40% of the length from the manifold end, Figure 3-4d shows a cross-section of tube 42 at 60% of the length from the manifold end, Figure 3-4e shows a cross-section of tube 42 at 80% of the length from the manifold end, and Figure 3-4f shows a cross-section of tube 42 at the end adapted to engage with interface structure 20. As shown in the figures, the D-shaped cross-sections vary along their length. Specifically, each cross-section has a width w and a height h, and the width and height of the various cross-sections vary along the length of the tube; for example, the manifold end is relatively wide and low in height, while the interface structure end is relatively narrow and high in height. Furthermore, all cross-sections have similar or common hydraulic diameters, for example, about 10-15 mm or about 13 mm. Their shape can be configured based on appearance and / or resistance requirements. Additionally, their shape can be configured to provide low profile, comfort, and / or stability.

[0063] However, the tube 42 may have other suitable cross-sectional shapes, such as trapezoidal, semicircular, cylindrical, oval, elliptical, or flatter cross-sections. The tube may also have a flat configuration with crush-resistant ribs. Such configurations are described in Patent Document 2, which is incorporated herein by reference in whole.

[0064] Figures 5-1 to 5-3 show alternative cross-sections of the tube. Figure 5-1 shows a tube 242 that conforms more gradually to the patient's face. As shown in Figure 5-2, the tube 342 can have a gap 343 on its inner surface to allow, for example, airflow or breathing. Although less preferred than the cross-sections shown in Figures 3-1, 5-1, and 5-2, the cross-section of the tube 442 in Figure 5-3 would be preferable to a conventional cylindrical tube due to its conforming contour.

[0065] It should be noted that D-shaped or generally trapezoidal tubes do not produce as clearly defined pressure areas along their bottom edge as semicircular tubes. This is because the side walls of D-shaped or generally trapezoidal tubes meet the base at an acute angle α, i.e., an angle less than 90 degrees, as shown in Figure 3-1. The side walls of semicircular tubes meet the base at approximately 90 degrees, and when the tube is pressed against the patient's face, the area where the side walls meet the base becomes more rigid, which can lead to a pressure point. Furthermore, semicircular tubes can result in a discontinuous shape when viewed in relation to the contours of the patient's face.

[0066] 1.3 Air-delivered stiffening element In the illustrated embodiment, a stiffening element or rigidizer 50 is provided to each tube 42 to add stiffness to the tube 42 (see, for example, Figures 1-6, 3-3, and 4-3 to 4-5). The stiffening element 50 according to the embodiment of the present invention is preferably thin and conforms well when a patient lies on it, but is stiff enough to resist out-of-plane bending. That is, the stiffening element 50 is constructed to be bendable in some planes and resist bending in some planes, for example, in the direction toward and away from the patient's face. The stiffening element 50 also makes the tube 42 non-stretchable or non-stretchable so that the tube 42 is strong against tension and maintains its dimensions.

[0067] In one embodiment, the rigidifying element 50 can ensure that the patient interface 10 maintains its shape and does not stack up, whether it is on or away from the patient's head, thereby providing the patient interface 10 with structural integrity or a self-retaining shape, for example, like shape memory. Such a shape-retaining mechanism can maintain the tube in a desired position and facilitate wearing the patient interface during use.

[0068] A stiffening element 50 can be provided on the inner and / or outer portion of the tube 42. For example, Figures 1-6 and 4-1 to 4-5 show a stiffening element 50 provided on the outer portion of the tube 42 (e.g., along the inner surface 44) that is adapted to engage with the patient's head during use. As shown, the stiffening element 50 may include a tubular end portion 52 to facilitate connection of the tube 42 to the manifold 70 and / or interface structure 20. The tube / rigidizer subassembly may also provide an extension portion 53 for supporting a backstrap 60 (see, for example, Figures 4-1, 4-2, and 4-4).

[0069] Figures 4-6 to 4-9 show other embodiments of the stiffening element 50 to which the tube 42 is attached. As shown, the stiffening element 50 can be constructed to extend under interface structures, manifolds, and / or backstraps when in use.

[0070] The stiffening element 50 may have varying thickness along its length, for example, to change the stiffness or rigidity of the tube 42 along its length. For example, the stiffening element 50 may be thinner at the patient's cheeks and thicker at the top of the patient's head. In one embodiment, the stiffening element 50 and / or the tube 42 may be constructed to accommodate each arm of the patient's eyeglasses.

[0071] In one embodiment, the stiffening element 50 can be cut from and / or formed from a thin plastic sheet, for example, 0.5 mm thick impact-resistant polystyrene (or EPP foam). However, other suitable materials are possible, such as textiles, nylon, polypropylene, high-duro silicone, elastomers, etc., and the stiffening element can have other suitable wall thicknesses, for example, about 0.3 mm to 5 mm.

[0072] In one embodiment, each piping / rigidizer subassembly may have a total thickness (e.g., the thickness of the crushed piping / rigidizer) of approximately 1.5 mm, for example, 0.5 mm for the rigidizing element, 0.5 mm for one tube wall, and 0.5 mm for the opposite tube wall. However, the total thickness can be thicker or thinner depending on the application, for example, 1-10 mm, 1-5 mm, thinner than 5 mm, approximately 10 mm, approximately 5 mm, and / or approximately 3 mm. It should be understood that the wall thickness of the tube and / or rigidizer can be adjusted for comfort and / or robustness, for example, by increasing the wall thickness. The wall thickness of the tube and rigidizer is preferably as thin as possible, but may be thicker to provide better shape retention, self-supporting, and / or robustness.

[0073] In one embodiment, a separate rigidifying element 50 can be incorporated. For example, see Patent Document 3, which is incorporated herein by reference in its entirety.

[0074] In one embodiment, separate rigidifying elements 50 can be formed and then attached to each tube 42, for example, by adhesive or by a mechanical interlocking mechanism.

[0075] In other embodiments, the stiffening elements 50 can be co-molded or co-extruded with each of the tubes 42. That is, the tubes 42 and the stiffening elements 50 can form an integrated, one-piece structure.

[0076] In other embodiments, the stiffening element can be made from polypropylene, and the tube can be made from a thermoplastic elastomer of a grade suitable for welding / co-forming to the polypropylene stiffening element.

[0077] In an alternative embodiment, the stiffening element may include a plurality of components that are adjustable or movable relative to each other, for example, slidable, in order to adjust the stiffness and / or position provided by the stiffening element.

[0078] 1.4 Backstrap In the illustrated embodiment, a backstrap 60 is provided to the piping / rigidizer subassembly (see, for example, Figures 1-2, 1-6, and 6-1 to 6-4). The backstrap 60 is adapted to be positioned overall on the patient's occipital bone when in use to facilitate stabilizing the interface with the patient over the patient's head. The backstrap 60 can also help provide interfacing force to the interface surface below the patient's nose, for example.

[0079] In one embodiment, the backstrap 60 (also referred to as an elastic stabilizer or stretchable stabilizer) includes a stretchable strap 62 of a certain length. Both ends of the stretchable strap 62 are attached to the piping / rigidizer subassembly through holes 46 provided by the respective tubes 42, as shown, for example, in Figures 6-3 and 6-4.

[0080] When in use, the back strap 60 can be positioned in a range of locations on the patient's head, again generating appropriate connecting force in both size and direction. This positioning allows for several different suitable dimensions, enhancing patient comfort when moving the back strap 60 to the most comfortable position, for example, higher or lower on the back of the patient's head, as shown in Figures 6-3 and 6-4. The elasticity of the back strap allows the interface with the patient to fit a wide range of the population, for example, 80-90% of the population.

[0081] The back strap 60 is not used to provide a connecting force, but rather primarily to maintain the interface with the patient on the patient's head. That is, the interface structure 20 does not require high tension for the interface (as described below), and therefore the back strap 60 does not need to be relied upon in terms of tension for the connecting force.

[0082] In one embodiment, the strap 62 may have selected elasticity properties such that the tension increases and then levels off from zero to a relatively small range of elongation. The tension may remain generally similar over relatively large further elongation until it is fully stretched to its elastic limit.

[0083] A range of alternative straps 62 with patient interfaces for use with heads of various dimensions can be provided, for example, with varying elasticity, thickness, length, etc.

[0084] The back strap 60 may have other suitable configurations of selectively adjustable length, such as a baseball cap adjuster (see, for example, Figure 10-4), hook and loop material, ladder lock, or adjustable elastic body. In one embodiment, as shown in Figure 6-5, the back strap may include a rigid side portion 65 (formed integrally with, for example, the stiffening element 50) and an elastic strap 62 connected to the free end of the rigid portion 65.

[0085] In other alternative embodiments, the backstrap can be constructed from the same material as the tube, for example, by constructing a tube and backstrap co-molded with the stiffening elements. In one embodiment, two sides of the patient interface can be molded simultaneously, for example, by molding two stiffening elements held together by a backstrap that harmonizes with both stiffening elements. To complete the patient interface, the tube will be engaged with the manifold and interface structure.

[0086] In an alternative embodiment, an ear anchor, adapted to engage with the patient's ear and support the interface with the patient on the patient's face, can be used instead of the backstrap.

[0087] In other embodiments, the back strap may extend across only a portion of the back of the head (for example, the back strap may have elastic fingers that extend inward from each side and press against the back of the head, generating a backward force).

[0088] 1.5 Manifold The manifold 70 interconnects two tubes 42 and is provided to direct air flowing from a suitable source, such as a blower, into those two tubes 42 (see, for example, Figures 1-2, 1-4, and 1-6). As best shown in Figure 2-2, the manifold 70 is generally T-shaped and includes a base portion 72 and an inlet tube portion 74 connected to the base portion 72 (movably connected by, for example, a ball joint, hinge, overall flexibility, etc.). In one embodiment, the manifold 70 is designed to have a smooth, continuous shape with the shape of the patient's head and the interface with the patient, for example, an inconspicuous shape. For example, the manifold may have a relatively flat shape or low profile to minimize the height or angle of air delivery.

[0089] The manifold provides a transition section from the air delivery piping connected to the PAP device to the inlet piping connected to the interface structure. Thus, the manifold transitions the air delivery piping, which is not crushable, to the inlet piping, which is crushable. The manifold also transitions the piping profile, for example, from the relatively circular piping of the air delivery piping to the relatively flat piping of the inlet piping.

[0090] The base portion 72 includes opposing tube portions 25, which are fitted to engage with each tube 42, for example, by friction fitting. The cross-sectional shape of the tube portions 25 may be non-circular and can correspond to the cross-sectional shape of the tubes 42. The base portion 72 may be curved to conform to the shape of the patient's head and, if not, appropriately contoured so that it rests on the top of the patient's head and is substantially flush with it during use. However, the base portion may include other suitable connections or air-retaining connections to the tubes.

[0091] The inlet tube portion 74 can be fixed to the base portion 72, or it can be movably connected to the base portion 72, for example, by a swivel, so that the inlet tube portion 74 can be angled relative to the base portion 72 when in use. The swivel configuration can provide 360-degree rotation or other suitable angle ranges. The inlet tube portion 74 has an inlet tube 75, for example, 15 mm in diameter, which is adapted to connect to an air delivery tube T1 (see, for example, Figures 1-2, 1-7, and 2-2) connected to a suitable air delivery source, for example, a blower.

[0092] In one embodiment, the manifold 70 and the tube 42 can be formed integrally as a single-piece structure, for example, to reduce the number of parts.

[0093] In one embodiment, the manifold can be constructed to control dynamic flow and / or reduce noise.

[0094] 1.5.1 Placement The manifold 70 is positioned in an area above the patient's head where the interface with the patient does not interfere with the pillow when in use (see, for example, Figures 1-2, 1-4, and 1-7). That is, the manifold 70 directs the air delivery tube T1 out of the bed, and therefore the air delivery tube T1 does not interfere with the pillow and does not pass along the patient's body. In one embodiment, the manifold 70 can be positioned above the patient's head, for example, generally in the plane of the patient's ears. For example, the manifold 70 can be positioned in the area of ​​the bregma generally when in use.

[0095] One advantage of this approach is that the dragging of the tube does not directly affect the interface during use. For example, by positioning the manifold 70 near the top of the head, it is positioned furthest from the interface structure 20, and therefore, when the air delivery tube is pulled or moved, the movement does not significantly affect the interface, for example, by changing the load distribution in the interface area, thus increasing the stability of the interface. In addition, the placement of the manifold makes it possible to make the tube connection to the mask less noticeable by avoiding the patient's field of vision.

[0096] A manifold can offer multiple functions or practical applications. For example, a manifold can provide a reference point or fixed point for the interface with the patient. That is, a manifold can act as a head support or stabilizer, an air delivery conduit, and an inlet piping mounting point. Furthermore, as mentioned above, a manifold can withstand the drag of tubing.

[0097] 1.5.2 Swivel Function In one embodiment, the manifold 70 is generally T-shaped and defines two axes that are generally right angles to each other, namely a base portion 72 along a first axis and an inlet tube portion 74 along a second axis perpendicular to the first axis.

[0098] The manifold 70 may incorporate a swivel function that allows the manifold 70 to pivot or move on a hinge around one or both axes (see, for example, Figure 7-1). Figure 7-2 shows the manifold 270 having a ball joint configuration that allows the inlet tube portion 274 to rotate or pivot with respect to the base portion 272. The base portion and / or the inlet tube portion may incorporate one or more stops to limit the pivoting during use. The swivel function allows the air delivery tube to be angled appropriately with respect to the interface with the patient, for example, so that the air delivery tube does not extend to a wall or the headboard of a bed.

[0099] 1.5.3 Offset Placement In the illustrated embodiment, the manifold 70 is positioned on the top of the patient's head (see, for example, Figures 1-2, 1-4, and 1-7). In an alternative embodiment, the manifold 70 can be offset from the top of the patient's head, for example, to the side of the patient's head. Such an offset position may make it more comfortable by reducing drag (specifically, when the patient lies with the opposite side of their head down). Such a position can also facilitate the attachment and routing of alternative tubes, such as lateral tube routing, like a snorkel.

[0100] The length of the tube 42 can be selected to adjust the manifold 70 to a position where the patient can see the connection point of the air delivery tube and operate it more easily.

[0101] In one embodiment, the manifold 70 may have adjustable couplings, such as sliding joints or parallel joints, and two or more positions of the manifold can be selected (for example, along the back strap of the headgear).

[0102] 1.6 Head position In the illustrated embodiment, the air delivery and stabilization system 30 includes two alternative, complementary air delivery pathways located on different parts of the patient's head (for example, preferably on both sides of the patient's face) so that the patient can turn over in a nearly complete circle without obstructing both pathways.

[0103] In one embodiment, the air delivery and stabilization system 30 has an overall oval or annular configuration (see, for example, Figures 8-1 to 8-4). When in use, each tube 42 of the system has one end that passes over the top of the patient's head and the other end that passes below the patient's nose, as shown in Figure 8-5. In this way, the air delivery and stabilization system 30 is outside the patient's eyes and does not interfere with the patient's field of vision or vision, and can be worn simply like putting on a cap. In an alternative embodiment, the annular configuration may incorporate a splitter to split the ring shape, for example, by splitting the ring shape in a manifold or below the nose.

[0104] Each tube 42 of the air delivery and stabilization system 30 runs along the side of the patient's face, between the patient's eyes and ears, providing a placement that does not obstruct the patient's field of vision. That is, each tube 42 is positioned sufficiently far from the ears to reduce noise and sufficiently far from the eyes, and therefore does not affect the field of vision. In one embodiment, the tube 42 runs in a straight line from the patient's nose to the top of the patient's head. However, the tube 42 is not limited to a specific path.

[0105] For example, as shown in Figure 8-6, each tube 42 can pass through a region defined between a first boundary curve P1 and a second boundary curve P2. The first and second boundary curves P1 and P2 are represented by two identical curves, one of which is rotated relative to the other. Both curves are positioned at the edges of their respective regions. As shown in the figure, the first boundary curve P1 is adjacent to the eye at the point where it intersects with the patient's field of vision, and the second boundary curve P2 is adjacent to the patient's ear. The second boundary curve P2 can be described as being adjacent to the upper front of the patient's auricle, where the auricle touches the patient's temple. Dimension B indicates the height of the head. As shown in the figure, curve P2 stops at the top of the patient's head; that is, if the curve represents piping, it will touch the top of the patient's head and fit substantially snugly. When the curve or piping rotates forward, dimension A indicates the height of the patient's head to which the curve or piping fits. As shown in the illustration, the conformance range delta AB can be achieved using the same non-adjustable piping.

[0106] In one embodiment, the air delivery and stabilization system 30 can pass along the upper side of the patient's jawbone, for example, avoiding the cheek and conforming to the thickness of the patient's facial tissue. In another embodiment, the air delivery and stabilization system 30 may be located midway across the patient's temples during use. However, the air delivery and stabilization system 30 may be sufficiently flexible so as not to need to avoid sensitive areas for comfort.

[0107] It should be understood that the placement of the air delivery and stabilization system 30 on the patient's head does not critically depend on precise alignment with specific facial features, as is done by conventional systems. In other words, the air delivery and stabilization system 30 can form and maintain a sufficient interface even when moving.

[0108] 1.7 Other aspects of the system 1.7.1 Assembly In one preferred embodiment, the patient interface 10 is configured to require little to no adjustment to fit the patient's head. Thus, the patient interface is relatively automatically positioned, intuitive, self-adjusting, and easy to fit. In one embodiment, for example, the patient interface can be assembled with one hand in a slip-on manner, like a hat.

[0109] As described above, the air delivery and stabilization system 30 is generally oval or annular in shape, for example, generally truncated elliptic or funnel-shaped. A tapered surface or elliptic ring is provided between the inner and outer edges to define the contact surface that engages with the patient. Depending on the dimensions of the patient's head, the tapered contact surface engages with the patient's head at various positions. For example, if the patient's head is larger, the interface with the patient can be positioned higher on the patient's head. If the patient's head is smaller, the interface with the patient can be positioned further back on the patient's head. Once fitted, the patient can adjust the back strap 60 as needed. Thus, the patient may only need to make one adjustment to fit the interface with the patient to their head. Further details of these arrangements are described in U.S. Provisional Application No. 60 / 833841, filed July 28, 2006, which is incorporated herein by reference in whole.

[0110] In one embodiment, the oval or annular configuration of the air delivery and stabilization system 30 can be adjusted, for example, according to the patient's fit and / or preference. For example, as shown in Figure 8-7, the top and / or bottom of the "ring" may include an adjustment mechanism 55 to allow adjustment of the ring's dimensions, for example, according to the dimensions of the patient's head.

[0111] 1.7.1.1 Method of attachment to the patient Figures 9-1 to 9-3 illustrate exemplary methods for attaching the patient interface to the patient. As shown in Figure 9-1, the interface structure 20 can first be positioned under the patient's nose. Then, as shown in Figure 9-2, the air delivery and stabilization system 30 can be rotated over the patient's head around the interface structure 20. The patient interface is rotated, for example, by X degrees until the air delivery and stabilization system 30 engages with the patient's head and prevents further movement. Finally, as shown in Figure 9-3, the back strap 60 can be adjusted as needed to comfortably secure the patient interface over the patient's head.

[0112] In an alternative embodiment, the patient interface can be configured to "fit" the patient interface in stages. In such an embodiment, a portion of the patient interface (e.g., the air delivery and stabilization system) can be engaged with the patient, and then other portions of the patient interface (e.g., the interface structure) can be engaged when the patient is ready to begin treatment. This configuration allows the air delivery and stabilization system to be engaged with the patient's head when the interface structure is not engaged. For example, in the case of Adam's circuit (trademark) (e.g., shown in Figures 30-1 to 30-4), the interface structure can be adapted to swivel upward or sideways to a "standby" position that is outside the patient's field of vision and / or not engaged with the patient's face or nose. Immediately before the patient is ready for use (e.g., before going to sleep), the interface structure can be moved from the "standby" position to a fully operational / engaged position. In one example, the tube or the joint between the tube and the mask can be swivelable / bendable / movable to move the mask away from the face while keeping the headgear in place. For example, Figure 30-3 shows an exemplary pivot axis 1915 at the joint between the tube and the mask, which allows the mask to move away from the face (for example, to the position shown by the dashed line).

[0113] 1.7.1.2 Dimension Setting In the illustrated embodiment, the interface with the patient includes a single adjustment point. The adjustment mechanism may be passive (e.g., an elastic back strap) or may require active adjustment (e.g., tailoring a baseball cap) to provide a one-size-fits-all configuration. In one embodiment, the adjustment point may be fitted or modified to the patient at the time of sale and then further adjusted, for example, to prevent tearing.

[0114] In alternative embodiments, the patient interface may be a non-adjustable slip-on shape, such as a shoe with little or no stretch. In such configurations, the patient interface can be provided in many different dimensions, e.g., up to 20 different dimensions, 5, 10, 15, or other numbers of dimensions (e.g., small, medium, and large). Such configurations can be aided by the high mechanical compliance of the sealed interface to provide a sufficient range of fits.

[0115] In other alternative embodiments, the patient interface may include a method for adjusting the dimensions (e.g., length) of the headgear in one or both of the upper and rear portions of the headgear.

[0116] 1.7.1.3 Surface characteristics In some embodiments, air delivery and stabilization systems can be textured, colored, foamed, and / or flocked (e.g., by spinning many small pieces of yarn or cotton attached thereto) to give them a cloth-like feel or flexibility for appearance and / or comfort. For example, piping, rigidity elements, backstraps, and / or manifolds can be textured, colored, foamed, and / or flocked.

[0117] In alternative embodiments, a sock S can be provided to substantially enclose one or more parts of piping, rigidity elements, backstraps, and / or manifolds (see, for example, Figures 10-1 to 10-6). Such configurations are described in U.S. Provisional Application No. 60 / 833841, filed July 28, 2006, which is incorporated herein by reference in its entirety.

[0118] In other embodiments, various materials can be co-molded in the same mold to provide a one-piece, integral structure. For example, instead of providing a cover or sock for a pipe, a fabric or cloth material can be co-molded with a silicone pipe to provide a one-piece, integral tube with a fabric / cloth exterior and a silicone interior. In such embodiments, the fabric / cloth material can be placed in a mold, and then silicone can be poured into the same mold to bond with the fabric / cloth material and form a one-piece, integral tube.

[0119] In other embodiments, multiple parts of the patient interface can be co-molded from various materials using the same mold to provide a single, integrated structure. For example, a fabric material can be co-molded with piping constructed from a first material, a manifold constructed from a second material, and a frame constructed from a third material to provide a single, integrated structure. In one embodiment, the first, second, and third materials may be the same material with different durometers or hardnesses, for example, piping constructed from relatively flexible silicone and manifolds and frames constructed from relatively hard silicone. Alternatively, the first, second, and third materials may be different polymers or materials. Furthermore, each part of the patient interface may include regions with different properties; for example, the end portion of the piping may be harder than the middle portion of the piping. In these embodiments, fabric / textile material can be placed in one mold, and then the first, second, and third materials can be poured into the same mold, resulting in all materials being joined together to form a single, integrated structure, such as a pipe, manifold, or frame with a fabric / textile cover.

[0120] In other embodiments, the piping, rigidity elements, manifolds, and / or backstraps may include silicone or other elastic beading for gripping. Such configurations may be particularly useful for bald patients, as the beading is adapted to grip a bald head and prevents the interface with the patient from sliding or moving against the patient's head during use. In one embodiment, the interface with the patient can be reversible so that the beading can be used selectively, for example, depending on whether the patient is bald or not. For example, the fabric may be provided on one side and the beading on the other, so that the patient can use one or the other side as they prefer, for example, with the beading facing the patient's head for a bald head and the fabric facing the patient's head for a hairy head.

[0121] 1.7.1.4 Manufacturing In one embodiment, each tube 42 can be manufactured as a branched tube having a co-formed thick portion that forms a rigidizer.

[0122] In other embodiments, each tube 42 can be constructed in two parts, namely an upper half and a lower half attached to the upper half. In one exemplary embodiment, the upper half can be constructed from a textile or foam (for example, together with a sealing layer), and the lower half can constitute a rigidizer together with the portion that comes into contact with the skin.

[0123] 1.7.2 Not being too much of an eyesore The patient interface may incorporate one or more areas with different colors (color contrasts), patterns, and / or surface textures to reduce or make them less noticeable to the user. Such coloring, patterns, and / or surface textures can be incorporated into piping, rigidity elements, manifolds, backstraps, and / or interface structures. Alternatively, socks with coloring, patterns, and / or surface textures can be provided as the patient interface.

[0124] For example, Figures 10-1 to 10-6 illustrate a patient interface including a cover or sock S having a two-color scheme, for example, a dark color D and a light color L. Such a patient interface is described in U.S. Provisional Application No. 60 / 833841, filed July 28, 2006, which is incorporated herein by reference in its entirety. As shown, the dark color D is positioned adjacent to the field of vision. Such a placement provides a visually inconspicuous, low-impact, unobtrusive, and smooth appearance for the patient and others.

[0125] Specifically, bright colors are more noticeable than dark colors; for example, bright colors reflect light into the patient's eyes, making them more easily noticed and therefore should be avoided in the patient's field of vision. Therefore, dark colors D are placed adjacent to the field of vision to be as unobtrusive or inconspicuous as possible. In one embodiment, the patient only sees the interface at the outer boundary of their field of vision, for example, only the portion of the interface below the patient's eye level. Furthermore, dark colors D appear to disappear at the edges of the field of vision, and as a result, are less distracting to the patient.

[0126] Furthermore, the two-color textile cover S can reduce the perception of the dimensions of the patient interface on the patient's face. That is, such a configuration has the functional advantage of being able to incorporate a lighter color, such as white, into the cover, making the relevant area appear smaller, thinner, or less bulky. Thus, the patient interface has a less visual impact (e.g., it is less visually jarring). Moreover, the patient interface can be made more fashionable, like clothing. In an alternative embodiment, one or more light-colored lines, such as white lines, can be incorporated into the cover. Also, in one embodiment, the interface surface of the interface structure can include a darker color to make it less visually jarring.

[0127] It should be understood that a variety of colors, patterns, and / or surface textures can be selected for different users. In one embodiment, the cover may be transparent, or a color that harmonizes with the patient's skin, such as a camouflaged color or a skin-tone color. For example, if the patient's skin tone is relatively dark, the cover may be black or dark brown to harmonize with the patient's skin. In an alternative embodiment, the color and / or fabric of the cover may be selected to match the patient's hair.

[0128] 1.7.3 Valve In one embodiment, as shown in Figure 11-1, a valve V, for example, a mechanical gate adapted to open when both tubes 42 are blocked, can be provided at the interface with the patient. For example, valve V can remain closed when the internal pressure Pint is greater than 2 cmH2O and open when the internal pressure Pint is less than 2 cmH2O, thereby allowing the patient to breathe when both tubes 42 are blocked.

[0129] 1.7.4 Connection to the blower In one embodiment, the patient interface 10 can be connected to a blower by a pair of air delivery tubes, namely a 15 mm tube and a 22 mm tube. As shown in Figure 1-2, the 15 mm tube T1 connects the manifold 70 to the 22 mm tube T2, and the 22 mm tube T2 connects the 15 mm tube T1 to the blower. A quick-release connector 90 is provided at the transition between the 15 mm tube T1 and the 22 mm tube T2 to allow for quick release of the 15 mm and 22 mm tubes T1 and T2, and thus quick release of the patient interface 10 from the blower. In an alternative embodiment, the quick-release connector can be provided on the manifold 70 located adjacent to the top of the patient's head. The quick-release connector can have an appropriate structure, such as a mechanical interconnect, friction fit, or screw mechanism, to facilitate assembly / disassembly of the piping. Various connection points facilitate assembly / disassembly of the patient interface system, and as a result, facilitate cleaning, adjustment, etc.

[0130] The 15mm tube T1 has an appropriate length to allow the patient to easily access the quick-release connector 90, for example, a quick-release connector 90 that is in the patient's field of vision. The 15mm tube T1 also has an appropriate length to position the quick-release connector 90 sufficiently far from the interface with the patient, so that the weight of the quick-release connector can be supported by the bed mattress or other support system.

[0131] To minimize resistance in the system, the treatment does not change significantly whether one or both ends of tube 42 are open. Accordingly, the system is designed so that a fluid pressure limit or bottleneck is provided upstream of the interface with the patient, including when only one end of tube 42 is open, i.e., the fluid pressure bottleneck is provided in or upstream of the manifold 70 (e.g., in the 15 mm tube and / or the 22 mm tube).

[0132] Resistance is based, at least to some extent, on the length of the tube. In the illustrated embodiment, the piping is designed such that tube 42 is shorter than the 15mm tube and the 22mm tube, for example, at least 40-50cm in length. In one embodiment, the 22mm inlet tube may be about 2m long and the 15mm inlet tube may be about 70-75cm long, and the bottleneck is in the 22mm inlet tube due to its length. However, other suitable lengths are possible.

[0133] In one embodiment, the air delivery piping connected to the manifold may have a similar appearance and feel to the inlet tube 42. The air delivery piping may have a smooth, noise-free outer portion, for example, an outer portion constructed from a material that provides flexible sound insulation. The air delivery piping can provide a continuity of shape from the PAP device or blower to the manifold interface with the patient.

[0134] 1.7.5.1 Clips to prevent the tube from dragging A clip or clamp can be provided for the air delivery tubes T1, T2 and / or quick-release connector 90, adapted for attachment to the bed headboard or other support system. The clip or clamp supports the air delivery tubes and / or quick-release connector on the bed headboard or other support system to prevent the interface with the patient from dragging the tubes. In one embodiment, the clip or clamp may be magnetic to allow for magnetic attachment.

[0135] For example, Figure 12-1 shows a quick-release connector 90 attached to the headboard by magnetic force, Figure 12-2 shows a clip 92 adapted to attach tube T1 to the headboard, and Figure 12-3 shows tube T1 clipped to the interface with the patient.

[0136] 1.7.5.2 Switch to turn CPAP treatment on / off A switch can be provided along an appropriate part of the patient interface, adapted to turn the blower providing CPAP therapy on and / or off. For example, the switch can be provided on the air delivery tube or quick-release connector. In one embodiment, the switch can communicate wirelessly with the blower.

[0137] 1.7.6 Inflatable Headgear In an alternative embodiment, an inflatable tube can be provided around a relatively rigid air delivery tube to insulate the air delivery tube from the patient's face.

[0138] 1.7.7 Movable Tube In an alternative embodiment, a tube can be provided that is adapted to move out of its path when the patient's head changes direction.

[0139] 2. Interface Structure 2.1 Background and Overview Interfaces with known patients typically involve silicone seals adapted to seal around and / or inside the patient's nose and / or mouth. Sealing mechanisms can be classified into (1) flap-type seals, (2) bulk compression or gasket-type seals, or (3) combinations of (1) and (2). Flap-type seals can utilize a flexible membrane mechanism to achieve a reliable sealed interface. Compared to flap-type seals, which operate by the deflection of the flap, bulk material seals operate by the compression of the material. The preferred interface structure of the present invention utilizes a foam in the form of a bulk compression-type seal, although the foam can take other forms.

[0140] One aspect of the present invention relates to an interface structure 20 in the form of an interface 80 with the subnasal area made of foam (see, for example, Figures 1-6, 1-8, 1-10, 13-1, and 13-2), the interface 80 with the subnasal area providing effective and comfortable engagement with the underside of the patient's nose during use. In some embodiments, the interface with the subnasal area may be in the form of a cup-shaped receiving portion, prongs, or a pillow. The foam interface 80 can be supported by a support and / or frame or shell adapted to communicate with each of the tubes 42 of the air delivery and stabilization system 30 described above.

[0141] For example, as shown in Figures 1-6, 1-8, and 1-10, a foam interface 80 can be provided to a relatively rigid shell or frame 22 formed from, for example, silicone, which includes a tubular portion 25 fitted to engage with each end of a tube 42, for example, by friction fitting.

[0142] In other embodiments, as shown in Figures 13-1 to 13-2, the foam interface 80 can be provided on a cylindrical support or base 82 constructed from, for example, silicone, the cylindrical support 82 being adapted to be mounted on a relatively rigid frame (not shown) adapted to engage with each end of the tube 42. The cylindrical support 82 may have a structure substantially similar to the base portion (without the nozzle) of a nozzle assembly described in Patent Document 4, which is entirely incorporated herein by reference. The flexibility of the cylindrical support 82 improves the compliance of the interface. The cylindrical support 82 may have a split base for connecting to channels in the frame. In one embodiment, the interface, cylindrical support, and / or frame can be adapted to rotate in order to further improve the compliance and / or adjustment of the interface. In one embodiment, rotational adjustment and positioning can be maintained by the use of friction, intermittent feeding, and locking mechanisms.

[0143] In the illustrated embodiment, the foam interface 80 can be constructed from a highly flexible foam that is compliant enough to gently support the patient's nose and provide an inconspicuous and comfortable interface with the nose, for example, a foam interface with the subnasal cavity. The foam interface with the subnasal cavity makes the nasal prongs visually invisible and inconspicuous without the intrusion and potential discomfort of silicone prongs inside the patient's nose.

[0144] One problem that has emerged with the widespread adoption of nasal prong interfaces is that, specifically, when inhalation and pressure are higher, and air passes through the nose more quickly, the forceful passage of air can cause a noticeable decrease in breathing comfort, resulting in a cold, frictional, or burning sensation inside the nose. This sensation is called the "jetting effect." The jetting effect is thought to be partly caused by air entering the nose through channels that pass through the narrow orifice of the prongs and colliding with the sensitive nasal mucosa. Air temperature and humidity can also be contributing factors. Therefore, another advantage of a subnasal foam interface is that it eliminates or minimizes the jetting effect known to occur with nasal prongs. This is because air is not forced through narrow orifices inside the nostrils but passes through larger orifices that cover the openings of both nostrils. By leaving all or most of the foam interface's exit outside the nose, the resistance (impedance) from the small orifice can be made comparable to or lower than that of the nasal opening, resulting in the flow not being confined to the inside of the nose and thus not forming a jet. The foam also has a diffusing effect at its boundary when the flow enters the nose. Its uneven surface can add turbulence to the boundary layer of the flow entering the nasal cavity, thus passing through the nasal cavity without applying concentrated force to the sensitive anatomical structures inside the nose. Its diffusing effect can also make the alignment of the interface with the nasal cavity less important in terms of generating the effects of a jet. The foam, which allows a small amount of air to pass through, also has the advantage of minimizing the aspects of the effects of a jet caused by humidity and temperature. Cold air and air of varying temperatures entering and leaving the nose can cause a tingling sensation inside the nose with known interfaces. When exhaling, warm exhaled air can be blown into the foam, and when inhaling thereafter, this small amount of warm air can heat the airflow that enters again and / or into the nose, thus reducing the effects of the jet. Another advantage of this foam in relation to the effects of the jet is its ability to retain moisture (e.g., humid air) due to its permeability.The stored moisture, when drawn in, is added to the humidity of the intake air, which can reduce the effects of the jet.

[0145] In other embodiments, the interface with the subnasal region may have a central portion that divides a single orifice into two. In this embodiment, the resulting two orifices may be of a size comparable to, smaller than, or larger than the nostrils.

[0146] In both of the above embodiments (single orifice and double orifice), the alignment of the nostril and the orifice can be relaxed compared to the design of nasal prongs. This is a result of not actively inserting the component (feature) into the interior of the nostril. The interface can move significantly along the surface of the skin without damaging the interface and / or seal. As a result of the very low hardness of the foam (e.g., specifically a very flexible viscoelastic grade), the foam may penetrate slightly into the interior of the nostril as it takes the shape of the anatomical structure it is in contact with.

[0147] In a preferred embodiment, the interface can be made from a highly flexible, viscoelastic foamed polyurethane grade. One way to quantify the viscoelastic properties of the foam is to measure the deformation rate or recovery rate of the foam after applying pressure to it. In one embodiment, the recovery rate is designed so that the interface remains comfortably sealed and engaged with the user's face while the mask is worn. The viscoelastic properties have a particular advantage in maintaining comfort and seal while moving while wearing the mask. In other embodiments, the viscoelastic range may extend from foams with very slow recovery rates to foams with very fast recovery rates.

[0148] Another aspect of the interface structure according to a preferred embodiment of the present invention is that it has a relatively slow recovery speed compared to known interface structures. Silicone or other rigid elastomer cushions have a relatively fast recovery speed of about 5 to 10 cm / second or more. In one embodiment of the present invention, the interface structure has a recovery speed slower than about 5 cm / second. In a preferred embodiment, the recovery speed is about 1 cm / second.

[0149] The recovery speed can be measured by placing a sample of bulk material between a rigid bottom plate and a rigid, lightweight top plate. The bulk material is compressed to move the top plate downwards by a predetermined distance, and then released. The time it takes for the bulk material to raise the top plate back to its original position is measured. Since the time it takes to return to the original position varies depending on the weight of the plate, the measurement is only relative. The recovery speed is equal to the thickness of the foam divided by the time it takes to return to its original position. Relatively fast recovery speeds occur in less than one second.

[0150] The preferred type of foam was measured using the recovery rate test described above, and a very lightweight top plate (of rigid foam) was used so that the weight of the top plate could be ignored. A block of foam sandwiched between two plates was 5 cm thick, and it was pressed down by hand until it was about 1 cm thick. It took 3.5 seconds to return to its original shape. This corresponds to a recovery rate of about 1 cm / second. In comparison, a typical conventional silicone film returned to its original shape in less than half a second.

[0151] A relevant material property is hysteresis. Referring to Figure 14-1, another preferred embodiment of the present invention is a material exhibiting hysteresis of 25 to 35%.

[0152] It should be understood that the interface with the area under the nose can be constructed from other materials that form a cellular polymer structure, such as polyethylene, polypropylene, silicone, and latex rubber.

[0153] It should also be understood that the interface with the subnasal area can be constructed from other suitable types and configurations of materials, such as textile-coated foam, textile, textile layer, silicone (e.g., a double-walled silicone interface with a membrane and undercushion), and silicone foam.

[0154] In other embodiments, the foam interface features a foam that functions as an HCH (Hygroscopic Condenser Humidifier) ​​or HME (Heat and Moisture Exchanger). This allows heat and moisture to be captured from and returned to the user's airway, improving the breathing comfort described above in relation to the effects of the jet.

[0155] Due to the porous moisture absorption and retention properties of the foam, a scented, vaporized liquid can be added to the interface before or during its application. Such a fragrance may or may not have an inherent therapeutic effect. The mechanical properties of the foam (e.g., pore size, surface tension) can be modified to control the evaporation rate of the scented liquid. Similarly, the drying efficiency of the foam can be adjusted.

[0156] 2.2 Characteristics of Bulk Materials In the illustrated embodiment, the foam interface 80 is a highly flexible, pliable, viscoelastic foam (e.g., modified slab material) having the properties defined in Figure 14-1, providing a soft and comfortable feel against the patient's skin and a hardness or rigidity similar to the flexible, thick anatomical structure of the patient's face. The hardness is ideally more flexible than the thick anatomical structure of the face, provided that sufficient stability and sealing force are provided by the patient interface design. The interface's hardness being more flexible than the anatomical structure it borders maximizes comfort by allowing minimal pressure on the face to enhance the interface against the user's airway or increase pressure (i.e., low hardness and high viscoelasticity reduce contact pressure and maximize conformability to the shape of the patient's face (shape-forming ability)). The dynamics of the interface can also be improved so that it conforms more closely to the anatomical structure of the face than an interface that deforms the face, for example, so that the interface can accommodate relatively small facial features on the patient's face (e.g., facial wrinkles and features, contours, etc., the size of a golf ball indentation).

[0157] The foam interface provides a fixation seal that allows lower strap tension from the headgear to generate a sealing force, and a motion seal that allows the interface to withstand larger movements, such as when the patient turns over in bed, and maintain its integrity. The characteristics of such an interface are described in more detail below.

[0158] Compared to conventional silicone interfaces, which can have a sweaty, plastic-like feel, viscoelastic foams have a more natural feel against the patient's skin. The foams can contain moisture and, for example, may be slightly damp or moist after use or washing, thus providing a cooling effect or refreshing sensation as air passes through the foam during use.

[0159] In one preferred embodiment, the foam interface 80 may be a low isocyanate index polyether foam polyurethane having low hardness, low to high density, flexibility, mild odor, low breathability, low elasticity, a fine heterogeneous cell structure, and viscoelastic behavior. The foam is also characterized by color and colorfastness to the Pantone standard. Furthermore, the foam can provide a water-absorbing function to draw moisture or sweat from the patient's skin. In one embodiment, the properties of the foam interface may vary along its thickness, for example, the density, porosity, or hardness of the foam may vary in different layers, and / or the properties of the foam interface may vary along its outer periphery, for example, breathability may vary in different regions of the outer periphery of the interface. Viscoelasticity is the range of recovery of the foam interface from compression.

[0160] For example, Figures 13-3 to 13-4 show a foam with a mixture of heterogeneous cell structures, and Figures 13-7a and 13-7b show a foam with layers of heterogeneous cell structures. Figures 13-7a and 13-7b also show how the properties of the foam change in different layers. As shown in Figures 13-7a and 13-7b, the foam may contain three layers, namely layers with small, medium, and large cell dimensions. In Figure 13-7a, the layer with small cells is near the surface, and the cell layers gradually increase in size towards the interior, while in Figure 13-7b, the layer with large cells is near the surface, and the cell layers gradually decrease in size towards the interior. However, these layers can have an appropriate arrangement; for example, the medium-sized layer may be near the surface, and the small and large layers may be closer to the interior. Such an arrangement of cell structures can be achieved by selecting a manufacturing method.

[0161] FIG. 13-7c shows a foam containing therein a reinforcing element R constructed, for example, from a stiffer foam, plastic, or metal laminate. The reinforcing element R is configured to impart rigidity to the foam in use. The foam portions on each side of the reinforcing element can include a homogeneous structure (as shown in FIG. 13-7c) and / or a heterogeneous structure (layered or mixed). In a preferred embodiment, the reinforcing element R can be located on a face of the foam interface that does not contact, for example, the bottom / face. In this way, the reinforcement can provide both of two functions, namely, reinforcement and a means for attachment to the mask (e.g., mechanical interference fit, Velcro®, pressure-sensitive adhesive).

[0162] FIG. 14-1 shows a table of the mechanical properties of a foam interface according to an embodiment of the present invention.

[0163] One aspect of a preferred embodiment of the present invention is a low-hardness foam (or other flexible material) of a sealing structure. The hardness can be defined in terms of both indentation hardness and compression hardness. The preferred indentation hardness is from 25 to 80 N at 40%, and the preferred compression hardness is from 0.4 to 1.5 kPa.

[0164] A foam interface according to an embodiment of the present invention can also include, to some extent, one or more of the following features.

[0165] Cellular foam type - flexible polyurethane;

[0166] Type of polyurethane - polyether-based;

[0167] In order to control the feel (also known as "tactility") and appearance of the cell structure - foam, it is desirable to control the cell structure. The cell structure can be controlled to have a more heterogeneous or more homogeneous distribution of cell sizes, thereby affecting the feel and appearance of the foam in various ways. The foam can be manufactured to have a cell structure that contains varying degrees of closed cells and open cells, which may affect some aspects of the properties of the foam, such as the permeability of air and moisture.

[0168] Sealing - A foam with a high content of closed cells can have a sufficiently low permeability so that it can create a positive pressure seal inside the interface when applying pressure to the skin. In one embodiment, the foam can contain significantly more closed cells than open cells, for example, 90% closed cells and 10% open cells. Thus, the compressive force exerted by the foam on the seal is a function of the mechanical firmness of the foam and also a function of the compressive firmness (e.g., air spring / air pressure firmness) applied by having compressed air inside the cell structure of the foam. In this way, a small, slow flow of air is allowed to leak along the surface of the foam structure and through its body while still providing the sealing function. In some embodiments, the foam has a cut open - cell structure that contacts the skin, while other embodiments can include a foam with a permeable outer skin. Other embodiments can have a foam that is coated (both permeable and impermeable outer skins) only on the surface of the interface that contacts the skin, leaving a flow through the body of the foam structure rather than along the surface where the skin contacts.

[0169] Permeability - Foams with a controlled range of permeability can be produced. Typically, in sealing applications, the foam will be produced to have the maximum possible closed-cell content, which is possible to prevent air or moisture from passing through the foam. In one embodiment, it may be desirable to allow a relatively small amount of permeability. This has several distinct advantages in terms of both interface comfort and sealing function when worn, for example, by allowing a small amount of diffuse flow through the foam, it gives the part of the skin in contact with the interface the ability to breathe and allows excess moisture to be removed from the interface during use.

[0170] Persistence of Permeability - Since flow through all elements of a mask system may be required to meet a given specification, it is desirable to maintain a desired level of permeability throughout the service life of the components. Changes in permeability can occur with periodic mechanical compressive loads, and therefore, measurements taken to improve the permeability persistence of the foam structure are beneficial. In a preferred embodiment, a polyurethane compound using an MDI (methylene-bis-di-Isocyanate) type isocyanate can be selected to give the foam a persistent closed-cell content.

[0171] Odor / Volatility - Since foams are intended to be used in close contact with the human nose, the ability to measure odor to minimize or selectively modify it is an advantage. In one preferred embodiment, polyurethane formulations using MDI (methylene bis-diisocyanate) type isocyanates are a preferred choice for minimizing odor.

[0172] The chemical properties and processing of the foam are selected so that the particulate matter components do not generate fine particles that may be inhaled during use.

[0173] Texture / Feel - Producing foams with a silky, supple feel offers aesthetic advantages. In preferred embodiments, the foam can be produced to have a heterogeneous cellular structure of microcells to maximize the smooth feel of the foam, which can also help minimize the possibility of skin abrasion and irritation. Another aspect of the foam's mechanical properties that can contribute to its aesthetic appeal is that it can be produced to have a high level of viscoelasticity, which gives the foam interesting interaction properties.

[0174] Durability - The chemical properties of the foam can be selected to maintain the desired mechanical properties for the required shelf life and service life of the components (for example, the structure of the foam can be manipulated to have a predetermined service life from single use to long-term use). This provides the advantage of providing users with a product that can be renewed at an appropriate replacement frequency, thereby allowing the components of the foam to be replaced daily, weekly, monthly, or on other criteria. Components packaged in predetermined multiples can then be supplied to the user, for example, every three months, every six months, every twelve months, or on other appropriate criteria.

[0175] Thermal Stability - The foam can be designed to withstand the thermal conditions of storage and transport. It can also be designed to withstand the temperatures of disinfection and sterilization treatments (e.g., autoclave temperatures and, in some cases, temperatures up to 180°C).

[0176] UV Stability / Light Resistance - The foam material is not easily damaged by exposure.

[0177] Swelling Resistance - The components of a foam can be designed to have a given swelling resistance when saturated with water or other liquids. Depending on the desired characteristics of the foam in the saturated state, it can also be designed to minimize or maximize changes in shape (for example, swelling may be desirable to open the pores of the foam for cleaning, or undesirable to preserve the functional shape in the saturated state).

[0178] Dryability – Foam components can be designed to dry under specific time constraints and environmental conditions. For example, components may be damp after use or cleaning procedures, and therefore it may be desirable for them to dry as quickly as possible before further use. For example, under certain usage conditions (a cold sensation on the skin in hot conditions), moisture in the interface may be desirable, and therefore it may be advantageous for components to retain moisture for a longer period. For example, components can be designed to dry during use (auto-dry) by air passing through the material under pressurized conditions, such as during CPAP therapy.

[0179] Hydrolysis Stability - The formulation of the polyurethane foam can be selected to give the foam a desired level of hydrolysis stability. The choice of polyether polyols over polyester polyols can improve the hydrolysis resistance (mechanical breakdown in the presence of moisture) of the foam.

[0180] Color - The components of the foam can be colored according to a defined Pantone standard (e.g., PC287).

[0181] Discoloration Resistance – A key challenge in the use of foams is discoloration due to both natural aging and environmental factors during use. This is particularly problematic with natural and light-colored foams. One way to counteract discoloration is to intentionally color the foam with a color that does not change very noticeably with aging and use (e.g., darker and more intense colors may discolor less). In other words, coloring the foam has functional properties in maintaining the usefulness and cleanliness of the recognized components throughout its service life. Another problem that may arise is the leaching of dyes or pigments that are removablely contained in the foam structure. In preferred embodiments, highly reactive colorants are incorporated so that the colorant reacts with the chemical structure of the foam to become part of the polyurethane chemical background (e.g., Reactint® colorants from Milliken Chemical). This gives the foam a significant advantage in applications where resistance to discoloration is intended so that the product looks good upon initial use and remains unsightly during continued use.

[0182] Packaging of slab materials - Slab foam can be packaged and sealed in plastic for transport and storage.

[0183] Packaging and Distribution Methods of Components - Components of a foam interface can be designed to have a predetermined service life. In this case, the components may need to be replaced more frequently than currently known in the industry. To facilitate replacement, components can be packaged so that multiple components are included in one package (e.g., box or container). For example, a box or container of components may contain 50 components, 100 components, and may include components for monthly supply, components for yearly supply, or other appropriate criteria. Components can be individually packaged and manufactured as part of a continuous perforated strip and supplied in a single package (e.g., one foam interface in a single package similar to a condom wrapper with two sides sealed along its outer circumference). Components can be placed in cells of grouped or individual components. In one embodiment, significant advantages are obtained by vacuum packaging the components. These forms of packaging offer protection against aging from environmental factors (e.g., oxygen, humidity) and the ability to supply components in a customized microenvironment (e.g., inert gases to prevent aging, scented gases for therapeutic and non-therapeutic purposes, color, flavor). Vacuum packing offers the significant advantage of reducing the physical volume of the product for transport efficiency and handling convenience. The foam can be compressed for extended periods of several weeks or months and returned to its uncompressed shape when the packaging is opened. Figure 14-3 is a schematic diagram of a continuous flow in this direction, adapted to dispense individual packaging P containing the foam interface, for example, separated by perforations so that it can be separated by perforations. However, the components can be separated by other suitable, foldable or breakable connections.

[0184] Machinability - The foam can be made sufficiently dense and hard so that it can be machined into complex three-dimensional shapes.

[0185] Biocompatibility – Biological safety (biocompatibility) is of paramount importance for the primary intended use of foams. Therefore, they must not release harmful volatile substances or have harmful or irritating interactions with the human body. The chemical properties and processing of the foams are selected to produce foams that comply with ISO 10993 biocompatibility standards.

[0186] Microbial Growth - The structure of foam can create an environment that allows for the potential growth of microorganisms (e.g., bacteria, fungi) near the nose, especially in warm and humid conditions. Means that can suppress the growth of fungi and bacteria may be desirable to maintain cleanliness and / or extend the service life of the components. Typically, this can be achieved by using non-porous materials or coated porous materials that are minimally absorbent and easily washable for components that come into close contact with the user. However, in the use of cut or open-cell structures (e.g., cut foam) exposed to the face (as outlined in this disclosure), there are significant advantages in terms of comfort and sealing performance during use, so other methods must be sought to address the cleanliness and service life of the components. In some embodiments, the components of the foam interface are configured to be replaced at an appropriate frequency (e.g., daily, weekly, monthly, or other appropriate regime). Appropriate cleaning and maintenance regimes may also be recommended for the components (e.g., washing, drying, cleaning solution (e.g., isopropyl alcohol), steam treatment, microwave sterilization). Another method to inhibit microbial growth is to include antimicrobial or bactericidal agents (e.g., the AEGIS brand, which is bactericidal against polyurethane foam) in the chemical properties of the foam.

[0187] Recyclability / biodegradability - Since the foam interface is a frequently replaced component, the grade of the foam can be selected to be decomposable within a selected time limit in order to minimize the impact on the environment. This can be described as the half-life of the substance for decomposition in a landfill. In one embodiment, the foam is designed to decompose within a much shorter time limit than substances known in the art (e.g., silicone, coated porous structures, gels). This can be achieved by enhancing the chemical properties of the foam and the porous structure of the foam to allow for the intrusion of microorganisms that assist in landfill waste and foam decomposition. Another important advantage of the foam in minimizing environmental impact is that the substance is much softer and much lower in density than typical substances known in the art, which means that the substance can be easily compressed and takes up much less space in a landfill.

[0188] As described above, the components of the foam interface are available separately and / or in boxed sets or cartons. Such configurations allow for a wide range of distribution channels and are commercially available, for example, through home healthcare providers, pharmacists, the Internet, etc.

[0189] In one embodiment, when the interface component wears or needs replacement, the patient can also order the box when needed, and replacement boxes (e.g., containing the commonly used interface components) can be sent to the patient regularly. For example, the patient can go through the procedure to receive monthly deliveries for a year.

[0190] Such configurations provide repetitive operations for home healthcare providers. Also, this configuration enhances the efficiency of the assembly line since the assembly step (i.e., attachment of the interface component to the frame) is transferred to the patient. By adapting this configuration to perform manufacturing locally, transportation can be reduced. Furthermore, this configuration can bring advantages to sleep laboratories since there is no need to sterilize and only disposable interface components are used.

[0191] In one embodiment, the packaging of the components may reflect replacement or reordering requirements. For example, the last product in a box may be packaged differently to indicate that it is the "last of the supply." In other examples, the packaging may include different colors to indicate different days, weeks, months, etc.

[0192] As described above, the structure of the foam can have a certain service life or lifespan. According to embodiments of the present invention, the structure of the foam may include an end-of-service-life indicator to show that it is approaching the end of its service life.

[0193] For example, the end-of-life indication may include one or more of the following: pH-based discoloration (microorganisms producing acid that causes discoloration during the replacement cycle), soiling / color change, environmental aging (releasing environmental gases from the packaging), adhesive degradation over time (glue is more adhesive than glue, providing a single assembly and therefore preventing the patient from removing the components without damaging them), and / or including a color guide on the packaging to match components to see if replacement is needed.

[0194] 2.3 Surface Properties The foam interface 80 can be manufactured (for example, from a free-rise slab) to have a coated surface or an uncoated cut surface. Since the foam has a cellular internal structure, when the foam is cut (e.g., die-cut), the open-cell structure is exposed. The cut open-cell structure on the skin-contacting surface of the interface has different performance characteristics compared to a coated foam, specifically when used as an interface with a patient. For example, Figures 13-3 and 13-4 show a foam interface 80 with an uncoated cut surface CS, and Figures 13-5 and 13-6 show a foam interface 80 with a coated surface SS. As shown, the cut surface CS in Figures 13-3 and 13-4 exposes the cellular structure of the foam, exposing, for example, bubbles and pinholes. In contrast, the coated surface SS in Figures 13-5 and 13-6 hides the cellular structure of the foam, being a smooth outer surface in which, for example, neither bubbles nor pinholes are exposed.

[0195] 2.3.1 Comfort Specifically, foams containing a sliced ​​cell structure (see, for example, Figures 13-3 and 13-4) on the surface that borders or contacts the patient's skin have a different feel to the skin compared to silicone materials, which are used almost without exception in this industry. Furthermore, foams can be designed to have a very pleasant, comfortable tactile property, without the stickiness or plastic feel of silicone. There is a correlation between the cellular structure of the foam and the comfort to the patient's skin. Foams can be produced with a coarse cellular structure to a very fine cellular structure and a homogeneous or heterogeneous distribution of cell dimensions. These properties can be controlled through the manufacturing process. In one preferred embodiment, a heterogeneous cellular structure containing many fine-sized cells may be preferred to maximize comfort to the patient's skin.

[0196] 2.3.2 Sealing and / or gripping function The cut cell surfaces of the foam (see, for example, Figures 13-3 and 13-4) provide sealing and / or gripping. The foam can be mechanically deformed and engage with the patient's face to provide sealing, for example, and can also grip the skin sufficiently so that it does not come off (e.g., impair the sealing) under minute movements (i.e., less than 1 mm). The cellular cut structure provides gripping (e.g., gripping by friction), and its cellular cut structure can be improved by combining the high flexibility and viscoelasticity of the foam grade with a "more moist" feel. If sealing and / or gripping comes off, the sealing and / or gripping properties should ideally be easily restored without the need to re-interface with the patient's face. An example of a preferred foam may be a very flexible, low (isocyanate) index foam having a moist, sticky and / or moist feel. The "stickiness" or "moisture" of the foam can allow it to slide along the patient's face without substantially breaking the seal (e.g., a "crawling" seal). That is, the position of the seal can be shifted without losing contact with the patient's face and without losing substantial therapeutic pressure. The degree of grip or stickiness can be determined, at least in part, by the surface tension (e.g., coefficient of static friction) and / or the shape of the cross-section (e.g., roughness).

[0197] 2.4 Shape The foam interface 80 can generally have a cradle shape (i.e., curved in one direction) or a saddle shape (i.e., curved in two directions). Depending on the intended function of its shape, the interface may also have a configuration of three or more curves and complex curves to correspond to, coincide with, or intentionally not coincide with specific anatomical regions.

[0198] In the illustrated embodiment, the upper surface of the foam interface 80 provides a saddle shape including two curvatures to facilitate engagement of the patient's nose and its orifice. For example, the curvature in the first direction (see, e.g., the front view in Figure 15-1) is configured to accommodate the anatomical structures that form the alae angle of the patient's nose, and the curvature in the second direction (see, e.g., the side view in Figure 15-2) is configured to accommodate the anatomical structures that form the nasolabial angle of the patient's nose. The degree of curvature in both the first and second directions can be interchanged if it adds thickness (lamination) to the interface and compliance in the mechanical properties of the interface, for example, if the interface has sufficient flexibility and thickness to comfortably and effectively cradle, engage, and seal the intersecting (e.g., nose and face) anatomical structures, the first and second curvature directions can be eliminated.

[0199] In alternative embodiments, the mechanical properties of the foam can be adjusted (e.g., made flexible) so that the interface effectively seals by utilizing a shape with a flat top surface (without curvature in the first and second directions as described above).

[0200] In other embodiments, the curvature and shape of the foam can be provided by a frame, backing, or other support structure to which the foam is attached.

[0201] Most sealing interfaces known in the art (specifically, silicone interfaces) are membrane-like. They are long, thin, and flexible. The cross-section of the membrane has a high aspect ratio (length divided by width or thickness), and therefore, combined with the flexibility of the membrane material, it easily deforms along its length and bends along its width. Because the membrane deforms easily and cannot support compressive loads in its longitudinal direction (the material deforms before it shrinks), it typically does not shrink along its length. This ability to deform and bend allows membrane-type sealings to conform to and adapt to the changing anatomical structure of the face, specifically when (typically) tangential to the face. It is known that the air pressure inside the mask provides a supporting reaction force to the membrane in contact with the face.

[0202] The interface with the subnasal region according to one aspect of the present invention is not a membrane and does not operate as such. Its cross-sectional shape has a low aspect ratio and is generally square, oblong, rectangular, or diamond-shaped, as shown in Figures 15-1 to 15-2. In other embodiments, the cross-section may be circular, elliptical, or other more organic shapes, depending on what can be given by the manufacturing process. Since the cross-section of the interface is not long or thin, it does not operate as a membrane but operates as a compression seal. Thus, rather than relying on the ability to deform to conform to the face (tangentially) as in conventional membrane seals, it relies on flexibility and compliance in the direction perpendicular to the face so that it conforms to the anatomical structure of the face it borders. The interface of the subject also does not rely so much on the air pressure that supports the interface structure and / or forms the seal. The very thick cross-section, along with the circular or annular profile, means that it is almost self-supporting, and as mentioned above, if the foam seal structure is permeable, the compressive force is incrementally a function of compressed air (stiffness of the air spring). The interface may deform outward due to the positive air pressure inside the mask chamber. This deformation is a property that can facilitate the interface's engagement with the anatomical structure it borders; for example, the shape of the interface can change under pressure to more closely conform to the shape of the patient's face.

[0203] 2.5 Thickness In one embodiment, the foam can be deformed to have the effect of cradling or wrapping around the base of the patient's nose, with a thickness of approximately 5 to 20 mm, for example, 15 mm, depending on the hardness and viscoelasticity of the foam. In other embodiments, the thickness can be varied to suit the number of foam layers constituting the sealing interface and the mechanical properties (e.g., hardness) of each layer, for example, 5 to 50 mm, 10 to 30 mm, or 14 to 20 mm. For example, the thickness of the skin-contacting layer of the foam can be very flexible and very thin (e.g., 1 to 3 mm), while the fitting layer can be harder and thicker (5 to 20 mm). A harder and similarly thin or thinner (e.g., thinner than 1 mm) layer of foam can act as a layer that functions as an attachment mechanism.

[0204] The thickness of the foam, along with its stiffness, can determine the mechanical compliance of the interface. More flexible foams, combined with greater thickness, can specifically add mechanical compliance and a wider range of fit compared to silicone sealants known in the art. The density, stiffness, and thickness of the foam can be controlled to achieve an interface that delivers therapeutic pressure and provides a comfortable fit without completely compressing the provided foam thickness. A clear advantage over other interfaces known in the art due to the tolerance and compliance properties of the foam is the possibility of dimensional integration, and even providing a free-size interface. That is, the flexibility and compliance of the material used in the interface can allow the interface components to fit a much larger number of people with the same or fewer dimensions.

[0205] 2.6 Orifice In a preferred embodiment, the foam interface 80 includes a single orifice 84 adapted to border both of the patient's nostrils (see, for example, Figures 13-1 to 13-2). Specifically, the interface compresses around the openings of both nostrils, for example, surrounding or partially obstructing the nostrils, so that the orifice 84 communicates with the nasal cavity through an air passage. In an alternative embodiment, communication through an air passage may be via two or more orifices. In some embodiments, the profile of the orifice 84 may generally be circular, rectangular, rounded rectangular, triangular, elliptical, or oblong. However, other suitable orifice shapes are possible, such as rounded triangle, rounded trapezoid, or rhombus. In a preferred embodiment, the orifice matches the shape of the outer profile of the component, although the orifice profile and the outer profile may be considerably different in shape (for example, the outer profile may be elliptical and the inner profile may be triangular). In an alternative embodiment, the foam interface may include a block of foam without an orifice, and the permeability of the foam adjacent to the airway opening may be made sufficiently high to allow sufficient airflow to the patient's nose.

[0206] 2.7 Interface path In the illustrated embodiment, the upper outer circumference of the foam interface 80 forms an interface path P (see, for example, Figures 13-1 to 13-2) that surrounds the width of the lower side of the nose and borders, for example, the outside of the nose or the external nostrils.

[0207] For example, a foam interface can be designed to engage with the underside of the nose. The shape of the interface can be described as generally annular, having an inner circumference and an outer circumference when viewed from above. The inner circumference of the interface (defining the orifice) can surround the nostrils or partially obstruct them, making the alignment of the interface with the nostrils less critical. The area between the inner and outer circumferences can engage with a wider area of ​​the face compared to other interfaces known in the art (e.g., nasal prongs), allowing for more even pressure distribution and reduced force on the face. The outer circumference can fit within the contour of the underside of the nose or be shaped very close to the width of the nose. In preferred embodiments, the outer circumference is located outside the contour of the underside of the nose to improve stability and fit by allowing the interface to have the effect of wrapping around or gently supporting the width of the nose. This can help to make the visual impression of the product less conspicuous when viewed from a non-subjective viewpoint. Alternatively, the outer perimeter of the interface can be positioned outside the contour of the underside of the nose, creating an effect of embracing or wrapping around the width of the nose. If the outer perimeter of the interface is wider than the nose, this configuration can improve the stability and comfort of the interface. Specifically, this can be combined with a curve or V-shape in a first direction (when viewed from the front of the face) to make the interface more intuitive to wear. The interface then features an automatic positioning mechanism and intuitive positioning for a comfortable fit on the nose.

[0208] In one embodiment, the foam interface is configured to be located below the nostrils, and the angle of the interface or tangent vector is more obliquely upward toward the top of the head, in contrast to the linear backward direction toward the plane of the face that is typical of conventional nose-covering interfaces.

[0209] For example, as shown in Figure 16-1, the interface with the patient may include a first loop LP1 (e.g., an air delivery tube) and a second loop LP2 (e.g., a back strap) connected to the first loop LP1 during use. As shown in the figure, the first loop LP1 runs along the underside of the patient's nose, along the cheek area, over the ears, and over the top of the patient's head, defining a sealing force against the underside of the patient's nose. The second loop LP2 runs generally over the occipital bone, defining the vector of the headgear at an angle α with the first loop LP1 of 40 to 80 degrees (e.g., 60 degrees).

[0210] Other embodiments are shown in Figures 16-2 to 16-3, which schematically illustrate a frame 222 for supporting a foam interface adapted to angle the interface vector further back. This, combined with piping having a rigidifying element, allows for the separation of the sealing force from the force stabilizing the interface with the patient on the head. Thus, these forces are given clearer control and regulation, with more stabilizing force supported above the patient's upper lip and cheek area. Consequently, the interface vector is less forced into the patient's nose, improving comfort for the patient. In other embodiments, the stabilizing force can be reduced from the upper lip and supported more on the cheek area by providing a load-bearing function to the portion of the headgear adjacent to the interface. This further stabilizes the mask system on the head without requiring the highly flexible interface to be pulled excessively into the nose. This load-bearing function can form an integral part of the foam interface components and extend along the face-contacting surface (e.g., the inner surface) of the headgear. They can also be permanently or detachably attached to a separate headgear from the interface.

[0211] Furthermore, the surface area provided by the frame can be reduced (for example, by making the width across the entire face narrower and the diameter smaller), thereby reducing the reaction force on the patient's face and achieving a more effective interface.

[0212] 2.8 Breathability According to one embodiment of the present invention, the foam interface may include a breathable or permeable foam (based on, for example, the exclusion of the cut surface and / or outer skin) that allows a planned amount of airflow both through the interface material (e.g., the bulk structure of the foam) and between the interface and the patient's skin (e.g., the cut surface of the foam). Patient comfort and compliance are enhanced by reducing sweat buildup around the face, keeping the skin dry, and maintaining a moderate temperature in the areas of skin in contact with and around the interface. Ideally, the airflow is designed to be less than the amount that would excessively dry the skin and cool the anatomical structures around the interface when worn on the face.

[0213] In other words, the construction of the foam provides a breathable interface that can avoid the accumulation of condensation and associated irritation at the contact interface between the patient and the interface. The foam provides a “leak” interface (e.g., measurable by the percentage of airflow) with intentional / controllable leakage through the foam structure / substrate, which helps circulate air and keep the contact surface relatively dry and comfortable (e.g., about 10% ventilation flow, 30-40% ventilation flow). The amount of leakage provided by the foam can be varied, for example, according to comfort, skin dryness, and / or discomfort.

[0214] In one embodiment, the foam interface can be constructed to leak predictably and within predetermined limits and physical locations, for example, by altering the permeability or breathability of airflow around the periphery of the interface. Furthermore, the foam material can be selected to handle moisture, for example, by avoiding moisture accumulation in certain areas and promoting moisture in other areas (e.g., near the nose for humidification). Hydrophobic and hydrophilic (e.g., water-absorbing) materials (or treatments that produce similar properties) are options. A water-absorbing foam adapted to "pull" moisture or sweat away from the patient's skin can reduce skin damage, pressure necrosis, and / or ulcer formation.

[0215] The foam can be designed to feature varying degrees of permeability through the bulk and surface of the foam. The foam may be impermeable in its body and permeable only at the interface surface. Conversely, the foam may be permeable in its body and impermeable at the interface surface, resulting in different sealing properties. For example, this makes it possible to achieve breathability while realizing alternative interface and / or sealing features to the cut-cell foam interface described herein. The foam may also be configured to be impermeable throughout or to be impermeable in specific locations where airflow permeability should be avoided (e.g., in the direction of the eye).

[0216] Breathable interfaces can improve the mobility interface performance (i.e., the ability to withstand large movements such as a patient turning over in bed and maintain the interface) compared to conventional interface materials. This is possible because a small amount of airflow is already flowing between the interface surface and the patient's skin, which is less critical to the interface mechanism when subjected to large movements compared to conventional silicone sealants. Silicone relies to some extent on its ability to "stick" to the patient's skin to provide a stable mobility seal. Thus, when a silicone sealant moves tangentially along the surface of the skin, it is forcibly distorted and completely detached from the skin, and then reattached to the face as usual to restore the shape it was designed to be positioned for sealing. In other words, silicone sealants suddenly leak out during shearing or large movements that would necessitate reattaching the interface, while breathable foam interfaces provide an interface that can easily regain its interface properties without the need to reattach the foam interface to the patient's face to recover from a distorted shape (e.g., from facial movements relative to the interface). This is also a result of having an interface that does not rely on a membrane mechanism for the interface and / or seal. The cross-sectional width of the interface can typically be greater than the thickness of the membrane (preferably 5-12 mm, more preferably 8-10 mm, compared to 0.35-1.0 mm). This greater width allows the interface to engage with the patient's face over a larger area and is therefore less susceptible to local separation in the interface mechanism due to movement or surface irregularities on the patient's face. Furthermore, the cross-section of the foam interface transmits lower tension across the entire surface when pressed against the face, improving the mobility and sealing performance of silicone membrane seals, which are prone to leakage when moving on the face.

[0217] In alternative embodiments, the foam interface may have a coated surface, which may be permeable to provide the same effect as a foam interface having an uncoated cross-section. For example, the coated surface may be in the form of a breathable polyurethane sheath, a permeable membrane, a textured surface, a spray-applied porous coating, a perforated sheath, and / or a textile. In another example, as shown in Figure 13-8, the foam interface 80 may have a coated surface SS, and vents 81 may extend from the inside of the foam to the outside air to allow permeability.

[0218] Figure 14-2 is a graph showing the characteristics of a foam interface according to an embodiment of the present invention. As shown, the foam interface can be configured such that leakage decreases as the force applied to the interface (both compression and expansion) increases. Furthermore, separation of the leakage flow due to movement away from the patient's face is minimized.

[0219] 2.9 Compliance Compared to interfaces made of silicone and other materials known in the art, foam interfaces possess (mechanical) compliance properties that allow them to accommodate a much wider range of facial shapes. These configurations offer the potential to integrate the necessary dimensions to suit the number of patients (e.g., a one-size-fits-all interface in some cases).

[0220] Because bulk materials have mechanical compliance, foam-based sealants can easily conform to a wider range of facial contours compared to non-foam sealants.

[0221] One method for quantifying compliance is to measure the extent to which bulk material wraps around a cylinder of a given diameter. More specifically, the angle at which the bulk material wraps around the cylinder can be measured relative to the cylinder's longitudinal axis.

[0222] A preferred embodiment of the present invention has a cut, i.e., uncovered, contact surface with the patient, with a thickness between 8 mm and 14 mm, and a density between 40 kg / cubic meter and 70 kg / cubic meter.

[0223] In other words, foam interfaces can provide excellent mechanical compliance, resulting in a simpler interface and reduced anthropometric differences, along with superior fit quality (compared to, for example, conventional nasal and full-face interfaces). Foam can be deformed to the appropriate dimensions and shape (e.g., locally) without damaging the interface (e.g., distorting or wrinkling) or causing discomfort to the patient (e.g., applying smaller, more uniform pressure to the face). Furthermore, highly compliant foams conform to a wider population with respect to a given shape (e.g., dimensions) compared to silicone interfaces. Moreover, the mechanical compliance of foam interfaces allows for patient interface design that does not rely on the tension of straps from the headgear. In one embodiment, the patient interface can be fitted to the patient's face by an air delivery and stabilization system (e.g., headgear), and then the interface can find its way to the patient's nose without the need for precise adjustments. In other words, foam interfaces effectively absorb improper fitting.

[0224] The conforming properties of the foam allow it to quickly conform to the patient's face without damaging the interface or causing discomfort to the patient (for example, during initial fitting or when the patient moves or turns over during sleep). In other words, the foam has a greater tolerance for misalignment.

[0225] 2.10 Warming The foam interface can provide a warming sensation to the patient's nostrils when exhaling, similar to breathing under a blanket on a cold night. This mechanism reduces the "frozen nose" effect experienced by some users of nasal prong or nasal pillow interfaces. In one embodiment, the foam interface may include an extended lateral portion that extends along the side of the patient's face, for example, along the upper cheek region between the air delivery tube and the patient's cheek near or extending from the mouth, in order to provide a warming sensation to other areas of the patient's face.

[0226] 2.11 layers In one embodiment, the interface structure may include a flexible foam attached to a more rigid structure, such as a cylindrical support described in Patent Document 4, which is entirely incorporated herein by reference, and a silicone shell with a Shore A of 40 and a wall thickness of approximately 1.5 mm.

[0227] In other embodiments, the interface structure may include multiple layers, each providing a specific function. For example, Figure 17-1 schematically shows an interface structure including four functional layers. The first layer L1 represents a skin contact layer configured to provide a comfortable seal to the skin of the patient's face and / or nose. The second layer L2 represents a conforming layer configured to easily conform to the anatomical structure of the patient's nose. The third layer L3 represents a shape-retaining layer configured to support the interface to maintain its overall shape (as the flexibility of layers L1 and L2 prevents it from providing sufficient self-support under load conditions). The fourth layer L4 represents a retaining / attaching layer configured to retain / attach the interface structure to the patient, e.g., a frame, shell.

[0228] To simplify things, all functions are provided by as few physical layers or components as possible. For example, the functions of the skin contact layer L1 and the conforming layer L2 can be provided by a single material that includes both a comfortable feel on the skin and the compression properties of a suitable plush that conforms around the underside of the nose. In other examples, the reinforcing function of the L3 layer and the attachment function of the L4 layer can be provided by an attachment mechanism (L4) and / or by a substrate (e.g., adhesive) used to join the functional layers together.

[0229] In one embodiment of the foam interface shown in Figures 13-1 and 13-2, the foam interface 80 having a cut cell structure can provide the functions of the first and second layers L1 and L2, the cylindrical support 82 (for example, made of silicone) can provide the function of the third layer L3, and the loop material for attachment to the frame can provide the function of the fourth layer L4 (described below).

[0230] In other embodiments, the shape-retaining layer L3 may include a malleable material (e.g., aluminum wire) so that the interface can be manually deformed into a more effective and comfortable shape.

[0231] In an alternative embodiment, the first layer, i.e., the skin contact layer L1, may be flocked or covered with a textile (or other suitable breathable material) for, for example, comfort, grip, alternative water absorption, and / or alternative breathability.

[0232] 2.12 Mounting Mechanism In the illustrated embodiment, the interface structure 20 is a separate component from the air delivery and stabilization system 30. Therefore, a mounting mechanism is provided to fix the interface structure to the air delivery and stabilization system (for example, detachably). As described above, a portion of the mounting mechanism can form a retaining layer L4 of the interface structure.

[0233] 2.12.1 General Physical Requirements Interface components are typically separate components from the rest of the interface with the patient. There are many reasons for this, including: the interface's shape is usually complex and difficult to manufacture in combination with the other components of the interface with the patient; the interface usually needs to accommodate large differences in anthropometric measurements, and therefore several interchangeable interface dimensions exist to cover the full range of differences; the interface may need to be cleaned many times during its lifespan, and making it detachable allows for more thorough cleaning and makes cleaning a simpler task; and / or the interface may be replaced more frequently than the rest of the interface with the patient and needs to be detachable for replacement.

[0234] The mounting mechanism is designed to make all assembly and disassembly as easy as possible for the patient, especially considering the potential for varying ages and intellectual and physical abilities of the patients.

[0235] To simplify assembly, elements of orientation, alignment, and force are considered in the design. In one embodiment, the interface includes the smallest possible asymmetry (e.g., allowing for functionally correct mounting in as many different (e.g., two) directions as possible), intuitive cues regarding mounting methods (e.g., auto-align or auto-orient), dimensions, shape, and texture that are not cumbersome (e.g., requiring minimal dexterity), tolerance for misalignment, the smallest possible force for assembly, and / or the smallest possible force for disassembly. The forces fed back from the mechanism can usually indicate to the user that assembly is complete and correct. The force required for assembly should be as small as possible, while accurate assembly should be clear to the user.

[0236] If the assembly force is very low, the disassembly force should be greater than the assembly force to ensure that unintended disassembly does not occur. The disassembly force should not be too high, depending on the risk of damaging the interface components or other components of the interface with the patient.

[0237] The attachment of the interface to the patient interface frame should be such that there are no air leaks (e.g., sealed) or that there are only small amounts of air leaks known to exceed the range of treatment pressures.

[0238] In one embodiment, as shown in Figure 17-2, a foam interface 80 can be provided on a base B, which is adapted to hold the foam interface in a frame F. As shown, the base B is sufficiently longer than the inlet to the frame (for example, length D is longer than the length d of the inlet to the frame), so that the base B is elastically pushed into and / or simply manipulated through the inlet provided to the frame F into the slot S, where it is held in the working position.

[0239] In other embodiments, as shown in Figures 17-3A to 17-3C, a mechanical interference mounting mechanism can be used to detachably attach the interface structure to the interface with the patient. As shown, a base B (e.g., a rigid laminate) can be provided on the underside of the interface structure (e.g., in the form of a foam interface 180), and a mounting structure AT can be provided on the frame of the interface with the patient.

[0240] As shown in the figure, the hook portion HP extends from the inner edge of the mounting structure AT. During use, the base B is elastically extended and / or simply operated from above the hook portion HP, where it is held in the working position, for example, by mechanical interference fit. As shown in Figure 17-3C, to prevent accidental detachment, the free end 185 of the hook portion HP overlaps the inner edge of the base B.

[0241] Furthermore, the free end 185 of the hook portion HP provides an internal lip that is pressed against the foam interface 180 to provide a seal. Thus, the base B and mounting structure AT provide both mounting between the interface structure and the frame and sealing of the outer periphery.

[0242] In the illustrated embodiment, the base B and the mounting structure AT each have an overall flat configuration, and the profiles of the base B and the mounting structure AT are substantially the same as the profiles of the underside of the interface structure, for example, being elongated or elliptical.

[0243] As shown in the figure, the outer edges of the base B and the mounting structure AT are substantially aligned with the outer edge of the lower surface of the foam interface 180. The inner edge of the mounting structure AT may be positioned slightly outside the inner edge of the lower surface of the foam interface 180, for example, by the hook portion HP.

[0244] However, other suitable outer boundaries are possible. For example, the range of the base B and mounting structure AT on the underside of the interface structure may be the same as, or further inward from, the inner and outer edges of the shape profile of the underside. In one embodiment, the base and mounting structure may be positioned inward relative to the outer edge of the underside to prevent the base and mounting structure from coming into contact with the patient's upper lip during use.

[0245] Mounting mechanisms of the mechanical interference type may have other suitable configurations. For example, mounting mechanisms of the mechanical interference type may include an internal lip with a sleeve portion, an internal lip with an angled portion, an external lip with a single reinforcing layer, an external lip with a double reinforcing layer, a push-in fit with a single foam layer, or a push-in fit with a double foam layer.

[0246] In other embodiments, an adhesive-type mounting mechanism can be used to detachably attach the interface structure to the interface with the patient. For example, an adhesive (e.g., a pressure-sensitive adhesive (PSA)) can be provided on the underside of the interface structure (e.g., in the form of a foam interface) that enables the interface structure to be detachably attached to the frame of the interface with the patient.

[0247] In one embodiment, the bottom surface and the adhesive (e.g., PSA) provided thereto may have an overall flat configuration. In another embodiment, the bottom surface and adhesive may result in a curve along a first direction. In another exemplary embodiment, the base and adhesive may result in a curve along two or more directions, for example, a saddle shape, through a centering action.

[0248] The extent of the adhesive on the underside of the interface structure may be the same as, or further inward or outward than, the inner and outer edges of the underside's shape profile. In one embodiment, the adhesive can be aligned with the edge of the profile to simplify manufacturing. In other embodiments, the adhesive can be located inside the outer edge of the underside to prevent contact between the adhesive and the patient's upper lip during use.

[0249] In other embodiments, the mounting mechanism can be configured to manipulate the service life of the interface, for example, by causing the mounting mechanism to fail after a predetermined time, thus requiring replacement of the interface.

[0250] In other embodiments, a large mounting mechanism is not required when the interface is sandwiched between the frame and the patient's face during use.

[0251] 2.12.2 Hooks and Loop Materials In one embodiment, the mounting mechanism may be in the form of hooks and loops, for example, Velcro®. For example, the hooks can be provided to the frame, and the loops, for example, an unbroken loop (UBL), can be provided to the underside or base of the interface structure. For example, the loops can be provided to the underside of a cylindrical support 82, for example, by adhesive.

[0252] While the configuration of the hook and loop members may be reversed, given that the interface is replaced very frequently, it is preferable that the less durable configuration of the hook and loop members, i.e., the loop members, is attached to the interface structure. The hook and loop style attachment mechanism allows for intuitive assembly, requiring very little force for assembly / disassembly.

[0253] Hook and loop interfaces are typically not airtight. Therefore, hook and loop interfaces according to embodiments of the present invention may contain the well-known small amount of leakage that is reproducible within a defined range during assembly operations.

[0254] In alternative embodiments, the functions of mounting and sealing between the interface and frame can be performed separately. For example, a hook-and-loop interface can be used for mounting, and a flexible, deformable closed-loop linear interface can be used for sealing. The hook-and-loop interface can mount between the interface structure and the frame, in which case it provides vertical forces on both sides of the interface / frame configuration that press the loop material against the flexible circumferential sealing material. The interface structure can be positioned on or adjacent to the hook material provided to the frame.

[0255] In other embodiments, instead of sealing by pressing the interface or loop material against it, the loop material may have a corresponding smooth rubber / plastic surface to interface or seal against it.

[0256] In exemplary embodiments, the interface structure can be formed by preparing a single sheet of foam material (for example, a slab or block of foam material (e.g., a block of 1m × 0.5m × 2m)), laminating or otherwise attaching hook material to the foam sheet, and die-cutting the foam sheet to form an interface structure of the desired shape.

[0257] Figures 17-4A to 17-4C show other embodiments of a hook-and-loop type attachment mechanism (e.g., Velcro®) configured to detachably attach the interface structure to the interface with the patient. As shown, a loop material LP can be provided on the underside of the interface structure (e.g., in the form of a foam interface 180), and a hook material HK can be provided on the frame of the interface with the patient. It should be understood that the arrangement of the hook and loop materials can be reversed.

[0258] As shown in the figure, the sealing lip SL extends from the inner edge of the hook member HK. During use, the hook and loop members engage detachably with each other, thereby pressing the loop member LP against the sealing lip SL to provide a seal. Thus, the hook and loop type mounting mechanism provides mounting between the interface structure and the frame, and the sealing lip SL is deformable to provide a circumferential seal between the interface structure and the frame.

[0259] In the illustrated embodiment, the hook and loop members HK and LP each have an overall flat configuration, and the profiles of the hook and loop members HK and LP are substantially the same as the profiles of the underside of the interface structure, for example, being elongated or elliptical.

[0260] As shown in the figure, the inner and outer edges of the hook and loop material are substantially aligned with the inner and outer edges of the lower surface of the foam interface 180. That is, the outer boundary of the hook and loop material can be aligned with the edge of the lower shape profile of the interface, for example, to facilitate manufacturing.

[0261] However, other suitable outer boundaries are possible. For example, the extent of the hook and loop material on the underside of the interface structure may be the same as, or further inward from, the inner and outer edges of the shape profile of the underside. In one embodiment, the hook and loop material may be located inward from the outer edge of the underside to prevent the hook and loop material from coming into contact with the patient's upper lip during use.

[0262] The hook and loop type mounting mechanism may have other suitable configurations. For example, the hook and loop material may provide a flat configuration, such as the above configuration without a sealing lip. In other exemplary embodiments, the hook and loop material may provide a curve along a first direction. In other exemplary embodiments, the hook and loop material may provide a curve along a first direction and a sealing lip as described above. In other exemplary embodiments, the hook and loop material may provide a curve along two or more directions by alignment action, for example, a saddle shape.

[0263] 2.12.3 Low-retaining-force snap mating Figures 18-1 to 18-3 show a method for joining a subnasal foam interface 380 to a frame 322 according to another embodiment of the present invention. In this embodiment, the subnasal interface 380 includes a structure that allows it to be attached to the frame 322 by a snap fit, and the connection relies on friction and / or mechanical interlocking between the subnasal interface 380 and the frame 322 for its strength. The resulting joint will have limited strength, but the position of the joint allows forces between the patient and the frame to help reinforce the joint.

[0264] As shown in Figures 18-1 and 18-2, the frame 322 includes an overall tubular structure that is curved along its length so that it can follow the contour of the patient's face and / or conform to the patient's facial shape during use. As shown in Figures 18-2 and 18-3, the subphiltrum interface 380 is configured to be attached to the frame 322 by a snap fit. Specifically, on the back of the subphiltrum interface 380 there is a groove 387 along the longitudinal axis that is adapted to receive a portion of the tubular frame 322 therein. One or more faces and / or edges of the groove 387 are adapted to engage with the frame 322 by a friction fit and / or mechanical interlock fit. In addition, each end of the subphiltrum interface 380 includes an arched notch 389 that is adapted to receive the end portion of the frame 322 when curved along its length.

[0265] 2.12.4 Snap mating with PSA In other embodiments, the subphilate interface or foam interface can be bonded to the frame by pressure-sensitive adhesive (PSA). Figures 19-1 to 19-3 are a series of diagrams illustrating the manufacturing process for applying PSA to the back of the subphilate interface according to embodiments of the present invention. Figure 19-1 shows the untreated subphilate interface 480, Figure 19-2 shows the subphilate interface 480 after PSA 485 has been applied, and Figure 19-3 shows the completed subassembly after a removable backing 486 has been attached to the PSA 485 on the subphilate interface 480.

[0266] The interface 480 with the subnose is assembled, for example, by snap fitting, as shown in Figures 18-1 to 18-3. Conversely, the backing 486 is removed from the interface 480 with the subnose before assembly to expose the PSA 485. The resulting joint is strengthened by the PSA 485. When selecting a PSA, it should be configured to adhere better to the interface with the subnose than to the frame. That is, the adhesive strength of the PSA is preferably higher than the adhesive strength. This configuration allows the PSA to remain on the interface with the subnose rather than on the frame when the interface with the subnose is pulled away from the frame for cleaning or replacement, for example.

[0267] 2.12.5 Snap fitting with groove or undercut Figures 20-1 to 20-3 illustrate a method for joining a subnose interface or foam interface 580 to a frame 522 according to another embodiment of the present invention. In this embodiment, the subnose interface 580 includes grooves or undercuts 595 on both sides thereof, which are adapted to fit or interlock with projections 596 provided on the frame 522, for example, by snap-fitting. The resulting joint has improved joint strength compared to the joints shown, for example, in Figures 18-1 to 18-3.

[0268] In alternative embodiments, the interface with the subphiltrum can provide a composite snap-fit ​​configuration. For example, Figures 20-4 to 20-7 are a series of diagrams showing the manufacturing process for forming a composite subphiltrum interface according to embodiments of the present invention. In Figure 20-4, a viscoelastic foam portion 1291 is formed, having a first side portion that provides an interface with the patient and a second side portion that provides spaced-out platforms 1293. In Figure 20-5, connecting portions 1297 are formed, each having grooves or undercuts 1295. The connecting portions 1297 are constructed from a material that is much more elastic and structural than the viscoelastic foam portion 1291, such as high-density foam, TPE, or TP. In Figure 20-6, an adhesive 1285, such as a hot-melt adhesive, is applied to each of the platforms 1293 of the foam portion 1291. Accordingly, as shown in Figure 20-7, the connecting portion 1297 is attached to each of the foam portion 1291 platforms 1293 by adhesive 1285 to assemble the composite subphile interface 1280. When in use, the composite subphile interface 1280 can be attached to a frame such as the frame described in Figures 20-1 to 20-3, for example, by the grooves or undercuts 1295 engaging with the projections provided on the frame. The composite subphile interface 1280 provides a connecting portion 1297 configured to have higher joint strength than a single viscoelastic foam. It should be understood that other suitable manufacturing processes may be used to create the composite subphile interface.

[0269] In other embodiments, the mounting mechanism can be configured such that the interface foam can be received in a receiving channel of the frame or shell. In this case, sealing and retention rely on an interference fit between the foam and the channel of the frame or shell. The highly flexible interface foam is preferably laminated or otherwise bonded to form a stiffer, denser foam (or other structure), thereby providing a greater interference fit force when engaged with the channel.

[0270] In other embodiments, the mounting mechanism can be realized by rigid or semi-rigid components bonded to the underside of the foam of the flexible interface. The rigid / semi-rigid components can be configured to provide several mechanical interlocking fits, for example, clipped into / on the frame.

[0271] 2.12.6 Magnetic Device In an alternative embodiment, the mounting mechanism may include a magnetic device to magnetically connect the frame and the interface structure.

[0272] 2.13 Structural Compliance 2.13.1 Background The local anatomy around the nose has steep slopes and pointed transitions between those slopes. For the interface to be most effective, it needs to be flush with all surfaces to realize the interface, for example, to seal. Low elasticity structures can maximize comfort while realizing the interface, such as a textile interface. However, textile interfaces are typically very thin (e.g., thinner than 2 mm) and cannot provide the properties necessary to add compliance on their own. Support structures are necessary for a textile interface to conform to the patient's face. However, support structures are not limited to textile interfaces; for example, foam and silicone interfaces also benefit from support structures.

[0273] 2.13.2 Flexible Frame In one embodiment, the interface can be mounted on a frame made of a flexible material, such as an injection-molded silicone frame. Each end of the frame is attached to each tube 42. When pulled against the patient's face, the flexible frame conforms to the patient's face and can wrap around it, for example, the patient's nose, without pinching it.

[0274] Frames can be constructed from materials with different hardnesses. If the frame is constructed from silicone, this configuration can be achieved simply by using silicones with different Shore hardnesses.

[0275] For example, Figures 21-1 to 21-3 show a frame 622 for supporting the subnasal interface 680 and vent 627 according to an embodiment of the present invention. As best shown in Figures 21-2 and 21-3, the central portion C of the frame 622 (shown in darker shades) is rigider than the side portions S of the frame 622.

[0276] This arrangement results in a side section S that is more flexible than the central section C of the frame 622. As shown in Figure 21-3, as the force applied to the frame 622 increases, the deflection of the side section S becomes greater than the deflection of the central section C. As a result, the frame 622 does not pinch the patient's nose, and the central section C remains relatively straight to prevent the interface from obstructing the nostrils. Furthermore, the rigider central section C ensures that the conduit in front of the patient's nose remains open during use.

[0277] Figure 22-1 shows a flexible frame 722 according to another embodiment of the present invention. In this embodiment, the frame 722 may be a molded foam conduit including an interface with a subnose, for example, an interface with a replaceable foam subnose, and openings 722.1 and 722.2 adapted to engage with a vent. The ends of the frame 722 can be attached to each tube 42 in any suitable manner.

[0278] 2.13.3 Flexible frame with spring element In other embodiments, the flexible frame described above may include a spring element to improve comfort. For example, Figure 23-1 shows a flexible frame 822 including a spring element 828 and an interface 880 provided to the frame 822. The spring element 828 may be made of thermoplastic elastomer (TPE) or metal (e.g., Polycurve, Nitinol, etc.). In the illustrated embodiment, the spring element 828 is incorporated horizontally along the frame 822. However, other suitable arrangements are possible. When in use, the spring element 828 is configured to counteract the force applied by the air delivery and stabilization system 30, for example, the tube 42. The spring element effectively expands the radius of the frame 822 when attached to a patient.

[0279] In one embodiment, the spring element can be a variable spring element in which the k value changes over its length (see, for example, the graph in Figure 23-2). As illustrated, the spring element can have a k value that is roughly similar to a bell-shaped curve, with the middle of the spring element being relatively stiff and the ends being relatively loose. Such a configuration can be advantageous because it can be well adapted to the curvature of the patient. For example, if the interface is a subnasal type interface, a relatively stiff spring can be provided in the middle of the frame, and then a spring that becomes looser as the frame moves away from the center of the nostrils.

[0280] To further enhance compliance, a less elastic foam can be added between the spring element and the interface. For example, Figure 23-3 shows an interface 980 provided to a frame having a less elastic foam 956, an intermediate density foam 957, and a spring element 929 constructed from, for example, nitinol.

[0281] 2.14 Exhaust In one embodiment, the breathable foam interface can remove or exhaust a required volume of CO2, thereby eliminating the need for separate CO2 removal vents. Furthermore, the breathable foam interface can provide a function to quiet or diffuse the exhaust. Thus, the breathable foam interface can provide a single component that serves the dual purpose of sealing and exhaust, for example. However, since condensation may clog one or more breathable portions of the breathable foam interface, for example, a CO2 exhaust vent may be used in conjunction with the foam interface. The exhaust of air from the CO2 exhaust vent can pass through the foam as a means of diffusing and reducing noise from the exhaust flow.

[0282] For example, the frame or support supporting the foam interface may include one or more exhaust holes for CO2 removal (see, for example, Figures 1-8, 2-1, and 18-1).

[0283] Figure 24-1 also shows a foam interface 1080 including a rigidizer 1098 for exhaust. The rigidizer 1098 may be in the form of a rigid / semi-rigid backing component including holes 1099 for exhaust. As shown, the foam interface 1080 has a "boomerang" shape. Due to the semi-porous nature of the foam and the "boomerang" shaped extension arms, the foam has a very small amount of diffuse airflow constantly coming out of the orifice, allowing the patient's skin to breathe beneath the foam.

[0284] Furthermore, in alternative embodiments, the frame or support supporting the foam interface may include one or more auxiliary holes, for example, to supply oxygen and / or collect pressure / humidity data.

[0285] 2.15 Alternative Interface Configurations It should be understood that the interface structure can have other interface configurations. That is, the type of foam interface is merely illustrative, and the foam interface can be adapted for use with other appropriate interface types, such as a nose-covering interface, nasal cushion, mouth, full face, nasal prongs, etc. For example, Figure 25-1 shows one embodiment of a patient interface 1110, which includes a subnasal interface 1180 and a mouth interface 1181, constructed from foam, for example, to fuse or seal to the patient's mouth when in use.

[0286] 2.16 Foamed Silicone Instead of using the viscoelastic foams (e.g., polyurethane) described above, and / or in addition thereto, various components of the patient interface can be constructed, at least partially, from foamed silicone, i.e., foamed silicone. That is, one or more parts of the components may be constructed from foamed silicone, or the entire component may be constructed from foamed silicone.

[0287] For example, a frontal pad for frontal support of a patient interface includes a shaft or connector adapted to connect the frontal pad to a frame, and a patient contact pad portion adapted to contact the patient's frontal head. In one embodiment, the shaft can be constructed from non-foamed silicone (e.g., LSR), and the patient contact pad portion can be constructed from foamed silicone.

[0288] In other examples, the cushions of the patient interface and / or the conduits connected to the patient interface can be constructed, partially or entirely, from foamed silicone.

[0289] Foamed silicone can provide each component having a different "feel" and / or different bonding properties.

[0290] For example, foamed silicone can offer one or more of the following characteristics: lightweight; attractive texture and comfort; use of less material; opaque or transparent; washable to extend the lifespan of components and reduce the frequency of replacement (e.g., if the proportion of closed cells is sufficiently high); greater flexibility at a given thickness or durometer; low stretchability and tear resistance; ability to change surface properties (e.g., having an outer skin); impermeability of air / biological substances; durability of sealing properties over time (e.g., oil / grease absorption); and / or the surface is breathable and the body is impermeable.

[0291] 3. Application to known masks As will be apparent to those skilled in the art, one or more aspects or characteristics of the present invention can be adapted for use and / or incorporated into known mask embodiments and / or components.

[0292] 3.1 Respironics' ComfortCurve (trademark) Figure 26-1 shows a known mask 1500, marketed by Respironics under the name ComfortCurve®, one or more parts of this mask are described in Patent Document 5, published November 24, 2005. As shown in the figure, the mask 1500 includes a frame 1502, a cushion 1504 provided for attachment to the frame 1502 and adapted to form a seal with the patient's nose during use, cheek pads 1506 provided to the frame 1502 to support the cushion 1504 during use, an inlet tube 1508 provided to the frame 1502 and adapted to deliver breathable gas to the patient, and a headgear 1505 detachably attached to the frame 1502 to maintain the mask 1500 in a desired position on the patient's face.

[0293] 3.1.0 Improved / Alternative Configuration The following embodiments describe improved and / or alternative configurations of Respironics' ComfortCurve® mask for enhancing respiratory therapy.

[0294] 3.1.1 Sealing of foam The ComfortCurve® mask includes a cushion constructed from a silicone material. In an alternative embodiment, as shown in Figure 26-2, the cushion may be a foam cushion 1504F constructed from a foam material F. The foam material F may include one or more of the foam properties described above, such as viscoelasticity and being uncoated.

[0295] In these embodiments, the frame mounting mechanism or clip 1507 can be maintained as a base, and the foam material F can be attached to the clip 1507. This configuration makes it possible to detachably attach the foam cushion to the existing frame of the ComfortCurve® mask.

[0296] In one embodiment, as shown in Figure 26-3, the foam cushion 1504F can extend along the side of the frame 1502 (for example, at the position of the cheek pad 1506) so that when pulled against the patient's face during use, the foam material F can wrap around the patient's nose and / or conform to the patient's face.

[0297] In one embodiment, the foam cushion 1504F may include multiple layers, for example, a first layer constructed from a high-density foam and a second layer constructed from a more compliant foam adapted to engage with the patient's face.

[0298] In other embodiments, as shown in Figure 26-4, the ComfortCurve® cushion 1504 may have a foam or fabric layer FL on a contact surface adapted to engage with the patient's face. The foam or fabric layer FL can be provided to the cushion in an appropriate manner, for example, by spraying the foam like flocking, or by bonding the fabric to the cushion. The foam or fabric layer FL can improve comfort, feel, and / or flexibility and can provide moisture-absorbing properties.

[0299] 3.1.2 Conduit headgear The ComfortCurve® mask includes a headgear constructed from a fabric-type material to maintain the mask in a desired position on the patient's face. In an alternative embodiment, as shown in Figure 26-5, the headgear may be replaced with or combined with a collapsible conduit 1540, which is adapted to deliver breathable gas and stabilize the cushion interface on the patient's face. The conduit 1540 may include the characteristics of one or more tubes described above, such as a partially or completely collapsible cross-sectional shape that conforms to the patient's face, and the conduit 1504 may include a rigidizer.

[0300] 3.1.3 Tube routing configuration In other embodiments, as shown in Figure 26-6, the path of the inlet tube 1508 can be configured, for example, upward toward the top of the patient's head via the headgear 1505, rather than hanging downward from the frame.

[0301] In these embodiments, support members can be provided to the headgear to improve stability. For example, a wire member (e.g., a magnesium wire) can be provided to the headgear strap extending from the frame to the top of the patient's head.

[0302] 3.1.4 Flexible material on headgear straps In other embodiments, as shown in Figure 26-7, one or more straps of the headgear 1505 may include a relatively flexible cover, sock, or pad 1509, for example, constructed from foam or gel, to improve comfort.

[0303] 3.1.5 Inlet tube attached to the cheek pad In other embodiments, as shown in Figure 26-8, the cheek pad 1506 may be inflatable, and the inlet tube 1508 may be attached to or otherwise connected to the cheek pad 1506 to inflate the cheek pad 1506 during use. Such a configuration can be adapted for use with the conduit headgear described above.

[0304] In one embodiment, the cheek pad can be fluidly connected to the cushion so that air flows from the inlet tube to both the cushion cavity and the cheek pad.

[0305] 3.1.6 Inlet piping along the inside of the frame / headgear In other embodiments, the inlet tube may extend along the inside of the frame and / or headgear (for example, adjacent to the patient's face) rather than along the outside of the patient's face.

[0306] 3.1.7 Accommodation of the nasal alae and nasolabial angles In other embodiments, the cushion can be configured to accommodate the nasal wings and nasolabial angles of the patient's nose.

[0307] 3.1.8 Elimination of cheek pads In other embodiments, the cheek pads can be omitted. In such embodiments, as shown in Figure 26-9, a yoke or rigidizer 1511 can be provided on one or more straps of the headgear 1505 to improve stability. For example, the rigidizer can be configured similarly to those provided in ResMed's VISTA® and SWIFT® masks (see, for example, Patent Documents 6 and 4, which are incorporated herein by reference in their entirety).

[0308] In one embodiment, the rigidizer 1511, the frame 1502, and the inlet port 1514 associated with the inlet tube 1508 can be formed as an integrated, one-piece structure.

[0309] In other embodiments, the cheek pads can be eliminated, and the frame can be extended to improve stability. For example, as shown in Figure 26-10, the frame may include extended lateral sections 1513 that extend along both sides of the patient's head and taper / thin towards the patient's temples. Each end of the lateral section 1513 may include a suitable structure for attachment to each headgear strap.

[0310] 3.2 OptiLife (trademark) of Respironics Inc. Figure 27-1 shows another known mask 1600, marketed by Respironics under the name OptiLife®. As shown in the figure, the mask 1600 includes a frame 1602, a nasal pillow 1604 provided to the frame 1602 and fitted to form a seal with the patient's nasal cavity when in use, an inlet tube 1608 provided to the frame 1602 and fitted to deliver a breathable gas to the patient, and a headgear 1605 including a chin strap 1606 that is detachably attached to the frame 1602 to maintain the mask 1600 in a desired position on the patient's face.

[0311] 3.2.0 Improved / Alternative Configuration The following embodiments describe improved and / or alternative configurations of Respironics' OptiLife® mask for enhancing respiratory therapy.

[0312] 3.2.1 Foam Interface The OptiLife® mask includes a nose pillow. In an alternative embodiment, as shown in Figure 27-2, a foam interface F constructed from a foam material F can be used instead of the nose pillow. The foam interface F may include one or more of the foam properties described above, such as viscoelasticity and uncoated.

[0313] In these embodiments, the foam interface F may include an adapter having a base that supports the foam interface F and connects the foam interface F to the current frame 1602 of the OptiLife® mask.

[0314] 3.2.2 Foam Cheek Pads In other embodiments, as shown in Figure 27-3, each side strap of the headgear 1605 may include a foam cheek pad 1607 to improve comfort and / or stability.

[0315] 3.2.3 Side Inlet Port In other embodiments, as shown in Figure 27-4, the frame 1602 may include side inlet ports 1614, which are adapted to engage with each of the inlet tubes 1608. For example, the frame may be configured similarly to those provided for Respironics' ComfortCurve® masks.

[0316] 3.2.4 Collapseable inlet tube In another embodiment, as shown in Figure 27-5, the frame 1602 may include a side inlet port 1614 adapted to engage with a crushable inlet tube 1640 having the characteristics of one or more crushable tubes described above.

[0317] In one embodiment, the path of the collapsible inlet tube 1640 can be set upward, for example, toward the top of the patient's head, so as to pass through the headgear 1605.

[0318] 3.2.5 Rigidizer In another embodiment, as shown in Figure 27-6, rigidizers 1611 can be provided on one or more straps of the headgear 1605 to improve rigidity and / or stability.

[0319] 3.2.6 Structures that fill gaps In other embodiments, the mask may include a structure (e.g., provided in the headgear, frame, etc.) adapted to fill a gap or space between the patient's face and the mask / headgear. The gap-filling structure can improve comfort and / or stability during use. For example, as shown in Figure 27-7, the mask may include a structure for filling a gap or space S between the patient's face and the mask / headgear.

[0320] 3.3 Respironics' ComfortLite® trademark and ComfortLite® 2 Figure 28-1A shows a known mask marketed by Respironics under the name ComfortLite®, and Figure 28-1B shows a known mask marketed by Respironics under the name ComfortLite® 2. As shown in the figures, the ComfortLite® and ComfortLite® 2 masks 1700 each include a frame 1702, a nasal pillow 1704 provided to the frame 1702 and fitted to form a seal with the patient's nasal cavity when in use, an inlet tube 1708 provided to the frame 1702 and fitted to deliver breathable gas to the patient, and a headgear 1705 for holding the mask 1700 in a desired position on the patient's face.

[0321] 3.3.0 Improved / Alternative Configurations The following embodiments describe improved and / or alternative configurations of Respironics' ComfortLite® and ComfortLite® 2 masks for enhancing respiratory therapy.

[0322] 3.3.1 Two-tube configuration In other embodiments, each mask may include two inlet tubes instead of a single inlet tube extending over the patient's nose to the top of the patient's head. For example, as shown in Figures 28-2A and 28-2B, the frame 1702 may include side inlet ports 1714 adapted to engage with each inlet tube 1708 routed toward the top of the patient's head.

[0323] In these embodiments, one or more parts of the headgear, such as the forehead support, can be eliminated.

[0324] 3.4 Opus (trademark) of Fisher & Paykel Figure 29-1 shows another known mask 1800, marketed by Fisher & Paykel under the name Opus®. As shown in the figure, the mask 1800 includes a frame 1802, a nasal pillow 1804 provided to the frame 1802 and fitted to form a seal with the patient's nasal cavity when in use, an elbow 1807 connected to an inlet tube 1808 provided to the frame 1802 and fitted to deliver a breathable gas to the patient, and a headgear 1805 including a support structure or rigidizer 1809 to maintain the mask 1800 in a desired position on the patient's face.

[0325] 3.4.0 Improved / Alternative Configuration The following embodiments describe improved and / or alternative configurations of Fisher & Paykel's Opus® mask for enhancing respiratory therapy.

[0326] 3.4.1 Quick Release The frame 1802, nose rest 1804, and elbow 1807 of the Opus® mask form a subassembly that is connected to a support structure 1809 via a clip mechanism. In an alternative embodiment, a quick-release mechanism may be provided to releasably connect the subassembly to the support structure. For example, the subassembly may be coupled to the support structure via a magnetic mechanism.

[0327] In other embodiments, the subassembly can be connected to a support structure in such a way that it can be removed while the headgear remains on the patient's head.

[0328] In other embodiments, the joint between the elbow and the frame can be configured with a quick-release design, for example, allowing the ball joint of the elbow to be elastically attached to / detached from the frame. Such a mechanism makes it possible to maintain the frame / nasal pillow along the headgear on the patient's head.

[0329] As shown in Figure 29-2, the clipping mechanism of the Opus® mask includes a clip 1817 at the bottom of the frame 1802, which is adapted to engage with a clip receiver 1819 provided on the support structure 1809. In an alternative embodiment, as shown in Figure 29-3, the clipping mechanism may have an inverted arrangement, for example, with the clip 1817 provided on the top of the frame 1802. Such a mechanism may allow for a more continuous shape across the front of the mask.

[0330] In other embodiments, as shown in Figure 29-4, the clip mechanism can be positioned to allow the subassembly to engage the support structure 1809 from the front of the support structure, rather than from the rear of the support structure (see, for example, Figure 29-2).

[0331] In other embodiments, as shown in Figure 29-5, the support structure may provide an annular ring 1821 which is adapted to engage with an elastic fit portion or snap-fit ​​connector 1823 provided on the frame 1802. The snap-fit ​​mechanism may be similar to the elbow coupling mechanism of ResMed's VISTA® mask (see, for example, Patent Document 6, which is incorporated herein by reference in its entirety).

[0332] In other embodiments, as shown in Figure 29-6, one of the frame 1802 and the support structure 1809 may include a flange (e.g., a flange F as shown in Figure 29-6), and the other of the frame 1802 and the support structure 1809 may include a recess (e.g., a recess R on the support structure as shown in Figure 29-6) adapted to receive the flange for holding the frame to the support structure.

[0333] 3.4.2 Adjustment mechanism In other embodiments, the frame and / or the nasal pillow may be provided with an adjustment mechanism to allow for adjustment of the nasal pillow to accommodate the alae and nasolabial angles of the patient's nose.

[0334] 3.4.3 Sliding elbow / inlet tube In other embodiments, the elbow and / or tube may be configured to slide relative to the frame to detach the seal from the tube's drag. For example, Figure 29-7 shows a sliding elbow 1807S that is slidable to multiple operating positions relative to the frame 1802, e.g., two or more operating positions.

[0335] 3.4.4 Low-profile elbow In other embodiments, a portion of the elbow may have a substantially oval cross-section (rather than a circular cross-section) in order to create an elbow with a lower profile.

[0336] 3.4.5 Tube routing In other embodiments, the mask may include two inlet tubes instead of a single inlet tube. For example, as shown in Figure 29-8, the frame 1802 may include a side inlet port 1814, which is adapted to engage with each inlet tube 1808 routed toward the top of the patient's head.

[0337] In these embodiments, the headgear can be eliminated or integrated with the tubing, and may consist of, for example, two inlet tubes adapted to deliver a breathable gas and stabilize the nasal pillow on the patient's face.

[0338] Furthermore, the inlet tube may be collapsible and may have the properties of one or more of the above-described collapsible tubes.

[0339] 3.4.6 Sealing of foam In an alternative embodiment, as shown in Figure 29-9, a foam interface 1815 constructed from foam F and having the properties of one or more foams described above can be used instead of the silicone nose pillow of the Opus® mask.

[0340] In one embodiment, the foam interface may be a block of foam (e.g., mesh foam), where the peripheral portion of the interface is sealed or relatively impermeable, and the central portion of the interface is breathable and acts as a diffusion mechanism. In such embodiments, the central portion of the interface may have two discontinuous regions for each nostril.

[0341] Other alternative shapes include food packaging foam, fibrous filter material, and foam prongs. The foam prongs may be bell-shaped with cylindrical outlet holes, and optional reinforcing materials may be provided on one or more parts of the foam prongs, such as the inner wall or outer wall.

[0342] In other embodiments, the silicone nasal pillow may have a foam layer on a contact surface adapted to engage with the patient's nose. This foam layer can be appropriately provided to the nasal pillow, for example, by spraying a microdiffusion layer (e.g., HC405). The foam layer can improve comfort, feel, and / or flexibility and can provide moisture-absorbing properties.

[0343] 3.5 Breeze®, SleepGear®, and DreamSeal®, manufactured by Puritan Bennett. Figures 30-1 and 30-2 show other known masks 1900 that are commercially available from Puritan Bennett under the names Breeze®, SleepGear®, and DreamSeal®. As shown in the figures, the mask 1900 includes a frame 1902, a cushion 1904 provided to the frame 1902 and fitted to form a seal with the patient's nose when in use, an inlet tube 1908 provided to the frame 1902 and fitted to deliver a breathable gas to the patient, and a head support 1905 provided to the frame 1902 to maintain the mask 1900 in a desired position on the patient's face.

[0344] 3.5.0 Improved / Alternative Configuration The following embodiments describe improved and / or alternative configurations of Puritan Bennett's Breeze®, SleepGear®, and DreamSeal® masks for enhancing respiratory therapy.

[0345] 3.5.1 Sealing with foam Breeze®, SleepGear®, and DreamSeal® masks include a cushion constructed from a silicone material. In an alternative embodiment, as shown in Figure 30-3, the cushion may be a foam cushion 1904F constructed from a foam material F. The foam material F may include one or more of the foam properties described above, such as viscoelasticity and being uncoated.

[0346] 3.5.2 Partial Tube / Head Support The head support 1905 of the Breeze®, SleepGear®, and DreamSeal® masks includes a metal spring 1911, which supports a cradle 1913 adapted to engage with the back of the patient's head (see, for example, Figure 30-1). In an alternative embodiment, a plastic component may be used instead of the metal spring 1911, which may be molded as a single piece with the rest of the head support. Furthermore, the single-piece head support may be overmolded with an inlet tube 1908, for example, to reduce the number of parts and simplify assembly.

[0347] 3.5.3 Low Profile As shown in Figure 30-2, the Breeze®, SleepGear®, and DreamSeal® masks include a gap G between the inlet tube 1908 and the patient's nose / forehead. In alternative embodiments, the gap G can be reduced by altering the shape and / or path of the inlet tube 1908. For example, as shown in Figure 30-4, the inlet tube 1908 can be made flatter toward the top of the patient's head (e.g., a more oval cross-section 1917, as opposed to a circular cross-section 1919) and may have a configuration (e.g., hourglass shape) that provides a narrower portion 1921 when passing between the patient's eyes.

[0348] 3.5.4 Two-tube configuration In other embodiments, the mask may include two inlet tubes instead of a single inlet tube. For example, as shown in Figure 30-5, the frame 1902 may include a side inlet port 1914, which is adapted to engage with each inlet tube 1908 routed toward the top of the patient's head.

[0349] In this configuration, a manifold 1916 can be provided at the top of the patient's head to interconnect the tubes 1908.

[0350] 3.5.5 Cover or socks In other embodiments, one or more parts of the frame, inlet tube, and / or head support may include a cover or sock to improve appearance and / or comfort.

[0351] 3.6 Nasal-Aire (trademark) of InnoMed Technologies Figures 31-1 and 31-2 show other known masks 2000, which are marketed by InnoMed Technologies under the name Nasal-Aire®. As shown in the figures, the mask 2000 includes a nasal interface 2004 provided to the patient's nose when in use, inlet tubes 2008 provided on each side of the nasal interface 2004 to deliver a breathable gas to the patient, a manifold 2006 connecting the inlet tubes 2008, and a head strap 2005 that holds the mask 2000 in a desired position on the patient's face.

[0352] 3.6.0 Improved / Alternative Configuration The following embodiments describe improved and / or alternative configurations of InnoMed Technologies' Nasal-Aire® mask for enhancing respiratory therapy.

[0353] 3.6.1 Collapseable tubing The inlet tube of the Nasal-Aire® mask is substantially indestructible and / or resistant to crushing. In alternative embodiments, instead of the inlet tube, a collapsible conduit adapted to deliver breathable gas and stabilize the interface with the nose on the patient's face may be used. The collapsible conduit may include one or more of the properties of the collapsible tube described above. For example, each conduit may be equipped with a rigidizer and / or each conduit may have an overall D-shaped cross-section.

[0354] 3.6.2 Backstrap In one embodiment, as shown in Figure 31-3, the mask may include a back strap 2009 instead of a full-head strap to maintain the mask in a desired position on the patient's face. The back strap 2009 may include one or more of the characteristics of the back straps described above.

[0355] 3.6.3 Sealing with foam The Nasal-Aire® mask includes a nose interface constructed from a silicone material. In an alternative embodiment, as shown in Figure 31-4, the nose interface may be a foam nose interface 2004F constructed from a foam material F. The foam material F may include one or more of the foam properties described above, such as viscoelasticity and uncoated.

[0356] 3.6.4 Manifold The manifold of the Nasal-Aire® mask includes a relatively rigid, one-piece plastic structure. In alternative embodiments, the manifold may be constructed from multiple materials, e.g., rigid and semi-rigid parts, to improve comfort and / or appearance.

[0357] In other embodiments, the manifold can be positioned above the patient's head rather than being suspended downwards from the patient's head.

[0358] A preferred interface structure according to an embodiment of the present invention uses a foam having the properties shown in Figure 14-1. Known sealing interfaces have completely different bulk properties; for example, typical silicones have densities of 1050 to 1150 kg / m³. 3 It has a tear strength of 20 to 40 N / mm, a tensile strength of approximately 10 MPa, an elongation at break of 600%, a Shore A hardness of 40, a hysteresis of less than approximately 5%, an elasticity of approximately 40 to 50%, and breathability of 0.

[0359] While the present invention has been described in relation to what is currently considered the most practical and preferred embodiment, it should be understood that the invention should not be limited to the disclosed embodiments, but rather covers a variety of modifications and equivalent configurations encompassed within the spirit and scope of the invention. Furthermore, the various embodiments described above can be implemented in combination with other embodiments; for example, an aspect of one embodiment can be combined with an aspect of another embodiment to realize yet another embodiment. Moreover, each independent characteristic or component of a given assembly can constitute an additional embodiment. Furthermore, while the present invention has a specific application for patients with OSA, it should be understood that patients with other diseases (e.g., congestive heart failure, diabetes, morbid obesity, stroke, bariatric surgery, etc.) can also benefit from the above teachings. Furthermore, the above teachings are equally applicable to both patients and non-patients in non-medical applications. [Explanation of symbols]

[0360] 10. Patient Interface 20 Interface Structure 30 Air Delivery Systems 42 tubes 50 Rigidizers 60 Backstrap 70 Manifold

Claims

1. A patient interface for supplying air to a patient at positive pressure from an air supply source for the treatment of sleep-disordered breathing, A flexible support containing silicone, A subnasal interface, directly supported by the flexible support and configured to engage and seal with the lower, outside side of the patient's nose during use, The flexibility of the support allows the interface with the subnasal region to support the patient's nose during use, and the interface with the subnasal region can be sealed and engaged over the entire lower outside of the patient's nose without being inserted into the patient's nose. The interface with the subnasal cavity comprises at least one orifice formed to deliver breathable gas to the patient's airway, the at least one orifice being positioned outside the patient's airway and configured to communicate fluidly with the patient's airway during use. The interface with the area below the nose, An air delivery and stabilization system for delivering a supply gas suitable for breathing to the interface with the subnasal region and for supporting the interface with the subnasal region at a desired position on the patient's head, The manifold portion is configured to be positioned on the top of the patient's head and to come into contact with the patient's head during use. A first tube portion and a second tube portion, each of which extends in opposite directions and forms a silicone passage that is in fluid communication with the manifold portion to supply breathable gas to the interface with the subnasal area during use, the first tube portion and the second tube portion are configured to pass along each side of the patient's face between the patient's eyes and ears, and the silicone passage of each of the first tube portion and the second tube portion is configured to transition to at least a partial collapse phase by the weight of the patient's head during use, in which state the first tube portion or the second tube portion at least partially obstructs the flow of gas, the first tube portion and the second tube portion, A backstrap, which is detachably connected to the first and second tubular portions and configured to extend around the back of the patient's head when in use, wherein the backstrap is the only strap for interface with the patient, A pair of tabs molded integrally with the first tube portion and the second tube portion, and projecting rearward from therein during use, each tab having a hole formed for receiving the end of the backstrap for length-adjustable connection to the first tube portion and the second tube portion, An air delivery and stabilization system including, It is equipped with, The aforementioned back straps extend only posteriorly from each tab and are configured to incline downward from the tabs toward the patient's occipital bone when in use. No portion of the back strap extends forward of the first tube portion and the second tube portion in the direction toward the patient's face. The flexible support has a pair of end portions, each end portion configured to engage with one of the first and second tube portions. The interface with the patient.

2. The interface with the patient according to claim 1, wherein the interface with the area below the nose includes silicone.

3. The patient interface according to claim 1 or 2, wherein the lateral portion of the flexible support is more flexible than the central portion of the flexible support.

4. The flexible support is positioned on the opposite side of the interface with the area below the nose, CO ２ An interface with a patient according to any one of claims 1 to 3, comprising an exhaust hole for removal.

5. The flexible support is constructed from a plurality of materials having different stiffnesses, the interface with the patient according to any one of claims 1 to 4.

6. The patient interface according to any one of claims 1 to 5, wherein each of the first tube portion and the second tube portion includes a substantially flat contact surface with the patient.

7. The interface with a patient according to any one of claims 1 to 6, wherein each of the first and second tubular portions is configured to allow transitions between (1) an opening phase that enables the flow of gas and (2) the at least partial collapse phase.

8. The interface with a patient according to any one of claims 1 to 7, wherein the manifold portion is integrally formed with the tube portion as a partial piece structure.

9. The interface with a patient according to any one of claims 1 to 8, wherein the manifold portion includes an inlet tube portion rotatably coupled to the base portion.

10. The patient interface according to any one of claims 1 to 9, wherein each of the tube portions is provided with a stiffening element for providing rigidity to the tube portion.

11. The patient interface according to any one of claims 1 to 10, wherein each of the tube portions has a cross-section that changes along its length.

12. The patient interface according to any one of claims 1 to 11, wherein each tubular portion has a cross-sectional area that changes along its length and has a substantially constant hydraulic diameter.

13. The interface with the patient according to any one of claims 1 to 12, wherein each tubular portion has a non-circular cross-sectional shape.

14. The back strap comprises hook and loop material, the patient interface according to any one of claims 1 to 13.

15. The aforementioned back strap is configured to be positioned on the occipital bone of the patient when in use. The patient interface according to any one of claims 1 to 14.

16. The flexible support comprising a frame, the patient interface according to any one of claims 1 to 15.

17. The patient interface according to any one of claims 1 to 16, wherein each of the aforementioned tube portions has a bellows structure.

18. The patient interface according to any one of claims 1 to 17, wherein the first ends of the first tube portion and the second tube portion are directly connected to the respective sides of the manifold portion.

19. The patient interface according to any one of claims 1 to 18, wherein the flexibility of the support allows the support to conform to the patient's face during use, thereby enabling the interface with the subnasal area to support the patient's nose.

Images