US20140053846A1 - Ventilation interface for sleep apnea therapy - Google Patents

Abstract

The ventilation interface for sleep apnea therapy interfaces a ventilation device to the patient's airways. The ventilation interface includes a pair of nasal inserts made from flexible, resilient silicone which are oval shaped in cross-section and slightly tapered from a base proximal the ventilation supply to the distal tip end. A bead flange is disposed about the exterior of each insert at the distal end of the insert. A bleed port for release of exhaled air is defined through a conical vent projecting normally to the path of the incoming air flow, and continues through a nipple extending to the exterior of the air conduit. In one embodiment, a pair of nasal inserts are integral with a nasal cannula body, with bleed ports axially aligned with each insert. In another embodiment, each insert is independently connected to a separate, thin-walled, flexible supply line.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of co-pending U.S. patent application Ser. No. 11/702,229, filed Feb. 5, 2007, titled “Ventilation interface for sleep apnea therapy;” which in turn is a continuation of U.S. patent application Ser. No. 10/940,989, filed Sep. 15, 2004, which is now U.S. Pat. No. 7,188,624; which in turn is a continuation of U.S. patent application Ser. No. 10/610,594, filed Jul. 2, 2003, which is now U.S. Pat. No. 6,807,967; which in turn is a continuation of U.S. patent application Ser. No. 10/044,925, filed Jan. 15, 2002, which is now U.S. Pat. No. 6,595,215; which in turn is a continuation-in-part of U.S. patent application Ser. No. 09/524,371, filed Mar. 13, 2000, which is now U.S. Pat. No. 6,478,026; which in turn claims priority to U.S. Provisional Patent Application No. 60/124,323, filed Mar. 13, 1999, the disclosures of which are all incorporated by reference herein in their entireties.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates to ventilation devices, and particularly to a ventilation device having nasal inserts which are inserted into the nostrils and seal against the nostrils without the aid of harnesses, head straps, adhesive tape or other external devices, and having exhalation ports designed to eliminate whistling noises, the ventilation interface having particular utility in various modes of therapy for obstructive sleep apnea.
• 2. Description of the Related Art
• Sleep apnea is a potentially lethal affliction in which breathing stops recurrently during sleep. Sleep apnea may be of the obstructive type (sometimes known as the pickwickian syndrome) in which the upper airway is blocked in spite of airflow drive; the central type with decreased respiratory drive; or a mixed type. Breathing may cease for periods long enough to cause or to exacerbate cardiac conditions, and may be accompanied by swallowing of the tongue. Sleep apnea frequently results in-fitful periods of both day and night sleeping with drowsiness and exhaustion, leaving the patient physically and mentally debilitated.
• In recent years it has been found that various forms of positive airway pressure during sleep can be an effective form of therapy for the apnea sufferer. Ventilation can be applied in the form of Continuous Positive Airway Pressure (CPAP) in which a positive pressure is maintained in the airway throughout the respiratory cycle, Bilevel Positive Airway Pressure (BiPAP) in which positive pressure is maintained during inspiration but reduced during expiration, and Intermittent Mechanical Positive Pressure Ventilation in which pressure is applied when an episode of apnea is sensed. Positive airway pressure devices have traditionally employed either a face mask which only covers the patient's nose, or nasal pillows as the interface between the ventilation device and the patient's airway. However, there are problems with both of these interfaces.
• The face mask requires a harness, headband, or other headgear to keep the mask in position, which many patient's find uncomfortable, particularly when sleeping. The face mask must seal the mask against the patient's face, and may cause irritation and facial sores, particularly if the patient moves his head while sleeping, causing the mask to rub against the skin. Face masks are also position dependent, and may leak if the mask changes position with movement of the patient's head. The face mask applies pressure to the sinus area of the face adjacent to the nose, causing the airways to narrow, thereby increasing the velocity of flow through the airway, but decreasing the pressure against the nasal mucosal walls. This strips moisture from the mucosal wall during inspiration, thereby causing drying and a burning sensation. These factors will often result in the patient's removal of the mask and discontinuance of positive airway pressure therapy.
• Nasal pillows are pillowed style nasal seals which are pressed against the inferior portion of the nares to close the nostril openings. Nasal pillows require a headband or harness to maintain the pressure, resulting in the same patient discomfort noted with face masks. Nasal pillows have about a 0.25″ internal diameter at the nasal entry port where the seal is made. Therefore, pressurized air must pass through a constricted port, increasing the velocity of airflow, with resultant drying and burning of the nasal airways. The narrowed interface diameter of the nasal pillows causes a pressure drop, which is directly proportional to the drop in the number of available air molecules within the closed system. It is the volume of air molecules at the area in the patient's throat where the apneic events appear that is needed to correct apnea. The narrower the airways or the internal diameter of the nasal interface, the lower the volume of air molecules that will be available and the greater the driving pressure that is required to meet the volume demand. An increase in driving pressure does not fully compensate for the loss in the number of air molecules available.
• A further problem with existing ventilation devices is that the carbon dioxide bleed ports for venting exhaled gases are noisy on both nasal face masks and nasal pillows. The whistling noise that occurs while utilizing such devices can prove quite annoying to the patient, awakening the patient and causing the patient to discontinue use of the ventilation device.
• A number of devices have been proposed which include a ventilation interface for supplying gases to be inhaled, for collecting exhaled gases, or for mounting sensors for measuring or monitoring respiratory function.
• U.S. Pat. Nos. 5,335,654 and 5,535,739, issued on Aug. 9, 1994 to Rapoport and Jul. 16, 1996 is to Rapoport et al., respectively, describe a CPAP system using a conventional nasal mask, the innovation comprising a flow sensor in the input line connected to a signal processor to determine the waveform of airflow, which is connected to a flow controller to adjust the pressure of airflow as required. U.S. Des. Pat. No. 333,015, issued Feb. 2, 1993 to Farmer et al. shows an ornamental design for a nasal mask. U.S. Des. No. 262,322, issued Dec. 15, 1981 to Mizerak, shows an ornamental design for a nasal cannula with a mouth mask.
• U.S. Pat. No. 4,782,832, issued Nov. 8, 1988 to Trimble et al., discloses nasal pillows held in the patient's nose by a harness arrangement, the device having a plenum with two accordion or bellows shaped nipples for fitting against the nostril openings. U.S. Pat. No. 4,774,946, issued Oct. 4, 1988 to Ackerman et al., teaches a nasal and endotracheal tube apparatus for administering CPAP to infants, the nose tubes having a bulbous portion for seating in the nares of an infant and a headband with a Velcro® closure for supporting the cannula and supply tubes.
• U.S. Pat. No. 5,269,296, issued to Landis on Dec. 14, 1993, and U.S. Pat. Nos. 5,477,852 and 5,687,715, issued to Landis et al. on Dec. 26, 1995, and Nov. 18, 1997, respectively, describe CPAP devices for the treatment of sleep apnea with relatively stiff or rigid nasal cannulae or prongs surrounded by inflatable cuffs to retain the cannulae in the nares, but which also may be supplemented by an inflatable head harness to position the cannulae and hold them in place, the two cannulae being joined by a conduit having vent holes to vent exhaled air. U.S. Pat. No. 5,533,506, issued Jul. 9, 1996 to the present inventor, discloses a nasal tube assembly in which the tubes are tapered, frustro-conical assemblies with a soft membrane over the distal tip and a washer at the base of the nasal tube to prevent the tubes from falling through a support bar connected to a harness, the nasal tubes forming a positive seal with the inside of the nostrils to prevent the escape of gases.
• U.S. Pat. No. 5,682,881, issued Nov. 4, 1997 to Winthrop et al., shows a nasal cannula for CPAP therapy with cone shaped nasal prongs in which the cannula is secured to the patient's upper lip by adhesive tape strips. U.S. Pat. No. 4,915,105, issued Apr. 10, 1990 to Lee, teaches a miniature respiratory breather apparatus in which relatively stiff or rigid nasal tubes have elastomeric packings for sealing the tubes in the nares.
• Several patents describe improvements to nasal cannulae, but without sealing the nose tubes against the nostrils to prevent leakage of gas, including: U.S. Pat. No. 3,513,844, issued May 26, 1970 to Smith (metal strip in cannula cross-tube to retain configuration matching patient's lip); U.S. Pat. No. 4,106,505, issued Aug. 15, 1978 to Salter et al. (cannula body with ends extending upward and rearward); U.S. Pat. No. 4,915,104, issued Apr. 10, 1990 to Marcy (clasp with lanyard supporting supply tubes to ease pressure on ears); U.S. Pat. No. 5,025,805, issued Jun. 25, 1991 to Nutter (cylindrical soft sponge cuff around supply tubes to ease pressure and prevent skin injuries); U.S. Pat. No. 5,046,491, issued Sep. 10, 1991 to Derrick (device for collecting gases exhaled from both nose and mouth); U.S. Pat. No. 5,335,659, issued Aug. 9, 1994 to Pologe (device for mounting optical sensor on nasal septum); U.S. Pat. No. 5,509,409, issued Apr. 23, 1996 to Weatherholt (nasal cannula with face guards); U.S. Pat. No. 5,572,994, issued Nov. 12, 1996 to Smith (rotatable coupling in supply tubing); U.S. Pat. No. 5,636,630, issued Jun. 10, 1997 to Miller et al. (support for supply tubes); U.S. Pat. No. 5,704,916, issued Jan. 6, 1998 to Byrd (novel head strap for nasal cannula); and U.S. Pat. No. 5,704,799, issued Apr. 21, 1998 to Nielsen (device with one-way flow through cannula and flow restrictor to equalize flow into two nose members).
• None of the above inventions and patents, taken either singly or in combination, is seen to describe the instant invention as claimed. Thus a ventilation interface for sleep apnea therapy solving the aforementioned problems is desired.
SUMMARY OF THE INVENTION
• The ventilation interface for sleep apnea therapy interfaces a ventilation device which provides positive airway pressure (either continuous, bilevel, or intermittent) with the patient's airways. The ventilation interface includes a pair of nasal inserts made from flexible, resilient silicone which are oval shaped in cross-section and slightly tapered from a base proximal the ventilation supply to the distal tip end. A bead flange is disposed about the exterior of each insert at the distal end of the insert. A bleed port for release of exhaled air is defined through a conical vent projecting normally to the path of the incoming air flow, and continues through a nipple extending to the exterior of the air conduit. In one embodiment, a pair of nasal inserts are integral with a nasal cannula body, with bleed ports axially aligned with each insert. In another embodiment, each insert is independently connected to a separate, thin-walled, flexible supply line.
• Advantageously, the construction of the nasal inserts permits the ventilation interface to be retained in the patient's nares without requiring a harness, head strap, or other-retaining device. The nasal inserts do not merely-seal the base of the nostrils, but are inserted into the nostrils farther than nasal pillows, as far as the nasal mucosal membrane, and are retained by resilient expansion of the inserts, the flanges engaging notches in the nares, together with the pressure of incoming air, which forms a positive seal to prevent the leakage of air past the inserts. The nasal inserts are constructed according to specifications which permit the inserts to be relatively thin-walled, and are oval shaped in cross-section to conform to the shape of the nostrils. This construction permits the nasal inserts to have a large internal diameter in order to pass a greater volume of air than nasal pillows or prongs, without significant narrowing of the air passages, thereby maintaining lateral pressure, and avoiding drying and burning of the patient's nasal passages, as well as supplying a sufficient number of air molecules at the desired pressure to keep the patient's airways patent. Consequently, the ventilation device is more comfortable for the patient to wear while sleeping than conventional positive airway pressure devices, but at the same time is more effective in treating the patient's apnea.
• The bleed ports are specially designed to avoid the whistling noises commonly experienced with conventional nasal masks and nasal pillows. By projecting the vent structure into the air passage normal to the direction of the air flow from the supply tubes, incoming air must turn ninety degrees and exit through a long, restricted diameter bleed port to vent to the atmosphere, eliminating whistling noises to increase patient comfort. In the embodiment having a nasal cannula body, the bleed ports are axially aligned with the nasal inserts, providing CO₂with a direct path to exit the cannula body. When the nasal inserts are attached to independent supply tubes, the bleed ports are at the base of the nostrils, providing essentially normal exhalation.
• When the nasal inserts are directly connected to the supply tubes, the nasal inserts may be even more thin-walled than when attached to a cannula body, resulting in an even greater volume of air supplied through the cannula body, up to a 20% increase in volume. In this case the supply tubes may be similar to heat-shrink tubing, being made from a very thin-walled thermoplastic is material that is lightweight and flexible so that the supply tubing may collapse when not in use, but will expand to a predetermined diameter under pressure applied by a ventilator.
• Accordingly, it is an object of the invention to provide a ventilation interface for sleep apnea therapy having nasal inserts which seal against the nares and do not require a harness, head strap, or other external devices to maintain pressure for retaining the inserts in or against the patient's nostrils.
• It is another object of the invention to provide a ventilation device having nasal inserts made of flexible, resilient plastic with a bead flange for retaining the inserts in the flares, wherein the walls of the insert are thin-walled and maintain lateral pressure in the nares in order to provide a greater internal diameter for the delivery of a greater volume of air molecules at a constant delivery pressure and without forcing ventilation gases through restricted ports or passageways so that drying and burning of the patient's nasal airways is avoided while delivering a therapeutic volume of air to maintain the apneic patient's airways in a patent condition.
• It is a further object ventilation interface for sleep ports to avoid whistling noises at the interface a vent passage for expired air.
• Still another object of the invention is to provide a ventilation interface which is lightweight and comfortable so that the apnea patient is not tempted to discard the ventilation device is while sleeping.
• It is an object of the invention to provide improved elements and arrangements thereof for the purposes described which is inexpensive, dependable and fully effective in accomplishing its intended purposes.
• These and other objects of the present invention will become readily apparent upon further review of the following specification and drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a front environmental view of a ventilation interface for sleep apnea therapy according to the present invention.
• FIG. 2A is an exploded elevational of a ventilation interface according to the present invention.
• FIG. 2B is a perspective view of a ventilation interface embodied in a nasal cannula body according to the present invention.
• FIG. 3 is a section view along the lines3-3 ofFIG. 2A.
• FIG. 4 is a section view along the lines4-4 ofFIG. 2A.
• FIG. 5 is a section view along the lines5-5 ofFIG. 2A.
• FIG. 6 is a perspective view of an embodiment of the ventilation interface with the nasal inserts incorporated into independent supply tubes.
• Similar reference characters denote corresponding features consistently throughout the attached drawings.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The present invention is a ventilation interface for sleep apnea therapy, designated generally as10 in the drawings. Theventilation interface10 provides an interface for connecting a ventilation device which provides positive airway pressure (either continuous, bilevel, or intermittent) with the patient's airways. As shown inFIGS. 1 and 2A, theventilation interface10 includes a conventional adapter or Y-connector12 having a first end adapted to receive asupply hose14 from a mechanical ventilator (not shown) and a second end having a pair ofports16 with barbed connectors for attachment to twosupply tubes18.Supply tubes18 may be, e.g., 0.3125″ ID (inside diameter) flexchem tubing, made of polyvinyl chloride or other conventional gas supply tubing. For sleep apnea therapy, the mechanical ventilator will usually supply room air at a pressure of between five and fifteen centimeters of water. The room air may be supplemented with oxygen if desired by splicing an oxygen supply line intosupply hose14 or using a triple port connector in lieu of Y-connector12. It is normally unnecessary to humidify or add moisture to the air supplied by the mechanical ventilator in using theventilation interface10 of the present invention, as theinterface10 is designed to avoid stripping moisture from the nares, so that moisture does not have to be added to relieve patient discomfort from drying or burning sensation in the nasal airways.
• In the embodiment shown inFIGS. 1 and 2A, the ends of the supply tubes distal from the Y-connector12 are attached to opposite ends of anasal cannula body22 bybarbed connectors20.Barbed connectors20 preferably have an inside diameter substantially equal to the inside diameter ofsupply tubes18 in order to prevent any constriction or narrowing of the air passage which may cause increased velocity in air flow.Nasal cannula body22, described more fully below, has a pair ofnasal inserts30 which are inserted into the nares of the patient P). The supply tubes may be looped over the patient's ears and joined to theY connector12, which may be suspended at about the patient's chest level when the patient is standing, as shown inFIG. 1. For Bi-level Positive Airway Pressure (BiPAP) or Intermittent Mechanical Positive Pressure Ventilation therapy, a suitable valve may be connected between thesupply tubes18 and thecannula body22. An exemplary valve is described in the Applicant's prior application Ser. No. 09/524,371, filed Mar. 13, 2000, which is hereby incorporated by reference in its entirety.
• Thenasal cannula body22 is shown in greater detail inFIG. 2B. Thecannula body22 is an arcuate, hollow, body having substantially flattop wall22aandflat sidewalk22bmerging with a semi-cylindricalbottom wall22cdefining anair chamber22d(seen more clearly inFIG. 3) for the passage of air and other gases, and havingcylindrical tubes24 at opposite ends which receive one end of thebarbed connectors20. Anotch26 is defined transversely across thetop wall22aof thecannula body22, defining a pair of mountingpads28. A pair ofnasal inserts30 are formed integral with the mountingpads28. The nasal inserts30 are hollow and form a continuous flow path or conduit for the passage of inhaled and exhaled gases between the patient's nasal air passages and theair chamber22d.
• The nasal inserts are shown in greater detail inFIGS. 3,4, and5. The nasal inserts30 are substantially oval in cross-section, with the major axis substantially parallel with the notch and the minor axis normal to the notch. The nasal inserts30 taper slightly from awide base32 proximal thecannula body22 to the open distal tip ends34. The nasal inserts30 have aflange36 about the distal tip ends34 on the exterior surface of theinserts30, which may be formed as a semi-cylindrical bead.
• Thecannula body22, including the nasal inserts30, are preferably made from silicone elastomer. Thecannula body22 orair chamber22dhas an internal diameter of at least 0.3125 inches throughout its length. The walls of the nasal inserts30 may be thinner than thetop wall22a. The thickness of the walls of the nasal inserts30 are preferably between about 1/32 and 1/20 inches. The thickness of the walls at theflange36 may be about 1/16 inches. The hardness of the walls of thenasal insert30, as tested on a type A Shore durometer, may range between about 15 and 40, preferably about 30. If the walls of the nasal inserts30 are made any thinner, they will fail to have sufficient integrity, and if made any thicker, they will have insufficient flexibility to form a seal against the nares. The thinness and softness of the nasal inserts30 make them virtually unnoticeable while in the nostrils. For an adult patient, the nasal inserts may have a height of between about 0.25 and 0.75 inches. The internal diameter of the nasal inserts30 may measure about 0.75″ on the major axis and 0.5 on the minor axis, allowing for generous laminar air flow and delivering pressure more by volume of air molecules than velocity of air flow, and deliver about double the volume of nasal pillows, which have a round internal diameter of, for example, about 0.25 inches. Nasal pillows cannot be made with such large internal diameters, because it becomes difficult to create a seal under the bottom of the nose, as the pillows would have an internal diameter larger than the internal diameter of the nares, and the pillows are not as flexible as the nasal inserts30 of the present invention.
• In use, the nasal inserts30 are inserted up the patient's nostrils until theflanges36 lodge against the mucous membranes. As such, the nasal inserts30 are considered an invasive device. Testing has confirmed that the nasal inserts30 are biocompatible and meet regulatory requirements. The nasal inserts are retained in the patient's nares by theflanges36, by the flexibility and resiliency of the silicone elastomer, and by lateral pressure of the room air, which is maintained at between five and fifteen centimeters of water. The oval cross-section of the nasal inserts30 is shaped to conform to the normally oval shape of the nares. The relative large internal diameter of the nasal inserts30 permits air to be supplied to the patient's airways in sufficient volume at the driving pressure without accelerating the rate of airflow that the patient has sufficient positive airway pressure to be of therapeutic value in maintaining the patient's airways patent during an episode of obstructive apnea without drying the nasal passages. Thenotch26 in thetop wall22aof thecannula body22 lends additional flexibility to thecannula body22, so that thenasal cannula22 can be adjusted for deviated septums, thick septums, and other anatomical variations in the configuration of the nostrils.
• Thecannula body22 has a pair ofbleeder ports38 disposed in thebottom wall22cdirectly below and axially aligned with the nasal inserts30. The bleeder ports are formed by an upper conically shapednipple40 extending upward into theair chamber22d, and a lower conically shapednipple42 extending below thebottom wall22c. The bleeder port has an internal diameter of about three millimeters and extends for a length of about 0.25 inches. Theupper nipple40 extends about 0.125 inches into theair chamber22d. The internal diameter of thebleeder port38 is ample to permit venting of carbon dioxide exhaled by the patient while not being so large as to cause a significant pressure drop in thecannula body22, and axial alignment of thebleeder port38 with the nasal inserts22 creates a direct path for venting of the expired gases. At the same time, laminar flow of air supplied by the supply tubes is normal to thebleeder ports38, so that air supplied by the ventilator must bend ninety degrees to exit through theelongated bleeder port38. The effect of this construction is that thebleeder port38 is virtually silent in operation, eliminating the whistle associated with bleeder holes in conventional ventilation interfaces.
• FIG. 6 is a generally diagrammatic view of an alternative embodiment of the ventilation interface, designated50 in the drawing. In this embodiment, eachnasal insert52 is connected to aseparate supply tube54, thesupply tubes54 being connected to the mechanicalventilator supply hose56 by a suitable Y-connector58 or adapter, thecannula body22 andcommon air chamber22dbeing omitted. The nasal inserts52 have substantially the same construction as nasal inserts30, being oval in cross-section and having a similar height and anannular flange60 about the distal tip for lodging thenasal insert52 in a naris. Thenasal insert52 is also made from silicone elastomer, and has the same softness, thickness, flexibility and resilience as thenasal insert30. In this configuration, since the inserts are not connected to thecannula body22, the angle at which theinserts52 enter the nostrils is not restricted by thecannula body22, and therefore the nares can accept a greater displacement, and may accommodate a 20% greater volume of air molecules through theinsert52 than theinsert30.
• In this embodiment, thesupply tubes54 may be made from a flexible, lightweight, but relatively inelastic thermoplastic material, similar to heat shrink tubing, so that thesupply tubes54 may be at least partially collapsed in the absence of pressure from the mechanical ventilator, but expand to their maximum diameter under a pressure of between five to fifteen centimeters of water. The lightweight of thesupply tubes54 decreases any pressure on the patient's ears resulting from the weight of the supply tubes, increasing patient comfort. Thebleeder ports62 have a similar construction to thebleeder ports38, having aninternal nipple65 normal to the axis of thenasal insert52 and anexternal nipple64, thebleeder ports62 being just above the base of theinserts52 and normal to the flow of supply air through theinserts52.
• It will be understood by those skilled in the art that the dimensions of the nasal inserts30 and52, and of thebleeder ports38 and62, are representative dimensions for aventilation interface10 or50 designed for adults, and that theventilation interface10 or50 may be made with correspondingly reduced dimensions for teenage children, preteens, and infants. It will also be understood that the nasal inserts30 and52 may be made from thermoplastic elastomers other than silicone, providing that the material has similar softness, resilience, flexibility, and biocompatibility. It will also be understood by those skilled in the art that the nasal inserts30 and52, although illustrated in conjunction with ventilation devices for the treatment of sleep apnea, may be used in any other application where it is desirable to have an interface forming a seal between at person's nasal airways and a ventilation or gas collection device, including, but not limited to, rescue breathing apparatus used by firefighters and other emergency personnel, scuba diving tanks, etc.
• It is to be understood that the present invention is not limited to the embodiments described above, but encompasses any and all embodiments within the scope of the following claims.

Claims (20)

What is claimed is:

1. A respiratory interface comprising:

an inlet aperture configured to allow air into at least one nostril of a patient;

a valve located near the inlet aperture, the valve configured to resist airflow during exhalation of the patient; and

an exhale aperture located at or proximate the valve.

2. The respiratory interface ofclaim 1, further comprising a nasal insert adjacent the inlet aperture, the nasal insert configured to fit at least partially into the at least one nostril of the patient.

3. The respiratory interface ofclaim 2, wherein the nasal insert is tapered slightly from a wide base proximal the inlet aperture.

4. The respiration interface ofclaim 2, wherein the nasal insert is flexible and resilient.

5. The respiration interface ofclaim 2, wherein the nasal insert has a diameter sufficient to form a seal between the nasal insert and the at least one nostril of the patient.

6. The respiration interface ofclaim 2, wherein the nasal insert comprises a flange on an exterior surface of the nasal insert.

7. The respiration interface ofclaim 6, wherein the flange is formed as a bead.

8. The respiratory interface ofclaim 2, wherein the walls of the nasal insert have a hardness that ranges from about 15 to 40, as tested on a type A Shore durometer.

9. The respiratory interface ofclaim 8, wherein the hardness of the walls of the nasal insert is about 30, as tested on a type A Shore durometer.

10. A respiratory interface for the treatment of a breathing problem, configured to provide a continuous flow path for the passage of inhaled and exhaled gases, the respiratory interface comprising:

at least one body;

at least one nasal aperture defined within the at least one body; and

at least one valve assembly comprising at least one valve member, the valve assembly coupled to the at least one body;

wherein the valve assembly is configured to impede flow in a first direction more than a second direction.

11. The respiratory interface ofclaim 10, wherein the first direction is an exhalation direction and the second direction is an inhalation direction.

12. The respiratory interface ofclaim 10, wherein the at least one valve member is suitable for use in positive airway pressure therapy or intermittent mechanical positive pressure ventilation therapy.

13. The respiratory interface ofclaim 10, wherein the at least one nasal aperture is located within a nasal insert configured to fit at least partially into one or more nostrils of a patient.

14. The respiratory interface ofclaim 13 wherein the nasal insert has walls with a hardness that ranges from about 15 to 40, as tested on a type A Shore durometer.

15. The respiratory interface ofclaim 10, further comprising a bleed port located at or proximate the valve assembly.

16. A respiratory interface comprising:

an inlet aperture configured to allow air into at least one nostril of a patient comprising at least one nasal insert adapted to seal against the at least one nostril of the patient without the aid of a harnesses or a head strap;

a valve located near the inlet aperture, the valve configured to resist airflow during exhalation of the patient; and

a bleed port located at or proximate the valve.

17. The respiratory interface ofclaim 16, wherein the at least one nasal insert is tapered slightly from a wide base proximal the inlet aperture.

18. The respiratory interface ofclaim 16, wherein the at least one nasal insert is flexible and resilient.

19. The respiratory interface ofclaim 16, wherein the at least one nasal insert comprises a flange on an exterior surface of the nasal insert.

20. The respiratory interface ofclaim 16, wherein the at least one nasal insert has walls with a hardness that ranges from about 15 to 40, as tested on a type A Shore durometer.

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