Headgear for masks

Abstract

To provide a headgear which makes it possible that one predetermined size of headgear fits a wide range of patients, eliminating the need to make a large number of adjustments to the headgear to achieve a fit, and which leaves no facial marks in use, and also to provide a cost-reduced method of manufacturing headgears for respiratory masks.SOLUTION: Provided is a headgear for use with a mask comprising a rigidizer 660; a conformable material; and at least one fabric, wherein edges of the at least one fabric are sealed by at least one joint so that the rigidizer, the conformable material, and the at least one joint are encapsulated by the at least one fabric over at least a portion of the headgear.SELECTED DRAWING: Figure 6

Description

[Technical field]

[0001] (CROSS REFERENCE TO APPLICATION) This application claims the benefit of Australian Provisional Patent Application No. 2008906390 (filed December 10, 2008), Australian Provisional Patent Application No. 2009900327 (filed January 29, 2009), Australian Provisional Patent Application No. 2009902731 (filed June 12, 2009), and Australian Provisional Patent Application No. 2009904236 (filed September 4, 2009), each of which is incorporated by reference in its entirety herein.

[0002] The present invention relates to headgear and methods of manufacturing headgear used to hold a mask in place on a patient's face, such as for treating Sleep Disordered Breathing (SDB) using Continuous Positive Airway Pressure (CPAP) or Non-Invasive Positive Pressure Ventilation (NIPPV). [Background technology]

[0003] Masks used for the treatment of SDB, such as obstructive sleep apnea (OSA), are usually held on the patient's head by a headgear. The headgear typically includes one or more headgear straps that are configured to engage the mask and hold it in place on the patient's face. The headgear should also be comfortable so that patients can wear the mask at night while they sleep. There is a continuing need in the art for headgear that is comfortable, fits a wide range of patients, is easily manufactured, and is inexpensive. Summary of the Invention [Problem to be solved by the invention]

[0004] A problem with some prior art headgear is that the prescribed sizes may only fit a small percentage of patients, or may require a significant number of adjustments to achieve a fit. Another problem with some prior art headgear is that the headgear has a tendency to leave marks on the face during use. Another problem with some prior art headgear is that the headgear is cumbersome and complicated to use. [Means for solving the problem]

[0005] A first aspect of the present invention is to provide headgear for a respiratory mask.

[0006] Another aspect of the present invention is to provide headgear that fits comfortably on a wide range of patients.Another aspect of the present invention is to provide an inexpensive method of manufacturing headgear for a respiratory mask.Another aspect of the present invention is to provide headgear that is easy to use.

[0007] One aspect of headgear according to the present invention is that the rear of the headgear is constructed and arranged to remain relatively fixed in position during use. In one form, the headgear has a rear that does not substantially "ride up" or slide forward. Another aspect of preferred headgear is that it does not rest against the ears during use.

[0008] In one embodiment, the headgear rear portion forms a rear loop that encircles the back of the head. In one embodiment, the rear portion comprises a rear loop that has substantially no extensibility along the length of the rear portion. In one embodiment of the invention, headgear for a respiratory mask is provided having a first region having a first extensibility and at least one further region having a different extensibility. In one embodiment, the headgear comprises a rear portion that is substantially inextensible and side portions that are elastic.

[0009] One aspect of the invention relates to headgear for use with a mask, the headgear may include a rigidizer constructed from a rigid or semi-rigid material and adapted to extend on either side of the patient's parietal bone, an upper strap adapted to releasably connect the rigidizer to an upper mask portion, and a lower strap adapted to releasably connect the rigidizer to a lower mask portion.

[0010] Another aspect of the invention relates to headgear for use with a mask, the headgear including a rigidizer constructed from a rigid or semi-rigid material and configured to extend over the crown and cheekbones of a patient's skull, and one or more straps configured to support the rigidizer at the back of the patient's head.

[0011] Another aspect of the invention relates to headgear comprising a relatively inextensible rear portion and a plurality of relatively extensible straps, preferably interconnecting the rear portion and the mask during use.

[0012] Another aspect of the present headgear technology is the relatively low cost manufacturing technique.

[0013] Another aspect of the invention relates to a method of constructing headgear comprising die cutting relatively straight sections from a sheet of material. Another aspect of the invention relates to a high yield layout of headgear strap components on a sheet.

[0014] Another aspect of the invention may include a method of manufacturing headgear for use with a mask, the headgear comprising components of generally simple geometrical configuration and cuttable from a flat piece of material, the method including (a) cutting a plurality of components of the same type from a single flat sheet of said material, (b) the components are nested within one another in said sheet, thereby minimizing the amount of waste material that is removed and discarded, and (c) the method provides a high yield, preferably defined as 11.5 or more pieces of headgear per square meter, and the shapes may include a generally rectangular shape or a generally arcuate shape.

[0015] Preferably, the shape may include a generally rectangular shape or a generally arcuate shape, and the component may include a strap or rigidizer.

[0016] Another aspect of the invention may include a headgear assembly for use in attaching a medical device to a patient's head, the headgear comprising a plurality of elongate straps, at least a portion of which include a rigid or semi-rigid layer encapsulated between first and second layers of flexible biocompatible material, and further a cushioning layer encapsulated between the first and rigid layers of material. Preferably, the layers of the straps are secured in place by vulcanization or gluing, and the straps, which may include a rigid layer, are positioned at the back of the head in use. Preferably, the material is fabric.

[0017] Another aspect of the headgear of the present invention is that it has a reduced tendency to cause facial marks compared to the prior art. In one form, the headgear of the present invention has softened edges. In one form, the joints are located away from the face contact. In one form, large radius edges are used. In one form, the die cut edges are not present towards the face in use.

[0018] Another aspect of the invention may include a process for making headgear including laminating foam and a textile material together, thermoforming the laminated foam and textile material, ultrasonically die cutting the thermoformed and laminated foam and textile material into one or more strap portions of the headgear, and joining the one or more strap portions together.

[0019] Another aspect of preferred headgear according to the invention is that the headgear is constructed and arranged to assume a predetermined shape when not in use. This predetermined shape may be substantially similar to the shape the headgear assumes when worn, making the headgear intuitively easier to use. In one form, headgear according to the invention is constructed and arranged to "spring to life" and assume a predetermined shape when removed from packaging and / or when forces (e.g., pressure) tending to deform the headgear are removed. In one form, the headgear comprises a section constructed from a resilient material. In one form, the headgear comprises a self-supporting rear portion.

[0020] A further aspect of the invention relates to headgear for use with a mask, comprising a rigidizer, a conformable material, and at least one fabric, wherein edges of the at least one fabric are sealed by at least one joint, such that the rigidizer, the conformable material, and the at least one joint are encapsulated in the at least one fabric over at least a portion of the headgear.

[0021] A further aspect of the invention relates to headgear for use with a mask comprising a first strap configured to engage the back of a patient's head and extend behind the patient's ears on either side of the patient's parietal bone and to assume a generally circular or oval shape during use, at least a portion of the first strap being substantially inextensible, and at least one second strap configured to releasably connect the first strap to the mask.

[0022] Another aspect of the invention relates to headgear for use with a mask comprising a first strap configured to extend over the top of a patient's head in use and to extend on either side of the patient's parietal bone and behind the patient's ears, and at least one second strap configured to releasably connect the first strap to the mask, at least a portion of the first strap being self-supporting such that the headgear maintains its three-dimensional shape when not in use.

[0023] Yet a further aspect of the invention relates to headgear for holding a respiratory mask in place on a patient's face, the headgear comprising a rear portion and respective left and right side portions configured to be connected to the respiratory mask, the rear portion comprising a substantially inextensible arch-shaped portion configured to elastically return to a predetermined shape when not in use, the arch-shaped portion including a first portion configured to be aligned generally parallel to the crown of the patient's head and a second portion configured to be generally aligned with a rear surface of the patient's head.

[0024] Yet another aspect of the invention relates to a method of making headgear for use with a mask, comprising the steps of placing a rigidizer over a first foam and a first fabric laminate, placing a second foam over the rigidizer and placing a second fabric over the second foam, thermoforming the first foam and first fabric laminate, the rigidizer, the second foam, and the second fabric to form a thermoformed sheet, and ultrasonically cutting the thermoformed sheet present around the periphery of the headgear.

[0025] Another aspect of the invention is to provide one size headgear that will fit a wide range of patients, reducing or eliminating the need for adjustments to achieve a headgear fit. In one form of the invention, a rear headgear portion is provided that has a constant size that does not require adjustment to fit a wide range of patients.

[0026] Other aspects, features, and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which are a part of the disclosure and illustrate, by way of example, the principles of the invention.

[0027] The accompanying drawings facilitate an understanding of various embodiments of the present invention. [Brief description of the drawings]

[0028] [Figure 1] FIG. 2 is a side view of headgear in place on a patient's head in accordance with an embodiment of the present invention. [Diagram 2] FIG. 13 is a rear perspective view of headgear in place on a patient's head according to another embodiment of the present invention. [Diagram 3] FIG. 13 is a partial perspective view of headgear according to another embodiment of the present invention. [Figure 4] FIG. 13 is a side view of headgear in place on a patient's head, according to another embodiment of the present invention. [Figure 4A] FIG. 5 is a cross-sectional view showing the junction of the headgear and mask of FIG. 4 according to an embodiment of the present invention. [Diagram 5] FIG. 13 is a side view of headgear in place on a patient's head, according to another embodiment of the present invention. [Figure 6] FIG. 13 is a rear perspective view of headgear in place on a patient's head according to another embodiment of the present invention. [Figure 7] FIG. 7 is a front perspective view of the headgear in FIG. [Figure 8] FIG. 7 is a front perspective view of the headgear of FIG. 6 provided with a different mask according to another embodiment of the invention. [Figure 9] FIG. 9 is a rear perspective view of the headgear arrangement in FIG. [Figure 10] FIG. 13 is a rear perspective view of headgear in place on a patient's head according to another embodiment of the present invention. [Figure 11] FIG. 11 is a perspective view of a rigidizer of the headgear in FIG. [Figure 12]FIG. 12 is an enlarged view of the rigidizer joint in FIG. 11. [Figure 13] FIG. 12 is a cross-sectional view of the rigidizer joint in FIG. 11. [Figure 14A] 11A-11C are cross-sectional views of alternative materials and configurations for rigidizers, according to embodiments of the present invention. [Figure 14B] 11A-11C are cross-sectional views of alternative materials and configurations for rigidizers, according to embodiments of the present invention. [Figure 14C] 11A-11C are cross-sectional views of alternative materials and configurations for rigidizers, according to embodiments of the present invention. [Figure 14D] 11A-11C are cross-sectional views of alternative materials and configurations for rigidizers, according to embodiments of the present invention. [Figure 14E] 11A-11C are cross-sectional views of alternative materials and configurations for rigidizers, according to embodiments of the present invention. [Figure 14F] 11A-11C are cross-sectional views of alternative materials and configurations for rigidizers, according to embodiments of the present invention. [Figure 14G] 11A-11C are cross-sectional views of alternative materials and configurations for rigidizers, according to embodiments of the present invention. [Figure 14H] 11A-11C are cross-sectional views of alternative materials and configurations for rigidizers, according to embodiments of the present invention. [Figure 14I] 11A-11C are cross-sectional views of alternative materials and configurations for rigidizers, according to embodiments of the present invention. [Figure 14J] 11A-11C are cross-sectional views of alternative materials and configurations for rigidizers, according to embodiments of the present invention. [Figure 15] FIG. 2 is a front view of a rigidizer in accordance with an embodiment of the present invention. [Figure 16A] 1 is an example of headgear components nested together with relatively high or improved yield. [Figure 16B] 1 is a prior art example of nested headgear components with low yield using prior art manufacturing methods. [Figure 17] 11 is a cross-sectional view of a strap portion according to a further embodiment of the present invention. [Figure 18]18 is a plan cross-sectional view of the strap according to the same embodiment depicted in FIG. 17. [Figure 19] FIG. 18 is a plan view of a bulk sheet of material used in the manufacture of the embodiment depicted in FIG. 17. [Figure 20] FIG. 18 is a stylized perspective view of assembled headgear according to the embodiment depicted in FIG. [Figure 21] FIG. 13 is a stylized perspective view of assembled headgear according to a further embodiment of the present invention. [Figure 22] FIG. 13 is a rear view of assembled headgear according to a further embodiment of the present invention. [Figure 23] FIG. 13 is a stylized perspective view of assembled headgear according to a further embodiment of the present invention. [Figure 24] FIG. 13 is a stylized perspective view of assembled headgear according to a further embodiment of the present invention. [Figure 25A] FIG. 13 is a front view of a forehead support according to a further embodiment of the present invention. [Figure 25B] FIG. 13 is a perspective view of a forehead support according to a further embodiment of the present invention. [Figure 25C] FIG. 13 is a cross-sectional view of a forehead support according to a further embodiment of the present invention. [Figure 26] FIG. 13 is a stylized perspective view of assembled headgear according to a further embodiment of the present invention. [Figure 27] 1 is a rigidizer according to a further embodiment of the present invention. [Figure 28] 1 is a series of nested rigidizers according to a further embodiment of the present invention; [Figure 29] FIG. 13 is a plan view of an unassembled top strap according to a further embodiment of the present invention. [Diagram 30] FIG. 13 is a plan view of an unassembled top strap according to a further embodiment of the present invention. [Diagram 31] 1 is a perspective view of an ultrasonically cut headgear strap according to an embodiment of the present invention. [Diagram 32] FIG. 2 is a perspective view of a headgear strap constructed from a nonwoven material according to an embodiment of the present invention. [Diagram 33] 1 is a fabric headgear strap with internal foam according to an embodiment of the present invention. [Diagram 34] 1 is a fabric headgear strap with internal foam according to an embodiment of the present invention. [Diagram 35] 1 is a method of stiffening with embossed ribs according to an embodiment of the present invention. [Diagram 36] 11A-11C illustrate different positions of the crown strap according to an embodiment of the present invention. [Figure 37] 11A-11C illustrate different positions of the crown strap according to an embodiment of the present invention. [Figure 38] 1 is a headgear with rigidizer according to an embodiment of the present invention. [Figure 39] 1 is a headgear with rigidizer according to an embodiment of the present invention. [Diagram 40] 1 is a rigidizer according to an embodiment of the present invention. [Diagram 41] 1 is an exemplary process for making stiffened headgear according to an embodiment of the present invention. [Diagram 42] 1 is an exemplary process for making non-rigidified headgear according to an embodiment of the present invention. [Diagram 43] 1 is a headgear including an outer layer of fabric formed around or over two strands of yarn, according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] The following description is provided in conjunction with several embodiments that may share common characteristics and features. It should be understood that one or more features in any one embodiment may be combinable with one or more features in other embodiments. Also, any single feature or combination of features in any embodiment may constitute an additional embodiment.

[0030] In this specification, the term "comprising" should be understood in the open sense, i.e., "including," and not limited to the close sense, i.e., "consisting only of." The corresponding words "comprise," "comprised," and "comprises" should be interpreted in a similar manner. Rigidizer means and includes any reinforcing element that increases the stiffness of another member, and may include the purpose of increasing stiffness in one or more axes.

[0031] As used herein, "substantially inextensible" refers to By a structure that is "tensile" it is meant a structure that will have an elongation of less than about 5%, and more preferably less than about 3%, when subjected to forces normally encountered in respirator use.

[0032] As used herein, a "self-supporting" structure refers to a structure that is capable of supporting substantially its own weight under the force of gravity. Such a self-supporting structure is not a "self-supporting" structure that is capable of supporting its own weight under the force of gravity. This is in contrast to a "floppy" structure.

[0033] As used herein, a "rigid" structure is intended to mean a structure that is relatively stiffer than "flexible" structures such as fabrics typically used as headgear. Fabrics typically cannot hold a given shape under gravity. A rigid structure can redirect vectors around physical structures such as the ears, unlike flexible fabrics that can bend or buckle.

[0034] 1. Headgear The figures show headgear according to another embodiment of the present invention. In the illustrated embodiment, the headgear is configured to be removably attached to a mask, thereby holding and maintaining the mask in a desired position on the patient's face. Although the headgear may be illustrated for use with a particular type of mask, it should be understood that each headgear can be configured for use with other suitable masks. That is, the masks are merely examples, and each headgear embodiment can be configured for use with any suitable mask, such as a full face mask, a nasal mask, a mouth mask, a nozzle or puff, a nasal cannula, etc., in any suitable configuration (e.g., with or without forehead support).

[0035] It should also be appreciated that the headgear may be used with new masks or may be retrofitted to existing masks.

[0036] In embodiments, the headgear configuration, materials, and / or adjustability can be designed to improve ease of use, ease of maintenance, comfort, and / or aesthetics, and the headgear configuration, materials, and / or adjustability can be designed to improve range of fit, e.g., one size fits all.

[0037] An advantage of the headgear according to the present invention is that it is relatively self-supporting and / or can retain its shape even when not being worn. This may allow the patient to understand how to use the headgear more intuitively or more clearly, which may also be contrasted with headgear systems that are entirely flexible and do not retain their shape. In one form, the self-supporting characteristics of the headgear are provided by the use of stiffened and / or thickened elements. In another embodiment, the configuration, materials, and / or adjustability of the headgear can be designed, for example, such that the headgear pops out of the box and is approximately in its in-use configuration. The configuration of the headgear can also be configured such that once outside the box, the headgear retains its in-use shape, for example with rigidizers that maintain the partial shape of the headgear.

[0038] The benefits of the present invention to the patient may include one or more of the following (but are not limited to): a comfortable headgear system, a perceived level of comfort and quality, a smooth continuous headgear shape that appeals to consumers, a pillow-like headgear appearance that is soft to the touch and comfortable to wear, and / or a headgear that is preformed to a shape that is intended to be worn and can support its own shape, thereby providing a clear orientation of the headgear, as the headgear shape is substantially curved to conform to the exact back of the patient's head, i.e. the headgear is generally dome shaped.

[0039] Additionally, the headgear may maintain its shape due to the manufacturing process employed to construct the headgear and / or the combination of materials that the headgear comprises.

[0040] Another aspect of the headgear described herein is to orient the mask system in direct contact with the patient's face, i.e., the headgear vector creates a normal or perpendicular pressure on the mask to the patient's face.

[0041] The headgear may also avoid contact with or obstruction to the patient's eyes and ears.

[0042] The headgear can also be constructed so that only one size can be configured for a wide range of patients.

[0043] 1.1 Connecting the headgear to the mask Preferably, each headgear includes two side sections with a back section connecting to the sides. The side sections provide a four-point connection with the mask making it compatible with (e.g., for retrofitting) conventional headgear. However, it should be understood that the headgear can be configured to provide more or fewer connection points, such as, for example, a two-point connection with the mask, a three-point connection with the mask, or a five-point connection with the mask.

[0044] The headgear can also be constructed and arranged to provide a force vector to the mask to be compatible with conventional headgear. For example, the headgear can be configured such that the force vectors applied by the headgear to the mask are approximately perpendicular to the mask and approximately parallel to each other (see, e.g., FIG. 1). This configuration improves the seal of the mask as the headgear presses the mask directly against the patient's face. However, adjustment of the headgear vector may be required depending on, for example, the type of mask used with the headgear.

[0045] 1.2 Rigidizer The headgear may include one or more rigidizers constructed from a rigid or semi-rigid material, the rigidizers configured to add rigidity to the headgear and secure it in place during use. The rigidizers may be flexible or deformable along the length of the rigidizer, but may resist or prevent stretching of the headgear in the direction of the length of the rigidizer. The rigidizers may be substantially inextensible. The rigidizers may be elastic. A rigidizer according to the present invention preferably has one or more of the following features: Holds its shape The headgear allows the sealing force vector to be redirected around curvatures such as around the eyes or ears; Flexible, and / or Provides structure to maintain a given shape on a particular surface

[0046] 1.2.1 Positioning the Rigidizer One or more rigidizers can be configured and positioned to engage different regions of the patient's head, for example, for comfort, aesthetics, usability, and the like.

[0047] The desired positioning on the patient's head is for the rigidizer to engage the rear of the patient's skull or head. Advantageously, the rigidizer also does not cover the back of the patient's head, thereby promoting comfort while the patient is sleeping or in a prone position. Preferably, the rigidizer partially or completely surrounds the top and / or rear of the patient's skull. The rigidizer is preferably mounted on an axis that is generally parallel to the orientation of the mask on the patient's face when the headgear and mask combination is worn.

[0048] 1.2.1.1 Top Rigidizer 1-3 illustrate headgear including rigidizers that are configured to fit generally perpendicularly on either side of a patient's parietal bone, thereby securing the headgear in place.

[0049] Preferably, the rigidizer is relatively inelastic and non-extensible along its length and is generally constructed from an inherently elastic material.

[0050] 1, rigidizers 60 are provided on either side of a patient's head, with each rigidizer 60 including an elongated body 62, a lower arm 64 extending generally laterally from a lower end of the body, and an upper arm 66 extending generally laterally downwardly and spaced apart from an upper end of the body. Upper side straps 20 releasably connect an upper portion of the mask 10 to the upper arm 66 (e.g., via a forehead support), lower side straps 30 releasably connect a lower portion of the mask 10 to the lower arm 64 (e.g., via a headgear clip coupled with a clip receptacle), a top strap 40 (e.g., an elastic connecting member) configured to cross the top of the patient's head in use and interconnect the upper ends of opposing rigidizers 60, and a rear strap 50 configured to pass behind the patient's head in use and interconnect the lower ends of opposing rigidizers 60.

[0051] In one embodiment, the upper side strap 20 can be a single piece that extends from one upper arm 66 across the patient's forehead to an opposing upper arm 66 on the opposite side of the patient's head. Preferably, the upper side strap 20 does not extend significantly back past the patient's ears. Also in FIG. 1, the range of motion of the upper and lower arms 66, 64 is illustrated by dashed lines. In another embodiment, the upper arm 66 can be It may be a single piece configured to extend from one body 62 across the patient's forehead to an opposing body 62 on the opposite side of the patient's head.

[0052] In FIG. 2, each rigidizer 260 has a composite construction (described below) and the upper and lower side straps 220, 230 are continuous and configured to extend from the upper and lower portions of the mask through the respective rigidizers 260, where the rigidizers 260 extend along the parietal bone of the patient's head.

[0053] In one embodiment, the upper side straps 220, the lower side straps 230, and the rigidizer 260 may each have different elastic properties that can provide adjustability and stability to the mask on the patient's face during use.

[0054] In one example, the upper side straps 220 can be constructed from a stretchable material, thereby providing adjustment to the mask during use. For example, the upper side straps 220 can be constructed from an elastic material. Furthermore, the stretch provided by the upper straps can provide a greater range of fit for the patient. Additionally, the lower side straps 230 can be constructed from a material that has a lower stretchability compared to the upper side straps. That is, the lower side straps 230 can be constructed from a material that has a lower elasticity to an applied force compared to the material used for the upper side straps 220. This is to secure the mask in place while still allowing some adjustment of the position of the mask on the patient's face. Additionally, the rigidizers 260 can have a lower stretchability and elasticity compared to the upper side straps 220 and / or the lower side straps 230, thereby providing structure and support to the headgear, thereby properly securing the mask to the patient's head during use.

[0055] The upper side straps 220 and / or the lower side straps 230 can be constructed from a composite material, such as Breath-O-Prene®, and die cut from bulk material. The upper side straps 220 and / or the lower side straps 230 may also be constructed from a narrow woven material, which reduces or eliminates waste generated by die cutting.

[0056] In Fig. 3, the rigidizer 360 has a mesh structure configured to rest over the back of the patient's head. As shown, the rigidizer 360 is generally trapezoidal in shape with an upper end configured to be releasably connected to an upper side strap 320 coupled to an upper mask portion and a lower end configured to be releasably connected to a lower side strap 330 coupled to a lower mask portion. The mesh rigidizer 360 can be flexible to conform to the patient's head, but may be non-stretchable, for example to secure the headgear in place. However, the mesh may have another suitable structure.

[0057] In each embodiment, the rigidizer extends generally vertically along the parietal bone of the patient's head and is cup-shaped and / or configured to rest on the back of the patient's head. As shown, the parietal rigidizer may be connected to the top and / or bottom (i.e., to rest over the back of the head) and may include additional rigid or semi-rigid components to facilitate connection (see, for example, the strap connections in Figs. 2 and 3). The rigidizer also avoids the use of any rigid or semi-rigid components at the back of the head, where the patient's head may contact the bed during use. Preferably, the rigidizer is flexible or compliant with the patient's head along the length of the rigidizer, but cannot flex or deform across its width. This allows the headgear to be comfortable while still maintaining the structural function of securing the mask in place.

[0058] 1.2.1.2 Parietal and zygomatic rigidizers 4-5 illustrate headgear including rigidizers configured to fit on either side of the patient's parietal bone (i.e., in a generally vertical direction) thereby securing the headgear in place at the back of the patient's head and extending to the front of the patient's head and the patient's cheekbones.

[0059] 4, rigidizer 460 is a continuous component having two sides configured to extend across mask 10. As shown, each side includes an upper strap portion 462 that extends along the parietal bone of the patient's skull, over the patient's ear and toward the patient's cheekbone, and a lower strap portion 464 that extends below the patient's ear. Upper strap portion 462 extends across an upper region of mask 10 and lower strap portion 464 extends across a lower region of mask 10.

[0060] 4A, the upper strap portion 462 may be removably clipped to the mask 10. As shown, the upper portion of the mask 10 may include a plurality of spaced apart slots 15, and the clip 470 may extend through an opening in the upper strap portion 462 and into a selected one of the slots 15.

[0061] A flexible strap configuration including a rear upper strap 440 and a rear lower strap 450 connects the left and right sides of the rigidizer 460 at the back of the patient's head. The rear upper strap 440 and the rear lower strap 450 may be a continuous component or may be separate components.

[0062] 5, each rigidizer 560 is a continuous component configured to connect to a respective side of the mask 10. As shown, each rigidizer 560 includes an upper strap portion 562 that extends along the patient's parietal bone, over the patient's ear and toward the patient's cheekbone, a lower strap portion 564 that extends below the patient's ear, and a front strap portion 566 that is configured to connect to the mask 10.

[0063] In the illustrated embodiment, each rigidizer 560 is configured to rotatably engage a side of the mask 10 (e.g., clip onto the side of the mask, wrap around an anchor on the side of the mask), thereby allowing rotational movement of the mask relative to the rigidizer 560, allowing the mask to be rotated and adjusted for proper fit of the mask.

[0064] A rear upper strap 540 and a rear lower strap 550 connect the left and right sides of the rigidizer 560 to the back of the patient's head.

[0065] 1.2.1.3 Occipital and parietal rigidizers 6-11 illustrate headgear including rigidizers configured to form a nearly full circle / oval shape (e.g., a shape that may have an arc for adjustability that is broken off at the back of the head) thereby securing the headgear in place at the back of the patient's head. As shown, the rigidizers extend along the patient's parietal and occipital bones.

[0066] 6 and 7, rigidizer 660 includes a generally circular or elliptical shape with a cut-off arc at the bottom. The cut-off at the bottom can allow for size adjustment of the circle / ellipse shape.

[0067] The upper side straps 620 releasably connect the upper portion of the mask 10 to the rigidizer (e.g., via a forehead support), and the lower side straps 630 releasably connect the lower portion of the mask 10 to the rigidizer (e.g., via headgear clips that mate with clip receptacles).

[0068] Preferably, the lower side straps 630 and / or rigidizer 660 engage the occipital bone, thereby maintaining the rigidizer in place and preventing the headgear from sliding up the back of the patient's head during use. In a different preferred form, the upper side straps 620 and / or rigidizer 660 can capture or cross a majority above the parietal bone of the patient during use, thereby preventing the headgear from sliding off the patient's head during use.

[0069] In different embodiments, the upper side strap 620 and / or the lower side strap 630 may have an adjustable length. This can be achieved, for example, through the use of hook and loop fasteners. The length of the upper side strap 620 and / or the lower side strap 630 should be such that the rigidizer 660 does not contact the patient's ear. For example, the length of the upper side strap 620 or the lower side strap 630 may be adjusted to such an extent that the rigidizer is biased against the patient's face and thus contacts the ear. This may cause discomfort to the patient.

[0070] In different preferred embodiments, the lower side straps 630 are threaded through openings in the rigidizer 660, which allows the rigidizer 660 to slide along the length of the lower side straps 630, thereby adjusting the size of the space encapsulated by the rigidizer 660, and then changing the shape of the headgear to accommodate different patient head sizes. In different preferred configurations, the lower side straps 630 may have engagement portions along their length, which allow the position of the rigidizer 660 on the lower straps 630 to be fixed in place when the size of the space encapsulated by the rigidizer 660 is adjusted by sliding the rigidizer 660 along the length of the lower straps 630. For example, the engagement portions may be clips, Velcro, raised stitching, or other means for fixing the rigidizer 660 in place.

[0071] In different preferred embodiments, the upper side straps 620, the lower side straps 630, and / or the rigidizers 660 may be formed separately, allowing each component to be efficiently manufactured and economical (i.e., by nesting the components), as described below.

[0072] As shown in FIG. 15, the rigidizer 660 may be formed from a flat component and then bent or deformed into a shape suitable for use. The rigidizer 660 may be die cut from a sheet of material. The rigidizer 660 may have an upper opening 2000 for engagement with the upper side strap 620. Multiple upper openings 2000 may be provided (e.g., four openings as shown in FIG. 15), allowing the patient to adjust the position of the upper side strap 620. The rigidizer 660 may also have a lower opening 2100 for engagement with the lower side strap 630.

[0073] Figures 8 and 9 show the headgear of Figures 6 and 7 connected to the mask in a different configuration. In this embodiment, the upper side straps 620 are connected to the side outstretchers of the mask 10, and the lower side straps 630 are removably connected to the mask 10 via headgear clips that mate with clip receptacles on the mask. As best shown in Figure 8, the upper side straps 630 may be adhesively connected to the side outstretchers of the mask 10, such that the upper side straps are adjustable only at the rigidizer. Alternatively, the upper side straps 630 may be adjustably connected to slots in the ends of the side outstretchers of the mask 10, such that the upper side straps are adjustable at both the rigidizer and the side outstretchers.

[0074] 10 and 11 show an alternative arrangement for attaching the rigidizer 660 to the upper and lower side straps 620, 630, as described below.

[0075] FIG. 40 illustrates a rigid body configured to lie generally along the rear of a patient's head in use. 7 illustrates an alternative configuration for a rigidizer 7560. The rigidizer may be formed in a generally bulb shape having two generally circular or curved portions, an upper portion 7562 configured to engage generally the parietal region of the patient's head in use, and a lower portion 7564 configured to engage generally the occipital region of the patient's head in use. An upper strap 7512 is provided on the upper portion 7562 for engagement with the upper mask portion, and a lower strap 7514 is provided on the lower portion 7564 for engagement with the lower mask portion.

[0076] 1.2.2 Rigidizer / Strap Installation One or more rigidizers can be coupled to the mask and / or different objects in different configurations.

[0077] In embodiments, each rigidizer may include one or more slots to allow headgear straps to pass therethrough. For example, in FIG. 1, each end of the body 62, the end of the lower arm 64, and the end of the upper arm 66 include slots to allow headgear straps to pass therethrough during use. In FIG. 3, a mesh rigidizer 360 is shown with an upper portion having slots to accommodate headgear straps, and lower connectors 365 and 366 (e.g., overmolded onto the mesh). In FIG. 5, the rear of the rigidizer 560 may include upper and lower slots to accommodate the rear upper and lower straps 540, 550. Also, FIGS. 6-11 show one or more slots in the rigidizer 660 to accommodate headgear straps.

[0078] In various embodiments, the rigidizer may provide loops to accommodate the headgear straps. For example, in FIG. 2, the upper and lower ends of the rigidizer 260 include connectors 265 that provide loops to accommodate the respective headgear straps. The lower connectors 265 align with slots in the overlying rigidizer such that the lower straps 230 pass through slots located at the back of the patient's head. That is, the lower straps 230 pass through gaps in the rigidizer 260.

[0079] 10-13 show a configuration in which the rigidizer and strap provide a press stud arrangement. As shown, the lower end of the rigidizer may include a strap portion 662 having a number of holes 663, and one end of a lower strap 630 may be fitted with a stud 665 (e.g., a strap) that is configured to be press-fit into a selected one of the holes 663. The bottom strap 630 may include a stud 665 or an ultrasonically welded stud 666 to the mask cap. As shown in Figure 13, the studs 665 and holes 663 are configured to provide a snap fit arrangement. The opposite end of the bottom strap 630 may include a Velcro tab for attachment to the mask.

[0080] 25A-25C show an additional adjustment mechanism for the top strap 4412. A forehead support 5000 may be provided on the mask 10. The forehead support 5000 may allow the top strap to be looped through an opening 5005. As best shown in FIG. 25C, the forehead support may be provided with a push tab 5010 that is preloaded or biased by a spring 5025 to allow engagement and disengagement of the looped portion of the top strap 4412. A grip portion 5015 may be provided on the opposite side of the forehead support 5000 so that the patient can press the tab 5010 to stabilize their forehead mechanism. An additional grip portion 5020 may be provided on the end of the loop portion of the top strap 4412 and may prevent disassembly of the loop portion by pulling back through the opening 5005.

[0081] 26 also shows yet another alternative method for adjusting the bottom strap 4513, where perforations 6000 may be provided along the length of the bottom strap 4513, allowing the patient to tear or cut a segment of the bottom strap 4513 to shorten the length of the bottom strap. The perforations 6000 may be areas of weakness along the bottom strap 4513, such as a thinner cross section, narrower strap width, etc.

[0082] [Additional embodiments] Also shown in FIG. 18 is a closed first strap 3010 with a rigidizer 3001 that may have an arch or bend 4000. The bend 4000 may be located at a limited portion of the rigidizer 3001, allowing the rigidizer to be easily bent or hinged at this portion. This may be beneficial to accommodate a wider range of patient head sizes. As shown in FIG. 18, the bend 4000 may be positioned to allow the lower portion of the rigidizer to bend outward toward the patient's ears or inward toward the center of the patient's head. The bend 4000 may be a weakened portion, allowing the rigidizer 3001 to achieve similar flexibility. For example, the bend 4000 may be a curved portion, a thinned cross section, or a narrowed width portion of the rigidizer 3001. This bend cannot be tensioned like different portions of the headgear, such as upper and lower headgear straps for direct connection to a mask system.

[0083] A further configuration is shown in Figure 20, where a first strap 3010 may have an enclosed rigidizer 3001 (not shown) and a top strap 3012 and a bottom strap 3013 may be provided. The top strap 3012 and bottom strap 3013 may each be a single length of material that may be looped or otherwise attached to the first strap 3010. Fastening means (e.g. hook and loop connections, press studs, adhesive) may be attached to the ends of the top strap 3012 and bottom strap 3013, allowing the length of the straps to be adjusted.

[0084] A further configuration is shown in FIG. 21, where a first strap 4010 (provided with a sealed rigidizer (not shown)) is joined to its lower end by sewing, gluing, welding or other means. Alternatively, the first strap 4010 can be formed of a circle or loop material. The first strap 4010 can be integrally formed by ultrasonic die cutting. The circumference of the first strap (measured from the inner edge or edge furthest from the top strap 4012 and the bottom strap 4013) can be about 420-600 mm. Preferably, the circumference can be about 480-550 mm. Preferably, the circumference can be about 490-505 mm. Preferably, the circumference can be about 500 mm. With circumferences of these values, the headgear can be configured to be worn on the top of most heads of an average person. In addition, the rigidizer can be prevented from contacting the patient's ears. Furthermore, the rigidizer can be prevented from contacting the patient's lower neck, upper back, or spine.

[0085] Also shown in FIG. 21 is a top strap 4012 attached to the first strap 4010 at a joint 4035. The joint 4035 may be stitched, ultrasonically welded, glued, or other attachment means, or a combination of means. The top strap 4012 may be provided with an adjustment means 4020, such as hook or loop material, pressed studs, etc., at the free end of the top strap. The bottom strap 4013 may be attached to the first strap 4010 by a joint 4035. The joint 4035 may be stitched, ultrasonically welded, glued, or other attachment means, or a combination of means. The bottom strap 4013 may be provided with an adjustment means 4020, such as hook or loop material, pressed studs, etc., at the free end of the bottom strap. In yet another embodiment, the first strap 4010, the top strap 4012, and the bottom strap 4013 may be integrally formed. The unitary component may be formed by manually rolling an ultrasonic welder around the circumference of the component. In certain embodiments, this method relies on manual labor and may result in some uneven edges. The unitary component may be constructed by ultrasonic die cutting. This may have the advantage that the process may be more tightly controlled, so each headgear piece may be more uniform or consistent. Alternative construction methods are also possible, including ultrasonic welding and CNC knife cutting.

[0086] FIG. 22 shows a rear view of the first strap 4110 (which may be provided with an enclosed rigidizer (not externally visible in FIG. 22)) in the use position. Angle a indicates the alignment angle of the bottom strap 4113 with respect to the horizontal plane. The bottom strap 4113 is preferably bent or biased downwards to angle a, which guides the bottom strap below the patient's ear. Angle a may be 0 degrees or more. Angle a may be between 0 degrees and 90 degrees. Preferably, angle a may be between about 10 degrees and 30 degrees. Preferably, angle a may be between about 15 degrees and 20 degrees. Angle a may be about 11 degrees. The first strap 4110 may also be provided with a top strap 4112, which may be elastic. The bottom strap 4113 may be attached to the first strap 4110 by joints 4134, 4135.

[0087] 22 also shows the length L of the first strap, which is the width of the lower portion of the first strap closest to the junction 4130. Preferably, the length L may be less than about 60 mm, thereby avoiding contact with the patient's neck or upper back or spine. Preferably, the length L may be between about 30 mm and 50 mm.

[0088] As shown in FIG. 22, the upper portion of the headgear formed by the first strap 4110 is arched to engage the top of the patient's head. In use, the first strap 4110 extends through its widest portion in the arched region toward a horizontal plane 4115, so that it lies flat on the top of the patient's head. The lower portion or side of the first strap 4110 extends through a vertical plane (parallel to the vertical axis 4116) at the widest portion of the lower portion, or side of the first strap. This configuration allows the headgear portion including the first strap 4110 to lie flat on the back of the patient's head. When the first strap 4110 is provided with an enclosed rigidizer, the configuration of the first strap 4110 in combination with the rigidizer provides a three-dimensional shape of the headgear.

[0089] A further configuration is shown in FIG. 23, where a first strap 4210 (which may be provided with a sealed rigidizer (not shown)) may be attached to a top strap 4212 by a joint 4235. The joint 4235 is shown as an ultrasonic weld, but may be any other suitable method for attaching the top strap 4212 to the first strap 4210. The top strap 4212 may be elastic or other suitable material. The bottom strap 4213 may pass through a loop 4235 in the first strap 4210. The bottom strap 4213 may be made of elastic or other suitable material. The bottom strap 4213 may also be adjustable by providing a ladder lock 4220 at its end. The ladder lock 4220 may be slid along the length of the bottom strap 4213 to change the length of the strap.

[0090] Also shown in FIG. 23 is the rigidizer lower section 4250. This rigidizer lower section may be curved in such a way as to avoid contacting behind the patient's ear in use. The curvature of this lower section 4250 in FIG. 20 is such that the first strap 4210 follows a similar radius of curvature along its length. As shown in FIG. 23, the radius of curvature of the lower section 4250 is different from the radius of curvature of the upper section 4260. The lower section 4250 may have a smaller radius of curvature than the radius of curvature of the upper section 4260. The shape of the first strap 4210 may be similar to the rigidizer 4201 (not externally visible in FIG. 23) that is enclosed within the first strap.

[0091] 27 shows rigidizer 4201. In this case, lower section 4251 may have a smaller radius of curvature than upper section 4261. Alternatively, bends 4200 may be provided in rigidizer 4201, which positions lower section 4251 further beyond the center of the patient's head, thereby avoiding contact behind the patient's ears during use.

[0092] FIG. 28 shows rigidizers 4201 arranged in a nested manner to allow multiple pieces to be molded on a single substrate, thereby explaining that multiple rigidizers 4201 can be manufactured while minimizing the amount of waste material.

[0093] 29 shows the flattened first strap 4210 with the encapsulated rigidizer 4201 (depicted by dashed lines) to reveal the similar curved or generally arcuate shape of the two parts when formed or joined together. In this embodiment, either end 4280 of the rigidizer 4201 has a maximum length that preferably does not exceed the farthest point of the end 4211 of the first strap 4210, and has a preferred minimum length that is equal to or greater than the distance required to keep the end 4211 from deforming or bending when additional straps are connected to the end 4211 and the headgear is tightened on the patient's head. This feature may also avoid the rigidizer 4201 from causing discomfort or irritation to the patient's neck or upper back / spine.

[0094] FIG. 30 shows a further embodiment of the present invention. In this case, the rigidizer 4601 may be encapsulated inside the first strap 4610. The rigidizer 4601 may extend across only the center of the first strap 4610 so that in use it is only located on the top half of the head of the patient. This may increase comfort while maintaining the restoring force of the previous embodiment. In addition, the reduced length of the rigidizer 4601 may increase comfort in this embodiment and may also allow the strap to retain its shape and configuration, allowing the user or patient to quickly don the headgear. One advantage of the rigidizer mounted inside the headgear is to have a portion of the headgear that engages the rear of the patient's head, thereby maintaining the basic shape of the headgear and maintaining a rigid shape to prevent or limit deformation while the patient is wearing the headgear.

[0095] A further embodiment is shown in Figure 24, where the top strap 4312 and bottom strap 4313 are adjustable by ladder locks 4320. The top strap 4312 and bottom strap 4313 may be attached to the first strap 4310 with an enclosed rigidizer (not shown).

[0096] In embodiments, one or more features of the headgear can be configured to prevent or at least reduce the likelihood that the headgear will ride up the patient's head during use, causing the straps to be adjacent to or contacting the undersides of the patient's ears.

[0097] For example, as shown in FIG. 36, the position of the crown strap 7360 may be moved rearward (i.e., the angle of the crown strap is changed), which reduces the possibility of the headgear slipping up. The original position of the crown strap 7360 is shown in FIG. 36 by a solid line. The original position of the crown strap 7360 may be vertical or in the direction of the frontal plane of the body. For example, the crown strap 7360 may be moved back up to 40 degrees from the position shown in FIG. 36, such as 15 degrees as indicated by α1, 20 degrees as indicated by α2, and 40 degrees as indicated by α3. Moving the crown strap rearward also improves the retention of the crown area of ​​the patient, thereby improving support. For example, the crown strap is not excessively loose at the crown of the patient's head. Additionally, as shown in Figure 36, the straps may include a "J" or "dog leg" curvature to direct the headgear vector around the ears, for example having a radius of about 50mm to 70mm, more preferably about 55mm to 65mm. Figure 37 shows how the crown straps 7360 help maintain sufficient spacing from the patient's ears to the lower straps 7364.

[0098] In a different example, as shown in Figs. 38 and 39, the rigidizer 7460 may be extended to provide additional support along the bottom strap along the bottom of the neck. The length of the top strap 7466 may also be extended to provide better positioning of the crown strap. Preferably, the rigidizer 7460 may support or position the bottom strap of the headgear below or in an area that does not contact the patient's ears. The rigidizer 7460 may also prevent the headgear from riding up or moving vertically upward on the patient's head by securing the headgear to the back of the patient's head and / or neck. The non-stretching nature of the rigidizer 7460 also prevents the crown strap 7462 from stretching and hitting the patient's ear. The crown strap 7462 secures the headgear in place so that the headgear does not slide forward or around the patient's head. The bottom strap 7464 and the top strap 7466 may be more elastic or have more stretchability as compared to the crown strap 7462 .

[0099] For example, as shown in Figs. 38 and 39, the diameter d of the top strap 7462 may be preferably about 500 mm, and the top strap 7466 may be oriented at an angle α1 that is about 90 degrees relative to the top strap. The lower strap 7464 may be oriented at an angle α2 that is about 15 degrees to 30 degrees, such as 20 degrees, downward from the horizontal. In a further example, the diameter d of the top strap 7462 may be about 440 mm to 600 mm. In a further example, the diameter d of the top strap 7462 may be about 500 mm to 600 mm. In a further example, the diameter d of the top strap 7462 may be about 550 mm to 600 mm. In a further example, the diameter d of the top strap 7462 may be about 440 mm to 550 mm. In a further example, the diameter d of the top strap 7462 may be about 440 mm to 500 mm. Diameter d forms a loop at the rear of the headgear that encircles the back of the patient's head so that when the patient is lying on their back, little or none of the headgear is between the patient's head and the pillow or bed.

[0100] 1.2.3 Rigidizer / Strap Adjustment In embodiments, adjustment of the rigidizer and headgear straps may be provided by hook and loop materials (eg, Velcro, elastic, press studs, etc.).

[0101] For example, in Figures 1, 2, and 6-10, one or both ends of straps 20, 30, 220, 230, 620, 630 include a Velcro® tab configured to engage the remainder of the strap, thereby securing the strap in place and allowing adjustment (e.g., with respect to the rigidizer and / or mask).

[0102] In Figures 1, 4 and 5, one or more of the straps 40, 440, 450, 540, 550 are in the form of elastic components, which allow for adjustment.

[0103] The elastic provided on the top strap of the headgear (e.g. top strap 3012 in FIG. 20) may be 250-450 mm long. Preferably, the elastic top strap may be about 320-400 mm long. The elastic top strap preferably requires no more than 10N force to elastically extend 100 mm from its original length. The elastic top strap preferably requires no more than 6N force to elastically extend 100 mm from its original length. The elastic top strap preferably requires no more than 4N force to elastically extend 100 mm from its original length. The elastic top strap preferably requires no more than 3N force to elastically extend 100 mm from its original length. This may ensure that the headgear is comfortable for a range of patient head sizes.

[0104] In Figures 10-13, one or more of the straps include a press stud arrangement as described above to allow for adjustment.

[0105] 1.2.4 Rigidizer Materials The rigidizer may have a composite structure with two or more materials (a rigid or semi-rigid material with a covering made of a softer, patient-contacting material), may be made of other textile or polymeric materials (3D woven, knitted, nonwoven, laminates) and may be manufactured in other ways.

[0106] For example, the rigidizer can be made of any suitable flexible material such as nylon, polypropylene, polycarbonate, polystyrene, polyethylene, thermoplastic elastomers (TPEs), thermoplastic urethanes (TPUs), silicone, polyester, etc. (See, e.g., FIG. 1.) In FIG. 3, the rigidizer 360 is a three-dimensional woven / knitted fabric with relief edges.

[0107] The rigidizer may also be constructed by thickening or treating the fabric, making it more stiff or less stretchable. For example, the fabric may be printed, with the ink of the print restricting or reducing the fabric's ability to stretch. Additionally, the fabric may be sewn together in selected areas, thereby stiffening it. The fabric may also be ultrasonically welded in selected areas, thereby stiffening it.

[0108] The rigidizer may be constructed from a non-woven material, such as a mesh, that is resistant to stretching in at least one direction.

[0109] Alternatively, the rigidizer may be formed from a woven material, in which case the grain of the material is aligned so that the fabric does not stretch laterally (when placed on the patient's head), thereby tightening and securing the headgear in place on the patient's head.

[0110] The rigidizer may also be formed with an additional layer of material, such as silicone, polyurethane or other adhesive material, which may be configured onto the fabric strap to reinforce the strap, or silicone beads or polymer overmolding may be used.

[0111] The rigidizer may be 0.1 mm to 10 mm thick. Depending on the rigidizer's material of construction, the rigidizer may preferably be 0.5 mm to 5 mm thick. Generally, a thinner rigidizer may result in more comfortable headgear for the patient. A thicker rigidizer may be more dimensionally stable or stiffer.

[0112] The rigidizer may be between 1 mm and 30 mm wide. Preferably, the rigidizer may be between 5 and 20 mm wide. Preferably, the rigidizer in some embodiments described herein may be 10 mm wide. To improve flexibility along the length of the rigidizer, the material may be thinner in width than in height, or for thicker materials, the width may be narrower.

[0113] In various embodiments, the rigidizer may have an equal or smaller width than the fabric backing material that contacts the patient's head during use to increase the comfort of the headgear system during use.

[0114] In a further embodiment, the rigidizer may be encapsulated within a suitable fabric material, thereby improving patient comfort and fit.

[0115] The rigidizer may be overmolded (e.g., TPE overmolded with a softer material (see, e.g., FIG. 10)) or may be formed separately and then a sock of patient-contacting material (e.g., Breath-O-Prene™) is wrapped or slid over the rigidizer (see, e.g., FIGS. 2, 6, and 9). In another embodiment, the patient-contacting material may be attached to the rigidizer by adhesives, ultrasonic welding, stitching, hook-and-loop material, and / or stud connectors. In an embodiment, the patient-contacting material may only be present on the patient-contacting side of the rigidizer, thereby reducing the volume and cost of the headgear.

[0116] The resilient structure of the rigidizer also improves the fixation of the straps to the rigidizer, preventing the straps from tearing or breaking through the rigidizer under normal use by a patient.

[0117] 14A-14G are cross-sectional views of alternative rigidizer configurations. As shown in FIG. 14A, the rigidizer may include a die-cut sheet material 780 that is covered with fabric 781, such as two pieces of fabric joined by stitching or glue. Preferably, the fabric join is inside the strap so that it cannot contact the patient's face during use. This may be accomplished by turning the strap inside out and stitching it back to the intended strap orientation so that the stitch is inside the pocket of the fabric. The fabric is provided with a soft material for contacting the patient's face during use. The soft material may also be suitable for selective attachment of Velcro® tabs. The fabric on the patient-contacting side may be the same as the fabric on the non-patient-contacting side. The fabric on the patient-contacting side may preferably have the same weave as the fabric on the non-patient-contacting side so that the stretch characteristics of the strap are approximately equal on both sides. It is also desirable for the fabric on the patient contacting side to have the same heat shrink properties as the non-patient contacting side to prevent uneven deformation of the headgear during thermoforming or other processes or exposure to heat. The fabric on the patient contacting side may be a different fabric than the non-patient contacting side, which makes the fabric on the patient contacting side more comfortable compared to the non-patient contacting side.

[0118] 14B, the rigidizer may include a die cut sheet material 880 that is overmolded with a soft polymeric material 881, such as TPE, TPU, etc. The polymeric material provides a softer material for contacting the patient's face during use.

[0119] As shown in FIG. 14C, the rigidizer may include a semi-rigid molded component 980 that is covered with fabric 981, for example by joining two pieces of fabric with stitching.

[0120] 14D, the rigidizer may include a semi-rigid molded component 1080 that is attached (e.g., by welding, gluing, overmolding) to a fabric composite 1081 (e.g., a Breath-O-Prene® material or similar material) that provides a softer material for contacting the patient's face during use.

[0121] As shown in Figure 14E, the rigidizer may include a semi-rigid molded component 1180 that is overmolded with a soft polymeric material 1181, e.g., TPE, TPU. The polymeric material provides a softer material for contacting the patient's face during use.

[0122] 14F, the rigidizer may include a soft molded component 1280 molded from a soft polymeric material such as TPE, TPU, etc. In an embodiment, the molded component may be provided with a soft touch coating or a flock coating.

[0123] As shown in FIG. 14G, the rigidizer may include a fabric outer layer 1381 that is thermoformed and attached to the rigidizer 1380. The rigidizer may be a die-cut sheet material. Alternatively, the rigidizer may be a molded, machined, or other formed part. The fabric outer layers may be heat sealed, sewn, ultrasonically cut, CNC knife cut, or otherwise joined together. As shown, the fabric outer layer 1381 is joined at approximately the center or approximately the middle of the edges. Preferably, the joint is at or near the center of the headgear side. Alternatively, the joint may be located away from the patient's face during use. It is also possible for the joint to be adjacent or near the patient's face during use. Preferably, a layer of foam or other compliant material may surround or be positioned around the rigidizer 1380. The foam may preferably extend along the horizontal edges of the sides of the rigidizer 1380 to prevent the ends of the rigidizer from abutting the patient's face and causing discomfort or marks on the face. For example, Fig. 14H illustrates a rigidizer 1480 having a fabric exterior layer 1481 and a foam layer 1482 disposed along at least a portion of the rigidizer 1480. As shown, the foam layer 1482 positions the bond 1483 away from the patient's face during use.

[0124] In an embodiment, the headgear straps may be thermoformed and then the edges of the straps may be ultrasonically cut. The thermoformed and ultrasonically cut straps are provided with rounded edges 7081 (shown in FIG. 31 ) that substantially prevent facial marking during use. The thermoformed and ultrasonically cut edges are also softer and gentler on the face, providing a more comfortable feel on the patient's face during use (e.g., a more comfortable feel around the patient's ears).

[0125] In a further embodiment, at least a portion of the headgear may be constructed from a spacer fabric, in which case the edges of the spacer fabric may be ultrasonically welded, causing the edges of the spacer fabric to be rounded, thereby reducing markings on the patient's face and increasing comfort.

[0126] In another embodiment, multiple outer layers of fabric may be connected together by adhesive. For example, as shown in FIG. 14I, a first layer of fabric 1581(1) may have wings 1585 located at one or both ends. An adhesive 1586 (e.g., glue) may be placed on the end of the second layer of fabric 1581(2) allowing the wings 1585 to be folded over the adhesive and seal the interior portion of the headgear to the interior fabric layers. As shown, the interior headgear portion may include a conformable material such as foam 1582, or rigidizer 1580, or a combination of both. Other interior components may include different elements disclosed herein, such as three-dimensional textiles. It should be understood that the adhesive and wings may be arranged in other embodiments, such as the adhesive being placed on the wings or the wings being placed on the second layer of fabric. Additionally, the first and second layers of fabric may be a single, continuous piece of fabric, which is sealed at one end by the wing and adhesive arrangement. 14J, for example, shows a single piece of fabric 1681 including wings 1685 at one end that are configured to fold over an adhesive 1686 (e.g., glue) at the other end. As shown, the headgear interior portion includes a compliant material such as foam 1682 and rigidizer 1680.

[0127] Preferably, the edges of the headgear are fully enclosed, i.e., the internal components of the headgear (such as the rigidizer and the conforming material) are fully contained within the outer fabric layer. This is to avoid discomfort caused by hair getting tangled in the internal components or coming into contact with the internal elements. Also, the cleanliness and durability of the system can be more easily maintained if the internal components are fully sealed or contained within the fabric layer.

[0128] Preferably, edges where fabric layers meet one another are sealed or otherwise concealed to prevent the fabric from separating or becoming dislodged, and this configuration may be preferred for creating rounded, continuous edges. See, e.g., Figure 14A.

[0129] In an embodiment, one or more aspects of the headgear straps can be configured to enhance the comfort of the crown straps (i.e., the straps are configured to cross the crown of the patient's head in use). For example, the rigidizer may be relatively thin, e.g., less than 1 mm, such as 0.5 mm to 0.8 mm. In a different example, the straps may include a nylon rigidizer encased by foam. In such an embodiment, the density of the foam may be increased, thereby improving comfort and reducing the likelihood of getting the feel of the nylon rigidizer. Additionally, the thickness of the foam may be utilized to modify the softness or roundness of the edges of the headgear. For example, a thicker foam layer may be more suitable for creating more rounded corners compared to a thinner foam layer. In a further embodiment, the foam may start at one thickness and be compressed to a different thickness in the process. The initial thickness of the foam may be 5 to 30 mm. Preferably, the initial thickness may be 7 to 12 mm. Alternatively, the initial foam thickness may be 10 to 20 mm. The second foam thickness may be 0.1 to 10 mm. Preferably, the thickness of the second foam may be 2 to 5 mm. Alternatively, the thickness of the second foam may be 3 to 7 mm.

[0130] In a different example, a nonwoven material (such as that shown in FIG. 32) may be used for the top strap because it may be stiffer or less flexible compared to a woven material, for example the collar stiffener of a business shirt is a nonwoven material.

[0131] In different examples, the rigid component can be detached from the crown strap, or alternatively, the fabric crown strap 7181 can be heat pressed or embossed with the inner foam 7180, which melts and forms to create the rigid sections (see FIGS. 33 and 34). For example, the thermoformed ribs can be formed by compressing the foam to about 80%.

[0132] In a different example, multiple ribs 7280 may be embossed into the rigidizer, which adds stiffness while reducing the apparent bulk, as shown in FIG.

[0133] The rigidizer may also include embossed ribs or other features to increase the flexibility of the headgear or control movement in certain areas, and embossing may be used to stamp brand logos.

[0134] For example, the headgear straps may include two foam layers. However, other suitable configurations are possible, such as one, two, three or more foam layers. In embodiments, the foam on the patient-contacting side may have a lower density or a lower hardness compared to the foam on the non-patient-contacting side. It is also possible to have more than one foam layer and more than one rigidizer component. Alternatively, the headgear may comprise more than one rigidizer and one foam layer.

[0135] For example, a nonwoven material may be inserted between additional foam or fabric layers in place of the nylon rigidizer.

[0136] In embodiments, the materials and / or headgear configuration may be selected to reduce cost.

[0137] 2.0 Manufacturing Preferably, the method of manufacturing the headgear may reduce costs by maximizing production yield and reducing material waste, for example, the components may be shaped to allow the components to be closely nested in the bulk material, which reduces waste material and therefore costs when die cutting the individual components.

[0138] Exemplary process steps for manufacturing the headgear described are shown in Figures 41 and 42. Alternative manufacturing steps are also possible.

[0139] For example, Figure 41 shows a typical process for making rigidized headgear. This typical process includes lamination of materials (foam and fabric are bonded together by a lamination process), thermoforming (lamination of foam and fabric is placed in a mold, a preformed rigidizer is placed in the mold on top of the first laminate, a second laminate of foam and fabric is placed on top of the rigidizer, the tool is closed, heated, and the laminate is permanently bonded around the periphery of the mold surface), ultrasonic die cutting (thermoformed sheet is placed in a die cutting machine and an ultrasonic welder is run along the headgear periphery), and bonding (bonding the lower portion of the headgear crown cap and connecting the headgear straps to the crown cap). In one process, lamination may be omitted. In another process, thermoforming and ultrasonic cutting may be completed in one step.

[0140] A typical process for making non-rigidized headgear is shown in Figure 42. This typical process includes lamination of materials (foam and fabric are bonded together through a lamination process), thermoforming (lamination of foam and fabric is placed into a mold, the tool is closed, heat is applied, and the laminate is permanently bonded around the periphery of the mold surface), ultrasonic die cutting (thermoformed sheet is placed into a die cutting machine and an ultrasonic welder is run along the headgear periphery), and sewing (bonding the lower portion of the headgear crown cap and connecting the headgear straps to the rigidizer).

[0141] As illustrated in FIG. 16A, headgear components 660 according to the present invention can be configured for die-cutting from a sheet. In the example of FIG. 16A, 12 headgear components 660 can be cut from a single sheet 2500 of fabric material. The headgear components 660 shown in FIG. 16A can be joined with a set of relatively straight straps that can be effectively nested (not shown) to create a complete headgear assembly. In the configuration shown in FIG. 16B, which is the prior art, only three headgear assemblies 2600 can be cut from a similarly sized sheet 2500, as in the different design shown in FIG. 16B. In FIG. 16B, about 11.5 pieces of headgear are produced per square meter. For purposes herein, "high production volume" shall be defined as any production volume exceeding 11.5 pieces of headgear per square meter.

[0142] In contrast to other prior art headgear configurations, such as the ResMedQuattro® headgear, the embodiment shown herein is constructed from multiple components that, when separated, have simple geometric shapes that are easy to store. For example, in the embodiment shown in FIG. 6, the upper headgear straps 620 and the lower headgear straps 630 are generally straight, generally rectangular components that can be nested together and cut from a bulk piece of material without waste. Alternatively, the upper headgear straps 620 and the lower headgear straps 630 are formed from a woven material and can be cut to length without waste. The rigidizer 660 can be formed from a flat piece, as shown in FIG. 15. In such a configuration, multiple rigidizers can be formed from a single bulk sheet of rigidizer material with minimal waste, since the rigidizers can be nested close to each other, as shown in FIG. 16A. The rigidizer 660 has a generally arcuate shape, which one of ordinary skill in the art would consider to be a relatively simple geometry.

[0143] In contrast to prior art headgear, such as the ResMedQuattro® headgear, this configuration allows for close nesting, but creates waste due to the general shape of the headgear (i.e., punched openings or holes in the headgear).

[0144] A further embodiment is illustrated in Figures 17 to 20. In Figure 20, an assembled headgear 3015 is shown for use in attaching a medical device to a patient's head. In this embodiment, the preferred medical device is a mask for a CPAP machine.

[0145] The depicted headgear 3015 is configured to attach a face mask to a patient's face. The headgear 3015 comprises a first strap 3010, a second strap 3012, and a third strap 3013. The second strap 3012 and the third strap 3013 are attached to the first strap 3010 by a connection means that comprises a series or a plurality of holes or openings in the first strap 3010 configured to accommodate other straps. The second strap 3012 and the third strap 3013 can be secured or connected to the first strap 3010 by the use of one or more Velcro® tabs that are folded back onto the original strap and preferably connected to a soft fabric material on the strap outer surface. Preferably, the Velcro® tabs and the soft fabric used in the straps can be selectively engaged with each other in a "hook and loop" attachment common to the use of Velcro®.

[0146] The first strap 3010 comprises the structure shown in Figures 17 and 18. A rigid or semi-rigid layer 3001 of a resilient material is sealed between a first layer 3004 and a second layer 3002 of a soft fabric material. Preferably, the soft fabric is configured to be biocompatible such that, during use, layers 3002 and 3004 may contact the patient's skin layer. Both biocompatibility and softness may reduce irritation to the patient's skin.

[0147] Sealed between the rigid layer 3001 and the first soft fabric layer 3004 is a cushioning layer 3003. Preferably, the cushioning layer 3003 is constructed from a soft, foam-like material. In use, the first strap 3010 is preferably configured to contact the patient's skin layer by contacting the first soft fabric layer 3004. The multi-layered configuration of the first strap 3010 illustrated in FIG. 17 only needs to extend along one strap portion and thus function correctly as disclosed in this embodiment.

[0148] Preferably, the layers of the first strap 3010 may be attached to one another by vulcanization or gluing. Additionally, the first fabric layer 3004 and the second fabric layer 3002 are not required to be of the same or identical material and may be substituted with other materials to improve the aesthetic appearance of the headgear 3015.

[0149] In this embodiment, the second strap 3012 and the third strap 3013 may be constructed entirely from a soft textile material, which provides increased comfort, however, other strap configurations are possible.

[0150] The stiff layer 3001 or rigidizer is preferably constructed of polycarbonate, Lexan® or similar elastic material having a thickness of about 1-2 mm. The soft fabric material may be Breath-O-Prene™ or other soft fabric materials including, but not limited to, nylon or Spandex™.

[0151] Preferably, the first strap 3010 may function as a rigidizer within the overall headgear assembly or configuration 3015 shown in Figure 20. One advantage of including a rigidizer within this structure is that it may allow for an even distribution of pressure along the patient's head, especially when installed in the configuration shown in Figure 20. This embodiment may provide increased patient comfort by mounting the rigidizer along or above the back of the patient's head.

[0152] A further advantage of this embodiment is that the strap construction may be optimized, thereby reducing waste. Traditionally, headgear straps have been constructed by cutting the entire headgear from a single bulk piece of material, which results in a relatively large amount of waste material. In FIG. 19, multiple straps are illustrated cut from a bulk piece of manufacturing material. As shown, the second layer 3002 of soft fabric material of the first strap 3010 is within a bulk sheet 3011 of material. Waste is limited and minimized in this example by having each component strap nested tightly within the same bulk sheet 3011.

[0153] In a further embodiment, an inner layer of foam may be molded, whereby the skinne foam forms the headgear shape. Alternatively, any foam (skinne, non-skinne, or partially skinne) may first be formed or otherwise shaped into the headgear shape. A fabric may then be laminated onto the foam layer.

[0154] In yet another embodiment, the fabric or weave may be placed into a mold and a polymer or other such moldable material may be injected onto the fabric, which will result in the desired headgear shape.

[0155] In further embodiments, the fabric outer layer may be filled with gel, air, and / or other gases. The gas may be selectively filled within the pockets, with the gas having a variable volume in each pocket, thereby affecting the stiffness or support provided by the section of the headgear. The fabric outer layer needs to be airtight, and thus may be laminated with, for example, an impermeable polymer layer.

[0156] In yet another embodiment, the outer layer of fabric can be formed along or around two cords of material. The cords are intended to create annular edges at the sides of the material. For example, FIG. 43 shows a cross section of a proposed headgear or portion thereof. In this case, cord 1785 is disposed inside outer layer of fabric 1781, forming a rounded spot in the material. The cords may be disposed on both sides (as shown) or just on one side of the headgear strap. The cords may be made of foam, gel, polymer, or other conformable material. The cords may have other shapes, for example, they may have an oval or elliptical cross section. The cords are further shown as separate (i.e., extending through the center of the headgear section) They are not joined to each other through a single strand), however it is possible to connect one strand to another.

[0157] It should also be understood that the foam exterior layer may also be constructed from a single piece of material which is continuously woven to create a tube of fabric.

[0158] Although the present invention will be described with respect to headgear for a mask system, it should be understood that the present invention may be applicable to different portions of a mask system, such as a forehead pad, a mask cushion, a comfort pad, a tube wrap, a comfort sock, a chin strap, a mask frame, or other suitable portions of the mask system.

[0159] A quick release mechanism may be attached to the headgear, such as a selectively removable portion at the rear of the headgear. This may include a hook and loop material connection with a drawstring. Alternatively, the quick release mechanism may be a clip or other mechanism that allows the patient to remove the mask system in an emergency.

[0160] In further embodiments, the tube attachment component may be attachable to or formed with headgear. For example, the headgear may be provided with a strap for wrapping around the tube, which may be attached to the tube by a hook and loop connection. Alternatively, clips or rings may be attached to or formed with the headgear for engaging the tube.

[0161] The rigidizer may also be made of a shape-changing material that is selectively adjustable. For example, the rigidizer may be made of a metal, allowing the patient to adjust the headgear shape to a desired position. The rigidizer may also be made of a heat-deforming material, whereby the headgear may be heated and placed on the patient's head, and then takes on the shape or contour of the patient's head. When the headgear cools, it may retain this shape. The rigidizer may also be made of a malleable material, such as nitinol, that can be shaped.

[0162] The headgear may also be provided with pockets or gaps for the insertion of additional material or for the removal of material. Pockets or gaps may be provided to allow the patient to modify and adapt the firmness or comfort of the headgear in a particular area. For example, a pocket or space may be provided in the rear of the headgear to allow the patient to add padding or adaptable material to this area of ​​the headgear.

[0163] In further embodiments, the headgear may be provided with socks or wraps of padding or soft material to provide additional comfort to the patient, if required by the patient, which are selectively attached to the headgear straps, for example by clip fastenings, hook and loop material, pullovers, or other suitable connection methods.

[0164] Headgear may also be provided with sensors for examining or monitoring the patient.

[0165] In another embodiment, the rigidizers described above may be replaced or supplemented by one or more elements that are substantially inextensible and / or elastic. For example, instead of using the rigidizers described above, stitching or embossing may be used to create a substantially inextensible structure. Additionally, elasticity may be provided by a non-rigid spring structure.

[0166] While the present invention will be described in connection with what are presently considered to be the most practical and desirable embodiments, it should be understood that the present invention is not to be limited to the disclosed embodiments, but rather is intended to cover various modifications and equivalent arrangements falling within the spirit and scope of the present invention. Additionally, the various embodiments described above may be implemented in combination with other embodiments, for example aspects of one embodiment may be combined with aspects of a different embodiment to achieve another embodiment. Furthermore, each independent feature or component in any given assembly may constitute a further embodiment. Additionally, while the present invention has particular application to patients suffering from OSA, it should be understood that benefits may be derived from the above teachings to patients suffering from different diseases (e.g., congestive heart failure, diabetes, morbid obesity, stroke, bariatric surgery, etc.). Additionally, the above teachings have applicability to patients and non-patients alike in non-medical applications.

[0167] Examples of embodiments of the present application are given below. (1) Headgear for use with a mask, comprising a rigidizer, a conforming material, and at least one fabric, wherein edges of the at least one fabric are sealed by at least one joint, such that the rigidizer, the conforming material, and the at least one joint are sealed by the at least one fabric over at least a portion of the headgear. (2) The headgear described in (1), wherein the at least one piece of fabric comprises a single piece of fabric that is folded and has a first edge portion attached to a second edge portion by the at least one joint portion. (3) Headgear as described in (1), wherein the at least one fabric comprises a first fabric and a second fabric, the first fabric having a first folded edge portion attached to a first edge portion of the second fabric by a first joint and a second folded edge portion attached to a second edge portion of the second fabric by a second joint. (4) The headgear described in (3), wherein the first and second edge portions of the second fabric are folded. (5) The headgear described in (1), wherein the at least one fabric comprises a first fabric and a second fabric, a first edge portion of the first fabric being attached to a first edge portion of the second fabric by a first joint at a center of the first edge portion of the rigidizer, and a second edge portion of the first fabric being attached to a second edge portion of the second fabric by a second joint at a center of the second edge portion of the rigidizer. (6) A headgear as described in (3) to (5), wherein the first fabric is a fabric different from the second fabric. (7) Headgear described in (1) to (6), wherein at least one of the joints is stitched, ultrasonically welded, heat sealed or CNC knife cut. (8) Headgear as described in (1) to (7), characterized in that the rigidizer comprises a die-cut sheet material or a semi-rigid molded component, and the compliant material comprises a soft polymeric material overmolded onto the rigidizer. (9) Headgear as described in (1) to (7), wherein the conforming material comprises foam. (10) Headgear as described in (1) to (9), wherein the compliant material extends to an edge portion of the rigidizer. (11) The headgear described in (1) to (10), wherein the at least one fabric is thermoformed and attached to the rigidizer. (12) Headgear for use with a mask, comprising: a first strap configured to engage a patient's back of the head and extend behind the patient's ears on either side of the patient's parietal bone and to assume a generally circular or oval shape during use, at least a portion of the first strap being substantially inextensible; and at least one second strap configured to removably connect the first strap to the mask. (13) The headgear of (12), wherein the substantially inextensible portion of the first strap comprises at least one thickened or treated area of ​​the first strap. (14) The headgear of (13), wherein the first strap is fabric and the substantially inextensible portion of the first strap has ink printed on the fabric or a seam or at least one ultrasonic weld. (15) The headgear of (12), wherein the substantially inextensible portion of the first strap comprises a rigidizer connected to the first strap. (16) The headgear of (15), wherein the rigidizer is sealed within the first strap or laminated to the first strap. (17) The headgear of (15), wherein the rigidizer comprises a woven material, a nonwoven material, a mesh material, or a knitted material. (18) Headgear described in (12) to (17), wherein the substantially inelastic portion is provided in a central portion of the first strap, thereby positioning the substantially inelastic portion in the upper half of the patient's head during use. (19) A headgear as described in any one of (12) to (17), wherein the substantially inextensible portion has a first length sufficient to prevent an end of the first strap connected to the at least one second strap from bending or deforming when the headgear is fastened to the patient's head. (20) The headgear described in (12) to (19), wherein the first strap is adjustably connected to the at least one second strap. (21) The headgear described in (12), wherein the first strap is provided with a rigidizer. (22) The headgear of (21), wherein the rigidizer has at least one flexure configured to allow the rigidizer to flex or hinge at the at least one flexure. (23) The headgear according to (21) or (22), wherein the rigidizer has at least one area of ​​increased rigidity. (24) The headgear of (23), wherein the at least one area of ​​increased stiffness comprises at least one rib or at least one embossed portion. (25) Headgear described in (12) to (24), wherein the at least one second strap includes at least one upper strap configured to extend over the patient's ears. (26) The headgear of (25), wherein the at least one upper strap is configured to be connected to a forehead support of the mask. (27) Headgear as described in (12) to (26), wherein the at least one second strap includes at least one lower strap configured to extend below the patient's ear. (28) The headgear of (27), wherein the at least one lower strap is bent downward, for example at an angle of about 10 degrees to 30 degrees, for example about 11 degrees. (29) The headgear according to any one of (12) to (28), wherein the diameter of the circular or elliptical shape of the first strap during use is from about 400 mm to about 660 mm, for example from about 500 mm to about 550 mm, and preferably about 500 mm. (30) The headgear according to any one of (12) to (29), wherein at least one of the second straps is elastic. (31) Headgear for use with a mask, comprising: a first strap configured to extend over a top of a patient's head in use and to extend to either side of the patient's parietal bone and behind the patient's ears; and at least one second strap configured to removably connect the first strap to the mask, wherein at least a portion of the first strap is self-supporting, such that the headgear maintains a three-dimensional shape when not in use. (32) The headgear of (31), wherein the first strap lies flat on the top of the patient's head during use. (33) The headgear of (31) or (32), wherein the self-supporting portion comprises a rigidizer attached to the first strap. (34) Headgear as described in (31) to (33), wherein the self-supporting portion of the first strap extends to the back of the head and / or neck of the patient in use. (35) Headgear for holding a respiratory mask in a predetermined position on a patient's face, the headgear comprising a rear portion and left and right side portions configured to be connected to the respiratory mask, the rear portion comprising a substantially inextensible arch-shaped region configured to elastically return to a predetermined shape when not in use, the arch-shaped region including a first portion configured to be aligned generally parallel to a top of the patient's head and a second portion configured to be aligned generally parallel to a rear surface of the patient's head. (36) A method of manufacturing headgear for use with a mask, the method comprising the steps of: placing a rigidizer over a first foam and a first fabric laminate; placing a second foam over the rigidizer and placing a second fabric over the second foam; thermoforming the first foam and first fabric laminate, the rigidizer, the second foam and the second fabric to form a thermoformed sheet; and ultrasonically cutting the thermoformed sheet around a periphery of the headgear. (37) The method of (36), wherein the rigidizer is configured to engage the back of the patient's head and extend behind the patient's ears on either side of the patient's parietal bone and to assume a generally circular or oval shape during use. (38) The method of (36), wherein the rigidizer is configured to extend across the top of the patient's head in use and to extend on either side of the patient's parietal bone and behind the patient's ears. (39) The method according to (37) or (38), further comprising joining a first end and a second end of the cut thermoformed sheet. (40) The method according to any one of (36) to (39), further comprising the step of attaching at least one strap to the cut thermoformed sheet. (41) Headgear for use with a mask, the headgear comprising: a rigidizer constructed from a rigid or semi-rigid material and configured to extend on either side of the patient's parietal bone; and at least one strap configured to releasably connect the rigidizer to the mask. (42) The headgear of (41), wherein the headgear includes an upper strap configured to releasably connect the rigidizer to an upper portion of the mask, and a lower strap configured to releasably connect the rigidizer to a lower portion of the mask. (43) The headgear of (42), wherein the rigidizer is configured to extend along the parietal and occipital bones of the patient. (44) The headgear of (43), wherein the rigidizer is cup-shaped and / or configured to form a partial or complete circular or elliptical shape configured to be placed on the back of the patient's head. (45) The headgear of (41), wherein the rigidizer is deformable or flexible along its length but rigid along its width. (46) Headgear for use with a mask, the headgear comprising: a rigidizer constructed from a rigid or semi-rigid material and configured to extend along the crown and cheekbones of the patient's skull; and one or more straps configured to support the rigidizer at the back of the patient's head. (47) A headgear for use with a mask, comprising a plurality of elongated straps and a headgear fastened to at least a first strap and adapted to cover at least a portion of the patient's occipital region. and a rigidizer configured to engage the first portion of the mask, wherein at least a second strap is attached between the first portion and the mask, the rigidizer increasing the stiffness of the headgear along one axis. (48) The headgear of (47), wherein, in use, the axis is approximately parallel to the length of the patient's head. (49) The headgear of (48), wherein the straps enable the mask and first portion to be attached in a generally parallel configuration to the patient's head. (50) Headgear as described in (41) to (49) above, wherein the rigidizer comprises a composite structure. (51) The headgear of (50), wherein the rigidizer comprises a rigid or semi-rigid material covered by a softer, patient-contacting material. (52) A mask system for supplying respiratory gas to the patient, comprising a mask and a headgear according to any one of (12) to (35) and (41) to (51). (53) A method of manufacturing headgear for use with a mask, the headgear comprising components of generally simple geometric shapes and capable of being cut from a flat piece of material, the method including: (a) cutting a plurality of components of the same type from a single flat sheet of the material; (b) the components are nested relative to one another on the sheet, thereby minimizing the amount of waste material removed and discarded; and (c) the method results in a high yield. (54) The method described in (53), wherein the high yield is defined as obtaining 11.5 or more headgears per square meter. (55) The method according to (54), wherein the shape comprises a substantially rectangular shape or a substantially arcuate shape. (56) The method according to any one of (53) to (55), wherein the component comprises a strap or a rigidizer. (57) The method according to (56), wherein at least five components are nested on each of the flat pieces. (58) A headgear assembly for use in attaching a medical device to a patient's head, the headgear comprising a plurality of elongated straps, at least a portion of the straps including a rigid or semi-rigid layer sealed between first and second layers of flexible biocompatible material, and further comprising a cushioning layer sealed between the first and rigid layers of biocompatible material. (59) A headgear assembly as described in (58), wherein the layers of the strap are secured together by vulcanization or gluing. (60) A headgear assembly as described in (59), wherein the strap including the stiffness layer is positioned at the back of the head when in use. (61) A headgear assembly as described in (60) above, wherein the material is fabric. (62) Headgear for use with a mask, comprising a plurality of straps configured to engage a user's head and at least one rigidizer constructed from a rigid or semi-rigid material, the at least one strap being joined to the rigidizer at a predetermined location relative to the upper and rear portions of the head. (63) A process for making headgear comprising the steps of laminating a foam and a textile material together; thermoforming the laminated foam and textile material; ultrasonically die cutting the thermoformed and laminated foam and textile material into one or more strap portions of the headgear; and bonding the one or more strap portions together. (64) The process according to (63), wherein the joining step comprises a suturing step. (65) The process of (63), wherein the thermoforming step includes disposing a preformed rigidizer between the laminated first and second layers of foam and a textile material. [Explanation of symbols]

[0168] 10. Mask 15 Slots 40,4012,4112,4212,4312,4412,7466 Top strap 62 Main Body 64 Lower Arm 66 Upper Arm 220,320,620 Upper side strap 230,330,630 Lower side strap 260,360,460,560,660,1380,1480,1580,1680,3001,4201,4601,7460,7560 Rigidizer 265 Connector 360 Mesh Rigidizer 440,540 Rear upper strap 450,550 Rear lower strap 462,562 Upper strap section 464,564 Lower strap part 470 clips 566 Front strap part 662 Strap part 663 holes 665 Stud 780,880 Die cut sheet material 781,981 Fabric 881,1181 Soft polymer materials 980,1080,1180 Semi-rigid molded components 1081 Fabric composite materials 1280 Soft Molded Components 1381,1481 Fabric outer layer 1482 Foam layer 1483 Joint 1581(1) First layer of fabric 1581(2) Fabric second layer 1582,1682 Foam 1585,1685 wing 1586,1686 Adhesive 1681 Single Fabric 2000 Top opening 2100 Lower opening 3003 Cushion layer 3010,4010,4110,4210,4610 First Strap 3012 Second Strap 3013,4013,4113,4213,4313,4513 Bottom Strap 4000 Arched or bent part 4020 Adjustment means 4035,4130,4134,4135,4235 Joint 4115 Horizontal plane 4116 Vertical axis 4200 Bend 4211,4280 End 4220,4320 Ladder Lock 4235 Loop 4250 Lower part of rigidizer 4251,7564 Lower part 4261,7562 Upper part 5000 Forehead support part 5005 Opening 5010 Push Tab 5015 Grip 5020 Additional grip part 5025 Spring 6000 perforation 7081 Rounded edges 7181 Fabric top strap 7280 Many Ribs 7360,7462 Top strap 7512 Top Strap 7514 Lower Strap

Claims

1. 1. Headgear for use with a mask, comprising: A rigidizer and Suitable materials and At least one fabric; Equipped with Headgear, characterized in that an edge of the at least one fabric is sealed by at least one joint, whereby the rigidizer, the conforming material and the at least one joint are enclosed by the at least one fabric over at least a portion of the headgear.

2. 2. The headgear of claim 1, wherein the at least one piece of fabric comprises a single piece of fabric having a first edge that is folded over and attached to a second edge by the at least one joint.

3. 2. The headgear of claim 1, wherein the at least one fabric comprises a first fabric and a second fabric, the first fabric having a first folded edge portion attached to a first edge portion of the second fabric by a first joint and a second folded edge portion attached to a second edge portion of the second fabric by a second joint.

4. 4. The headgear of claim 3, wherein the first and second edge portions of the second fabric are folded over.

5. 2. The headgear of claim 1, wherein the at least one fabric comprises a first fabric and a second fabric, a first edge of the first fabric attached to a first edge of the second fabric by a first joint at a center of the first edge of the rigidizer, and a second edge of the first fabric attached to a second edge of the second fabric by a second joint at a center of the second edge of the rigidizer.

6. A headgear according to any one of claims 3 to 5, characterized in that the first fabric is a different fabric from the second fabric.

7. 7. The headgear of any one of claims 1 to 6, wherein the at least one joint comprises a stitch, an ultrasonic weld, a heat seal or a CNC knife cut.

8. 8. Headgear according to any one of claims 1 to 7, wherein the rigidizer comprises a die cut sheet material or a semi-rigid moulded component, and the compliant material comprises a soft polymeric material overmolded onto the rigidizer.

9. Headgear according to any one of the preceding claims, wherein the conformable material comprises foam.

10. Headgear according to any one of the preceding claims, characterized in that the compliant material extends to edges of the rigidizer.

11. 11. The headgear of any one of claims 1 to 10, wherein the at least one fabric is thermoformed and attached to the rigidizer.

12. 1. Headgear for use with a mask, comprising: a first strap adapted to engage the back of the patient's head, extend behind the patient's ears on either side of the patient's parietal bone, and assume a generally circular or oval shape in use, at least a portion of the first strap being substantially inextensible; at least one second strap configured to releasably connect the first strap to the mask; A headgear comprising:

13. 13. The headgear of claim 12, wherein the substantially inextensible portion of the first strap comprises at least one thickened or treated area of ​​the first strap.

14. 15. The headgear of claim 14, wherein the first strap is fabric, and the substantially inextensible portion of the first strap comprises ink baked into the fabric or a seam or at least one ultrasonic weld.

15. 13. The headgear of claim 12, wherein the substantially inextensible portion of the first strap comprises a rigidizer connected to the first strap.

16. 16. The headgear of claim 15, wherein the rigidizer is enclosed within the first strap or laminated to the first strap.

17. 16. The headgear of claim 15, wherein the rigidizer comprises a woven material, a nonwoven material, a mesh material, or a knit material.

18. 18. Headgear as described in any one of claims 12 to 17, characterized in that the substantially inextensible portion is provided in a central portion of the first strap, such that during use the substantially inextensible portion is positioned over the upper half of the patient's head.

19. 18. The headgear of any one of claims 12 to 17, wherein the substantially inextensible portion has a first length sufficient to prevent an end of the first strap connected to the at least one second strap from bending or deforming when the headgear is fastened to the patient's head.

20. 20. Headgear according to any one of claims 12 to 19, wherein the first strap is adjustably connected to the at least one second strap.

21. 13. The headgear of claim 12, wherein the first strap comprises a rigidizer.

22. 22. The headgear of claim 21, wherein the rigidizer comprises at least one flexure configured to allow the rigidizer to flex or hinge at the at least one flexure.

23. 23. Headgear according to claim 21 or 22, characterized in that the rigidizer comprises at least one area of ​​increased stiffness.

24. 24. The headgear of claim 23, wherein the at least one area of ​​increased stiffness comprises at least one rib or at least one embossed portion.

25. 25. Headgear according to any one of claims 12 to 24, wherein the at least one second strap comprises at least one top strap configured to extend over the patient's ears.

26. 26. The headgear of claim 25, wherein the at least one upper strap is configured to be connected to a forehead support of the mask.

27. 27. Headgear according to any one of claims 12 to 26, wherein the at least one second strap comprises at least one lower strap configured to extend below the patient's ears.

28. 28. Headgear according to claim 27, wherein the at least one lower strap is bent downwards at an angle of, for example, about 10 degrees to 30 degrees, for example about 11 degrees.

29. 29. Headgear as claimed in any one of claims 12 to 28, characterized in that the diameter of the circular or elliptical shape adopted by the first strap in use is between about 400mm and about 660mm, such as between about 500mm and about 550mm, preferably about 500mm.

30. 30. Headgear according to any one of claims 12 to 29, characterized in that the at least one second strap is elastic.

31. 1. Headgear for use with a mask, comprising: a first strap configured in use to extend over the top of the patient's head and to extend to either side of the patient's parietal bone and behind the patient's ears; at least one second strap configured to releasably connect the first strap to the mask; Equipped with At least a portion of the first strap is self-supporting, thereby allowing the headgear to maintain a three-dimensional shape when not in use.

32. 32. Headgear according to claim 31, wherein the first strap, in use, lies flat on the top of the patient's head.

33. 33. Headgear according to claim 31 or 32, characterized in that the self-supporting portion comprises a rigidizer attached to the first strap.

34. Headgear according to any one of claims 31 to 33, wherein the self-supporting portion of the first strap extends, in use, around the back of the head and / or neck of the patient.

35. 1. Headgear for holding a respiratory mask in place on a patient's face, said headgear comprising: The rear and a left and right side portion configured to be connected to the respiratory mask; Equipped with the rear portion comprises a substantially inextensible arcuate region configured to elastically return to a predetermined shape when not in use, the arcuate region including a first portion configured to be aligned generally parallel to a top of the patient's head and a second portion configured to be aligned generally parallel to a rear surface of the patient's head.

36. 1. A method of making headgear for use with a mask, comprising: placing a rigidizer over the first foam and the first fabric laminate; placing a second foam over the rigidizer and placing a second fabric over the second foam; thermoforming the first foam and first fabric laminate, the rigidizer, the second foam and the second fabric to form a thermoformed sheet; ultrasonically cutting the thermoformed sheet present on the outer periphery of the headgear; A method for providing the above.

37. 37. The method of claim 36, wherein the rigidizer is configured to engage the back of the patient's head and extend behind the patient's ears on either side of the patient's parietal bone and to assume a generally circular or oval shape during use.

38. 37. The method of claim 36, wherein the rigidizer is configured to extend across the top of the patient's head in use and to extend on either side of the patient's parietal bone and behind the patient's ears.

39. 39. The method of claim 37 or 38, further comprising joining a first end and a second end of the cut thermoformed sheet.

40. 40. The method of any one of claims 36 to 39, further comprising attaching at least one strap to the cut thermoformed sheet.

41. 1. Headgear for use with a mask, comprising: a rigidizer constructed from a rigid or semi-rigid material and configured to extend on either side of the patient's parietal bone; at least one strap configured to releasably connect the rigidizer to the mask; A headgear comprising:

42. 42. The headgear of claim 41, wherein the headgear includes an upper strap configured to releasably connect the rigidizer to an upper portion of the mask, and a lower strap configured to releasably connect the rigidizer to a lower portion of the mask.

43. 43. The headgear of claim 42, wherein the rigidizer is configured to extend along the crown and occipital bones of the patient's head.

44. 44. The headgear of claim 43, wherein the rigidizer is cup-shaped and / or configured to form a partial or complete circular or elliptical shape configured to be placed on the back of the patient's head.

45. 42. Headgear as recited in claim 41, wherein the rigidizer is deformable or flexible along its length but rigid along its width.

46. 1. Headgear for use with a mask, comprising: a rigidizer constructed from a rigid or semi-rigid material and configured to extend along the crown and cheekbones of the patient; one or more straps configured to support the rigidizer at the back of the patient's head; A headgear comprising:

47. 1. Headgear for use with a mask, comprising: A number of elongated straps; a rigidizer coupled to at least the first strap and configured to engage at least a portion of the patient's occipital region; Equipped with At least a second strap is attached between the first portion and the mask; 11. Headgear, wherein the rigidizer increases the stiffness of the headgear along one axis.

48. 48. Headgear according to claim 47, wherein, in use, the axis is generally parallel to the length of the patient's head.

49. 49. Headgear according to claim 48, wherein the straps enable the mask and first section to be attached in a generally parallel configuration to the patient's head.

50. 50. Headgear according to any one of claims 41 to 49, wherein the rigidizer comprises a composite structure.

51. 51. Headgear as recited in claim 50, wherein the rigidizer comprises a rigid or semi-rigid material covered by a softer, patient-contacting material.

52. 1. A mask system for delivering respiratory gas to the patient, comprising: With a mask, A headgear according to any one of claims 12 to 35 and 41 to 51; A mask system comprising:

53. 1. A method of manufacturing headgear for use with a mask, the headgear comprising components of generally simple geometric shapes and capable of being cut from a flat piece of material, the method comprising: (a) cutting multiple components of the same type from a single flat sheet of material; (b) the components are nested relative to one another on the sheet, thereby minimizing the amount of waste material removed and discarded; and (c) the method results in a high yield.

54. 54. The method of claim 53, wherein said high yield is defined as obtaining 11.5 or more headgear pieces per square meter.

55. 55. The method of claim 54, wherein the shape comprises a generally rectangular shape or a generally arcuate shape.

56. 56. The method of any one of claims 53 to 55, wherein the component comprises a strap or a rigidizer.

57. 57. The method of claim 56, wherein at least five components are nested on each flat strip.

58. 1. A headgear assembly for use in attaching a medical device to a patient's head, the headgear comprising a plurality of elongated straps, at least a portion of the straps being formed of a rigid layer or a flexible layer of a biocompatible material sealed between first and second layers. A headgear assembly comprising a semi-rigid layer, and further comprising a cushioning layer sealed between said first layer of biocompatible material and said rigid layer.

59. 60. The headgear assembly of claim 58, wherein the layers of the strap are secured together by vulcanization or gluing.

60. 60. A headgear assembly as recited in claim 59, wherein the strap including the stiffening layer is positioned at the back of the head in use.

61. 61. A headgear assembly as recited in claim 60, wherein the material is fabric.

62. 1. Headgear for use with a mask, comprising: a plurality of straps configured to engage a user's head; At least one rigidizer constructed from a rigid or semi-rigid material; Equipped with At least one strap is joined to a rigidizer at a predetermined location relative to the upper back of the head.

63. 1. A process for making headgear, comprising: laminating the foam and the fabric material together; thermoforming the laminated foam and fabric material; ultrasonically die cutting the thermoformed and laminated foam and fabric material into one or more strap portions of the headgear; joining the one or more strap portions together; A process comprising:

64. 64. The process of claim 63, wherein the joining step comprises a suturing step.

65. 64. The process of claim 63, wherein the thermoforming step includes disposing a preformed rigidizer between the laminated first and second layers of foam and a fabric material.

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