STRAPLESS NASAL INTERFACE DEVICE

Abstract

A nasal interface device is configured to be positioned about a user's nose. The nasal interface device includes an air supply interface including first and second attachment surfaces, a bendable metallic member including a bridge portion between first and second ends, an adhesive secured to an underside of the bendable metallic member, a first elastic member, and a second elastic member. The bridge portion compresses downward over the nasal bone of the bridge of the user's nose and the bendable metallic member compresses downward toward the first and second sides of the user's nose during use. The first and second elastic members are adjustable in position on the bendable metallic member and on the air supply interface body. The first and second elastic members are pulled taut to form a seal where the air supply interface body meets the user's nose.

Claims

1. A nasal interface device configured to be positioned about a nasal hone of a bridge, a first side, and a second side of a user's nose, comprising: an air supply interface including an air supply opening, at least one nasal opening, and first and second attachment surfaces, wherein the nasal device is selected from the group of a se mask, nostril interface tubes, and nose pillows; a bendable metallic member including a bridge portion between first and second ends, wherein the bridge portion compresses downward over the nasal bone of the bridge of the user's nose and the bendable metallic member compresses downward toward the first and second sides of the user's nose; an adhesive secured to an underside of the bendable metallic member; a first elastic member having a first proximal end and a first portion, the first proximal end including a first coupling means for directly or indirectly attaching to the first end of the bendable metallic element, and the first portion engaging with the first attachment surface on the air supply interface body; and a second elastic member having a second proximal end and a second portion, the second proximal end including a second coupling means for directly or indirectly attaching to the second end of the bendable metallic element, and the second portion engaging with the second attachment surface on the air supply interface body; wherein the proximal ends of the first and second elastic members are adjustable in position on the bendable metallic member; wherein the first and second portions of the first and second elastic members are adjustable in position on the air supply interface body; and wherein each of the first and second elastic members is pulled taut in order to form a seal where the air supply interface body meets the user's nose without needing straps extending around the user's head.

2. The nasal interface device of claim 1, wherein the first portion is a first distal end of the first elastic member, and wherein the second portion is a second distal end of the second elastic member.

3. The nasal interface device of claim 1, wherein each of the first and second elastic members has a length of between about 5 cm and about 6 cm.

4. The nasal interface device of claim 1, wherein each of the first and second elastic members comprises a rubber material.

5. The nasal interface device of claim 1, wherein each of the first and second elastic members comprises a woven elastic band.

6. The nasal interface device of claim 5, wherein each of the first and second coupling means has a length of at least about 3 cm.

7. The nasal interface device of claim 1, wherein the air supply interface connects to one of a ventilator, a continuous positive airway pressure (CPAP) machine, and a bilevel positive airway pressure (BiPAP) machine.

8. A nasal interface device configured to be positioned about a nasal hone of a bridge, a first side, and a second side of a user's nose, comprising: a nose mask including an air supply opening, wherein the nose mask is positioned about the user's nose; a bendable metallic member including a bridge portion between first and second ends, wherein the bridge portion compresses downward over the nasal bone of the bridge of the user's nose and the bendable metallic member compresses downward toward the first and second sides of the user's nose; an adhesive secured to an underside of the bendable metallic member; wherein the bendable metallic member is secured to the nose mask.

9. The nasal interface device of claim 8, wherein the nose mask includes first and second attachment surfaces, and wherein the first and second ends of the bendable metallic member engage with the first and second attachment surfaces, respectively, of the nose mask.

10. The nasal interface device of claim 9, further comprising: a first elastic member having a first proximal end and a first portion, the first proximal end including a first coupling means for directly or indirectly attaching to the first end of the bendable metallic element, and the first portion engaging with the first attachment surface on the air supply interface body; and a second elastic member having a second proximal end and a second portion, the second proximal end including a second coupling means for directly or indirectly attaching to the second end of the bendable metallic element, and the second portion engaging with the second attachment surface on the air supply interface body; wherein the proximal ends of the first and second elastic members are adjustable in position on the bendable metallic member; wherein the first and second portions of the first and second elastic members are adjustable in position on the air supply interface body; and wherein each of the first and second elastic members is pulled taut in order to form a seal where the air supply interface body meets the user's nose without needing straps extending around the user's head.

11. A method of wearing a nasal interface device about a nasal bone of a bridge, a first side, and a second side of a user's nose, comprising the steps of: providing the nasal interface device comprising: an air supply interface including an air supply opening, at least one nasal opening, and first and second attachment surfaces, e nasal device is selected from the group of a nose mask, nostril interface tubes, and nose pillows; a bendable metallic member including a bridge portion between first and second ends; an adhesive secured to the underside of the bendable metallic member; a first elastic member having a first proximal end and a first portion, the first proximal end including a first coupling means for directly or indirectly attaching to the first end of the bendable metallic element, and the first portion engaging with the first attachment surface on the air supply interface body; and a second elastic member having a second proximal end and a second portion, the second proximal end including a second coupling means for directly or indirectly attaching to the second end of the bendable metallic element, and the second portion engaging with the second attachment surface on the air supply interface body; wherein the proximal ends of the first and second elastic members are adjustable in position on the bendable metallic member; and wherein the first and second portions of the first and second elastic members are adjustable in position on the air interface body; compressing the bridge portion of the bendable metallic element downward over the nasal bone of the bridge and toward the first and second sides of the user's nose; positioning the air supply interface body about the user's nose, wherein the first and second attachment surfaces of the air supply interface body are adjacent to the first and second sides, respectively, of the user's nose; adjusting the positioning of the proximal ends of the first and second elastic members on the bendable metallic member; adjusting the first and second portions of the first and second elastic members on the air interface body; pulling the first and second elastic members taut in order to form a seal where the air supply interface body meets the user's nose; and securing each of the first and second coupling means to maintain the seal without needing straps extending around the user's head.

12. The method of claim 11, wherein the first portion is a first distal end of the first elastic member, and wherein the second portion is a second distal end of the second elastic member.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0034] FIG. 1 shows an embodiment of the nasal interface device of the present application.

[0035] FIG. 2 shows another embodiment of the nasal interface device of the present application, having optional side and front straps for mounting the device.

[0036] FIG. 3 shows an embodiment of FIG. 2 as mounted on a user's nose.

[0037] FIG. 4 shows an embodiment of the nasal interface element used in the embodiments of the nasal interface devices of FIGS. 1 and 2.

[0038] FIG. 5 shows another embodiment of the nasal interface device of the present application.

[0039] FIG. 6 shows an exploded view of the embodiment of FIG. 5.

[0040] FIG. 7 shows a perspective view of a further embodiment of the nasal interface device of the present application.

[0041] FIG. 8 shows another embodiment of the nasal interface device of the present application.

[0042] FIG. 9 is a perspective view of a further embodiment of the nasal interface device of the present application.

[0043] FIG. 10 is a front elevational view of the nasal interface device of FIG. 9.

[0044] FIG. 11 is a rear elevational view of the nasal interface device of FIG. 9.

[0045] FIG. 11A is a cross-sectional view generally taken along lines 11A-11A shown in FIG. 11.

[0046] FIG. 12 is a front elevational view of a bendable element used in the nasal interface device of FIG. 9.

[0047] FIG. 13A is a perspective view of an alternative air supply interface for use with any of the illustrated embodiments.

[0048] FIG. 13B is a front elevational view of the alternative air supply interface of FIG. 13A.

[0049] FIG. 14A is a further embodiment of the nasal interface device of the present application including a nose mask.

[0050] FIGS. 14B and 14C are further embodiments of the nasal interface device of the present application including a nose and mouth mask.

[0051] FIG. 15 is a further embodiment of the nasal interface device of the present application adapted for use with a cannula.

[0052] FIG. 16 is a further embodiment of the nasal interface device of the present application for use with a feeding tube.

[0053] FIG. 17 is a further embodiment of the nasal interface device of the present application adapted for use with a cannula.

[0054] FIG. 18 is a perspective view of another embodiment of the nasal interface device of the present application.

[0055] FIG. 19 is a front elevational view of the nasal interface device of FIG. 18.

[0056] FIG. 20 is a rear elevational view of the nasal interface device of FIG. 18

[0057] FIG. 21 is a perspective view of a further embodiment of the nasal interface device of the present application.

[0058] FIG. 22 is a front elevational view of the nasal interface device of FIG. 21.

[0059] FIG. 23 is a perspective view of a further embodiment of the nasal interface device of the present application.

[0060] FIG. 24 is a front elevational view of the nasal interface device of FIG. 23.

[0061] FIG. 25 is a perspective view of a further embodiment of the nasal interface device of the present application.

[0062] FIG. 26 is a front elevational view of the nasal interface device of FIG. 25.

DETAILED DESCRIPTION OF THE DISCLOSURE

[0063] While this invention is susceptible of embodiments in many different forms, there are shown in the drawings and will herein be described in detail, preferred embodiments of the invention with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the broad aspect of the invention to the embodiments illustrated.

[0064] The present invention is a strapless nasal interface device 10 suitable for use with a CPAP or BIPAP device, or any other ventilator type device. The device 10 includes an interface body 20 having an interior cavity. The cavity is fluidly connected to an air tube 40 extending from the body 20 for use with a CPAP or other device. The body 20 ideally includes exhalation holes 30 to enable expelled air to escape the device 10.

[0065] The device 10 further includes at least one nostril interface tube 50 extending from the body 20 to interface with the nasal passages of a user or a person. Preferably, two such tubes 50 are included. Surrounding the tubes are compressible expandable nasal interface elements 60. These elements 60 are formed such that they can be compressed to fit within the nostril of the user, after which they expand to make contact with the interior of the nostril at the inner edge of the nostril to hold the interface tube 50 in place within the nostril. Thus, the need for straps or headgear in conjunction with the device is eliminated.

[0066] In various embodiments of the present invention, the interface elements 60 are permanently mounted to the interface tubes 50. However, in various other embodiments, the interface elements 60 are removably mounted to the tubes 50. If removably mounted, the interface elements 60 may be mounted to the tubes 50 by any suitable means. For example, they may be threaded, frictionally fit, or adhered with an adhesive 62.

[0067] Interface elements 60 can be formed of any suitable material. In certain embodiments, they are formed of an expandable, compressible foam. Preferably, the elements 60 have an anti-bacterial agent. Optionally, elements 60 may include a mild adhesive 64 on the outer surface to make contact with the skin on the interior of the nostril. Ideally, elements 60 form a seal within the nostril. Ideally, they are shaped to optimize such a seal. For example, they may be formed to conform to the interior shape of the nostril so as to form a proper fit.

[0068] In various embodiments of the present invention, a skirt 70 is also included. The skirt 70 is disposed on the nostril interface tube 50 between the interface element 60 and the interface body 20. The skirt interfaces with the end of the nostril opening to help aid in sealing the air passage. Optionally, a mild adhesive can be disposed on the surface 75 of the skirt 70 adjacent the rim of the nostril opening to further seal the passageway.

[0069] In various further embodiments, the device 10 includes one or more flaps in order to further secure it on the user. For example, in certain embodiments, side flaps 80 extend from the body 20. The side flaps 80 have an adhesive thereon to adhere the flaps to the exterior of the nose, further securing it. Side flaps 80 may be mounted to the interface body 20 by any suitable method, such as via a groove in the interface body 20 allowing an end of flap to be inserted. Such a fit may be a friction fit, or it may be a dovetail groove. However, any other suitable method of attachment is contemplated as within the scope of the invention.

[0070] Additionally, an optional front flap 90 may extend from the interface body 20. The front flap 90 covers an exterior portion of the nose. It can be mounted to the nose via any suitable method. For example, a separate strip of tape or adhesive may be used. In certain embodiments, it may be mounted via an adhesive on the underside of the front flap 90. Thus, the device 10 is further secured to the nose of the user. Front flap 90 may be mounted to the interface body 20 by any suitable method, such as via a groove in the interface body 20 allowing an end of flap 90 to be inserted. Such a fit may be a friction fit, or it may be a dovetail groove. However, any other suitable method of attachment is contemplated as within the scope of the invention.

[0071] In various embodiments, the front flap 90 of the device 10 further includes tension bows or strips 95. These strips 95 are formed of a resilient material. Thus, the strips 95 may be deformed when adhered to the exterior of the nose via an adhesive on the underside of the front flap 90, after which they apply pressure tending to expand the nasal passageway. Thus, the passageways are expanded, relieving a tendency of snoring and potentially reducing the air pressure required for the user's purposes. While a single such strip 95 can be used, in certain embodiments multiple strips 95 are used to open the passageway along an entire portion of the passageway. The front flap 90 can be used without side flaps 80, or in conjunction therewith.

[0072] In various other embodiments, the present invention includes a strapless nasal interface device 100 having an interface body 105 having an internal cavity 110. The cavity 110 is in communication with an air tube 115 which extends from the body 105. The air tube 115 is preferably rotatably attached to the interface body 105 at a first point of attachment 120. Ideally, this point of attachment 120 allows the air tube 115 to rotate 360 degrees, yet maintains a substantially leak-proof connection regardless of how the air tube 115 is oriented with respect to the interface body 105. A sealing o-ring may be incorporated to facilitate the rotatable mounting. This first point of attachment 120 may be located at any suitable position on interface body 105, however, in a preferred embodiment it is located on a front wall which is adjacent the wall on which nostril interface tubes 135 are located such that the air tube 115 extends out perpendicular to the plane of the face and away from the face, thus keeping air tube 115 and air supply tube 125 from rubbing against the face of the user.

[0073] Preferably, the device 100 comprises at least one exhalation hole, and preferably a plurality of exhalation ports or holes 122 which are sized to allow exhaled air to pass therethrough, but which are sized so that they do not substantially depressurize the cavity 110 of the interface body 105. Exhalation holes 122 can be placed in any suitable location on the interface body 105. For example, they may be placed on the side opposite of where nostril interface tubes 135 are located, or on the top side of the interface body 105 near the first point of attachment 120, or in both locations, or in any other suitable location. In certain embodiments, 35 to 40 exhalation holes sized at about 0.023 inches each may be suitable to enable carbon dioxide rich exhalation air to leave the cavity 110, yet such holes 122 are small enough such that air pressure intended to pressurize the nasal passage is maintained. In another embodiment, hole sizes may be approximately 0.02 inches in diameter, and about 78 of them may be suitable. However, any size, number, and configuration of exhalation holes 122 which function as described is suitable and contemplated within the scope of the present invention.

[0074] In various embodiments, the air tube 115 is also attached to an air supply tube 125. Preferably, this is a removable attachment. Optionally, the connection at a second attachment point 130 between the air tube 115 and the air supply tube 125 also allows rotation while maintaining a leak-proof connection. Ideally, 360 degrees of rotation is enabled. In certain embodiments, the air tube 115 is bent somewhere along its length, such that the planes of rotation at the two attachment points 120 and 130 are different planes of rotation. For example, if the air tube is bent by about 90 degrees, the planes of rotation will be substantially orthogonal with respect to one another. In some embodiments, one plane of rotation will be parallel to the face of the user, and the other will be perpendicular to the user. This allows for a great degree of freedom of movement of the user without compromising the integrity of the seal formed between the device and the user's nostrils.

[0075] In various embodiments, the device includes at least one nostril interface tube 135 having an internal passage extending from the interface body 105 to the nostrils of a user. Preferably, there are two such tubes or nostril interface elements 135 extending to the nostrils of a user. In certain embodiments, the nostril interface elements 135 include an upper cushion 140, which is a radial protrusion, preferably formed of compressible material such that the upper surface of the cushion can be compressed against the outer edge of the nostril to help form a seal with the nostril of the user. Ideally, nostril interface tubes 135 are each formed as a single integral piece which can be attached and removed from the interface body 105.

[0076] Preferably, the nostril interface elements 135 also include a lower radial element 145 which is a radial protrusion adapted to be urged toward the upper cushion 140 and to compress the upper cushion 140 to aid in forming a seal between the upper cushion 140 and a user's nostril when the device 100 is worn by a user. In certain embodiments, the lower radial element 145 includes an internal substantially rigid rim 152 adapted to aid in compressing the upper cushion 140 when the device 100 is worn by a user.

[0077] Ideally, the nostril interface elements 135 have substantially non-porous surfaces. For example, they may be formed entirely of a non-porous material such as silicone or any other suitable material. Alternatively, at least the exposed surfaces of the nostril interface elements 135 are coated with a non-porous material such as silicone, or any other suitable material. In certain embodiments, the nostril interface elements 135 are removably attached to the interface body 105, such as via a snap fit, frictional fit, threading, or any other suitable method. Thus, they can be removed for cleaning or replacement.

[0078] The device 100 includes a facial patch 150. The facial patch can be adhered to the face of a user. Preferably, the facial patch 150 is a nose cover 150 which adheres to the nose of a user. The nose cover 150 preferably includes an adhesive on its bottom surface to removably adhere to the skin of the user's nose. The adhesive is ideally suitable for use on skin and removable. This nose cover 150 is ideally disposable and replaceable.

[0079] The nose cover 150 is ideally formed of a flexible material. Optionally, a bendable element 155 is included as part of the nose cover 150 which may be embedded within it or on one of its surfaces. The bendable element 155 is formed of a material which can be bent to fit the contour of the nose and hold its shape so as to help the nose cover 150 adhere to the nose. The bendable element may be formed of any suitable material, such as a metal as aluminum, or any other material with suitable properties.

[0080] In the embodiment illustrated in FIGS. 5 and 6, one or two attachment flaps 160 are connected to the nasal interface body 105 to hold the device 100 in place properly. They secure to the surface of the nose cover 150. Any suitable manner of removable attachment is contemplated. For example, hook and loop attachment in which one element of the hook and loop material 165 is attached to the flaps 160, and the other element of the hook and loop material 170 is attached to the surface of the nose cover 150. However, an adhesive or other manner of attachment can be used. Ideally, the flaps 160 extend around the sides of the interface body 105 and hold the device 100 snug against the nostrils. In this way, no straps around the head of the user are required.

[0081] In an alternate embodiment, the nostril interface elements 135 may include a magnet or iron or nickel bearing material, and they may be secured to the nose via magnets on the external surface of the nose. In a further alternate embodiment, as shown in FIG. 8, the nose cover 150 may be eliminated and one or more flaps 160 may be adhered directly to the outer surface of the nose of the user.

[0082] FIGS. 9-12 illustrate a further embodiment of a strapless nasal interface device 300 suitable for use with a CPAP or BIPAP device, or with any other ventilator type device. The device 300 includes an air supply interface 302 defining an interior cavity or chamber 304, an intermediate air tube 306, and an air supply tube 310 extending therefrom.

[0083] The device 300 includes one or two nostril interface tubes 312 extending from a body 313 of the air supply interface 302 to engage with the nasal passages of the user as described with respect to previous embodiments. Referring to FIG. 10, compressible expandable nasal interface elements 314 surround the tubes 312 and are formed such that they can be compressed to fit within the nostril of the user, after which they expand to make contact with the interior of the nostril at the inner edge of the nostril to hold the interface tube 312 in place within the nostril. Each of the interface tubes 312 may also include a skirt (see FIG. 1) to aid in sealing the air passage.

[0084] Seen best in FIGS. 10 and 11, a bendable element 316 is secured to the air supply interface 302 and is sufficiently flexible so that its shape corresponds to contours of the user's face as seen in FIG. 9. First and second ends 318, 320 of the bendable element 316 engage with first and second slots 322, 324 on the interface body 313 to hold the air supply interface 302 in position relative to the user's nose as the bendable element 316 is secured to the user's face.

[0085] The bendable element 316 illustrated in FIG. 12 is a metallic strip including bends that correspond to contours of the user's nose and face. The plasticity of the material of the bendable element 316 is deformable so that it bends to match contours of the user's nose while maintaining its shape so as to secure the positioning of the air supply interface 302 relative to the user's nose. The material of the bendable element 316 may be aluminum or other suitable material.

[0086] A first bend 326 of the bendable element 316 corresponds to the bridge area of a user's nose. Second and third bends 328, 330 define first and second side portions 336, 338, respectively, of the bendable element 316 that are seated against the sides of the user's nose. Fourth and fifth bends 332, 334 adjacent to first and second ends 318, 320 of the bendable element 316 engage the body 313 of the air supply interface 302. While the illustrated embodiment includes five bends, the bendable element 316 may be free from bends yet be shaped to conform to the user's face, or may include any number of bends necessary to conform to the user's face and/or to engage the air supply interface 302.

[0087] In the embodiment illustrated in FIG. 9, the first and second ends 318, 320 of the bendable element 316 are threaded through the first and second slots 322, 324 on the interface body 313 and moveable so that the position of the bendable element 316 can be adjusted for varying sizes and heights of users' noses. As shown in FIG. 12, the first and second ends 318, 320 may include protrusions that are received by openings in the first and second side portions 336, 338, although other suitable fasteners such as, but not limited to, buttons and/or clasps for securing the first and second ends 318, 320 to first and second side portions 336, 338 of the bendable element 316 may be used. During use, the user can adjust the height of the bendable element 316 so that it is positioned comfortably and appropriately on the user's nose while the air supply interface 302 is positioned at the user's nostrils.

[0088] Referring to an alternative embodiment illustrated in FIGS. 18-20, a strapless nasal interface device 700 secures a bendable element 702 to the bridge area 703 of the user's nose using first and second elastic members 704, 706. First ends of the first and second elastic members 704, 706 are secured to first and second ends 708, 710, respectively, of the bendable element 702. In the illustrated embodiment, the first and second elastic members 704, 706 are threaded through first and second slots 712, 714, respectively, within the interface body 716. In other embodiments, the first and second elastic members 704, 706 may be attached to the sides of interface body 716 by any suitable means, such as, for example, through a slotted surface on the interface body 716 or any other attachment means as described with respect to other embodiments of the present application.

[0089] In a preferred embodiment, each elastic member 704, 706 is a rubber or other suitable material having a minimum Young's modulus of 0.01 to 0.1 GPa. In some embodiments, each elastic member 704, 706 may have a length of about 3 cm to about 4 cm and a width of about 1 cm to 1.5 cm.

[0090] At second ends of the first and second elastic members 704, 706, first and second adhesive members 718, 720 adhere to first and second sides 722, 724 of the user's nose. Each adhesive member 718, 720 may comprise an elastic surgical tape material. One example material is a foam adhesive tape that conforms easily to facial features such as 3M Microfoam (St. Paul, Minn.). In some embodiments, each adhesive member 718, 720 may have a length of about 3 cm to about 6 cm and a width of about 1 cm to 1.5 cm.

[0091] During use, the user first inserts the interface body 716 and/or nose pillows adjacent to the nose or nostrils. The user then adjusts the positioning of each elastic member 704, 706 within the respective slot 712, 714 so that each adhesive member 718, 720 is positioned on the side 722, 724 of the nose and is taut between first and second ends 708, 710, respectively, of the bendable element 702 and the adhesive members 718, 720. In the embodiment illustrated in FIG. 18, the first and second adhesive members 718, 720 cross the user's nose and are secured to the opposite sides 724 and 722, respectively. In other embodiments, the first and second adhesive members 718, 720 are secured to the adjacent sides 722 and 724. Due to the stretching of the elastic members 704, 706 and the adhesive members 718, 720, the interface body 716 fits snug against the user's nose without the need for straps extending around the head or extending along the cheeks of the user. The lack of straps and additional attachment means provides a more comfortable sleep for the user due to the elimination of the straps as well as the minimization of the unit altogether. Further, the combination of the elastic members 704, 706 in conjunction with the metallic bendable element 702 secure the seal of the interface body 716 at the user's nose and maintains the interface body 716 in close proximity to the nostrils. Simultaneously, the elastic members 704, 706 and the bendable element 702 allow the user to conform and adjust the device about the user's face and as necessary to maintain the seal.

[0092] FIGS. 21 and 22 illustrate a strapless nasal interface device 800 including a bendable element 802 secured to the interface body 803 via first and second elastic members 804, 806. In this embodiment, first and second elastic members 804, 806 are positioned such that first ends 808, 810 are adjacent to first and second slotted surfaces 812, 814, respectively, of the interface body 803. In other embodiments, the first and second elastic members 804, 806 may extend through first and second slot within the interface body 803, or the first and second elastic members 804, 806 may attach to the interface body 803 through any other suitable attachment means, particularly as described with respect to other embodiments of the present application.

[0093] Second ends 816, 818 of the first and second elastic members 804, 806 are threaded through first and second rings 820, 822, respectively, that are secured to the first and second ends 824, 826, respectively, of the bendable element 802. The first and second ends 824, 826 of the bendable element 802 may be bent in a folding fashion to provide a hooking surface to receive the first and second rings 820, 822, respectively. Other connection means may also be used.

[0094] In one embodiment, each of the first and second elastic members 804, 806 include a first hook and loop fastener surface 828, 830 on at least one side of each first and second elastic members 804, 806 adjacent to the interface body 803 and a second hook and loop fastener surface 832, 834 on second ends 816, 818 of the first and second elastic members 804, 806. During use, the first and second elastic members 804, 806 are taut between the first and second slots 812, 814 of the interface body 803 and the second hook and loop fastener surface 832, 834 of the first and second elastic members 804, 806.

[0095] Similar to the device described above, the combination of the elastic members 804, 806 in conjunction with the metallic bendable element 802 secure the seal of the interface body 803 at the user's nose and maintains the interface body 803 in close proximity to the nostrils. Simultaneously, the elastic members 804, 806 and the bendable element 802 allow the user to conform and adjust the device 800 about the user's face and as necessary to maintain the seal. In some embodiments, the strapless nasal interface device 800 delivers pressures between about 4 and about 20 cmH.sub.2O.

[0096] In a still further embodiment illustrated in FIGS. 23 and 24, a strapless nasal interface device 900 is secured to the user's nose by first and second elastic members 902, 904 and corresponding adhesive members 906, 908. More specifically, the first and second elastic members 902, 904 extend through first and second slots 914, 916, respectively, of the interface body 918, although any suitable attachment means may be used. In the illustrated embodiment, the first and second slots 914, 916 are sufficiently narrow so as to secure first ends 910, 912 of the first and second elastic members 902, 904 in place.

[0097] First and second adhesive members 906, 908 are attached to second ends 920, 922 of the first and second elastic members 902, 904, respectively. Referring to FIG. 24, each elastic member 902, 904 is secured to the respective adhesive member 906, 908 by a ring 924, 926 or other suitable securing mechanism. The adhesive member 906, 908 may comprise an elastic surgical tape material. One example material is a foam adhesive tape that conforms easily to facial features such as 3M Microfoam (St. Paul, Minn.).

[0098] During use, the user first inserts the interface body 918 and/or nose pillows adjacent to the nose or nostrils. The user then adjusts the positioning of each elastic member 902, 904 within the slot 914, 916 to position each adhesive member 906, 908 on the side of the nose so that each elastic member 902, 904 is taut between the slot 914, 916 and the adhesive member 906, 908. In the embodiment illustrated in FIG. 23, the user adheres the first adhesive member 906 to the bridge area of the user's nose, and then adheres the second adhesive member 908 to the bridge area of the user's nose overlapping with the first adhesive member 906. In other embodiments, the interface device 900 may be used to position a cannula that is connected to an oxygen tank so that the nasal prongs of the cannula are at the user's nostrils. In a further embodiment, the nasal interface device may be used to maintain the positioning of a feeding tube at the user's nostrils. Any of the nasal devices described herein may be in fluid communication with a ventilator, a continuous positive airway pressure (CPAP) machine, and a bilevel positive airway pressure (BiPAP) machine.

[0099] Similar to the embodiments mentioned above, the stretching of the elastic members 902, 904 and the adhesive members 906, 908 allows the interface body 918 to fit snugly against the user's nose without the need for straps extending around the head or extending along the cheeks of the user. The lack of straps and additional attachment means provides a more comfortable sleep for the user due to the elimination of the straps as well as the minimization of the unit altogether.

[0100] A mild adhesive may be applied to the underside of the bendable element 316 to hold it in place against the user's face. Such adhesive must be mild enough that the element can be easily removed by the user without causing significant discomfort or irritation or abrasion. The adhesive may also be a soft foam or non-foam (such as a silicone) adhesive. Further, the adhesive may include a slit so that it can slide onto the bendable element 316.

[0101] In a still further embodiment illustrated in FIGS. 25 and 26, a strapless nasal interface device 1000 is secured to the user's nose by first and second elastic members 1002, 1004. The first and second elastic members 1002, 1004 extend between an air supply interface 1016 at the user's nostrils and a metallic bendable element 1003 across the bridge of the user's nose. In this embodiment, the elastic members 1002, 1004 are adjustable with respect to both the air supply interface 1016 and the metallic bendable element 1003. Each elastic member 1002, 1004 includes a series of openings 1020 along the length thereof. The air supply interface 1016 includes side tabs 1022, 1024 having protrusions or buttons 1026, 1028 thereon, which engage with an opening 1020 at a lower end 1002a, 1004a in the respective elastic member 1002, 1004. The metallic bendable element 1003 also includes opposing attachment surfaces 1030, 1032 that each engage with an opening 1020 at an upper ends 1002b, 1004b of the respective elastic member 1002, 1004. The attachment surfaces 1030, 1032 include a rigid structure that curves upward, although any suitable structure such as a button, protrusion, or other securement means may be used. Through the use of the openings 1020, the elastic member 1002, 1004 is adjustable at both of its lower and upper ends 1002a,b, 1004a, b, providing greater flexibility to the patient when attempting to secure the device 1000 in place.

[0102] In some embodiments, the elastic member 1002, 1004 engages with the side tabs 1022, 1024 of the air supply interface 1016 through any suitable coupling means which allows for adjustability. Similarly, the elastic member 1002, 1004 engages with the side structures 1030, 1032 of the metallic bendable element 1003 through any suitable coupling means which allows for adjustability.

[0103] The embodiment illustrated in FIGS. 25 and 26 also features a torsion shaped air supply interface 1016, although the elastic member structure 1002, 1004 described herein may be used with any nasal mask, nostril interface, donut-shaped nasal aperture with soft, stretchable margins or other suitable structure, including but not limited to other embodiments shown herein. In some embodiments, the margins surrounding the nose mask, the donut-shaped nasal aperture, or similar device may include an adhesive, such as (but not limited to) a mild, washable, reusable adhesive, to improve the seal between the air interface body and the face.

[0104] In the embodiment illustrated in FIGS. 9-12, the adhesive 346 is positioned along the underside of the bendable element 316 to adhere to the user's skin, primarily along the first bend 326 of the bendable element 316. Second and third adhesives 348, 350 may optionally be positioned along the bendable element 316 between the second and third bends 328, 330 and the fourth and fifth bends 332, 334, respectively. In the illustrated embodiment, an inner surface 316a of the bendable element 316 includes first and second grooves 316b, 316c that receive the adhesive 346 as shown in FIG. 11A. Each groove 316b, 316c is formed by first and second ledges 316d, 316e extending from first and second outer edges 316f, 316g of the bendable element 316. The adhesive 346 includes an outer adhesive surface 346a spaced apart from an inner non-adhesive surface 346b by a body 346c. The inner surface 346b is positioned within the first and second grooves 316b, 316c, and the outer surface 346a is positioned outwardly of the grooves 316b, 316c. The sizes, shapes, and dimensions of the grooves 316b, 316c of the bendable element 316 and surfaces 346a, 346c and body 346b of the adhesive 346 may vary from those shown in the illustrated embodiment of FIG. 11A as desired or necessary. The grooves 316b, 316c may be formed along the length of the bendable element 316 or at discrete portions of the bendable element 316.

[0105] In an alternative embodiment, a single adhesive may be applied that extends between the first and second side portions 336, 338, optionally including the second and third bends, 328, 330, across the first bend 326. The adhesives 346, 348, 350 may be reused a number of times (rewetting with water as necessary), and easily replaced as necessary. Another suitable adhesive is a polyolefin foam tape for dermatological use, such as 3M CoTran 9773 Tape. In other embodiments, any number of adhesives may be used as necessary to sufficiently secure the bendable element 316 to the user's face. In an alternative embodiment, first and second edges of the adhesive 346 may be pre-coiled so that they can be easily received by the first and second grooves 316b, 316c of the bendable element 316. The adhesive stability improves as the bendable element 316 is bent because such bending improves the retention of the adhesive 346 within the grooves 316b, 316c. In another embodiment shown in FIG. 13B, the adhesive 346d has a tubular shape that is threaded onto the bendable element 316. The outer surface of the adhesive 346d may be completely adhesive or may include adhesive and non-adhesive portions. For example, the tubular adhesive 346d may include an inner adhesive portion along the inner surface of the bendable element and an outer non-adhesive portion along the outer surface of the bendable element.

[0106] In a further embodiment illustrated in FIGS. 13A and 13B, the air supply interface 302 includes an adjusting device 340 to modify the height and position of the bendable element 316 relative to the air supply interface. The adjusting device includes a bendable element base 342 that is received by an adjustment dial 344. The adjustment dial is threaded onto a tubing connector 346. The first and second ends 318, 320 of the bendable element 316 are secured to or integral with the bendable element base 342 so that rotation of the adjustment dial 344 along the tubing connector 346 causes the first and second ends 318, 320 to move vertically, thereby causing the bendable element 316 to adjust for varying sizes and heights of users' noses.

[0107] FIGS. 14A-14C illustrate further embodiments of the strapless nasal interface device 400 that is similar to the strapless nasal interface device 300 except for the features described as follows. The primary difference is the use of a nose mask 402 in lieu of the nostril interface tubes 312. As shown in FIGS. 14A-14C, the nose mask 402 is connected to an air supply interface 404. In FIG. 14A, the nose mask 402 covers the nose of the user. In FIGS. 14B and 14C, each of the nose masks 402a and 402b covers the mouth in addition to the nose. In FIGS. 14A and 14B, the bendable element 406, 406b is positioned outside of the nose mask 402, 402a, while in FIG. 14C, the bendable element 406c is positioned along the underside of the nose mask 402 at an outer edge 408. Each of the nose masks 402, 402a of FIGS. 14A and 14B include a handle 408, 408a through which an end of the bendable element 406, 406a is threaded and wrapped around in order to secure the positioning of the bendable element 406, 406a relative to the nose mask 402, 402a. The bendable element 406b shown in FIG. 14B extends along the bottom of the nose mask 402a and is threaded through a second handle 410a to secure positioning as well. Other manners of securing the bendable element to the nose mask are envisioned.

[0108] The nose mask 402 is shaped in such a manner to form a seal or snug fit with the face of the user. The nose mask 402 may have curved edges around the opening at the nasal air interface to improve the seal around the nose. The edges may be made of medical grade silicone. In some embodiments, the outer margins of the nose mask may include an adhesive to promote the sealing of the nose mask onto the user's face. Air flows from a body 410 of the air supply interface 404 into the nose mask 402 and is inhaled by the user. Similar to the bendable element 316 of the nasal interface device 300, the bendable element 406 is a metallic strip that corresponds to contours of the user's nose and face. The plasticity of the material of the bendable element 406 is deformable so that it bends to match contours of the user's nose while maintaining its shape so as to secure the positioning of the air supply interface 404 relative to the user's nose. The height of the bendable element 406 may be adjusted for various sizes and shapes of users' noses. The strapless nasal interface device 400 may be modified to include first and second elastic members as described with respect to FIGS. 18-26.

[0109] Referring to FIG. 15, a further embodiment of the strapless nasal interface device 500 includes a bendable element 502 that engages with an air supply interface 504. In this embodiment, the air supply interface 504 is a cannula 506 including a pair of nasal prongs 508 and first and second lanyards 510, 512 extending from either side of the nasal prongs 508.

[0110] Similar to the bendable elements 316, 406 of the nasal interface devices 300, 400, respectively, of FIGS. 9 and 14, respectively, the bendable element 502 is a metallic strip that corresponds to contours of the user's nose and face. The plasticity of the material of the bendable element 502 is deformable so that it bends to match contours of the user's nose while maintaining its shape so as to secure the positioning of the cannula relative to the user's nose.

[0111] The bendable element 502 includes first and second ends 514, 516 and first and second bends 518, 520 adjacent the bridge area of the user's nose during use. The curvature of the bendable element 502 near the first and second ends 514, 516 provides first and second platforms or shelves 522, 524, respectively, that engage the first and second lanyards 510, 512 of the cannula 506. In other embodiments, the bendable element 502 may be free of bends or may include any number of bends as desired to facilitate corresponding to contours of the user's nose.

[0112] Referring to FIG. 15, the first and second lanyards 510, 512 are positioned on the first and second platforms 522, 524 of the bendable element 502 to assist in positioning the nasal prongs 508 of the cannula 506 adjacent to or within the user's nostrils. As shown in FIG. 16, the nasal interface device 500 may be used to maintain the position of a feeding tube 534 relative to the user's nostrils. Specifically, the first and second platforms 522, 524 of the bendable element 502 support and maintain the position of the feeding tube 534 adjacent to or within the user's nostrils.

[0113] In the embodiment illustrated in FIG. 15, protrusions 526 extending from the first and second ends 514, 516 engage with openings 528 along first and second side portions 530, 532 of the bendable element 502 so that the user can adjust the sizing and shape of the platforms 522, 524. The device 500 may include other suitable fasteners such as, but not limited to, buttons and/or clasps for securing the first and second ends to first and second side portions of the bendable element.

[0114] FIG. 17 illustrates an embodiment of the strapless nasal interface device 600 that is similar to the device 500 of FIG. 15 in that it includes a bendable element 602 that engages with an air supply interface 604 comprising a cannula 606. The bendable element 602 is shaped to form first and second platforms 608, 610 adjacent first and second ends 612, 614, respectively, for supporting first and second lanyards 616, 618 of the cannula 606. In the illustrated embodiment, the first and second ends 612, 614 remain free from first and second side portions 620, 622 of the bendable element 602.

[0115] The strapless nasal interface device 600 may be secured to a pair of glasses 624 that has first and second pad arms 626, 628 that carry first and second nose pads (not shown), respectively, adjacent first and second frames 634, 636, respectively. Specifically, the bendable element 602 includes a bridge portion 638 between the first and second side portions 620, 622. First and second ends 640, 642 of the bridge portion 638 may be held between the first and second pad arms 626, 628, respectively, and the first and second frames 634, 636, respectively.

[0116] While the above describes example embodiments of the present disclosure, these descriptions should not be viewed in a limiting sense. Rather, several variations and modifications can be made without departing from the scope of the present disclosure.