The present subject matter relates generally to face masks. More specifically, the present subject matter relates to face masks for oro-nasal ventilation that include a first chamber and a second chamber, with one or more inter-chamber connections providing a pressure differential between the two chambers.
Many currently available oro-nasal ventilation face masks provide air to the patient equally across both the nasal and oral passages, providing an equilibrium in pressure at the respiratory tract opening. During periods of apnea and at the end of expiration when respiratory flow is zero, air within the oro-nasal cavity remains stagnant even if both the nasal and oral passages are open. Further, this constant and equal pressure provided to the nasal and oral passages simultaneously is inefficient for patients that inhale primarily through one passage. The user or treatment provider is unable to customize the air flow and air pressure to address this issue.
Accordingly, a need exists for an oro-nasal ventilation face mask that provides separate chambers having a pressure differential therebetween, allowing the user or treatment provider to assign a customized pressure and flow profile to each chamber that more effectively meets the patient's needs.
To meet the needs described above and others, the present disclosure provides an oro-nasal ventilation face mask including a first chamber and a second chamber connected through a restrictive element. Each chamber is fully enclosed and sealed against the patient's face during use. The separation enables different air pressures to be maintained at the patient's nasal passage and oral passage in order to promote breathing. The face mask is secured to headgear which maintains the positioning of the face mask on the patient during sleep.
In one embodiment, the first chamber is an oral chamber and the second chamber is a nasal chamber. The oral chamber receives airflow from an inflow tube, and air is provided to the nasal chamber through the restrictive element. A constant flow of air through the resistive element occurs by placing at least one vent, or diffuser, in the second nasal chamber in this embodiment.
A front frame is positioned on an external front portion of the oral chamber. The front plate includes slots on opposite sides to receive and hold straps of the headgear. The front plate also includes an opening for receiving the inflow tube. A second opening within the front portion of the oral chamber receives an internal flange on the opening of the front plate, providing an airtight seal where the inflow tube engages with the face mask.
The restrictive element positioned between the oral chamber and the nasal chamber allows air to flow into the nasal chamber. The restrictive element may be, for example, a restrictive orifice, a low-pressure valve, a venturi element, a laminar flow resistor, one or more resistive tubes, or another suitable apparatus, and may include baffles or other diffusive elements to guide the flow of air and reduce noise. The purpose of the restrictive element is to create a pressure differential between the oral chamber and the nasal chamber, enabling the air pressure in the oral chamber to be greater than the air pressure in the nasal chamber. The pressure differential in this embodiment allows air to flow into the patient's mouth, through the patient's oro-nasal cavity, and out through the patient's nose. In other embodiments, the air pressure in the nasal chamber may be greater than the air pressure in the oral chamber, causing air to flow freely into the patient's nose, through the patient's oro-nasal cavity, and out through the patient's mouth.
The oro-nasal ventilation face mask described herein may also include an anti-asphyxia safety valve in one or both chambers which allows air to flow into the mask when positive air pressure is not being provided by an air pump or positive pressure machine.
In one embodiment, the air flows into the mask into a first chamber chambers, and a vent or diffuser that is open to atmosphere is located in the second chamber. It is contemplated that the inflow may be to either the nasal or oral chamber, with the corresponding vent or diffuser in the other chamber.
In a first embodiment, the first chamber may be an oral chamber and the second chamber may be a nasal chamber. In a second embodiment, the first chamber is a nasal chamber and the second chamber is an oral chamber.
Each of the first chamber and the second chamber may include a cushion along a sealing edge of each of the first chamber and the second chamber that, in combination with the headgear, assists in sealing the chamber against the user.
One advantage to the invention is that the bias flow significantly reduces the amount of physiological dead space within the respiratory tract.
A further benefit of the invention is that the bias flow lowers the metabolic demand attributed to respiratory muscles for patients with various types of pulmonary disorders.
An advantage to the invention is that by creating a pressure differential between the two chambers, the flow of air can be tailored to suit each patient's needs.
Another advantage to the invention is that creating a pressure differential between the nasal passages and oral passage will allow air to flow freely into the patient's oro-nasal cavity through the cavity opening within the higher pressure chamber.
Another advantage of the invention is that creating a pressure differential between the two chambers can improve upper airway patency during events of the patients mouth opening.
Additional objects, advantages and novel features of the examples will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon examination of the following description and the accompanying drawings or may be learned by production or operation of the examples. The objects and advantages of the concepts may be realized and attained by means of the methodologies, instrumentalities and combinations particularly pointed out in the appended claims.
The drawing figures depict one or more implementations in accord with the present concepts, by way of example only, not by way of limitations. In the figures, like reference numerals refer to the same or similar elements.
In the embodiment illustrated in
A restrictive element 106 positioned between the oral chamber 104 and the nasal chamber 102 allows air to flow into the nasal chamber 102, while a vent 122 in the nasal chamber 102 is open to the ambient environment and allows air to escape. The restrictive element 106 and vent 122 operate in conjunction to maintain an air pressure within the nasal chamber lower than an air pressure in the oral chamber 104. The restrictive element 106 may be, for example, a restrictive orifice, a low-pressure valve, a venturi element, a laminar flow resistor, one or more of resistive tubes, or another suitable apparatus, and may include baffles or other diffusive elements to guide the flow of air and reduce noise. The pressure drop effectuated by airflow through the restrictive element 106 depends on the length, the cross-sectional area, and the surface area roughness of the restrictive element 106. These aspects may vary as desired.
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In some embodiments, each chamber 102, 104 has a cushion around its edge which improve the seal and prevent air leaks from the chamber. The cushion may comprise silicone or another material with similar properties (e.g., resilient, cushioned, comfortable against the user's skin, etc.).
It should also be noted that while particular combinations of features have been described, the scope of the present invention is not limited to the particular combinations presented herein, but instead extends to encompass any combination of features disclosed. Various changes and modifications to the presently preferred 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.
This application incorporates by reference and claims the benefit of priority to U.S. Provisional Patent Application No. 62/785,689 filed Dec. 27, 2019.
Number | Date | Country | |
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62785689 | Dec 2018 | US |