WO2014020473A2

WO2014020473A2 - Headgearless patient interface assembly

Info

Publication number: WO2014020473A2
Application number: PCT/IB2013/055841
Authority: WO
Inventors: Justin Edward Rothermel; Maureen Harp; Eric Alan HIGGINS; Jonathan Paul Todd
Original assignee: Koninklijke Philips NV
Current assignee: Koninklijke Philips NV
Priority date: 2012-08-03
Filing date: 2013-07-16
Publication date: 2014-02-06
Anticipated expiration: 2015-02-03
Also published as: WO2014020473A3

Description

HEADGEARLESS PATIENT INTERFACE ASSEMBLY

[01] This patent application claims the priority benefit under 35 U.S.C. § 1 19(e) of U.S. Provisional Application No. 61/679,121 filed on August 3, 2012, the contents of which are herein incorporated by reference.

BACKGROUND OF THE INVENTION

1 . Field of the Invention

[02] The present invention generally relates to patient interface assemblies for use in a pressure support system that supplies a flow of gas to the airway of a patient, and, more particularly, to patient interface assemblies that are held securely to the head of a patient without the use of a conventional headgear assembly.

2. Description of the Related Art

[03] 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 no n- invasive ventilation (NIV). It is also known to deliver continuous positive airway pressure (CPAP) or variable airway pressure, which varies with the patient's respiratory cycle, to treat a medical disorder, such as sleep apnea syndrome, in particular, obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or congestive heart failure (CHF).

[04] Non-invasive ventilation and pressure support therapies involve the

placement of a patient interface device, which is typically a nasal or nasal/oral mask (i.e., a full face 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.

[05] Typically, patient interface devices include a mask shell having a cushion attached to the shell that contacts, and seals against, the surface of the patient. The mask shell and cushion are held in place by a headgear that wraps tightly around the head of the patient. The mask and headgear form the patient interface assembly. A typical headgear includes flexible, adjustable straps that extend from the mask around the sides, back and top of a patient's head in order to secure the mask snugly to the patient's head.

[06] Such straps are used to aid in proper placement and to compress the mask and cushion to the patient's face in order to provide proper seal. Several issues commonly arise from the use of such straps for mask attachment: the straps are uncomfortable on the patient's head, the straps slip on the patient's hair and cause sealing issues, the straps can be adjusted improperly and cause the mask to sit on the wrong location on the patient's face, the straps can cause undesired perspiration, and overtightening the straps can cause the mask to place too much pressure on sensitive facial skin.

SUMMARY OF THE INVENTION

[07] As an aspect of the present invention, a patient interface assembly for use in a system delivering a flow of treatment gas from a pressure generating device to the airway of a patient is provided. The patient interface assembly comprises: a pillow member structured to accommodate the patient's head thereon; a support member disposed above the pillow member; and a mask assembly coupled to the support member. The mask assembly includes a cushion structured to sealingly engage at least one of the nasal or oral orifices of the patient and the cushion is structured to be coupled to the pressure generating device for delivering the flow of treatment gas to the airway of the patient.

[08] The support member may be generally arcuate in shape. The support member may comprise a first end and an opposite second end and the first end and the opposite second end may be coupled to or near the pillow member. The support member may comprise a first portion extending from the first end and a second portion extending from the second end the first and second portions may be selectively coupled. The first and second portions may be selectively coupled by at least one of: a latch mechanism, a hook and loop fastener, or a snap.

[09] The support member may be generally rigid. The support member may comprise a first end and an opposite second end, only one of the first end and the opposite second end being coupled to or near the pillow member. The one of the first end and the opposite second end may be hingedly coupled to or near the pillow member.

[10] The cushion may be slidingly coupled to the support member.

[11] As another aspect of the invention, another patient interface assembly for use in a system for delivering a flow of a treatment gas to the airway of a patient is provided. The patient interface assembly comprises: a pillow member structured to accommodate the patient's head thereon, the pillow member including a number of first coupling portions and a mask assembly. The mask assembly comprises: a cushion structured to sealingly engage at least one of the nasal or oral orifices of the patient, the cushion being adapted to receive the flow of treatment gas from a pressure generating device; and a number of strap members coupled to and extending from the cushion, each strap member of the number of strap members having at least one second coupling portion. Each of the second coupling portions are adapted to be selectively coupled to at least one of the first coupling portions.

[12] The first coupling portions and the second coupling portions may be

selectively coupled via a magnetic force.

[13] Each strap member may include an elastic portion disposed between the cushion and the second coupling portion.

[14] 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

[15] FIG. 1 is an isometric view of an example embodiment of a patient

interface assembly according to the principles of the present invention shown (schematically) connected to a gas flow/pressure generating system to form a pressure support system;

[16] FIG. IB is a cross sectional view of the patient interface assembly of FIG.

i;

[17] FIG. 2 is an isometric view of another example embodiment of a patient interface assembly according to the principles of the present invention shown

(schematically) connected to a gas flow/pressure generating system to form a pressure support system; and

[18] FIG. 3 is an isometric view of yet another example embodiment of a patient interface assembly according to the principles of the present invention shown

(schematically) connected to a gas flow/pressure generating system to form a pressure support system.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[19] 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 phrase that two or more elements are "selectively coupled" shall mean the elements are coupled in a manner that may be readily positioned in either of a coupled or uncoupled position.

[20] 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).

[21] As used herein, the phrase "pillow member" shall refer to any suitable member or assembly for supporting the head of a patient thereon. As used herein, the phrase "generally rigid" shall refer to any suitable material that has a relative stiffness great enough to at least retain a desired predetermined shape.

[22] 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 intended to be limiting upon the claims unless expressly recited therein.

[23] FIGS. 1-3 illustrate example embodiments of systems 10, 10', 10" for administering a treatment gas to the airway of a patient without the use of a conventional headgear according to the principles of the present invention. Referring to the example of FIGS. 1 and IB, system 10 includes a patient interface assembly, shown generally at 12, for communicating a flow of breathing gas between the patient's airway (via at least one of the patient's nasal or oral orifices) and a pressure/flow generating system 14 (shown schematically), such as a ventilator, CPAP device, or variable pressure device, e.g., a BiPAP^® device manufactured and distributed by Philips Respironics, Inc. of Pittsburgh, Pa., or an auto-titration pressure support system.

[24] 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, pressure/flow generating system 14 is also referred to as a gas flow generating device, because gas flow results when a pressure gradient is generated. The present invention contemplates that pressure/flow generating system 14 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 noninvasive ventilation systems.

[25] Communicating a flow of breathing gas between the patient's airway and pressure/flow generating system 14 includes delivering a flow of breathing gas to the patient from the pressure/flow generating device 14 and exhausting a flow of gas from the patient to ambient atmosphere. System 10 further includes a conduit 16 (shown schematically), which is also referred to as a patient circuit, having a first end portion (not numbered) operatively coupled to the gas flow generating device and a second end portion (not numbered) coupled to patient interface assembly 12 such that conduit 16 carries the flow of gas from pressure/flow generating device 14 during operation of the system to patient interface assembly 12. Conduit 16 corresponds to any structure suitable for communicating the flow of gas from pressure/flow generating device 14 to patient interface assembly 12. A typical conduit is a flexible tube.

[26] Continuing to refer to FIG. 1, patient interface assembly 12 includes a pillow member 18 structured to accommodate the patient's head thereon. In the example embodiment shown in FIG. 1, pillow member 18 comprises a cushiony pillow such as commonly used for supporting a human head during sleep, it is to be appreciated, however, that other suitable structures for supporting the head of a patient, whether in a lying or seated position, may be employed without varying from the scope of the present invention.

[27] Patient interface assembly 12 further includes a support member 20 having a mask assembly 22 coupled thereto. Support member is positioned such that mask assembly 22 is disposed generally above pillow member 18. Depending on the particular application, mask assembly 22 may be fixedly coupled or slidingly coupled to support member 20. In the example embodiment shown in FIG. 1, support member 20 is formed in a generally arcuate shape from a generally rigid material and includes a first end 20a and an opposite second end 20b. As shown in the example embodiment illustrated in FIG. 1, first and second ends 20a, 20b may be coupled directly or indirectly to pillow member 18. Additionally, it is to be appreciated that first and second ends 20a, 20b may also be suitably coupled to another fixed member near pillow member 18 as long as support member 20 is provided above pillow member 18 substantially as shown in FIG. 1.

[28] Referring now to FIGS. 1 and IB, mask assembly 22 includes a shell

portion 23 and a cushion 24 coupled thereto. Cushion 24 is structured to sealingly engage at least one of the nasal and/or oral orifices of the patient. Although shown in the illustrated embodiment as being an oral/nasal cushion which encompasses both the nasal and oral orifices of the patient, it is to be appreciated that cushion 24 may encompass either the nasal or oral orifices alone, or encompass both separately, without varying from the scope of the present invention.

[29] In the example embodiment illustrated in FIGS. 1 and IB, cushion 24 is coupled to conduit 16, via shell portion 23, in a manner such that the flow of gas is communicated to the interior of cushion 24 through a passage (not numbered) in shell portion 23 for subsequent delivery to the patient. Conversely, gas exhaled from the patient is communicated from cushion 24 into conduit 16 via the passage in shell portion 23, where an exhaust port (not numbered) is located. In the exemplary embodiment shown in FIGS. 1 and IB, shell portion 23 is formed from a generally rigid material, such as polycarbonate. It is to be understood that the present invention contemplates that one or more of the size, shape, or composition of shell portion 23 may be varied without varying from the scope of the present invention.

[30] In the example embodiment shown in FIGS. 1 and IB, cushion 24 is

formed of a soft, cushiony, elastomeric material, such as silicone, and may also be formed from appropriately soft thermoplastic elastomers, closed cell foams, thin materials, or any combination of suitable materials. Although in the example embodiment shown in FIGS. 1 and 1A cushion 24 is coupled to conduit 16 via shell portion 23, it is to be appreciated, however, that cushion 24 may also be directly coupled to conduit 16 without varying from the scope of the present invention.

[31] In use, a patient's head is rested on pillow member 18 such that it is

disposed between pillow member 18 and cushion 24 such that the appropriate one or both of the patient's oral and/or nasal orifices are sealingly engaged by cushion 24. In order to assist in placement of the patient's head in such positioning, support member 20 may be formed by two portions selectively coupled together. In the example embodiment shown in FIG. 1 , support member 20 includes a first portion 25 extending from first end 20a and a second portion 26 extending from second end 20b. First and second portions 25, 26 are selectively coupled via a clip mechanism, however, other means such as hook and loop structures, snaps, or other suitable mechanisms may be employed without varying from the scope of the present invention. It is also to be appreciated that support member 20 may also be provided with one or more adjustment mechanisms (not numbered) which provide for one or more of the length and/or relative height of support member 20 to be adjusted in order to provide for initial fitment of patient interface assembly 12 to the head of a patient.

[32] It is to be appreciated that as a result of the arrangement of support

member 20, cushion 24 is held securely to the face of a patient without the need for any tight fitting straps or headgear such as commonly found in the art. Accordingly, patient interface assembly 12 provides a patient experience that overcomes many of the drawbacks of known interfaces previously discussed.

[33] FIG. 2 shows another example embodiment of a system 10' for use in administering a treatment gas to the airway of a patient without the use of a conventional headgear according to the principles of the present invention. Similar to system 10, previously discussed, system 10' includes a patient interface assembly, shown generally at 12', for communicating a flow of breathing gas between a patient's airway (via at least one of the patient's nasal or oral orifices) and a pressure/flow generating system 14 (shown schematically), to which patient interface assembly 12' is coupled via a conduit 16.

[34] Patient interface assembly 12', similar to patient interface assembly 12, includes a pillow member 18 structured to accommodate the patient's head thereon. Unlike support member 20 of system 10 which was coupled at or near pillow member 18 at both ends, patient interface assembly 12' includes a support member 20' that is only coupled at or about pillow member 18 by a first end 20a', and thus includes an opposite second end 20b' which is freely disposed generally above a portion of pillow member 18. More particularly, support member 20' is hingedly coupled to a fixed point at or about pillow member 18 such that support member 20' (and thus opposite second end 20b') may pivot about an axis 28 in order to allow a patient's head to be generally disposed thereunder, such as shown in the illustrated embodiment of FIG. 2. In order to selectively prevent movement of support member 20' about axis 28, a lock mechanism (not shown), is provided at or about axis 28 which inhibits movement of support member 20' about axis 28, and thus may be used to effectively lock support member 20' in a lowered position over the head of a patient.

[35] In the example embodiment shown in FIG. 2, support member 20' is

hingedly coupled to a riser member 30 (which is coupled at or about the member or structure on which pillow member 18 rests) which generally elevates first end 20a' with respect to pillow member 18, however, it is to be appreciated that the mounting location/position of first end 20a' may be varied without varying from the scope of the present invention.

[36] Continuing to refer to FIG. 2, support member 20' includes a cushion 24' coupled to an underside (not numbered) thereof which is coupled to conduit member 16 for communicating a flow of breathing gas between a patient's airway (via at least one of the patient's nasal or oral orifices) and pressure/flow generating system 14. Cushion 24', like cushion 24 previously described, is structured to sealingly engage at least one of the nasal and/or oral orifices of the patient. Although shown in the illustrated embodiment as being an oral/nasal cushion which encompasses both the nasal and oral orifices of the patient, it is to be appreciated that cushion 24' may encompass either the nasal or oral orifices alone, or encompass both separately, without varying from the scope of the present invention. In the example embodiment illustrated in FIG. 2, cushion 24' is coupled directly to conduit 16, such that the flow of gas from pressure/flow generating system 14 is communicated to the interior of cushion 24' for subsequent delivery to the patient. Conversely, gas exhaled from the patient is communicated from cushion 24' into conduit 16, where an exhaust port (not numbered) is located. Alternately, support member 20' may include a passage (not shown) formed therein which serves as an intermediary connection between conduit 16 and cushion 24'.

[37] In use, support member 20' is rotated upward allowing a patient's head to be rested on pillow member 18. Next, support member 20' is rotated downward until cushion 24' engages the appropriate portion of the patient's face such that cushion 24' sealingly surrounds the appropriate one or both of the patient's nasal and/or oral orifices. Once appropriately positioned, support member 20' is locked in place via the lock mechanism. In order to assist in proper positioning of support member 20' with respect to the patient's head, an adjustment mechanism may be provided which allows for the relative of height of first end 20a' to be adjusted relative to the patient's head.

[38] It is to be appreciated that as a result of the arrangement of support

member 20', cushion 24' is held securely to the face of a patient without the need for any tight fitting straps or headgear such as commonly found in the art. Accordingly, patient interface assembly 12' provides a patient experience that overcomes many of the drawbacks of known patient interfaces.

[39] FIG. 3 shows yet another example of a system 10" for use in administering a treatment gas to the airway of a patient without the use of a conventional headgear according to the principles of the present invention. Similar to systems 10 and 10', previously discussed, system 10" includes a patient interface assembly, shown generally at 12", for communicating a flow of breathing gas between a patient's airway (via at least one of the patient's nasal or oral orifices) and a pressure/flow generating system 14 (shown schematically), to which patient interface assembly 12" is coupled via a conduit 16.

[40] Similar to patient interface assemblies 12 and 12' previously discussed, patient interface assembly 12" includes a pillow member 18" structured to accommodate the patient's head thereon. However, unlike pillow members 18 previously discussed, pillow member 18" includes a number of first coupling portions 32, the function of which is discussed in detail below. [41] Continuing to refer to FIG. 3, patient interface assembly 12" further includes a mask assembly 22" including a mask shell 23" and a cushion 24" structured to sealingly engage at least one of the nasal or oral orifices of the patient. Cushion 24" may be of conventional shape such as used in known applications and may be of an oral, nasal, or oral/nasal, design depending on the particular application. Cushion 24" is coupled to conduit 16 and thus adapted to receive a flow of treatment gas from pressure generating device 14. Mask assembly 22" further includes a number of strap members 34 coupled to and extending from one of mask shell 23" or cushion 24". Each strap member 34 includes at least one second coupling portion 36 adapted to be selectively coupled to at least one of first coupling portions 32 of pillow member 18". Each of first coupling portions 32 and second coupling portions 36 may be selectively coupled via a magnetic force provided by a magnetic material, and a corresponding material provided in each of portions 32 and 36. Although the illustrated example embodiment employs magnetic structures, it is to be appreciated that other suitable mechanisms which provide for selective coupling may be employed without varying from the scope of the present invention. Examples of such mechanisms include, without limitation, snaps and hook and loop fasteners.

[42] In use, a patient's head is first rested on pillow member 18" and then cushion 24" of ask assembly 22" is sealingly engaged with the appropriate portion of the patient's face. In order to ensure such seal is maintained, each of strap members 34 are then coupled to pillow member 18" via coupling of corresponding first and second coupling portions 32 and 36. In order to optimize comfort and fitment of cushion 24" on the face of a patient, one or more of strap members 34 may be provided with an elastic portion 38 or other adjustment mechanism which allows for selective sizing of strap members 34. It is to be appreciated that each of first coupling portions are preferably spaced a distance D such that when mask assembly 22" is disposed on a patient's face each of strap members 34 are generally disposed a distance from the sides of the patient's head, and thus not a nuisance to the patient. [43] From the example embodiments described herein, it is to be readily appreciated that embodiments of the present invention provide patient interface assemblies that readily deliver a flow of treatment gas to the airway of a patient without having to utilize a tight fitting convention headgear assembly. Instead, embodiments of the present invention provide generally open, less restrictive mechanisms for suitably securing a mask to the head of a patient which provide for greater patient comfort than conventional interface assemblies.

[44] 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.

[45] 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.

Claims

What is Claimed is:

1. A patient interface assembly (12, 12') comprising:

a pillow member (18) structured to accommodate the patient's head thereon;

a support member (20, 20') disposed above the pillow member; and a mask assembly coupled to the support member, the mask assembly having a cushion (24, 24') structured to sealingly engage at least one of the nasal or oral orifices of the patient, and the cushion being structured to be coupled to the pressure generating device for delivering the flow of treatment gas to the airway of the patient.

2. The patient interface assembly of claim 1 , wherein the support member is generally arcuate in shape.

3. The patient interface assembly of claim 2, wherein the support member comprises a first end and an opposite second end and wherein the first end and the opposite second end are coupled to or near the pillow member.

4. The patient interface assembly of claim 3, wherein the support member comprises a first portion extending from the first end and a second portion extending from the second end and wherein the first and second portions are selectively coupled.

5. The patient interface assembly of claim 4, wherein the first and second portions are selectively coupled by at least one of: a latch mechanism, a hook and loop fastener, and a snap.

6. The patient interface assembly of claim 1 , wherein the support member is generally rigid.

7. The patient interface assembly of claim 6, wherein the support member comprises a first end and an opposite second end and wherein only one of the first end and the opposite second end are coupled to or near the pillow member.

8. The patient interface assembly of claim 7, wherein the one of the first end and the opposite second end is hingedly coupled to or near the pillow member.

9. The patient interface assembly of claim 1 , wherein the cushion is slidingly coupled to the support member.

10. A patient interface assembly (12") comprising:

a pillow member (18") structured to accommodate the patient's head thereon, the pillow member including a number of first coupling portions (32); and

a mask assembly (12") comprising:

a cushion (24") structured to sealingly engage at least one of the nasal or oral orifices of the patient, the cushion being adapted to receive the flow of treatment gas from a pressure generating device (14); and

a number of strap members (34) coupled to and extending from the cushion, each strap member of the number of strap members having at least one second coupling portion (36),

wherein each of the second coupling portions are adapted to be selectively coupled to at least one of the first coupling portions.

11. The patient interface assembly of claim 10, wherein the first coupling portions and the second coupling portions are selectively coupled via a magnetic force.

12. The patient interface assembly of claim 11, wherein each strap member includes an elastic portion (38) disposed between the cushion and the second coupling portion.