Patent ID: 12257388

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

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 system2adapted to provide a regimen of respiratory therapy to a patient according to one exemplary embodiment of the invention is generally shown inFIG.1. System2includes a pressure generating device4(shown schematically), a delivery conduit6(shown schematically), a patient interface device8having a fluid coupling conduit10coupled via a conduit segment12, and a headgear (only straps14thereof are shown). Pressure generating device4is 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 conduit6is structured to communicate the flow of breathing gas from pressure generating device4to patient interface device8through fluid coupling conduit10and conduit segment12. In the exemplary embodiment illustrated inFIG.1, fluid coupling conduit10is 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 segment12may be eliminated, and thus delivery conduit6connected directly to patient interface device8or connected via an aforementioned coupling without varying from the scope of the present invention. Delivery conduit6and patient interface device8are 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 device4is 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 device4is 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 toFIG.1, patient interface device8includes a cushion16coupled to a frame18via a magnetic arrangement, discussed further below. Cushion16may be formed of any pliable material (e.g., without limitation, silicone). Frame18may be formed of a substantially rigid material (e.g., without limitation, one or more plastics). Frame18includes a central portion20formed as a generally thin member having a patient facing side22and an opposite outward facing side24. Central portion20is curved such that patient facing side22is generally concave-shaped, while outward facing side24is generally convexly-shaped. Frame18further includes a first wing portion26, which extends generally from a first end28of central portion20in a slightly tapering manner to a first distal tip30; and a second wing portion32, which extends generally from a second end34of central portion20in a slightly tapering manner to a second distal tip36. In the example embodiment illustrated inFIG.1, each of first and second wing portions26and32are each offset a distance from patient facing side22of central portion20by a respective spacer portion which are each of narrower dimensions than the portions of central portion20and wing portions26and32immediately adjacent thereto.

Each wing portion26and32is structured to cooperatively engage a respective one of headgear straps14in a manner that secures each strap14to frame18. More particularly, each strap14is formed from an elastic fabric material as a generally flattened tubular member having a closed leading end14A. An aperture which provides access to the inner portion of each flattened tubular member is defined in each strap14a distance from closed leading end14A thereof. To secure a strap14to frame18, distal portion30of wing portion26is inserted into the aperture of one strap14. The aperture is then slid along wing portion26until an outward facing portion of the perimeter of the aperture contacts the spacer portion. At such time, the majority of wing portion26is positioned inside the flattened tubular member which is strap14. Next, the aperture is generally stretched around the remaining portion of wing portion26such that the previously remaining portion of wing portion26is positioning in the portion of the flattened tubular member generally between the aperture and sealed end14A. When fully installed, the aperture of strap14is disposed encircling the spacer portion between central portion20and wing portion26. The other strap14is likewise secured to frame18by repeating the same steps with second wing portion32.

Referring now toFIGS.2-8, details of cushion16will now be described. Cushion16includes a generally hollow base40that defines a main cavity42therein. Base40includes at least one aperture44for receiving a flow of breathing gas generated by pressure generating device4into main cavity42, such as previously discussed in regard toFIG.1. In the example embodiment illustrated inFIGS.1-8, base40includes a number of magnetic elements46disposed in a lower portion thereof that are positioned to magnetically couple to corresponding magnetic elements provided in frame18so as to selectively couple cushion16to frame18, such as shown inFIG.1.

Continuing to refer toFIGS.2-8, cushion16further includes a pair of nasal pillows48, each extending directly from base40. More particularly, each nasal pillow48includes a generally cone-shaped head50that tapers inward (without flaring outward) and upward from a base portion52(that extends directly from base40) to a top opening54. Each cone shaped head50is tapered so as to be shaped to sealingly engage an inner portion of a nare of a patient with top opening54thereof positioned within the nare of the patient. Each cone-shaped head50defines a passage56therethrough that extends between main cavity42and top opening54and is structured to further convey the flow of breathing gas from main cavity42to a nasal passage of the patient. As shown in the section views ofFIGS.5and8, each nasal pillow48may include one or more ribs58that extend from an inner surface of cone-shaped head50partially into passage56defined therein in a direction roughly normal to the inside surface of each cone-shaped head50. Such ribs58serve to stiffen each cone-shaped head50so as to resist collapse when in contact with the nostril of a patient. Such ribs58are 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. Ribs58may be spaced around the inner perimeter of each cone-shaped head50. In an example embodiment, ribs50are spaced away from the portion of each cone-shaped head50that 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 portion52extends directly from base40. More particularly, each base portion52includes an inner edge52A that is positioned near the center of cushion16and merges with an outer surface40A (and wall) of base40. Each base portion52further includes an outer edge52B opposite inner edge52A that is spaced a distance d away from outer surface40A of base40. As shown inFIGS.4-6, each base portion52is generally positioned at an angle θ relative a central reference plane P bisecting cushion16. In example embodiments of the present invention, base portions52oriented at angles θ from between 30 and 135 degrees have been employed, however, angles θ of between 45 and 90 degrees have been found to generally be best for most applications. In the example embodiment illustrated inFIGS.1-8, cushion16is formed as a unitary element from an elastomeric material (e.g., without limitation, silicone). However, it is to be appreciated, that cushion16may be formed as a modular element with components formed from any suitable material or materials without varying from the scope of the present invention.

From the foregoing example, it is thus to be appreciated that the intersection between each inner edge52A of each base portion52and base40creates a hollow hinge that allows each cone shaped head50to articulate with respect to base40without the use of a stalk portion such a described in the Background section herein. Such intersection between base portion52and base40may 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 head50to articulate. Such design provides for a lighter, more streamlined cushion16than conventional designs.

FIG.9illustrates a partially schematic view of another system2′ adapted to provide a regimen of respiratory therapy to a patient that includes a patient interface device8′ having another cushion16′ according to one exemplary embodiment of the present invention. Cushion16′ is of similar construction as cushion16previously discussed and as such includes a generally hollow base40′ that defines a main cavity (not numbered) therein. Base40′ includes a first aperture44′, disposed at a first end of base40′ for receiving a flow of breathing gas generated by pressure generating device4, as well as a second aperture44″, disposed at an opposite second end of base40′, that is also structured to receive a flow of breathing gas generated by pressure generating device4. Cushion16′ further includes a pair of nasal pillows48like those previously discussed in regard toFIGS.1-8that are positioned with respect to base40′ in a similar manner as previously discussed in regard to base40. From such further example, it is once again to be appreciated that such design provides for a lighter, more streamlined cushion16′ than conventional designs.

In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word “comprising” or “including” does not exclude the presence of elements or steps other than those listed in a claim. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The word “a” or “an” preceding an element does not exclude the presence of a plurality of such elements. In any device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination.

Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.