Patent Description:
Obstructive sleep apnea (OSA) is a condition that affects millions of people from around the world. OSA is characterized by disturbances or cessation in breathing during sleep. OSA episodes result from a partial or complete blockage of airflow during sleep that lasts at least <NUM> seconds and often as long as <NUM> to <NUM> minutes. In a given night, people with moderate to severe apnea may experience complete or partial breathing disruptions as high as <NUM>-<NUM> per night. Because their sleep is constantly disrupted, they are deprived of the restorative sleep necessary for efficient functioning of body and mind. This sleep disorder has also been linked with hypertension, depression, stroke, cardiac arrhythmias, myocardial infarction and other cardiovascular disorders. OSA also causes excessive tiredness.

One method for treating OSA is positive airway pressure (PAP) therapy. Known PAP therapies include continuous positive airway pressure (CPAP), wherein a constant positive airway pressure is provided to the airway of the patient in order to splint the patient's airway open, and variable airway pressure, wherein the pressure provided to the airway of the patient is varied with the patient's respiratory cycle. Such therapies are typically provided to the patient at night while the patient is sleeping.

Non-invasive ventilation and pressure support therapies as just described involve the placement of a patient interface device, which is typically a nasal or nasal/oral mask, on the face of a patient to interface the ventilator or pressure support system with the airway of the patient so that a flow of breathing gas can be delivered from the pressure/flow generating device to the airway of the patient.

Because patient interface devices are typically worn for an extended period of time, a variety of concerns must be taken into consideration. For example, in providing CPAP to treat OSA, the patient normally wears the patient interface device all night long while he or she sleeps. One concern in such a situation is that the patient interface device is as comfortable as possible, otherwise the patient may avoid wearing the interface device, defeating the purpose of the prescribed pressure support therapy. Another concern is that an improperly fitted patient interface device can include gaps between the patient interface device and the patient that cause unwanted leakage. Thus, it is desirable to select a patient interface device that properly fits a patient.

One type of patient interface device is a nasal pillows mask. Typically, nasal pillows masks use a silicone sealing cushion having a pair of heads, each in the shape of a truncated cone that is inserted into a respective nostril of a patient and seals against the interior and exterior surfaces of the nostril opening. Current designs also comprise a hollow stalk which connects to the bottom of the cone-shaped head on one end and extends to an elastomeric base membrane on the other end, thus spacing the entire cone-shaped head from the base membrane. Air travels from the cushion base, through the cylindrical stalk, and into the head as the patient inhales. Stalks allow the cone-shaped heads to move and rotate with respect to the cushion base, improving the ability of the cushion to conform to variations in a patient's facial geometry and allowing the cone-shaped heads to stay in contact with a patient's nose even if the cushion base moves a small amount (e.g. when cushion base contacts bedding as patient rolls over in bed). The stalks in current pillows designs allow the head to articulate with respect to the cushion base, but they also have some disadvantages. For instance, stalks add extra size, bulk, and weight to the cushion. This is especially problematic since nasal pillows masks are typically constructed to be the smallest/lightest masks on the market. Stalks also add extra airflow resistance. The small diameters of cylindrical stalks add airflow resistance and reduces breathing comfort for the patient.

For example, <CIT> discloses a ventilation interface device that may include a hollow cannula, at least one nasal insert and at least one exhaust port or may include a mask designed to cover a user's nose, mouth or both nose and mouth. The at least one nasal insert may be formed so as to fit in any size nares of any user and may be detachable. Additionally, the at least one exhaust port may be in any of a variety of orientations and, in some embodiments, contain sealable ports.

As one aspect of the present disclosure a cushion for use in providing a regimen of respiratory therapy to a patient comprises: a hollow base defining a main cavity therein, the hollow base defining at least one aperture for receiving a flow of breathing gas generated by a pressure generating device; a pair of nasal pillows each extending from the hollow base, each nasal pillow having a generally cone-shaped head that tapers inward and upward from a base portion, that extends directly from the base, to a top opening, wherein each cone shaped head is structured to sealingly engage an inner portion of a nare of the patient with the top opening thereof positioned within the nare of the patient, wherein each cone-shaped head defines a passage therethrough that extends between the main cavity and the top opening and is structured to further convey the flow of breathing gas from the main cavity to a nasal passage of the patient, and wherein each base portion includes an inner edge positioned near the center of the cushion that merges with the hollow base and an opposite outer edge that is disposed at an outer portion of the cushion and spaced a distance upward from an outer surface of the hollow base.

Each base portion may be positioned at an angle relative to a central reference plane bisecting the cushion, and the angle may be in the range of <NUM>-<NUM> degrees.

The hollow base and the pair of nasal pillows may each be portions of a single unitary member.

A region where the inner edge of each base portion and the hollow base merge may be at least one of: a lessor thickness than a wall of the hollow base adjacent thereto or formed of a softer material than the hollow base adjacent thereto.

The at least one aperture may comprise a first aperture disposed at a first end of the hollow base and a second aperture disposed at an opposite second end of the hollow base.

Each cone-shaped head may include a number of ribs that each extend from an inner surface of the cone-shaped head partially into the passage defined therein.

As another aspect of the present disclosure, a patient interface device for use in providing a regimen of respiratory therapy to a patient comprises: a frame structured to be coupled to the head of the patient by a headgear; and a cushion coupled to the frame, the cushion comprising: a hollow base defining a main cavity therein, the base defining at least one aperture for receiving a flow of breathing gas generated by a pressure generating device; a pair of nasal pillows each extending from the hollow base, each nasal pillow having a generally cone-shaped head that tapers inward and upward from a base portion, that extends directly from the hollow base, to a top opening, wherein each cone shaped head is structured to sealingly engage an inner portion of a nare of the patient with the top opening thereof positioned within the nare of the patient, wherein each cone-shaped head defines a passage therethrough that extends between the main cavity and the top opening and is structured to further convey the flow of breathing gas from the main cavity to a nasal passage of the patient, and wherein each base portion includes an inner edge positioned near the center of the cushion that merges with the hollow the base and an opposite outer edge that is disposed at an outer portion of the cushion and spaced a distance upward from an outer surface of the hollow base.

A region where the inner edge of each base portion and the base merge may be at least one of: a lessor thickness than a wall of the hollow base adjacent thereto or formed of a softer material than the hollow base adjacent thereto.

As yet another aspect of the present disclosure, a system adapted to provide a regimen of respiratory therapy to a patient comprises: a pressure generating device structured to generate a flow of breathing gas; a delivery conduit having a first end coupled to the pressure generating device and an opposite second end; and a patient interface device comprising: a frame structured to be coupled to the head of the patient by a headgear; and a cushion coupled to the frame, the cushion comprising: a hollow base defining a main cavity therein, the hollow base defining at least one aperture for receiving a flow of breathing gas generated by the pressure generating device from the second end of the deliver conduit; and a pair of nasal pillows each extending from the hollow base, each nasal pillow having a generally cone-shaped head that tapers inward and upward from a base portion, that extends directly from the hollow base, to a top opening, wherein each cone shaped head is structured to sealingly engage an inner portion of a nare of the patient with the top opening thereof positioned within the nare of the patient, wherein each cone-shaped head defines a passage therethrough that extends between the main cavity and the top opening and is structured to further convey the flow of breathing gas from the main cavity to a nasal passage of the patient, and wherein each base portion includes an inner edge positioned near the center of the cushion that merges with the hollow base and an opposite outer edge that is disposed at an outer portion of the cushion and spaced a distance upward from an outer surface of the hollow base.

These and other objects, features, and characteristics of the present technology, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures.

As used herein, the singular form of "a", "an", and "the" include plural references unless the context clearly dictates otherwise. As used herein, the statement that two or more parts or components are "coupled" shall mean that the parts are joined or operate together either directly or indirectly, i.e., through one or more intermediate parts or components, so long as a link occurs. As used herein, "directly coupled" means that two elements are directly in contact with each other. As used herein, "fixedly coupled" or "fixed" means that two components are coupled so as to move as one while maintaining a constant orientation relative to each other.

As used herein, the statement that two or more parts or components "engage" one another shall mean that the parts exert a force against one another either directly or through one or more intermediate parts or components. As employed herein, the term "number" shall mean one or an integer greater than one (i.e., a plurality). Directional phrases used herein, such as, for example and without limitation, left, right, upper, lower, front, back, on top of, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the claims unless expressly recited therein. As employed herein, the term "and/or" shall mean one or both of the elements separated by such term. For example, "A and/or B" would mean any of: i) A, ii) B, or iii) A and B.

A system <NUM> adapted to provide a regimen of respiratory therapy to a patient according to one exemplary embodiment of the technology is generally shown in <FIG>. System <NUM> includes a pressure generating device <NUM> (shown schematically), a delivery conduit <NUM> (shown schematically), a patient interface device <NUM> having a fluid coupling conduit <NUM> coupled via a conduit segment <NUM>, and a headgear (only straps <NUM> thereof are shown). Pressure generating device <NUM> is structured to generate a flow of breathing gas and may include, without limitation, ventilators, constant pressure support devices (such as a continuous positive airway pressure device, or CPAP device), variable pressure devices (e.g., BiPAP®, Bi-Flex®, or C-Flex™ devices manufactured and distributed by Philips Respironics of Murrysville, Pennsylvania), and auto-titration pressure support devices. Delivery conduit <NUM> is structured to communicate the flow of breathing gas from pressure generating device <NUM> to patient interface device <NUM> through fluid coupling conduit <NUM> and conduit segment <NUM>. In the exemplary embodiment illustrated in <FIG>, fluid coupling conduit <NUM> is a straight connector, however, it is to be appreciated that other suitable couplings may be employed without varying from the scope of the present invention. It is also to be appreciated that conduit segment <NUM> may be eliminated, and thus delivery conduit <NUM> connected directly to patient interface device <NUM> or connected via an aforementioned coupling without varying from the scope of the present invention. Delivery conduit <NUM> and patient interface device <NUM> are often collectively referred to as a patient circuit.

A BiPAP® device is a bi-level device in which the pressure provided to the patient varies with the patient's respiratory cycle, so that a higher pressure is delivered during inspiration than during expiration. An auto-titration pressure support system is a system in which the pressure varies with the condition of the patient, such as whether the patient is snoring or experiencing an apnea or hypopnea. For present purposes, flow/pressure generating device <NUM> is also referred to as a gas flow generating device, because flow results when a pressure gradient is generated. The present invention contemplates that flow/pressure generating device <NUM> is any conventional system for delivering a flow of gas to an airway of a patient or for elevating a pressure of gas at an airway of the patient, including the pressure support systems summarized above and non-invasive ventilation systems.

Continuing to refer to <FIG>, patient interface device <NUM> includes a cushion <NUM> coupled to a frame <NUM> via a magnetic arrangement, discussed further below. Cushion <NUM> may be formed of any pliable material (e.g., without limitation, silicone). Frame <NUM> may be formed of a substantially rigid material (e.g., without limitation, one or more plastics). Frame <NUM> includes a central portion <NUM> formed as a generally thin member having a patient facing side <NUM> and an opposite outward facing side <NUM>. Central portion <NUM> is curved such that patient facing side <NUM> is generally concave-shaped, while outward facing side <NUM> is generally convexly-shaped. Frame <NUM> further includes a first wing portion <NUM>, which extends generally from a first end <NUM> of central portion <NUM> in a slightly tapering manner to a first distal tip <NUM>; and a second wing portion <NUM>, which extends generally from a second end <NUM> of central portion <NUM> in a slightly tapering manner to a second distal tip <NUM>. In the example embodiment illustrated in <FIG>, each of first and second wing portions <NUM> and <NUM> are each offset a distance from patient facing side <NUM> of central portion <NUM> by a respective spacer portion which are each of narrower dimensions than the portions of central portion <NUM> and wing portions <NUM> and <NUM> immediately adjacent thereto.

Each wing portion <NUM> and <NUM> is structured to cooperatively engage a respective one of headgear straps <NUM> in a manner that secures each strap <NUM> to frame <NUM>. More particularly, each strap <NUM> is formed from an elastic fabric material as a generally flattened tubular member having a closed leading end 14A. An aperture which provides access to the inner portion of each flattened tubular member is defined in each strap <NUM> a distance from closed leading end 14A thereof. To secure a strap <NUM> to frame <NUM>, distal portion <NUM> of wing portion <NUM> is inserted into the aperture of one strap <NUM>. The aperture is then slid along wing portion <NUM> until an outward facing portion of the perimeter of the aperture contacts the spacer portion. At such time, the majority of wing portion <NUM> is positioned inside the flattened tubular member which is strap <NUM>. Next, the aperture is generally stretched around the remaining portion of wing portion <NUM> such that the previously remaining portion of wing portion <NUM> is positioning in the portion of the flattened tubular member generally between the aperture and sealed end 14A. When fully installed, the aperture of strap <NUM> is disposed encircling the spacer portion between central portion <NUM> and wing portion <NUM>. The other strap <NUM> is likewise secured to frame <NUM> by repeating the same steps with second wing portion <NUM>.

Referring now to <FIG>, details of cushion <NUM> will now be described. Cushion <NUM> includes a generally hollow base <NUM> that defines a main cavity <NUM> therein. Base <NUM> includes at least one aperture <NUM> for receiving a flow of breathing gas generated by pressure generating device <NUM> into main cavity <NUM>, such as previously discussed in regard to <FIG>. In the example embodiment illustrated in <FIG>, base <NUM> includes a number of magnetic elements <NUM> disposed in a lower portion thereof that are positioned to magnetically couple to corresponding magnetic elements provided in frame <NUM> so as to selectively couple cushion <NUM> to frame <NUM>, such as shown in <FIG>.

Continuing to refer to <FIG>, cushion <NUM> further includes a pair of nasal pillows <NUM>, each extending directly from base <NUM>. More particularly, each nasal pillow <NUM> includes a generally cone-shaped head <NUM> that tapers inward (without flaring outward) and upward from a base portion <NUM> (that extends directly from base <NUM>) to a top opening <NUM>. Each cone shaped head <NUM> is tapered so as to be shaped to sealingly engage an inner portion of a nare of a patient with top opening <NUM> thereof positioned within the nare of the patient. Each cone-shaped head <NUM> defines a passage <NUM> therethrough that extends between main cavity <NUM> and top opening <NUM> and is structured to further convey the flow of breathing gas from main cavity <NUM> to a nasal passage of the patient. As shown in the section views of <FIG> and <FIG>, each nasal pillow <NUM> may include one or more ribs <NUM> that extend from an inner surface of cone-shaped head <NUM> partially into passage <NUM> defined therein in a direction roughly normal to the inside surface of each cone-shaped head <NUM>. Such ribs <NUM> serve to stiffen each cone-shaped head <NUM> so as to resist collapse when in contact with the nostril of a patient. Such ribs <NUM> are advantageous for this purpose (e.g. compared to thickening the wall or using a stiffer material) because they selectively stiffen the pillow against collapse while still allowing the pillow to deform circumferentially to match the shape of the nostril. Ribs <NUM> may be spaced around the inner perimeter of each cone-shaped head <NUM>. In an example embodiment, ribs <NUM> are spaced away from the portion of each cone-shaped head <NUM> that is structured to engage at or near the nasal septum of the patient as such area is generally sensitive and thus undesirable to have stiffened.

As previously mentioned, each base portion <NUM> extends directly from base <NUM>. More particularly, each base portion <NUM> includes an inner edge 52A that is positioned near the center of cushion <NUM> and merges with an outer surface 40A (and wall) of base <NUM>. Each base portion <NUM> further includes an outer edge 52B opposite inner edge 52A that is spaced a distance d away from outer surface 40A of base <NUM>. As shown in <FIG>, each base portion <NUM> is generally positioned at an angle θ relative a central reference plane P bisecting cushion <NUM>. In example embodiments of the present invention, base portions <NUM> oriented at angles θ from between <NUM> and <NUM> degrees have been employed, however, angles θ of between <NUM> and <NUM> degrees have been found to generally be best for most applications. In the example embodiment illustrated in <FIG>, cushion <NUM> is formed as a unitary element from an elastomeric material (e.g., without limitation, silicone). However, it is to be appreciated, that cushion <NUM> may be formed as a modular element with components formed from any suitable material or materials without varying from the scope of the present technology.

From the foregoing example, it is thus to be appreciated that the intersection between each inner edge 52A of each base portion <NUM> and base <NUM> creates a hollow hinge that allows each cone shaped head <NUM> to articulate with respect to base <NUM> without the use of a stalk portion such a described in the Background section herein. Such intersection between base portion <NUM> and base <NUM> may be formed from a thinner amount of material than the surrounding portions and/or may be formed from a softer material to further enhance the ability of each head <NUM> to articulate. Such design provides for a lighter, more streamlined cushion <NUM> than conventional designs.

Claim 1:
A cushion (<NUM>) for use in providing a regimen of respiratory therapy to a patient, the cushion comprising:
a hollow base (<NUM>) defining a main cavity (<NUM>) therein, the hollow base defining at least one aperture for receiving a flow of breathing gas generated by a pressure generating device; and
a pair of nasal pillows (<NUM>) each extending from the hollow base, each nasal pillow having a generally cone-shaped head (<NUM>) that tapers inward and upward from a base portion (<NUM>), that extends directly from the base, to a top opening (<NUM>),
wherein each cone shaped head is structured to sealingly engage an inner portion of a nare of the patient with the top opening thereof positioned within the nare of the patient,
wherein each cone-shaped head defines a passage (<NUM>) there through that extends between the main cavity and the top opening and is structured to further convey the flow of breathing gas from the main cavity to a nasal passage of the patient, and
characterized in that each base portion (<NUM>) includes an inner edge (52A) positioned near the center of the cushion that merges with the hollow base (<NUM>) and an opposite outer edge (52B) that is disposed at an outer portion of the cushion and spaced a distance (d) upward from an outer surface of the hollow base.