Patient Interface Systems

Abstract

A patient interface system is disclosed. The present invention also discloses a patient interface structure for delivering a positive pressure air supply to an entrance of a patient's airway to treat sleep disordered breathing, comprising: a seal forming portion adapted to form a seal on the underside of the patient's nose; a base portion connected to the seal and located adjacent to the upper lip when in use; and an elastic structure located between the seal forming portion and the base portion, the elastic structure being relatively hard on a side adjacent to the upper lip so as to rotate the base portion away from the upper lip.

Description

[0001] This application is a divisional application of the invention patent application with application number 2018105238584, application date October 22, 2008, and invention name “PATIENT INTERFACE SYSTEM”. The application with application number 2018105238584 is a divisional application of the invention patent application with application number 201510015312.4, application date October 22, 2008, and invention name “PATIENT INTERFACE SYSTEM”. The application with application number 201510015312.4 is a divisional application of the invention patent application with application number 200880112819.X (international application number: PCT / AU2008 / 001557), application date October 22, 2008, and invention name “PATIENT INTERFACE SYSTEM”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to Australian Application Nos. 2007905737 and 2007906276, filed on October 22, 2007 and November 16, 2007, respectively, and U.S. Application Nos. 61 / 031,173 and 61 / 129,982, filed on February 25, 2008 and August 4, 2008, respectively, the entire contents of each of which are incorporated herein by reference. Technical Field

[0004] The present invention relates to a patient interface for delivering respiratory therapy to a patient. Examples of such therapy include continuous positive airway pressure (CPAP), non-invasive positive airway pressure ventilation (NIPPV), and variable positive airway pressure (VPAP). The therapy is used to treat various respiratory conditions including sleep disordered breathing (SDB), such as obstructive sleep apnea (OSA). Background Art

[0005] 1. Introduction

[0006] Providing a positive pressure air supply to the entrance of a patient's airway to treat SDB was first disclosed in U.S. Pat. No. 4,944,310 to Sullivan. A patient interface, such as a mask, facilitates the delivery of pressurized fluid. Mask systems can be classified as "nasal masks," "full face masks," "nose and mouth masks," and various orifice designs, including "nasal pillows," "nasal sprays," "nasal prongs," and "nasal cannula" designs. An example of a nasal pillow mask system is disclosed in WO 2004 / 073778 (Gunaratnam et al.), the contents of which are incorporated herein by reference.

[0007] Although different manufacturers use different terms to refer to different components, a patient interface system, also called a mask system, typically includes:

[0008] i) cushioning elements;

[0009] ii) a head strap system for positioning and holding the cushioning element in place;

[0010] iii) a rigid structure, commonly known as a frame or casing; and

[0011] iv) Air delivery pipe.

[0012] 1.1 Gasket elements

[0013] The cushioning element, or cushion, typically comprises a soft, conforming structure made of a material such as silicone, gel or foam. The cushion is held against an appropriate portion of the face to achieve a seal when in use. The cushioning element should form an adequate seal with the entrance to the airway to maintain sufficient air pressure to splinting open the airway. A perfect seal may not be necessary in some cases, provided that an adequate supply of air is provided at appropriate pressure and flow rates for effective treatment.

[0014] Nasal pillows and nasal sprays form a seal on the outside of the nostrils, while nasal prongs and nasal tubes are placed further into the nostrils and can form a seal on the inner surface of the nostrils instead of the outer surface. The location of the seal needs to be considered because different surfaces have different orientations, which means that the force vectors needed to form a seal can have different orientations. This may cause a headband that is suitable for one design to be unsuitable for another design. Moreover, different patients may prefer different seals, and some patients may find different seals more comfortable.

[0015] 1.2 Headband system

[0016] The mask system typically also includes a series of frame and head strap systems, the purpose of which is to provide force vectors of appropriate size and direction to hold the cushion in place.

[0017] 1.3 Framework

[0018] Many mask systems include a rigid or semi-rigid structure called a shell or frame. The cushioning element and the frame together can define a cavity. Typically, the cushion, headband, and air delivery tube are connected to the frame. The frame serves as an anchor point for the cushion, headband, and tube. Previous efforts in mask design have been directed to mechanisms for anchoring the frame in a fixed position relative to the face and then connecting the cushion to the frame to form a seal.

[0019] 1.4 Tube

[0020] Many mask systems require some form of tube, hose or conduit to deliver airflow to the mask for the patient to breathe. During use, tube drag can disrupt the seal. This is due to the weight of the tube and / or the movement of the patient. Although tube drag can be alleviated to some extent through the use of swivel tubes, ball joints and tube anchors, many patients still feel the need for overly tight headbands, which try to reduce this problem, but this causes discomfort.

[0021] 2. Prior Art

[0022] There are many factors to consider when designing an effective respirator system. Minor changes in appearance can improve or degrade comfort or effectiveness.

[0023] Although millions of people suffer from sleep-disordered breathing conditions, many fail to comply with treatment due to issues of comfort, ease of use, stability, leakage, and compliance, thereby exposing themselves to health risks.

[0024] Some prior art mask systems attempt to anchor a rigid frame in a fixed position relative to the face and require the patient to increase headgear tension to a level high enough to overcome the seal-breaking effects of patient movement, and / or tube drag.

[0025] While some smaller patient interfaces (e.g., some nasal sprays and some nasal prongs) may be less rigid than larger masks (e.g., full-face masks), they lack stability. The interface stability of such smaller interfaces is improved by holding a frame in a fixed position in front of and below the patient's nostrils. A cushion including a nozzle extends from the frame to the nostrils. The frame is held in a rigid manner (i.e., a set position) in order to ensure accurate alignment of the nasal pillows.

[0026] Some prior art patient interfaces include a swivel elbow or a ball and socket joint.

[0027] Some headgear designs incorporate semi-rigid elements that increase the stability of the mask frame. Some frames are designed with a horizontal center tube connection point.

[0028] Some existing patient interfaces require the patient to increase headgear tension to high levels in an effort to overcome the breaking force. This can cause excessive forces on sensitive areas of the face, causing discomfort to the patient.

[0029] refer to Figure 1, a prior art respiratory mask system may include a cushion 24, which includes, for example, a nasal pillow. The cushion 24 is supported on a rigid frame or shell 18 and a flexible element 22, such as a gusset, is disposed between the cushion 24 and the frame 18. An air delivery hose or tube 16 is connected to the frame 18 to deliver a pressurized flow of breathable gas. A rigid headband 20 is connected to the frame 18 to maintain the cushion 24 in sealing contact with the nose of the patient 1.

[0030] Available in Figure 1 The cushions used in the prior art respiratory mask systems shown include those of ResMed Corporation, for example. Those pads disclosed in LT.

[0031] Figure 2 Another respiratory mask system according to the prior art is schematically shown, the 481 mask. A cushion 24 including a nose prong 23 is connected to a mask frame or shell 18. The mask frame includes a headband connector 26 disposed on one side of the mask frame 18. A vent including a plurality of vent holes 28 is also disposed in the mask frame 18.

[0032] The mask frame 18 is connected to an air delivery hose or tube 16 via a swivel elbow 17. The air delivery tube 16 is connected via a connection element 30 to a flow of pressurized breathable gas, such as generated by a blower or flow generator.

[0033] When the headgear is connected to the mask frame 18 via the headgear connector 26, any relative movement between the mask frame 18 and the patient's face may cause a disruption to any seal that has been formed. Summary of the invention

[0034] One approach is to provide a comfortable, stable, effective, non-compulsive patient interface system to deliver a positive pressure air supply to the entrance of a patient's airway. Another approach is to provide a patient interface system that fits a wide range of patients, has improved manufacturability and improved ease of use.

[0035] Another approach is directed to providing a patient interface system in which forces applied to the patient interface structure, such as by tube drag or patient movement, do not disrupt the seal between the patient interface structure and the patient's airway.

[0036] Still another approach involves providing a patient interface system in which a patient interface structure including a seal and a seal positioning and stabilizing structure is connected to the patient, and the air delivery tube is isolated from the seal. Another approach is to isolate the forces on the air delivery tube and elbow from the nasal pillows and headgear.

[0037] Yet another aspect relates to a patient interface system in which the tension of the seal positioning and stabilizing structure can be set with less concern for overcoming tube drag, since tube drag does not disrupt the seal effect due to isolation. Thus, according to this aspect, the tension of the seal positioning and stabilizing structure can be reduced and the comfort of the patient can be increased.

[0038] Yet another approach is directed to providing a patient interface system in which a patient interface structure is coupled to a swivel elbow assembly without the use of a rigid frame or housing.

[0039] Another aspect of the present technology is to provide a patient interface structure that reduces the number of rigid elements or does not include a rigid element. For example, one form of the patient interface structure does not include a rigid frame.

[0040] Another embodiment of the present technology is a patient interface structure that flexibly wraps around the underside of the patient's nose and accommodates different nasal angles when in use.

[0041] Another aspect of the present technology is a patient interface structure that accommodates movement of the air delivery tube while maintaining an effective seal.

[0042] Another solution of the present technology is a stabilizing structure that directs the sealing force to an area close to the sealing surface, such as the bottom of the nose. The force close to the sealing surface reduces the bending arm.

[0043] According to yet another aspect of the present technology, the front portion of the seal positioning and stabilizing structure is molded from a flexible polymer such as silicone. Preferably, the seal positioning and stabilizing structure does not include a hard plastic stabilizer.

[0044] According to an exemplary embodiment, a patient interface system for delivering a positive pressure air supply to an entrance to a patient's airway to treat sleep-disordered breathing includes: an air delivery tube connected to a flexible portion of an inflatable chamber; a ventilation structure having sufficient rigidity to support its own weight under gravity and / or not to block or collapse in the event of tube movement or tube drag; a patient interface structure including a seal-forming structure arranged on a top of the inflatable chamber; and a seal positioning and stabilizing structure connected to the flexible portion of the inflatable chamber, wherein the seal-forming structure is substantially isolated from tube drag forces.

[0045] According to another exemplary embodiment, a nasal pillow for delivering a positive pressure air supply to the entrance of a patient's airway to treat sleep disordered breathing includes: a rod; a truncated cone portion connected to the rod at the base of the truncated cone portion, the truncated cone portion including a resilient structure at the base of the truncated cone portion, the resilient structure being configured to engage the patient's upper lip and rotate the rod away from the patient's upper lip.

[0046] According to yet another exemplary embodiment, a patient interface structure for delivering a positive pressure air supply to an entrance of a patient's airway to treat sleep disordered breathing comprises: a flexible base portion; a seal-forming structure connected to the base portion; and a transverse connector connected to the flexible base portion in substantially the same plane as a base of the seal-forming structure, wherein the flexible base portion includes a flexible side wall plenum chamber including an orifice adapted to receive an air supply, the orifice having an axis substantially parallel to an axis of the seal-forming structure.

[0047] According to another exemplary embodiment, a decoupling assembly is provided for isolating forces applied by a tube to a patient interface structure, the patient interface structure being configured to deliver a positive pressure air supply to an entrance of a patient's airway to treat sleep disordered breathing, the patient interface structure comprising a flexible base portion connected to a seal-forming structure, wherein when in use the patient interface structure is maintained in engagement with the patient by a seal positioning and stabilizing structure connected to the flexible base portion, the decoupling assembly comprising a flexible base portion, a seal-forming structure, and at least one of: a portion of the seal positioning and stabilizing structure, a swivel elbow, a ball and socket member, a swivel seal ring, and a tube.

[0048] According to yet another exemplary embodiment, a seal positioning and stabilizing structure of a patient interface structure for delivering a positive pressure air supply to an entrance to a patient's airway to treat sleep disordered breathing includes a flexible molded strap having a reinforced portion.

[0049] In another disclosed embodiment, a patient interface suitable for connection to an air delivery tube includes: a subnasal air delivery unit and a plurality of elements operably connected to the air delivery unit, the elements including a headband, an inflatable chamber, a frame or base, and an elbow; and an isolation system for isolating (or isolating in an alternative manner) at least a portion of the drag (or other power) from the air delivery tube, which would otherwise be applied to the air delivery unit. The air delivery unit may be in the form of a nasal prong that is inserted into the nostrils to form a seal in the user's nasal passages; in the form of a nozzle that seals the lower outer surface of the nostrils; or in the form of a nasal tube (which is partially inserted into the nasal passages but not necessarily formed to form a seal). The nozzle may include a rod, a head, or other structure to help isolate the drag or other power. The plurality of elements may also include a sealing ring that may help isolate the tube drag force. The isolation system (or isolation method) may include two or more (or all) of the above elements (and the air delivery unit itself, such as various parts of the nozzle), which work in concert to isolate the force from the air delivery unit.

[0050] Other aspects, features and advantages will become more apparent from the following detailed description taken in conjunction with the accompanying drawings, which are a part of this disclosure and illustrate other aspects and principles by way of example. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] The accompanying drawings facilitate understanding of the various embodiments, wherein:

[0052] Figure 1 Schematically illustrates a patient interface system according to the prior art;

[0053] Figure 2 Schematically illustrates a patient interface system according to the prior art;

[0054] Figure 3a schematically illustrates a patient interface system according to an exemplary embodiment;

[0055] Figure 3b schematically illustrates vectors provided by an exemplary embodiment;

[0056] Figure 4 schematically illustrates a patient interface structure according to an exemplary embodiment;

[0057] Figure 5a schematically illustrates a patient interface system according to another exemplary embodiment;

[0058] Figure 5b schematically illustrates a flexible elbow according to an exemplary embodiment;

[0059] Figure 5c and 5d schematically illustrates a bent pipe structure according to an exemplary embodiment;

[0060] Figure 6 schematically illustrates a patient interface system according to another exemplary embodiment;

[0061] Figure 7a schematically illustrates a patient interface system according to other exemplary embodiments;

[0062] Figure 7b and 7c schematically illustrates a strap according to an exemplary embodiment;

[0063] Figure 7d schematically illustrates a patient interface structure according to an exemplary embodiment;

[0064] Figure 8a schematically illustrates a patient interface structure including nasal pillows according to an exemplary embodiment;

[0065] Figure 8bschematically illustrates a connector of a patient interface structure according to an exemplary embodiment;

[0066] Figure 8c schematically illustrates a patient interface structure including nasal pillows according to another exemplary embodiment;

[0067] Figure 8d schematically illustrates a patient interface structure including nasal pillows according to another exemplary embodiment;

[0068] Figure 8e schematically illustrates a patient interface structure including nasal pillows according to another exemplary embodiment;

[0069] Figure 8f schematically illustrates a patient interface structure including nasal pillows according to another exemplary embodiment;

[0070] Figure 8g schematically illustrates a patient interface structure including nasal pillows according to another exemplary embodiment;

[0071] Figure 8h Schematically shows Figure 8f a linking element of a patient interface structure;

[0072] Figure 8i schematically illustrates a patient interface structure including nasal pillows according to another exemplary embodiment;

[0073] Figure 8j Schematically shows Figure 8i an adjustment element of a patient interface structure;

[0074] Figure 8k schematically illustrates a patient interface structure including nasal pillows according to another exemplary embodiment;

[0075] Figure 8l and 8m Schematically illustrating a comparison between exemplary embodiments;

[0076] Figure 8n schematically illustrates a patient interface structure including nasal pillows according to another exemplary embodiment;

[0077] Figure 9a and 9b schematically illustrates a patient interface structure connected to an elbow or frame according to an exemplary embodiment;

[0078] Fig.10 schematically illustrates a patient interface system according to an exemplary embodiment;

[0079] Fig.11 schematically illustrates a patient interface system according to an exemplary embodiment;

[0080] Fig.12a and 12b schematically illustrating a side view and a rear view, respectively, of a patient interface system according to another exemplary embodiment;

[0081] Fig.13a and 13b schematically illustrating a side view and a rear view, respectively, of a patient interface system according to another exemplary embodiment;

[0082] Fig.14a and 14b schematically illustrating a side view and a rear view, respectively, of a patient interface system according to another exemplary embodiment;

[0083] Fig.15a and 15b schematically illustrating a side view and a rear view, respectively, of a patient interface system according to another exemplary embodiment;

[0084] Figures 16a to 16g Schematically illustrating left and right main straps of a main strap loop of a seal positioning and stabilizing structure according to an exemplary embodiment;

[0085] Figures 17a to 17g schematically illustrates an exemplary embodiment of a patient interface structure according to an exemplary embodiment;

[0086] Figure 17h and 17i schematically illustrates a rotating seal according to an exemplary embodiment connected to a patient interface structure according to an exemplary embodiment;

[0087] Fig.17j Schematically illustrates a patient interface system according to an exemplary embodiment, which includes an air delivery tube, an elbow, a rotating seal ring, and a patient interface structure;

[0088] Figure 17k Schematically illustrates a seal formed between an elbow and a rotating seal ring according to an exemplary embodiment;

[0089] Figure 17l schematically illustrates a sealing ring according to another exemplary embodiment;

[0090] Figure 17m schematically illustrates a sealing ring according to another exemplary embodiment;

[0091] Figure 17n and 17o schematically illustrates a rotary seal ring according to another exemplary embodiment;

[0092] Figures 18a to 18cschematically illustrates the connection of a patient interface structure to a seal positioning and stabilizing structure according to an exemplary embodiment;

[0093] Figures 18d to 18q schematically illustrates the connection of a patient interface structure to a seal positioning and stabilizing structure according to other exemplary embodiments;

[0094] Figure 18r and 18s schematically illustrates a cross-section of a patient interface structure according to an exemplary embodiment;

[0095] Figures 19a to 19e schematically illustrates a step lock connector according to an exemplary embodiment;

[0096] Fig.20a and 20b schematically illustrates a seal positioning and stabilizing structure strap connector according to an exemplary embodiment;

[0097] Fig.21a and 21b Another exemplary embodiment of a seal positioning and stabilizing structure strap connector is schematically illustrated;

[0098] Fig.22a and 22b Schematically illustrates an exemplary embodiment of a seal positioning and stabilizing structure strap connector;

[0099] Figures 23a to 23c schematically illustrates a seal positioning and stabilizing structure strap connector according to another exemplary embodiment;

[0100] Figures 24a to 24l schematically illustrates a seal positioning and stabilizing structure including a connector according to another exemplary embodiment;

[0101] Figures 24m to 24q A patient interface system according to an exemplary embodiment is schematically shown, the patient interface system comprising Figures 24a to 24l Sealing positioning and stabilizing structure;

[0102] Figure 24r schematically illustrates a strap connector according to another exemplary embodiment;

[0103] Figures 25a to 25f schematically illustrates a seal positioning and stabilizing structural connector according to other exemplary embodiments;

[0104] Fig.26a and 26b schematically illustrates a nasal pillow according to an exemplary embodiment;

[0105] Fig.27a and 27bschematically illustrates a nasal pillow according to another exemplary embodiment;

[0106] Fig.28a and 28b schematically illustrates a nasal pillow according to another exemplary embodiment;

[0107] Fig.29a and 29b schematically illustrates a nasal pillow according to another exemplary embodiment;

[0108] Fig.30a and 30b schematically illustrates a nasal pillow according to another exemplary embodiment;

[0109] Fig.31a and 31b schematically illustrates a nasal pillow according to another exemplary embodiment;

[0110] Figures 32a to 32f schematically illustrates a nasal pillow according to another exemplary embodiment;

[0111] Fig.33a and 33b schematically illustrates a nasal pillow according to another exemplary embodiment;

[0112] Fig.34 schematically illustrates a nasal pillow according to another exemplary embodiment;

[0113] Fig.35 schematically illustrates a nasal pillow according to another exemplary embodiment;

[0114] Fig.36 schematically illustrates a nasal pillow according to another exemplary embodiment;

[0115] Fig.37 schematically illustrates a nasal pillow according to yet another exemplary embodiment;

[0116] Fig.38a and 38b schematically illustrates a nasal pillow according to another exemplary embodiment;

[0117] Figures 39a to 39h schematically illustrates nasal pillows according to other exemplary embodiments;

[0118] Fig.40 schematically illustrates a nasal pillow structure according to another exemplary embodiment;

[0119] Fig.41 schematically illustrates a nasal pillow according to another exemplary embodiment;

[0120] Figures 42a to 42cschematically illustrates a patient interface system according to an exemplary embodiment in various stages of sealing engagement with a patient;

[0121] Figures 43a to 43c schematically illustrates a patient interface system according to an exemplary embodiment in various stages of sealing engagement with a patient;

[0122] Fig.44a and 44b schematically illustrates a patient interface system according to an exemplary embodiment;

[0123] Figures 45a to 45e schematically illustrates a patient interface system according to an exemplary embodiment;

[0124] Fig.46a and 46b schematically illustrates a strap of a seal positioning and stabilizing structure according to an exemplary embodiment; and

[0125] Fig.47a and 47b A patient interface system according to an exemplary embodiment is schematically shown. DETAILED DESCRIPTION

[0126] The description provided below relates to some embodiments that may share common characteristics and features. It should be understood that one or more features of any one embodiment may be combined with one or more features of other embodiments. In addition, any single feature or combination of features in any one embodiment may constitute other embodiments.

[0127] In this specification, the word "include" should be understood in its "open" sense, that is, the meaning of "including", rather than being limited to its "closed" sense, that is, the meaning of "including only". The corresponding words "include", "included" and "comprising" have corresponding meanings.

[0128] The term "air" will include breathable gases, such as air with supplemental oxygen. It is also recognized that the blowers or flow generators described herein can be designed to pump fluids in addition to air. The term "rigid" means not easily deformed under finger pressure and / or under the tension or pressure typically encountered when installing and maintaining a patient interface in sealing contact with the entrance of a patient's airway. The term "semi-rigid" means sufficiently rigid so as not to be significantly distorted under the effects of tube drag.

[0129] 3. Patient interface system

[0130] 3.1 Introduction

[0131] Figure 3aSchematically illustrates one approach to the present technology whereby headband tension is directed near the base of the nose and the potentially damaging effects of tube drag are isolated or disconnected from the seal. Figure 4 By comparing the method, refer to Figure 1 , where the headband structure attempts to stabilize the frame at a point away from the sealing surface (base of the nose) so that the tube is connected directly to the headband through a rigid frame. Figure 3a , a patient interface system according to an exemplary embodiment may include a patient interface structure 32 configured to sealingly engage the airway of patient 1. Patient interface structure 32 may include a seal such as a nasal pillow or a nasal prong to sealingly engage the airway of the patient. As used herein, the term "nasal pillow" refers to a nozzle-like structure that is configured to be at least partially inserted into the nasal passage of the patient and form a seal on the outer surface of the patient's nostril.

[0132] A nasal pillow according to the present technology includes: a frustoconical portion, at least a portion of which forms a seal on the underside of a patient's nose; a rod, a flexible region on the underside of the conical portion and connecting the conical portion to the rod. In addition, the structure connecting the nasal pillows of the present technology includes a flexible region adjacent to the base of the rod. The flexible region can work together to facilitate a universal joint structure that can accommodate relative movement - both displacement and angulation - between the frustoconical portion and the structure connecting the nasal pillow. For example, the frustoconical portion can move axially toward the structure to which the rod is connected.

[0133] Related nasal pillows according to the present technology are described in WO 2006 / 130903 A1, the contents of which are incorporated herein by reference, for example, paragraphs

[00254] and

[00255] and Figure 66c. The term "nasal prong" refers to a nozzle-like structure that is configured to be inserted into the patient's nasal passage and form a seal with the interior of the patient's nasal passage. It should also be understood that the patient interface structure 32 may include a nasal patient interface structure or a full-face patient interface structure, that is, a structure configured to cover part or all of the patient's nose and / or mouth and seal the patient's face. The patient interface structure may be formed of materials such as silicone, foam, gel.

[0134] The patient interface structure 32 may be connected to the air delivery hose or tube 16 via a spacer 34. The spacer 34 may include, for example, a flexible portion of the patient interface structure 32, a swivel elbow including, for example, a ball and socket connection and / or a swivel seal. The air delivery hose may be a retractable hose, such as disclosed in U.S. Application No. 12 / 211,896 filed September 17, 2008, the entire contents of which are incorporated herein by reference.

[0135] The patient interface system may also include a seal positioning and stabilizing structure 36 configured to position and stabilize the patient interface structure 32 by sealingly engaging the patient's airway. The seal positioning and stabilizing structure 36 may be flexible. Figure 3a As shown, the seal positioning and stabilizing structure is connected to the patient interface structure 32. The seal positioning and stabilizing structure 36 may include side straps or components 38 that are configured to extend along each side of the patient's face. Figure 3a Only one is shown; a top strap 40, which is configured to extend across the top of the patient's head; and a rear strap 42, which is configured to extend around the back of the patient's head.

[0136] In use, each side strap 38 of the seal positioning and stabilizing structure 36 can be connected to the patient interface structure 32. For example, a connector can be provided on each side of the patient interface structure 32, with one connector on each side of the patient's 1 nose. It should be understood that multiple connectors can be provided to the patient interface structure and in any arrangement, such as two connectors on each side of the patient's nose. The pair of connectors form a connection between the patient interface structure 36 and the seal positioning and stabilizing structure 36, as described in more detail herein. The connection is proximate the entrance to the patient's 1 nostrils. In this way, the straps 38, 40, 42 of the seal positioning and stabilizing structure 36 maintain a seal on the patient's face in a more direct manner than the arrangements of the prior art, such as Figure 1 The prior art arrangement shown in FIG. Figure 1 In the prior art arrangements, the connection of the seal positioning and stabilizing structure straps to the frame is moved from the entrance of the patient's nostrils and the patient interface structure is held to the patient's face in an indirect manner.

[0137] exist Figure 3a In the illustrated arrangement, the isolation device 34 is disposed between the connection of the strap 38 of the seal positioning and stabilizing structure 36 and the connection to the air delivery tube 16 so that tube drag does not directly affect the seal formed between the patient interface structure 32 and the patient's airway.

[0138] In typical Figure 1 In the prior art arrangements shown, the headband tension is often set at a level that both creates a seal and overcomes possible tube drag. Figure 3a In the exemplary embodiment shown, tube drag is somewhat isolated from the seal formed between the patient interface structure 32 and the patient's airway, and the tension provided by the seal positioning and stabilizing structure need only be set to a level necessary for the seal. Thus, the tension can be set with less concern for overcoming tube drag. Reduced tension can increase patient comfort.

[0139] like Figure 3aAs shown, the flexible seal positioning and stabilizing structure 36 can be configured so that the force vectors provided by the straps 38, 40, 42 of the seal positioning and stabilizing structure 36 maintain the patient interface structure 32 in sealing engagement with the nares of the patient 1. However, it should be understood that other seal positioning and stabilizing structures can be used, as described in more detail herein. For example, the straps can be routed to wrap around and engage with the patient's ears. According to another exemplary embodiment, the straps can be removed and a nose clip can be used to maintain the seal of the patient interface structure 32 in place.

[0140] The seal positioning and stabilizing structure 36 may be formed from a foam and fabric laminate, such as Alternatively, the seal positioning and stabilizing structure 36 may be formed from silicone or other polymers. One advantage is that when using silicone or There is no change in the temperature of the patient's skin when the headband is worn. However, silicone can discolor over time (typically oxidizing to a yellow color). Therefore, it is desirable to add a tint, such as a light blue, to the silicone to reduce the visual impact of the discoloration. Sharp corners of the headband can also be blunted to reduce irritation of the patient's skin.

[0141] Silicone can be polished or matte on both sides, or matte on one side and polished on the other - preferably matte on both sides, or matte on the skin contact side and polished on the outside. Matte surface finish Feels comfortable.

[0142] The isolation device 34 acts as a flexible connector and connects the patient interface structure 32 to the air delivery tube 16. Figure 3a In the exemplary embodiment shown, only the seal of the patient interface structure 32 is maintained in a set position. No housing or frame needs to be maintained in a set position. The isolation device 34 moves freely with the air delivery tube 16, thereby reducing tube drag and increasing the stability of the seal formed between the patient interface structure 32 and the airway of the patient 1.

[0143] The use of the seal positioning and stabilizing structure 36 also allows the plane of the patient interface structure 32 to be rotated relative to the seal positioning and stabilizing structure 36, thereby accommodating different nasolabial angles and different mask positions during use. For example, a connector provided on the patient interface structure 32 may include multiple connection points to allow the relative position of the patient interface structure 32 relative to the seal positioning and stabilizing structure 36 to be changed or adjusted. The axis about which the rotation is made may be defined as being parallel to a line passing through the patient's eyes and located below the patient's nose.

[0144] like Figure 3bAs shown, the desired vector 404 will produce a normal force to the nostril. The entire vector 404 pulls a seal such as a nasal pillow relative to the nostril.

[0145] The vectors of the seal positioning and stabilizing structure 36 of the exemplary embodiment are configured to elevate a seal such as a nasal pillow relative to the patient's nose. The vectors can be varied by the orientation of the straps 38, 40, 42. For example, the straps 38 can extend higher on the face (i.e., closer to the eyes than the ears of the patient's cheeks) to increase the force in the vertical axis to increase the upward force and against the user's nose.

[0146] The shape of the straps 38, 40, 42 may also be configured to provide the desired vectors: According to an exemplary embodiment, the frameless arrangement requires the use of the seal positioning and stabilizing structure alone to position the nasal pillows. The width of the straps may be varied to force the seal to tilt in the direction indicated by vector 404. The width of the straps may be gradually increased from the cheek region to the nose region to stabilize the patient interface structure 32.

[0147] Changing the thickness of the strap changes the stiffness and thus the force distribution along the strap.

[0148] refer to Fig.44a and 44b , according to an exemplary embodiment, the patient interface system includes a patient interface structure 32 having a flexible base portion 6. A seal is supported by the flexible base portion 6. The patient interface structure 32 is configured to maintain sealing engagement with an entrance to the patient's airway. The patient interface structure 32 is maintained in sealing engagement with the patient's face by a seal positioning and stabilizing structure 36, which includes a main strap loop 74 and a rear strap 42. The main strap loop 74 includes a right main strap 74r and a left main strap 74l, which are configured to be connected to the patient interface structure 32 at respective first ends. The right and left main straps 74r, 74l are configured to be connected to each other at respective second ends, for example, by a connector 71 such as a buckle. The rear strap 42 of the seal positioning and stabilizing structure 36 extends around the back of the patient's head at a position above the patient's ears and is connected to the right and left main straps 74r, 74l at respective ends at a position between the first and second ends of the straps 74r, 74l.

[0149] refer to Fig.47a and 47bAccording to another exemplary embodiment, a patient interface system includes a patient interface structure 320, which includes a flexible substrate. The seal is supported by the flexible substrate. The patient interface structure 320 is configured to maintain sealing engagement with the entrance of the patient's airway. The patient interface structure 320 is maintained in sealing engagement with the patient's face by a seal positioning and stabilizing structure, which includes a main strap ring 74 and a rear strap 85 with an adjustable end 85e. The main strap ring 74 includes a right main strap 74r and a left main strap 74l, which are configured to be connected to the patient interface structure 320 at their respective first ends. The right and left main straps 74r, 74l can be connected to each other at their respective second ends, for example, by a connector such as a buckle. The rear strap 85 of the seal positioning and stabilizing structure extends around the back of the patient's head at a position above the patient's ears and is connected to the right and left main straps 74r, 74l at each end at a position between the first and second ends of the straps 74r, 74l.

[0150] The right and left main straps 74r, 74l may be formed of, for example, silicone. The silicone may be, for example, translucent or transparent. The patient interface system is thus less obtrusive and presents a more visually appealing appearance (eg, to a companion of the patient).

[0151] The "take off angle" of the straps 74r, 741 to the connection point provides a more corrective angle to the bottom of the patient's temple and generally higher on the patient's face. The patient interface structure also conforms to or wraps around the patient's mouth area and has less interference with the area around the mouth. Also, the seal positioning and stabilizing structure covers a smaller area of ​​the patient's face.

[0152] 3.2 Patient interface structure

[0153] 3.2.1 Patient interface structure including nozzle assembly seal

[0154] refer to Figure 4, according to an exemplary embodiment, the patient interface structure 32 includes a seal 2 configured to sealingly engage the patient's airway. The seal 2 may include a nozzle assembly 3, which may include a pair of nasal pillows 4 connected to a base 6. Each nasal pillow 4 includes a conical portion 8, which is at least partially adapted to form a seal with the nostrils of the patient 1. As described above, a portion of each nasal pillow 4 is configured to be inserted into the patient's nasal passage, but does not form a seal inside the nasal passage. The conical portion 8 of the nasal pillow 4 includes a sealing surface or area 8a configured to engage the patient's nostrils and form a seal. The sealing surface or area 8a may be as disclosed in Figure 21 of WO 2004 / 073778 A1, which is incorporated herein by reference. Each nasal pillow 4 also includes a rod or neck 10, which connects the nasal pillow 4 to the flexible base 6. The rod or neck 10 may have a length between approximately 3 mm and 6 mm.

[0155] The flexible base 6 is capable of wrapping around the underside of the nose under tension when in use and is capable of adapting to different facial shapes. The flexible base 6 includes a pair of connectors 12 configured to connect to the seal positioning and stabilizing structure. The seal positioning and stabilizing structure connectors 12 are arranged at the top 6t of the flexible base 6, generally in the same plane as the base of the stem of the nasal pillow 4. As used herein, the term "top" refers to the portion of the flexible base adjacent to the seal of the patient interface structure. When the seal is extended from one side (e.g., at Figure 17g and 17h When viewed in the middle, the axis of the rod passing through the nasal pillow is generally parallel to the normal of the hole 324 through which the air supply is delivered. This arrangement is more convenient than, for example, Resmed's I (see, for example, FIG. 76A of WO 2004 / 073778 A1) or NASAL AIRE of Innomed TM Contributes to the typically narrower patient interface structure, in Innomed’s NASAL AIRE TM Air is supplied from one side of the mask structure, which is wider than the overall structure, so the patient interface structure according to the present technology is more acceptable to patients for side sleeping. TM and OPUS TM Other patient interface structures in 360 include Figure 17g and 17h The air is delivered at an obtuse angle relative to the axis of the nasal pillow when viewed in the corresponding direction. This approach can result in a larger volume structure.

[0156] Tension 14 is applied to the patient interface structure 32 by the seal positioning and stabilizing structure to maintain the sealing engagement of the nasal pillows 4 of the seal 2 with the nostrils of the patient 1. The lower portion 61 of the flexible base 6 forms part of the isolation device. For example, the lower portion 61 of the flexible base 6 may include a gusset such as disclosed in WO 01 / 97893 A1, which is incorporated herein by reference. As used herein, the term "lower portion" refers to a portion of the flexible base that is configured to be connected to an air delivery tube or hose, or to a frame or housing. The lower portion 61 can define an inflatable chamber by flexible side walls. The inflatable chamber is flexible, but not so soft or loose that it cannot support its own weight. In other words, the inflatable chamber is able to maintain its own shape before being pressurized by a breathable airflow. In this manner, the inflatable chamber can be described as semi-rigid.

[0157] The plenum chamber may have a flexible bellows-like structure on the left and right hand sides, with narrow portions adjacent to the top edge and underside of the nose to avoid contact therewith during use. See, for example Fig.17a , the end of line 329 is located within the flexible bellows-shaped region 339 and the end of arrow 320 is adjacent to the narrowed region 321, as shown in FIG. Figure 18r See also Fig.17d , where T4 indicates suitable for providing Figures 42a-42c and Figures 43a-43c The flexibility of the inflatable chamber can be enhanced by manufacturing with a material such as silicone having a Shore A durometer range of about 20 to 60, more preferably about 30 to 50, and most preferably about 40. Harder silicones can use thinner walls, and softer silicones can use thicker walls. The rounded bellows-like structure also promotes flexibility, regardless of the material of construction. Another inflatable chamber can be molded from polyurethane foam. Existing INFINITY TM 481、OPUS TM OPUS TM 360 and Respironics' OPTILIFE TM Patient interfaces include a range of rigid materials such as polycarbonate. TM Other Ultimate masks include a rigid headband connector.

[0158] The patient interface structure 32 may be formed as a unitary piece, for example by molding a material such as silicone. In one form of exemplary embodiment, the range of movement provided by the flexibility of the nasal pillows 4 relative to the top 6t of the flexible base 6 may be relatively small compared to the range of movement provided by the lower portion 6l of the flexible base 6 as part of the isolation device.

[0159] In use, the straps of the seal positioning and stabilizing structure are connected to each of the seal positioning and stabilizing structure connectors 12, one on each side of the patient's nose, as shown in FIG. 3, to establish a connection. The connection is close to the plane of the entrance of the patient's nostril. In this way, the straps of the seal positioning and stabilizing structure 36 are more flexible than, for example, Figure 1 The prior art arrangement shown in FIG. 4 more directly holds the nasal pillow 4 in place. Figure 1 In the embodiment of the invention, the plane connecting the entrance of the nostril deviates from the patient's nostril. TM 481、OPUS TM OPUS TM 360 and Respironics' OPTILIFE TM Other prior art patient interfaces place the connection point some distance from the nostrils. The lower portion 61 of the flexible base 6 acts as part of a spacer between the plane of connection to the straps of the seal positioning and stabilizing structure 36 and the plane of connection to the air delivery tube 16 so that tube drag does not directly affect the seal formed between the nasal pillows 4 and the patient's nostrils.

[0160] refer to Figure 8b and 8n , a patient interface structure 32 according to another exemplary embodiment may include a seal 2 including a nozzle assembly 3 having a pair of nasal pillows 4. The flexible base 6 may include an integrally formed connector 50. The patient interface structure 32 may be connected to an isolation device such as a swivel collar to isolate tube drag forces, as will be described in more detail.

[0161] Each nasal pillow 4 may include a conical portion 8 and a neck 10. Each conical portion 8 may include a sealing area 8a, which is configured to form a seal against the patient's nares. The nasal pillows 4 may be formed with or removably connected to a patient interface structure 32, as described in WO 2005 / 063328, the entire contents of which are incorporated by reference. The patient interface structure 32 may further include an aperture 46 to direct the flow of breathable gas into the patient interface structure 32. The aperture 46 may be formed in the lower portion 61 of the flexible base 6 and surrounded by a flange 48, and the aperture 46 is configured to engage an air delivery tube, or a swivel elbow assembly, or a ball and socket connection. It should also be understood that the flange 48 of the patient interface structure 32 may be configured to connect to a frame or housing.

[0162] The patient interface structure 32 may be formed of a flexible material such as silicone. The patient interface structure 32 may be formed as a single piece, including the nasal pillows 4, the flange 48, and a pair of connectors 50 disposed at each end of the patient interface structure 32. Figure 8bAs shown, each connector 50 may include a first slot 52 and a second slot 54 for receiving one end of a strap of the seal positioning and stabilizing structure. The first slot 52 and the second slot 54 are separated by a crossbar 56, which can engage the end of the strap to keep the end of the strap in contact with the connector 50. The patient interface structure 32 including the connector 50 is flexible, and the connector 50 is stretched by the force applied by the seal positioning and stabilizing structure, such as through the side straps, thereby enhancing the force applied by the crossbar 56 on the seal positioning and stabilizing structure strap.

[0163] The patient interface structure 32 including the connector 50 can be integrally formed, for example, by molding. The patient interface structure 32 can be formed to have different densities and / or hardnesses. For example, the nasal pillows 4 and / or the flexible substrate 6 can be formed of a first density and / or hardness, while the connector 50 can be formed of a second density and / or hardness. The second density and / or hardness can be higher than the first density and / or hardness. This allows the patient interface structure 32 to be formed to have a softer feel in those areas that engage the patient's face (e.g., the nozzle assembly of the seal) and a harder, or more rigid feel in the area connecting the seal positioning and stabilizing structure. The hardness of the patient interface structure, such as a durometer, can be different from the hardness of the seal positioning and stabilizing structure described below. For example, the hardness of the connector and / or the flexible substrate of the patient interface structure can be different from the straps and / or connectors of the straps of the seal positioning and stabilizing structure.

[0164] 3.2.2 Patient interface structure including nasal prongs as seal

[0165] Figure 5a and 6 One aspect of the present technology is shown whereby the connection point of the seal positioning and stabilizing structure is moved closer to the base of the seal, such as closer to the base of a nasal pillow or prong. Figure 5a , according to an exemplary embodiment, the patient interface system includes a patient interface structure 32a, which includes a seal 2a, and the seal 2a includes a nozzle assembly 3a. The nozzle assembly 3a includes a pair of nasal prongs 4a. Each nasal prong 4a includes a rod or neck 10a, which connects the nasal prong 4a to the flexible base 6a of the patient interface structure 32a. Flaps 4b are disposed between the nasal prongs 4a and the rods 10a. When the nozzle assembly 2a is held in engagement with the patient's face by the sealing positioning and stabilizing structure, the nasal prongs 4a form a seal with the patient's nasal passages.

[0166] A pair of seal positioning and stabilizing structure connectors 12a are provided on the flexible base 6a of the patient interface structure 32a. The connectors 12a are provided on the flexible base 6a to connect the straps of the seal positioning and stabilizing structure to the patient interface structure 32a.

[0167] The connector 12a may include a plurality of connection points 13a, 13b to allow the relative position of the patient interface structure 32a with respect to the seal positioning and stabilizing structure 36 to be changed or adjusted.

[0168] Reference again Figure 2 , the patient interface system may include Figure 5a The patient interface structure and Figure 2 A mask shell or frame is shown which is modified to not include a connector on the frame and include a vent having a plurality of vent holes. The mask frame can be connected to the air delivery tube via a swivel elbow. The end of the swivel elbow can include a ball and socket joint with the frame and the air delivery tube so that the swivel elbow acts as a separation element or joint. The delivery tube can accommodate a pressurized flow of breathable gas by connecting to a flow generator or blower via a connecting element. It should be understood that Figure 2 The mask frame may be formed of a flexible material rather than Figure 2 The rigid material in the prior art shown in FIG. 1 and the connector 12 may be disposed on a flexible frame.

[0169] In another exemplary embodiment, the elbow can be flexible. In this form, it is desirable to locate the vent elsewhere on the mask system. Alternatively, a solid vent insert can be placed in the flexible elbow. In another form, a reinforcement can be provided to the flexible elbow to maintain its structural integrity and prevent clogging of the tube.

[0170] 3.2.3 Patient interface structure including nasal prong seal and connector on nasal prong

[0171] refer to Figure 6 In another exemplary embodiment, the seal positioning and stabilizing structure connector 12a is disposed at a point just below the flap 4b of the nose fork 4a. The seal positioning and stabilizing structure connector 12a is connected to the neck or base 10a of the nose fork 4a. According to this embodiment, the plane of the connection formed by the seal positioning and stabilizing structure connector 12a is larger than Figure 5a The illustrated embodiment is closer to the plane of the patient's nostril entrance. Figure 6 The patient interface structure can also be used for Figure 2 The modification shown is a mask frame that does not include a connector on the frame. It should also be understood that Figure 6 The patient interface structure can be used for example Figure 2 The improvement shown is a mask frame formed from a flexible material.

[0172] 3.2.4.1 Patient Interface Structure Including Adjustment Element—First Embodiment

[0173] refer to Figure 8a and 8b According to another exemplary embodiment, a patient interface structure 32 may include a seal 2 including a nozzle assembly 3 having nasal pillows 4. The patient interface structure 32 may include an optional adjustment portion or adjustment element 47 configured to link the tension applied from one side of the patient interface structure 32 to the other side by the seal positioning and stabilizing structure so as to isolate the force applied by the seal positioning and stabilizing structure on the top 6t of the flexible base 6, thereby isolating the tube drag force at the lower portion 6l of the flexible base 6 of the patient interface structure 32. By isolating the forces in this manner, the sealing area 8a of the nasal pillows 4 of the seal 2 can be stabilized on the patient's nostrils when in use. In some forms of the present technology, there may be no physical adjustment element. The line of force defined by the adjustment element when used with an under-the-nose mask such as a nasal pillow or a nasal prong is preferably close to the bottom of the nose.

[0174] like Figure 8a As shown, the adjustment element 47 may take the form of a reinforced and / or stiffened top portion 6t when compared to the lower portion 61 of the flexible base 6. The lower portion 61 may include, or take the form of, a gusset as disclosed in WO 01 / 97893. The gusset may also be configured similar to an accordion, with a plurality of ridges to increase its elasticity and flexibility, as disclosed in WO 2006 / 074515, the entire contents of which are incorporated herein by reference.

[0175] The gusset may also be reinforced to control where and how it folds, ie, so that it can move laterally and axially but cannot compress longitudinally. The reinforcement may include support ribs, thickened portions or areas, or a rigid or semi-rigid frame surrounded by a flexible material.

[0176] Strengthening and / or reinforcement can be achieved by thickening the material used for the patient interface structure 32, for example, increasing the thickness of the silicone at the top 6t to about 10 mm compared to the lower portion 6l of the flexible base 6. Such strengthening and / or reinforcement can also be achieved by using a higher hardness material at the top 6t, such as silicone with a durometer of about 50-80 on the Shore A scale. In addition, or alternatively, a metal insert such as a wire or mesh can be used for the adjustment element 47. Strengthening and / or reinforcement can also be achieved by a gel insert. The gel insert can increase the comfort of the patient at, for example, the diaphragm. Moreover, strengthening and / or reinforcement can also be achieved by a foam insert. The foam insert can increase the comfort of the patient at, for example, the diaphragm, and act as a second seal to compensate for leakage formed by the primary seal. The adjustment element 47 can also be formed by co-molding, such as a material that is generally inextensible, such as nylon, TPE, metal or alloy. The adjustment element 47 can also be in the form of a crimped, thickened portion as described in more detail below. Ideally, reinforcing and / or stiffening the top portion 6t will allow the forces exerted by the seal positioning and stabilizing structure to be more isolated from the lower portion 61 as the lower portion 61 stretches more, for example to form the adjustment element 47. This allows the lower portion 61 of the flexible base 6, such as a gusset, to flex more easily while ensuring that the nasal pillows 4 maintain sealing contact with the patient's nares.

[0177] In another form, the adjustment element 47 may be configured to be rigid along its length, e.g., from connector 50 to connector 50, but flexible throughout its height, i.e., in the general direction of the nasal pillow 4. This allows the neck 10 of the nasal pillow 4 to flex more easily while maintaining the primary function of the adjustment element 47, i.e., isolating the forces applied by the seal positioning and stabilizing structure.

[0178] In one variation, the adjustment element 47 may be formed of a material that can be molded to the patient's face, such as an elastic material used to form a mask. Due to its unique fit, it has the advantage of providing isolation and increasing the comfort of the patient interface system.

[0179] 3.4.2 Patient Interface Structure Including Adjustment Element—Second Embodiment

[0180] As in Figure 8a In one exemplary embodiment of the patient interface structure shown, the adjustment element 47 may extend across the entire top 6t of the flexible base 6 from connector 50 to connector 50 and include the entire width. Fig.17a W1 in. Figure 8cIn another exemplary embodiment of the patient interface structure 32 shown, the adjustment element 47 may extend over a portion or multiple portions of the entire top portion 6t of the flexible base 6, such as only the portion of the top portion 6t between the nasal pillows 4. The adjustment element 47 may cover a small portion of the width of the top portion 6t, such as half of the width. The tension adjustment element 47 may cover a portion or multiple portions of the top portion 6t, as long as it is sufficient to isolate the forces as described above.

[0181] 3.2.4.3 Patient Interface Structure Including Adjustment Element—Third Embodiment

[0182] refer to Figure 8d , the adjustment element may be formed as a series of ridges 47a. The number of ridges 47a may be determined so as to be sufficient to isolate the forces as described above. Figure 8d As shown, the ridge 47a can be set to the top 6t just between the nasal pillows 4. The ridge 47a can be thicker than the top 6t. The ridge 47a can generally be circular or rectangular or any other shape. The ridge 47a can extend upward and / or downward from the top 6t. The ridge 47a can also be formed of a harder material than the material used to form the top 6t, such as a silicone or metal with a higher hardness. The ridge 47a can be formed as a whole with the patient interface structure 32, or can be retrofitted to the patient interface structure 32. For example, an adjustment element such as the ridge 47a can be adhesively connected to the patient interface structure 32. The ridges 47a can also be independent of each other, or the ridges 47a can be connected together. In the case where the adjustment element includes a plug-in, the plug-in can be set separately or connected together. The ridge 47a can also be formed to have a separate shape, size, thickness, material and / or hardness.

[0183] 3.2.4.4 Patient Interface Structure Including Adjustment Element—Fourth Embodiment

[0184] refer to Figure 8e The ridge 47a may be provided along the entire length of the flexible substrate 6, ie, from connector 50 to connector 50, to the top 6t.

[0185] 3.2.4.5 Patient Interface Structure Including Adjustment Element—Fifth Embodiment

[0186] refer to Figure 8f , the adjustment element 47 may be formed in the top portion 6t of the flexible base portion 6 of the patient interface structure 32. For example, the patient interface structure 32 may be molded around the adjustment element 47 so that the adjustment element 47 is embedded in the top portion 6t of the flexible base portion 6 of the patient interface structure 32. The adjustment element 47 may be formed of a material such as metal or an elastomeric material. The adjustment element may also be in the form of a wire or mesh, for example.

[0187] 3.2.4.6 Patient Interface Structure Including Adjustment Element—Sixth Embodiment

[0188] refer to Figure 8g and 8h According to another exemplary embodiment, an adjustment element 47 may be disposed along the top 6t of the flexible base 6. The adjustment element 47 may include a slot or opening 47o that corresponds to the first and second slots 52, 54 of the connector 50 to accommodate a strap that is connected to the seal positioning and stabilizing structure of the patient interface structure 32. Figure 8h As shown, the adjustment element 47 can have a contour that matches the top 6t of the flexible base 6 of the patient interface structure 32 and include an opening 47p that is configured to receive the stem or neck 10 of the nasal pillow 4. The adjustment element 47 can also include a slit 47s that allows the portion of the adjustment element 47 surrounding the opening 47p to be moved relative to each other so as to insert the adjustment element 47 onto the nasal pillow 4 and onto the top 6t of the flexible base 6.

[0189] The element 47 may be formed of, for example, metal or plastic. For example, the adjustment element 47 may be a thin metal sheet attached to the Figure 8h It should also be understood that the connector 50 of the patient interface structure 32 may be removed and the straps of the sealing positioning and stabilizing structure connected directly to the adjustment element 47 without any direct connection to the patient interface structure 32.

[0190] 3.2.4.7 Patient Interface Structure Including Adjustment Element—Seventh Embodiment

[0191] refer to Figure 8i and 8j , the adjustment element 47 can extend around the neck 10 of the nasal pillow 4. Figure 8j As shown, the adjustment element 47 may have a figure 8 configuration and include an opening 47p configured to receive the neck 10 of the nasal pillow 4. The adjustment element 47 may be formed of, for example, metal or plastic. For example, the adjustment element 47 may be formed of a wire.

[0192] 3.2.4.8 Patient Interface Structure Including Adjustment Element—Eighth Embodiment

[0193] refer to Figure 8k According to another exemplary embodiment, the adjustment element 47 may include a bridge portion between the stem or neck 10 of the nasal pillows 5. The adjustment element 47 may be integrally formed with the patient interface structure 32, such as by molding. The adjustment element 47 may also be formed of a material different from the material used to form the patient interface structure 32. For example, the adjustment element 47 may be formed of a material that is harder than the patient interface structure material. The adjustment element 47 may be formed to be more rigid than the top 6t of the flexible base 6 of the patient interface structure 32.

[0194] 3.2.5 Nasal Pillow Seal—Offset

[0195] refer to Fig.27a and 27b Each nasal pillow 4 may include a nasal pillow opening 5 for delivering breathable gas to the patient's nostrils. Each nasal pillow 4 is inserted into the patient's nostrils and seals at the sealing surface 11. Figure 27b As shown, by offsetting the nasal pillow opening 5 from the main axis 13, the nasal pillow opening 5 is offset from the neck opening 9 of the rod or neck 10 along the main axis 13 of the elliptical nasal pillow 4. Therefore, the portion 11a of the sealing surface 11 that contacts the patient's upper lip is reduced, which can increase the comfort of the patient. Although the nasal pillow opening 5 is shown to be offset from the neck opening 9 along the main axis 13, it should be understood that the nasal pillow opening 5 can be offset along the main axis 13 and / or the secondary axis 15.

[0196] 3.2.6 Nasal pillow seal including double wall

[0197] refer to Fig.17a —17f, the patient interface structure 320 includes a connector 322 on each side, the connector 322 being connected to the flexible base 329 of the patient interface structure 320 by an extension 323. It should be understood that the connector 322 is similar to the connector described above with respect to the flexible base 329 of the patient interface structure 320. Figure 6 In the manner described above, the connector 322 is connected to the corresponding neck 332 of a pair of nozzles 328 through the extension 323. The connector 322 can be linear with the upper surface of the flexible substrate 329 (such as Fig.17b and 17d Alternatively, the connector 322 may be tilted or angled to change the position of the patient interface structure 320 when the connector 322 is connected to the seal positioning and stabilizing structure.

[0198] The patient interface structure 320 includes a seal 333 having a nozzle assembly including a pair of nozzles in the form of nasal pillows 328. Fig.17b and 17d As shown, each nasal pillow 328 includes a neck 332 connected to a flexible base 329, which defines a nasal breathing cavity 336. Fig.17d and 17e As shown, each nasal pillow 328 includes an inner cone 334 and an outer cone 330. Such nasal pillows are disclosed, for example, in U.S. Patent Application Publications 2007 / 0144525A1 and 2006 / 0283461A1, each of which is incorporated herein by reference in its entirety. It should also be understood that the nasal pillows may be as described in U.S. Patent No. 7,318,437, the entirety of which is incorporated herein by reference. The outer cone 330 includes a sealing surface or region 330a configured to seal against the patient's nostrils. Fig.17dAs shown, the inner cone portion 334 and the outer cone portion 330 may have different thicknesses.

[0199] refer to Fig.17d , 17f 17g, flexible base 329 includes aperture 324 for directing a flow of breathable gas. Flexible base 329 also includes flange 326 that extends radially inward and defines aperture 324. Flange 326 may include ramp 327 for inserting a swivel seal as described in more detail below. Thus, also as described in more detail below, flexible base 329 of patient interface structure 320 may be connected to a frame, swivel elbow or tube or conduit.

[0200] It should be understood that the flexible base 329 may include an adjustment element between the neck 332 such as the nasal pillows 328, similar to the adjustment element for the Figure 8a-8g Published and discussed.

[0201] refer to Fig.17a , the hole 324 may have a diameter D1 of about 17 mm-20 mm, for example, about 18.5 mm. The patient interface structure 320 may have a width W1 of about 25 mm-35 mm, for example, about 30.5 mm. The patient interface structure 320 may have a length L1 of about 80 mm-90 mm, for example, about 84.5 mm. The seal positioning and stabilizing structure connector 322 may have a length of about 12 mm-18 mm, for example, about 15.5 mm.

[0202] refer to Fig.17d The flexible base 329 may have a length L3 of about 45 mm-50 mm, such as about 47.5 mm. The patient interface structure 320 may have a height H1 of about 30 mm-37 mm, such as about 33 mm. The base portion 329 may have a height H2 of about 15 mm-23 mm, such as about 19 mm.

[0203] refer to Fig.17d and 17g , the extension 323 may have a thickness T1 of about 1.5 mm-2.0 mm, such as about 1.8 mm. The thickness T2 of the flexible base 329 between the nasal pillows 328 is about 1.5 mm-2.5 mm, such as about 2.0 mm. It should be understood that in the case where the patient interface structure 320 is formed as a single piece, such as between the adjustment element and the nasal pillows 328, the thickness T2 may be thicker. The flange 326 may have a thickness T3 of about 1.5 mm-2.5 mm, such as about 2.0 mm. The flexible base 329 may have a thickness T4 of about 0.6 mm-1.0 mm, such as about 0.8 mm.

[0204] The rod 32 may have a length of about, such as 3 mm to about 6 mm.

[0205] 3.2.6.1 Nasal pillow seals including double walls—equal displacement and non-concentric

[0206] refer to Fig.28a and 28b , the nasal pillow 328 may include an outer cone 330 and an inner cone 334. A portion 360a of the sealing area 360 of the outer cone 330 that contacts the patient's upper lip is offset from the stem or neck 332 of the nasal pillow 328 by a distance 362, which is equal to the distance 362 of a portion 360b of the sealing area 360 that seals with the patient's nostrils. The sealing area 360 and the nasal pillow orifice 354 are not concentric with the stem 332 of the nasal pillow 328.

[0207] 3.2.6.2 Nasal pillow seals including double wall—unequal displacement and concentric

[0208] refer to Fig.29a and 29b , the distance 364 that the portion 360a of the sealing area 360 that engages the patient's upper lip is offset from the rod 332 is not equal to the distance 366 that the portion 360b is offset from the rod 332. The nasal pillow opening 354 and the sealing area 360 are concentric with the rod 332.

[0209] 3.2.6.3 Nasal pillow seals including double walls—unequal displacement and concentric with support ribs

[0210] refer to Fig.30a and 30b , the offset of portion 360a from the rod 332 is not equal to the offset of portion 360b of the sealing zone from the rod 332. The sealing zone 360 ​​and the nasal pillow opening 354 are concentric with the rod 332. Support ribs 368 may be provided below portion 360b of the sealing zone 360 ​​to maintain the nasal pillow sealing zone in a vertical direction so that it can seal the nostrils.

[0211] 3.2.6.4 Nasal pillow seals including double wall—concentric and angled

[0212] like Fig.31a and 31b As shown, the inner cone 334 and the outer cone 330 are inclined at an angle 370 relative to the rod 332 of the nasal pillow 328. The angle tilts the nasal pillow toward the patient's face and can be, for example, -30° to 45°, with another example being 15°. The portion 360a configured to engage the patient's upper lip has a larger radius than the sealing zone portion 360b to provide greater comfort to the patient. The nasal pillow orifice 354 and the sealing zone 360 ​​are eccentric relative to the rod 332.

[0213] 3.2.6.5 Nasal pillow seals including double wall—symmetrical, concentric, and angled

[0214] refer to Figures 32a-32f , the orifice of the inner conical surface 1100 of the nasal pillow 1150, the outer wall 1000, and the rod 1200 are concentric with respect to the centerline CL. The radius of the portion 1600 on the opposite side of the portion 1500 is smaller than the radius of the portion 1500 adjacent to the patient's upper lip. The larger radius of the portion 1500 has a thickened area 1550, which helps to avoid contact between the nasal pillow and the upper lip, pushing the structure away from the upper lip. Avoiding contact with the upper lip can improve comfort for some patients. One of the advantages is that since the nasal pillow can automatically leave the upper lip, the need to provide a separate artificial nasal pillow rotation mechanism can be reduced to adapt to the patient's nasolabial angle. This can be partially supported by the patient interface structure connector 84 of the curved seal positioning and stabilizing structure.

[0215] The base of the nasal pillow 1150 is angled relative to the adjustment element 1400. The angle α allows the adjustment element 1400 to be tilted. Fig.32d In order for the nasal pillows 1150 to engage the entrance of the patient's airway, the nasal pillows are placed at the entrance of the nostrils. Fig.32e As shown, when the seal positioning and stabilizing structure is adjusted, the strap tension begins to pull the pillow into the nostril. The pillow continues to be inserted into the nostril so that the rod 1200 compresses the adjustment element 1400 through the elastic cushion (trampoline) 1300, moving the adjustment element 1400 to contact the base of the pillow 1150.

[0216] The thickened region 1550 creates a relatively stiff resilient structure compared to the thinner portion 1600, which allows the patient interface structure to be rotated away from the upper lip. Because the base of the nasal pillow 1150 is at an angle α relative to the adjustment element 1400, the adjustment element 1400 is aligned with the base of the nasal pillow 1150 so that they are connected or in continuous contact along the entire surface of the base of the nasal pillow 1150. This means that the adjustment element 1400 and the adjacent resilient pad 1300 are rotated upward, that is, rotated α° toward the top of the patient's nose. The adjustment element 1400 and the resilient pad 1300 are therefore angled away from the bottom of the nasal pillow or the patient's upper lip. This improves the comfort and stability of the patient interface system.

[0217] Rotating the resilient pad 1300 and adjustment element 1400 away from the patient's upper lip can be similarly accomplished by tilting the shape of the resilient pad 1300 and / or adjustment element 1400 (e.g., by changing the size of the flexible base of the patient interface structure), changing the properties of the resilient pad so that it is stiffer in some areas than in other areas so that the rod is squeezed in a certain manner (e.g., stiffer toward the bottom / upper lip side of the nasal pillows), or changing the properties of the rod so that it squeezes more in one direction than another (e.g., stiffer toward the bottom / upper lip side of the nasal pillows).

[0218] 3.2.6.6 Nasal pillow seals including double wall—offset inner and outer cone portions

[0219] refer to Fig.33a and 33b The nasal pillow 328 may include an elliptical inner and outer conical portions 334, 330, respectively. Fig.33a and 33b As shown, the apertures 354, 355 of the inner and outer conical portions 334, 330, respectively, may be offset along the axis of the ellipse. The radius of the portion 360a of the sealing zone 360 ​​configured to engage the patient's upper lip is greater than the radius of the portion 360b configured to seal the patient's nostril.

[0220] 3.2.7 Nasal Pillow Seals—Truncated

[0221] refer to Fig.34 The nasal pillow 328 may be provided with a cutout or truncated portion 350 to improve the comfort of the patient's upper lip. Fig.35 As shown, according to one variation, the nasal pillow opening 354, the sealing area 360, and the stem 332 are concentric. The upper lip contacting side of the nasal pillow 328 includes a truncated portion 350 to prevent interference and discomfort.

[0222] As in Fig.36 As shown in another variation shown in FIG. 3 , the nasal pillow opening 354 and the sealing area 360 are concentric along the centerline 358. The rod 332 is not concentric with the centerline 358 so that the rod opening 356 is offset from the nasal pillow opening 354. Fig.36 As shown, the rod 332 can be offset in a direction away from the truncated portion 350. Fig.37 In one variation shown in , the rod 332 may be offset in a direction toward the truncated portion 350 .

[0223] 3.2.8 Nasal Pillow Seals—Coincident Sealing Surfaces and Stems

[0224] like Fig.38a and 38b As shown, the rod 332 can be disposed in a position that coincides with a portion 360b of a sealing region 360 that is configured to engage the patient's upper lip.

[0225] 3.2.9 Nasal Pillow Seals—Curved Stems and / or Sealing Surfaces

[0226] refer to Figures 39a-39h , the outer conical portion 330 of the nasal pillow 328 can be set at a certain angle relative to the rod 332 and / or the rod can be angled and / or have a variable cross-section.

[0227] 3.2.10 Nasal Pillow Seal—Rosebud

[0228] like Fig.40 As shown, two nasal pillows 328 can be combined. The portion 360a configured to contact the sealing area of ​​the patient's upper lip can have a shallow radius, and the portion 360b configured to engage the nostril can have a large radius at the outer edge of the sealing area, thereby increasing the fitting range of the nasal pillows. The nasal pillows 328 can generally have a rosebud-shaped configuration, as shown in the figure.

[0229] 3.2.11 Nasal pillow seal—olive shape

[0230] refer to Fig.41 The sealing area of ​​the nasal pillow can have a large radius on either or both sides. The nasal pillow can act as a nasal dilator. As shown in the figure, the nasal pillow 328 can generally have an olive-shaped configuration.

[0231] 3.2.12 Patient interface structure including foam seal

[0232] refer to Figures 45a-45e , according to another exemplary embodiment, a patient interface system includes a patient interface structure 32 having a flexible base 6. A seal 2 is disposed on the flexible base 6. The seal 2 may be formed of foam. A swivel elbow 7 is connected to the flexible base 6 for delivering a breathable gas flow from a hose or tube or conduit (not shown) connected to the swivel elbow 7 to a nasal breathing cavity defined by the flexible base 6 and the seal 2.

[0233] The patient interface structure 32 is maintained in sealing engagement with the patient's face by a seal positioning and stabilizing structure 36, which includes side straps 38, a top strap 40 ( Fig.45c ) and a rear strap (not shown). Although the side straps 38 are shown as being connected to the flexible base 6 in an integral manner, it should be understood that the side straps 38 can be connected to the flexible base 6 in a manner that allows the side straps 38 to be connected and disconnected from the flexible base 6, such as described in more detail herein. It should also be understood that one or both sides of the side straps 38 can be configured to be connected and disconnected from the base 6.

[0234] like Fig.45b As shown, the seal 2 includes an aperture 19 configured to surround both nostrils of the patient. Fig.45cAs shown, the flexible base 6 is adapted to fit around the nose of the patient 1 during use. Figure 45c-45e As shown, seal 2 may be configured to partially seal above the tip of the patient's nose.

[0235] 3.3 Sealing positioning and stable structure

[0236] 3.3.1 Sealing Positioning and Stabilizing Structure - First Embodiment

[0237] Referring again to 7a-7c, the seal positioning and stabilizing structure 36 may be formed, for example, from a flat silicone sheet. Typically, headbands for respiratory masks are formed from a foam and fabric laminate, such as Such headbands are stamped and cut to have right angle edges. This makes the patient's face appear bulky and uncomfortable due to its edges. In the exemplary embodiments disclosed herein, the seal positioning and stabilizing structure made of silicone can be molded to have rounded edges. Such rounded edges improve comfort. In one form, the rounded edges can have a radius greater than 0.5 mm. Figure 7b As shown, the straps 38, 40, 42 of the seal positioning and stabilizing structure 36 may have rounded edges 420 formed on the patient contacting (i.e., skin contacting) side 418 of the straps 38, 40, 42. The parting line 416 of the tool forming the straps 38, 40, 42 may be further away from the patient contacting side 418 to avoid proximity to the patient's face, which may cause irritation. Figure 7c As shown, the straps 38 , 40 , 42 may include a larger radius 422 on the patient contacting side 418 by providing a portion 424 on the opposite side of the patient contacting side 418 inverted from the parting line 416 .

[0238] Other polymers such as TPE may be used to form the seal positioning and stabilizing structure 36. The seal positioning and stabilizing structure 36 may include two side straps 38 (at Figure 7a The ends 38a of the side straps 38 are connected to the connector 12 (only one is visible in FIG. 1 ), the top strap 40, and the rear strap 42. Figure 7a 1 and 12), connectors 12 are disposed on the flexible base 6 of the patient interface structure 32. The connectors 12 are located on a side of the flexible base 6 to which nasal pillows may be connected. The connection of the connectors 12 to the flexible base 6 enables the flexible base 6 to wrap around the bottom of the patient's nose and pull back to maintain the nasal pillows in sealing contact with the underside of the patient's nose.

[0239] Figure 7aThe respiratory mask system of the present invention can be adjusted by adjusting the connection between the ends 38a of the side straps 38 and the connector 12. For example, each connector 12 may include a slot or multiple slots configured to accommodate the ends 38a of the side straps 38. The sealing force provided by the seal positioning and stabilizing structure 36 can be adjusted by adjusting the ends 38a of the side straps 38. For example, to increase the sealing force applied by the seal positioning and stabilizing structure 36, the patient 1 can pull the ends 38a of the side straps 38. The sealing force can be reduced by shortening the ends 38a of the side straps 38, such as by pulling the side straps 38 through the connector 12. The patient interface structure 32 can be rotated relative to the seal positioning and stabilizing structure 36 about an axis that is generally parallel to a straight line passing through the patient's eyes and under the patient's nose by the inherent flexibility of the straps. It should be understood that inelastic straps can be used. It should also be appreciated that angular adjustment of the patient interface structure 32 relative to the seal positioning and stabilizing structure 36 may be achieved by adjusting buckles / connectors, such as those disclosed in, for example, US Pat. No. 6,907,882, the entire contents of which are incorporated herein by reference.

[0240] 3.3.2 Sealing Positioning and Stabilizing Structure—Second Embodiment

[0241] refer to Fig.10 In another exemplary embodiment, the seal positioning and stabilizing structure 36 may include a strap 41 configured to wrap around the patient's head at a position above the patient's ears. Fig.10 The patient interface structure 32 may be connected to a swivel elbow or connector 17 via a spacer 34, although it should be understood that the patient interface structure may be connected to a rigid or semi-rigid frame or housing. The swivel elbow is connected to an air delivery tube 16 to deliver a pressurized flow of breathable gas.

[0242] A reinforcing or stiffening element 66 may be connected to each side strap 38. Fig.10 As shown, to avoid affecting the vision of patient 1, the reinforcing or stiffening element 66 passes over the eye socket of patient 1. The provision of the reinforcing element thus allows the force vector of the seal positioning and stabilizing structure to pass near the patient's eye without obscuring the patient's vision. The tension force can thus be directed perpendicular to the sealing surface in a more ideal direction, in this case on the underside of the patient's nose.

[0243] The reinforcing element 66 can be constructed of a sufficiently rigid material along its longitudinal length to resist bending under tension in the seal positioning and stabilizing structure, but can be adapted to lie flat on the patient's face in an out-of-page direction. Suitable materials for the reinforcing element 66 include, for example, nylon, polypropylene, and silicone.

[0244] The reinforcing elements 66 may be passed through the side straps 38, or the reinforcing elements 66 may be adhered or sewn in place on the side straps 38. Alternatively, the reinforcing elements may be movable on the side straps 38 of the seal positioning and stabilizing structure 36, such as by sliding along the side straps 38.

[0245] 3.3.3 Sealing Positioning and Stabilizing Structure - Third Embodiment

[0246] refer to Fig.11 In another exemplary embodiment, the top strap 40 may be configured to extend at an angle to the rear strap 42. This configuration generates a force vector that increases the sealing force applied by the seal positioning and stabilizing structure 36 without increasing tension. The component of the force provided by the top strap 40 is directed upward, which increases the sealing force applied to the patient interface structure 32. In other words, the sealing force component of the top strap 40 is added to the sealing force component of the side straps 38 to provide an improved seal without increasing tension.

[0247] 3.3.4 Sealing Positioning and Stabilizing Structure - Fourth Embodiment

[0248] refer to Fig.12a and 12b According to another exemplary embodiment, the patient interface system includes a seal positioning and stabilizing structure 36, which is connected to the patient interface structure 32 by lateral side arms 68, and the lateral side arms 68 are arranged on each side of the face of the patient 1. Each lateral side arm 68 may include a first side arm connector 68a and a second side arm connector 68b, the first side arm connector 68a is connected to the patient interface structure, and the second side arm connector 68b is opposite to the side arm connector 68a. Fig.12a The lateral side arm 68 is connected to the patient interface structure 32 below the first side arm connector 68a in the direction shown in FIG. The lateral side arm 68 can be connected to the rear strap 42 of the seal positioning and stabilizing structure 36 through the groove 68c provided on the lateral side arm 68 to accommodate the rear strap 42. Fig.12a and 12b As shown, the side straps 38 of the seal positioning and stabilizing structure 36 can extend along a portion of the lateral side arms 68. However, it should be understood that the side straps 38 can be eliminated and the lateral side arms 68 can extend from the connection of the top strap 40 and the back strap 42. Each lateral side arm 68 can be configured to extend across the patient's face from a point at the main area of ​​the temple to near the bottom of the patient's nose.

[0249] The lateral side arm 68 may be formed similarly to the Fig.10 and 11 Alternatively, the lateral side arm 68 may be formed of a soft, flexible material, such as The lateral side arms 68 may be constructed to be sufficiently rigid along their longitudinal length to avoid bending under the tension of the seal positioning and stabilizing structure, but to be adapted to lay flat on the patient's face in an out-of-page direction.

[0250] The first and second side arm connectors 68a, 68b connect to the patient interface structure 32 at two points and are wide enough at the connection to improve control of the rotational stability of the seal, but allow the patient interface structure 32 to rotate to present a seal such as a nasal pillow, at right angles to the sealing surface.

[0251] 3.3.5 Sealing Positioning and Stabilizing Structure - Fifth Embodiment

[0252] refer to Fig.13a and 13b , the lateral side arms 68 are connectable to the side straps 38 via slots 68c. The side straps 38 are connectable to the straps 41 via strap connectors 70. The side straps 38 are connected to the strap connectors 70 at one end and to the lateral side arms 68 at the opposite end via slots 68c. The strap connectors 70 are movable along the straps 41 to allow the patient to adjust the position of the lateral side arms 68. Thus, the patient can adjust the position of the lateral side arms 68 to achieve a good seal between the patient interface structure 32 and the patient's nostrils, and the patient interface system can be adjustable to fit patients of various sizes.

[0253] 3.3.6 Sealing Positioning and Stabilizing Structure—Sixth Embodiment

[0254] refer to Fig.14a and 14b According to another exemplary embodiment, the seal positioning and stabilizing structure 36 may be formed from a single piece, including the top strap 40, the back strap 42, the side straps 38, and the lateral side arms 68. Buckles 71 may be provided on the top strap 40 to adjust the fit of the seal positioning and stabilizing structure 36 to the patient. It should be understood that the buckles may be provided additionally or selectively to the back strap 42. The single piece seal positioning and stabilizing structure 36 may be connected to the patient interface structure 32 by a connector such as a hook and loop fastener. Optionally, the single piece seal positioning and stabilizing structure 36 may be a complete circular element that can surround the patient interface structure 32, such as the base of the patient interface structure 32 between the patient interface structure 32 and the elbow 17, or the top of the patient interface structure 32 between the flexible base of the patient interface structure 32 and the seal (e.g., a nozzle device). In another exemplary embodiment, the entire patient interface system, including the patient interface structure 32 and the seal positioning and stabilizing structure 36, may be formed as a single element. Additionally, the elbow 17 may also be formed together with the patient interface structure 32 and the seal positioning and stabilizing structure 36 .

[0255] like Fig.14a and 14b as well as Figures 12a-13b As shown, the lateral side arm 68 can be divided into a first and a second side arm connector 68a, 68b to form a triangular cutout close to the patient interface structure 32, as shown in the figure. The length of the first and second side arm connectors 68a, 68b affects the angle at which the patient interface structure 32 is located. For example, if the first side arm connector 68a is longer than the second side arm connector 68b, the patient interface structure 32 may be rotated away from the patient's nostrils. Conversely, if the second side arm connector 68b is longer than the first side arm connector 68a, the patient interface structure 32 may be rotated toward the patient's nostrils. In another exemplary embodiment, the length of the first side arm connector 68a can be adjusted to rotate the patient interface structure 32 by an adjustment mechanism such as a buckle. Similarly, the second side arm connector 68b can be adjusted to change its length so as to rotate the patient interface structure by an adjustment mechanism such as a buckle. Both the first side arm connector 68a and the second side arm connector 68b can also be adjusted to allow more adjustments to the patient interface structure 32.

[0256] 3.3.7 Sealing Positioning and Stabilizing Structure—Seventh Embodiment

[0257] refer to Fig.15a and 15b According to another exemplary embodiment, the side straps 38, top straps 40, and rear straps 42 of the seal positioning and stabilizing structure 36 are connected by connectors 72. The side straps 38 are connected to the patient interface structure 32 by the seal positioning and stabilizing structure connectors 12, which are disposed on the patient interface structure 32. The patient interface structure 32 can be directly connected to the air delivery tube 16 via the swivel elbow 17. The connectors 72 allow the position of each strap 38, 40, 42 to be adjusted to allow the patient to achieve a seal between the patient interface structure 32 and the patient's airway and to allow the seal positioning and stabilizing structure 36 to be made to a size suitable for a variety of patients.

[0258] 3.3.8 Sealing Positioning and Stabilizing Structure—Eighth Embodiment

[0259] Figure 24m-24q The patient interface assembly of the eighth embodiment including the seal positioning and stabilizing structure is shown. The seal positioning and stabilizing structure includes the main strap loop 74 and the rear strap 85. Figure 24qThe main strap loop 74 includes a strap connector 82 that is arranged to connect the rear strap 85 at an angle A of about 90° to about 140°, preferably about 95° to about 110°, and most preferably about 110° relative to the top of the head that engages the top main loop 74. Angles A closer to the preferred values ​​provide a more gradual improvement in the fit range of the headgear, allowing the patient interface to comfortably fit a range of heads from smaller to larger.

[0260] Further references Figure 24q , 16a and 16d, the main strap loop 74 has a curved middle portion between two generally straight portions. The first straight portion is at the top of the patient's head when in use. The second straight portion has one end connected to a lateral portion of the patient interface structure, and the second straight portion is generally parallel to the lateral portion of the patient interface structure. The curved middle portion corresponds to the reinforcement portion 78 discussed below. The angle B between the two straight portions is preferably in the range of about 150° to about 90°, such as about 130° to about 90°, further preferably about 120° to about 100°, and most preferably about 111°. The closer the angle B is to the preferred value, the more gradual improvement in the fitting range of the headband, allowing the patient interface to comfortably fit a range of heads from smaller to larger. Moreover, the reinforced, curved portion allows the headband tension to be applied to the underside of the patient's nose at a more effective angle, preferably perpendicular to the underside of the nose, without the headband obscuring the patient's vision or contacting the sensitive eye area. In a preferred structure, the headband can be used with, for example, ResMed's There is no significant change in orientation compared to the LT. Moreover, the headband (i.e., seal positioning and stabilization structure) arrangement avoids affecting the patient's ears over a wide range of head sizes.

[0261] refer to Fig.46a and 46b The angle Y between a line generally perpendicular to the strap connector 82 and a line extending from the first end of the strap ring 74 may be in the range of 90° to about 140°, preferably about 95° to about 125°, and most preferably about 100°.

[0262] refer to Figures 16a-16g , as mentioned above Fig.44a and 44b As discussed, the seal positioning and stabilizing structure may include a main strap ring 74, which includes Fig.16d and 16a 1 and 12. The right and left main straps 74r, 74l are shown in the figure respectively. Each main strap 74r, 74l may include a first flexible region 76, a reinforced region 78, and a second flexible region 80. Figures 16a-16gAs shown in FIG. 1 , the thickness of the zones 76, 78, 80 along the main straps 74r, 74l can be varied to enable the main straps 74r, 74l to be sufficiently rigid in areas under load and sufficiently flexible in areas where they need to fit the face. The first flexible zone 76 is thinner than the reinforced zone 78 and may have a thickness of approximately 0.5 mm-1.5 mm, for example, greater than 1 mm. The second flexible zone 80 is also thinner than the reinforced zone 78 and may have a thickness of approximately 1 mm-3 mm, for example, 2 mm. Fig.16b , 16c and 16e, the second flexible zone 80 may have varying thickness and may have increased flexibility at its thinnest portion. The reinforced zone 78 is thicker than the first and second flexible zones 76, 80 and may have a thickness of approximately 3mm-10mm, for example approximately 6mm.

[0263] The main strap loop 74 is preferably molded from silicone having a Shore A durometer in the range of about 40 to about 80, further preferably in the range of about 60 to about 70, and most preferably about 65. Making the main strap loop 74 from a harder silicone makes it more rigid and may allow it to be thinner than if it were made from a softer silicone. The main loop 74 is preferably not an air delivery tube, or is not connected to an air delivery tube, although it can be either. Using the main loop as an air delivery tube or connected to an air delivery tube can reduce the advantages provided by the isolation device. When the main loop 74 is made of the preferred silicone and has a thickness that is more flexible than the foam and fabric structures reinforced with nylon, the main loop 74 has sufficient structure that retains a certain degree of shape when placed alone, which facilitates use by patients who may be confused by an overly floppy headband structure that does not give clues about how it should be used. Moreover, making the main ring 74 from silicone in a preferred hardness range and in a preferred thickness range means that improved sealing stability, avoiding sensitive areas of the face, and an improved fit range can be achieved without the need to use stronger or harder materials (such as nylon stabilizers) that may cut the patient's skin or leave marks on their face. The curved shape of the reinforced area reduces or eliminates the need for a stronger, harder stabilizer that may be needed, and the angle between the top of the head and the front of the main ring 74 is more acute. Moreover, the use of silicone in the main ring provides bending as the air delivery tube moves, isolating it without affecting the seal, unlike more rigid or inextensible stabilizers. Silicone can provide an improved "clamp" on the patient's skin. Molding the main ring is a relatively simple, low-loss manufacturing step and does not require additional installation processes (such as sewing reinforcements to foam and fabric laminates). Stamping and cutting shapes that cannot be easily nested from a thin sheet will cause waste of material. According to a preferred form of the present technology, the rear strap 85 is relatively straight, so it can be stamped and cut from the material of the thin sheet with relatively no waste. Therefore the preferred form of seal positioning and stabilizing structure is more economical and effective.

[0264] The main straps 74r, 74l may have a width of about 5 mm to about 15 mm, such as about 10 mm, in an area configured to engage the top of the patient's head, and may have a width widened to about 15 mm to about 25 mm, such as about 20 mm, in an area configured to contact the patient's face in the area of ​​the cheek, such as around the strap connector 82. The width of the main straps 74r, 74l between the strap connector 82 and the connector 84 may be narrowed, such as from about 20 mm to about 10 mm, and then increase toward the connector, such as increasing to about 15 mm to about 25 mm, such as about 20 mm.

[0265] The strap connector 82 may be disposed on the reinforcement region 78. The strap connector is configured to receive, for example, a rear strap configured to extend around the back of the patient's head to secure the seal positioning and stabilizing structure to the patient and to facilitate longitudinal adjustment of the rear strap at one or two points. The rear strap may be formed of the same material as the main straps 74r, 74l, such as silicone, or may be formed of, for example, a It should be appreciated that the rear straps may be formed of a different material, such as elastic, than the main straps 74r, 74l, or a combination of materials. It should also be appreciated that the stiffness of the main straps 74r, 74l may vary along their length rather than, or in addition to, varying the thickness of the main straps 74r, 74l.

[0266] Each primary strap 74r, 74l includes a patient interface structure connector 84 configured to receive a corresponding connector formed on the patient interface structure, as described below with respect to Figures 17a-17f As described. Figures 16a-16g As shown, the patient interface structure connector 84 may be formed in the form of a triangular cutout at the end of the main straps 74r, 74l. However, it should be understood that the patient interface structure connector 84 may include a cutout having a shape other than a triangle.

[0267] 3.3.9 Sealing Positioning and Stabilizing Structure—Band Connector

[0268] Silicone is more The standard headband materials are more flexible and may not be used as desired with standard headband connectors. For example, silicone has a tendency to slide on the connector and become loose. As described in more detail below, exemplary embodiments of the seal position and stabilizing structure strap connector are particularly suitable for use with silicone seal position and stabilizing structure straps, although the exemplary embodiments are not limited to silicone seal position and stabilizing structure straps.

[0269] 3.3.9.1 Step Locking Strap Connector

[0270] refer to Fig.19a and 19b, a sealing positioning and stabilizing structure such as the top strap 40 can be secured by a step lock connector 86. The step lock connector 86 may include a first side member 88 and a second side member 90. A first cross member 92 and a second cross member 94 extend between the first side member 88 and the second side member 90. A third cross member 96 is spaced from the first cross member 92 to define a first strap slot 100. A fourth cross member 98 defines a second strap slot 102 with the second cross member 94 as a base. A central hole 104 is defined in the first cross member 92 and the second cross member 94 to allow the end 40a of the top strap 40 to pass through the central hole 104 and above the cross members 92, 94, respectively, and below the cross members 96, 98, respectively, as shown in FIG. Fig.19b As shown. Fig.19a As shown, the third and fourth cross members 96, 98 are wider than the first and second cross members 92, 94 to increase the contact area between the cross members 96, 98 and the end 40a of the strap 40. The increased width of the third and fourth cross members 96, 98 increases the frictional contact between the step lock connector 86 and the strap 40 to provide a more secure seal position and stable structural fit.

[0271] like Fig.19a As shown, the first and second side members 88, 90 can include textured surfaces 89, 91, respectively, which are configured to improve the user's grip on the connector 86 to connect and / or adjust the strap 40 relative to the connector 86. For example, the textured surfaces 89, 91 can be ridges. In addition, each side member 88, 90 can include a depression on the textured surface 89, 91 to accommodate the user's fingers.

[0272] In the form of changes, such as Figure 19c-19e As shown, the step lock connector 86 may have guides 96a and 98a to ensure that the end 40a of the strap 40 is properly aligned. Fig.19b In the illustrated configuration, only the step lock connector 86 can be adjusted. As shown in the figure, silicone is used to seal the positioning and stabilizing structure, and the step lock connector 86 will not be able to be adjusted due to the flexibility of the silicone. Fig.19b The alignment shown (e.g., the step lock connector 86 tends to be rotated 90°). To address this issue, guide rods 96a and 98a can extend distally from cross members 96 and 98. Guides 96a and 98a can be generally rectangular or any other desired shape. Guides 96a and 98a can surround the strap 40 and end 40a or can surround only a portion of the strap 40 and end 40a. Guides 96a and 98a can be approximately 5-30 mm long, such as approximately 10 mm long, such as in Fig.19d By L LGuide rods 96a and 98a may closely conform to the perimeter formed by strap 40 and end 40a, ie, the contour of strap 40 and end 40a when looped through the connector. Optionally, as Fig.19e As shown, guide rods 96a and 98a may leave a gap C of at least 1 mm around the circumference formed by strap 40 and end 40a, such as about 2 mm, and only about 10 mm in another example.

[0273] 3.3.9.2 Separate adjustable strap connector

[0274] refer to Fig.20a and 20b , according to another exemplary embodiment, the strap connector includes a first strap 108 having a first strap connector 110 formed at an end thereof. A second strap 114 has a second strap connector 116 disposed at an end thereof. The second strap 114 may include a stud 118 that may be inserted into a selection hole 112 formed at the end of the first strap 108. The stud 118 may be generally mushroom-shaped to lock the first strap 108 in place. Thus, by selecting the appropriate hole 112, the seal positioning and stabilization structure is adjusted, which provides optimal comfort for the patient while maintaining an effective seal between the patient interface structure and the patient's airway.

[0275] refer to Fig.21a and 21b According to another exemplary embodiment, a seal positioning and stabilizing structure strap connector assembly includes a first strap 120 having a peg 124 formed at one end thereof. A guide 122 is disposed at one end of the first strap 120. A second strap 126 of the seal positioning and stabilizing structure may include a plurality of holes or apertures 130 that are selectively received by the peg 124 of the first strap 120. The second strap 126 may include a step lock connector 128 and an end thereof. The second strap 126 is threaded through the guide 122 of the first strap 120 and the peg 124 is inserted into a selected hole or aperture 130 to adjust the fit of the seal positioning and stabilizing structure.

[0276] refer to Figures 23a-23c According to another exemplary embodiment, a seal positioning and stabilizing structure strap connector assembly includes a first strap 300 having an elastic portion 302 connected to an end thereof. A second strap 301 of the seal positioning and stabilizing structure may include a plurality of ridges or corrugations 303 that are selectively accommodated by the elastic portion 302 of the first strap 300. The elastic portion 302 may include elastic fingers 325 that can contract when a force F is applied to pull the corrugations 303 past the elastic fingers 325. Fig.22aAs shown, the elastic finger can be disposed on the elastic cantilever finger 305 of the elastic portion 302. Fig.22a As shown, the elastic portion 302 may include a crossbar 307 and the first strap 300 may be connected to the elastic portion 302 by wrapping the end of the first strap 300 around the crossbar 307. Alternatively, the elastic portion 302 may be integrally formed with the first strap 300, such as Figures 23a-23c shown.

[0277] 3.3.9.3 Main strap connector

[0278] refer to Figure 24a-24p , the left main strap 741 of the seal positioning and stabilizing structure includes a strap connector 82, which is configured to receive one end of the rear strap of the seal positioning and stabilizing structure. The left main strap 741 also includes a patient interface structure connector 841, such as a generally triangular cutout, which is configured to receive the left connector of the patient interface structure. The main strap 741 also includes a plurality of locking protrusions 75 and a final locking protrusion 77. The locking protrusions 75 may have a generally circular, oval, or elliptical configuration. The final locking protrusion 77 is larger than the locking protrusion 75 and extends above the locking protrusion 75, such as Figure 24b as shown to prevent the seal positioning and stabilizing structure from being completely disassembled.

[0279] refer to Figure 24e-24h The right main strap 74r of the seal positioning and stabilizing structure includes a strap connector 82 configured to receive the other end of the rear strap. The right main strap 74r also includes a patient interface structure connector 84r such as a cutout configured to connect to the right connector of the patient interface structure. A locking connector 79 such as a step locking connector is provided at the end of the right main strap 74r to receive the end of the left main strap 74l. Fig.24i As shown, the end of the left main strap 74l is inserted into the step lock connector 79 in the direction shown by the arrow to connect the left main strap 74l to the right main strap 74r. The end of the left main strap 74l may include a recess 74d to assist insertion through the lock connector 79.

[0280] like Figure 24l As shown, the locking connector 79 includes a locking protrusion 81 configured to engage the left main strap 74l between the locking protrusions 75 to maintain the connection between the left and right main straps 74l, 74r. The locking protrusion 81 is larger than the distance between the corresponding locking protrusions 75 to improve the retention force of the main straps 74l, 74r. Figure 24lAs shown, the last locking projection 77 is higher than the locking projection 75 to prevent the seal positioning and stabilizing structure from being completely disassembled. It should be understood that the main straps 74l, 74r and the locking projections 75, 77, 81 can be formed of a material that is flexible enough to allow disassembly when sufficient force is applied. The main straps 74l, 74r and the locking projections 75, 77, 81 can be configured to resist disassembly due to forces such as tube drag or generally applied to the seal positioning and stabilizing structure when used with the mask system and / or sleeping. One advantage of molding the main strap connector on the strap is that the manufacturing process is simplified and more cost-effective because no additional fasteners are required.

[0281] like Figure 24l As shown, a groove 83 is provided in the right main strap 74r to allow the end of the left main strap 74l to bend downward when the locking protrusion 81 engages the locking protrusion 75. When the locking protrusion 81 engages the left main strap 74l between the locking protrusions 75, the groove 83 allows the portion of the left main strap 74l extending above the groove 83 to be displaced downward.

[0282] Combination Figure 24m , the rear strap 85 may be connected to the main straps 74l, 74r via the strap connector 82. The end 85e of the rear strap 85 may be provided with a hook or loop type fastener to engage a corresponding loop or hook fastener material provided on the remainder of the rear strap 85 to allow adjustment of the length of the rear strap 85 extending between the main straps 74l, 74r. Although Figure 24m-24q The rear strap 85 is shown as having two adjustable ends 85e, but it should be understood that the rear strap 85 may be provided with only one adjustable end.

[0283] The hardness of the left main strap 74l can be higher in specific areas to provide increased durability, ease of adjustment, and shape retention. For example, the strap connector 82, the portion surrounding the cutout 84l, the locking projection 75, and the last locking projection 77 can be provided with a higher hardness than other portions of the left cross member 74l. The higher hardness of the locking projection 75 and the last locking projection 77 improves the function of the step locking buckle, which is formed by the connection of the locking projection 75 with the step locking connector 79 of the right main strap 74r. The higher hardness provided at the strap connector 82 can improve the durability of the seal positioning and stable structure. The silicone material surrounding the groove of the strap connector 82 can also have sufficient thickness to prevent the groove from being stretched too much when in use. The higher hardness of the portion surrounding the cutout 84l can improve the connection stability and improve durability.

[0284] Similarly, right main strap 74r may have increased stiffness at step lock connector 79, strap connector 82, and portions surrounding cutout 84r to provide similar benefits as discussed above for left main strap 741.

[0285] like Figures 24a to 24q As shown, the left and right main straps 741, 74r are connected at the top of the patient's head. The rear strap 85 does not include a connection such as a buckle or a step-lock connector. This configuration allows the patient to sleep on either side or on the patient's back without the step-lock connector 79 causing any discomfort.

[0286] Combination Figure 24r The left main strap 741 may include a tapered end 74t that facilitates insertion of the left main strap 741 into the connector 79 of the right main strap 74r.

[0287] Combination Figures 25a-25d According to a variant, the left main strap 741 may be provided with a locking protrusion 75 but without a final locking protrusion. Fig.25d As shown, the locking protrusion 81 of the step lock connector 79 can be substantially the same size as the locking protrusion 75 of the left main strap 74l. This allows the main straps 74l, 74r to be more Figure 24a-Figure 24p The disclosed connections are connected in a relatively easier manner.

[0288] The right and left main straps 74r, 74l are adjustable by means of spring loaded clips which, when squeezed together, open and allow the lateral side members to pass through, but hold the straps in a locked position when not squeezed. Such spring loaded clips are similar to the draw cords used to allow adjustment of cords, such as cords used as bag closures or cords to adjust the fit of a hat or cap.

[0289] Combination Fig.25e In an alternative embodiment, the right main strap 74r may be provided with a slit or opening that is closed when relaxed, but when squeezed at its farthest edge (as indicated by the arrow), the slit or opening opens and allows the left main strap 74l to pass through the slit or opening. It should be understood that the left main strap may include a slit or opening, and the right main strap may be inserted therein.

[0290] The right and left main straps 74r, 74l of the main strap ring 74 may be formed of, for example, silicone. The silicone may be molded to include mushroom-shaped pegs 74m on both lateral side members 74l, 74r. Fig.25fAs shown, the pegs 74m create an interference fit when pushed together. The pegs 74m may have any other shape, such as a tree, arrow, or lollipop. The pegs 74m may also be retrofitted into the lateral side members 74l, 74r or molded together with the lateral side members 74l, 74r.

[0291] 3.3.9.4 Additional strap connectors

[0292] Such as Hook and loop fastener material may be provided to the main straps 74r, 74l, i.e., the hook material is on one lateral side member and the loop material is on the other lateral side member. The hook and loop fastener material may be connected to the main straps by means such as adhesive or by overmolding the material onto the main straps. Optionally and / or additionally, other adjustment mechanisms such as magnets, elastic bands or push clips may be overmolded onto the lateral side members. A patient interface in accordance with a preferred form of the present technology includes three longitudinal adjustment positions: one on the top of the patient's head for longitudinal adjustment of the main loop; and one (two in total) on each side of the patient's head approximately above the ears for longitudinal adjustment of the rear straps. Some prior art patient interfaces may require adjusting ten different positions to find the appropriate seating for the headband, thereby making the installation process more complicated. Preferably, the rear strap does not include a buckle at the back of the patient's head because lying on such a buckle would be uncomfortable.

[0293] 3.4 Patient interface structure and seal positioning and stabilization structure connector

[0294] 3.4.1 The connector extends toward the flexible base of the patient interface structure

[0295] In use, the patient interface structure 320 can be connected to the main strap ring 74 of the seal positioning and stabilizing structure by inserting the connector 322 into the patient interface structure connector (e.g., cutout) 84 of each main strap 74r, 74l. Fig.17c As shown, the connector 322 is wider than the patient interface structure extension 323. The connector 322 is also wider than the cutout 84 in the main strap loop 74. Figures 18a-18c As shown, connector 322 is inserted into cutout 84 to connect patient interface structure 320 to main strap ring 74. Fig.17a As shown, the cutout 84 and the connector 322 include complementary surfaces 84c, 322c, respectively, which engage when the connector 322 is connected to the main straps 74r, 74l. The connector 322 also includes an inclined side wall 322s ( Fig.17c ), the inclined side wall 322s is aligned with the inclined wall 84s ( Fig.16a) so that the connector 322 and the main straps 74r, 74l present flush surfaces when connected, such as Fig.18b As shown. Fig.18a As shown, the cutout 84 may include an inwardly directed protrusion 84p which will engage the end of the connector 322 when the patient interface structure 32 is connected to the main strap rings 74 (i.e., the right and left main straps 74r, 74l) to provide a more secure connection of the patient interface structure 320 to the main strap rings 74 of the sealing positioning and stabilizing structure.

[0296] 3.4.2 Connector extends toward seal of patient interface structure

[0297] According to yet another exemplary embodiment, Figure 18d-18f As shown, the connector 322 can extend from the extension 323 generally in the direction of the nozzle 328 and away from the flexible substrate 329, as shown in FIG. Fig.18d The connector 84 is placed on the connector 322 so that when the connector 322 is engaged with the connector 84, the extension 323 is visible, as shown in FIG. Fig.18e and 18f As shown. The components can be Figures 18a-18c The mask system is secured in the same manner and can provide a more secure connection when the mask system is in use.

[0298] Combination Figure 18g , the left and right connectors 3221, 322r of the patient interface structure 320 are connected to the left and right main straps 741, 74r of the seal positioning and stabilizing structure respectively through the left and right connectors (e.g., cutouts) 841, 84r. The geometry of the connectors 3221, 322r matches the geometry of the cutouts 841, 84r to provide intuitive assembly to the user. The user can obtain a tactile indication that the connectors 3221, 322r are properly inserted into the cutouts 841, 84r and assembled in the connected position.

[0299] 3.4.3 Connectors with alignment indicators

[0300] Combination Figure 18h In order to ensure the correct alignment of the patient interface structure 320 to the left main strap 741 and the right main strap 74r of the seal positioning and stabilizing structure, the connectors 3221, 322r may include markings 340 indicating the left and right sides. The connectors 3221, 322r may also include left and right indicators 342, 344 to correctly align the patient interface structure 320 in the seal positioning and stabilizing structure. Figure 18hAs shown, the indicators 342, 344 may have different shapes to facilitate alignment of the patient interface structure 320 in the seal positioning and stabilizing structure. Although the alignment indicators 342, 344 are shown on the connectors 3221, 322r of the patient interface structure 320, it should be understood that the alignment indicators may be provided on the main straps 741, 74r of the seal positioning and stabilizing structure, or the alignment indicators may be provided on both the connectors of the patient interface structure and the main straps of the seal positioning and stabilizing structure.

[0301] Combination Fig.18i , the connectors 3221, 322r may include different numbers of alignment indicators 342, 344 to indicate the proper orientation. For example, the left connector 3221 may include one indicator 342 and the right connector 322r may include two indicators 344. It should also be understood that the positions of the alignment indicators 342, 344 may be set in different places to indicate the orientation. For example, the left indicator 342 may be set on the side of the connector 3221 and the right indicator 344 may be set on the top of the right seal positioning and stabilizing structure connector 322r. It should also be understood that the marking 340 may also be set on, for example, the alignment indicators 342, 344.

[0302] like Fig.18j As shown, according to another exemplary embodiment, the patient interface structure 320 can be properly aligned with the seal positioning and stabilizing structure by making the left seal positioning and stabilizing structure connector 3221 have a different shape than the right seal positioning and stabilizing structure connector 322r. Figure 18k As shown, the left cutout 841 has a shape corresponding to the left connector 3221 and the right cutout 84r has a different shape corresponding to the differently shaped right connector 322r. The different shapes of the connectors and cutouts ensure that the patient interface structure 320 is in contact with the seal positioning and stabilizing structure. Figure 18l The assembly positions shown in are properly aligned.

[0303] Combination Figure 18m-18p , the seal positioning and stabilizing structure connectors 3221, 322r may face upward toward the nasal pillows 328 of the patient interface structure 320. This configuration may be provided to prevent the patient interface structure 320 from being accidentally detached from the seal positioning and stabilizing structure. Fig.18o and 18pAs shown, the connectors 3221, 322r may include a step 322s that engages with the step 84s of the cross members 741, 74r so that the connection between the patient interface structure and the seal positioning and stabilizing structure is not accidentally disconnected from the tabs by pulling the seal positioning and stabilizing structure upward. The seal positioning and stabilizing structure must be pushed inward toward the nasal pillows 328 to disengage the step 322s, and then the seal positioning and stabilizing structure is pulled upward to disconnect the patient interface structure from the cross member of the seal positioning and stabilizing structure.

[0304] like Figure 18q As shown, the cutout 841 may include a notch or cutout 337 to improve the flexure of the material of the left strap ring 741 to facilitate connection and disconnection of the connector 3221 with the cutout 841. It should be understood that the cutout 337 may be alternatively or additionally provided to the right strap ring 74r.

[0305] As described above, the seal positioning and stabilizing structure is not connected to any "hard" component, such as a rigid polycarbonate shell or frame such as used in prior art mask assemblies, although it should be understood that the patient interface structure may be connected to a hard component such as a rigid frame or shell, which in turn is connected to the seal positioning and stabilizing structure.

[0306] 3.5 Isolation device

[0307] 3.5.1 Hinge or universal joint

[0308] Recombination Figures 7a-7d , the air delivery tube 16 can be connected to the patient interface structure 32 via a spacer 44. The spacer 44 can include, for example, a hinge mechanism. The spacer 44 can include a connection between the tube 16 and the patient interface structure 32 that provides more than one axis of rotation. In conjunction with FIG. 7d, the flexible base 6 of the patient interface structure can be divided into a lower portion 61 and a top portion 6t by a hinge or universal joint 440 to further isolate the tube drag forces from the forces of the seal positioning and stabilizing structure.

[0309] 3.5.2 Flexible elbow

[0310] Combination Figure 5b , the flexible elbow 409 may include a flexible "skeleton" 411, which includes a plurality of rigid hoops or loops 405 connected by a flexible grid 406. An overmold 408, such as formed of silicone, is provided on the skeleton 402 to form the flexible elbow. The loops 405 provide a minimal support structure to ensure that the elbow 400 does not collapse, but maintain the flexibility of the elbow 409 and prevent clogging.

[0311] 3.5.3 Diaphragm

[0312] In another form, the isolation device 44 may include a membrane between the elbow connected to the tube 16 and the patient interface structure 32 or the flexible base 6 of the patient interface structure 32. The membrane may be a thin sheet with a flat cross-section. Alternatively, the cross-section of the membrane may be wavy, zigzag, or any other desired shape.

[0313] Combination Figure 5c and 5d , elbow 400 may have a rigid collar 410 supported by a diaphragm 414 disposed between the collar 410 and a rigid frame 412 or a relatively more rigid portion of the patient interface structure. Diaphragm 414 may be flat, or have a corrugated or concertina-like configuration. Diaphragm 414 may be formed of, for example, silicone.

[0314] 3.5.4 Adjustment elements

[0315] Combination Figure 8l and 8m , the seal positioning and stabilizing structure is used to stabilize the mask system on the patient's face. However, the stable state can be offset by the drag force of the air delivery tube. Typically, the frame of the mask system will guide the forces from the headband and the air delivery tube in a way that the mask can still seal. In an exemplary embodiment, the seal positioning and stabilizing structure is connected to the patient interface structure, rather than the frame. The patient interface structure is therefore required to guide the forces, i.e., the seal positioning and stabilizing structure and the drag force of the air delivery tube. As shown in FIG. 1, according to, for example Figure 4 In the patient interface structure of the illustrated embodiment, the drag force of the air delivery tube acts on the patient interface structure at the top 6t, which may cause the nasal pillows to be pulled away from the patient's nostrils. Figure 8l The patient interface structure shown is unable to direct the forces of the seal positioning and stabilizing structure and the air delivery tube while maintaining a seal.

[0316] like Figure 8m As shown, one or more adjustment elements are provided to the top portion to isolate the seal positioning and stabilizing structure forces and appropriately direct the seal positioning and stabilizing structure and tube drag forces. The line for directing tension passes through the top 6t of the patient interface structure 32, thereby allowing the base 6 of the patient interface structure 32 to be isolated from the tube drag forces. By passing the tension line of the pulling force through the top of the patient interface structure 32, the adjustment element makes it easy to isolate the top 6t relative to the lower portion 6l and isolate the force from the base of the patient interface structure. The tension adjustment element isolates the tube drag forces at the base 6 of the patient interface structure, such as at the lower portion 6l, and the base 6 of the patient interface structure may include a gusset or be configured as a gusset. By distributing the force to the lower portion 6l, the patient interface structure is stabilized in the patient's nostrils when in use.

[0317] 3.5.5.1 Sealing ring - first embodiment

[0318] Combination Figure 9a and 9b , a respiratory mask system according to another exemplary embodiment includes a patient interface structure 32. Figure 9a A cross section of the flexible substrate 6 through the patient interface structure 32 between the nasal pillows 4 is shown. It should be understood that the patient interface structure can be, for example, a nasal cushion or a full facial cushion. It should also be understood that the patient interface structure can be formed into a compact oral and nasal interface in a manner similar to that disclosed in U.S. Patent Application Publication No. 2007 / 0144525A1, the entire contents of which are incorporated herein by reference. For example, the compact oral and nasal interface can be modified to include a connector for a sealing positioning and stabilizing structural strap disposed on the patient interface structure or nozzle. The patient interface structure 32 can be connected to an elbow 60, which can be connected to an air delivery tube. The elbow 60 can include a vent 62 to allow discharge of the patient's exhaled air.

[0319] The patient interface structure 32 may be rotatably connected to the elbow 60 via a rotatable seal 64. As shown in FIGS. 9a and 9b, the patient interface structure 32 may include a flexible base 6 having a hole 46 for introducing a breathable gas flow. The hole 46 may be surrounded by a flange 48 that extends radially inwardly around the hole 46. The flange may include a ramp 45 that extends around the circumference of the flange 48. Figure 9b As shown, the flange 48 of the patient interface structure 32 is received in the space between the first flange 64a and the second flange 64b of the rotating seal ring 64 to form a stable seal assembly. The ramp 45 allows the flange 48 of the patient interface structure 32 to be more easily inserted into and removed from the space. The rotating seal ring 64 is retained on one end of the curved tube 60 between the first flange 60a and the second flange 60b of the curved tube 60. A radial seal is formed at the contact point between the second flange 64b of the rotating seal ring 64 and the second flange 60b of the curved tube 60. The connection of the flange 48 of the patient interface structure 32 to the rotating seal ring 64 allows the patient interface structure to rotate or turn relative to the curved tube. The rotating seal ring 64 thereby helps to isolate the tube drag force from the seal. Therefore Figure 9a and 9b The embodiments replace the prior art patient interface structure to frame connection mechanism with a patient interface structure to elbow connection.

[0320] 3.5.5.2 Sealing ring - second embodiment

[0321] exist Figure 17h and 17iIn the illustrated variation, the flange 326 of the patient interface structure may have a varying thickness T3. For example, the flange 326 may be formed as a tapered flange 331 to make it easier to insert into the rotating ring 64. The taper may be an angle α in the range of about 5°-50°, for example about 15°. The surface of the tapered flange 331 may be polished to improve the seal. Optionally, the surface of the tapered flange 331 may be textured to facilitate the sliding of the rotating ring 64.

[0322] Combination Fig.17j The patient interface structure 320 is connected to the swivel elbow assembly 17, which has the hose 16 connected thereto via the sealing ring 64. The hose 16 is connected to the swivel elbow assembly 17 via the sealing ring 64, which can be inserted into the hole 324 of the patient interface structure 320 to engage with the flange 326. Figure 17k As shown, the flange 326 includes a tapered flange 331 that is configured to be inserted into a groove or slot defined by the sealing ring 64 .

[0323] The tapered flange 331 may be assembled to the sealing ring 64 by simply inserting the sealing ring 64 into the hole 324 of the patient interface structure 320, or by inserting the tapered flange 331 of the patient interface structure 320 over the sealing ring 64, or by a combination of these actions.

[0324] The tapered flange 331 and the sealing ring 64 provide a small and simple connection of the patient interface structure 320 to the swivel elbow assembly 17 without affecting the performance of the patient interface structure. The sealing ring 64 also allows the swivel elbow assembly 17 to be assembled to the patient interface structure 320 in a manner that does not destroy the retention force of the swivel elbow assembly 17 to the patient interface structure 320.

[0325] 3.5.5.3 Sealing ring - third embodiment

[0326] Combination Figure 17l , the aperture 324 of the patient interface structure 320 may include a threaded portion 324t , and the sealing ring 64 may include a corresponding threaded portion 64t to allow the sealing ring 64 to be threadably fastened to the patient interface structure 320 .

[0327] 3.5.5.4 Sealing ring - fourth embodiment

[0328] like Figure 17mAs shown, according to another variation, the hole 324 of the patient interface structure 320 may have a plurality of retaining portions 324h and a corresponding number of release portions or openings 324r. The sealing ring 64 includes a corresponding number of protrusions 64p, which are received in the release portions 324r and rotated to engage with the retaining portions 324h to form a bayonet connection between the sealing ring 64 and the patient interface structure 320.

[0329] 3.5.5.5 Sealing ring - fifth embodiment

[0330] Combination Figure 17n and 17o , the rotating seal ring 64 may have an asymmetric configuration including a first flange 64a having a larger diameter than a second flange 64b. A gap or space 64g is provided between the first and second flanges 64a, 64b to accommodate the flange of the patient interface structure. The second flange 64b includes an inclined surface 64s that facilitates insertion of the seal ring 64 into the hole of the patient interface structure. The second flange 64b is configured to contact the edge 60e of the elbow 60 to form a radial seal.

[0331] 3.5.6 Elastic pad

[0332] Combination Fig.26a and 26b , the stem or neck 10 of the nasal pillow 4 may be connected to the top 6t of the base portion 6 of the patient interface structure and includes a thinned portion or reduced thickness portion 7. The thinned portion 7 allows the nasal pillow 4 to easily pop up or bounce and thus adjust to more easily fit the patient's alar angle.

[0333] exist Figure 18p and 18s In the illustrated variation, the top portion 6t of the flexible base 6 may include a thinned portion or resilient pad 335 between the stem or neck 332 of the nasal pillow 328 and the adjustment element 47 .

[0334] 3.5.7 Flexible substrate

[0335] Combination Figures 42a-42c The flexible base 6 of the patient interface structure is configured to conform under tension around the underside of the patient's nose when in use. The flexible base 6 can help isolate seals such as nasal pillows 328 from tube drag forces on the tube 16 that may be connected to the patient interface structure via elbow 17. Fig.42a As shown, substantially no tube drag is exerted on the patient interface structure. Both nasal pillows 328 are in sealing engagement with the patient's nostrils. Figure 42b , force can be applied to the tube 16 on the right side of the patient's face. The flexible base 6 compresses the right side of the patient's face while allowing the nasal pillows 328 on the left side of the patient's face to remain in sealing engagement with the patient's nostrils. Figure 42bAs shown, the stem or neck 332 of the left nose pad 328 is less compressed than the stem 332 of the right nose pad 328. It should be appreciated that the compressibility of the stem 332 and, for example, the thinned region or resilient pad near the stem 332 can further help isolate forces exerted on the tube or patient interface structure, such as tube drag, from the seal. Figure 42c As shown, with tube drag applied to the left side of the patient's face, the left side of the flexible base 6 is compressed like the stem of the left nasal pillow 328. The right nasal cushion 328 remains in sealing engagement with the patient's right nostril. The stem 332 of the right nasal cushion 328 can be hinged to help keep the right nasal cushion 328 in sealing engagement.

[0336] Combination Figures 43a-43c The flexible substrate 6 can also assist forces such as tube drag applied in the up-down direction. Fig.43a As shown, the nose pads 328 are in sealing engagement with the patient's nostrils without the application of external forces. Figure 43b As shown, if an upward force is applied to the patient interface structure, the flexible base 6 helps to isolate the force so that the nose pad 328 remains in sealing engagement. Fig.43c As shown, if a downward force is applied to the patient interface structure, the flexible base 6 helps to isolate the force so that the nose cushion 328 remains in sealing engagement with the nostril. Figure 43b In the case of the upward force shown, the rod 332 may also be compressed, or Fig.43c In the case of the downward force shown, the stem 332 expands to help isolate the force. It will also be appreciated that a thinned area or resilient pad disposed near the stem and / or at the base of the frustoconical sealing surface or region in the patient interface structure may help isolate the force.

[0337] although Figures 42a-42c Describes the forces that isolate the left and right directions and Figures 43a-43c Isolating forces in the up-and-down direction is described, but the flexible substrate can help isolate forces in other directions, such as side-to-side or a combination of up-and-down, or toward or away from the patient's face.

[0338] As described above, the plenum chamber of the base of the patient interface structure is semi-rigid or flexible so that the plenum chamber will bend or flex when forces such as tube drag are applied to the patient interface structure. The plenum chamber is semi-rigid or flexible enough to maintain ventilation of the patient interface structure, such as through a vent provided in an elbow connected to the patient interface structure. In other words, the plenum chamber is semi-rigid or flexible enough to prevent the plenum chamber from folding on itself and prevent ventilation of the patient interface structure.

[0339] 3.5.8 Flexible straps

[0340] As mentioned above for Figures 42a-43c As described above, for example, the straps of the flexible main straps 74r, 74l may stretch to help isolate forces such as tube drag applied to the patient interface structure. The straps may also bend or flex to help isolate forces applied to the patient interface structure. For example, the main straps 74r, 74l may bend or flex in a plane and / or out of a plane defined by the straps to help isolate the forces. As another example, the bifurcation region of the straps 74r, 74l defined by the connector 84 may bend, flex and / or stretch in response to an applied force.

[0341] Although various exemplary embodiments have been described with respect to a seal positioning and stabilizing structure that generally includes side straps, top straps and back straps, and main strap loops and back strap loops, it should be understood that other seal positioning and stabilizing structures may also be used. For example, the seal positioning and stabilizing structure may include straps that are routed to surround and engage the patient's ears. The seal positioning and stabilizing structure may include elastic and / or inelastic straps. The seal positioning and stabilizing structure may also be provided in various sizes. The seal positioning and stabilizing structure may be formed from silicone. For example, the seal positioning and stabilizing structure may be molded from silicone as a single piece. However, it should be understood that the seal positioning and stabilizing structure may be molded into several pieces, such as two, three, or six pieces. Optionally, silicones of varying hardness (i.e., hardness) may be molded together. For example, as Figures 16a to 16g As shown, the silicone may also vary in width or depth (thickness) throughout the seal positioning and stabilizing structure to reinforce the seal positioning and stabilizing structure in areas of higher force concentration, such as the cheek area. The strap may also have anti-sweating features. For example, the side of the strap configured to contact the patient's face may be textured to minimize or prevent sweating.

[0342] It will be appreciated that the seal positioning and stabilising structure and the patient interface structure may be formed as an integral piece with interchangeable nasal pillows, such as disclosed in Australian application number 2004308536 filed on 24 December 2004, the entire contents of which are incorporated herein by reference.

[0343] It should be understood that the patient interface system may include a nose clip, rather than a seal positioning and stabilizing structure, to hold the patient interface structure in place on the patient's face.

[0344] With respect to the exemplary embodiments shown, the patient interface structure has been described above as being formed, for example, from silicone. It will be appreciated that the patient interface structure may be formed, for example, from a foam material, such as disclosed in International Applications PCT / AU2007 / 001051 filed on July 30, 2007 and PCT / AU2007 / 001052 filed on July 27, 2007, and Australian Provisional Application No. 2007906102 filed on November 6, 2007, the entire contents of which are incorporated herein by reference. It will also be appreciated that the patient interface structure may include a gel.

[0345] Although various exemplary embodiments of nasal pillows or nasal prongs have been described above, it will be appreciated that other forms of orifice or nasal seals may be used, such as disclosed in U.S. Pat. No. 4,782,832 (Trimble), U.S. Pat. No. 7,201,169 (Wilkie et al.), U.S. Pat. No. 7,059,328 (Wood), and WO 2000 / 074758 (Lovell).

[0346] Although the present invention has been described in conjunction with what are currently considered to be the most practical and preferred embodiments, it should be understood that the present invention is not limited to the disclosed embodiments, but on the contrary, the present invention is intended to cover various modifications and equivalents included in the spirit and scope of the present invention. At the same time, the various embodiments described above can be implemented in conjunction with other embodiments, for example, the scheme of one embodiment can be combined with the scheme of another embodiment to form other embodiments. In addition, each independent feature or component of any given component can constitute another embodiment. Moreover, each independent component of any given component, one or more parts of any given independent component of the component, and various combinations of components of one or more embodiments may include one or more decorative design features. In addition, although the present invention has specific applications for patients with OSA, it should be understood that patients with other diseases (e.g., congestive heart failure, diabetes, morbid obesity, stroke, and obesity treatment surgery, etc.) can also benefit from the above teachings. Moreover, the above teachings have the same practicality for patients and non-patients in non-medical applications.

Claims

1. A patient interface system for delivering a positive pressure air supply to an entrance of a patient's airway to treat sleep disordered breathing, the patient interface system comprising: a patient interface structure comprising a flexible, unitary silicone structure at least partially forming a plenum chamber provided with a seal adapted to engage and form a seal with the underside of a patient's nose in use; and A flexible seal positioning and stabilizing structure, the seal positioning and stabilizing structure is used to position and stabilize the patient interface structure in sealing engagement with the patient airway, the seal positioning and stabilizing structure comprising: a pair of main sections molded as a single piece, the main sections comprising only flexible silicone material, each main section being configured to engage, in use, a respective side of a patient's face between the patient's eyes and ears, a patient interface structure connector being disposed at a base of each main section, each patient interface structure connector being removably connectable to a respective side of the patient interface structure; and an adjustable rear strap connected at respective ends thereof to the main portion of the seal positioning and stabilising structure and configured to extend around the back of the patient's head in use, wherein the rear strap is formed of a material different from the silicone material of the pair of main portions.

2. A patient interface structure according to claim 1, wherein each main portion includes a strap connector, and the corresponding end of the rear strap is removably and adjustably connected to the strap connector.

3. A patient interface structure according to claim 2, wherein each strap connector includes a slot to receive a corresponding end of the rear strap.

4. A patient interface structure according to claim 3, wherein each main portion has a top portion opposite the bottom portion and is arranged to be positioned on the top of a patient's head in use.

5. A patient interface structure according to claim 4, wherein the rear strap is connected to the corresponding strap connector at a position between the bottom and top of the corresponding main portion.

6. A patient interface structure according to claim 2, wherein each strap connector is positioned along the curve of the corresponding main portion, and the middle portion of each main portion is arranged to be positioned between the patient's eyes and ears in use.

7. A patient interface system according to any one of claims 1 to 6, wherein the silicone of the main portion has a matte surface on a first side arranged to face towards the patient and on a second side arranged to face away from the patient.

8. A patient interface system according to any one of claims 1 to 6, wherein: The silicone of the main portion has a Shore A hardness in the range of 40-80.

9. A patient interface system according to any one of claims 1 to 6, wherein: Each main portion has a width of 5 mm to 25 mm.

10. A patient interface system according to any one of claims 1 to 6, wherein: The patient interface structure includes a left connector and a right connector arranged on opposite sides thereof, and the left connector and the right connector are configured to be respectively connected to the patient interface structure connector of the main part to connect the seal positioning and stabilizing structure to the patient interface structure.

11. The patient interface system of claim 10, wherein: The left connector and the right connector are formed integrally with the patient interface structure.

12. A patient interface system according to any one of claims 1 to 6, wherein: At least one side of the patient interface structure has markings corresponding to the markings of the corresponding main part of the seal positioning and stabilizing structure to indicate the correct main part to connect to the at least one side of the patient interface structure.

13. A patient interface system according to any one of claims 1 to 6, wherein: The main portion is configured to stretch, bend or flex to help isolate forces applied to the patient interface structure.

14. A patient interface system according to any one of claims 1 to 6, further comprising an isolation device, the isolation device comprising a flexible portion of the patient interface structure, an air delivery tube being connected to the flexible portion, wherein the isolation device is configured to isolate a force applied by the air delivery tube on the patient interface system so that the force is separated from the seal.

15. The patient interface system of claim 14, wherein: The isolation device forms a flexible connection to connect the patient interface structure to the air delivery tube.

16. The patient interface system of claim 14, wherein: The isolation device also includes a swivel ring and a swivel elbow rotatably coupled to the swivel ring to allow the air delivery tube to move relative to the swivel ring when coupled to the elbow to isolate tube drag forces.

17. A patient interface system according to claim 16, wherein: The patient interface structure is coupled to the swivel elbow.

18. A patient interface system according to any one of claims 1 to 6, wherein: The unitary silicone structure includes a flexible substrate and the seal, the seal being supported by the flexible substrate.

19. A patient interface system according to claim 18, wherein: The flexible substrate at least partially forms the plenum.

20. The patient interface system of claim 19, wherein: The flexible base is configured to wrap around the underside of the patient's nose when under tension in use to accommodate varying facial geometries.

21. A patient interface system according to any one of claims 1 to 6, wherein: The seal comprises only a single orifice which is configured, in use, to deliver a supply of air to both nostrils of the patient.

22. A patient interface system according to any one of claims 1 to 6, wherein: The rear strap comprises a fabric material.

23. The patient interface system of claim 1, wherein: Each main portion includes a strap connector to which the respective end of the rear strap is removably and adjustably connected, wherein each strap connector includes a slot to receive a corresponding end of the rear strap, wherein each main portion has a top portion opposite said bottom portion and is arranged to be positioned, in use, on the top of a patient's head, wherein the rear strap is connected to a corresponding strap connector at a location between a bottom and a top of the corresponding main portion, wherein each strap connector is positioned along the curve of the corresponding main portion and the intermediate portion of each main portion is arranged to be positioned between the patient's eye and ear in use, wherein the silicone of the main portion has a matte surface on a first side arranged to face the patient and on a second side arranged to face away from the patient, Each of the main portions has a width of 5 mm to 25 mm.

24. The patient interface system of claim 1, wherein: the seal comprises only a single orifice configured, in use, to deliver a supply of air to both nostrils of the patient, wherein the main portion forms a loop configured to extend, in use, from adjacent an underside of the patient's nose to an area at or adjacent the top of the patient's head, wherein the patient interface structure comprises a left connector and a right connector disposed on opposite sides thereof, the left connector and the right connector being configured to be respectively connected to the patient interface structure connector of the main portion to connect the seal positioning and stabilizing structure to the patient interface structure, and Wherein at least one side of the patient interface structure has markings corresponding to markings of corresponding main parts of the seal positioning and stabilizing structure to indicate the correct main part to be connected to at least one side of the patient interface structure.

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