Patent Application
20140069434
1. Field of the Invention
The present invention relates to respiratory therapy systems, such as non-invasive ventilation and pressure support systems, and, in particular, to a patient interface device for a respiratory therapy system that includes a lever arm attachment mechanism for attaching a facial sealing cushion to a frame member.
2. Description of the Related Art
There are numerous situations where it is necessary or desirable to deliver a flow of breathing gas non-invasively to the airway of a patient, i.e., without intubating the patient or surgically inserting a tracheal tube in their esophagus. For example, it is known to ventilate a patient using a technique known as non-invasive ventilation. It is also known to deliver positive airway pressure (PAP) therapy to treat certain medical disorders, the most notable of which is obstructive sleep apnea (OSA). Known PAP therapies include continuous positive airway pressure (CPAP), wherein a constant positive pressure is provided to the airway of the patient in order to splint open the patient's airway, 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 including a mask component having a soft, flexible cushion on the face of a patient. The mask component may be, without limitation, a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs that are received within the patient's nares, a nasal/oral mask that covers the nose and mouth, or a full face mask that covers the patient's face. Such patient interface devices may also employ other patient contacting components, such as forehead supports, cheek pads and chin pads. The patient interface device is connected to a gas delivery tube or conduit and interfaces the ventilator or pressure support device 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. It is known to maintain such devices on the face of a wearer by a headgear having one or more straps adapted to fit over/around the patient's head.
Adherence and compliance to therapy, such as CPAP or other pressure support therapies, is growing to be an industry-wide issue. Factors such as comfort and ease of a patient interface device can greatly affect a patient's adherence and compliance to therapy.
Current patient interface devices having removable cushions typically employ one of three main types of attachment mechanisms for attaching the cushion to the faceplate thereof. The most common mechanism employs a physical snap on each side of the cushion (e.g., most commonly each of the three sides of a triangular cushion) that applies a force in the center of each side to maintain a proper seal. Another mechanism employs a hinge and two snaps, one on each side of the cushion. In these implementations, one of the multiple snaps is often missed, which causes a mask leak. The third mechanism employs a groove in the faceplate into which the cushion is pressed. The cushion, when inserted into the groove, presses against the two sides of the groove to create a proper seal. Insertion and removal of the cushion in this implementation can be difficult (the patient must ensure that the cushion is seated all of the way around), and does not provide an audible snapping sound to let the patient know that the cushion has been properly attached.
In one embodiment, a patient interface device is provided that includes a frame member having a front surface and a rear surface opposite the front surface, the frame member including a faceplate portion, the frame member having an orifice extending from the front surface of the frame member to the rear surface of the frame member, and a cushion assembly including a support frame and a sealing cushion coupled to a coupling portion of the support frame. The support frame includes a lever arm extending from the coupling portion, wherein the lever arm is received through the orifice and engages an engagement surface forming a part of the front surface of the frame member, and wherein a top surface of the coupling portion engages a rear portion of the faceplate portion forming a part of the rear surface of the frame member.
In another embodiment, a method of assembling a patient interface device is provided that includes holding a frame member having a front surface and a rear surface opposite the front surface, the frame member including a faceplate portion, the frame member having an orifice extending from the front surface of the frame member to the rear surface of the frame member, and holding a cushion assembly including a support frame and a sealing cushion coupled to a coupling portion of the support frame, the support frame having a lever arm extending from the coupling portion. The method further includes inserting the lever arm through the orifice, and rotating the cushion assembly relative to the frame member and causing the lever arm to engage an engagement surface forming a part of the front surface of the frame member and a top surface of the coupling portion to engage a rear portion of the faceplate portion forming a part of the rear surface of the frame member.
These and other objects, features, and characteristics of the present invention, 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. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention.
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 word “unitary” means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a “unitary” component or body. As employed 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, top, bottom, left, right, upper, lower, front, back, 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.
A system 2 adapted to provide a regimen of respiratory therapy to a patient according to one exemplary embodiment is generally shown in
In the exemplary embodiment, patient interface 8 includes a patient sealing assembly 12, which in the illustrated embodiment is a nasal/oral mask. However, other types of patient sealing assemblies, such as, without limitation, a nasal mask or a full face mask, which facilitates the delivery of the flow of breathing gas to the airway of a patient, may be substituted for patient sealing assembly 12 while remaining within the scope of the present invention. Patient sealing assembly 12 includes a frame member 14 having a cushion assembly 16 coupled thereto, each of which is described in greater detail below.
Frame member 14 also includes a forehead support member 22 that is coupled to faceplate portion 18 by a connecting member 24. An orifice 26 extends through connecting member 24, the function of which is described elsewhere herein. As seen in
Connecting elements 40A, 40B are attached to the bottom of faceplate portion 18, and are structured to receive and hold the upper straps of a headgear component (not shown). In addition, a peg member 42 extends outwardly from the bottom of faceplate portion. The function of peg member 42 is described below.
Cushion assembly 16 is removably attached to frame member 14 in the following manner. First, lever arm 58 of support frame 44 is inserted through orifice 26 of connecting member 24 of frame member 14. When this is done, the bottom of lever arm 58 will engage the front of receiving channel 34, which acts a pivot point for support frame 44. A force is then applied to lever arm 58 to cause cushion assembly 16 to rotate about the pivot point as shown by the arrows in
The insertion of peg member 42 into hole 52 produces a single audible click that indicates to the patient that the cushion assembly 16 has been properly attached to frame member 14. Receiving channel 34 may be sized to provide a friction fit between it and lever arm 58 to help secure cushion assembly 16 to frame member 14. Also, a releasable attachment mechanism, such as a detent or the like, may be provided on lever arm 58 or in receiving channel 34 to temporarily secure the two parts to one another. Cushion assembly 16 may be removed from frame member 14 by disengaging peg member 42 from hole 52 and rotating cushion assembly in the opposite direction. While peg member 42 an hole 52 are shown as the exemplary locking mechanism, it will be appreciated that other suitable locking mechanisms, such as conventional snaps or cooperating magnets, may also be used.
In alternative embodiments, the surface that lever arm 58 engages does not need to be on the forehead support member 22. Instead, it may be on other portions of the frame member 14, such as, without limitation, the connecting member 24 or the faceplate portion 18. In such embodiments, the receiving channel 34 may be provided on that engagement surface.
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.
This patent application claims the priority benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 61/487,013 filed on May 17, 2011, the contents of which are herein incorporated by reference.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IB12/52450 | 5/16/2012 | WO | 00 | 11/14/2013 |
| Number | Date | Country | |
|---|---|---|---|
| 61487013 | May 2011 | US |
