Patent Publication Number: US-2021170131-A1

Title: Patient interface having a restrictor element for varying flow resistance through an exhalation port thereof

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This patent application claims the priority benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 62/945,583, filed on Dec. 9, 2019, the contents of which are herein incorporated by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention pertains to patient interfaces for use in delivering a flow of a breathing gas to an airway of a patient. More particularly, the present invention pertains to patient interfaces having a restrictor element for tailoring the resistance of an exhaust port thereof. The present invention further pertains to kits for use in selectively tailoring the flow resistance of an exhaust port in a patient interface for use in delivering a flow of a breathing gas to an airway of a patient. 
     2. Description of the Related Art 
     Many individuals suffer from disordered breathing during sleep. Sleep apnea is a common example of such sleep disordered breathing suffered by millions of people throughout the world. One type of sleep apnea is obstructive sleep apnea (OSA), which is a condition in which sleep is repeatedly interrupted by an inability to breathe due to an obstruction of the airway; typically the upper airway or pharyngeal area. Obstruction of the airway is generally believed to be due, at least in part, to a general relaxation of the muscles which stabilize the upper airway segment, thereby allowing the tissues to collapse the airway. Another type of sleep apnea syndrome is a central apnea, which is a cessation of respiration due to the absence of respiratory signals from the brain&#39;s respiratory center. An apnea condition, whether obstructive, central, or mixed, which is a combination of obstructive and central, is defined as the complete or near cessation of breathing, for example a 90% or greater reduction in peak respiratory airflow. 
     Those afflicted with sleep apnea experience sleep fragmentation and complete or nearly complete cessation of ventilation intermittently during sleep with potentially severe degrees of oxyhemoglobin desaturation. These symptoms may be translated clinically into extreme daytime sleepiness, cardiac arrhythmias, pulmonary-artery hypertension, congestive heart failure and/or cognitive dysfunction. Other consequences of sleep apnea include right ventricular dysfunction, carbon dioxide retention during wakefulness, as well as during sleep, and continuous reduced arterial oxygen tension. Sleep apnea sufferers may be at risk for excessive mortality from these factors as well as by an elevated risk for accidents while driving and/or operating potentially dangerous equipment. 
     Even if a patient does not suffer from a complete or nearly complete obstruction of the airway, it is also known that adverse effects, such as arousals from sleep, can occur where there is only a partial obstruction of the airway. Partial obstruction of the airway typically results in shallow breathing referred to as a hypopnea. A hypopnea is typically defined as a 50% or greater reduction in the peak respiratory airflow. Other types of sleep disordered breathing include, without limitation, upper airway resistance syndrome (UARS) and vibration of the airway, such as vibration of the pharyngeal wall, commonly referred to as snoring. 
     It is well known to treat sleep disordered breathing by applying a continuous positive air pressure (CPAP) to the patient&#39;s airway. This positive pressure effectively “splints” the airway, thereby maintaining an open passage to the lungs. It is also known to provide a positive pressure therapy in which the pressure of gas delivered to the patient varies with the patient&#39;s breathing cycle, or varies with the patient&#39;s breathing effort, to increase the comfort to the patient. This pressure support technique is referred to as bi-level pressure support, in which the inspiratory positive airway pressure (IPAP) delivered to the patient is higher than the expiratory positive airway pressure (EPAP). It is further known to provide a positive pressure therapy in which the pressure is automatically adjusted based on the detected conditions of the patient, such as whether the patient is experiencing an apnea and/or hypopnea. This pressure support technique is referred to as an auto-titration type of pressure support, because the pressure support device seeks to provide a pressure to the patient that is only as high as necessary to treat the disordered breathing. 
     Pressure support therapies as just described involve the placement of a patient interface device including a mask component having a soft, flexible sealing cushion on the face of the patient. The mask component may be, without limitation, a nasal mask that covers the patient&#39;s nose, a nasal/oral mask that covers the patient&#39;s nose and mouth, or a full face mask that covers the patient&#39;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 typically secured to the patient&#39;s head by a headgear component. The patient interface device is connected to a gas delivery tube or conduit and interfaces the 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. 
     Humidifiers are frequently provided between or integral with a PAP machine and the user interface in order to humidify the otherwise relatively-dry compressed air generated by the PAP machine. The most conventional type of humidification used in homecare ventilation is a passover arrangement. In such arrangement, air from the CPAP machine flows into a water chamber and over an area of water before exiting the humidifier and passing on to the patient. This carries the moisture via a patient circuit (i.e., tubing and mask) to the patient. The water can be at room temperature or at an elevated temperature. The elevated temperate approach is more popular because it delivers more water in the air due to the fact that it is heated. The water for this type of humidifier is commonly heated using a resistive heater and has multiple set points for comfort. 
     Small travel CPAP devices typically do not have built-in or stand-alone humidifiers and in-line humidifiers (i.e., HMEs) are very large compared to the small form factors of many modern CPAP masks. Hence, it would be desirable to provide the benefits of a humidifier in small travel CPAP or in other instances where a conventional humidifier arrangement is unavailable or undesirable. 
     SUMMARY OF THE INVENTION 
     Embodiments of the present invention provide a patient receiving treatment via a patient interface with adequate humidity without the use of a large tank-style humidifier or an obtrusive HME. As one aspect of the invention, a patient interface for use in delivering a flow of a breathing gas to an airway of a patient is provided. The patient interface comprises: a body defining a cavity therein that is structured to receive the flow of breathing gas; a first aperture defined in the body, the first aperture being positioned and structured to communicate the flow of breathing gas from the cavity to an airway of the patient; a second aperture defined in the body, the second aperture being sized and configured to provide a pathway between the cavity and an ambient environment in which the body is disposed; and a restrictor element selectively coupled to the body, the restrictor element comprising a blocking portion that obstructs at least a portion of the second aperture. 
     The blocking portion may include an opening defined therethrough having a smaller cross-sectional area than the second aperture of the body such that when the blocking portion is disposed over the second aperture the cross-sectional area of the second aperture is limited to that of the opening. 
     The blocking portion may comprise a membrane of a predetermined porosity. 
     The restrictor element may further include a securement arrangement securing the restrictor element to the body such that the blocking portion covers the second aperture. 
     The securement arrangement may comprise a first prong and a second prong that each extend from the blocking portion and are both disposed at least partially in the second aperture and engage the body in a manner that secures the blocking portion in place covering the second aperture. 
     Each of the first and second prongs may engage the body in a manner that provides a snap-fit or a friction-fit between the restrictor element and the body. 
     The securement arrangement may comprise an adhesive that secures the blocking portion in place covering the second aperture. 
     The securement arrangement may comprise a flange that engages the body in a manner that secures the blocking portion in place covering the second aperture. 
     As another aspect of the invention a kit for use in selectively tailoring the flow resistance of an exhaust port in a patient interface for use in delivering a flow of a breathing gas to an airway of a patient is provided. The kit comprises a plurality of restrictor elements, each restrictor element comprising: a blocking portion structured to obstruct at least a portion of the exhaust port; and a securement arrangement structured to selectively couple the restrictor element to the body such that the blocking portion covers the exhaust port. 
     The blocking portion may include an opening defined therethrough having a smaller cross-sectional area than the exhaust port such that when the blocking portion is disposed over the exhaust port the cross-sectional area of the exhaust port is limited to that of the opening. 
     The opening of one of the restrictor elements may have a first cross-sectional area, and the opening of another one of the restrictor elements may have a second cross-sectional area different that the first cross-sectional area. 
     The blocking portion may comprise a membrane of a predetermined porosity. 
     The membrane of one of the restrictor elements may have a first porosity, and the membrane of another one of the restrictor elements may have a second porosity different than the first porosity. 
     The securement arrangement may comprise a structure adapted to selectively couple the restrictor element to the body via one of a snap-fit or a friction-fit. 
     The securement arrangement may comprise an adhesive. 
     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. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a partially schematic depiction of a respiratory interface system for use in providing a flow of positive pressure breathing gas to the airway of a patient in accordance with one example embodiment of the present invention, shown with a mask thereof disposed on the head of a patient; 
         FIG. 2  is a front elevation view of the mask of  FIG. 1 ; 
         FIG. 3  is a section elevation view of the patient interface of the mask of  FIG. 2  taken along line  3 - 3  of  FIG. 2 ; 
         FIG. 4A  is a perspective view of a restrictor element in accordance with one example embodiment of the present invention for use with the mask of  FIGS. 1 and 2 ; 
         FIG. 4B  is a side elevation view of the restrictor element of  FIG. 4A ; 
         FIG. 5  is a front elevation view of a portion of the mask of  FIGS. 1 and 2  showing the restrictor elements of  FIGS. 4A and 4B  installed on the patient interface thereof; 
         FIG. 6  is a front elevation view of another mask in accordance with another example embodiment of the present invention; 
         FIGS. 7A-7D  are example restrictor elements in accordance with example embodiments of the present invention for use with the patient interface of the mask of  FIG. 6 ; 
         FIGS. 8A-8C , respectively, are detail views of the patient interface portion of the mask of  FIG. 6  shown with the restrictor elements of  FIGS. 7A-7C  positioned thereon; 
         FIGS. 9A and 9B  are further example restrictor elements in accordance with example embodiments of the present invention for use with the patient interface of the mask of  FIG. 6 ; and 
         FIGS. 10A and 10B  respectively, are detail views of the patient interface portion of the mask of  FIG. 6  shown with the restrictor elements of  FIGS. 9A and 9B  positioned thereon. 
     
    
    
     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. 
     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. 
     As used herein, the statement that two or more parts or components “engage” one another shall means that the parts exert a force against one another either directly or through one or more intermediate parts or components. 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 used herein, the term “number” shall mean one or an integer greater than one (i.e., a plurality). 
     As used herein, a “coupling assembly” includes two or more couplings or coupling components. The components of a coupling or coupling assembly are generally not part of the same element or other component. As such the components of a “coupling assembly” may not be described at the same time in the following description. 
     As used herein, a “coupling” is one element of a coupling assembly. That is, a coupling assembly includes at least two components, or coupling components, that are structured to be coupled together. It is understood that the elements of a coupling assembly are compatible with each other. For example, in a coupling assembly, if one coupling element is a snap socket, the other coupling element is a snap plug. 
     As used herein, “correspond” indicates that two structural components are sized and shaped to be similar to each other and may be coupled with a minimum amount of friction. Thus, an opening which “corresponds” to a member is sized slightly larger than the member so that the member may pass through the opening with a minimum amount of friction. This definition is modified if the two components are said to fit “snugly” together or “snuggly correspond.” In that situation, the difference between the size of the components is even smaller whereby the amount of friction increases. If the element defining the opening and/or the component inserted into the opening is/are made from a deformable or compressible material, the opening may even be slightly smaller than the component being inserted into the opening. This definition is further modified if the two components are said to “substantially correspond.” “Substantially correspond” means that the size of the opening is very close to the size of the element inserted therein. That is, not so close as to cause substantial friction, as with a snug fit, but with more contact and friction than a “corresponding fit,” i.e. a “slightly larger” fit. 
     A respiratory interface system  2  adapted to provide a regimen of respiratory therapy to a patient P according to one exemplary embodiment of the present invention is shown in  FIG. 1 . Respiratory interface system  2  includes a pressure generating device  4  (shown schematically), and a delivery conduit  6  (shown schematically) fluidly coupled to a mask  8 . Pressure generating device  4  is structured to generate a flow of positive pressure 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, Pa.), and auto-titration pressure support devices. Delivery conduit  6  is structured to communicate the flow of breathing gas from pressure generating device  4  to mask  8 , and mask  8  is structured to further communicate the flow of breathing gas received from conduit  6  to an airway of patient P. Delivery conduit  6  and mask  8  are often collectively referred to as a patient circuit. 
     Continuing to refer to  FIG. 1 , as well as to  FIG. 2 , mask  8  includes a tubing assembly  10  and a patient interface  12  fluidly coupled to tubing assembly  10 . Tubing assembly  10  includes a manifold portion  14  structured to receive the flow of positive pressure breathing gas from delivery conduit  6 , a number (two are shown in the example of  FIGS. 1 and 2 ) of tubular portions  16  which each extend from manifold portion  14  to a distal end (not numbered) which is selectively coupled to patient interface  12 . It is to be appreciated that other arrangements aside from tubing assembly  10  may be employed in mask  8  to provide the flow of positive pressure breathing gas produced by pressure generating device  4  to patient interface  12  without varying from the scope of the present invention. 
     Referring now to  FIG. 3 , in addition to  FIGS. 1 and 2 , patient interface  12  includes a body  18  that defines a cavity  20  therein that is structured to receive (e.g., via tubing assembly  10 ) the flow of breathing produced by pressure generating device  4 . In the one example shown in  FIGS. 1-3 , body  18  is made of a soft, flexible material, such as, without limitation, silicone, an appropriately soft thermoplastic elastomer, a closed-cell foam, or any other suitable material or combination of such materials, however, it is to be appreciated that body  18  may be formed from one or more other suitable materials without varying from the scope of the present invention. 
     Patient interface  12  further includes a first aperture  22  defined therein that is positioned and structured to communicate the flow of breathing gas from cavity  20  to the airway of the patient and a sealing element  24  disposed thereabout first aperture  22  which is structured to sealingly engage about one or more of the nares and/or mouth of patient P. In the example embodiment illustrated in  FIGS. 1-3 , sealing element  24  is formed as an integral portion of body  18 , and thus is made of a soft, flexible material, such as, without limitation, silicone, an appropriately soft thermoplastic elastomer, a closed-cell foam, or any other suitable material or combination of such materials. It is to be appreciated, however, that sealing element  24  made be formed as a separate element and may take the form of any type of patient sealing element, such as a nasal/oral mask, a nasal pillow or a full face mask, which facilitates the delivery of the flow of breathing gas to the airway of a patient, without varying from the scope of the present invention. 
     Patient interface  12  further includes a second aperture  26  defined in body  18  that is sized and configured to provide a pathway between cavity  20  and an ambient environment in which body  18  is disposed. When patient interface  12  is positioned on the face of patient P, second aperture  26  functions as an exhalation port for venting gases exhaled by the patient from cavity  20  to the ambient environment in which patient P is positioned 
     Embodiments of the present invention selectively increase the humidity of the air within cavity  20  by restricting the escape of gases exhaled by the patient through second aperture  26 . As the gases exhaled by a patient are of a higher humidity than the flow of breathing gas produced by pressure generating device  4 , restricting the escape of such exhaled gases effectively increases the humidity of the air within cavity  20  which is inhaled by the patient. In order to selectively restrict the escape of exhaled gases through second aperture  26 , a restrictor element  30 , such as the one example shown in  FIGS. 4A and 4B , that reduces the size of second aperture  26  may be coupled to body  18 . Restrictor element  30  includes a blocking portion  32  that obstructs at least a portion of second aperture  26  of body  18  when restrictor element  30  is coupled to body  18 , such as shown in  FIG. 5 . 
     In the example shown in  FIGS. 4A and 4B , blocking portion  32  includes an opening  34  defined therethrough that has a smaller cross-sectional area than second aperture  26  of body  18  such that when blocking portion  32  is disposed over second aperture  26  the cross-sectional area of second aperture is limited to that of opening  34 . Restrictor element  30  further includes a securement arrangement  36  for securing restrictor element  30  to body  18  such that blocking portion  32  covers second aperture  26  such as shown in  FIG. 5 . In the example shown in  FIGS. 4A and 4B , securement arrangement  36  includes a first prong  38 A and a second prong  38 B that each extend from blocking portion  32  and are both sized and configured to be disposed at least partially in second aperture  26  and engage body  18  in a manner that secures blocking portion  32  in place covering second aperture  26 . First and second prongs  38 A and  38 B may each include a flared portion  40 A and  40 B that engage body  18  providing a snap-fit between restrictor element  30  and body  18 . In another example embodiment, first and second prongs  38 A and  38 B engage body  18  providing a friction fit between restrictor element  30  and body  18 . 
     Another mask  108  in accordance with another example embodiment of the present invention is shown in  FIG. 6 . Mask  108  is of similar arrangement as mask  8  previously discussed in regard to  FIGS. 1 and 2  and as such include tubing assembly  10  such as previously discussed. Mask  108  further includes a patient interface  112 , similar to patient interface  12  previously discussed, that is fluidly coupled to tubing assembly  10 . Patient interface  112  differs from patient interface  12  (previously discussed) in that patient interface  112  includes a second aperture  126  of a larger size (i.e., greater cross-sectional area) than second aperture  26  of patient interface  12 . Such difference in sizing is due to the fact that second aperture  126  is sized and configured to be used only in conjunction with a restrictor element  130  (e.g., without limitation, such as shown in  FIGS. 7A-7D , as well as  FIGS. 9A and 9B ) and not without (in contrast patient interface  12  is designed to be used without restrictor element  30 , hence restrictor element functions generally as a retro-fit arrangement). 
     Referring now to  FIGS. 7A-7D and 8A-8C , some restrictor elements  130 A- 130 D in accordance with several example embodiments of the present invention for use with patient interface  112  are shown (partially schematically). Similar to restrictor element  30  previously discussed, each restrictor element  130 A- 130 D includes a blocking portion  132  and a securement arrangement  136  for securing blocking portion  132  to body  118  of patient interface  112  such that blocking portion  132  covers second aperture  126  (such as shown in  FIGS. 8A-8C ). 
     Unlike the mechanical arrangement (i.e., prongs  38 A and  38 B) of securement arrangement  36  utilized in restrictor element  30 , securement arrangements  136  of each of restrictor elements  130 A- 130 D utilize an adhesive  138  (shown single-hatched in  FIGS. 7A-7D  for exemplary purposes) suitable for bonding to silicone. In the examples shown in  FIGS. 7A-7D , adhesive  138  is disposed completely around blocking portion  132 , however, it is to be appreciated that adhesive  138  could be otherwise suitably positioned without varying from the scope of the present invention. 
     Unlike restrictor element  30  that utilized smaller sized opening  34  to restrict flow through second aperture  26 , restrictor elements  130 A- 130 C utilize membranes (shown cross-hatched in  FIGS. 7A-7D and 8A-8C ) of different porosity as blocking portion  132  in order to provide different resistance to airflow therethrough. Hence, the flow of air through second apertures  126  of patient interface  112  may be selectively varied by adhering different ones of restrictor elements  130 A- 130 D to body  118  with blocking portion  132  thereof covering second aperture  126 . For example, such potential range of flow may vary from a very porous blocking portion  132 , such as shown in restrictor element  130 A, to a not porous (i.e., solid) blocking portion  132 , such as shown in restrictor element  130 D. 
     Restrictor elements  130 A- 130 D may be formed by selectively depositing an adhesive on a mesh, film, fabric or other porous or non-porous sheet. From this sheet, restrictor element “stickers” can be cut with a laser, die, knife, or any method of cutting. For partially restrictive embodiments, the adhesive should not cover some portion of the sheet, allowing flow through the structure, but restricted compared to an open exhalation. The stickers may include a release tab, such as tab  40  shown in dashed line in  FIG. 8A , without adhesive to aid in removal. The stickers may be provided on a sheet of release liner, in a multi-pack, or any other suitable “kit” form. The restrictor elements  130 A- 130 D may be disposable or re-usable. 
       FIGS. 9A and 9B  show further restrictor elements  230 A and  230 B in accordance with other example embodiments of the present invention that may be employed with patient interface  112 . Restrictor elements  230 A and  230 B function similarly to restrictor element  30  previously discussed in regard to  FIGS. 1-5 . Accordingly, each restrictor element  230 A and  230 B includes a blocking portion  32  having an opening  34 A,  34 B and a securement arrangement  236  for securing each restrictor element  230 A and  230 B to body  118  such that blocking portion  32  thereof covers second aperture  126 , such as shown in  FIGS. 10A and 10B . In the example shown in  FIGS. 9A and 9B , securement arrangement  236  includes a flange  238  that is sized and configured to engage body  118  (either within or adjacent to second aperture  126 ) in a manner that secures blocking portion  32  in place covering second aperture  126 . Such engagement between flange  238  and body  118  may be structured to provide a snap-fit or a friction-fit between each restrictor element  230 A or  230 B and body  118 . Similar to restrictor elements  130 A- 130 D, restrictor elements  230 A and  230 B may be provided in a kit, allowing a user to select the resistance member desirable for their particular application. 
     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. Accordingly, it is to be appreciated that restrictor elements employing membranes may utilize mechanical securement arrangements without varying from the scope of the present invention. Likewise, restrictor elements utilizing different sized apertures may utilize adhesive securement arrangements without varying from the scope of the present invention. 
     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.