Positive airway pressure respiration mask

A nasal respiratory mask system configured to be placed on a user's face to provide respiratory gas under positive pressure to the user, the nasal respiratory mask system includes: a nasal mask shell configured to cover a user's nose and mouth, the nasal mask shell includes a first valve opening and a second valve opening, wherein the first valve opening is configured to receive a respiratory tube connected to a positive gas pressure source, wherein the second valve opening is configured to enable the entrance of fresh air when the pressure within the nasal mask shell cavity falls below a threshold pressure; and a securing system configured to secure the nasal mask shell to the user's face, wherein the securing system includes at least one horizontal securing strap, wherein the horizontal securing strap extends from a first side face of the nasal mask shell to a second side face of the nasal mask.

BACKGROUND OF THE INVENTION

The present subject matter relates generally to a respiratory facemask. More specifically, the present invention relates to respiratory facemask that may be pressurized and worn during sleep to reduce the effects of central sleep apnea.

Central sleep apnea is a disorder that causes repeated cessation of breathing during sleep. For individuals suffering from central sleep apnea, the condition may cause discomfort during sleep, such as abruptly waking up with shortness of breath, mood changes, insomnia, headaches and snoring. One treatment option for central apnea is called continuous positive airway pressure (CPAP). This method involves wearing a mask over the nose during sleep, with the mask being attached a pump that supplies a continuous amount of pressurized air. This acts to hold open the upper airway, which may cause central apnea when closed.

Wearing masks during sleep, however, may cause difficulties for the user, especially when it comes to comfort for the user. Additionally, if the user moves around in certain positions, the mask may come off. Most importantly, wearing certain conventional respiratory facemasks has been known to cause suffocation if the pump providing the positive air pressure stops working and the user does not realize they are not getting air from the pump and the mask is sealed to the user's face.

Accordingly, there is a need for positive airway pressure respiration mask that provides a secure fit to the face, is comfortable to sleep with, and provides a mechanism to prevent suffocation in the event the positive air pressure fails, as described herein.

BRIEF SUMMARY OF THE INVENTION

To meet the needs described above and others, the present disclosure provides a nasal respiration mask system that provides a secure fit to the face, is comfortable to sleep with, and minimizes the risk of blockage and suffocation.

A nasal respiratory mask system configured to be placed on a user's face to provide respiratory gas under positive pressure to the user, the nasal respiratory mask system includes: a nasal mask shell configured to cover a user's nose and mouth, the nasal mask shell includes a first valve opening and a second valve opening, wherein the first valve opening is configured to receive a respiratory tube connected to a positive gas pressure source, wherein the second valve opening is configured to enable the entrance of fresh air when the pressure within the nasal mask shell cavity falls below a threshold pressure; and a securing system configured to secure the nasal mask shell to the user's face, wherein the securing system includes at least one horizontal securing strap, wherein the horizontal securing strap extends from a first side face of the nasal mask shell to a second side face of the nasal mask.

An advantage of the present device includes correcting higher outflow exhaust pressures associated with conventional masks. The present device is designed to operate at optimal exhaust rates and zero leak rates.

An advantage of the present device is that it provides a tight seal to the face but applies less pressure to the face than conventional models.

Another advantage of the present device is that the mask deforms rather than remaining rigid, thereby making the mask suitable for back, side and stomach sleepers.

A further advantage of the present device is that it may be fully disassembled and cleaned. It may also withstand the heat of blow dryers or machine dryers.

Yet another advantage of the present device is that it may have a low leak rate due to its optimal seal.

A further advantage of the present device is the incorporation of a safety valve positioned between a first end and second end of the respiratory tube, such that if the positive pressure from the air pump decreases, the safety valve allows fresh air to enter into the respiratory tube leading to the nasal face mask to prevent suffocation.

DETAILED DESCRIPTION OF THE INVENTION

By providing a lightweight and flexible mask that conforms to the face with a secure seal, the disclosed mask achieves both comfort, safety, and effectiveness. The close fit on the face and flexible construction enables the mask to deform rather than getting pulled from the face like more rigid models. Additionally, the unique harness design increases the comfort and adjustability of the system.

As shown inFIGS. 1A-1C, the disclosed nasal respiratory mask system10includes a nasal mask shell12, a first opening valve14configured to receive a respiratory tube16connected to a positive gas pressure source, a second opening valve18configured to function as a anti-suffocation valve, and a securing system configured to secure the nasal mask shell to a user's face.

The first opening valve14may be positioned on a side face34of the nasal mask shell12, and the second opening valve18(i.e., anti-suffocation valve) may be positioned on a center front side face32of the nasal mask shell12. The second valve opening18is configured to enable the entrance of fresh air when the pressure within the nasal mask shell cavity36falls below a threshold pressure. The nasal mask shell12may also include an exhaust valve20, wherein the exhaust valve20may be positioned on a side face of the nasal mask shell12.

The second opening valve18can be double layered to eliminate leaks under pressure. The function and placement of the second opening valve18is to supply additional air if the user suddenly gasps for air (crisis breathing) and/or supply air when the machine/pump is off. If there is any positive pressure in the mask, the second opening valve is closed. The second opening valve18opens to fresh air (due to mechanical flexibility of the rubber disks) only if the machine/pump is off (i.e., zero pressure) or the user gasps at a pressure higher than the machine is supplying. In an example, the nasal respiratory mask system10may also include a pressure sensor such that when the detected pressure in the nasal mask cavity36is less than a selected threshold pressure (e.g., less than 15 mm Hg, less than 10 mm Hg, or less than 6 mm Hg), the second opening valve18opens to allow fresh air to enter into the nasal mask shell cavity36. Such mechanism may guarantee that fresh air will pass through the mask even if the pumping machine has stopped providing air for some reason, thereby preventing suffocation of the user. Specifically, by providing the anti-suffocation valve, users may avoid air deprivation episodes that cause them to be awakened during sleep. Additionally, the position of the second opening valve18on the center front face side, the second opening valve18is difficult to block due to its size and central placement. Further, even if the nasal mask shell is pushed inward, the second opening valve18may open rather than become blocked, further preventing suffocation.

The second opening valve18may include a filter that allows for fresh air to enter. Alternatively, or in addition, the anti-suffocation valve may be open to function as a drink port, with openings in the second opening valve18that may accommodate a straw that the users may drink liquids through.

As shown inFIGS. 2-4, the securing system may connect to the nasal mask shell12from two to five points or areas on the nasal mask shell12. The securing system may include at least one horizontal securing strap22, wherein the horizontal securing strap22extends from a first side face of the nasal mask shell12to a second side face of the nasal mask shell12. The securing system may include a vertical securing strap24, wherein when the nasal mask system is placed on the user, the vertical securing strap24can extend from a top side face38of the nasal mask shell12to a portion of the horizontal securing strap22positioned on the backside of a user's head. The nasal respiratory mask system can further include a chin strap26extending from a first bottom side face of the nasal mask shell12to a second bottom side face of the nasal mask shell12, wherein when the nasal mask system10is placed on a user, the vertical securing strap24extends from a top side face of the nasal mask shell12to a portion of the chin strap26positioned at the base of a user's neck, as shown inFIG. 3.

The horizontal securing strap22may split into two straps wherein when in use on a user a first branch is positioned above the crown of the head of the user and the second branch is positioned below the crown of the head of the user, as shown inFIG. 4.

In other words, the vertical securing strap24may extend from the bridge of the nose of the nasal mask shell over the crown of the user's head and to the horizontal strap22positioned near the crown of the head of the user, and/or may connect to the chin strap positioned at the nape of the neck and looping around a horizontal strap22or a chin strap26.

The vertical securing strap24and the horizontal securing strap22may be available in a variety of sizes. Alternatively, or in addition to, the vertical securing strap24and the horizontal securing strap22may be adjustable. In addition, a fabric tape can be applied to the one or both of the vertical and horizontal securing strap to protect the skin of the wearer, to prevent dermatitis.

The chin strap26may be composed of one or two separate straps that extend from a first bottom side face40to a second bottom side face42of the chin component of the nasal mask shell12around the back of the head, meeting in the middle at the nape of the neck. These two straps comprising the chin strap26may be connected with a clasp. By releasing the clasp (which may be accomplished using only one hand), the user may remove the mask. The chin straps26may be adjustable for the user's comfort. The chin straps26may also act to keep the jaw in position. This may help to stabilize the pressure by keeping the mouth from opening too much. If the mouth opens slightly during sleep, the pressure change will not cause wake-up. Further, a beard guard (inlet protection device) inside the nasal mask shell12can be incorporated to guard the inlet opening if the user has a heavy beard or facial feature that can possibly clog or block the first opening valve.

The straps of the securing system may provide varying elasticities and length adjustments to optimize user comfort.

The nasal respiratory mask system10may include an exhaust valve20to further prevent blockages. The exhaust valve can include a fabric patch in the valve, wherein the fabric patch extends over the opening of the valve and includes a perforated fabric. The perforated fabric can be applied to the valve via double-sided tape (inside and/or outside the mask). In addition, the present design prevents the air flowing from the exhaust valve from forcibly contacting the user or a partner sleeping next to the user. The exhaust valve20may be positioned on a side face of the mask where there is less leverage, making it harder to pull off compared to conventional mask models that place the exhaust valve in the center of the mask.

The first opening valve14may be on either the left or right side of the mask. The side positioning of the first opening valve14adapted to receive an inlet respiratory hose16will allow air to blow in from the side and gently onto the cheek, instead of directly up the nose or into the mouth, which may increase comfort during use of the nasal respiratory mask system10.

The respiratory tube16can connect directly to the first opening valve14. Alternatively, or in addition to, as shown inFIG. 1B, the respiratory tube16can connect to the first opening valve14via a junction28, wherein an O-ring30is used to further secure the seal from the respiratory tube16to the first opening valve14to prevent gas leaks. The junction28can be an elbow junction, which may facilitate a direct flow of air into the nasal mask shell12, and prevent the respiratory tube from being bent and preventing air flow. The respiratory tube16connects the first opening valve14to an air pump for supplying positive pressure to the nasal mask shell12. In an example, the respiratory tube16can be between 1800 and 1900 mm, for example 1850 mm, which provides a volume of the hose for optimal function and safety.

As shown inFIG. 5, a safety valve50can be positioned within the respiratory tube16, wherein the safety valve50is positioned along the respiratory tube16between the first opening valve14and the air pump. The safety valve is light in weight and does not contribute to a significant increase in sound during operation. In an example, the safety valve is positioned at the end of the respiratory tube16and the air pump (i.e., between the respiratory tube16and the air pump). As shown inFIGS. 6A-6B, the safety valve50includes an inner tube housing a spherical member52and a compressible spring54. The inner tube56is perpendicular to an air flow tube64wherein the air flow from the air pump (e.g., positive gas pressure source) passes through the air flow tube64from a first end60and second end62of the safety valve50. The first end and second end can connect to two sections of the respiratory tube16, or wherein the first end attaches to the respiratory tube16and the second end attaches to the air pump. The safety valve50also includes a fresh air opening58that extends from the inner tube56to the outer surface of the safety valve exposed to fresh air. As shown inFIG. 6A, when the pressure is less than 2 mm Hg (i.e., the air pump is not supplying positive pressure through the respiratory tube), the spring is depressed such that the spherical member does not block a fresh air opening. In other words, when the pressure is less than 2 mm Hg, the spring is depressed, removing the spherical member from the opening to allow fresh air to enter the respiratory tube and flow to the nasal mask to prevent suffocation. In contrast, as shown inFIG. 6B, when the pressure is greater than 2 mm Hg (the air pump is supplying positive pressure through the respiratory tube) the forced air causes the spring54to be compressed, thereby pushing the spherical member52to block the fresh air opening58.

The safety valve50can be a backflow valve, wherein the backflow valve is closed to fresh air when the machine/pump is on and it is open to fresh air when the machine/pump is off. The backflow valve is protected by a circular filter medium such that the user is protected from dust when the machine/pump is off. For safety, the backflow valve is designed such that the user can breathe normally if the machine is off and not supplying air (i.e., preventing suffocation).

FIGS. 7A-7Bdepicts an embodiment of a beard guard70.FIG. 7Ais a cross section of the beard guard depicting the perforations72to allow air to enter the beard guard70.FIG. 7Bis a top perspective view of the beard guard70. The perforations can be any suitable size to allow air to enter inside the beard guard. The beard guard can also include slits to allow in air into the beard guard.

The nasal respiratory mask system10may also include an outlet valve for fluids or other failure issues. The mask may be easily lifted from the face in case of emergency to eject undesirable matter like bodily fluids or stray hair, and also allows the user to scratch under the mask. The mask may be returned to its original position without the need to remove the mask.

The nasal mask shell12may include a lightweight, flexible construction that allows the structure to be deformed and bend at the application of external pressure, in contrast to the conventional rigid structure. The nasal mask shell12may also come in a variety of sizes to accommodate the needs of the user. The interior edge of the nasal mask shell12may include a rim of cushion for comfort and provide a secure seal to a user's face. Further, a broad chin seal area on the face piece may help to circumscribe facial hair and provide a better seal. The optional chin seal can be broadened, narrowed, adjusted, or customized for a particular user.

The volume of the nasal mask shell and external placement of the exhaust valve20may cause re-breathing of carbon dioxide trapped in the mask dead space, which may help to reduce central apnea. The design of the nasal respiratory mask system10includes comparatively high volume in the nasal mask shell12and an external tuned exhaust valve20, with a comparatively tight seal. A curved seal edge of the nasal mask shell may increase dead space in the mask, but not mask weight or size, so it maximizes mask volume while minimizing mask size.

The nasal respiratory mask system may be made according to OSHA specifications and may be worn for 8 hours or more per day. Additionally, it may be chemical resistant to prevent skin oils, creams, ointments, etc. from adhering to the system.

The nasal respiratory mask system may be used at normal CPAP machine pressures. The pressure can be adjusted to ensure a reliable and comfortable seal between the mask and the user. For example, the pressure of can be up to about 12 mm Hg, up to 25 mm Hg, up to 40 mm Hg, or up to 45 mm Hg.

The nasal respiratory mask system may be worn with a ski mask at higher pressures to help seal under the eyes. It may also be worn with a nose strip or other breathing aids, such as a dental appliance or nasal insert.

Yet another advantage of the nasal respiratory mask system is that it does not require a humidifier because an appropriate humidity level is better retained in the mask compared to other masks. The moist, heated air remains in the mask shell. This may reduce machine/system costs overall because a humidifier is not required. Without a humidifier, the present system may be run for relatively longer periods of time on a battery. It also travels more easily. If weight and size and lack of electrical utilities are an issue, the present system may be used ‘in the field’ with a battery. For the performance, the machine has the advantage of being lightweight and portable.

Another advantage of the present system is that it may not require pressure relief features (i.e., machine algorithmic pressure adjustments for comfort). The nasal respiratory mask system takes time to pressurize and de-pressurize due to its volume and flexibility, so pressure-relief comfort is built in to the design. Additional pressure relief may be achieved using the nasal respiratory mask system with existing comfort algorithms. Because pressure relief isn't required, the present system costs may be decreased.

A further advantage of the invention is that the nasal respiratory mask system may be produced inexpensively of durable materials.

Another advantage is the nasal mask shell may be trimmed with a sharp scissors along the chin edge to allow the mask to sit closer the face and seal better.

Acknowledging that all CPAP masks may cause facial indentations from use, the present system is advantageous in that the depth and placement of the indentations may be in places that are physically more comfortable and attractive than other masks.

Acknowledging that all CPAP masks may cause dermatitis, an advantage of the present system is that any thin cotton handkerchief, bandana, or cap may be worn under the headgear to reduce the dermatitis. In addition, fabric tape can be used with the headgear to reduce dermatitis.

It should be noted that various changes and modifications to the embodiments described herein will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the spirit and scope of the present invention and without diminishing its attendant advantages. For example, various embodiments of the systems and methods may be provided based on various combinations of the features and functions from the subject matter provided herein.