This application does not claim the benefit of a provisional patent.
None.
None.
The following is a tabulation of some prior art that presently appears relevant:
This patent application relates specifically to a mattress which allows a person to lie with their face straight into the mattress plane or what is referred to as Pure Prone Positioning (PPP) and then sleep in this position. This position is where the neck is “kept in extension in line with the body (180 degree) during sleep,” Afrashi, et al page 2. The patient is positioned face-down with their head in a neutral position without excessive flexion, extension, or rotation of the head and neck. Normally when a human sleeps on their stomach in a prone position they must turn their head, with a PPP mattress they do not have to.
Humans are one of the few mammals which sleep on their back or supine position. Some in the medical field theorize that is why humans have so many sleep disorders because we are still evolving toward being able to sleep in a supine position. One sleep disorder that affects a diverse segment of the population is Obstructive Sleep Apnea (OSA). This is where a sleeping persons throat collapses and closes completely and they must wake up to begin breathing again. This can happen up to 50 times or more per hour, according to the Dale Schneider overnight sleep study. A popular misconception about OSA is that it is related to obesity. According to Rami N Khayat, MD Director of the UCI sleep medicine center, evidence shows that even with a normal BMI people still suffer from OSA.
It is estimated that 22 million American's suffer from OSA. OSA can have profound negative health consequences over time according to, Khayat, R; Pleister A, Sleep Medicine Clinics, “Consequences of Obstructive Sleep Apnea: Cardiovascular Risk of Obstructive Sleep Apnea and Whether Continuous Positive Airway Pressure Reduces that Risk.” The gold standard treatment is the Continuous Positive Airway Pressure (CPAP) machine. Unfortunately, about 50% of users reject the CPAP machine within 6 months, it's really tough to sleep with a mask blowing air into your face. These sufferers of OSA are left to other strategies. Unfortunately, other strategies/devices have about the same compliance rates. So many devices are additions beyond the normal parameters of sleeping that they drive non-compliance. They are clumsy, hard to use, and uncomfortable.
There are numerous medical studies which show improvement with OSA symptoms by using positional therapy for mild and medium OSA suffers including Ravesloot, M. J. L. et al; “The undervalued potential of positional therapy in position-dependent snoring and obstructive sleep apnea—a review of the literature,” and Afrashi et al “Effect of prone positioning in mild to moderate obstructive sleep apnea.” This therapy concentrates on positioning while sleeping on your side or your stomach by using aids like pillows or proning devices. In fact, Dr Khayat the Director of the UCI sleep medicine center said to me, “Sleeping on your stomach is an excellent strategy, many of my patients do it.”
Sleeping on one's stomach on a regular flat mattress forces the sleeper to twist their head to the side. To get comfortable they must use various pillows or foam pads in an attempt to compensate for the neck stress. I did this for years. Still after years of sleeping on my stomach without proper support, I was told by Jon White MD I had developed a “Swan Neck Cervical Deformity.” This left me unable to sleep on my stomach while bending my neck. With this type of injury, a person can only sleep on their stomach with a true PPP mattress.
What I needed was a device or mattress which enables a person to sleep prone with their face straight ahead, perpendicular in relation to the mattress, a face rest which conforms to the size of their face and keeps their neck aligned with their spine longitudinally and laterally, fits within a traditional mattress footprint with a headboard and footboard but doesn't require them to operate.
One platform which allows a person to lie on their stomach in a true PPP prone position is the traditional massage table. These are rectangular shaped padded tables with legs and at one end sticking out of the table's plane is a face rest. With the face rest sticking outside of the plane of the bed by about a foot this would not work with a head board. Further a sleeper uses the spaces on the bed beside their head to turn over. A person on a massage table must wiggle down the table until their head is within the table plane. Then they can use their hands to turn over.
Some massage tables have a hole in the table plane where one can put your face through instead of the usual face cradle. These holes work OK on a massage table because the table is only 2 to 3 inches thick, and your mouth hangs down below allowing you to breathe. If the face hole was made on a traditional mattress of 8 to 10 inches thick you would rebreathe your carbon dioxide within seconds. Also, traditional mattress sits on a platform which would block any hole within the mattress. Placing your face in one of these massage table holes you will notice that the forehead is tilted upward, and the neck is not in full alignment. This relates to the size of your belly or human mid-section, because if your mid-section protrudes your face isn't going to lay flat. Since the face rest juts out from the mattress footprint by about a foot, this makes it awkward to use long term in a normal bedroom setting.
For years my sleeping position mirrored the sleeping position in foreign patent JP 2011-240098. The person's head is only supported on the forehead. In subsequent pictures the person uses their arms to support their head. In this position the weight of the head is not completely supported and the effect is for the chin and jaw to pull downward, while the forehead tilts upward in relation to the body. Over time you could damage the vertebrae in your neck, like I did.
U.S. Pat. No. 2,959,794 is a true PPP mattress. It has a hole to put your face in which is one size fits all not considering different face shapes. Routed through the device are tubes leading from the face hole cavity to the outside of the mattress for oxygen exchange. These were referred to as Air Intake Aperture 22 and in my experience this type of air exchange is inadequate. During normal breathing you would begin to rebreathe your own carbon dioxide. Normal breathing is a slow methodical process, it doesn't have the force required to clear the airspace and in your last exhale you leave carbon dioxide within the face cavity.
US2009021745A1 is a PPP mattress. This mattress is an air mattress claim 11 with a “cavity” claim 1 for your face to recline in. It's a one-hole size fits all face cavity not taking into account different face shapes. Throughout the device are tubes and pipes FIGS. 10 & 10A, some with valves, to control the air flow from the person breathing. There is also an environmental insert FIGS. 2 & 6 & 7 which is for filtering air. In one embodiment the mattress is made of “a coiled springs mattress, air can travel from outside through the mesh,” 116 FIG. 6. These airflow devices would be difficult to work. The human body breathing normally simply doesn't have the capacity to clear the devices of carbon dioxide. For someone with a swan neck cervical deformity this could be a dangerous bed to sleep on. Too often neck pain is so severe for someone like this, they resort to taking a strong dose of pain medication at bedtime. Without being able to detect the signals of CO2 poisoning (hyperventilating) one could fall off to sleep and have a problem.
US patent 2021/307520A1 is another example of a true PPP mattress. The device fits within a standard bed footprint, with a face removal cushion FIG. 1 104. This opening is a one size fits all face cavity not considering different face shapes. Also, the opening cannot move the head up or down. The drawing assumes your neck will be in alignment. This may be so with a large part of the population but individuals with neck injuries and an extended belly (bodily mid-section) require a slight elevation. When I tried to sleep on a table with a face hole like this my forehead tended to want to elevate creating pressure at the back of the skull, this related to the belly size of the sleeper. In one embodiment it is to raise the mattress 0040 218 “to allow airflow for proning position.” Further FIG. 6 states “an environmental view,” which purport to show the mattress raised. FIG. 6 does not appear to show the upper portion raised for airflow.
Foreign patent CN202400282U is another patent which is for a PPP mattress. Like the mattress mentioned before no concern is given to the face-hole size or height. Additionally, no contingency is shown for how the person sleeping will breathe.
There are devices when coupled with a bed or other sleeping platform which allow one to sleep in a PPP position. They are typically called proning platforms. One I have used is made by Oak Works. Several medical procedures require proning and during the procedure the proning platform is placed on the table/bed. From there the person lies face down and has the procedure done. The proning platform is in the plane of the bed but since it is on top of the bed it would not work overnight. Most proning platforms have a slant tilt to get your face off the table, including the upper torso. A key point is all proning platforms allow a person to breathe normally without any aid. Also, people can be medicated on this device. Since proning devices sit on top of the mattress plane comfort is an issue which makes it awkward to use long term in a normal bedroom setting. They are outside the normal parameters of sleep comfort and it will drive non-compliance.
U.S. Pat. No. 2,556,629 is another example of a proning device. The structure in FIG. 1 allows for one's head to rest and breathe normally and in FIG. 3 it is adjustable to the size of the face. These allow a person to sleep in a PPP position while the device is on the bed. Since this is a proning device outside the normal parameters of sleep comfort it will drive non-compliance.
U.S. Pat. No. 6,047,420 is a true PPP device which is placed on top of a mattress. The person's head and shoulders are supported yet the legs are not. This is like the Oak Works proning device. This is not something one could sleep comfortably on all night. Since this is a proning device outside the normal parameters of sleep comfort it will drive non-compliance.
U.S. Pat. No. 7,017,213B2 is an example of the kind of pillows used to help with prone sleeping. Still like all pillow devices this is not a true PPP device, it keeps the neck at a comfortable angle. One never gets to a true PPP as the neck is slightly twisted to one side.
US patent 2013/0245395A1 Pillow and Mattress for OSA is an example of a mattress pillow combination for the treatment of OSA. The pillow is “T” shaped claim 1 in various embodiments the head FIGS. 9 & 10 can lay on either side of the pillow. In some instances, FIG. 9A a person's head could slip off to the left, in other instances, FIG. 9B a person's head could slip off to the right. I tried sleeping on a massage table several times, one night while sleeping I rolled over and my head popped out of the face rest and jolted downward off the table. It really hurt.
In claim 10 there are recesses on the side of the mattress FIGS. 20, 21, 22, and 23, in addition in claim 12 there is a recess for the chin. This clearly is not shaped like any regular mattress. Without these embodiments the device will not work as mentioned. In claim 18 FIG. 31 it is shown how to adjust the head rest, “which structure resembling a shelf for the pillow upward and downward motion,” without a headboard or other method of hanging the headrest FIG. 12 36 the device will not work. There are circumstances where headboards and footboards are not available, mostly for medical procedures. To be a workable PPP mattress it must be fully self-contained within the footprint of the bed.
Concluding my search I found that there was no device or mattress which enables a person to sleep prone with their face straight ahead, a face rest which conforms to the size of their face and adjusts to keep their neck aligned with their spine longitudinally and laterally, fits within a traditional mattress footprint with a head board and foot board but doesn't require them to operate, and the mattress plane is substantially flat.
This patent is for a Pure Prone Positioning (PPP) mattress allowing for one or more people to sleep on a bed in the prone position, with their face straight into the mattress plane. Structurally the mattress fits within a standard bed footprint and midpoint where the head is normally positioned on the mattress, a cavity of substantial size is designed for placement of a face rest proning assembly to be positioned at that location. The face rest proning assembly allows for longitudinal and lateral adjustments of the head and neck, and the padded face rest is adjustable to the face width. The face rest proning assembly allows for easy breathing of oxygen and exhalation of carbon dioxide. Since breathing is normal a person can be medicated while sleeping on the PPP mattress. Additionally, since the face rest proning assembly is within the footprint of a normal mattress, a sleeper can easily and safely turn over to reposition their body throughout the night, by simply pulling the pillow to the side exposing the face rest.
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The second embodiment of said mattress is the use of an innerspring coiled mattress for the mattress core, instead of memory foam. Padding layers are added to the outside of the coils and built up to aid in comfort. Then it is enclosed in a cloth cover. Midpoint where the head is normally positioned on the mattress, a cavity of substantial size is designed for the face rest assembly. Once the assembly is in place, the subject's head is cradled in a face rest assembly allowing adjustments for comfort and natural breathing, with no neck bending or cervical stress. A face rest proning assembly a combination of a foam padded fabric enclosed face pad mounted on a lab jack scissor stand platform. The description focuses on a single sleeper but it could very well be for two sleepers.
The third embodiment of said mattress is the use of either a foam or innerspring coiled mattress for the mattress core. Midpoint where the head is normally positioned on the mattress, a cavity of substantial size is designed for the face rest assembly. In this embodiment I envision the face rest proning assembly to be attached physically to the mattress structure through an internal structure, instead of a standalone lab jack scissor stand platform. The face rest would be mounted on a typical face rest with prongs jutting out. The prongs would be inserted into matching holes which are connected to the face rest proning base within the mattress itself. Since the structure is internal there is more room for medical tubing and other devices to be used.
The above spring mattress embodiment is focused on a Bonnell coils, but it could easily be used for offset coils, continuous coils, pockets coils, or a mixed/hybrid of, latex on top of coils, memory foam on top of coils, memory foam mixed with latex on top of coils, latex, memory foam, and coils on top of polyfoam.
In operation before lying down, one adjusts the massage table pillow to their face at the same time they affix it to the plastic horseshoe shaped 007 with hook Velcro on the face rest proning assembly. Once in place the person lays with their face in the face rest proning assembly. From there they reach into the cavity and turn the plastic handle to adjust the height of the face rest. At this point the bed is ready for sleep. The person now lays on the PPP mattress and positions their head on the face rest proning assembly. Gravity works in the person's favor as the tissue that normally collapses is now held in place by gravity.
The face rest proning cavity combined with the face rest proning assembly creates a gap between the top edges of the mattress and the face rest pillow. This gap allows exhaled air to be dissipated throughout the room. The structure under the face rest pillow is open which also allows ease of transfer throughout the room. This gap also protects a sleeper's head from inadvertently rolling off the mattress plane. If a person turns over in the middle of night their head would still be supported by either the FPA or the main mattress. These two factors allow a sleeper to be medically sedated.
If the PPP mattress has a pillow and bed spread the FPA is undetectable: The bed appears to the eye to be a regular bed. All they need to do is lay on the bad supine or on their side, when they are ready to sleep prone, simply roll over while pulling the pillow to the side. Now the FPA is exposed and the sleeper puts their face in it and goes to sleep. This minimal movement is important, if this was a massage table you would expend considerable energy to wiggle down to where you could use your hands to roll over making it hard to fall back asleep.
In one embodiment the FPA is attached to the mattress. This would create more space under the proning pillow which would allow for medical tubing and sensors to be placed. It would have no effect on air exchange but the extra tubing space would be helpful. COVID patients are regularly proned and many have been intubated before being put into a medically induced coma. The tubing for an intubated patient is extensive and the added space will aid in the treatment.
A sleep study mattress is one of the embodiments I foresee. An important part of a sleep study is the way your chest moves and the devices used to detect the movement. In a polysomnogram (overnight sleep study) an elastic band is affixed around a patient's chest to measure breathing. The device that collects the data sits on the front of the chest it is hard plastic and sticks out almost 2 inches. It is very difficult to sleep on your stomach with this, a simple solution would be to carve a small cavity out of the mattress to fit where this plastic box is. In this embodiment a patient would be able to roll over and the plastic box would fit into the cavity. In the current take home sleep study there is no way to sleep conformably on one's stomach.
After reading the description, the reader will see that at least one embodiment of the pure prone positioning mattress provides therapeutic value like no other mattress. This mattress can significantly reduce mild to medium OSA. The unique mattress shape combined with a face rest proning device allows a person to sleep with their face perpendicular to the mattress plane. With their head and neck in a neutral position gravity keeps their airway open allowing normal respiration. Additionally therapy compliance has been shown to be an issue with many sleep aids. With the PPP mattress it sets on the same platform as a regular bed and is switchable from supine (back) to prone (stomach) in a quick turn and a pull of the pillow to the side.
The ramifications are that the PPP mattress has other uses and advantages in that:
While my above description contains many specifics, these should not be construed as limitations on the scope but rather as an exemplification of one or more embodiments thereof. Many variations are possible. For example, I presently contemplate the PPP mattress to be made of memory foam enclosed in a cloth bag, with the face proning assembly not connected to the mattress but standing independently. Future PPP mattress will be made with the face proning assembly connected to an internal structure within the mattress. This will open up a lot of space under the face rest pillow for medical devices, tubing, intubating and patient monitoring sensors.
Accordingly, the scope should be determined not by the embodiment illustrated but by the appended claims and their legal equivalents.