HEADGEAR

Abstract

A mask assembly suitable for the treatment of sleep disordered breathing, comprising: a mask to provide pressurized air to a patient; upper and lower slot features located on each side of the mask; a headgear assembly, comprising: a back portion; a pair of upper straps provided to the back portion, each upper strap having a loop portion and a hook portion at a free end thereof for releasably attaching to the loop portion; a pair of lower straps extending away from the back portion, each lower strap having a loop portion and a hook portion at a free end thereof for releasably attaching to the loop portion; and a connection region of each loop portion of each strap, the connection region being adapted to receive a respective hook portion, the connection region being wider than each respective hook portion along each respective hook portion's entire length.

Claims

1-20. (canceled)

21. A mask assembly suitable for the treatment of sleep disordered breathing, comprising: a mask configured to provide pressurized air to a patient in the range of 3 to 20 cmH2O throughout the patient's respiratory cycle; and a headgear assembly configured to hold the mask in position on the patient's face during treatment, the headgear assembly comprising: a back portion comprising a bottom portion; a pair of elongated lower straps connected to the back portion and configured to extend below the patient's ears and across the patient's facial skin in use; and a transition between the bottom portion and the pair of elongated lower straps, the transition being angled downwardly relative to the bottom portion such that a lower edge of at least a portion of each of the pair of elongated lower straps is positioned lower on the patient's head than a lower edge of the bottom portion in use.

22. The mask assembly of claim 21, wherein: the mask further comprises a soft, face-contacting portion, a rigid shell, a pair of upper headgear attachment points, and a pair of lower headgear attachment points, the back portion further comprises a top portion and a pair of side portions connecting the top portion and the bottom portion, and the headgear assembly further comprises an opening defined by the top portion, the bottom portion, and the pair of side portions and a pair of elongated upper straps connected to the back portion and configured to extend above the patient's ears in use.

23. The mask assembly of claim 22, wherein at least a portion of the headgear assembly is constructed of an anisotropic, composite material having different extensibilities in different directions.

24. The mask assembly of claim 22, wherein a length of a generally inextensible material is attached to at least a portion of the headgear assembly to reduce extensibility of the headgear assembly.

25. The mask assembly of claim 22, wherein stitching is added to at least a portion of the headgear assembly to stiffen the headgear assembly.

26. The mask assembly of claim 25, wherein the stitching is added as lines, in a crisscross pattern, or both the lines and the crisscross pattern.

27. The mask assembly of claim 22, wherein each of the pair of elongated upper straps and each of the pair of elongated lower straps include a loop material positioned along an external surface thereof and a hook material configured to releasably attach to the loop material to attach the pair of elongated upper straps and the pair of elongated lower straps to the mask, and wherein the loop material of each of the pair of elongated upper straps and each of the pair of elongated lower straps includes a connection region adapted to attach to the hook material of a corresponding strap, the connection region being wider than the hook material such that when the hook material is attached to the loop material, in use, the loop material at each connection region is configured to shield the patient's facial skin from contact with the hook material.

28. The mask assembly of claim 27, wherein a leading end of each of the pair of elongated upper straps is configured to pass through a corresponding one of the pair of upper headgear attachment points and be doubled-back on itself to attach the hook material to the loop material to secure the headgear assembly to the mask, and wherein the loop material of each of the pair of elongated lower straps is configured to pass through a corresponding one of the pair of lower headgear attachment points and doubled-back on itself to attach the hook material to the loop material to secure the headgear assembly to the mask.

29. The mask assembly of claim 28, wherein at least a portion of the headgear assembly is constructed of a composite having a first layer to be positioned against the patient's head, a second, middle layer constructed from foam, and a third layer including the loop material.

30. The mask assembly of claim 22, further comprising vent holes adapted to vent exhaled air from the mask.

31. The mask assembly of claim 22, further comprising an elbow connected to the mask, the elbow adapted to deliver pressurized gas to an interior of the mask.

32. The mask assembly of claim 22, wherein the mask is a full face mask.

33. The mask assembly of claim 22, wherein the mask is a nasal mask.

34. The mask assembly of claim 22, wherein the opening is arranged to receive the occiput of the patient's head.

35. The mask assembly of claim 22, wherein the mask further comprises a forehead support, and wherein the pair of elongated upper straps are configured to pass from the patient's forehead region to the back of the patient's head.

36. The mask assembly of claim 22, wherein: a length of a generally inextensible material is attached to at least a portion of the headgear assembly to reduce extensibility of the headgear assembly, stitching is added to at least a portion of the headgear assembly to stiffen the headgear assembly, the stitching is added as lines, in a crisscross pattern, or both the lines and the crisscross pattern, each of the pair of elongated upper straps and each of the pair of elongated lower straps include a loop material positioned along an external surface thereof and a hook material configured to releasably attach to the loop material to attach the pair of elongated upper straps and the pair of elongated lower straps to the mask, the loop material of each of the pair of elongated upper straps and each of the pair of elongated lower straps includes a connection region adapted to attach to the hook material of a corresponding strap, the connection region being wider than the hook material such that when the hook material is attached to the loop material, in use, the loop material at each connection region is configured to shield the patient's facial skin from contact with the hook material, a leading end of each of the pair of elongated upper straps is configured to pass through a corresponding one of the pair of upper headgear attachment points and be doubled-back on itself to attach the hook material to the loop material to secure the headgear assembly to the mask, the loop material of each of the pair of elongated lower straps is configured to pass through a corresponding one of the pair of lower headgear attachment points and doubled-back on itself to attach the hook material to the loop material to secure the headgear assembly to the mask, at least a portion of the headgear assembly is constructed of a composite having a first layer to be positioned against the patient's head, a second, middle layer constructed from foam, and a third layer including the loop material, the mask assembly further comprises vent holes adapted to vent exhaled air from the mask, the mask assembly further comprises an elbow connected to the mask, the elbow adapted to deliver pressurized gas to an interior of the mask, the mask is a full face mask, the opening is arranged to receive the occiput of the patient's head, the mask further comprises a forehead support, and the pair of elongated upper straps are configured to pass from the patient's forehead region to the back of the patient's head.

37. The mask assembly of claim 36, wherein at least a portion of the headgear assembly is constructed of an anisotropic, composite material having different extensibilities in different directions.

38. The mask assembly of claim 22, wherein: a length of a generally inextensible material is attached to at least a portion of the headgear assembly to reduce extensibility of the headgear assembly, each of the pair of elongated upper straps and each of the pair of elongated lower straps include a loop material positioned along an external surface thereof and a hook material configured to releasably attach to the loop material to attach the pair of elongated upper straps and the pair of elongated lower straps to the mask, the loop material of each of the pair of elongated upper straps and each of the pair of elongated lower straps includes a connection region adapted to attach to the hook material of a corresponding strap, the connection region being wider than the hook material such that when the hook material is attached to the loop material, in use, the loop material at each connection region is configured to shield the patient's facial skin from contact with the hook material, a leading end of each of the pair of elongated upper straps is configured to pass through a corresponding one of the pair of upper headgear attachment points and be doubled-back on itself to attach the hook material to the loop material to secure the headgear assembly to the mask, the loop material of each of the pair of elongated lower straps is configured to pass through a corresponding one of the pair of lower headgear attachment points and doubled-back on itself to attach the hook material to the loop material to secure the headgear assembly to the mask, at least a portion of the headgear assembly is constructed of a composite having a first layer to be positioned against the patient's head, a second, middle layer constructed from foam, and a third layer including the loop material, the mask assembly further comprises vent holes adapted to vent exhaled air from the mask, the mask assembly further comprises an elbow connected to the mask, the elbow adapted to deliver pressurized gas to an interior of the mask, the mask is a nasal mask, the opening is arranged to receive the occiput of the patient's head, the mask further comprises a forehead support, and the pair of elongated upper straps are configured to pass from the patient's forehead region to the back of the patient's head.

39. The mask assembly of claim 38, wherein at least a portion of the headgear assembly is constructed of an anisotropic, composite material having different extensibilities in different directions.

40. The mask assembly of claim 22, wherein: each of the pair of elongated upper straps and each of the pair of elongated lower straps include a loop material positioned along an external surface thereof and a hook material configured to releasably attach to the loop material to attach the pair of elongated upper straps and the pair of elongated lower straps to the mask, the loop material of each of the pair of elongated upper straps and each of the pair of elongated lower straps includes a connection region adapted to attach to the hook material of a corresponding strap, the connection region being wider than the hook material such that when the hook material is attached to the loop material, in use, the loop material at each connection region is configured to shield the patient's facial skin from contact with the hook material, a leading end of each of the pair of elongated upper straps is configured to pass through a corresponding one of the pair of upper headgear attachment points and be doubled-back on itself to attach the hook material to the loop material to secure the headgear assembly to the mask, the loop material of each of the pair of elongated lower straps is configured to pass through a corresponding one of the pair of lower headgear attachment points and doubled-back on itself to attach the hook material to the loop material to secure the headgear assembly to the mask, at least a portion of the headgear assembly is constructed of a composite having a first layer to be positioned against the patient's head, a second, middle layer constructed from foam, and a third layer including the loop material, the mask assembly further comprises vent holes adapted to vent exhaled air from the mask, the mask assembly further comprises an elbow connected to the mask, the elbow adapted to deliver pressurized gas to an interior of the mask, the mask is a nasal mask, the opening is arranged to receive the occiput of the patient's head, the mask further comprises a forehead support, and the pair of elongated upper straps are configured to pass from the patient's forehead region to the back of the patient's head.

41. The mask assembly of claim 40, wherein at least a portion of the headgear assembly is constructed of an anisotropic, composite material having different extensibilities in different directions.

42. The mask assembly of claim 22, wherein: stitching is added to at least a portion of the headgear assembly to stiffen the headgear assembly, the stitching is added as lines, in a crisscross pattern, or both the lines and the crisscross pattern, each of the pair of elongated upper straps and each of the pair of elongated lower straps include a loop material positioned along an external surface thereof and a hook material configured to releasably attach to the loop material to attach the pair of elongated upper straps and the pair of elongated lower straps to the mask, the loop material of each of the pair of elongated upper straps and each of the pair of elongated lower straps includes a connection region adapted to attach to the hook material of a corresponding strap, the connection region being wider than the hook material such that when the hook material is attached to the loop material, in use, the loop material at each connection region is configured to shield the patient's facial skin from contact with the hook material, a leading end of each of the pair of elongated upper straps is configured to pass through a corresponding one of the pair of upper headgear attachment points and be doubled-back on itself to attach the hook material to the loop material to secure the headgear assembly to the mask, the loop material of each of the pair of elongated lower straps is configured to pass through a corresponding one of the pair of lower headgear attachment points and doubled-back on itself to attach the hook material to the loop material to secure the headgear assembly to the mask, at least a portion of the headgear assembly is constructed of a composite having a first layer to be positioned against the patient's head, a second, middle layer constructed from foam, and a third layer including the loop material, the mask assembly further comprises vent holes adapted to vent exhaled air from the mask, the mask assembly further comprises an elbow connected to the mask, the elbow adapted to deliver pressurized gas to an interior of the mask, the mask is a full face mask, and the opening is arranged to receive the occiput of the patient's head.

43. The mask assembly of claim 42, wherein at least a portion of the headgear assembly is constructed of an anisotropic, composite material having different extensibilities in different directions.

44. The mask assembly of claim 22, wherein: stitching is added to at least a portion of the headgear assembly to stiffen the headgear assembly, the stitching is added as lines, in a crisscross pattern, or both the lines and the crisscross pattern, each of the pair of elongated upper straps and each of the pair of elongated lower straps include a loop material positioned along an external surface thereof and a hook material configured to releasably attach to the loop material to attach the pair of elongated upper straps and the pair of elongated lower straps to the mask, the loop material of each of the pair of elongated upper straps and each of the pair of elongated lower straps includes a connection region adapted to attach to the hook material of a corresponding strap, the connection region being wider than the hook material such that when the hook material is attached to the loop material, in use, the loop material at each connection region is configured to shield the patient's facial skin from contact with the hook material, a leading end of each of the pair of elongated upper straps is configured to pass through a corresponding one of the pair of upper headgear attachment points and be doubled-back on itself to attach the hook material to the loop material to secure the headgear assembly to the mask, the loop material of each of the pair of elongated lower straps is configured to pass through a corresponding one of the pair of lower headgear attachment points and doubled-back on itself to attach the hook material to the loop material to secure the headgear assembly to the mask, at least a portion of the headgear assembly is constructed of a composite having a first layer to be positioned against the patient's head, a second, middle layer constructed from foam, and a third layer including the loop material, the mask assembly further comprises vent holes adapted to vent exhaled air from the mask, the mask assembly further comprises an elbow connected to the mask, the elbow adapted to deliver pressurized gas to an interior of the mask, the mask is a nasal mask, and the opening is arranged to receive the occiput of the patient's head.

45. The mask assembly of claim 44, wherein at least a portion of the headgear assembly is constructed of an anisotropic, composite material having different extensibilities in different directions.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIG. 1 shows a front three-quarter view of a MIRAGE full-face mask and prior art headgear system in position on a patient's head.

[0026] FIG. 2 shows a rear three-quarter view of a MIRAGE full-face mask and prior art headgear system on a patient's head.

[0027] FIG. 3 shows a view of prior art full-face mask headgear laid flat.

[0028] FIG. 4 shows a view of headgear according to an embodiment of the present invention.

[0029] FIG. 5 shows a view of the quick release mechanism according to the present invention.

[0030] FIG. 6A shows a view of a mask headgear strap in accordance with the present invention laid flat.

[0031] FIG. 6B shows a view of a mask headgear strap in accordance with the present invention laid flat.

DETAILED DESCRIPTION OF THE INVENTION

[0032] The invention provides headgear (10) for securing and positioning a mask suitable for the treatment of sleep disordered breathing. [0033] (i) Material

[0034] The headgear is constructed from a composite of polyurethane foam, loop material and hook material whose shape includes a pair of upper straps (20) and lower straps (30) and a generally triangular back portion (40). A piece of hook material (22) is attached to the end of each of the four straps so that the straps may be secured to the attachment points on the mask. The end includes a main body (23) and a tapered free end portion (25).

[0035] The composite has three layers. The first layer, which in use is positioned against the head of the patient, is constructed from polyester or nylon fabric. The second, middle layer is constructed from an hypoallergenic breathable polyurethane foam. The third layer is constructed from loop material. A suitable material for constructing the composite is BREATH-O-PRENE manufactured by ACCUMED, New York, United States of America. The total thickness of the composite is approximately 2 mm. The upper and lower pairs of straps are approximately 150 mm apart when laid flat. The upper and lower straps have an approximate total length (from the left side to the right side) of 610 mm.

[0036] The generally triangular back portion (40) of the headgear (10) is constructed and arranged to engage generally with the occiput of the patient's head in use. In use, the base of the triangle is positioned at the crown of the head, while the apex of the triangle lies generally just above the point of contact between the skull and the muscles of the neck. [0037] (ii) Relatively Narrow Strap Ends

[0038] The headgear of the present invention is configured to minimize the discomfort associated with the use of hook material. In prior art headgear, that discomfort can arise where the hook material may be in contact with the patient's skin, say the cheek or neck regions, for extended periods of time. That undesirable contact will occur where the hook material, to some extent is not entirely located on the receiving loop material, but lies tangential to the loop material, and to some extent extends beyond the loop material and comes in contact with the patient's skin, either continuously while the headgear is in use or when it is compressed against the skin, as can occur when the patient head changes position during the sleep period.

[0039] As shown in FIG. 4, the width of each lower strap is constant for approximately half their length, forming a relatively wide portion (24), and then over a relatively short distance, changes to a narrower width for the remaining half of their length, forming a relatively narrow portion (26), terminating at the point where the hook material (22) is joined to the composite material. A characteristic of this configuration is that the point of contact where the hook material detachably binds with the strap loop material is positioned on the wide portion (24) and is wider by approximately 1 cm than the width of the engaging hook material. By adopting this configuration, the target region for binding is relatively greater in area than is the case with prior art. Prior art headgear includes a tapered end hook section that is of narrower width than that of the intended contact loop section of the strap. However, the prior art hook section tapered end is less than one half the length of the hook section, that is, it does not represent the majority of the length of the hook section nor does its length represent the majority of the length of the intended corresponding contact loop section (i.e., the maximum extent of the loop section covered by the hook section).

[0040] In contrast to the prior art, with the present invention the attachment of the hook material is facilitated, as relatively less precision is required in the placement of the hook section to achieve binding. This reduced dependence on precision is of advantage to all persons using the headgear and is of particular benefit to the user that may be trying to fit the headgear in a home environment and where it is not possible to directly sight the headgear components they are manipulating. Furthermore, compared to the prior art (where the hook material and the target region are of substantially the same width), this configuration reduces the chance of exposing some of the hook material to interfere with the wearer, causing discomfort and possibly skin irritation or abrasion. [0041] (iii) Displaced Lower Strap

[0042] A length of each of the left and right lower straps is displaced vertically lower by approximately 1 cm (28). By adopting this configuration, it is possible to optimize the design of the base of the back portion so as to achieve the desired security of attachment but avoid compromising comfort in a situation where the lowest point of the headgear in the occiput region is extended to a position that is lower than is otherwise required in order to achieve a sufficiently lowest strap point. This approach avoids the prior art problem of having the headgear rear portion extending beyond what would otherwise be required and thereby engaging the sensitive area below the occipital lobe. [0043] (iv) Quick Release Mechanism

[0044] Preferably the headgear of the present invention includes a quick release mechanism (50) (see FIG. 5), and this is especially so when the headgear is intended to be used with a mask that covers the patient's nose and mouth.

[0045] The quick-release mechanism (50) suitable for incorporation into the preferred embodiment is constructed from a sub-assembly of three components: (i) a release loop of a cord material (52), (ii) a generally rectangular length of hook material (54), and (iii) a generally rectangular length of a composite fabric (56) which can bind to the hook material, as discussed above. The sub-assembly is generally rectangular in shape and in use forms an extension of one of the lower straps. Preferably the loop cord is constructed from braided cord about 17 cm long. The cord loop (52) is sewn to one end of the length of hook material (54). The hook material (54) and composite fabric (56) are joined at the other end of the hook material (54), preferably via a weld joint. In use, the end of the hook material (54), to which is connected the loop cord (52), is secured, using the hook and loop mechanism, to the end of a modified lower strap which, in contrast to the lower straps (30) shown in FIG. 4, does not contain hook material. The other end (56) of the quick release mechanism (50) is free to be connected to a headgear attachment point on the mask shell and releasably attached to an exposed portion of the hook material (54). If it is desired to use the quick-release mechanism (50), it is convenient for the patient to pull down on the loop of braided cord (52), thereby disengaging the lower strap from the mask shell and allowing the mask to then be readily removed from the patient's face. A quick-release mechanism of this configuration may be used on headgear that is fabricated of materials and in configurations that are different to those of the type described above and as such is an invention in its own right. [0046] (v) Altering the Stiffness and Extensibility

[0047] In one form of the invention, the extensibility of the straps can be altered by attaching lengths of generally inextensible material (62) such as cotton or silk to the straps, as shown in FIG. 6B. The effect of this arrangement is to make the headgear less extensible along the length of the straps than in a vertical direction. In a preferred embodiment, lengths of cotton are sewn to the straps.

[0048] In another form of the invention, the stiffness of the straps can be altered by attaching stiffening material (64) to the top and bottom edge of the straps, as shown in FIG. 6A. Alternatively, or in addition, the strap may be stiffened by any other suitable means including by adding stitching as lines, in a crisscross pattern, or both. This makes the headgear less floppy and more convenient to put on the head of a wearer.

[0049] In another form of the invention, the headgear is constructed from an anisotropic material that is more extensible in a first direction than in a direction at an angle of 90 degrees to the first direction. This enables the headgear to be cut from a single piece of composite material and yet have different extensibilities in different directions. Preferably, the headgear will be more extensible in a vertical direction than in a horizontal direction. Hence the upper and lower straps will be less extensible in a direction along their length than in a direction along their width. This means that the back portion of the headgear can be more extensible in a direction from the base of the skull to the crown, than in a direction at right angles to that direction.