Patent Publication Number: US-2013233315-A1

Title: Strapless nasal interface device

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of and claims priority to U.S. patent application Ser. No. 12/641,094, filed on Dec. 17, 2009, which claims the benefit of U.S. Provisional Application No. 61/138,472, filed Dec. 17, 2008. The subject matter of these applications are incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to a strapless nasal interface device, and more particularly, to a device for use with a ventilator, CPAP, or BIPAP for strapless interface with the nasal passages. 
     BACKGROUND 
     Nasal passage interface devices are commonly used in conjunction with CPAP devices, BIPAP, ventilators, and other devices. For example, in CPAP applications, a nasal passage interface device is used to provide a passageway for air to enter the nasal passages of the user. Such devices must be secured to the nasal passages so that it remains in place during sleep. 
     Various existing interfaces are typically held in place by straps or headgear. Such straps can become uncomfortable to the user, and can 5 deter use of the device. Thus, existing devices are deficient in that they fail to provide an ideal method of attachment. 
     Numerous such interfaces have been disclosed. For example, U.S. Pat. No. 6,405,729, issued to Thornton, discloses an oral appliance for improving breathing. The appliance includes a mouthpiece and two nasal cushions which sit on the outside of the nose. The device requires the use of the mouthpiece to hold it in place, which would be uncomfortable for a user not in need of the mouthpiece. Without the mouthpiece, the nasal interface would not hold the unit in place. 
     U.S. Pat. No. 6,478,026, issued to Wood, discloses a nasal ventilation interface. The unit includes tubes which insert into the nose of the user. However, the inserts do not hold the unit in place. The devices require that the air tubes be looped over the ears of the user to hold the unit in place, which would be uncomfortable and easily dislodged during sleep. 
     Another device is disclosed in U.S. Pat. No. 6,581,594, issued to Drew et al. In this patent, a cumbersome respiratory mask is disclosed which covers the nose of the user. A forehead piece extends from the unit and is attachable to straps to hold the unit in place. The device is rather obtrusive and would have both straps to hold the device in place and a mask, both of which would be uncomfortable for a user. 
     Yet another device is disclosed in U.S. Pat. No. 7,000,613, issued to Wood et al. In this patent, an interface device also has tubes which extend into the nasal passage. Again, straps in the form of head straps are used to secure the device, which can cause discomfort to a user. 
     In U.S. Published Patent Application No. 2004/0182397, filed by Wood, a ventilation interface is disclosed having tubes extending into the nares of 5 the nose. In this disclosure, seal portions inserted into the nostrils are disclosed. However, these seal portions are not capable of securing the device to the user, and thus, further securing methods such as straps are needed, again causing potential discomfort to the user. 
     Another typical interface device is disclosed in U.S. Published Patent Application No. 2007/0272249, filed by Chandran et al. In this device, pillows are included which wedge into the nares of the nose. However, again, these pillows do not secure the device, and straps of various sorts would be required to hold it in place. 
     While a number of other interface devices have been used or disclosed, none of them enable securing via nasal inserts to eliminate the use of straps or air tube contraptions to secure the device to the user&#39;s nose. Furthermore, they each pose a level of potential discomfort to the user which render them problematic for sleeping. 
     Thus, there continues to be a need for a particular suitable nasal passage interface device which can be secured without the need for straps or air tube arrangements, and which provides a greater comfort level to the user. 
     SUMMARY 
     The present invention is a strapless nasal interface device for use with a CPAP or BIPAP device, or any other ventilator type device. The nasal interface device of the present invention enables the user to secure the device in place without the need for straps or headgear, which can be uncomfortable for the user. Typical PAP devices are secured to the user via straps which wrap around the head of the user. These straps can be very uncomfortable, and can even deter use of the device altogether. Straps can be particularly uncomfortable when the head is tilted in various directions during sleep. This problem may also be particularly present in patients having claustrophobia issues when headgear or straps can be perceived as enclosing on a patient. Additionally, eliminating straps or headgear can make the maintenance and cleaning of the device easier. Providing a lightweight device which can be secured without straps or headgear is thus most advantageous. 
     The nasal interface device of the present invention includes an interface body which is preferably light weight and low profile. A ventilation tube is connected to the body, such as a tube through which air is supplied via a CPAP or other device. The body also includes exhalation holes. Thus, when the user exhales, the carbon dioxide rich exhalation air can exit through the exhalation holes, allowing new air to enter. 
     The body of the device interfaces with the nasal passage via nostril interface tubes extending from the body. These tubes include a nasal interface element designed to aid in securing the device in place, and thus eliminating the need for straps or headgear. The nasal interface elements are formed of an expandable, compressible material, meaning they can be compressed in order to insert them into the nostril, and once inserted they expand to apply pressure to the inner surfaces of the nostril opening to hold the device in place. Preferably, the contact is made at the end portion of the nostril so that only the section in the nostril covered by skin is contacted, thus avoiding the more sensitive nasal mucosa. Alternatively, the nostril interface elements are held against the outer edge of the nostrils. 
     These nasal interface elements can be formed of any suitable material which can be deformed, but are resilient in that they tend back to their original shape. A compressible foam is one material which may be well-suited for use in the invention. The interface element can be either permanently mounted to the interface tubes, or they may be removable and disposable so that they can be replaced after use. Thus, they can be mounted to the tubes via any suitable method. For example, they can be mounted via threading, frictional fit, or adhesive. However, other suitable methods of mounting the element to the tubes are contemplated and considered within the scope of the present invention. 
     The nasal interface elements of the present invention are ideally shaped in such a manner that they will form a seal or snug fit within the nostril of the user. This may mean they have more material on the bottom part toward the user&#39;s face, or that they may be specially formed to conform to the shape of the interior of the nostril. By exerting a small amount of pressure to the inside of the nostril, an additional advantage can be obtained by widening the passageway to allow more airflow. Furthermore, to enhance the securing of the device, the interface elements may include a mild adhesive on their exterior surface to hold them in place against the inner surfaces of the nostril. Such adhesive must be mild enough that the element can be easily removed by the user without causing significant discomfort or irritation or abrasion. 
     Optionally, these interface elements may contain an anti-bacterial agent to reduce the growth of contaminants. Once used, the user may replace the elements onto the tubes. 
     In various embodiments of the present invention, the interface tubes may further include a skirt surrounding the tube below the interface elements. Such skirts can be fitted against the outside of the nostril opening to help form a seal. Optionally, a mild adhesive can be disposed on the surface of the skirt which touches the outside edge of the nasal opening to help hold it in place. 
     In various embodiments of the present invention, the device also includes one or more flaps to assist in holding the device in place while in use. For example, side flaps are optionally included extending from the sides of the body of the device. The side flaps have an adhesive, enabling them to be adhered to the outer surface of the nose of the user to secure the device in place. Alternatively, the side flaps may removably secure to a nose cover which is adhered to the nose of the user. 
     Furthermore, an optional front flap may be included. The front flap extends from the body of the device and is secured to the exterior surface of the nose of the user. It may be secured via a strip of tape, and adhesive on the underside of the flap, or by any other suitable method. This front flap holds the device in place during use. In certain embodiments, the front flap may include resilient strips traversing the exterior of the nasal passageways. These strips can be deformed when applying the front flap to the nose via an adhesive, and will apply pressure tending to open the nasal passageways. A single one of such strips can be used. Alternatively, multiple strips can be used. Thus, the passageway is opened to allow more airflow, reducing the tendency of snoring in the user, and potentially reducing the air pressure required through the device to accomplish its purpose. Greater airflow may be enhanced by the combination of the strips and the expanding nasal interface elements, thus reducing air pressure requirements. 
     Still other objects and advantages of the present invention will become readily apparent to those skilled in the art from the following detailed description, wherein it is shown and described only the preferred embodiments of the invention, simply by way of illustration of the best mode contemplated of carrying out the invention. As will be realized, the invention is capable of other and different embodiments and its several details are capable of modifications in various obvious respects, without departing from the invention. Accordingly, the drawings, wherein like reference numerals represent like features, and description are to be regarded as illustrative in nature and not as restrictive. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows an embodiment of the nasal interface device of the present invention. 
         FIG. 2  shows another embodiment of the nasal interface device of the present invention, having optional side and front straps for mounting the device. 
         FIG. 3  shows an embodiment of the nasal interface device of the present invention as mounted on the nose of a user. 
         FIG. 4  shows an embodiment of the nasal interface element of the present invention. 
         FIG. 5  shows another embodiment of the nasal interface device of the present invention. 
         FIG. 6  shows an exploded view of one embodiment of the nasal interface device of the present invention. 
         FIG. 7  shows a perspective view of one embodiment of the nasal interface device of the present invention. 
         FIG. 8  shows another embodiment of the nasal interface device of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     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. 
     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 . 
     The device  10  further includes at least one nostril interface tube  50  extending from the body  20  to interface with the nasal passages of the user. 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. 
     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 . 
     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. 
     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. 
     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. 
     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. 
     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&#39;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. 
     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. 
     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. 
     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&#39;s nostrils. 
     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 . 
     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 person&#39;s nostril when the device  100  is worn by a person. 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 person. 
     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. 
     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&#39;s nose. The adhesive is ideally suitable for use on skin and removable. This nose cover  150  is ideally disposable and replaceable. 
     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. 
     In various embodiments, in order to hold the device  100  in place properly, at least one attachment flap  160 , and preferably two attachment flaps  160  are connected to the nasal interface body  105 . 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. 
     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. 
     While specific embodiments have been illustrated and described, numerous modifications come to mind without significantly departing from the spirit of the invention and the scope of protection is limited by the scope of the accompanying claims.