STRAPLESS NASAL INTERFACE DEVICE
A strapless nasal interface device is disclosed. The device is used in conjunction with CPAP, BIPAP, ventilators, or any other suitable device. The device includes a body with a passageway to a ventilating tube, exhalation holes, and a passageway to nostril interface tubes. The nostril interface tubes include a nasal interface element which is an expandable, compressible material such that the user can compress the element, insert it into the end of the nostril and allow it to expand to hold the tube in place. Alternatively, the nasal interface elements are held against the outer edge of the nostrils. Optionally, a skirt is included at the outer side of the nostril to aid in sealing against air leaks. Optionally, flaps are included to assist in holding the device in place, such as side flaps, a front flap, or both. The front flap may be adherable to the exterior of the nose and optionally includes resilient strips to open the nasal passageway. Alternatively, a nose cover is adhered to the nose and side attachment flaps secure the device to the nose cover. Thus, the device requires no additional straps or headgear in order to maintain the device in operable position during sleep.
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 INVENTIONThe 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.
BACKGROUNDNasal 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'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.
SUMMARYThe 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'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.
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'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'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'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'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
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.
Claims
1. A device comprising:
- a housing including a cavity, a first opening in fluid communication with the cavity and a positive pressure source, a second opening in fluid communication with the cavity and atmosphere, a third opening, and a fourth opening;
- a first nostril tube removably coupled to the third opening and in fluid communication with the cavity;
- a second nostril tube removably coupled to the fourth opening and in fluid communication with the cavity; and
- a nasal interface element removably coupled to one of the first nostril tube and the second nostril tube, wherein the nasal interface element is compressible to fit within a nostril of a user and expandable to make contact with an inner edge of the nostril to hold the nostril tube in place within the nostril and to form a seal sufficient for CPAP operation.
2. The device of claim 1, further comprising a facial patch which is adherable to a portion of a person's face above the level of such a person's nostrils.
3. The device of claim 2, further comprising at least one attachment flap coupled to the housing and removably attachable to the facial patch.
4. The device of claim 3, further comprising a second attachment flap coupled to the housing and removably attachable to the facial patch.
5. The device of claim 2, wherein the facial patch at least partially covers a person's nose and includes an adhesive on a bottom surface thereof adapted to removably adhere to the outer surface of a person's nose.
6. The device of claim 5, wherein the facial patch comprises a bendable element adapted to bend to match contours of a person's nose and hold its shape.
7. The device of claim 1, wherein the second opening is of sufficient size and configured to allow exhaled air to pass therethrough without substantially depressurizing the cavity.
8. The device of claim 7, wherein the second opening is about 0.02 inches in diameter.
9. The device of claim 1, wherein the second opening includes a plurality of openings, and wherein each of the openings is of sufficient size and is configured to allow exhaled air to pass therethrough without substantially depressurizing the cavity.
10. The device of claim 9, wherein each of the plurality of openings is about 0.02 inches in diameter.
11. A device comprising:
- a housing including a cavity, and a port in fluid communication with the cavity and extending from the housing, the port being rotatable with respect to the housing and connectable to a positive pressure source;
- a first nostril tube coupled to the housing and in fluid communication with the cavity;
- a second nostril tube coupled to the housing and in fluid communication with the cavity;
- a nasal interface element coupled to one of the first nostril tube and the second nostril tube, wherein the nasal interface element is compressible and expandable to form a seal within a nostril of a user that is sufficient for CPAP operation.
12. The device of claim 11, further comprising a facial patch which is adherable to a portion of a person's face above the level of such a person's nostrils.
13. The device of claim 12, further comprising at least one attachment flap coupled to the housing and removably attachable to the facial patch.
14. The device of claim 13, further comprising a second attachment flap coupled to the housing and removably attachable to the facial patch.
15. The device of claim 12, wherein the facial patch at least partially covers a person's nose and includes an adhesive on a bottom surface thereof adapted to removably adhere to the outer surface of a person's nose.
16. The device of claim 15, wherein the facial patch comprises a bendable element adapted to bend to match contours of a person's nose and hold its shape.
17. The device of claim 11, wherein the second opening is of sufficient size and configured to allow exhaled air to pass therethrough without substantially depressurizing the cavity.
18. The device of claim 17, wherein the second opening is about 0.02 inches in diameter.
19. The device of claim 11, wherein the second opening includes a plurality of openings, and wherein each of the openings is of sufficient size and is configured to allow exhaled air to pass therethrough without substantially depressurizing the cavity.
20. The device of claim 19, wherein each of the plurality of openings is about 0.02 inches in diameter.
21. A device comprising:
- a housing including a cavity, and a port in fluid communication with the cavity and extending from the housing, the port connectable to a positive pressure source;
- an attachment flap coupled to the housing and releasably coupled to a facial patch applied to a nose of a user;
- a first nostril tube coupled to the housing and in fluid communication with the cavity;
- a second nostril tube coupled to the housing and in fluid communication with the cavity;
- a nasal interface element coupled to one of the first nostril tube and the second nostril tube, wherein the nasal interface element is compressible and expandable to form a seal within a nostril of a user that is sufficient for CPAP operation.
Type: Application
Filed: Apr 17, 2013
Publication Date: Sep 12, 2013
Inventor: Venkata Buddharaju (Park Ridge, IL)
Application Number: 13/864,853
International Classification: A61M 16/06 (20060101); A61M 16/08 (20060101); A61M 16/00 (20060101);
