Sleepnea: New Therapy Options 
for Obstructive Sleep Apnea

Sleepnea has a growing intellectual property portfolio that currently comprises eight pending patents for devices and methods to treat Obstructive Sleep Apnea.  This portfolio includes new mask technologies to create masks with the potential to be more comfortable, fit better, leak less, and are less prone to being dislodged by head-to-pillow interaction than masks that are currently available.  Of these patent-pending mask technologies, the two that are the most developed thus far are the "Adjustable-Contour Mask" and the "Fabric-Channel Mask."   Sleepnea also has pending patents for non-surgical, non-neurostimulation devices and methods to keep the tongue out of the airway during sleep.

The first of Sleepnea's more-developed mask designs is the Adjustable-Contour Mask.  This mask has an engaging user interface that allows a patient to custom fit the mask to their face while they are wearing it in manner that is not possible with currently-available masks.   Figure 1 below shows one way in which the Adjustable-Contour Mask may be embodied.  The right side of Figure 1 shows a mask with individually-inflatable compartments around the perimeter of the mask where it fits again the persons face.  The left side of Figure 1 shows a touch-screen user interface that allows the patient to individually inflate or deflate each of the compartments around the perimeter of the mask in order to custom adjust and conform the mask to the contours of their face.  This user-interface enables custom fitting to reduce leaks and tight spots around the perimeter of the mask.
 
 


Figure 1: Adjustable-Contour Mask
(with Custom-Fitting Touch-Screen User Interface)

In this example, each of the inflatable compartments around the perimeter of the mask interface can be individually inflated or deflated by adjusting the pressure of a gas within the compartment.  The ability to differentially and selectively adjust the size and/or shape of each of these inflatable compartments by individually adjusting the pressure within each compartment allows customization of the shape of the perimeter of the mask to better fit the contours of an individual's face while the mask is being worn.  This helps to avoid areas of excess pressure (that can cause skin irritation and pain) and to avoid areas of inadequate pressure (that can cause air leaks). 

Having differentially and selectively movable members around the face-contacting contour (perimeter) of the mask allows a better and more comfortable seal than is possible with methods that rely on straps to hold the mask against one's face.  One can adjust the overall position and pressure of a standard respiratory mask by adjusting straps, but there are limits to how accurately the straps can change the face-contacting contour of a standard mask.  Having differentially and selectively adjustable members around the perimeter of the mask also allows a better seal than is possible with a single inflatable ring or a single compressible gel ring.  With a single inflatable ring, it can be difficult or impossible to find a single inflation pressure that stops leaks at spots where there is a gap between the mask surface and face without pinching or overly compressing the skin at other spots.

The second of Sleepnea's more-developed mask designs is the Fabric-Channel Mask.  This mask has multiple, redundant air channels that are integrated into soft fabric for greater comfort and reduced leaks, especially for patients who toss and turn in their sleep.  Figure 2  below shows one way in which a Fabric-Channel Mask may be embodied.   In this figure, the Fabric-Channel mask is embodied in a "ski-mask" design with multiple tubes woven into, or threaded through fabric channels within, each side of the mask face. 
 
 


Figure 2: Fabric-Channel Mask
(with Multiple, Redundant Air Channels on Both Sides of the Face)

The left side of Figure 2 shows roughly equal airflow through multiple air channels on both sides of the face when the mask is worn without any contact with an external surface such as a pillow.  The right side of Figure 2 shows how proper airflow is maintained by greater airflow through one side of the mask when the other side of the mask is compressed by contact with an external surface such as a pillow. 

This design with multiple, redundant air channels allows a more comfortable mask design that accommodates more tossing, turning, and extensive head-to-pillow interaction than conventional masks with one central (and relatively-incompressible) air tube.  If the person were wearing a conventional mask with one large tube, then the mask would be subject to torque force from the pillow and would likely leak or be dislodged entirely.  However, the Fabric-Channel mask with multiple redundant channels can provide proper air pressure and flow, without leakage or dislodging, even when a person's face is pressed against a pillow. 

In the right side of in Figure 2 with the head pressed against a pillow, airflow through the air channels on the downward side of the person's face is significantly reduced by compression of these tubes against the pillow.  However, the same total airflow is maintained by an increase in airflow through the channels on the upward side of the person's face, away from the pillow.   Accommodation of compression in redundant pathways allows the use of thinner tubes.  The use of thinner tubes can result in a more flexible and comfortable textile member to deliver pressurized gas.   Accordingly, the Fabric-Channel Mask may be tolerated by many people suffering from obstructive sleep apnea who cannot tolerate current masks. 

Sleepnea has submitted a Phase I SBIR grant to NIH for funding to prototype and benchtest these two novel mask designs.  Research milestones for the Adjustable-Contour Mask include achieving 50% reduction in mask leakage and facial pressure variation as compared to currently-available masks.  Research milestones for the Fabric-Channel Mask include maintenance of therapeutic values of air pressure and flow and 50% reduction in mask leakage and facial pressure variation as compared to currently-available masks, including maintenance of air pressure and flow during simulated torque forces and head-to-pillow interaction.

Sleepnea also has several pending patents for novel non-surgical, non-neurostimulation devices and methods to: keep the tongue out of the airway during sleep; and move the tongue forward out of the airway if it slips backwards during sleep.  The details of these pending patents are not disclosed in this website at this time, but those interested in learning more are encouraged to contact Sleepnea for more information.

Disclaimer: These products are not yet approved by the FDA 
and are not available for patient care.

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