Patent Application
20220096768
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 exhaust arrangements for use in such patient interfaces. The present invention further pertains to a method of cleaning an exhaust arrangement utilized in patient interface.
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'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 air-flow.
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 air-flow. 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'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's breathing cycle, or varies with the patient'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 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's nose, a nasal/oral mask that covers the patient's nose and mouth, or a full face mask that covers the patient's face. Such patient interfaces may also employ other patient contacting components, such as forehead supports, cheek pads and chin pads. The patient interface is typically secured to the patient's head by a headgear component. The patient interface 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 via the patient interface. An exhaust port (also referred to as an exhalation vent, exhalation port, and/or exhaust vent) is provided in the gas delivery tube or conduit and/or the patient interface device to allow exhaust gas, such as the exhaled gas from the patient, to vent to atmosphere.
Typical exhaust ports comprise a single orifice (e.g. a slot) or an array of smaller holes which extend directly from the interior of the patient interface and/or tube/conduit via the shortest path (i.e., generally perpendicular to the wall of the patient interface and/or tube/conduit) to the surrounding environment. Common complaints for such type of exhaust port are that the exhausted air blows onto the patient (e.g. hits the patient's hands) or a patient's bed partner resulting in an uncomfortable feeling. Some newer exhaust port designs have tried to reduce such air jetting by using a mesh material or by covering the exhaust port hole(s) with a fiber material to attempt to diffuse the exhausted air. A common complaint with such mesh/fiber approaches is that they are difficult for a patient to keep clean and may provide a place for germs to grow as they are difficult or impossible to clean.
As one aspect of the present invention an arrangement structured to provide for the passage of gases from a cavity of a patient interface to an ambient environment in which patient interface is disposed, the patient interface being for use in providing a flow of a treatment gas to the airway of a patient, comprises: a body member sized and configured to form a portion of the patient interface between the cavity and the ambient environment, the body member comprising: a number of inlets defined in a first side of the body member, each inlet being positioned and structured to receive gases from the cavity; a number of outlets defined in a second side of the body member opposite the first side, each outlet being positioned and structured to provide for the exit of gases from the patient interface to the surrounding environment; and a number of high-drag passages defined in the body member, each high-drag passage extending laterally between an inlet of the number of inlets and an outlet of the number of outlets.
The number of high-drag passages may comprise a plurality of high-drag passages extending from one inlet of the number of inlets.
The one inlet may be in the shape of an elongated slot.
The body member may comprise an internal member and an external member coupled to the internal member, wherein the number of inlets are defined in the internal member, and wherein the number of outlets are defined in the external member.
The number of high-drag passages may be defined by a corresponding number of grooves formed in one or both of the internal member and/or the external member.
The number of high-drag passages may be defined by a corresponding number of grooves formed in the external member that are each bounded by a portion of the internal member thus defining each high-drag passage.
The number of grooves may be formed via one of: injection molding, machining, or 3D printing.
The external member may be selectively coupled to the internal member.
The internal member may comprise a portion of the patient interface.
Each high-drag passage may comprise at least one of: a number of textured surfaces, multiple bends, a length of at least 20 mm, and/or a minor diameter of 0.8 mm or less.
As another aspect of the present invention a patient interface for use in providing a flow of a treatment gas to the airway of a patient comprises: a body that defines a cavity therein that is structured to receive the flow of treatment gas; a first aperture defined therein that is positioned and structured to communicate the flow of treatment gas from the cavity to the airway of the patient; a sealing element disposed thereabout the first aperture, the sealing element being structured to sealingly engage about one or more of the nares and/or mouth of the patient; and an arrangement structured to provide for the passage of gases from the cavity to an ambient environment in which the patient interface is disposed, the arrangement comprising: a body member sized and configured to form a portion of the patient interface between the cavity and the ambient environment, the body member of the arrangement comprising: a number of inlets defined in a first side, each inlet being positioned and structured to receive gases from the cavity; a number of outlets defined in a second side opposite the first side, each outlet being positioned and structured to provide for the exit of gases from the patient interface to the ambient environment; and a number of high-drag passages defined in the body member of the arrangement, each high-drag passage extending laterally between an inlet of the number of inlets and an outlet of the number of outlets.
The body member of the arrangement may comprise an internal member and an external member coupled to the internal member, wherein the number of inlets are defined in the internal member, and wherein the number of outlets are defined in the external member.
Each high-drag passage may comprise at least one of: a number of textured surfaces, multiple bends, a length of at least 20 mm, and/or a minor diameter of 0.8 mm or less.
As yet a further aspect, a respiratory interface system for use in providing a regimen of respiratory therapy to a patient comprises: a pressure generating device structured to provide a flow of a treatment gas; a patient interface structured communicate the flow of treatment gas to an airway of the patient; and a delivery conduit coupled between the pressure generating device and the patient interface, the delivery conduit structured to communicate the flow of the treatment gas from the pressure generating device to the patient interface, wherein the patient interface comprises: a body that defines a cavity therein that is structured to receive the flow of treatment gas received from the delivery conduit; a first aperture defined therein that is positioned and structured to communicate the flow of treatment gas from the cavity to the airway of the patient; a sealing element disposed thereabout the first aperture, the sealing element being structured to sealingly engage about one or more of the nares and/or mouth of the patient; and an arrangement structured to provide for the passage of gases from the cavity to an ambient environment in which the patient interface is disposed, the arrangement comprising: a body member sized and configured to form a portion of the patient interface between the cavity and the ambient environment, the body member of the arrangement comprising: a number of inlets defined in a first side, each inlet being positioned and structured to receive gases from the cavity; a number of outlets defined in a second side opposite the first side, each outlet being positioned and structured to provide for the exit of gases from the patient interface to the ambient environment; and a number of high-drag passages defined in the body member of the arrangement, each high-drag passage extending laterally between an inlet of the number of inlets and an outlet of the number of outlets.
Each high-drag passage may comprise at least one of: a number of textured surfaces, multiple bends, a length of at least 20 mm, and/or a minor diameter of 0.8 mm or less.
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.
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
Continuing to refer to
Referring now to
In the example embodiment illustrated in
Referring now to
Body member 28 also includes a number of high-drag passages 34 defined therein, with each high-drag passage extending laterally (i.e., within body member 28 generally parallel to outer surfaces thereof and/or perpendicular to a straight through passage) a distance between an inlet 30 of the number of inlets 30 and an outlet 32 of the number of outlets 32. As used herein, a “high drag passage” is a passage having walls dimensioned and/or positioned so as to slow the airflow velocity of gases passing therethrough without the use of a blocking material positioned therein. For example, a passage having a fibrous material disposed therein is not a “high-drag passage”. As another example, a passage extending straight through a wall (i.e., perpendicular to the wall) is also not a “high drag passage”. In the example shown in
As shown in the example embodiment of
By relying on the geometry of mating surfaces of multiple components to create the enclosed high-drag passages 34, it is possible to create passages that otherwise could not be easily manufactured due to their small size, small diameter to length ratio, and/or torturous shape. The channels or grooves from which the high-drag passages are defined in-part may be formed from any suitable method such as, for example, without limitation, injection molding, machining, chemical etching, and/or 3D printing. In addition to providing for forming passages of complex geometries to be readily created, such modular construction additionally provides for the elements to be separated without damage if/when selectively coupled together (e.g., a snap fit, interference fit, or other suitable arrangement), thus exposing the channels that form each of the high-drag passages for cleaning thereof and/or replacement depending on the particular application.
Another respiratory interface system 102 adapted to provide a regimen of respiratory therapy to a patient P according to another exemplary embodiment of the present invention is shown in
Patient interface 112 further includes an arrangement 126 coupled to, or provided in-part as a portion of, body 118 that provides for the passage of gases (e.g., patient exhalation gases) from cavity 120 of patient interface 12 to an ambient environment in which body 118, and thus patient interface 112, is disposed. Similar to arrangement 26 previously discussed, arrangement 126 includes a generally thin, plate-like, internal member in the form of a generally rigid faceplate 140 that is positioned bounding cavity 120 and generally surrounded by sealing element 124, and a generally thin, plate-like, external member in the form of a frame 142 that may be permanently or selectively coupled to faceplate 140 and positioned in communication with the ambient environment in which patient interface 112 is disposed. Frame 142 includes a number of securement points or structures 150 to which a suitable headgear or other stabilizing (e.g., a forehead support) and/or securement arrangement (not shown) may be coupled in order to secure/stabilize patient interface on the face/head of a patient. In such example embodiment, a number of inlets 130 are defined in, and through faceplate 140, while a number of outlets 132 (shown generally schematically enlarged in order to merely demonstrate their general positioning in the example embodiment) are defined in and through frame 142. Additionally in such embodiment, a number of high-drag passages 134 are defined in-part by a corresponding number of channels or grooves 136 defined in frame 142 and, when frame 142 is coupled to faceplate 140, by corresponding portions of faceplate 140. Alternatively, the number of high-drag passages 134 may be similarly formed by channels or grooves defined in faceplate 140 that interact with corresponding portions of frame 142 or by channels or grooves formed in both faceplate 140 and frame 142 that interact with corresponding portions of the other element 140, 142 to define high-drag passages 134.
The example arrangement 126 shown in
From the foregoing examples it is to be appreciated that embodiments of the present invention provide arrangements for exhausting gases from a patient interface that improve upon known solutions. Such arrangements may include anywhere form a single large channel to an array of hundreds of channels depending on the particular application. When more channels are utilized, channels of shorter length and/or lesser cross-sectional area are needed. Accordingly, embodiments of the present invention can generally be tailored as needed to fit a particular patient interface arrangement.
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.
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.
This patent application claims the priority benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 63/085,436, filed on Sep. 30, 2020, the contents of which are herein incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63085436 | Sep 2020 | US |
