Pillow for PAP therapy and methods of use

Abstract

A pillow for providing positive airway pressure (PAP) therapy to a patient, which comprises a pillow body having a pressurizable facial cavity that can accommodate at least a patient's nose, mouth, or both, and that sufficiently seals with the patient's face to create a pressurizable air zone that permits PAP therapy. The pillow in some embodiments can be folded to engage the patient's face with the pressurizable facial cavity and optionally a fastener can be used to maintain the pillow in the sealed position. By replacing or concealing the traditional PAP therapy mask within a pillow appliance and / or eliminating the headgear, the physical and psychological shortcomings associated with PAP therapy may be avoided.

Description

PILLOW FOR PAP THERAPY AND METHODS OF USEField of the Invention

[0001] The present invention relates to a pillow for use in positive airway pressure (PAP) therapies that can avoid the drawbacks associated with the conventional mask and headgear assembly.Background of the Invention

[0002] Sleep apnea is a common but potentially serious condition in which a person’s breathing stops and restarts many times during sleep. The most common type of sleep apnea, obstructive sleep apnea, happens when the upper airway becomes blocked during sleep, either reducing or completely stopping airflow. The most common treatment of sleep apnea is positive airway pressure (PAP) therapy, often continuous positive airway pressure (CPAP) therapy. During PAP therapy, a PAP machine is used to deliver (continuous) pressurized air through tubing into a mask that is worn during sleep. The mask provides a seal with the patient’s face so that the pressurized air is delivered to the patient’s airway and the therapy is achieved.

[0003] Current PAP therapy masks use a nasal or oronasal mask (i.e. “full face mask”). The typical PAP mask is comprised of a hard plastic shell with an attached silicone cushion that contacts and seals against the face of the patient. The mask (shell and cushion) is held in place by “headgear” - straps that wrap tightly around the patient’s head. Conventionally, the headgear straps extend from the mask around the sides, vertex, and posterior aspect of the patient’s head. The headgear’s purpose is to hold and seal the mask against the patient’s face while they receive positive pressure ventilation in order to maintain therapeutic airway pressures.

[0004] There are well-known shortcomings of these mask-headgear assemblies.The most common and bothersome effect is sleep-disruption from mask discomfort, headgear discomfort, or mask leaking during the night. This can make the patient wake repeatedly and have to readjust mask or headgear. Headgear straps can also cause skin irritation or red marks on the face. In some cases, allergic reactions to strap materials can occur. Over- tightened headgear can leave unsightly indentations on the face the following morning, causing social or occupational embarrassment. Straps can pull on hair causing pain or traction alopecia (hair loss). Additionally, the tubing or “hose” that connects the mask to the PAP machine can also be problematic. Standard hoses are six feet long and can drag or pull on the mask. The patient can also get tangled in the air hose, which can also lead to dislodgment / leaking of the mask or sleep disruption.

[0005] What is less talked about is the psychological impact of having to wear a PAP therapy mask. This is often particularly troublesome for women. Masks can induce a feeling of claustrophobia. But more commonly, donning the mask and headgear nightly is a constant reminder of one’s medical condition. This process feels clinical and unnatural. Men and women alike may feel embarrassed, develop poor self-image, or body shame while wearing these devices, especially while sleeping next to their partner. Consequently, it is not surprising that fewer than 50% of patients will continue PAP therapy for their sleep apnea long term.

[0006] To address some of the problems with PAP therapy, various pillows have been proposed. For example, Published Application US 2010 / 0200001 relates to an adjustable pillow that can be used in conjunction with a mask and PAP therapy. The pillow has special construction that permits various conformations and shapes, including forming an indentation or pocket for a PAP therapy mask to occupy without incurring a pushback from the pillow. This makes the pillow less likely to dislodge the mask during sleeping. Another head positioning pillow for respiratory titration is disclosed in Published Application US 2015 / 0265793. The pillow seeks to optimize the angle between the patient’s mouth and throat which in turn should optimize the opening of the patient’s airway. More generally, CPAP pillows are commercially available, such as online at www.thecpapstore.com, in which irregular shapes or side cutouts are provided to give space for the mask. By allowing the mask to overhang the edge of the pillow, the risk of bumping, dislodging, and leaks are reduced. All of the above-mentioned pillows are intended to be used in conjunction with a traditional mask (and headgear) and while patient comfort (or the effectiveness of the PAP therapy) may be enhanced, most of the basic PAP therapy mask problems remain.

[0007] Other pillows seek to minimize the hose issues by providing a hose management design. For example, Published Application US 2008 / 0210236 describes a pillow structured to allow the tubing to be routed therethrough. Typically, the tubing enters from one side of the pillow and exists another. Because the tubing extends only a short distance from the side of the pillow to the mask, the weight and drag of the hose is reduced. The chance of patient tangling with the hose is also reduced. Another example is shown in WO 2023 / 102115 where the air hose is routed through the pillow and exists in a vertical direction above and behind the patient’s head before turning downwards. The result is to suspend and deliver the hose vertically above the user’s face, reminiscent of a large, curved sink faucet. This construction is intended to reduce patient tangling with the hose and / orimprove patient comfort. While routing the hose through the pillow can be useful, such pillows do not address the basic mask and headgear problems associated with PAP therapy.

[0008] Separate from PAP therapy, pillows have been proposed to permit breathing while the patient is lying face down in the prone position, such as during surgery, physical therapy, etc. US Patent No. 4,752,064 is an example of such a pillow. A void extending through the pillow (often T-shaped) is provided so that the head is supported without interfering with the eyes, nose, and mouth. The patient can see through the pillow and has an unobstructed passageway for air. Also, if the patient is unconscious then an endotracheal tube may be inserted into mouth. US Patent No. 6,230,350 also proposes a pillow for face down prone position such as during medical procedures, physical therapy, etc. The pillow is wedge-shaped and provides a recess for breathing or “air access.” The recess provides peripheral support for the patient’s head and can be square, rectangular, oval, circular, U- shaped, V-shaped, or T-shaped. Air flow conduits, typically a pair of them, can be provided through the pillow to the recess to permit air flow access. Alternatively, the recess can be a through hole which gives direct air access without conduits. These prone pillows do not create a pressurized zone for delivering PAP therapy and instead are seeking to provide mere breathable air to the patient.

[0009] A more complicated prone pillow is described in Published Application US 2006 / 0037608. The pillow support device, which is primarily intended for a patient in the prone position to receive medical attention, can be used to provide gas delivery and monitoring. A head support (e.g. a pillow) is provided with a facial cavity that extends through the pillow. The facial cavity is designed to fit the contours of the patient’s face, thereby providing support for the head while helping to prevent the creation of pressure points around the eyes and mouth. The facial cavity is exemplified as having a figure 8 pattern. The facial cavity is also intended to provide an oxygen rich environment. This is achieved by providing a gas delivery tube at least near to the facial cavity. In an exemplified embodiment, the tube travels through the head support and the proximal end of the tube is flush with an inner surface of the head support near the point where the patient’s nose and mouth would be. Thus, with the extra oxygen or air provided by the gas tube, the facial cavity “provides an oxygen rich environment in which the patient can breathe comfortably.” A second tube can be provided to facilitate sampling and monitoring of gas products exhaled by the patient, e.g., sampling end-tidal carbon dioxide exhaled by the patient. Though supplemental air or oxygen is provided through the head support to the facial cavity, the opendesign of the facial cavity (a through hole) precludes creating a pressurized zone, which is necessary for delivering PAP therapy to a patient.

[0010] Other attempts to improve PAP therapy masks involve replacing the headgear. One commercial product, sold by BLEEP ™ (Bleep, LLC) under the brand DreamPort®, uses adhesive strips to seal and hold an airway port to the patient’s nose. The airway port is connected through a diffuser and hose to the positive air pressure generated by the PAP machine. Another version, sold as the ECLIPSE ™ by BLEEP™ adds a magnet to the adhesive strip which allows the port to attach magnetically to the adhesive pads. In both cases, the adhesive pads seal around the exterior of the nose to create and maintain the pressurized zone for positive airway pressure therapy through the nose / nostrils. These devices avoid the headgear straps, but are limited to nasal therapy, do not address the hose issues such as entanglement, and do not significantly alter the clinical feeling or psychological impact of PAP therapy.

[0011] Another nasal PAP product is sold by Airway Management as the myTAP PAP® nasal pillow mask. The device is a variation of the myTAP® oral appliance, which is similar to a dental tray and held between the teeth. An extension from the appliance out of the mouth provides a platform to hold nasal air conduits. The air conduits are flexible and when pressed against the nostril can seal to maintain the pressurized zone for providing PAP therapy. While achieving removal of the headgear, the device is limited to nasal PAP therapy, does not address the hose entanglement issues, and does not significantly alter the clinical feeling or psychological impact of PAP therapy.

[0012] Despite numerous attempts to mitigate the problems with PAP masks and PAP therapy, deficiencies still exist. Providing a PAP interface that could increase treatment compliance for sleep apnea would be desirable.Summary of the Invention

[0013] The present invention relates to a pillow that has a pressurizable air zone for delivery of PAP therapy to a patient. In one aspect, the pillow comprises a pillow body having a pressurizable facial cavity therein that can accommodate at least a patient’s nose, mouth, or both; and a passageway to the pressurizable facial cavity that is suitable to transmit pressurized air. The pressurizable facial cavity and / or the pillow body surrounding it can sufficiently seal with the patient’s face to form a pressurizable air zone suitable for PAP therapy. The passageway can be located to pass through the pillow body and thus connect the pressurizable facial cavity with an external surface of the pillow body. This embodiment facilitates connection of the PAP machine air hose either through the pillow body or to aconnector port on the external surface, etc. The pressurizable facial cavity typically has an exhaust port that facilitates the removal of exhaled gases from the patient, as is conventionally employed in traditional PAP therapy masks. In some embodiments, the pillow body is strapped to the patient’s face or head, often with folding of the pillow body, to maintain the pressurizable air zone. Various fasteners can be used to strap the pillow body such as a drawstring, elastic band, hook and loop, buckle, spring, magnets, etc., and such fasteners can be internal or external of the pillow body. The pillow body can be of regular shape, such as rectangular, square, circular, etc., or irregular shape having, inter alia, one or more arms extending from a central portion.

[0014] Another aspect of the present invention relates to a method for positive airway pressure therapy, which comprises engaging at least a patient’s nose and / or mouth into a pressurizable facial cavity in a pillow body to form a seal between the patient’s face and the pressurizable facial cavity and / or the pillow body surrounding it; and providing pressurized air to said pressurizable facial cavity to form a pressurized zone for PAP therapy.

[0015] An additional aspect of the invention resides in a method for PAP therapy in which a pressurized air zone is created around the patient’s nose and / or mouth, the improvement for which comprises that the pressurized air zone is embedded into a pillow body. By placing the pressurized air zone in the pillow body, the traditional mask headgear can be avoided.

[0016] The present invention permits replacement of the traditional PAP therapy mask and / or headgear with a far less clinical and more familiar appliance, namely a pillow. By embedding the pressurized air zone within a pillow body, the psychological objections to the traditional PAP therapy mask and headgear can be avoided. In some embodiments, a PAP therapy mask is part of the pressurized air zone, i.e., forms part of the pressurizable facial cavity, but the headgear is not employed by the patient which results in improved psychological and physical experiences. Likewise, the physical shortcomings of discomfort, repeated waking, skin irritation, hair loss, etc., can be reduced or alleviated in certain embodiments.Brief Description of the Drawing

[0017] FIGS. 1 A-1D show a perspective view, a rear view, a top view and a side view of a pillow of the invention (Prone Pillow).

[0018] FIGS 2A and 2B show a top and side view of a variation of the pillow of FIGS 1A-1D.

[0019] FIGS. 3 A-3C show a front view, a front view in use, and a side view of a pillow of the invention (H-Pillow).

[0020] FIG. 4 shows a dual pressurizable facial cavity variation of the pillow shown in FIGS. 3A-3C.

[0021] FIGS. 5A-5C show a perspective view, a top view, and a front view in use of a pillow of the invention (Taco Pillow).

[0022] FIGS. 5D-5F show a top view, a top view in use, and a front view in use of a pillow of the invention (Taco Pillow 2).

[0023] FIG. 6 shows a variation of the pillow shown in FIGS. 5D-5F.

[0024] FIGS. 7A-7C show a top view, a perspective bottom view, and a perspective side view of a pillow of the invention in use in supine position. FIG. 7D shows a perspective view of the pillow in use in a side sleeper position (weighted Taco Pillow).

[0025] FIGS. 8A-8D show a top view, a front view in use, a side view in use, and a top view in use of a pillow of the invention (Saturn Pillow).

[0026] FIGS. 9A-9D show a side view in use, a front view in use, a top view in use, and a perspective view of a pillow of the invention (Starfish Pillow).

[0027] FIGS. 10 A- 10C show a top view, a back view, and a view in use of a pillow of the invention (Starfish).

[0028] FIG. 11 shows an alternative design of the pillow of FIGS. 10A-10C.

[0029] FIG. 12 shows a front view of an alternative design of the pillow of FIGS. 10A-10C.

[0030] FIGS. 13A and 13B are detail plan views of two embodiments of the pressurizable facial cavity of the pillow shown in FIG. 12.

[0031] FIG. 14 is a plan view of a pillow of the invention in use (Record Player Pillow).

[0032] FIGS. 15A and 15B are a perspective view and a side view of a pillow of FIG. 14.

[0033] FIG. 16 is a partial side view of a pillow of the invention with a mounding profile around the pressurizable facial cavity.

[0034] FIGS. 17A and 17B are each a perspective view of a liner insert for a pressurizable facial cavity.Detailed Description of the Invention

[0035] The pillow of the present invention comprises a pillow body having a pressurizable facial cavity therein. The pillow body is a three-dimensional cushioningappliance. Typically, the pillow body comprises cushioning fill provided in a cover or casing, which is often made of fabric, though in some cases the cushioning fill material is self-supporting and such a cover or casing is optional. The cushioning fill can be any conventional pillow fill. Examples of the fill material include natural and / or synthetic materials including latex foam, polyurethane-based foams such as memory foam, goose down, feathers, wool, cotton, and polyester, but is not limited thereto. Fill materials can be continuous, such as one or more layers of foam material(s), or discontinuous, such as shredded or cut foam pieces, down, feathers, etc. The fill can be a combination of different fill materials and / or a combination of continuous and discontinuous materials. Likewise, different portions of the pillow body can use different fill materials.

[0036] The shape of the pillow body is not particularly limited. In some embodiments, the pillow body has a regular shape such as a rectangle, square, or circle, etc. In other embodiments the pillow body can have cutouts or irregular shapes, often involving one or more arms extending from a main portion or linking two main portions. The pillow body can be substantially flat, i.e., a relatively uniform profile, or it can be structured to have varying heights when viewed in profile. Such structured arrangements may be variable in 2 or 3 dimensions. In some embodiments, the pillow body can be flat when not in use but can be folded when in use. This creates two different profiles, e.g., the open or flat profile and the closed or folded profile.

[0037] The pillow body contains a pressurizable facial cavity. The cavity is accessible or open from an external surface of the pillow body, typically a top surface. The cavity has sides and a bottom. While termed a “facial” cavity, the main purpose of the pressurizable facial cavity is to accommodate a patient’s nose, mouth, or both, and a limited portion of the surrounding area of the patient’s face along the cheek, chin, bridge of the nose, etc. The opening and depth of the cavity generally does not permit the majority of a patient’s face to be inserted into the cavity, though such is possible in some embodiments. For example, the cavity is typically not so large that a person’s eyes are within the cavity as the positive air pressure can dry out the eyes. Yet, in some embodiments, however, the portion of the patient’s face that fits within the cavity can include the eyes but usually with some precaution such as a protective strip across the cavity that aligns with the patient’s eyes, the patient wearing eyewear / googles, etc.

[0038] The pressurizable facial cavity can form a pressurizable air zone when the patient’s face is engaged therewith. The patient’s face can form a sufficient seal with the facial cavity, more precisely the rim or perimeter of the cavity, and / or the pillow body thatsurrounds the facial cavity, e.g., surrounds the rim of the cavity, to permit a pressurized air zone once air is delivered by the PAP machine. The seal does not have to be perfect, nor does the cavity have to be perfectly airtight, but sufficiently sealed / airtight to permit maintenance of the therapeutic pressures used in PAP therapy. The pressurizable facial cavity thus serves the function of the traditional PAP therapy mask but in a different form factor and in a less clinical or psychologically disturbing presentation. Burying the patient’s face into a pillow, for example, is normally considered relaxing and comfortable.

[0039] The sides and bottom of the pressurizable facial cavity are generally formed from the pillow body, though a liner or insert can also be present or used as part of the pressurizable facial cavity. The liner can have several purposes. One use of a liner is for hygienic purposes wherein the liner is removable so as to be disposable and / or washable. Another use of a liner is for additional sealing power with the patient’s face, such as by incorporating a silicone coating or other sealing agent. Furthermore, the liner could provide dimensional stability to the cavity to help maintain the cavity shape so that the seal, and pressure within the cavity, can be maintained during use. The liner could also provide or enhance the air pressure retention ability of the pressurizable facial cavity. The pillow material, such as open-cell form, tends to allow the pressurized air to pass through the pillow body. A liner can prevent or reduce such unwanted transmission. For enhancing the dimensional stability and / or air pressure retention of the cavity, the liner can be made from a more resilient material than the pillow body, typically made of plastic, hard rubber, or the like. Generally, the location of the liner can be primarily around the rim of the cavity and surrounding pillow body and / or it can extend down into the cavity including providing full coverage of the interior. In other embodiments, the pressurizable facial cavity can be formed of a liner and pillow body along the sides and only the liner as defining the bottom of the cavity or a portion of the bottom of the cavity.

[0040] In one embodiment, the pressurizable facial cavity can receive a PAP therapy mask. The face engaging edge or surface of the mask can extend above the opening to the cavity, be flush with the opening, or be recessed into the cavity. The mask is camouflaged by the pillow and cavity, which minimizes the psychological objections, and is not attached via the traditional headgear. In this embodiment, it is possible that the mask, as a liner of the cavity, also provides part or all of the bottom of the cavity without any underlying pillow body, e.g., a through hole in the pillow body but the therapy mask provides the bottom of the pressurizable facial cavity over the through hole portion. But morecommonly the mask and pillow body form the sides and bottom of the cavity, e.g., no through hole in the pillow body.

[0041] The pressurizable facial cavity can be located in a variety of locations in the pillow body and is not particularly limited. For instance, the opening to the cavity can be centrally located on a top surface of the pillow body. In other embodiments, the cavity is in an arm of the pillow body.

[0042] A passageway to the pressurizable facial cavity permits the flow of pressurized air for PAP therapy to the cavity. The passageway generally passes through a portion of the pillow body, but such is not required. The path through the pillow body can be long, e.g., laterally extending from a side entrance of the pillow body to the pressurizable facial cavity, or short, e.g., through a bottom surface of the pillow body up to the pressurizable facial cavity. Where a mask forms all or part of the bottom of the pressurizable facial cavity, the passageway can connect directly to the mask without passing through any portion of the pillow body. The passageway is suitable for transmission of the pressurized air. This can be a PAP machine hose, a passageway in the pillow body that permits a PAP machine hose to pass through and connect to the pressurizable facial cavity, or by providing internal structure within the pillow body to convey the pressurized air. In the last embodiment, a port may be found on the pillow body for connecting a PAP machine hose to the internal structure. In some embodiments, the passageway is similar to the above- mentioned prior art hose management designs.

[0043] In addition to receiving pressurized air through the passageway, the pressurizable facial cavity typically contains an exhaust port to permit exhaled gases to be released from the pressurizable facial cavity. The exhaust port can be one or a series of small passageways connecting the cavity to external atmosphere. The exhaust port can have a check valve. In a different embodiment, the exhaust port is incorporated into the passageway or PAP hose. The exhaust port and check valve design and location can be adopted from their conventional usage in PAP therapy masks. As is well known in the art, a check valve serves as a safety and opens if pressurized air stops flowing, e.g., PAP machine failure, to ensure the patient can breathe / has access to air.

[0044] The pillow of the invention may optionally contain a fastener. In use, the pressurizable facial cavity is pressurized. The resulting pressurized air zone can push against the patient’s face and may cause the seal to be broken. In a simple embodiment for prone sleeping, the patient can press his or her face into the cushion of the pillow, engage the pressurizable facial cavity, and the weight of the patient’s head is typically sufficient tomaintain the seal. No fastener would be needed. But in other embodiments, a fastener to hold the face in an engaged position with the pressurizable facial cavity may be advantageous or even necessary. For example, when a pillow is intended to be in a folded position when in use, then a fastener is often used to secure or maintain the folded conformation. A fastener is any device that can strap the pressurizable facial cavity in position on the patient’s face or head. The fastener can be external of the pillow body, attached to the pillow body, internal of the pillow body, or a combination thereof. Examples of a fastener include a drawstring, an elastic band or bungee, a buckle, a spring and catch, hook and loop, etc. Often the fastener connects one portion of the pillow with another. But in some embodiments, the fastener can include a second pillow. For instance, a pillow of the invention having a pressurizable facial cavity can have two or more buckles or straps, etc., that connect to a second pillow. In use, the pillow of the invention is positioned over the patient’s face for PAP therapy, and the second pillow is on the back and / or side of the patient’s head. The fastener permits tensioning of the two pillows around the patient’s head sufficient to create reliable engagement of the pressurizable facial cavity for PAP therapy. Other fastener examples include surface or interior magnets to magnetically fasten two portions of the pillow body together or two or more pillows together in a multi-pillow embodiment. Interior fasteners also include posable or bendable interior structures. When the pillow body has arms, the posable arms can serve to strap the pressurizable facial cavity into position. Though the fastener is applying pressure / force, the cushioning provided by the pillow body can increase comfort and reduce irritation in comparison to traditional headgear straps. Accordingly, the pillow of the present invention can be used as a replacement for traditional headgear straps.

[0045] The pillow of the invention will be described with reference to specific embodiments and the drawing figures, wherein like reference numerals have like meaning.

[0046] FIGS 1 A-1D depict a pillow of the invention intended for prone sleepers. The pillow body 100 is generally rectangular and the pressurizable facial cavity 120 is located centrally on a top surface. The cavity is not a through hole and the pillow body forms the sides 121 and bottom 122 of the pressurizable facial cavity. For convenience, a notch 130 was removed from the pillow body 100 so that the length of (1) the passageway 112 to supply pressurized air to the cavity and (2) the exhaust port 145 could extend a shorter distance through the pillow body 100. Note that the exhaust port 145 is referred to in the singular but, as shown in the figure, is made up of a plurality of small passageways. The port 140 on the side of the pillow body in the notch area 130 is an extension of the passageway 112 and has a check valve 141 as is common in CPAP equipment. As shown in FIG. 1C, air supply hose110 attaches to the port 140 to supply pressurized air through the passageway 112 and into the pressurizable facial cavity 120. The other end of the air supply hose 110 connects to the PAP machine (not shown). FIG. ID shows the patient’s face engaged with the pressurizable facial cavity 120. The opening to the cavity is sized so that the patient’s nose and mouth fit in the cavity. The patient’s eyes do not fit in the cavity but are supported by the surrounding pillow body. The patient’s face forms a seal with the edge or rim of the cavity and the surrounding pillow body that is sufficient to create a pressurized air zone suitable for PAP therapy.

[0047] FIGS. 2 A and 2B show an alternative prone pillow body 200 that uses a larger cavity opening that would seal more of the patient’s face in the pressurizable facial cavity 220. To protect the patient’s eyes, and provide alignment cues, a soft strip 221 bridges the opening. In use as shown in FIG. 2B the patient would rest their eyes on the strip 221, which can be made of pillow body material or a different padding, to protect the eyes from the pressure and drying effect of the therapy.

[0048] FIGS. 3A-3C show another pillow of the invention that is referred to as the “H-type.” As seen in FIG. 3 A, the pillow body 300 has an H-like shaped cross section with the pressurizable facial cavity 320 being located on the left upright of the pillow body. FIG. 3B shows that in use the weight of the patient’s head 380 causes the pillow body to deform and the top of the upright section move closer to each other in a closed position. As a side sleeper, the patient’s nose and / or mouth can engage the pressurizable facial cavity 320 and the weight of the patient’s head can serve to maintain the seal during sleeping. FIG 3C shows the multi-hole exhaust port 345 located on the bottom of the cavity (from the patient’s perspective) and connecting to ambient atmosphere. Likewise, a semicircular tunnel 315 provides a passageway for the hose 310 so that pressurized air can be supplied at the bottom of the cavity.

[0049] Fig. 4 is a perspective view of an alternative H-type pillow body 400 that has a pressurizable facial cavity 420, 421 in each of the upright pillow body members. In this embodiment the passageways 412, 413 for delivering pressurized air pass through pillow body 400 to enter on the sidewall of the pressurizable facial cavity 420, 421, respectively, while the exhaust port 445 remains located on the bottom of the cavity (not shown for cavity 420 but symmetrical with cavity 421). The PAP machine 490 supplies pressurized air through hose 410 and through the Y splitter 415 having diverter 416 for sending the pressurized air through the left or right hose branch 418, 419 to the left or right pressurizable cavity 420, 421, respectively. This facilitates a patient sleeping on either side and, as inabove H-type pillow, the weight of the patient’s head will deform the pillow body to make a seal with the pressurizable cavity 420, 421, in analogous fashion as shown in FIG. 3B.

[0050] FIGS. 5A-5E depict a pillow of the invention (referred to as the Taco) that is open and flat when not in use, but is folded when used. FIG. 5A shows a perspective view of the pillow body 500 in the open position. The pressurizable facial cavity 520 is located in the narrow section of the U-shaped pillow body. The passageway 512 for delivering pressurized air enters from the side, passes through the pillow body, and connects to the side of the pressurizable facial cavity 520. The hose 510 can attach to the passageway 512 or travel along / though the passageway to the pressurizable facial cavity 520. Magnets 571, 572, which are present along the long portions of the pillow body, are provided as a fastener for holding the pillow in the folded position. The magnets can be exterior of the pillow body, as shown in FIG. 5A or internal, e.g., FIG. 5B. The arms of the U-shaped pillow body can be folded in the direction of the arrows shown in FIG. 5B. The patient can engage their nose and mouth in the pressurizable facial cavity 520 and fold up the sides so that the magnets 571, 572 on each side attach to each other as illustrated in FIG. 5C. The magnets act as fasteners which permits the patient to sleep face down / prone as well as on their side and maintain the pressurizable seal suitable for PAP therapy. While depicted as having space behind the patient’s head, such is not required and a tighter, more snug fit can also be employed in pillows of the invention. A similar design is shown in FIGS. 5D and 5E where the magnets 575, 576 are in a different orientation in pillow body 501 and permit a different folded position when fastened. Though envisioned primarily for side sleepers, the patient can sleep on his or her back, as shown in FIG. 5F, as well as in side positions or prone once the Taco pillow is magnetically latched. While magnets are illustrated as the fastener in the Taco pillow, it should be understood that other fasteners could replace the magnets, if desired. FIG. 6 is a Taco pillow but the pressurizable facial cavity is reduced in size / perimeter such that only the patient’s nose is sealed with the cavity. Both Fig. 5E and FIG. 6 show the exhaust ports 545 as connected to the bottom of the pressurizable facial cavity. Only FIG. 5E contains check valve 541 as the FIG. 6 embodiment does not cover the mouth and thus no safety valve is needed.

[0051] FIGS. 7A-7D relate to a Taco pillow but using weights instead of magnets to ensure maintenance of the pressurizable air zone. FIGS. 7 A and 7B show the pillow used in the supine position (sleeping on one’s back). The pressurizable facial cavity 720, passageway 712 thereto through the pillow body 700, the exhaust port 745, and the weights exemplified as 782 are shown. The number and location of the weights are adjustable owingto a channel 781 cut into the pillow body 700 that can hold the weights. Sufficient weight pressing down will maintain the seal between the patient’s face 790 and the pressurizable facial cavity 720. FIGS 7C and 7D show the pillow used in the side sleeping mode. The weights 782 going rear of the patient’s head can weigh down the pillow body and maintain the seal.

[0052] FIGS. 8A-8D show another folding pillow embodiment known as Saturn. FIG. 8A shows the pillow in the open, flat position with a pressurizable facial cavity 820 designed for a patient’s nose (though it could be designed larger for nose and mouth). A hose 810 conveys the supply of pressurized air, enters on the top side of the pillow body 800, and extends through the pillow body (not shown) to the pressurizable facial cavity 820. A fastener 860 is provided on the far left side of the Saturn pillow. FIGS. 8B-8D show the Saturn pillow in use. The patient’s nose engages the pressurizable facial cavity as shown in FIG. 8B by wrapping or folding the pillow body around his or her head 880. The exhaust port 845 is opposite the pressurizable facial cavity, i.e., is on the outside of the folded pillow body while the cavity is on the inside and engaged with the user’s nose. The fastener 860 as shown in FIG. 8C and in top view FIG. 8D connects one side of the pillow body with another to strap the pillow body in place. The fastener can be a spring or elastic material that hooks or catches on the opposing portion of the pillow body. Other fasteners can also be used to connect the two portions of the pillow body such as a drawstring, a buckle, hook and loop, magnet, etc. The Saturn pillow is intended for both supine and side sleepers.

[0053] FIGS. 9A-9D depict a structured pillow known as Starfish. FIG 9D shows the 3D structure of the pillow body 900 when not in use. Internal supports 992, 994, and 996, preferably with spring bias, hold the arms 991, 993, and 995 in the structured conformation. The internal supports can be a continuous structure as shown, or separate structures, and generally extends into each of the arms 991, 993, and 995. The internal support can be made of bendable or deformable material such as metal, plastic, or rubber and preferably has resistance / bias to maintain the 3D structure. The internal supports are fasteners within the meaning of the present invention as they fasten or strap the pillow into position. FIGS. 9A- 9C show the Starfish Pillow in use. The pressurizable facial cavity (not shown) is located in one arm 995 and seals with the patient’s face. As shown, only the patient’s nose and not the mouth enters the pressurizable facial cavity. Alternative embodiments have a larger cavity and engage both the nose and mouth in the pressurized zone. Opposite the facial cavity on the outside of the pillow arm 995 is the exhaust port 945. The passageway 912 within the pillow body 900 conveys the pressurized air from hose 910 to the pressurizable facial cavity.

[0054] FIGS. 10A-10C and FIG. 11 depict another version of the Starfish where the open conformation is not 3D but flat. As shown in the FIG. 10A, one arm 1090 of the pillow body 1000 has a pressurizable facial cavity 1020 that can engage a patient’s nose and mouth, a passageway 1012 through the pillow body 1000 to the cavity. The exhaust port 1045 on the bottom of the cavity is seen in FIG. 10C along with check valve 1041. FIG. 10B, which shows the opposite face of the pillow body 1000 from FIG. 10A, shows that some of the arms 1092, 1093 have internal flexible supports, such as wire, while the arm 1090 that has the pressurizable facial cavity 1020 has a ratcheting device 1061. FIG. 10C shows the pillow in use with the arms 1090, 1092, and 1093 wrapping around the patient’s head. The pressurizable facial cavity is fastened using the ratchet mechanism 1061 while the other arms are bent into place. Any suitable ratcheting device / design can be used to permit the fixing of arm 1090 in position so the patient’s nose and mouth enter the pressurizable facial cavity and in combination with the fastening force provided by arms 1092 and 1093 make a sufficient seal to form a pressurized air zone for PAP therapy. As shown in FIG 11, the arms 1092a and 1093a can be in different angles than as shown in FIGS. 10A-10C as can the hose 1010.

[0055] FIG. 12 is a Starfish style pillow but designed to accept conventional PAP therapy masks. Arm 1290 contains mask 25 that is connected via hose 1210 to the PAP machine (not shown). Arms 1292 and 1293 wrap around the patient’s head to permit a proper seal with the mask to create a pressurized air zone for PAP therapy. The mask 25 is part of the pressurizable facial cavity 1220. FIGS. 13A and 13B show the details of the mask 25 as a liner in the pressurizable facial cavity of the Starfish style pillow. In FIG 13 A the mask 25 is pushed into the cavity 1220 in the pillow arm 1290 and is locked in place in a groove. The mask is part of the pressurizable facial cavity and provides the bottom of the cavity. The patient engages the pressurizable facial cavity from the open side of the cavity but does not contact the mask, only the pillow body, to make a seal. In FIG 13B the mask is positioned so that the patient’s face contacts the mask 25 to make the seal with the pressurizable facial cavity. In this embodiment, the mask defines the sides and bottom of the pressurizable facial cavity supported and disposed within the pillow body. The passageway can be internal of the arm 1290, lie along a depression / channel cut into the arm of the pillow body as shown for hose 1210a, or external of the pillow body as shown for hose 1210. In most embodiments, the passageway, i.e., the hose, is internal or at least resident in a groove as shown in FIGS 13A and 13B.

[0056] The mask 25 is shown as engaging only the patient’s nose (a nasal mask), but an oronasal mask could be used instead. The use of a mask to form the bottom of thepressurizable facial cavity in full (as shown) or in part, is applicable to all embodiments described above. Likewise, the positioning of the mask relative to the pillow body as shown in FIGS. 13A and 13B can be applied to any embodiment. For the Taco, Saturn, and Starfish designs, the thickness of the pillow body can be varied. One arm or portion can be more (or less) padded than other portions and the fill material can be varied as well in different portions.

[0057] FIG. 14 is a perspective view of another pillow of the invention, referred to as the Record Player. The pillow body 1400 has a base or main portion 1401 and a moveable arm 1402. The pressurizable facial cavity is located in the arm 1402. A fastener 1460 is used to apply bias force to the arm 1402 which holds the pressurizable facial cavity in an engaged position with the patient’s nose and / or mouth sufficient to create a pressurizable air zone. The fastener 1460 can be a spring as shown, which may be removable / releasable or permanent. The hose 1410 connects to or passes through the passageway 1412 for delivering the pressurized air to the pressurizable facial cavity. The passageway 1412 runs through the base portion 1401 of the pillow body and up through the arm 1402. Exhaust port 1445 is shown connecting to the bottom of the pressurizable facial cavity. Check valve 1441 is also provided for safety. FIGS. 15A and 15B show the Record Player pillow without a patient. The arm 1402 contains a support member 1461 for attaching the fastener spring 1460 so as to create suitable down force within the arm 1402; e.g., so that the pressurizable facial cavity 1420 can achieve the desired seal with the patient’s face. In use, the patient would lift up on the pillow arm 1402 to allow positioning of his or her head / face and then release the pillow arm whereby the spring 1460 pulls the arm down and the pressurizable facial cavity can form the intended sealing relationship with the patient’s face.

[0058] In the above-described embodiments, the pressurizable facial cavity has been shown as generally circular in shape and / or cylindrical, but such is not required. The rim of the pressurizable facial cavity can have any suitable or desired shape, especially one intended to engage a human face, e.g., a mask-like shape. Also, the rim of the pressurizable facial cavity and surrounding pillow area has been shown as generally planar, but such is not required. As shown in FIG. 16, the top surface 1601 of the pillow body 1600 can raise up to make a mound surrounding the pressurizable facial cavity 1620. This mounding can help maintain the cavity shape and / or assist with sealing to the patient’s face in use. The mounding material can be the same as the fill used in the pillow body such as memory foam molded with the mounded shape and cavity, or different, such as firm, more resilient foam or non-fill materials such as plastic, rubber, etc. Additionally, the mounding shape can beprovided by a liner insert. FIGS. 17A and 17B illustrate mounding liner insert embodiments. The mushroom-shaped mound 1703 is connected to shaft 1704 that is designed to slide into a facial cavity in the pillow body (not shown) and serve as a liner. The mound can be made of resilient and / or soft material, optionally with a silicone coating, to enhance the comfort and / or seal with the patient’s face. Though depicted here as mushroom shape, any suitable shape can be used. The shaft material is generally rigid and made of plastic or rubber.Though shown as a unitary structure, in some embodiments the mound liner insert can be two or more pieces that are joined together such as by a snap fit or screw threads, to form a unitary structure. The ability to disassemble the liner can be useful for insertion, removal, and / or cleaning. In some embodiments, the mounding top 1703, or an outer layer thereof, can be removable for cleaning and / or disposable. The insert liner in FIG. 17A has a shaft 1704 that is intended to extend part way down the cavity in the pillow body. The shaft 1704 in FIG. 17B extends to the bottom of the pressurizable facial cavity and contains the air input connection 1712 and the exhaust port 1745. The liner in FIG. 17B can serve as the bottom of the pressurizable facial cavity (through hole in pillow body) or it can line the bottom of the pillow body-formed cavity.

[0059] The present invention also relates to a method for positive airway pressure therapy, which comprises (i) engaging at least a patient’s nose and / or mouth into a pressurizable facial cavity in a pillow body to form a seal between the patient’s face and the pressurizable facial cavity and / or the pillow body surrounding it; and (ii) providing pressurized air to said pressurizable facial cavity to form a pressurized zone for PAP therapy. Steps (i) and (ii) can occur in either order or simultaneously. The term “air” means a breathable gas that contains oxygen and is not limited to ambient air. Typically, PAP machines such as CPAP machines use ambient air and do not supplement the pressurized gas with oxygen (nor use pure oxygen), but such is not excluded and such oxygen-containing or consisting of gases are included within the meaning of “air.”

[0060] By use of the pillow of the invention, PAP therapy can be improved. Whereas a pressurized air zone around the patient’s nose and / or mouth is required in such therapy, the present invention uses the pillow of the invention to provide the pressurized air zone instead of the conventional PAP therapy mask and headgear combination. By embedding the pressurized air zone into the pillow, i.e., in the pressurizable facial cavity, the physical and psychological drawbacks of the conventional mask and headgear can be avoided or reduced. The cushion of the pillow and its non-clinical appearance provide comfort and reduce the stigma, embarrassment, or self-consciousness associated with traditional mask andheadgear-based therapy. That PAP therapy according to the present invention can be carried out without the traditional headgear straps represents an advantage over traditional therapy.

[0061] As understood by workers skilled in the art, PAP therapy is a generic term. The most commonly mentioned type of PAP therapy is CPAP therapy, but BiLevel PAP therapy (BPAP), auto-titrating PAP therapy (APAP), and more complex ventilation modes including adaptive servoventilation (ASV) and intelligent volume-assured pressure support (iVAPS) or average volume-assured pressure support (AV APS) are also included within the meaning of PAP therapy for the present invention.

[0062] Each of the patents and patent applications mentioned above are incorporated herein by reference in their entirety. The invention having been described it will be obvious that the same may be varied in many ways and all such modifications are contemplated as being within the scope of the invention as defined by the following claims.

Claims

CLAIMS1. A pillow for positive airway pressure therapy, which comprises: a pillow body having a pressurizable facial cavity therein that can accommodate at least a patient’s nose, mouth, or both; and a passageway to the pressurizable facial cavity that is suitable to transmit pressurized air; wherein the pressurizable facial cavity and / or the pillow body surrounding it can sufficiently seal with the patient’s face to form a pressurizable air zone suitable for PAP therapy.

2. The pillow according to claim 1, wherein said passageway passes through said pillow body to connect said pressurizable facial cavity with an exterior surface of said pillow body.

3. The pillow according to claim 1 or 2, wherein said pressurizable facial cavity further comprises an exhaust port.

4. The pillow according to any of claims 1-3, which further comprises a fastener that can strap the pressurizable facial cavity to the patient’s face with sufficient force to form said pressurizable air zone.

5. The pillow according to claim 4, wherein said fastener is attached on the exterior of the pillow body.

6. The pillow according to claim 5, wherein said fastener is selected from a drawstring, an elastic strap, a buckle, hook and loop, magnets, and a spring.

7. The pillow according to claim 4, wherein said fastener is within the pillow body.

8. The pillow according to claim 7, wherein said fastener is selected from magnets, deformable staves, springs, and rachets.

9. The pillow according to any of claims 1-8, wherein said pillow body is comprised of foam, preferably memory foam.

10. The pillow according to any of claims 1-9, wherein said pillow body comprises a central portion and at least one arm portion.

11. The pillow according to claim 10, wherein said pressurizable facial cavity is located in said arm portion of said pillow body.

12. The pillow according any of claims 1-11, wherein said pressurizable facial cavity has a side wall and bottom surface made of said pillow body.

13. The pillow according to any of claims 1-12, wherein said pressurizable facial cavity has a liner, preferably a removable liner, covering at least a portion of said cavity and / or the cavity perimeter that seals with the patient’s face.

14. The pillow according to claim 13, wherein said liner is a PAP therapy mask.

15. A method for positive airway pressure therapy, which comprises: engaging at least a patient’s nose and / or mouth into a pressurizable facial cavity in a pillow body to form a seal between the patient’s face and the pressurizable facial cavity and / or the pillow body surrounding it; and providing pressurized air to said pressurizable facial cavity to form a pressurized zone for PAP therapy.

16. In a method for PAP therapy in which a pressurized air zone is created around the patient’s nose and / or mouth, the improvement for which comprises that the pressurized air zone is embedded into a pillow body.

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