Mask headgear

Abstract

This invention provides a headgear that can fit many patients with a single standard size, does not require a large number of adjustment components, and does not leave marks on the face during use. It also provides an inexpensive method for manufacturing headgear for breathing masks. [Solution] A headgear for use with a mask is provided, comprising a rigidizer 660, a suitable material, and at least one piece of fabric, wherein the edge portion of at least one piece of fabric is sealed by at least one joint, so that the rigidizer, the suitable material, and at least one joint are sealed by at least one piece of fabric over at least a portion of the headgear.

Description

Technical Field

[0001] (Cross-reference to Applications) This application claims the benefit of Australian Provisional Patent Application No. 2008906390 (filed Dec. 10, 2008), Australian Provisional Patent Application No. 2009900327 (filed Jan. 29, 2009), Australian Provisional Patent Application No. 2009902731 (filed Jun. 12, 2009), and Australian Provisional Patent Application No. 2009904236 (filed Sep. 4, 2009), each of which is hereby incorporated by reference in its entirety.

[0002] The present invention relates to a headgear and a method of manufacturing a headgear for holding a mask in a predetermined position on a patient's face, the mask being used, for example, in the treatment of sleep disordered breathing (SDB) using continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV).

Background Art

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

Summary of the Invention

Problems to be Solved by the Invention

[0004] Problems with some conventional headgear include the fact that the prescribed size may only fit a very small number of patients, or that a large number of adjustment components may be required to achieve a suitable fit. Another problem with some conventional headgear is that it tends to leave marks on the face during use. Yet another problem with some conventional headgear is that it is cumbersome and complex to use. [Means for solving the problem]

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

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

[0007] One embodiment of the headgear according to the present invention is such that the rear portion of the headgear is configured and positioned to remain relatively fixed in a predetermined position during use. In one embodiment, the headgear has a rear portion that does not substantially "ride up" or slide forward. Another preferred embodiment of the headgear is that it does not come into contact with the ears during use.

[0008] In one embodiment, the rear of the headgear forms a rear loop that surrounds the back of the head. In one embodiment, the rear comprises a rear loop that is substantially inflexible along the length of the rear. In one embodiment of the present invention, the headgear for a breathing mask is provided having a first portion having a first degree of stretchability and at least one further portion having different degrees of stretchability. In one embodiment, the headgear comprises a rear portion that is substantially inflexible and elastic side portions.

[0009] One aspect of the present invention relates to a headgear for use with a mask, the headgear being made of a rigid or semi-rigid material and comprising a rigidizer that is fitted to extend on both sides of the patient's parietal bones, an upper strap fitted to detachably connect the rigidizer to the upper part of the mask, and a lower strap fitted to detachably connect the rigidizer to the lower part of the mask.

[0010] Another aspect of the present invention relates to a headgear for use with a mask, comprising a rigidizer made of a rigid or semi-rigid material and configured to extend to the parietal and zygomatic bones 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 present invention relates to a headgear comprising a relatively non-stretchable rear section and a plurality of relatively stretchable straps. Preferably, during use, the relatively stretchable straps interconnect the rear section and the mask.

[0012] Another aspect of this headgear technology is a relatively low-cost manufacturing technique.

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

[0014] Another aspect of the present invention may include a method for manufacturing a headgear for use with a mask, the headgear comprising components that have a generally simple geometric shape and can be cut from a flat piece of material, the method comprising (a) cutting out a number of components of the same kind from a single flat sheet of the material, (b) the components being arranged nested to one another on the sheet, thereby minimizing the amount of waste material removed and discarded, and (c) the method resulting in a high yield. Preferably, a high yield is defined as obtaining 11.5 or more headgears per square meter, and the shape may include a generally rectangular or generally arched shape.

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

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

[0017] Another aspect of the headgear according to the present invention is that it is less likely to leave marks on the face compared to the prior art. In one embodiment, the headgear according to the present invention has a softened edge. In one embodiment, the joint is located away from the contact area with the face. In one embodiment, an edge with a large radius is used. In one embodiment, the die-cut edge is not present facing the face during use.

[0018] Another aspect of the present invention may include a process for manufacturing a headgear, comprising the steps of laminating a foam and a 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; and joining one or more strap portions together.

[0019] Another preferred embodiment of the headgear according to the present invention is one in which the headgear is configured and positioned to take a predetermined shape when not in use. This predetermined shape may be substantially the same as the shape the headgear takes when worn, making the use of the headgear more intuitively easier. In one embodiment, the headgear according to the present invention is configured and positioned to "spring to life" and take a predetermined shape when removed from packaging and / or when a force that tends to deform the headgear (e.g., pressure) is removed. In one embodiment, the headgear comprises a portion made of an elastic material. In one embodiment, the headgear comprises a self-supporting rear portion.

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

[0021] A further aspect of the present invention relates to a headgear for use with a mask, comprising: a first strap that engages with the back of the patient's head, extends on both sides of the patient's parietal bone to behind the patient's ears, and is configured to take on a substantially circular or oval shape during use, with at least a portion of the first strap being substantially non-stretchable; and at least one second strap configured to detachably connect the first strap to the mask.

[0022] Another aspect of the present invention relates to a headgear for use with a mask, comprising: a first strap configured to extend over the top of the patient's head when in use and to extend to both sides of the patient's parietal bone and behind the patient's ears; and at least one second strap configured to detachably connect the first strap to the mask, wherein at least a portion of the first strap is self-supporting, so that the headgear maintains its three-dimensional shape when not in use.

[0023] A further aspect of the present invention relates to a headgear for holding a breathing mask in place on a patient's face, comprising a rear section and left and right side sections, each configured to connect to a breathing mask, wherein the rear section comprises a substantially non-stretchable arched portion configured to elastically return to a predetermined shape when not in use, the arched portion including a first portion configured to be positioned substantially parallel to the top of the patient's head and a second portion configured to be positioned generally with the posterior surface of the patient's head.

[0024] A further aspect of the present invention relates to a method for manufacturing a headgear for use with a mask, comprising the steps of: positioning a rigidizer over a first foam and a first fabric laminate; positioning a second foam over the rigidizer and a second fabric over the second foam; thermoforming the first foam and the first fabric laminate, the rigidizer, the second foam, and the second fabric in order to form a thermoformed sheet; and ultrasonically cutting the thermoformed sheet present on the outer circumference of the headgear.

[0025] Another aspect of the present invention provides a single-size headgear that fits a wide range of patients, reducing or eliminating the need for adjustment to achieve a fit. In one embodiment of the present invention, a rear section of the headgear is provided, which has a fixed 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, which is to be read in conjunction with the accompanying drawings. This is part of the disclosure and illustrates the principles of the present invention by way of example.

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

Brief Description of the Drawings

[0028] [Figure 1] FIG. 12 is a side view of a headgear at a predetermined position on a patient's head according to an embodiment of the present invention. [Figure 2] FIG. 15 is a rear perspective view of a headgear at a predetermined position on a patient's head according to another embodiment of the present invention. [Figure 3] FIG. 18 is a partial perspective view of a headgear according to another embodiment of the present invention. [Figure 4] FIG. 21 is a side view of a headgear at a predetermined position on a patient's head according to another embodiment of the present invention. [Figure 4A] FIG. 24 is a cross-sectional view showing a joint portion between the headgear and the mask in FIG. 4 according to an embodiment of the present invention. [Figure 5] FIG. 27 is a side view of a headgear at a predetermined position on a patient's head according to another embodiment of the present invention. [Figure 6] FIG. 30 is a rear perspective view of a headgear at a predetermined position on a patient's head according to another embodiment of the present invention. [Figure 7] FIG. 33 is a front perspective view of the headgear in FIG. 6. [Figure 8] FIG. 36 is a front perspective view of the headgear in FIG. 6 provided with a different mask according to another embodiment of the present invention. [Figure 9] FIG. 39 is a rear perspective view of the headgear configuration in FIG. 8. [Figure 10] FIG. 42 is a rear perspective view of a headgear at a predetermined position on a patient's head according to another embodiment of the present invention. [Figure 11] FIG. 45 is a perspective view of a rigidizer of the headgear in FIG. 10. [Figure 12]Figure 11 is an enlarged view of the rigidizer joint. [Figure 13] Figure 11 is a cross-sectional view of the rigidizer joint. [Figure 14A] This is a cross-sectional view of another material and configuration for a rigidizer according to an embodiment of the present invention. [Figure 14B] This is a cross-sectional view of another material and configuration for a rigidizer according to an embodiment of the present invention. [Figure 14C] This is a cross-sectional view of another material and configuration for a rigidizer according to an embodiment of the present invention. [Figure 14D] This is a cross-sectional view of another material and configuration for a rigidizer according to an embodiment of the present invention. [Figure 14E] This is a cross-sectional view of another material and configuration for a rigidizer according to an embodiment of the present invention. [Figure 14F] This is a cross-sectional view of another material and configuration for a rigidizer according to an embodiment of the present invention. [Figure 14G] This is a cross-sectional view of another material and configuration for a rigidizer according to an embodiment of the present invention. [Figure 14H] This is a cross-sectional view of another material and configuration for a rigidizer according to an embodiment of the present invention. [Figure 14I] This is a cross-sectional view of another material and configuration for a rigidizer according to an embodiment of the present invention. [Figure 14J] This is a cross-sectional view of another material and configuration for a rigidizer according to an embodiment of the present invention. [Figure 15] This is a front view of a rigidizer according to an embodiment of the present invention. [Figure 16A] This is an example of nested headgear components with relatively high or improved yields. [Figure 16B] This is an example of prior art involving nested headgear components with low yield, using a manufacturing method described in the prior art. [Figure 17] This is a cross-sectional view of the strap portion according to a further embodiment of the present invention. [Figure 18]This is a plan cross-sectional view of the strap according to the same embodiment as depicted in Figure 17. [Figure 19] This is a plan view of the bulk material sheet used in the manufacture of the embodiment depicted in Figure 17. [Figure 20] This is a stylized perspective view of an assembled headgear, in accordance with the embodiment depicted in Figure 17. [Figure 21] This is a stylized perspective view of an assembled headgear according to a further embodiment of the present invention. [Figure 22] This is a rear view of an assembled headgear according to a further embodiment of the present invention. [Figure 23] This is a stylized perspective view of an assembled headgear according to a further embodiment of the present invention. [Figure 24] This is a stylized perspective view of an assembled headgear according to a further embodiment of the present invention. [Figure 25A] This is a front view of a forehead support portion according to a further embodiment of the present invention. [Figure 25B] This is a perspective view of a forehead support portion according to a further embodiment of the present invention. [Figure 25C] This is a cross-sectional view of a forehead support portion according to a further embodiment of the present invention. [Figure 26] This is a stylized perspective view of an assembled headgear according to a further embodiment of the present invention. [Figure 27] This is a rigidizer according to a further embodiment of the present invention. [Figure 28] A series of rigidizers arranged in a nested manner according to a further embodiment of the present invention. [Figure 29] This is a plan view of an unassembled top strap according to a further embodiment of the present invention. [Figure 30] This is a plan view of an unassembled top strap according to a further embodiment of the present invention. [Figure 31] This is a perspective view of an ultrasonically cut headgear strap according to an embodiment of the present invention. [Figure 32] This is a perspective view of a headgear strap made of a nonwoven material according to an embodiment of the present invention. [Figure 33] This is a fabric headgear strap having an internal foam material, according to an embodiment of the present invention. [Figure 34] This is a fabric headgear strap having an internal foam material, according to an embodiment of the present invention. [Figure 35] This is a method for rigidifying a material with embossed ribs according to an embodiment of the present invention. [Figure 36] These are different positions of the top strap according to embodiments of the present invention. [Figure 37] These are different positions of the top strap according to embodiments of the present invention. [Figure 38] This is a headgear with a rigidizer according to an embodiment of the present invention. [Figure 39] This is a headgear with a rigidizer according to an embodiment of the present invention. [Figure 40] This is a rigidizer according to an embodiment of the present invention. [Figure 41] This is a typical process for creating a rigid headgear according to an embodiment of the present invention. [Figure 42] This is a typical process for creating a non-rigid headgear according to an embodiment of the present invention. [Figure 43] An embodiment of the present invention provides a headgear including an outer layer of fabric formed around or covering two twisted yarns. [Modes for carrying out the invention]

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

[0030] In this specification, the term "comprising" should be understood in its "open" sense, that is, "including," and therefore not limited to its "close" sense, that is, "consisting only of." The same interpretation should apply to the corresponding terms "comprise," "comprised," and "comprises." A rigidizer means any reinforcing element that increases the stiffness of other members, and may include any reinforcing elements that increase the stiffness of other members, and may also include the purpose of increasing stiffness along one or more axes.

[0031] In this specification, "substantially inextendable" A structure having "stretchability" means a structure that will have less than approximately 5%, more preferably less than approximately 3%, elongation when subjected to the forces typically encountered when using a respiratory mask.

[0032] In this specification, a “self-supporting” structure means a structure that is substantially capable of supporting its own weight under gravity. Such a self-supporting structure is one that cannot support its own weight under gravity. This is in contrast to a "floppy" structure.

[0033] In this specification, the term "rigid" refers to a structure that is relatively more rigid than "flexible" structures such as the fabrics typically used for headgear. Fabrics typically cannot maintain a given shape under gravity. Unlike flexible fabrics that can bend or buckle, rigid structures can change the direction of vectors around physical structures such as ears.

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

[0035] It should also be understood that the headgear may be used with the new mask or incorporated into an existing mask.

[0036] In some embodiments, the configuration, materials, and / or adjustability of the headgear can be designed to improve usability, maintainability, comfort, and / or aesthetics. Furthermore, the configuration, materials, and / or adjustability of the headgear can be designed to improve the range of fit, for example, by ensuring that 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 allows the patient to understand how to use the headgear more intuitively or more clearly, which would further contrast with headgear systems that are flexible as a whole and do not retain their shape. In one embodiment, the self-supporting characteristic of the headgear is provided by the use of hardened and / or thickened elements. In another embodiment, the configuration, material, and / or adjustability of the headgear can be designed, for example, so that the headgear is almost in its use configuration when it comes out of the box. Alternatively, the configuration of the headgear can be formed so that it retains its use shape once it is out of the box, for example, so that a rigidizer maintains the partial shape of the headgear.

[0038] The benefits to the patient in this invention may include, but are not limited to, one or more of the following: a comfortable headgear system, a perceived level of comfort and quality, a smooth and continuous headgear shape that appeals to consumers, a soft-touch, comfortable-to-wear pillow-like headgear appearance, and / or a headgear that is pre-formed to be worn and capable of supporting its own shape, thereby clearly indicating the orientation of the headgear. The orientation of the headgear is clear to the patient because the shape of the headgear is substantially curved to conform to the back of the patient's head. That is, the headgear is substantially dome-shaped.

[0039] Furthermore, the headgear can maintain its shape through the manufacturing process employed to construct the headgear and / or the combination of materials it comprises.

[0040] Another embodiment of the headgear described herein is one in which the mask system is oriented to make direct contact with the patient's face, that is, the vector of the headgear generates a pressure on the mask that is perpendicular, or vertical, to the patient's face.

[0041] The headgear can also be designed to avoid contact with the patient's eyes and ears, or to prevent damage to the eyes and ears.

[0042] Furthermore, the headgear can be configured to be available in only one size for a wide range of patients.

[0043] 1.1 Connecting the headgear to the mask Preferably, each headgear includes two side sections, along with a rear section that connects to the side sections. The side sections provide four-point connections to a mask that is compatible with conventional headgear (for example, allowing conventional headgear to be retrofitted). However, it should be understood that the headgear may be configured to provide more or fewer connection points, such as two-point, three-point, or five-point connections to a mask.

[0044] Furthermore, the headgear can be configured and positioned to provide a force vector to the mask in order to be compatible with conventional headgear. For example, the headgear can be configured such that the force vector applied to the mask by the headgear is approximately perpendicular to the mask and approximately parallel to each other (see, for example, Figure 1). This configuration improves the airtightness of the mask because the headgear presses the mask directly against the patient's face. However, adjustment of the headgear vector may be necessary depending on the type of mask used with the headgear, for example.

[0045] 1.2 Rigidizer The headgear may include one or more rigidizers made of a rigid or semi-rigid material, which are configured to add rigidity to the headgear and to fix the headgear in place during use. The rigidizers may be bendable or deformable along the length of the rigidizer, but can resist or prevent stretching of the headgear in the longitudinal direction of the rigidizer. The rigidizers may be substantially non-stretchable. The rigidizers may be elastic. The rigidizers according to the present invention preferably have one or more of the following features. • Maintains shape • The headgear allows the direction of the sealing force vector to be changed along curved areas such as around the eyes or ears. • Having flexibility, and / or • Provides a structure for maintaining a predetermined shape on a specific surface.

[0046] 1.2.1 Rigidizer positioning One or more residizers can be configured and positioned to engage with other parts of the patient's head, for example, for comfort, aesthetics, or usefulness.

[0047] The desired positioning of the restorer on the patient's head is to engage it with the patient's skull or the back of the head. Furthermore, the restorer should not cover the back of the patient's head, which is advantageous in promoting comfort while the patient is sleeping or in a prone position. Preferably, the restorer partially or entirely surrounds the top and / or back of the patient's skull. The restorer is preferably mounted on an axis that is substantially parallel to the direction of the mask on the patient's face when the headgear and mask combination is worn.

[0048] 1.2.1.1 Top of head rigidizer Figures 1 to 3 illustrate a headgear including a rigidizer. This rigidizer is configured to fit approximately perpendicular to either side of the patient's parietal bone, thereby securing the headgear in place.

[0049] Preferably, the rigidizer is generally made of a material that is relatively inelastic along its length, not stretchable, and yet inherently elastic.

[0050] In Figure 1, each retarder 60 is provided on both sides of the patient's head, with each retarder 60 including an elongated body 62, a lower arm 64 extending substantially laterally from the lower end of the body, and an upper arm 66 extending substantially laterally downward at a distance from the upper end of the body. The upper side straps 20 detachably connect the upper portion of the mask 10 to the upper arm 66 (e.g., via a forehead support), the lower side straps 30 detachably connect the lower portion of the mask 10 to the lower arm 64 (e.g., via a headgear clip connected to a clip insertion port), the top strap 40 (e.g., an elastic connecting member) is configured to cross the top of the patient's head during use and interconnect the upper ends of opposing retarders 60, and the rear strap 50 is configured to pass behind the patient's head during use and interconnect the lower ends of opposing retarders 60.

[0051] In one embodiment, the upper side strap 20 can be a single component extending 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 backward past the patient's ear. Also in Figure 1, the range of motion of the upper and lower arms 66, 64 is shown by dashed lines. In another embodiment, the upper arm 66 is It can be a single component 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 Figure 2, each restorer 260 has a composite structure (shown below), and the upper and lower side straps 220, 230 are continuous and configured to extend from the upper and lower parts of the mask through each restorer 260, where the restorer 260 extends along the parietal bone of the patient's head.

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

[0054] In one example, the upper side strap 220 may be made of an elastic material, thereby providing adjustability to the mask during use. For example, the upper side strap 220 may be made of an elastic material. Furthermore, the elasticity provided by the upper strap can give the patient a wider range of fit. In addition, the lower side strap 230 may be made of a material with lower elasticity compared to the upper side strap. That is, the lower side strap 230 can be made of a material that has lower elasticity to applied force compared to the material used for the upper side strap 220. This is to fix the mask in place while allowing some adjustment of the position of the mask on the patient's face. Furthermore, the rigidizer 260 may have lower elasticity and lower elasticity compared to the upper side strap 220 and / or lower side strap 230, thereby providing structure and support to the headgear, and thus properly fixing the mask to the patient's head during use.

[0055] The upper side straps 220 and / or lower side straps 230 may be constructed from composite materials such as Breath-O-Prene® and die-cut from bulk material. The upper side straps 220 and / or lower side straps 230 may also be constructed from narrow braided material, thereby reducing or eliminating waste generated by die-cutting.

[0056] In Figure 3, the retarder 360 has a mesh structure configured to cover and rest on the back of the patient's head. As shown, the retarder 360 is substantially trapezoidal in shape and has an upper end configured to be detachably connected to an upper side strap 320 attached to the upper part of the mask, and a lower end configured to be detachably connected to a lower side strap 330 attached to the lower part of the mask. The mesh retarder 360 may be flexible to conform to the patient's head, but may also be non-stretchable, for example, to fix the headgear in place. However, the mesh may have another suitable structure.

[0057] In each embodiment, the rigidizer extends substantially perpendicularly along the parietal bone of the patient's head, is cup-shaped, and / or is configured to rest on the back of the patient's head. As illustrated, the parietal bone rigidizer may be connected to the top and / or bottom (i.e., to cover and rest on the back of the head) and may include additional rigid or semi-rigid components to facilitate connection (see, for example, the strap connections in Figures 2 and 3). The rigidizer also avoids the use of any rigid or semi-rigid components on the back of the head, where the patient's head may touch the bed during use. Preferably, the rigidizer is flexible or conformable to the patient's head along its longitudinal direction, but not flexible or deformable in its width direction. This ensures that the headgear is comfortable while maintaining its structural function of securing the mask in place.

[0058] 1.2.1.2 Reducers of the parietal and zygomatic bones Figures 4 and 5 illustrate a headgear that includes a rigidizer configured to fit either side of the patient's parietal bone (i.e., in a substantially vertical direction), thereby securing the headgear in a predetermined position on the back of the patient's head, and extending to the front of the patient's head and the patient's cheekbones.

[0059] In Figure 4, the rigidizer 460 is a continuous component having two lateral sections configured to extend across the mask 10. As shown, each lateral section includes an upper strap portion 462 that extends along the patient's parietal bone, above the patient's ears, and toward the patient's cheekbones, and a lower strap portion 464 that extends below the patient's ears. The upper strap portion 462 extends across the upper portion of the mask 10, and the lower strap portion 464 extends across the lower portion of the mask 10.

[0060] As shown in Figure 4A, the upper strap portion 462 may be detachably clipped to the mask 10. As illustrated, the upper portion of the mask 10 may include a plurality of slots 15 with gaps between them, and the clip 470 may extend into a selected slot 15 through an opening in the upper strap portion 462.

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

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

[0063] In the illustrated embodiment, each rigidizer 560 is configured to rotatably engage with the side of the mask 10 (for example, by clipping onto the side of the mask or wrapping around an anchor on the side of the mask), thereby allowing the mask to rotate relative to the rigidizer 560, and enabling the mask to be rotated and adjusted for proper fitting.

[0064] The posterior upper strap 540 and posterior 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 Rigidizers for the back and top of the head Figures 6 to 11 illustrate a headgear including a rigidizer configured to form a nearly perfect circle / ellipse shape (for example, a shape that may have an adjustable arc separated at the back of the head), thereby securing the headgear in place at the back of the patient's head. As shown, the rigidizer extends along the parietal and occipital bones of the patient.

[0066] In Figures 6 and 7, the rigidizer 660 includes a substantially circular or substantially elliptical shape having a circular arc that is cut off at the lower end. The portion cut off at the lower end allows for size adjustment of the circular / elliptical shape.

[0067] The upper side strap 620 detachably connects the upper portion of the mask 10 to the rigidizer (for example, via the forehead support), and the lower side strap 630 detachably connects the lower portion of the mask 10 to the rigidizer (for example, via a headgear clip that is coupled to a clip insertion port).

[0068] Preferably, the lower side straps 630 and / or the rigidizer 660 engage with the occipital bone, thereby holding the rigidizer in place and preventing the headgear from sliding up the back of the patient's head during use. In a different preferred configuration, the upper side straps 620 and / or the rigidizer 660 may be able to grip or traverse a large portion of the patient's parietal bone during use, thereby preventing the headgear from slipping off the patient's head during use.

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

[0070] In a different preferred embodiment, the lower side strap 630 is screwed through an opening in the rigidizer 660, thereby allowing the rigidizer 660 to slide along the length of the lower side strap 630, thereby adjusting the size of the space encapsulated by the rigidizer 660, and subsequently changing the shape of the headgear to fit different patient head sizes. In a different preferred embodiment, the lower side strap 630 may have an engagement portion along its length, thereby allowing the position of the rigidizer 660 on the lower strap 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 strap 630. For example, the engagement portion may be a clip, Velcro®, raised stitching, or other means for fixing the rigidizer 660 in place.

[0071] In different preferred embodiments, the upper side strap 620, the lower side strap 630, and / or the rigidizer 660 may be formed separately, so that each component can be manufactured efficiently and economically (i.e., by arranging the components in a nested manner) as described below.

[0072] As shown in Figure 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 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 (for example, four openings as shown in Figure 15), which allows 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 by different configurations. In this embodiment, the upper side strap 620 is connected to the side protrusions of the mask 10, and the lower side strap 630 is detachably connected to the mask 10 via a headgear clip coupled to a clip insertion point on the mask. As best shown in Figure 8, the upper side strap 630 may be attached to the side protrusions of the mask 10 by adhesive, thereby making the upper side strap adjustable only in the rigidizer. Alternatively, the upper side strap 630 may be adjustably connected to a slot provided at the end of the side protrusions of the mask 10, thereby making the upper side strap adjustable in both the rigidizer and the side protrusions.

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

[0075] Figure 40 shows a rigid device configured to be positioned along the approximate back of the patient's head during use. Another configuration for the 7560 is shown. The rigidizer may be formed in a substantially bulb shape, and this shape has two substantially circular or substantially curved portions, namely an upper portion 7562 configured to engage with the parietal region of the patient's head when in use, and a lower portion 7564 configured to engage with the occipital region of the patient's head when in use. An upper strap 7512 is provided on the upper portion 7562 for engagement with the upper portion of the mask, and a lower strap 7514 is provided on the lower portion 7564 for engagement with the lower portion of the mask.

[0076] 1.2.2 Attaching the Rigidizer / Strap One or more rigidizers can be connected to a mask and / or other objects in different configurations.

[0077] In some embodiments, each rigidizer may include one or more slots through which a headgear strap can be passed. For example, in Figure 1, each end of the main body 62, the end of the lower arm 64, and the end of the upper arm 66 include slots, allowing a headgear strap to be passed through these slots during use. Figure 3 shows a mesh-like rigidizer 360, including an upper section with slots for accommodating a headgear strap, and lower connectors 365 and 366 (e.g., overmolded into the mesh). In Figure 5, the rear of the rigidizer 560 may include upper and lower slots for accommodating rear upper and rear lower straps 540 and 550. Figures 6 to 11 also show one or more slots provided on the rigidizer 660 for accommodating a headgear strap.

[0078] In different embodiments, the rigidizer may be provided with loops to accommodate the headgear straps. For example, in Figure 2, the upper and lower ends of the rigidizer 260 include connectors 265, which provide loops for accommodating each of the headgear straps. The lower connector 265 is aligned with a slot in the covering rigidizer, so that the lower strap 230 passes through a slot located at the back of the patient's head. That is, the lower strap 230 passes through a gap in the rigidizer 260.

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

[0080] Figures 25A to 25C show further adjustment mechanisms 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 loop through the opening 5005. As best shown in Figure 25C, the forehead support may be provided with a push tab 5010, which is pre-pressurized or biased by a spring 5025, thereby enabling engagement and disengagement of the looped portion of the top strap 4412. A grip portion 5015 is provided on the side opposite 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 at the end of the loop portion of the top strap 4412. The additional grip portion 5020 can also prevent the loop portion from coming apart by being pulled back through the opening 5005.

[0081] Figure 26 also shows another method for adjusting the bottom strap 4513. Here, the 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 at a vulnerable site along the bottom strap 4513, such as a thinned cross section or a narrowed strap width.

[0082] [Additional Implementations] Figure 18 also shows a sealed first strap 3010 equipped with a rigidizer 3001 which may have an arched or bendable portion 4000. The bendable portion 4000 may be provided on a limited portion of the rigidizer 3001, thereby allowing the rigidizer to be easily bent or hinged at this portion. This may be beneficial for accommodating a wider range of patient head sizes. As shown in Figure 18, the bendable portion 4000 can 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 bendable portion 4000 may also be a fragile portion, thereby achieving similar flexibility in the rigidizer 3001. For example, the bendable portion 4000 may be a curved portion, a thinned portion in cross-section, or a narrowed portion in the rigidizer 3001. This bendable portion cannot be subjected to tension, like different parts of the headgear, such as the upper and lower headgear straps for direct connection to a mask system.

[0083] Figure 20 shows a further configuration. Here, the first strap 3010 may have a sealed rigidizer 3001 (not shown), and a top strap 3012 and a bottom strap 3013 may be provided. The top strap 3012 and the bottom strap 3013 may each be made of a single length of material, which may be looped or otherwise attached to the first strap 3010. Fastening means (e.g., hook-and-loop connections, pressure studs, adhesives) may be attached to the ends of the top strap 3012 and the bottom strap 3013, thereby allowing adjustment of the strap length.

[0084] Figure 21 shows a further configuration, where the first strap 4010 (with a sealed rigidizer (not described)) is joined to its lower end by suture, gluing, welding or other means. Alternatively, the first strap 4010 can be formed from a circular 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 the edge furthest from the top strap 4012 and bottom strap 4013) may be approximately 420 to 600 mm. Preferably, the circumference may be approximately 480 to 550 mm. Preferably, the circumference may be approximately 490 to 505 mm. Preferably, the circumference may be approximately 500 mm. With these circumference values, the headgear can be configured to fit on the top of the head of most people. In addition, contact between the rigidizer and the patient's ears can be avoided. Furthermore, contact between the rigidizer and the patient's lower neck, upper back, or spine can be avoided.

[0085] Figure 21 also shows a top strap 4012 attached to the first strap 4010 at a joint 4035. The joint 4035 may be sutured, ultrasonically welded, glued, or other joining means, or a combination of means. The top strap 4012 may be provided with an adjustment means 4020 at the free end of the top strap, such as a hook or loop material or a pressure stud. The bottom strap 4013 may be attached to the first strap 4010 by a joint 4035. The joint 4035 may be sutured, ultrasonically welded, glued, or other joining means, or a combination of means. The bottom strap 4013 may be provided with an adjustment means 4020 at the free end of the bottom strap, such as a hook or loop material or a pressure stud. In yet another embodiment, the first strap 4010, the top strap 4012 and the bottom strap 4013 can be formed integrally. A single component can be formed by manually rotating an ultrasonic welding machine along the outer circumference of the component. In certain embodiments, this method relies on manual labor, which may result in somewhat uneven edges. A single component can also be constructed by ultrasonic die cutting. This has the advantage of allowing for more precise control of the process, potentially resulting in each headgear being more uniform or consistent. Other construction methods are also possible, including ultrasonic welding and CNC knife cutting.

[0086] Figure 22 shows a rear view of the first strap 4110 (which may be provided with a sealed rigidizer (outwardly invisible in Figure 22)) in the position of use. 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 shifted downward to angle a, thereby guiding the bottom strap below the patient's ear. Angle a may be greater than 0 degrees. Angle a may be between 0 and 90 degrees. Preferably, angle a may be about 10 to 30 degrees. Preferably, angle a may be about 15 to 20 degrees. Angle a may be about 11 degrees. The first strap 4110 may also be provided with an elastic top strap 4112. The bottom strap 4113 may be attached to the first strap 4110 by joints 4134 and 4135.

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

[0088] As shown in Figure 22, the upper portion of the headgear formed by the first strap 4110 is curved in an arch shape to engage with the top of the patient's head. When in use, the first strap 4110 extends toward the horizontal plane 4115 through the widest part of the arched region, thereby lying flat on the top of the patient's head. The lower portion or side of the first strap 4110 extends through the vertical plane (parallel to the vertical axis 4116) at the widest part of the lower portion, or through the 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. If the first strap 4110 is provided with a sealed rigidizer, the configuration of the first strap 4110 in combination with the rigidizer provides a three-dimensional headgear.

[0089] Figure 23 shows a further configuration, 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 ultrasonic welding, but there may be other reasonable methods for attaching the top strap 4212 to the first strap 4210. The top strap 4212 may be made of an elastic material or other suitable material. The bottom strap 4213 may pass through the loop 4235 in the first strap 4210. The bottom strap 4213 may be made of an elastic material or other suitable material. The bottom strap 4213 can also be adjusted by providing a ladder lock 4220 at its end. The length of the strap may be changed by sliding the ladder lock 4220 along the length of the bottom strap 4213.

[0090] Figure 23 further shows the lower portion 4250 of the retarder. This lower portion of the retarder may be curved in such a way that it avoids contact with the back of the patient's ear during use. The curvature of this lower portion 4250 in Figure 20 is such that the first strap 4210 follows a similar radius of curvature along its length. As shown in Figure 23, the radius of curvature of the lower portion 4250 is different from the radius of curvature of the upper portion 4260. The lower portion 4250 may have a smaller radius of curvature than the upper portion 4260. The shape of the first strap 4210 may be similar to the retarder 4201 (which is not externally visible in Figure 23) enclosed within the first strap.

[0091] Figure 27 shows the rigidizer 4201. In this case, the lower portion 4251 may have a smaller radius of curvature than the upper portion 4261. Alternatively, a bend 4200 may be provided on the rigidizer 4201, so that the lower portion 4251 is positioned further beyond the center of the patient's head, thereby avoiding contact with the back of the patient's ear during use.

[0092] Figure 28 shows a nested arrangement of rigidizers 4201 that allows for the production of multiple pieces from a single substrate, illustrating how a large number of rigidizers 4201 can be manufactured while minimizing the amount of waste material.

[0093] Figure 29 shows the flattened first strap 4210 together with the enclosed rigidizer 4201 (indicated by a dashed line), thereby illustrating the similar curved or substantially arched shape of the two parts when formed or joined together. In this embodiment, each end 4280 of the rigidizer 4201 preferably has a maximum length not exceeding the furthest point of the end 4211 of the first strap 4210, and a preferred minimum length greater than the distance required to prevent the end 4211 from deforming or bending when an additional strap is connected to the end 4211 and the headgear is tightened on the patient's head. This feature also helps to avoid the rigidizer 4201 causing discomfort or inflammation in the patient's neck or upper back / spine.

[0094] Figure 30 shows a further embodiment of the present invention. In this case, the rigidizer 4601 may be enclosed inside the first strap 4610. The rigidizer 4601 may extend only across the central part of the first strap 4610 so that it is positioned only on the upper half of the substantially top of the patient's head when in use. This can increase comfort while maintaining the restorative force of the previous embodiment. In addition, the reduced length of the rigidizer 4601 can increase comfort in this embodiment and may also allow the strap to retain its shape and configuration, and may allow the user or patient to quickly put on the headgear. One advantage of a rigidizer incorporated inside the headgear is that it has a headgear portion that engages with the back of the patient's head, thereby maintaining the basic shape of the headgear and maintaining a rigid shape so as to prevent or limit deformation while the patient is wearing the headgear.

[0095] Figure 24 shows a further embodiment. In this case, the top strap 4312 and bottom strap 4313 can be adjusted by a ladder lock 4320. The top strap 4312 and bottom strap 4313 may be attached to the first strap 4310 together with a sealed rigidizer (not shown).

[0096] In embodiments, one or more features of the headgear may be configured to prevent or at least reduce the possibility of the headgear sliding up the patient's head during use and the straps being adjacent to or in contact with the underside of the patient's ears.

[0097] For example, as shown in Figure 36, the position of the top of the head strap 7360 may be moved to the rear (i.e., the angle of the top of the head strap is changed), which reduces the possibility of the headgear riding up. The original position of the top of the head strap 7360 is shown by a solid line in Figure 36. The original position of the top of the head strap 7360 may be vertical or in the direction of the frontal surface of the main body. For example, the top of the head strap 7360 may be moved back by up to 40 degrees from the position shown in Figure 36, for example, 15 degrees shown by α1, 20 degrees shown by α2, and 40 degrees shown by α3. Moving the top of the head strap to the rear also improves the retention of the patient's head area, thereby improving support. For example, the top of the head strap will not become excessively loose at the top of the patient's head. Furthermore, as shown in Figure 36, the straps may include a "J" or "dog leg" shape to direct the vector of the headgear around the ears, and have a radius of approximately 50mm to 70mm, more preferably 55mm to 65mm. Figure 37 shows how the top strap 7360 helps to maintain sufficient distance from the patient's ears to the lower strap 7364.

[0098] In different examples, as shown in Figures 38 and 39, the rigidizer 7460 may extend to reinforce support along the bottom strap that follows the base of the neck. The length of the top strap 7466 may also extend to further improve the positioning of the top strap. Preferably, the rigidizer 7460 can support or position the lower strap of the headgear below the patient's ears or in an area that does not come into contact with the patient's ears. The rigidizer 7460 can also prevent the headgear from sliding up the patient's head or moving vertically upward by securing the headgear to the back of the patient's head and / or neck. The non-stretchability of the rigidizer 7460 also prevents the top strap 7462 from stretching and coming into contact with the patient's ears. The top strap 7462 secures the headgear in place, thereby preventing it from sliding forward or around the patient's head. The bottom strap 7464 and the top strap 7466 may be more elastic or more stretchable than the top strap 7462.

[0099] For example, as shown in Figures 38 and 39, the diameter d of the top strap 7462 may preferably be about 500 mm, and the top strap 7466 may be oriented at an angle α1 of about 90 degrees with respect to the top strap. The lower strap 7464 may be oriented at an angle α2 of about 15 to 30 degrees downward from the horizontal, for example, 20 degrees. 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, which surrounds the back of the patient's head, so that when the patient is lying supine, the headgear is little to nowhere between the patient's head and the pillow or bed.

[0100] 1.2.3 Adjusting the Rigidizer / Strap In embodiments, adjustment of the rigidizer and headgear strap can be provided by hook-and-loop material (e.g., Velcro®, elastic material, compression stud, etc.).

[0101] For example, in Figures 1, 2, and 6-10, one or both ends of straps 20, 30, 220, 230, 620, 630 include Velcro® tabs configured to engage with the rest of the straps, thereby securing the straps 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 straps 40, 440, 450, 540, and 550 are in the form of elastic components, thereby allowing for adjustment.

[0103] The elastic body provided on the top strap of the headgear (for example, top strap 3012 in Figure 20) may be 250 to 450 mm in length. Preferably, the elastic top strap may be approximately 320 to 400 mm in length. It is preferable that the elastic top strap does not require a force exceeding 10 N to elastically stretch 100 mm from its original length. It is preferable that the elastic top strap does not require a force exceeding 6 N to elastically stretch 100 mm from its original length. It is preferable that the elastic top strap does not require a force exceeding 4 N to elastically stretch 100 mm from its original length. It is preferable that the elastic top strap does not require a force exceeding 3 N to elastically stretch 100 mm from its original length. This ensures that the headgear is comfortable for a range of head sizes in the patient.

[0104] In Figures 10 to 13, one or more straps include a pressure stud configuration as described above, thereby enabling adjustment.

[0105] 1.2.4 Rigidizer Materials The rigidizer may have a composite structure comprising two or more materials (a rigid or semi-rigid material having a coating composed of a softer material that comes into contact with the patient), may be composed of another fabric or polymer material (three-dimensional woven fabric, knitted fabric, nonwoven fabric, laminate), and may be manufactured by other means.

[0106] For example, the rigidizer can be made from any suitable flexible material such as nylon, polypropylene, polycarbonate, polystyrene, polyethylene, thermoplastic elastomer (TPE), thermoplastic urethane (TPU), silicone, polyester, etc. (see, for example, Figure 1). In Figure 3, the rigidizer 360 is a three-dimensional woven / knitted fabric with relief processing applied to its edges.

[0107] The rigidizer may also be constructed by thickening or treating the fabric, thereby making the rigidizer more rigid or preventing stretching. For example, the fabric may be printed, and the ink of the print may limit or reduce the amount of stretching the fabric. In addition, the fabric may be sewn together in selected areas, thereby hardening it. The fabric may also be ultrasonically welded in selected areas, thereby hardening it.

[0108] The rigidizer may be made of a nonwoven material, such as a mesh, which provides resistance to stretching in at least one direction.

[0109] Alternatively, the rigidizer may be made of a woven material in which the weave of the material is aligned so that the fabric does not stretch laterally (when positioned 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 by a further layer of material such as silicone, polyurethane, or other adhesive material, which may constitute a fabric strap that reinforces the strap. Overmolding with silicone beads or polymer may also be used.

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

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

[0113] In different embodiments, the rigidizer may have a width equal to or smaller than the fabric backing material. The fabric backing material is in contact with the patient's head during use. This is to increase the comfort of the headgear system during use.

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

[0115] The rigidizer may be overmolded (e.g., TPE overmolded with a softer material (see, e.g., Figure 10)), or it may be separately formed and then covered by a sock of patient-contacting material (e.g., Breath-O-Prene®) by wrapping around or sliding over the rigidizer (see, e.g., Figures 2, 6, and 9). In another embodiment, the patient-contacting material may be attached to the rigidizer by adhesive, ultrasonic welding, sutures, hook-and-loop material, and / or stud connectors. In an embodiment, the patient-contacting material may be present only on the patient-contacting side of the rigidizer, thereby reducing the volume and cost of the headgear.

[0116] Furthermore, the resilient structure of the rigidizer improves the fixation of the strap to the rigidizer, preventing the strap from tearing or ripping through the rigidizer under normal patient use.

[0117] Figures 14A to 14G are cross-sectional views showing alternative rigidizer configurations. As shown in Figure 14A, the rigidizer may include a die-cut sheet material 780, which is covered by a fabric 781, such as two pieces of fabric joined together by suture or gluing. Preferably, the joint of the fabric is inside the strap so that it does not come into contact with the patient's face during use. This may also be achieved by turning the strap inside out and sewing it back to its intended orientation, so that the suture is inside a pocket of fabric. The fabric is made of a soft material to allow it to come into contact with the patient's face during use. The soft material may also be suitable for the selective attachment of Velcro® tabs. The fabric on the side that comes into contact with the patient may be identical to the fabric on the side that does not come into contact with the patient. Preferably, the fabric on the side that comes into contact with the patient may have the same weave as the fabric on the side that does not come into contact with the patient so that the stretch characteristics of the strap are substantially equal on both sides. Furthermore, it is desirable that the fabric on the side in contact with the patient has the same heat shrinkage properties as the side that does not come into contact with the patient. This prevents the headgear from deforming unevenly during thermoforming or other processes, or when exposed to heat. The fabric on the side in contact with the patient may be different from the fabric on the side that does not come into contact with the patient, thereby making the fabric on the side in contact with the patient more comfortable than the fabric on the side that does not come into contact with the patient.

[0118] As shown in Figure 14B, the rigidizer may include a die-cut sheet material 880, which is overmolded with a soft polymer material 881, such as TPE or TPU. The polymer material provides a softer material for contact with the patient's face during use.

[0119] As shown in Figure 14C, the rigidizer may include a semi-rigid molded component 980, which is covered by a fabric 981, for example, by joining two fabrics together by sewing.

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

[0121] As shown in Figure 14E, the rigidizer may include a semi-rigid molded component 1180, which is overmolded with a soft polymer material 1181, such as TPE or TPU. The polymer material provides a softer material for contact with the patient's face during use.

[0122] As shown in Figure 14F, the rigidizer may include a flexible molded component 1280 formed from a flexible polymer material such as TPE or TPU. In embodiments, the molded component may be provided with a soft-touch coating or a flock coating.

[0123] As shown in Figure 14G, the rigidizer may include a fabric outer layer 1381 that is thermoformed and attached to the rigidizer 1380. The rigidizer may be made of die-cut sheet material. Alternatively, the rigidizer may be a molded part, a machined part, or another formed part. The fabric outer layers may be heat-sealed to each other, sutured, ultrasonically cut, CNC knife cut, or otherwise joined. As shown, the fabric outer layers 1381 are joined approximately in the center or midway along the edge. Preferably, the joint is in the center of the side of the headgear or close to the center. Alternatively, the joint may be positioned away from the patient's face during use. It may also be possible to position the joint adjacent to or close to the patient's face during use. Preferably, a layer of foam or other suitable 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, thereby preventing the rigidizer end from being adjacent to the patient's face and causing discomfort or leaving marks on the face. For example, Figure 14H shows a rigidizer 1480 having a fabric outer layer 1481 and a foam layer 1482 provided along at least a portion of the rigidizer 1480. As shown, the foam layer 1482 positions the joint 1483 away from the patient's face during use.

[0124] In some embodiments, the headgear strap may be thermoformed, and the edges of the strap may then be ultrasonically cut. The thermoformed and ultrasonically cut strap is provided with rounded edges 7081 (shown in Figure 31), which substantially prevent marks from being left on the face during use. Furthermore, the thermoformed and ultrasonically cut edges are softer and gentler on the face, providing a more comfortable feel on the patient's face during use (for example, a more comfortable feel around the patient's ears).

[0125] In a further embodiment, at least a portion of the headgear may be made of spacer fabric, in which case the edges of the spacer fabric may be ultrasonically welded. This results in rounded edges on the spacer fabric, which reduces the likelihood of leaving marks on the patient's face and increases comfort.

[0126] In another embodiment, multiple outer fabric layers may be joined together by an adhesive. For example, as shown in Figure 14I, the first fabric layer 1581(1) may have wing-shaped portions 1585 located at one or both ends. Adhesive 1586 (e.g., glue) may be placed at the end of the second fabric layer 1581(2), so that the wing-shaped portions 1585 can be folded over the adhesive to seal the internal portion of the headgear within the fabric layers. As shown, the internal portion of the headgear may include a suitable material such as foam 1582, or a rigidizer 1580, or a combination of both. Another internal component may include different elements disclosed herein, such as a three-dimensional fabric. Furthermore, it should be understood that the adhesive and wing-shaped portions may be arranged in another embodiment, such as the adhesive being placed on the wing-shaped portions, or the wing-shaped portions being placed on the second fabric layer. Furthermore, the first and second fabric layers may be a single, continuous piece of fabric, which is sealed at one end by the configuration of the wing-shaped portions and the adhesive. For example, Figure 14J shows a single piece of fabric 1681 including a wing-shaped portion 1685 at one end, which is configured to fold over an adhesive 1686 (e.g., glue) at the other end. As shown, the internal components of the headgear include a foam 1682 and a suitable material such as a rigidizer 1680.

[0127] Preferably, the edges of the headgear are completely closed, meaning that the internal components of the headgear (such as the rigidizer and fitting material) are completely housed within the outer fabric layer. This is to avoid discomfort caused by hair getting tangled in or coming into contact with the internal components. Furthermore, when the internal components are completely sealed or housed within the fabric layer, the cleanliness and durability of the system can be more easily maintained.

[0128] Preferably, the edges where the fabric layers come into contact with each other are sealed or otherwise concealed, thereby preventing the fabrics from separating or coming loose. This configuration may also be preferable for creating rounded, continuous edges. See, for example, Figure 14A.

[0129] In embodiments, one or more aspects of the headgear strap may be configured to enhance the comfort of the top of the head strap (i.e., the strap is configured to cross the top of the patient's head when in use). For example, the rigidizer may be relatively thin, for example, less than 1 mm, or about 0.5 mm to 0.8 mm. In a different example, the strap may include a nylon rigidizer encased in foam. In such embodiments, the density of the foam can be increased, thereby improving comfort and reducing the likelihood of feeling the nylon rigidizer. Furthermore, the thickness of the foam may be used to alter the softness or roundness of the edges of the headgear. For example, a thicker foam layer would be more preferable than a thinner foam layer for creating rounder corners. In a further embodiment, the foam may start at a certain thickness and be compressed to different thicknesses 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 thickness of the second foam 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 different cases, nonwoven materials (such as those shown in Figure 32) may be used for the head strap because they may be more rigid or less flexible than woven materials, for example, the stiffening material for the collar of a business shirt is a nonwoven material.

[0131] In different examples, the rigid component can be removed from the crown strap, or alternatively, the fabric crown strap 7181 may be heat-pressed or embossed together with the internal foam 7180, thereby melting and forming a rigid portion (see Figures 33 and 34). For example, a thermoformed rib can be formed by pressurizing the foam to about 80%.

[0132] In a different example, a number of ribs 7280 may be embossed on the rigidizer, thereby adding rigidity while reducing the external volume, as shown in Figure 35.

[0133] The rigidizer may also include embossed ribs or other mechanisms that increase the flexibility of the headgear or control its movement in a specific area. Embossing may also be used to stamp a brand logo.

[0134] For example, a headgear strap 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 side in contact with the patient may have a lower density or lower hardness compared to the foam on the side not in contact with the patient. It is also possible to have two or more foam layers and two or more rigidizer components. Alternatively, the headgear may comprise two or more rigidizers and one foam layer.

[0135] For example, a nonwoven material may be inserted between further foam or fabric layers instead of a nylon rigidizer.

[0136] In some embodiments, the materials and / or headgear configuration can be selected to reduce costs.

[0137] 2.0 Manufacturing Preferably, the method for manufacturing the headgear can reduce costs by maximizing production volume and reducing material waste. For example, components may be shaped so that they can be arranged close together and nested in the bulk material, thereby reducing waste when die-cutting the individual components and thus lowering costs.

[0138] Figures 41 and 42 show typical process steps for manufacturing the described headgear. Other manufacturing steps are also possible.

[0139] For example, Figure 41 shows a typical process for creating a rigid headgear. This typical process includes lamination of materials (bonding foam and fabric by a lamination process), thermoforming (placing the foam and fabric laminate in a mold, placing a pre-formed rigidizer on top of the first laminate in the mold, placing the second foam and fabric laminate on top of the rigidizer, closing the tool, heating, and permanently bonding the laminates around the mold surface), ultrasonic die cutting (placing the thermoformed sheet in a die cutting machine and moving an ultrasonic welding machine along the outer circumference of the headgear), and bonding (bonding the lower portion of the headgear crown cap and connecting the headgear strap to the crown cap). Lamination may be omitted in one process. In different processes, thermoforming and ultrasonic cutting may be completed in a single step.

[0140] Figure 42 shows a typical process for creating a non-rigid headgear. This typical process includes lamination of materials (bonding foam and fabric by a lamination process), thermoforming (placing the foam and fabric laminate in a mold, closing the tool, heating, and permanently bonding the laminate around the surface of the mold), ultrasonic die cutting (placing the thermoformed sheet in a die-cutting machine and moving an ultrasonic welding machine along the outer circumference of the headgear), and suturing (joining the lower portion of the headgear crown cap and connecting the headgear strap to the rigidizer).

[0141] As illustrated in Figure 16A, the headgear component 660 according to the present invention can be configured for die-cutting from a sheet. In the example in Figure 16A, twelve headgear components 660 may be cut from a single sheet 2500 of fabric material. The headgear components 660 shown in Figure 16A may be joined with a set of relatively linear straps (not shown) which can be efficiently arranged in a nesting manner, and this combination produces a complete headgear assembly. In the prior art configuration shown in Figure 16B, as in the different design shown in Figure 16B, only three headgear assemblies 2600 can be cut from a sheet 2500 of similar size. In Figure 16B, approximately 11.5 headgears are produced per square meter. For the purposes of this specification, “high production volume” is defined herein as any production volume exceeding 11.5 headgears per square meter.

[0142] In contrast to other prior art headgear configurations, such as ResMedQuattro® headgear, the embodiments shown herein consist of multiple components, and when separated, these components have a simple geometric shape that does not pose a problem in terms of storage space. For example, in the embodiment shown in Figure 6, the upper headgear strap 620 and lower headgear strap 630 are substantially straight, substantially rectangular components, which can be arranged in a nesting manner and can be cut from a bulk piece of material without generating waste. Alternatively, the upper headgear strap 620 and lower headgear strap 630 are formed from a woven material and can be cut to a fixed length without generating waste. The rigidizer 660 can be formed from a flat piece, as shown in Figure 15. In such a configuration, the rigidizers can be arranged in close proximity to each other in a nesting manner, as shown in Figure 16A, so that a large number of rigidizers can be formed from a single bulk sheet of rigidizer material with minimal waste. The rigidizer 660 has a substantially bow-shaped form, but those skilled in the art will consider this to be a relatively simple geometric shape.

[0143] In contrast to conventional headgear such as ResMedQuattro® headgear, this shape allows for close, nested placement, but waste is generated due to the typical shape of the headgear (i.e., openings or holes in the headgear formed by punching).

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

[0145] The described 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 connecting means, which provide the first strap 3010 with a series or more holes or openings configured to accommodate the other straps. The second strap 3012 and the third strap 3013 can be secured or attached to the first strap 3010 by the use of one or more Velcro® tabs that fold back onto the original strap and connect to a soft fabric material on the outer surface of the strap. Preferably, the Velcro® tabs and soft fabric used in the straps can selectively engage with each other in a hook-and-loop fastener common to the use of Velcro®.

[0146] The first strap 3010 has the structure shown in Figures 17 and 18. A rigid or semi-rigid layer 3001, which is made of an elastic material, is sealed between the first layer 3004 and the second layer 3002, which are made of a soft fabric material. Preferably, the soft fabric is configured to be biocompatible, and during use, layers 3002 and 3004 may come into contact with the patient's skin layer. Both biocompatibility and softness can reduce inflammation of the patient's skin.

[0147] A cushioning layer 3003 is sealed between the rigid layer 3001 and the first soft fabric layer 3004. Preferably, this cushioning layer 3003 is made of a soft, foamy material. During use, the first strap 3010 is preferably configured to come into contact with the patient's skin layer by coming into contact with the first soft fabric layer 3004. The multilayered configuration of the first strap 3010 illustrated in Figure 17 extends along one strap portion and is therefore required only to function precisely as disclosed in this embodiment.

[0148] Preferably, the layers of the first strap 3010 may be attached to each other by vulcanization or gluing. In addition, the first fabric layer 3004 and the second fabric layer 3002 do not need to be made of the same or identical material and may be replaced 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 made entirely of soft fabric material, which improves comfort. However, other strap configurations are also possible.

[0150] The rigid layer 3001 or rigidizer may preferably consist of polycarbonate, Lexan®, or a similar elastic material with a thickness of about 1 to 2 mm. The flexible fabric material may include, but is not limited to, Breath-O-Prene®, or nylon or Spandex®.

[0151] Preferably, the first strap 3010 can function as a rigidizer within the entire headgear assembly or configuration 3015 shown in Figure 20. One advantage of including a rigidizer in this structure is that it can enable even distribution of pressure along the patient's head, particularly when installed in the configuration shown in Figure 20. This embodiment can improve patient comfort by positioning the rigidizer along or over the back of the patient's head.

[0152] A further advantage of this embodiment is that the strap structure can be optimized, thereby reducing waste. Conventionally, headgear straps were constructed by cutting the entire headgear from a single bulk piece of material, which resulted in a relatively large amount of waste material. Figure 19 illustrates multiple straps cut from a bulk piece of manufacturing material. As shown, the second layer 3002 of the soft fabric material of the first strap 3010 is located within the bulk sheet 3011 of material. In this example, waste is limited and minimized by arranging each component strap in a nested manner without gaps within the same bulk sheet 3011.

[0153] In a further embodiment, the inner layer of the foam may be molded so that the exposed (skinne) foam forms a headgear shape. Alternatively, any foam (exposed, not exposed, or partially exposed) may first be formed into a headgear shape or shaped by other means. The fabric can then be laminated on top of the foam layer.

[0154] In yet another embodiment, the fabric or textile may be placed in the mold and polymer, or other such molding material may be injected onto the fabric, thereby achieving the desired headgear shape.

[0155] In further embodiments, the outer fabric layer may be filled with a gel, air, and / or other gases. The gas may be selectively filled into the pockets, having a variable volume in each pocket, thereby affecting the rigidity or support provided by the headgear section. The outer fabric layer requires airtightness and can therefore be laminated with, for example, an impermeable polymer layer.

[0156] In yet another embodiment, the outer layer of the fabric can be formed along or around two cords of material. The cords of material are intended to create annular edges on the sides of the material. For example, Figure 43 shows a cross-section of the proposed headgear or a portion thereof. In this case, the cords 1785 are provided inside the outer layer of the fabric 1781 and form a rounded portion in the material. The cords may be provided on both sides (as shown) or on just one side of the headgear strap. The cords may be made of foam, gel, polymer, or other suitable 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 pieces (i.e., the central part of the headgear section) (They are not joined together through the threads), however, it is possible to connect the twisted threads to the other side.

[0157] Furthermore, the outer layer of the foam may also be composed of a single piece of material, which is continuously woven to form a fabric tube.

[0158] Although the present invention is described in relation to headgear for a mask system, it should be understood that the present invention may be applicable to different parts of a mask system, such as a forehead pad, mask cushion, comfort pad, tube wrap, comfort sock-like device, chin strap, mask frame, or other suitable parts of a mask system.

[0159] A quick-release mechanism can also be attached to the headgear, for example, a selectively removable section at the rear of the headgear. This quick-release mechanism may include a connection using hook-and-loop material with a pull cord. Alternatively, the quick-release mechanism may be a clip fastening or other mechanism, which would allow the patient to remove the mask system in an emergency.

[0160] In further embodiments, tube attachment components can be attached to or formed on the headgear. For example, a strap for wrapping around the tube may be provided on the headgear, and this strap may be attached to the tube by a hook-and-loop connection. Alternatively, a clip or ring for engaging with the tube may be attached to or formed on the headgear.

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

[0162] The headgear may also be provided with pockets or gaps for inserting or removing additional materials. These pockets or gaps may allow the patient to modify and adjust the stiffness or comfort of the headgear in specific areas. For example, the pockets or gaps may be located at the rear of the headgear, allowing the patient to add fillings or adjustment materials to this area.

[0163] In a further embodiment, the headgear may be provided with padded or soft sock portions or wraps if required by the patient, thereby providing additional comfort. The sock portions or wraps may be selectively attached to the headgear straps by means of, for example, clips, hook-and-loop materials, pullovers, or other suitable fastening methods.

[0164] The headgear can also be equipped with sensors for examining or monitoring the patient.

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

[0166] While the present invention is described in relation to the most practical and desirable embodiments currently available, it should be understood that the present invention should not be limited to the disclosed embodiments, but rather aims to encompass various modifications and equivalent configurations that fall within the spirit and scope of the invention. Furthermore, the various embodiments described above may be implemented in combination with other embodiments, for example, an aspect of one embodiment may be combined with an aspect of a different embodiment to realize another embodiment. Moreover, each independent mechanism or component in any given assembly may constitute a further embodiment. Furthermore, while the present invention has a specific application for patients with OSA, it should be understood that the benefits for patients with different diseases (e.g., congestive heart failure, diabetes, morbid obesity, stroke, bariatric surgery, etc.) can be derived from the teachings described above. Furthermore, the teachings described above have a scope applicable to both patients and non-patients, similarly in non-medical applications.

[0167] Examples of embodiments in this application are shown below. (1) A headgear for use with a mask, comprising a rigidizer, a suitable material, and at least one piece of fabric, wherein the edge of the at least one piece of fabric is sealed by at least one joint, so that the rigidizer, the suitable material, and the at least one joint are sealed by the at least one piece of fabric over at least a portion of the headgear. (2) The headgear according to (1), wherein the at least one piece of fabric comprises a single piece of fabric having a first edge portion that is folded and attached to the second edge portion by the at least one joint portion. (3) The headgear according to (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 the first edge portion of the second fabric by a first joint, and a second folded edge portion attached to the second edge portion of the second fabric by a second joint. (4) The headgear according to (3), wherein the first and second edges of the second fabric are folded. (5) The headgear according to (1), wherein the at least one fabric comprises a first fabric and a second fabric, the first edge of the first fabric being attached to the first edge of the second fabric by a first joint at the center of the first edge of the rigidizer, and the second edge of the first fabric being attached to the second edge of the second fabric by a second joint at the center of the second edge of the rigidizer. (6) The headgear according to (3) to (5), wherein the first fabric is a different fabric from the second fabric. (7) The headgear according to (1) to (6), wherein at least one joint is sutured, ultrasonically welded, heat-sealed, or CNC knife-cut. (8) The headgear according to (1) to (7), characterized in that the rigidizer comprises a die-cut sheet material or a semi-rigid molded component, and the compatible material comprises a soft polymer material overmolded onto the rigidizer. (9) The headgear according to (1) to (7), wherein the suitable material comprises foam. (10) The headgear according to (1) to (9), wherein the suitable material extends to the edge portion of the rigidizer. (11) The headgear according to (1) to (10), wherein at least one of the fabrics is thermoformed and attached to the rigidizer. (12) A headgear for use with a mask, comprising: a first strap that engages with the back of a patient's head, extends on both sides of the patient's parietal bones toward the back of the patient's ears, and is configured to take on a substantially circular or oval shape during use, wherein at least a portion of the first strap is substantially non-stretchable; and at least one second strap configured to detachably connect the first strap to the mask. (13) The headgear according to (12), wherein the substantially non-stretchable portion of the first strap comprises at least one thickened or treated portion of the first strap. (14) The headgear according to (13), wherein the first strap is made of fabric, and the substantially non-stretchable portion of the first strap is made of the fabric, a seam, or at least one ultrasonically welded portion, which is printed with ink. (15) The headgear according to (12), wherein the substantially non-stretchable portion of the first strap comprises a rigidizer connected to the first strap. (16) The headgear according to (15), wherein the rigidizer is sealed within the first strap or laminated on the first strap. (17) The headgear according to (15), wherein the rigidizer comprises a woven material, a nonwoven material, a mesh material, or a knitted material. (18) The headgear according to (12) to (17), wherein the substantially non-stretchable portion is provided in the center of the first strap, so that the substantially non-stretchable portion is positioned on the upper half of the patient's head during use. (19) The headgear according to (12) to (17), wherein the substantially non-stretchable portion has a first length sufficient to prevent the end of the first strap connected to the at least one second strap from bending or deforming when the headgear is tightened on the patient's head. (20) The headgear according to (12) to (19), wherein the first strap is adjustablely connected to at least one second strap. (21) The headgear according to (12), wherein the first strap comprises a rigidizer. (22) The headgear according to (21), further comprising at least one bending portion, wherein the rigidizer is configured to allow the rigidizer to bend or hinge at the at least one bending portion. (23) The headgear according to (21) or (22), wherein the rigidizer comprises at least one portion with increased rigidity. (24) The headgear according to (23), wherein the at least one rigidity-increased portion comprises at least one rib or at least one embossed portion. (25) The headgear according to (12) to (24), wherein the at least one second strap comprises at least one upper strap configured to extend over the patient's ear. (26) The headgear according to (25), wherein the at least one upper strap is connected to the forehead support portion of the mask. (27) The headgear according to (12) to (26), wherein the at least one second strap comprises at least one lower strap configured to extend below the patient's ear. (28) The headgear according to (27), wherein at least one lower strap is bent downward at an angle of, for example, about 10 to 30 degrees, for example, about 11 degrees. (29) The headgear according to (12) to (28), wherein the diameter of the circular or elliptical shape taken by the first strap during use is approximately 400 mm to approximately 660 mm, for example, approximately 500 mm to approximately 550 mm, preferably approximately 500 mm. (30) The headgear according to (12) to (29), wherein at least one second strap is elastic. (31) A headgear for use with a mask, comprising: a first strap configured to extend over the top of the patient's head when in use and to extend to both sides of the patient's parietal bone and behind the patient's ears; and at least one second strap configured to detachably connect the first strap to the mask, wherein at least a portion of the first strap is self-supporting, thereby maintaining a three-dimensional shape when not in use. (32) The headgear according to (31), wherein the first strap is positioned flat on the top of the patient's head during use. (33) The headgear according to (31) or (32), wherein the self-supporting portion comprises a rigidizer attached to the first strap. (34) The headgear according to (31) to (33), wherein the self-supporting portion of the first strap extends to the back of the patient's head and / or neck when in use. (35) A headgear for holding a breathing 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 breathing mask, wherein the rear portion comprises a substantially non-stretchable arched region configured to elastically return to a predetermined shape when not in use, the arched region comprising a first portion configured to be positioned substantially parallel to the top of the patient's head and a second portion configured to be positioned substantially parallel to the posterior surface of the patient's head. (36) A method for manufacturing a headgear for use with a mask, comprising the steps of: positioning a rigidizer over a first foam and a first fabric laminate; positioning a second foam over the rigidizer and positioning a second fabric over the second foam; thermoforming the first foam and the first fabric laminate, the rigidizer, the second foam and the second fabric to form a thermoformed sheet; and ultrasonically cutting the thermoformed sheet present on the outer circumference of the headgear. (37) The method of (36), wherein the retarder engages with the back of the patient's head and extends on both sides of the patient's parietal bone toward the back of the patient's ears and is formed to take on a substantially circular or oval shape during use. (38) The method of (36), wherein the restorer is formed to extend over the top of the patient's head when in use and to extend to both sides of the patient's parietal bone and behind the patient's ears. (39) The method according to (37) or (38), further comprising the step of joining the first end and the second end of the cut thermoformed sheet. (40) The method according to (36) to (39), further comprising the step of attaching at least one strap to the cut thermoformed sheet. (41) A headgear for use with a mask, comprising: a rigidizer made of a rigid or semi-rigid material and configured to extend on both sides of the parietal bone of the patient; and at least one strap configured to detachably connect the rigidizer to the mask. (42) The headgear according to (41), wherein the headgear includes an upper strap configured to detachably connect the rigidizer to the upper portion of the mask, and a lower strap configured to detachably connect the rigidizer to the lower portion of the mask. (43) The headgear according to (42), wherein the retarder is configured to extend along the parietal and occipital bones of the patient. (44) The headgear according to (43), wherein the retarder is configured to form a cup shape and / or a partially or completely circular or elliptical shape that is positioned to rest on the back of the patient's head. (45) The headgear according to (41), wherein the rigidizer is deformable or flexible along its length but rigid along its width. (46) A headgear for use with a mask, comprising: a rigidizer made of a rigid or semi-rigid material and configured to extend along the parietal and zygomatic bones 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 at least a portion of the back of the patient's head, attached to at least the first strap. A headgear comprising a rigidizer configured to engage with a first portion, wherein at least a second strap is attached between the first portion and the mask, and the rigidizer increases the rigidity of the headgear along one axis. (48) The headgear according to (47), wherein, when in use, the axis is substantially parallel to the length of the patient's head. (49) The headgear according to (48), wherein the strap enables the mask and the first part to be attached in a configuration substantially parallel to the patient's head. (50) The headgear according to (41) to (49), wherein the rigidizer includes a composite structure. (51) The headgear according to (50), wherein the rigidizer comprises a rigid or semi-rigid material covered with a softer material that comes into contact with the patient. (52) A mask system for supplying respiratory gas to the patient, comprising a mask and a headgear as described in (12) to (35) and (41) to (51). (53) A method for manufacturing a headgear for use with a mask, the headgear comprising components having a generally simple geometric shape and being cut from a flat piece of material, the method comprising (a) cutting a plurality of components of the same kind from a single flat sheet of the material, (b) the components being arranged nested relative to one another on the sheet, thereby minimizing the amount of waste material removed and discarded, and (c) the method resulting in a high yield. (54) The method according to (53), wherein the high yield is defined as obtaining 11.5 or more headgear per square meter. (55) The method according to (54), wherein the shape includes a substantially rectangular shape or a substantially arched shape. (56) The method according to (53) to (55), wherein the component includes a strap or a rigidizer. (57) The method of (56), wherein at least five components are arranged in a nested manner on each flat piece. (58) A headgear assembly used to attach a medical device to the head of a patient, the headgear comprising a plurality of elongated straps, at least a portion of which includes a rigid or semi-rigid layer sealed between a first layer and a second layer made of a flexible biocompatible material, and further comprising a cushioning layer sealed between the first layer and the rigid layer made of a biocompatible material. (59) The headgear assembly according to (58), wherein the layers of the strap are fixed by vulcanization or gluing. (60) The headgear assembly according to (59), wherein the strap including the rigid layer is positioned at the back of the head when in use. (61) The headgear assembly according to (60), wherein the material is fabric. (62) A headgear for use with a mask, comprising: a plurality of straps configured to engage with the user's head; and at least one rigidizer made of a rigid or semi-rigid material, wherein at least one strap is joined to the rigidizer at a predetermined position relative to the upper back of the head. (63) A process for creating a headgear, comprising the steps of laminating a foam and a 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; and joining the one or more strap portions together. (64) The process according to (63), wherein the joining step includes a suturing step. (65) The process according to (63), wherein the thermoforming step includes placing a pre-formed rigidizer between the first and second layers of the laminated foam and the fabric material. [Explanation of symbols]

[0168] 10 masks 15 slots 40,4012,4112,4212,4312,4412,7466 Top strap 62 Main unit 64 Lower Arm 66 Upper Arm 220, 320, 620 Upper side straps 230, 330, 630 Lower side straps 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 section 470 clips 566 Front strap section 662 Strap section 663 holes 665 Stud 780,880 die-cut sheet materials 781,981 fabrics 881,1181 Flexible polymer materials 980, 1080, 1180 Semi-rigid molded components 1081 Fabric Composite Materials 1280 Flexible molded components 1381,1481 Fabric outer layer 1482 Foam layer 1483 Joint 1581(1) First layer of cloth 1581(2) Second layer of fabric 1582,1682 foam 1585,1685 wing 1586,1686 Adhesive 1681 Single cloth 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 Arch-shaped or curved portion 4020 Adjustment means 4035,4130,4134,4135,4235 Joint 4115 Horizontal plane 4116 Vertical axis 4200 Bending section 4211,4280 End 4220, 4320 Ladder Lock 4235 Loop 4250 Lower part of the residizer 4251,7564 Lower part 4261,7562 Upper part 5000 Forehead support part 5005 Opening 5010 Push Tab 5015 Grip section 5020 Additional grip section 5025 spring 6000 perforation 7081 Rounded edges 7181 Fabric head strap 7280 Numerous ribs 7360,7462 Top strap 7512 Upper Strap 7514 Lower strap

Claims

1. A headgear to be used with a mask, Rigidizer and, Suitable materials, At least one piece of fabric, Equipped with, The edge of the at least one piece of fabric is sealed by at least one joint, thereby sealing the rigidizer, the compatible material and the at least one joint by the at least one piece of fabric over at least a portion of the headgear.

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

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

4. The headgear according to claim 3, characterized in that the first and second edges of the second fabric are folded.

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

6. The 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. The headgear according to any one of claims 1 to 6, characterized in that the at least one joint is sutured, ultrasonically welded, heat-sealed, or CNC knife-cut.

8. The headgear according to any one of claims 1 to 7, characterized in that the rigidizer comprises a die-cut sheet material or a semi-rigid molded component, and the compatible material comprises a soft polymer material overmolded onto the rigidizer.

9. The headgear according to any one of claims 1 to 7, characterized in that the suitable material comprises a foam.

10. The headgear according to any one of claims 1 to 9, characterized in that the suitable material extends to the edge portion of the rigidizer.

11. The headgear according to any one of claims 1 to 10, characterized in that at least one of the fabrics is thermoformed and attached to the rigidizer.

12. A headgear to be used with a mask, A first strap that engages with the back of the patient's head, extends on both sides of the patient's parietal bones toward the back of the patient's ears, and is configured to take on a substantially circular or oval shape during use, wherein at least a portion of the first strap is substantially non-stretchable, At least one second strap configured to detachably connect the first strap to the mask, Headgear equipped with [specific feature].

13. The headgear according to claim 12, characterized in that the substantially non-stretchable portion of the first strap comprises at least one thickened or treated portion of the first strap.

14. The headgear according to claim 14, characterized in that the first strap is made of fabric, and the substantially non-stretchable portion of the first strap is equipped with ink baked onto the fabric, the seam, or at least one ultrasonically welded portion.

15. The headgear according to claim 12, characterized in that the substantially non-stretchable portion of the first strap comprises a rigidizer connected to the first strap.

16. The headgear according to claim 15, characterized in that the rigidizer is sealed within the first strap or laminated on the first strap.

17. The headgear according to claim 15, characterized in that the rigidizer comprises a woven material, a nonwoven material, a mesh material, or a knitted material.

18. The headgear according to any one of claims 12 to 17, characterized in that the substantially non-stretchable portion is provided in the center of the first strap, thereby positioning the substantially non-stretchable portion on the upper half of the patient's head during use.

19. The headgear according to any one of claims 12 to 17, characterized in that the substantially non-stretchable portion has a first length sufficient to prevent the end of the first strap, which is connected to the at least one second strap, from bending or deforming when the headgear is tightened on the patient's head.

20. The headgear according to any one of claims 12 to 19, characterized in that the first strap is adjustably connected to the at least one second strap.

21. The headgear according to claim 12, characterized in that the first strap includes a rigidizer.

22. The headgear according to claim 21, characterized in that the rigidizer comprises at least one bending portion configured to allow the rigidizer to bend or hinge-like at the at least one bending portion.

23. The headgear according to claim 21 or 22, characterized in that the rigidizer comprises at least one portion with increased rigidity.

24. The headgear according to claim 23, characterized in that the at least one portion with increased rigidity comprises at least one rib or at least one embossed portion.

25. The headgear according to any one of claims 12 to 24, characterized in that the at least one second strap comprises at least one upper strap configured to extend over the patient's ear.

26. The headgear according to claim 25, characterized in that the at least one upper strap is configured to be connected to the forehead support portion of the mask.

27. The headgear according to any one of claims 12 to 26, characterized in that the at least one second strap comprises at least one lower strap configured to extend below the patient's ear.

28. The headgear according to claim 27, characterized in that the at least one lower strap is bent downward at an angle of, for example, about 10 to 30 degrees, or for example, about 11 degrees.

29. The headgear according to any one of claims 12 to 28, characterized in that the diameter of the circular or elliptical shape taken by the first strap during use is about 400 mm to about 660 mm, for example, about 500 mm to about 550 mm, preferably about 500 mm.

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

31. A headgear to be used with a mask, A first strap, configured to extend over the top of the patient's head when in use, and to extend to both sides of the patient's parietal bone and behind the patient's ears, At least one second strap configured to detachably connect the first strap to the mask, Equipped with, The headgear is characterized in that at least a portion of the first strap is self-supporting, thereby allowing the headgear to maintain its three-dimensional shape when not in use.

32. The headgear according to claim 31, characterized in that the first strap is positioned flat on the top of the patient's head during use.

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

34. The headgear according to any one of claims 31 to 33, characterized in that the self-supporting portion of the first strap extends to the back of the patient's head and / or neck when in use.

35. A headgear for holding a breathing mask in a predetermined position on a patient's face, wherein the headgear is The rear and, Each of the left and right sides is configured to be connected to the aforementioned breathing mask, Equipped with, The rear portion of the headgear is characterized by comprising a substantially non-stretchable arched region configured to elastically return to a predetermined shape when not in use, the arched region comprising a first portion configured to be positioned substantially parallel to the top of the patient's head, and a second portion configured to be positioned substantially parallel to the posterior surface of the patient's head.

36. A method for manufacturing a headgear for use with a mask, The steps include: placing the rigidizer over the first foam and the first fabric laminate, The steps include: placing the second foam over the aforementioned rigidizer, and placing the second fabric over the aforementioned second foam; The process involves the steps of thermoforming the first foam and the first fabric laminate, the rigidizer, the second foam and the second fabric in order to form a thermoformed sheet, The steps include ultrasonically cutting the thermoformed sheet located on the outer circumference of the headgear, A method for providing this.

37. The method according to 36, characterized in that the retarder engages with the back of the patient's head and extends on both sides of the patient's parietal bone toward the back of the patient's ears, and is formed to take on a substantially circular or oval shape during use.

38. The method according to 36, characterized in that the retarder extends over the top of the patient's head when in use and is formed to extend to both sides of the patient's parietal bone and behind the patient's ears.

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

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

41. A headgear to be used with a mask, A rigidizer, composed of a rigid or semi-rigid material and configured to extend on both sides of the patient's parietal bone, The rigidizer is configured to be detachably connected to the mask by at least one strap, Headgear equipped with [specific feature].

42. The headgear according to claim 41, characterized in that the headgear includes an upper strap configured to detachably connect the rigidizer to the upper portion of the mask, and a lower strap configured to detachably connect the rigidizer to the lower portion of the mask.

43. The headgear according to claim 42, characterized in that the retarder is configured to extend along the parietal and occipital bones of the patient.

44. The headgear according to claim 43, characterized in that the retarder is configured to form a cup shape and / or a partially or completely circular or elliptical shape, which is configured to be placed on the back of the patient's head.

45. The headgear according to claim 41, characterized in that the rigidizer is deformable or flexible along its own length, but rigid along its own width.

46. A headgear to be used with a mask, A rigidizer, which is made of a rigid or semi-rigid material and is configured to extend along the parietal and zygomatic bones of the patient's skull, One or more straps configured to support the regisizer at the back of the patient's head, A headgear characterized by having the following features.

47. A headgear to be used with a mask, Multiple long, thin straps, A rigidizer configured to be attached to at least the first strap and to engage with at least a portion of the patient's occipital region, Equipped with, At least the second strap is attached between the first part and the mask, A headgear characterized in that the rigidizer increases the rigidity of the headgear along one axis.

48. The headgear according to claim 47, characterized in that when in use, the axis is substantially parallel to the length of the patient's head.

49. The headgear according to claim 48, characterized in that the strap allows the mask and the first part to be attached in a configuration substantially parallel to the patient's head.

50. The headgear according to any one of claims 41 to 49, characterized in that the rigidizer includes a composite structure.

51. The headgear according to claim 50, characterized in that the rigidizer includes a rigid or semi-rigid material covered with a softer material that comes into contact with the patient.

52. A mask system for supplying respiratory gas to the aforementioned patient, masks and, A headgear according to any one of claims 12 to 35 and 41 to 51, A mask system equipped with the following features.

53. A method for manufacturing a headgear for use with a mask, wherein the headgear comprises components that are generally simple geometric in shape and can be cut from a flat piece of material, the method comprising the step of (a) cutting a plurality of components of the same kind from a single flat sheet of the material, (b) the components are arranged in a nesting manner with respect to one another on the sheet, thereby minimizing the amount of waste material removed and discarded, and (c) the method yields a high yield.

54. The method according to 53, characterized in that the high yield is defined as obtaining 11.5 or more headgears per square meter.

55. The method according to 54, characterized in that the shape includes a substantially rectangular shape or a substantially arched shape.

56. The method according to any one of claims 53 to 55, characterized in that the component includes a strap or a rigidizer.

57. The method according to 56, characterized in that at least five components are arranged in a nesting manner on each of the flat pieces.

58. A headgear assembly used to attach a medical device to a patient's head, wherein the headgear comprises a plurality of elongated straps, and at least a portion of the straps is a rigid layer sealed between a first layer and a second layer made of a flexible biocompatible material or A headgear assembly characterized by including a semi-rigid layer, and further having a cushioning layer made of a biocompatible material sealed between the aforementioned layer and the rigid layer.

59. The headgear assembly according to claim 58, characterized in that the strap layers are fixed by vulcanization or gluing.

60. The headgear assembly according to claim 59, characterized in that the strap including the rigid layer is positioned at the back of the head when in use.

61. The headgear assembly according to claim 60, characterized in that the material is a fabric.

62. A headgear to be used with a mask, Multiple straps configured to engage with the user's head, A rigidizer comprising at least one rigidizer made of a rigid or semi-rigid material, Equipped with, A headgear characterized in that at least one strap is attached to a rigidizer at a predetermined position relative to the upper back of the head.

63. The process for creating headgear, The steps include laminating the foam and the fabric material together, The process involves thermoforming the laminated foam and the fabric material, The steps include ultrasonically die-cutting the thermoformed and laminated foam and fabric material onto one or more strap portions of the headgear, The steps of joining one or more strap portions together, A process that includes [something].

64. The process according to claim 63, characterized in that the joining step includes a suturing step.

65. The process according to 63, characterized in that the thermoforming step includes a step of placing a pre-formed rigidizer between the first and second layers of the laminated foam and the fabric material.

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