Patent Application
20230112217
The present disclosure generally relates to components for medical systems for conveying gases to and/or from a patient. In one particular aspect, the disclosure relates to patient interfaces that form a part of a breathing system.
In assisted breathing, respiratory gases are supplied to a patient through a patient interface via one or more flexible breathing tubes. The patient interface can be a nasal cannula, nasal mask, full face or oro-nasal mask, endotracheal tube, or other known types of interfaces. The gases expired by the patient may be channeled through a similar breathing tube to other equipment (valves, ventilators, pressure devices, or the like) or expelled to the patient’s surroundings.
In medical applications, such as assisted breathing, the gases inhaled by a patient are preferably delivered close to body temperature (usually between 33° C. and 37° C.) and with a high relative humidity (commonly near saturation). In other medical applications, such as continuous positive airway pressure (CPAP) systems or positive pressure ventilations systems that provide patient’s suffering obstructive sleep apnea (OSA) with positive pressure breathing gases, the breathing gases may be heated and/or humidified to varying levels to improve user comfort or supplied without heating or humidification.
In the specification where reference has been made to patent specifications, other external documents, or other sources of information, this is generally for the purpose of providing a context for discussing the features of the disclosure. Unless specifically stated otherwise, reference to such external documents is not to be construed as an admission that such documents, or such sources of information, in any jurisdiction, are prior art, or form part of the common general knowledge in the art.
Further aspects and advantages of the present disclosure will become apparent from the ensuing description which is given by way of example only.
It would be advantageous to provide a system for gas delivery treatment with interchangeable patient interface, such as a nasal cannula, nasal mask, or oro-nasal mask. Such an alternative or improved system may further assist with improved compliance and flexibility of gas delivery treatment.
An aspect of the present disclosure involves a patient interface assembly including a first interface body, a second interface body, and a housing configured to detachably couple with the first interface body or the second interface body. The first interface body and the second interface body are interchangeable, such that the first interface body is coupled to the housing in a first configuration, and the second interface body is coupled to the housing in a second configuration.
In some configurations, the first interface body is a cannula body.
In some configurations, the cannula body comprises one or more nasal prongs.
In some configurations, the one or more prongs are configured to be inserted into nares of a user and form a seal.
In some configurations, the second interface body is a mask body.
In some configurations, the second interface body is a nasal mask.
In some configurations, the second interface body is an oro- nasal mask.
In some configurations, the mask defines a breathing chamber and having a user-contacting surface configured to contact a face of the user and surround at least the nares of the user.
In some configurations, the housing comprises an upper edge and a lower edge.
In some configurations, the upper edge and the lower edge of the housing are symmetrical.
In some configurations, the lower edge of the housing is curved inwardly to the housing.
In some configurations, each of the first interface body and the second interface body comprises a manifold, wherein the manifold is configured to be at least partially received by the housing when the first interface body or the second interface body is detachably coupled to the housing.
In some configurations, the manifold comprises a housing coupling portion configured to be received within the housing when the first interface body or the second interface body is detachably coupled to the housing.
In some configurations, the manifold further comprises a raised portion adjacent the housing coupling portion, wherein the raised portion is configured to inhibit rotation of the manifold about the housing when the first interface body or the second interface body is detachably coupled to the housing.
In some configurations, the housing and/or the manifold comprises a feedback mechanism to provide a visual or audible feedback when the first interface body or the second interface body is detachably coupled to the housing.
In some configurations, the patient interface assembly further includes one or more interface tubes.
In some configurations, the housing comprises one or more tube engaging receiving portions configured to receive interface tubes.
In some configurations, the patient interface assembly further includes a securement member configured to be attached to the housing.
In some configurations, the first interface body can comprise a mask or nasal prongs of a first size and the second interface body comprises a mask or nasal prongs of a second size, wherein the first size is different from the second size.
An aspect of the present disclosure involves a patient interface including, an interface body, a housing, one or more interface tubes, a first securement member and a second securement member extending vertically for providing vertical stability to the patient interface.
In some configurations, the interface body is configured to be engaged on the patient’s face and form a seal.
In some configurations, the interface body is a mask body or a cannula body.
In some configurations, the one or more tubes are configured to be coupled to the housing.
In some configurations, the one or more tubes are formed as a single piece with the housing.
In some configurations, each of the one or more tubes comprises an overmoulded grip.
In some configurations, the first securement member includes a central portion, a pair of support pads and a pair of bridging portions. Each of the support pads are configured to engage a securing mechanism at the face of a user on opposing sides of the central portion. Each of the bridging portions connects the central portion and a respective one of the support pads.
In some configurations, the first securement member further comprises a patch assembly coupled to each of the support pads for securing the support pads to the user.
In some configurations, the second securement member is coupled to the housing.
In some configurations, the second securement member is configured to engage the forehead of a user.
In some configurations, the second securement member is constructed from a fabric material
In some configurations, the second securement member further comprises a patch assembly for securing the second securement member to the user.
In some configurations, the interface body has a Shore hardness between 20A-100A.
In some configurations, each of the one or more interface tubes is tapered toward one end.
An aspect of the present disclosure involves a patient interface including an interface body. The interface body includes one or more prongs extending from a base region at the interface body, and one or more openings to allow the flow of respiratory gases into and from the interface body. The one or more prongs are configured to flex at the base region while maintaining seal with the nares of the user.
In some configurations, the interface body comprises a right prong and a left prong.
In some configurations, a thickness of the one or more prongs varies along the length of the one or more prongs.
In some configurations, a thickness of the one or more prongs maintains a constant thickness along the length of the one or more prongs.
In some configurations, the base region has a thickness smaller than the rest of the interface body.
In some configurations, the base region has a surface recessed relative to the adjacent region of the interface body.
In some configurations, the base region has a recessed surface around the one or more prongs.
In some configurations, the base region has a recessed surface extending around two prongs.
In some configurations, the one or more prongs are configured to flex in forward and rear directions.
In some configurations, the one or more prongs are configured to flex in right and left directions.
In some configurations, the one or more prongs are configured to flex in right and left directions.
In some configurations, the one or more prongs have a circular cross-section adjacent at a top end of the prongs.
In some configurations, the one or more prongs are configured to flex while maintaining their diameter and cross-sectional shape along their lengths.
In some configurations, the one or more prongs are configured to flex while maintaining their resistance to flow (RTF).
An aspect of the present disclosure involves a respiratory system including a gas flow source, an inspiratory conduit fluidically connected to the gas flow source, and a patient interface. The patient interface includes an interface body, a housing, one or more interface tubes; and a first securement member.
In some configurations, the respiratory system further includes an expiratory conduit configured to receive gases from the patient interface.
In some configurations, the respiratory system further includes a bubbler device.
In some configurations, the respiratory system further includes a humidifier.
In some configurations, the housing is configured to receive each of a plurality of interface bodies, such that the interface bodies are interchangeable.
In some configurations, the interface body is a mask body or a cannula body.
In some configurations, the one or more interface tubes are configured to be coupled to the housing.
In some configurations, one of the one or more interface tubes is configured to be connected to the inspiratory conduit.
In some configurations, the one or more tubes are formed as a single piece with the housing.
In some configurations, each of the one or more tubes comprises an overmoulded grip.
In some configurations, the first securement member comprises a central portion, a pair of support pads and a pair of bridging portions. Each of the support pads is configured to engage the face of a user on opposing sides of the central portion. Each of the bridging portions connects the central portion and a respective one of the support pads.
In some configurations, the first securement member further comprises a patch assembly coupled to each of the support pads for securing the support pads to the user.
In some configurations, the patient interface further comprises a second securement member is coupled to the housing.
In some configurations, the second securement member is configured to engage the forehead of a user.
In some configurations, the second securement member is constructed from a fabric material
In some configurations, the second securement member further comprises a patch assembly for securing the second securement member to the user.
In some configurations, the respiratory system further incudes a headgear or a bonnet.
In aspect of the present disclosure involves a securement member for a patient interface of a respiratory system including a soft, flexible barb for detachably coupling with a housing of the patient interface.
In some configurations, the barb comprises one or more tabs.
In some configurations, the housing comprises an opening, wherein the one or more tabs are configured to catch on the housing at the opening of the housing.
In some configurations, the barb includes a cutout. The cutout is configured to aid in collapsing of the barb.
In some configurations, the barb comprises an extended top portion that is configured to prevent the barb from being over inserted into the opening of the housing.
In some configurations, the barb is overmoulded onto the securement member.
In aspect of the present disclosure involves a securement member for a patient interface of a respiratory system including a support pad that secures to a patch assembly on a patient, wherein the support pad is hinged relative to the rest of the securement member.
In some configurations, the support pad is flexible.
In some configurations, the securement member further comprising a hinge between the support pad and a portion of the securement member.
In some configurations, the support pad is overmoulded onto the securement member.
In some configurations, the hinge is a 180-degree hinge.
An aspect of the present disclosure involves a securement member for a patient interface of a respiratory system including a first flexible portion connectable with a patient interface component, a second flexible portion connectable to a patient’s forehead, and a third rigid portion extending between the first and second portions.
In some configurations, the first flexible portion is a barb.
In some configurations, the second flexible portion is a support pad.
In some configurations, the first and/or second flexible portions are overmoulded onto the third rigid portion.
In some configurations, the second flexible portion is hinged relative to the third rigid portion.
In some configurations, the securement member is detachably connectable to housing of the patient interface.
In some configurations, the component is a housing or interface body.
An aspect of the present disclosure involves a patient interface assembly including an interface body comprising a manifold comprising a front side configured to contact the patient and a rear side opposite the front side, wherein the manifold comprises a raised portion of a housing coupling portion positioned between the rear side of the manifold and the front side of the manifold, the manifold comprising a width that runs along an inner lumen of the manifold and a horizontal axis that runs along the width, wherein the raised portion is angled with respect to the horizontal axis, wherein the angled raised portion of the housing coupling portion is configured to improve the assembly and alignment of the interface body when it detachably couples with a housing via the manifold; a housing comprising a front patient facing side and a rear side opposite the front side, wherein the housing comprises a width that extends from a first tube engaging portion on one end of the housing to a second tube engaging portion on an opposite end of the housing and a horizontal axis that runs along the width, wherein the housing comprises an interface body receiving portion between the front side of the housing and the rear side of the housing, wherein the interface body receiving portion is angled with respect to the horizontal axis, wherein the angled interface body receiving portion is configured to improve the assembly and alignment when the manifold is detachably coupled and received by the housing.
In some configurations, the raised portion of the manifold comprises a first width on the front side of manifold that is greater than a second width on the rear side of the manifold.
In some configurations, the raised portion of the manifold comprises a first width on the front side of manifold that is less than a second width on the rear side of the manifold.
In some configurations, the angled raised portion of the housing coupling portion of the manifold extends at an angle of 120 degrees from the rear side of the manifold.
In some configurations, the angled raised portion of the housing coupling portion of the manifold extends at an angle of 60 degrees from the rear side of the manifold.
In some configurations, the angled raised portion of the housing coupling portion of the manifold extends at an angle of between 30 degrees and 170 degrees from the rear side of the manifold.
In some configurations, the patient interface assembly further comprising an engagement surface where the raised portion of the housing coupling portion and the interface body receiving portion contact each other, wherein a portion of the raised portion of the manifold at the engagement surface is higher relative to the engagement surface of the housing.
In some configurations, the manifold comprises a portion on either side of manifold that is configured to extend within the housing, wherein the portion that extends within the housing has a ridge configured to seal to the housing.
In some configurations, the ridge is an annular ridge.
In some configurations, the ridge is configured to seal with the internal surface of housing.
In some configurations, the manifold has a first distance between the front side of the engagement surface and the annular ridge and a second distance between the rear side of the engagement surface and the annular ridge, wherein the second distance is greater than the first distance.
In some configurations, the front side of the manifold has a first wall thickness and the rear side of the manifold has a second wall thickness, wherein the first wall thickness is thicker than the second wall thickness.
An aspect of the present disclosure involves a patient interface assembly involving a housing that detachably couples with a manifold of an interface body, wherein the housing comprises a side protrusion and a central protrusion, wherein the side protrusion comprises features for coupling a first securement member to the housing and wherein the central protrusion comprises one or more features for coupling a second securement member to the housing.
In some configurations, the housing is a rigid housing.
In some configurations, the one or more features for coupling with a second securement member to the housing are one or more openings.
In some configurations, the second securement member is detachably coupled with the housing.
In some configurations, the one or more openings comprise a lip configured to catch a complementary fitting portion of the second securement member.
In some configurations, the features of the side protrusion comprise an enlarged head and a stem for a push-fit coupling.
In some configurations, the first securement member is detachably coupled with the housing.
In some configurations, the patient interface assembly further comprising a tubing, wherein the tubing is integral with the housing.
In some configurations, the patient interface assembly further comprising a tubing, wherein the tubing is detachably coupled with the housing.
An aspect of the present disclosure involves a securement member for a patient interface of a respiratory system including a central portion, a pair of support pads, each of the support pads configured to engage the face of a user on opposing sides of the central portion, and a pair of bridging portions, each of the bridging portions connecting the central portion and a respective one of the support pads, wherein the bridging portions comprise cutouts for receiving a housing, wherein the bridging portions comprise a thickened portion surrounding the cutouts.
In some configurations, the securement member further comprises a patch assembly coupled to each of the support pads for securing the support pads to the user.
In some configurations, the securement member further comprises openings configured to detachably couple the securement member to protrusions on a housing, wherein the first securement member is push-fit over the protrusions on the housing.
In some configurations, the securement member further comprises a recess on the rear side of the securement member, wherein the recess is configured to accommodate for a central protrusion on the housing when the securement member is coupled to the housing.
An aspect of the present disclosure involves a patient interface assembly of a respiratory system including an interface body; and a housing, wherein the interface body is detachably coupled to the housing; and a feature that limits rotation of the interface body relative to the housing.
In some configurations, the interface body comprises a manifold and the feature comprises a shoulder portion on the rear of the manifold.
In some configurations, the shoulder portion abuts against the housing to limit rotation.
In some configurations, the feature comprises a keyed feature on manifold and housing.
In some configurations, the interface body comprises a cannula body.
In some configurations, the interface body comprises a mask body.
In some configurations, the housing comprises one or more tube engaging receiving portions configured to receive interface tubes.
An aspect of the present disclosure involves a patient interface assembly of a respiratory system including a housing, an inspiratory conduit with a first end and a second end, the first end configured to connect the housing and deliver incoming flow of gases and the second end with locking fingers, and an expiratory conduit with first end and second end, the first end configured to connect a housing and receive flow of expiratory gases and the second end with locking fingers.
In some configurations, the locking fingers at the second end of the expiratory conduit are configured to couple to a downstream component.
In some configurations, the downstream component comprises a bubbler.
In some configurations, the locking fingers at the second end of the inspiratory conduit are configured to couple to an upstream component.
In some configurations, the upstream component comprises a flow source.
In some configurations, the locking fingers extend away from a connector, the locking fingers being spaced apart and narrowing along their length away from the connector.
In some configurations, the locking fingers comprising locking recesses that are formed at least on outer surfaces of each of the locking fingers, the locking recesses being configured to lock with portions of a gas delivery tube connector, the locking fingers being configured to interact with recesses of the gas delivery tube connector to align the connector and the gas delivery tube connector.
An aspect of the present disclosure involves a patient interface assembly of a respiratory system including an interface body, and a housing, wherein at least a portion of an external surface of the housing and/or the interface body comprises a low friction surface coating or finish.
In some configurations, the interface body comprises a cannula body.
In some configurations, the interface body comprises a mask body.
In some configurations, the low friction surface coating or finish is a parylene coating or achieved by a blasting process, such as bead blasting.
In some configurations, the interface body comprises a rear side comprising patient contacting surface and a front side opposite the rear side, wherein the rear side has a low friction surface coating or finish.
In some configurations, the interface body is detachable with the housing and the interface body comprises a manifold with a low friction surface coating or finish that engages with the housing.
An aspect of the present disclosure involves a manufacturing process for a patient interface assembly for a respiratory system including manufacturing an interface body and coating an external surface of the interface body in a low friction surface coating or finish.
In some configurations, the interface body comprises a cannula body.
In some configurations, the interface body comprises a mask body.
In some configurations, the interface body is detachable with a housing.
In some configurations, substantially an entire external surface of the interface body is coated.
In some configurations, a portion of the interface body is coated, wherein the interface body comprises a rear patient facing side of the interface body and a front side opposite the rear side, wherein the coated portion is a rear portion of a manifold of the interface body.
In some configurations, a portion of the interface body is coated, wherein the interface body comprises a rear patient facing side of the interface body and a front side opposite the rear side, wherein the coated portion is a front portion of a manifold of the interface body.
An aspect of the present disclosure involves a patient interface assembly including an interface body including a manifold comprising a front side configured to contact the patient and a rear side opposite the front side, wherein the manifold comprises a raised portion of a housing coupling portion positioned between the rear side of the manifold and the front side of the manifold, wherein the manifold comprising a width that runs along an inner lumen of the manifold and a horizontal axis that runs along the width, wherein the raised portion is angled with respect to the horizontal axis, wherein the angled raised portion of the housing coupling portion is configured to improve the assembly and alignment of the interface body when it detachably couples with a housing via the manifold, and a feature that limits rotation of the interface body relative to the housing, and the housing including a front patient facing side, a rear side opposite the front side, wherein the housing comprises a width that extends from a first tube engaging portion on one end of the housing to a second tube engaging portion on an opposite end of the housing and a horizontal axis that runs along the width, wherein the housing comprises an interface body receiving portion between the front side of the housing and the rear side of the housing, wherein the interface body receiving portion is angled with respect to the horizontal axis, wherein the angled interface body receiving portion is configured to improve the assembly and alignment when the manifold is detachably coupled and received by the housing, a first securement member comprising a central portion, a pair of support pads, each of the support pads configured to engage the face of a user on opposing sides of the central portion, and a pair of bridging portions, each of the bridging portions connecting the central portion and a respective one of the support pads wherein the bridging portions comprise cutouts for receiving the housing, wherein the bridging portions comprise a thickened portion surrounding the cutouts, a second securement member comprising a first flexible portion connectable with a patient interface component, a second flexible portion connectable to a patient’s forehead, and a third rigid portion extending between the first and second portions, an inspiratory conduit with a first end and a second end, the first end configured to connect to the housing and deliver incoming flow of gases and the second end with locking fingers, and an expiratory conduit with first end and second end, the first end configured to connect to the housing and receive flow of expiratory gases and the second end with locking fingers.
In some configurations, the interface body comprises a cannula body.
In some configurations, the interface body comprises a mask body.
In some configurations, the inspiratory and expiratory conduit are integral with the housing.
In some configurations, the first and second securement members are connectable with the housing.
In some configurations, the second securement member is connectable with a patch assembly or headgear of a patient.
In some configurations, the second securement member is detachably coupled to the housing.
In some configurations, the interface body is detachably coupled to the housing.
An aspect of the present disclosure involves a patient interface assembly comprising an interface body, and a housing configured to detachably couple with the interface body, the housing comprises one or more tube engaging portions at lateral entry points on opposite ends of the housing, wherein the tube engaging portions are configured to receive interface tubes.
In some configurations, the interface body can comprise a cannula body.
In some configurations, the interface body can comprise a mask body.
An aspect of the present disclosure involves a patient interface assembly comprising a first interface body, a second interface body, and a housing configured to detachably couple with the first interface body or the second interface body, the housing comprises one or more tube engaging portions at lateral entry points of the housing, wherein the tube engaging portions are configured to receive interface tubes, wherein the first interface body and the second interface body are interchangeable, such that the first interface body is coupled to the housing in a first configuration, and the second interface body is coupled to the housing in a second configuration.
An aspect of the present disclosure involves an interface body comprising a mask comprising a breathing chamber and having a user-contacting surface configured to contact a face of the user and surround at least the nares of the user, and a manifold in fluid communication with the breathing chamber, the manifold comprising a first opening on a first lateral side of the manifold and a second opening on the second lateral side of the manifold, wherein the first and second openings permit gas flow into and out of the breathing chamber.
In some configurations, the first and second openings can be configured to be in communication with interface tubes configured to deliver a flow of gas entering and exiting the mask and the first and second lateral side of the manifold.
An aspect of the present disclosure involves an interface body comprising a mask, wherein the mask defines a breathing chamber and having a user-contacting surface configured to contact a face of the user and surround at least the nares of the user, the mask comprising a mask seal, wherein at least part of the mask seal comprises a region of reduced stiffness, wherein the region of reduced stiffness is positioned between a first stiffer region and a second stiffer region, wherein the first and second stiffer regions have a stiffness greater than the stiffness of the region of reduced stiffness, wherein when the first stiffer region is moved toward the second stiffer region, the region of reduced stiffness buckles in a single direction as the first stiffer region continues to move towards the second stiffer region.
In some configurations, the first stiffer region can comprise a structural support portion extending partially around the circumference of the mask.
In some configurations, the second stiffer region can be a front portion of the mask.
An aspect of the present disclosure involves a patient interface assembly comprising an interface body comprising a housing coupling portion, the housing coupling portion comprise a first patient facing side and an opposite second side, wherein the housing coupling portion comprises a shape defined between the first side and the second side of the housing coupling portion, and a housing comprising an interface body receiving portion, wherein the interface body receiving portion is a complementary shape to the shape of the housing coupling portion of the interface body, wherein the housing is configured to detachably coupled with the interface body.
In some configurations, the shape of the housing coupling portion can comprise a trapezoidal shape.
In some configurations, the housing coupling portion of the interface body can comprise a wider base of the trapezoid proximal to the front portion of the housing.
In some configurations, the housing coupling portion of the interface body can comprise a wider base of the trapezoid proximal to the rear portion of the housing.
An aspect of the present disclosure involves an interface body comprising one or more prongs extending from a base region and one or more openings to allow the flow of respiratory gases into and from the prongs, wherein the one or more prongs are configured to flex at the base region while maintaining seal with the nares of the user.
In some configurations, the one or more prongs can comprise a thickness that varies along the length of the one or more prongs.
In some configurations, the one or more prongs can maintain a constant thickness along the length of the one or more prongs.
An aspect of the present disclosure involves an interface body, wherein the interface body can comprise one or more prongs extending from a base region at the interface body, and one or more openings to allow the flow of respiratory gases into and from the interface body, wherein the one or more prongs are configured to flex at the base region while maintaining seal with the nares of the user.
Throughout the drawings, reference numbers can be reused to indicate general correspondence between reference elements. The drawings are provided to illustrate example embodiments described herein and are not intended to limit the scope of the disclosure.
Embodiments of systems, components and methods of assembly and manufacture will now be described with reference to the accompanying figures, wherein like numerals refer to like or similar elements throughout. Although several embodiments, examples and illustrations are disclosed below, it will be understood by those of ordinary skill in the art that the inventions described herein extends beyond the specifically disclosed embodiments, examples and illustrations, and can include other uses of the inventions and obvious modifications and equivalents thereof. The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive manner simply because it is being used in conjunction with a detailed description of certain specific embodiments of the inventions. In addition, embodiments of the inventions can comprise several novel features and no single feature is solely responsible for its desirable attributes or is essential to practicing the inventions herein described.
Certain terminology may be used in the following description for the purpose of reference only, and thus are not intended to be limiting. For example, terms such as “above” and “below” refer to directions in the drawings to which reference is made or directions relative to an orientation of the device as used with the user in an upright position. Terms such as “front,” “back,” “left,” “right,” “rear,” and “side” describe the orientation and/or location of portions of the components or elements within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the components or elements under discussion or relative to an orientation of the device as used with the user in an upright position.
Referring now to
In some embodiments, the pressure regulator 40 takes the form of discharging the flow of exhalatory gases into a chamber 204 containing a column of water138. The gases flowing through the expiratory conduit 201b are discharged into the body of water 138 from a short conduit 136 which extends from the expiratory conduit 201b into the chamber 204. This results in a bubbling effect, whereby the gases eventually exit the chamber 204 via the outlet port, which can also be used to initially fill the chamber 204 with water. The outlet port includes shielding to prevents liquid aerosols created by the vigorous bubbling on the surface of the water from being expelled. It will be appreciated that the short conduit 136, could equally be integrated into the end of the expiratory conduit 201b.
In some embodiments, the housing 3400 can be detachably coupled to the cannula body 3200a, the mask body 3200b, or any other type of interface bodies. The housing 3400 can be detachably coupled with an interface body, for example using mechanisms to be described in further detail herein, such that a user or a clinician can swap between different types of interface bodies (e.g. between the cannula body 3200a and the mask body 3200b) and/or different sizes of interface body. This may assist with better fitting while reusing the same housing without disassembling or removing the entire patient interface 3000 during treatment. For example, the interface body may be coupled to and/or decoupled from the housing 3400 while the first securement member 3600, the interface tubes 3800 and/or the forehead support member 3900 are kept coupled to the housing 3400. In some occasions, a mask body and a cannula body may need to be used alternately during treatment, for example to reduce or prevent skin irritation or damage. The interface body could be swapped while maintaining the housing 3400 connected to a headgear, a bonnet, a chinstrap, or the face of the user. Further, detachable coupling of the interface body and the housing 3400 may be advantageous for cleaning and maintenance. In some embodiments, a kit for treating a patient includes one or more cannula bodies and/or one or more mask bodies compatible with the housing 3400, such that a user or a clinician can choose and use an appropriate interface body. In some embodiments, the kit includes cannula bodies with different sizes and/or mask bodies with different sizes. The different sizes of mask bodies and/or cannula bodies may be indicated by different colours or other means, such as letters and/or symbols. The letters and/or symbols may be moulded, laser marked, printed or otherwise displayed on the mask bodies and/or cannula bodies.
In some embodiments, the housing 3400 may be permanently coupled to the cannula body 3200a, the mask body 3200b, or any other type of interface bodies. A user or a clinician can swap between different types of interface bodies (e.g. between the cannula body 3200a and the mask body 3200b) or the interface body of different sizes for better fitting, by interchanging the assembly with the housing and the interface body. For example, the interface body and the housing 3400 may be coupled to and/or decoupled with the interface tubes 3800. In some embodiments, a kit for treating a patient includes one or more cannula bodies and/or one or more mask bodies attached with the housing 3400, such that a user or a clinician can choose and use an appropriate interface body attached to the housing 3400.
The first securement member 3600 may secure or support the patient interface 3000 relative to the user. The first securement member 3600 may be coupled to the housing 3400 and facilitate securement of the interface body to the user’s face and thereby help the interface body to form and maintain a seal with the user’s face. In some embodiments, the first securement member 3600 includes means to attach and secure the patient interface 3000 on a headgear, a chinstrap, a patient interface patch or a dermal patch on the patient’s face, or otherwise on the patient’s face by any suitable mechanisms. For example, the first securement member 3600 may include hook and loop material or adhesive on the user facing side as described in further detail herein. Even though the first securement member 3600 is coupled with the housing 3400 in the illustrated embodiments, the patient interface 3000 may be used without the first securement member 3600. For example, the housing 3400 may be secured on the user’s face, for example on cheeks, directly or with other securement means, such as a headgear or chinstrap. As illustrated in
The patient interface 3000 may further include other securement means in addition to or instead of the first securement member 3600. For example, in the illustrated embodiment, the patient interface 3000 includes the second securement member 3900. In some embodiments, the patient interface 3000 includes both the first securement member 3600 and the second securement member 3900. In some embodiments, the patient interface includes one of the first securement member 3600 and the second securement member 3900. As illustrated in
The patient interface 3000 may further include one or more interface tubes 3800. In some embodiments, the walls of the interface tubes can be made of a material that can allow for the passage of moisture vapor through the walls of the interface tubes. In some embodiments, the one or more interface tubes 3800 are at least partially insulated. The interface tubes 3800 may be coupled to the housing 3400 at one end, and may connect to a CPAP therapy delivering device, for example through the tubes 201a and 201b, at the other end, and allow gas from and to the user to flow through the housing 3400 and the interface body. Each of the interface tubes 3800 may include a connector 3860 for the connection to the respiratory component, such as tubes 201a and 201b. The connector 3860 may be overmoulded to the tube 3800. The connector 3860 may be or comprise a silicone or elastomer material. The connector 3860 may have similar or greater stiffness than the interface tubes 3800. The connector 3860 may be or comprise the same material as a component of the tube 3800, such as a bead of the interface tube 3800, provided in a stiffer geometry relative to the tube 3800. In some embodiments, the connector 3860 includes one or more ports to monitor gas properties such as pressure. In some embodiments, the patient interface 3000 may include one or more sensors to monitor gas properties such as pressure at the one or more ports or any other suitable locations. The connector 3860 may be suitable for receiving a clip, which may be used to clip to bed sheets or clothing to provide additional securement of the patient interface 3000 and the tubes 3800. In some embodiments, each of the interface tubes 3800 further include a grip 3850. The grip 3850 may be directly or indirectly overmoulded to the tube 3800, for example over both the tube 3800 and the connector 3860. In some embodiments, the tube 3800 may be attached with adhesives or threadably attached to the connector 3860 or other regions of the grip 3850. The clinician or the user may hold the grip 3850 to connect or plug-in the connector 3860 to the respiratory component, such as tubes 201a and 201b. In some embodiments, one or more components of the interface tubes 3800 can rotate relative to the other components of the interface tubes 3800. For example, the grip 3850 can rotate relative to the connector 3860, such that the torsion or movement caused by holding of the grip 3850 may not be translated through the rest of the tubes 3800 to the housing 3400 and the interface body.
In some embodiments, the tubes 3800 can be detachably coupled to the housing 3400. In some embodiments, the one or more of interface tubes 3800 are permanently attached to the housing 3400. For example, the one or more of interface tubes 3800 may be directly or indirectly overmoulded to the housing 3400, thereby forming an integral piece. In some embodiments, the tubes 3800 may be attached with an adhesive or threadably attached with the housing 3400. In some embodiments, the tube 3800 can rotate or swivel relative to the housing 3400, such that the torsion or movement of the tubes 3800 may not conduct to the housing 3400 and the interface body. In some embodiments, the interface tubes 3800 have a varying diameter and/or thickness along the length of the interface tubes 3800. For example, each of the interface tubes 3800 may be tapered toward one end. In some embodiments, the interface tubes 3800 have a constant diameter and/or thickness along their lengths. In some embodiments, the interface tubes 3800 may have a circular, semicircular, or D-shaped cross-sectional shape. When the semicircular or D-shaped cross-sectional shape is used, a flat side of the interface tubes 3800 can be patient facing.
In the illustrated embodiment, the front portion 3430 includes one or more attachment elements. The one or more attachment elements may extend outwardly from the front portion 3430. In the embodiment illustrated in
In some embodiments, such as shown in
The central protrusion and front extension can be used to secure one or more securement members to the housing 3400. The central protrusion and front extension can be shaped to receive the complementary portion of a securement member. As shown in
As illustrated in
In some embodiments, the front extensions 3420 can be positioned on either side of the central protrusion 3440 as shown in
In the illustrated embodiment, the rear portion 3450 of the housing 3400 includes an interface body receiving portion 3480 for receiving an interface body, such as the cannula body 3200a or the mask body 3200b. At the interface body receiving portion 3480, an inner surface of the housing 3400 is exposed. The interface body receiving portion 3480 and the inner surface of the housing 3400 may be shaped and/or sized to match the shape and/or size of the interface body, and to allow removal and interchangeability of the interface body relative to the housing 3400. For example, the inner surface of the housing 3400 may have a cylindrical shape, such that it can receive and fit with a cylindrical shaped portion of the interface body.
The housing 3400 may further include one or more tube engaging portions 3460 to receive one or more interface tubes, such as the one or more interface tubes 3800. The tube engaging portions 3460 may be sized and/or shaped to match the shape and/or size of the interface tubes, such that the interface tubes can be coupled to the tube engaging portions 3460 without a leak. The tube engaging portion 3460 may be positioned such that the housing 3400 can receive a gas from the interface tubes through the tube engaging portion 3460, and allow the gas to flow to the interface body coupled to the interface body receiving portion 3480.
The housing 3400 further includes an upper edge 3470 and a lower edge 3490 opposite the upper edge 3470. In some embodiments, the upper edge 3470 and the lower edge 3490 are symmetrical, such that a user or a clinician can orient the housing 3400 in either direction when assembling the interface 3000. As shown in
In some embodiments, the housing 3400 is constructed from a material having greater stiffness than the interface body, such as the cannula body 3200a and the mask body 3200b, such that the housing 3400 can provide structural stability to the patient interface 3000. For example, the housing 3400 may be constructed from a material having Young’s modulus of 0.1 GPa - 7 GPa, 0.5 GPa - 7 GPa, 0.5 GPa - 6 GPa, 0.8 GPa - 6 GPa, 1 GPa - 6 GPa, 1.8 GPa - 6 GPa, 2 GPa - 5 GPa, or 3 GPa - 5 GPa. The thickness of the housing 3400 may be then altered to achieve the desired stiffness of each regions of the housing 3400. The housing 3400 may be constructed from thermoplastic elastomers, such as polycarbonate, thermoplastic polyurethane (TPU), polyamide, nylons. The front extension 3420 forms a raised portion with greater thickness as described herein, such that the front extension 3420 contributes to the stiffness of the housing 3400. The size and/or thickness of the front extension 3420 may be adjusted to adjust the rigidity of the housing 3400.
As described herein, the patient interface 3000 includes an interface body which can form a seal with a user’s face and allow gas flow from and to the user. The interface body can be coupled to a housing 3400. In some embodiments, the interface body is a cannula body 3200a that can mate with the housing 3400 and form a nasal cannula that can form a seal with nares of the user’s nose. In other embodiments, the interface body is a mask body, such as the mask body 3200b.
In the illustrated embodiment, the manifold 3240 defines one or more openings 3246, such as a pair of openings 3246 which can be coupled to the tube engaging portion 3460 of the housing 3400 to receive the interface tubes, and allow gas flow from and to the patient via the manifold 3240 and the nasal prongs 3220. The openings 3246 may be in fluid communication with each other via the manifold 3240. Except for the openings 3246 and the lumens of the nasal prongs 3220, the manifold 3240 may be sealed. The openings 3246 can be positioned on the side of the manifold 3240. As shown in
The cannula body 3200a can include nasal prongs with an orientation and/or geometry that may assist with gas flow and delivery of gas to the patient. For example,
As shown in
The lumen of the nasal prong 105 may have an internal cross-section that varies along the length of the nasal prong 105. For example, as shown in and described with reference to
As described in more detail herein, the nasal prong 105 may be shaped to substantially align the flow of breathing gas through the gas outlet with a user’s upper airways.
The nasal prong 105 may be shaped to extend generally upwardly and rearwardly into a user’s nares, the nasal prong 105 having a curvature that includes at least two inflection points, for example, as shown in
The prongs 105 may extend from the cannula body or manifold, toward the user’s septum and curve around the corners of a user’s nostrils upwardly and rearwardly into the user’s nares. Each prong 105 may extend along a generally inclined posterior trajectory, passing through two mediolateral points of inflection. This geometry may assist to orientate the gas outlet 108 with respect to the user’s upper airway passages.
The at least one prong 105 may have a shaped trajectory fitting or comparable with the anatomical shape of the user’s nostril. In a first portion (or phase) of the prong 105, the trajectory may move horizontally towards the midline of the face. In a second portion (or phase) of the prong 105, the trajectory may curve upwards into the nostril towards the crown of the head. In a third portion (or phase) of the prong 105, the trajectory may roll backwards into the head, generally following the anatomical curvature of the nostril. In a fourth portion (or phase) of the prong 105, the trajectory may tilt horizontally towards the center of the interface assembly to align the outlet 108 with the user’s upper airway.
The prong 105 may have a cross-section that varies along the central trajectory, such as described above. For example, the cross-section may be generally circular at the base of the trajectory and become generally circular or oval or elliptical towards the end of the trajectory or prong 105. The cross-section may be generally circular or oval or elliptical at the base of the trajectory, becoming generally circular towards the end of the trajectory or prong 105.
The cross-sectional diameter may generally decrease along the trajectory from the first portion (or phase) to the end of the fourth portion (or phase).
The geometry of the prongs, such as shown in
The prongs 105 may be premoulded or preformed according to the anatomical shape of a nare. In some embodiments, the prongs 105 may include at least one thinned wall section which is conformable so as to limit pressure on the patient’s septum. In other embodiments, the prong wall thickness can be uniform throughout.
From a base 1415, each prong 105 may curve generally upwardly or superiorly toward the crown of the user’s head (away from the transverse plane) and generally rearwardly or posteriorly (toward the user’s coronal plane) with respect to the user’s upper lip. Between the ellipses 1131 and 1133 (the second phase) the lumen of the prongs 105 may transition from a generally mediolateral orientation along the user’s upper lip to a predominantly inclined posterior orientation. This configuration may direct gas flow toward an upper portion of the back of a user’s head. The lumen of the prong 105 may reduce slightly during this phase. The lumen may also become more elliptical, which may utilize the space available within the nare.
In the third phase (between the ellipses 1133 and 1134) the prongs 105 may continue along an inclined posterior trajectory toward the upper back of a user’s head (away from the transverse plane and toward the coronal plane). There may be a smooth reduction in the rate of incline in the superior component of the prongs trajectory 1420, which may cause the lumen to move away from the transverse plane. During this phase, the prongs 105 may have negligible or minimal convergence (or mediolateral component) toward the sagittal plane. The prong lumen may reduce further during this phase and may become increasingly elliptical.
In the final phase (between ellipses 1134 and 1135) the prongs 105 may continue along an inclined posterior trajectory with some mediolateral convergence toward the sagittal plane. The mediolateral convergence of the prongs 105 may begin at the illustrated trajectory inflection point 107a at the start of the fourth phase (or slightly prior) adjacent the ellipse 1134.
A second inflection point 107b may be adjacent the final ellipse 1135. The second inflection point may reduce convergence of the prongs 105 and orientate the prong outlet 1411 generally posteriorly (toward the coronal plane) with a slight mediolateral component toward the sagittal plane (represented by the orientation of the final ellipse 1135 in
The incline rate of the prong trajectories 1420 may continue to decrease during the fourth phase, until the respective trajectories 1420 are substantially parallel with the transverse plane at the prong outlet 1411 (represented by ellipse 1135). The mediolateral and superior-inferior adjustments of the prong trajectories 1420 adjacent the final ellipse 1135 may position the prong outlet 1411 generally in alignment with the passage of the upper airway. This may assist to reduce soft tissue irritation caused by exiting breathing gases.
The prong lumen may be elliptical at the outlet 1411. The major elliptical axis may be arranged in a generally transverse plane. The prong lumen may be circular or substantially circular at the outlet 1411. The outlet 1411 may direct breathing gases upwardly or superiorly toward the crown of the user’s head (away from the transverse plane) and rearwardly or posteriorly (toward the user’s coronal plane).
In alternative embodiments the cross-section of the lumens may be triangular, or quadrilateral.
As shown in
In the illustrative embodiment shown, the prong sealing region 1109 tapers from about 5 mm to about 4 mm, for example. The measurements of the prong (5 mm and 4 mm) refer to an equivalent diameter of an oval. The equivalent diameter may be a diameter calculated from the perimeter of the prong (circular and ovular prongs may have the same equivalent diameter) or it may be the largest width dimension of the prong (circular and ovular prongs may have a different equivalent diameter). The tapered sealing region 1109 may allow the patient interface 1101 to be used for a patient having a nare size that is anywhere between about 4 mm and about 5 mm. For example, if a patient’s nare size is 4.5 mm, the prongs 1105 may be inserted in the nares such that the section of the sealing region 1109 having a diameter of 4.5 mm seals with their nares.
The prong sealing region 1109 may have different dimensions, and/or different amounts of taper. The length range for the sealing region may be between about 1 mm to about 10 mm. The length of the sealing region may be about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm. The diameter of the sealing region may be between about 2 mm and about 10 mm. The diameter of the sealing range may be about 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm.
The ratio of the taper from the wider portion to the narrower portion may be about 1.1:1, 1.2:1, 1.3:1, 1.4:1, 1.5:1, 1.6:1, 1.7:1, 1.8:1, 1.9:1, or 2:1.
For example, the prong sealing region may taper from 10 mm to 9 mm, 9 mm to 8 mm, 8 mm to 7 mm, 7 mm to 6 mm, 6 mm to 5 mm, 5 mm to 4 mm, or 4 mm to 3 mm, 3 mm to 2 mm, for example. The taper may be steeper, for example, the prong sealing region may taper from 10 mm to 8 mm, 9 mm to 7 mm, 8 mm to 6 mm, 7 mm to 5 mm, 6 mm to 4 mm, 5 mm to 3 mm, or 4 mm to 2 mm, for example. The taper may be less steep, for example, the prong sealing region may taper from 10 mm to 9.5 mm, 9.5 mm to 9 mm, 9 mm to 8.5 mm, 8.5 mm to 8 mm, 8 mm to 7.5 mm, 7.5 mm to 7 mm, 7 mm to 6.5 mm, 6.5 mm to 6 mm, 6 mm to 5.5 mm, 5.5 mm to 5 mm, 5 mm to 4.5 mm, 4.5 mm to 4 mm, or 4 mm to 3.5 mm, 3.5 mm to 3 mm, 3 mm to 2.5 mm, or 2.5 mm to 2 mm for example.
Different sizes of the patient interface 101, 1101 may be provided, for which different prong sealing region dimensions may be utilized.
The outlet of the prong lumen can be substantially circular. In some embodiments, the outlet of the prong lumen can be substantially elliptical. It should be appreciated by one of skill in the art that any suitable shape of outlet may be used.
The nasal prong lumen may be flared out at or near the outlet of the lumen. An example of a nasal prong lumen with flared out portions at the outlet or alternative outlet shapes are shown in
The cannula body can have a base region at and/or adjacent the base of the nasal prong. The base region can form a portion of the cannula body where the base of the nasal prong meets the manifold. The base region can be configured to allow movement of the manifold and/or housing while maintaining the nasal prongs within the patient’s nares. The base region may assist to provide comfort and conformability to the patient while also ensuring the flow path is maintained between the manifold and nasal prongs.
In some embodiments, the base region can allow the nasal prongs to bend in different directions without compromising the gas flow path from manifold to prong outlet. For example, the base region can allow the prongs to move relative to the housing/manifold without the prongs kinking. The base region may function to decouple the position of the or each prong from the position of the manifold/housing. In this manner, the housing/manifold can move, e.g. from forces applied to the interface by pulling on tubes, facial movements and/or grasping of the interface, whilst retaining the prongs in position in the nares. The base region may also provide a spring mechanism which may operate to assist in compensating external forces applied to or experienced by the interface. The spring mechanism may also allow for movement of the housing/manifold whilst assisting the prongs to remain in an operational, i.e. sealed position in the nares. In some cases, the base region can include a groove, dip, channel or any other mechanism between the prongs to provide for adequate clearance of the septum.
This portion of the cannula body can be an alternation in the material at or adjacent the base of the prong and/or a specific shape of the base of the prong. For example, the base region can be a groove, sunken or recessed region, a thinning of the nasal prong wall, base or surrounding region of the manifold, a shape of the nasal prong and/or manifold, and/or any other feature that may provide elasticity or conformability. Embodiments of the base region described herein can be used with any of the cannula body embodiments and/or nasal prong embodiments described herein.
In some embodiments, the manifold 3240 may have a base region that can be a sunken or recessed region under the prongs 3220 and/or adjacent the base of the prongs 3220. For example, in the illustrated embodiment of
The grooves 3222 may allow one size of prongs to fit a wider range of nare sizes. The groove 3222 around each prong 3220 may allow the prong 3220 to move or flex forward and backward when inserting and fitting the prongs 3220 into the patient’s nares. This movement can adjust for variation in face and philtrum size of patients. The groove 3222 may also allow for sideways movement to adjust for variation in septum size and/or to assist accommodating movement of the interface 3000, for example caused by cheek movement of the user. The sunken or recessed region such as the grooves 3222 may further make the effective length of the prongs 3222 greater, such that the prongs 3222 can have greater degree of adjustability.
The manifold 3240 may have varying thicknesses at different regions. For example, at least a portion of the grooves 3222 may be thinner relative to the prongs 3220 and the rest of the manifold 3240, as illustrated in
As illustrated in
In some embodiments, the groove or sunken region at the base of the prongs 3220 can be continuous.
In some embodiments, the base region comprises a thinner region of material at and/or adjacent the base of the nasal prongs. In some embodiments, the groove or sunken region may be absent. The thinner region of material can surround or partially surround the base of each nasal prong. The thinner region of material may be partly or wholly formed in the base of the nasal prongs.
The nasal prong can have a wall thickness that varies from the base of the prong 309 to the outlet 308. As shown in
The cannula body 3200a can be constructed from a single material or a combination of materials. The cannula body 3200a may be constructed from a material having a Shore hardness of between 20A - 100A. For example, the cannula body 3200a may have a Shore hardness of between 20A-90A, 40A-100A, 40A - 90A, 50A-80A, or 60A-70A. The cannula body 3200a can be constructed from a silicone material. As described herein, the thickness proportions of this material may be then altered to achieve the desired stiffness of each regions of the cannula body 3200a, such as the prongs 3220, the grooves 3222, and the sunken region 3223. The grooves 3222 and the sunken region 3223 may have a thickness between 0.1 mm-1.5 mm, 0.2 mm-1.5 mm, 0.2 mm-1.3 mm, 0.3 mm-1.3 mm, 0.5 mm- 1.2 mm, or 0.5 mm - 1.0 mm. The wall of the prongs 3220 and thickened region 3249 may have thicknesses greater than the grooves 3222 and the sunken region 3223. For example, the wall of the prongs 3220 and thickened region 3249 may have thicknesses between 0.3 mm - 2.0 mm, 0.5 mm - 2.0 mm, 0.6 mm - 2.0 mm, 0.3 mm-1.8 mm, 0.5 mm - 1.8 mm, 0.6 mm - 1.8 mm, 0.7 mm - 1.8 mm, 0.6 mm - 1.5 mm, or 0.7 mm - 1.5 mm.
The prongs 3220 extend from the manifold 3240 and can be shaped and formed to minimize tissue compression and kinking during insertion into a user’s nares. As illustrated in
In some embodiments, the prongs 3220 have a constant or substantially constant shape of cross section along their lengths. For example, each of the prongs 3220 may have a circular or oval cross-sectional shape along its length. When the prongs 3220 have a constant cross section along the region at the distal end (i.e. end adjacent the outlet) of the prongs 3220, the prongs 3220 may compensate for slight movements in and out of the nares, which may assist to maintain a seal. In some embodiments, the prongs 3220 may have a varying shape along their lengths. For example, the prongs 3200 may have a circular cross-section at a portion closer to the base, while the prongs 3200 may have an oval cross-section at a portion closer to the top of the prongs. The varying cross-section at portions of the prongs can be similar to the varying shapes described herein with reference to
The base region 3228 may assist to accommodate varying septum spacings. The base region 3228 may allow one or both prongs 3220 to flex back and forth to adjust for different facial geometries. The base region 3228 may alternatively or additionally provide an upwards push into the nares to maintain a constant seal.
In some embodiments, the base region 3228 can be a reduced thickness region. The reduced thickness region can allow for the spring at the base of the prongs. The base region 3228 can be a reduced thickness relative to the prongs 3220 and the rest of the manifold 3240. The reduced thickness region can be used in combination with or as an alternative to other base regions. For example, the base region 3228 can be a bellows region that can allow for the spring at the base of the prongs by providing a bellows-like structure or configuration at the base region. In further embodiments, as described previously, the nasal prongs can have grooves or sunken regions at the base of the prongs 3220 that allow for the spring-like movement at the base of the prongs.
In some embodiments, the prongs 3220 can have a constant wall section with a constant thickness which transitions towards the base region 3228 around the prongs. The base region 3228 may be thinner than the constant wall thickness of the prongs 3220. This base region 3228 can also have a substantially constant thickness throughout that region. In some embodiments, the thickness of the prong 3220 can be between 0.3 mm - 2.0 mm, 0.5 mm - 2.0 mm, 0.6 mm - 2.0 mm, 0.3 mm-1.8 mm, 0.5 mm - 1.8 mm, 0.6 mm - 1.8 mm, 0.7 mm - 1.8 mm, 0.6 mm - 1.5 mm, or 0.7 mm - 1.5 mm. The thickness of the base region 3228 can be between 0.1 mm-1.5 mm, 0.2 mm-1.5 mm, 0.2 mm-1.3 mm, 0.3 mm-1.3 mm, 0.5 mm- 1.2 mm, or 0.5 mm - 1.0 mm. For example, in one embodiment, the thickness of the prong 3220 can be 0.6 mm and the thickness of the base region 3228 can be 0.3 mm. In such an embodiment, the ratio of the thickness between the prongs 3220 to the base region 3228 can be 1:0.5. The ratio of thickness between the prongs 3220 to the base region 3228 can be any other ratio that provides the desired transition therebetween.
As described herein, the thickness proportions of this material may be altered to achieve the desired stiffness of each regions of the cannula body 3200a, such as the prongs 3220, the base region 3223 and 3228, and grooves 3222 (described with reference to
The base region 3228 can be a thin localized region at the base of the prongs that allows the manifold and/or housing to move relative to the nasal prongs. For example, when movement from the patient or external forces puts pressure on the prongs, the base region 3228 can at least partially absorb the movement and/or force of the prong. The base region 3228 may accommodate or at least partially absorb the movement and/or force of the prong by flexing or deflecting inward. In some embodiments, the base region 3228 may have greater clearance from the septum than the grooves 3222, such that the cannula body 3200a has smaller chance to interfere and/or damage the septum. The base region 3228 may also make cleaning of the cannula body 3200a easier due to the relative lack of small cavities or spaces.
Turning back to
In the illustrated embodiment, the manifold 3240 includes a raised portion 3242 which defines a raised surface relative to the housing coupling portion 3244 and the rest of the manifold 3240. The raised surface defined by the raised portion 3242 may be discontinuous with the surface of the housing coupling portion 3244. In some embodiments, the raised portion 3242 is formed both at an upper portion and a lower portion of the manifold 3240, such that the housing coupling portion 3244 is surrounded by the raised portion 3242. In some embodiments, the raised portion 3242 may be formed only at an upper portion or a lower portion of the manifold 3240. In some embodiments, the raised portion 3242 can inhibit or prevent the rotation of the cannula body 3200a about the housing 3400, when the cannula body 3200a and the housing 3400 are assembled, as described in further detail herein. In some embodiments, the manifold 3240 does not include the raised portion 3242, and may have a generally continuous outer surface adjacent the housing coupling portion 3244. In some embodiments, the manifold 3240 may include a band or reinforcing member to increase structural integrity of the manifold 3240. For example, the band or reinforcing member can be formed at least in part by a region of significantly increased thickness relative to the rest of the manifold 3240.
As discussed herein, the cannula body 3200a may be coupled with the housing 3400 by inserting the housing coupling portion 3244 of the manifold 3240 to the interface body receiving portion 3480.
The raised portion 3242 may also assist with visual alignment of the manifold 3240 relative to the housing 3400. For example, the user or the clinician can align the raised portion 3242 with the upper edge 3470 and the lower edge 3490 of the housing 3400 to assemble the manifold 3240 in the correct position. In some embodiments, the manifold 3240 and/or the housing 3400 can include an audible and/or tactile indicator to provide a feedback when the manifold 3240 and the housing 3400 are in the correct position. For example, the manifold 3420 and/or the housing 3400 can make a “click” sound when the manifold 3420 and/or the housing 3400 are correctly positioned and properly assembled. In some embodiments, the manifold 3420 and/or housing 3400 can include a visual indicator that indicates when the manifold 3420 and/or the housing 3400 are correctly positioned and properly assembled. In some cases, the visual indication can be a color indicator. The color indicator can be used with transparent components of the manifold and/or housing. Examples of color indicators are described further herein with reference to
When the housing 3400 and the manifold 3420 are assembled, the housing 3400 may only contact the manifold 3420, and it may not interfere with the prongs 3220. In some embodiments, the sunken region 3223 or the grooves 3222 may be fully or partially exposed, and the movement of the prongs 3220 may not be interfered by the housing 3400.
In the illustrated embodiment, the mask body 3200b further includes the mask 3232 or mask cushion, extending rearward from the manifold 3240. The mask 3232 may be applied on the face of a patient. In the illustrated embodiment, the mask 3232 is a nasal mask. The nasal mask may form a nasal seal applied over a nose of a patient. The nasal mask may form a seal on or about the nose surrounding the nares of the patient. In some embodiments, the mask 3232 could cover both a nose and a mouth of the patient.
The mask 3232 or mask cushion includes a face-contacting surface 3234. The face-contacting surface 3234 may have an inner peripheral edge 3235 that defines a nose-receiving opening into a mask cavity 3236 for receiving the user’s nose in use. In some embodiments, the face-contacting surface 3234 is located generally opposite the manifold 3240. In use, the contacting surface 3234 of the mask 3232 may envelop or circumscribe a portion of the user’s nose defining the nares. The contacting surface 3234 may sealingly engage about the user’s nose such as against one or more of the cheek surfaces and/or lateral side surfaces of the user’s nose, the upper lip region below the user’s nose, and across the nasal bridge region or nasal tip region of the user’s nose.
The mask 3232 may be substantially hollow and generally shaped to provide or define the mask cavity 3236. The mask cavity 3236 may receive the flow of gases from the manifold 3240. The mask cavity 3236 may be fluidically connected with the manifold 3240 and the openings 3246, such that gas from and to the patient flows through the mask cavity 3236.
To assist with the rolling of the region 3237, the region 3237 may have a varying thickness or a varying stiffness. The region 3237 can be formed by and/or be coextensive with a reduced stiffness region. In some embodiments, the wall thickness of the mask 3232 may be substantially constant through the rolling region 3237. In some embodiments, the wall thickness of the mask 3232 may vary or alternate between relatively thick and thin regions. The wall thickness of the mask 3232 may be relatively thicker along other portions of the mask, thereby providing support for the structure of the mask 3232. However, other arrangements to induce or facilitate rolling in the rolling region 3237 can also be used. Examples of mask seals comprising rolling portions are disclosed in WO2014/062070, the entirety of which is incorporated by reference herein.
In some embodiments, a lower or base portion 3256 of the mask 3232 may have a region having greater thickness/stiffness, which may allow greater structural stability of the mask. For example, the base or a portion thereof can be formed at least in part by a region of significantly increased thickness relative to the reduced stiffness region. This base portion 3256 may have greater thickness relative to the face-contacting portions of the mask.
The base portion 3256 may be formed of the same material forming the mask 3232. A region of the base portion having increased thickness may be configured as a thickened band. The base portion 3256 can be positioned on the lower or bottom portion of the mask below the rolling region 3237. The mask can pivot at or about the base portion or thickened band when the rolling region rolls under a force when applying the mask over the patient’s face. In other arrangements, the base portion can be or include a component formed of a material that has increased stiffness relative to the silicone or other material(s) forming the mask 3232. This may help with inserting and removing the mask 3232 from the housing 3400 and maintaining a seal in use.
The mask body 3200b can be constructed from a single material or from two or more different materials. The mask body 3200b can be constructed from silicone. The mask body 3200b may be constructed from a material having a Shore hardness of between 15A-80A. For example, the mask body 3200b may have a Shore hardness of between 15A-80A, 20A-80A, 30A-80A, 40A-70A, or 40A - 60A. As described herein, the thickness proportions of this material may be then altered to achieve the desired stiffness of each regions of the mask body 3200b.
In some embodiments, the mask 3232a can be provided in various or alternative shapes or sizes to achieve the desired fit to achieve comfort, compliance and/or deliver therapy effectively. The mask 3232a illustrated in
When the mask 3232 is seated on the face of the user in use, the contacting surface 3234 may lie over the bridge of the nose, sides of the nose and above the upper lip of the user. With a supply of positive pressure air, the contacting surface 3234 may balloon and seal against the face of the user. Leaks may occur where a seal contact pressure between the contacting surface 3234 and the face of the user is less than the pressure of the air being delivered. For therapy to be successfully delivered, the mask contacting surface 3234 pressure should be higher than air pressure around a perimeter of the contacting surface 3234 forming the mask seal.
The mask 3232a can include a rolling region 3237 as described in relation to
To assist with the rolling or bending, the region 3237 can have a varying thickness or a varying stiffness. In the configuration shown in for example
The reduced stiffness of the regions 3237b and 3237c can be formed by a thin material forming the section. The patient contacting surface of region 3237b and the region 3237c are shown in
The mask 3232b can have a stiffened structural portion 310 in between the two regions 3237b and 3237c. The stiffened structural portion 310 can be stiffer or formed of a thicker material than the regions 3237b and region 3237c. The structural portion 310 may be continuous or unbroken around the circumference of the mask. The structural portion 310 may extend partially around the circumference of the mask. In the embodiment shown in for example,
The stiffer or thicker structural portion 310 or band may gradually transition into the rest of the rolling region. In other words, the structural portion 310 or band may gradually transition into region 3237b and/or 3237c. This can improve comfort as it reduces likelihood of the band or other such relatively hard section from contacting the user’s skin and/or nasal bridge which may occur if the thickened section does not gradually transition. In some embodiments, the gradual transition of the structural portion 310 into the rest of the rolling region 3237 can also improve the ease of cleaning. In some embodiments, the structural portion 310 may gradually transition into the rest of the rolling region 3237.
In some cases, such as at higher pressures, the structural portion 310 may help prevent the mask from inflating. The structural portion 310 can also help to prevent folds or creases in the thin material sections of the regions 3237b, 3237c, which may assist to keep the region 3237b conformable to the patient. In some embodiments, the structural portion 310 can make it easier to clean the mask 3232b.
The mask 3232b and the region 3237c may be designed to roll or bend at the top of the mask as well as at the sides of the mask. The rolling at the top is intended to reduce pressure on the bridge of the nose and to better accommodate a range of patient facial geometries. The rolling at the sides is intended to enable the mask to sink down into the cheek (nasolabial) folds and achieve sufficient contact to create a seal. The rolling at the sides can allow the mask to rock side to side while maintaining a seal, thus decreasing the likelihood that side forces will dislodge the seal (e.g. lying in lateral position). In some cases, cheek folds can be increased through patient positioning, the use of chinstraps, and/or tension applied to other patient securing mechanisms or devices.
The structural portion 310 can blend in at the front or patient facing side of the mask 3232b so that there are no hard edges should the region 3237b that contacts the patient buckle. The blending may be less necessary on the opposite or non-patient facing side of the structural portion 310. However, in some cases, the structural portion 310 can be blended on both sides of the structural portion 310. The structural portion 310 can be positioned to affect the force-displacement profile of the rolling region at the top and/or side. For example, the force profile may be relatively flat as the thin material of the reduced stiffness section rolls until the thickness of the rolling material begins to increase (either abruptly or gradually). The increase in the thickness of the rolling material can then ramp up the force-displacement profile. The gradual thinning or gradual reduction in stiffness of the structural portion 310 can be used to allow the rolling region to roll for certain distance before gently resisting displacement rather than going from a low force to a high force when the rolling region stops rolling.
The mask 3232b can roll at the sides and pivot at or adjacent the base of the mask. As shown in
To aid with stability it can be useful to have an interface retention or stability apparatus (for example, headgear) attach near the pivot point. The base of region 3237c as shown in
In some embodiments, the reduced stiffness section of material can have a thickness of approximately 0.5 mm or less. The reduced stiffness section of material can have a thickness of 0.8 mm or less, 0.7 mm or less, 0.6 mm or less, 0.5 mm or less, 0.4 mm or less, or 0.3 mm or less. In some embodiments, the ratio of thickness of the structural portion 310 to the reduced stiffness section can be about 20:1, 15:1, 10:1, 5:1, 2:1, or 1.5:1.
The mask 3232b can assist with sealing and the seal contact pressure between the face-contacting surface 3234 and patient can be sufficient to prevent leaks. The seal contact pressure can be applied to the skin at the nasal bone and the region 3237b at the top of the mask 3232b can contact the patient’s skin.
The mask 3232a can be used in combination with one or more securement members to provide stability of the mask on the user. The mask 3232b can be used in combination with a midline securement member (for example, the securement member described with reference to
The rolling region of the mask 3232b can roll at the sides as well as the top.
The side roll of the mask can allow the seal to be compliant at the sides by allowing the mask to sink in at the nasolabial folds. The side roll of the mask may also help to accommodate cheek movement.
In some embodiments, the interface body can have lateral entry and exit points to the mask chamber or nasal prongs so that the flow of gas can enter the interface body from the tubing on each end of the housing. The lateral flow of gas entering and exiting the interface body can result in greater CO2 clearance when compared to a mask or fluid interface that has an entry and exit point located in the middle or top of the mask. Additionally, the lateral entry and exit points for the flow of gas can reduce dead space outside the flow path in the interface body. In some embodiments, the housing is configured such that gas may enter and/or exit the interface body substantially in line with a horizontal axis of the housing and/or interface body. In some embodiments, ends of the housing at or adjacent the entry/exit points may curve or extend generally downwards. In such embodiments, the entry/exit points may direct gas into the interface body laterally, but at an angle offset from the horizontal.
As illustrated in
The support pads (e.g., the support pads 3660) can rest directly or indirectly on a user’s face when the patient interface (e.g., the patient interface 3000) is worn by the user. For example, the support pads 3660 can be secured to the user’s face directly or indirectly by an external force, such as using an adhesive connection, a headgear arrangement, a hook or loop connection as discussed above, or another suitable support structure, such as any of those described herein. In some arrangements, the support pads 3660 can be connected to a headgear and/or a chinstrap for the securement of the interface body. In some embodiments, the support pads 3660 can be connected to one or more facial pads or dermal patches. The facial pads or dermal patches can have a patient side and an interface side. The interface side can have a first fastener element. The first fastener element can removably couple or attach to a complementary fastener element on a patient side of the support pad 3660. In some embodiments, the support pad 3660 may include tabs 3666 at either end of the support pad 3660 to aid in positioning and/or removing the support pad 3660 and/or the first securement member 3600.
Accordingly, the bridging portions (e.g., the bridging portion 3630), which are connected to the support pads, may be moved or deflected when the user’s face moves. For example, when a portion of the user’s face on which the support pads rest moves, such external force or movement may be conducted to the bridging portion 3630, then to the central portion (e.g., the central portion 3610), and eventually to the housing (e.g., the housing 3400) and the interface body (e.g., the cannula body 3200a, the mask body 3200b). In some instances, the bridging portions themselves may move or deflect when an external force is exerted on them. Accordingly, it is desirable for the bridging portion to be constructed such that the interface body can maintain its seal with the user even when the user’s face and/or the support pads move. In some configurations, the deformable configuration of the bridging portion 3630 provides some degree of de-coupling of the support pads 3660 from the interface body. Preferably, the deformation of the bridging portion 3630 at least reduces or possibly eliminates disruption of the seal between the interface body and the user’s face as a result of cheek movements of the user’s face or external forces exerted on the face of the user. Additionally, the deformation of the bridging portion of the securement members can work in combination with the rolling regions of the mask to maintain a seal between the interface body and the user’s face.
In some embodiments, the first securement member 3600 can accommodate movements of the patient’s face with one or more hinge points located further outward from the surface of the patient’s face than the location of the support pads 3660. As shown in
In some embodiments, the bridging portion 3630, or the entire first securement member 3600 are made of a flexible material, such that the bridging portion 3630 is flexible or deformable, such as described above. In some embodiments, the bridging portion 3630 are made of the same material as the central portion 3610 in an assembled or unitary construction. In some embodiments, the first securement member 3600 may be made of one or more elastomer materials, such as silicone, rubber, polyethylene, etc. In some embodiments, the first securement member 3600 may be made of a single material. In some embodiments, the first securement member 3600 may be made of two or more materials, such that a region of the bridging portion 3630 has a different flexibility relative to another region. In some embodiments, at least a region of the bridging portions 3630 may be made of flexible but tensile material, such that the bridging portions 3630 are stiff enough to resist torsion forces, while being able to be compressed. This may assist to minimize translation of forces and/or movements from the patient’s cheeks to the sealing region. In some embodiments, the first securement member 3600 may be constructed from a same material as the interface body (e.g. the cannula body 3200a, the mask body 3200b) and/or the housing 3400.
The patient facing side of the support pad 3660 can have a fastener element to allow direct attachment to the face (for example, an adhesive) or indirect attachment to headgear or a patient interface patch or dermal patch which can have a complementary fastener element on the non-patient facing side. The user-facing surface 3680 of the support pads 3660 can be initially provided without a user interface patch or a dermal patch. The surface 3680 can receive or retain a patient interface patch or a dermal patch. Such a patient interface patch may be connected to the surface 3680 by an adhesive or other suitable connection as is known in the art (such as by hook-and-loop fastener, ultrasonic welding, and/or co-molding or overmolding). Once the support pad patch is in position, it may be connected to or receive a dermal patch. Alternatively, the patient interface patch may be assembled to the surface 3680 of the support pad 3660 in the same operation as molding the facial pad. In some embodiments, the user-facing surface 3680 is configured such that the user-facing surface 3680 may not cause excessive abrasion or disturbance on the patient’s face. For example, the user-facing surface 3680 will include a loop material of the hook-and-loop mechanism, while the user interface patch or the dermal patch includes a hook material of the hook-and-loop mechanism. In some embodiments, the user-facing surface 3680 engages a securement mechanism other than the dermal patch, such as a headgear, a chinstrap or a bonnet.
In some embodiments, the first securement member 3600 may be coupled to the housing 3400 by coupling the central portion 3610 to the housing 3400. The first securement member 3600 may have a mechanism or attachment portion which can be retained by the housing 3400. For example, the first securement member 3600 may include a central opening 3620. The central opening 3620 may be coupled with one or more attachment elements of the housing 3400. For example, the central opening 3620 may be coupled with one or more front extension 3420 and/or central protrusion 6440 of the housing 3400. The central opening 3620 may be sized and shaped to receive and retain the one or more attachment elements of the housing 3400, such as front extension 3420. For example, the central opening 3620 may be sized and shaped to be retained at or around the ridge 3422. In some embodiments, the first securement member 3600 may be detachably coupled to the housing 3400. In some embodiments, the first securement member 3600 may be coupled to the housing 3400 with a clip. In some embodiments, the first securement member 3600 may be permanently coupled to the housing 3400. In some embodiments, the first securement member may not have the central portion 3610 and/or the bridging portion 3630 and may include the support pads 3600 directly coupled with the housing 3400 or the interface body detachably or permanently.
In some embodiments, the bridging portion 3630 may include a cutout 3640. The cutout 3640 may be located to allow passage of interface tubes, such as the interface tube 3800 through the first securement member 3600. In some embodiments, the bridging portion 3630, or any other region of the first securement member 3600 may include a mechanism to further retain the interface tube 3800 to facilitate or assist the management of the interface tube 3800. For example, the bridging portion 3630 may include a hook and loop fastener or an adhesive at the cutout 3640, which may be detachably coupled to the interface tube 3800.
In some embodiments, the first securement member 3600 may be constructed from a fabric material.
The coupling portion 3910 may be attached to or attachable with the housing 3400 to couple the second securement member 3900 to the patient interface 3000. In some embodiments, the coupling portion 3910 includes a hole or recess 3912. The hole or recess 3912 can be configured to receive the central protrusion 3440, such that the coupling portion 3910 is attached to the housing 3400. In some embodiments, the coupling portion 3910 and/or the housing 3400 may be configured such that the rotation of the second securement member 3900 about the housing 3400 is inhibited. For example, the outer perimeter of the coupling portion 3910 may be multisided and embedded between the central protrusion 3440 and the front extension 3420, such that the front extension 3420 inhibits the rotation of the coupling portion 3910. In some embodiments, the second securement member 3900 may be configured such that it can rotate about the housing 3400. In some embodiments, the central protrusion 3400 may be symmetric, such that the housing 3400 can be symmetric, as described herein. In some embodiments, the second securement member 3900 may be coupled to the housing either in upwardly, or downwardly direction. In some embodiments, the second securement member 3900 may be applied in other orientations, such as sideways or any angled orientations.
In some embodiments, the second securement member 3900 may be detachably attached to the housing 3400. In some embodiments, the second securement member 3900 may be permanently attached to the housing 3400. The second securement member 3900 may be overmoulded and/or formed as an integral piece with the housing 3400. In some embodiments, the second securement member 3900 may be detachably or permanently coupled to the interface body, such as the cannula body 3200a and the mask body 3200b. In some embodiments, the second securement member 3900 may be detachably or permanently coupled to the first securement member 3600. In some embodiments where the secondary securement member 3900 is integral with the first securement member 3600, the secondary securement member 3900 may include perforated strips such that the second securement member 3900 can be cut or torn off from the first securement member 3600. In some embodiments, the first securement member and/or the second securement member can be integral with a headgear of a patient.
The support pad 3980 can be configured to rest directly or indirectly on a user’s face. For example, the support pad 3980 can be positioned at or on the forehead, when the patient interface 3000 is worn by the user. For example, the support pad 3980 can be secured to the user’s forehead directly or indirectly by an external force, such as using an adhesive connection, a headgear arrangement, a hook or loop connection as discussed above, or another suitable support structure, such as any of those described herein. In some arrangements, the support pad 3980 can be connected to a headgear and/or a chinstrap for the securement of the interface body.
In some embodiments, the second securement member 3980 may be constructed from a fabric material. The fabric material may be the fabric material described in relation to
In some embodiments, the interface housing comprises a horizontal axis extending from one tube engaging portion to a second tube engaging portion on the opposing end of the housing. In some embodiments, the interface tubes can engage with the housing at the tube engaging portions and can extend laterally outward along the horizonal axis from the tube engaging portions as shown in
In some embodiments, the first securement member 4600 and/or second securement member 4900 may be coupled to or with the housing 4400. In some embodiments, the first securement member 4600 and/or second securement member 4900 may be integral with the housing 4400 and/or the interface body.
In some embodiments, the housing 4400 can be formed from a rigid material. The housing 4400 can be detachably coupled with an interface body as described herein. The housing 4400 can be detachably coupled with a manifold of the interface body. In the illustrated embodiment, the front portion 4430 includes one or more attachment elements in the form of one or more protrusions. The protrusions may include one or more side protrusions 4420 and a central protrusion 4440. The side protrusions 4420 may be raised toward a front direction. The side protrusions 4420 may extend outwardly from the front portion 4430. The side protrusions may have an enlarged head 4422 and a stem 4424. The head 4422 may have a larger cross section than the stem 4424. The side protrusions 4420 can be received by and engage with one or more complementary or receiving components. For example, the or each side protrusion 4420 may be received by and engage with a hole or recess which fits to the enlarged head 4422, for example by push-fit. For example, the first securement member 4600 can be detachably coupled to the housing 4400 at the side protrusions 4420. The first securement member 4600 may have one or more holes or recesses configured to receive or engage with the side protrusions 4420.
The central protrusion 4440 can include a feature to couple the second securement member 4900 to the housing 4400. The central protrusion 4440 can include an opening 4442. In some embodiments, the second securement member 4900 can be coupled to the housing 4400 through the opening 4442 in the central protrusion 4440. In some embodiments, the opening 4442 can have one or more channels 4443 for insertion of the second securement member 4900. In some embodiments, the central protrusion 4440 can include two channels in the opening 4442 as shown in
The first securement member 4600 can include a pair of support pads 4660 configured to rest on or engage with the face of a user on opposing sides of the central portion 4610. In some embodiments, the first securement member 4600 includes means to attach and secure the patient interface on a headgear, a chinstrap, a patient interface patch or a dermal patch on the patient’s face, or otherwise on the patient’s face by any suitable mechanisms.
In some embodiments, the first securement member 4600 may include cutouts 4640 and two arms 4642 bridging the central portion 4610 and the support pads 4660. The cutouts 4640 can allow the interface tube 4800 to pass through between the two arms 4642 and through the cutouts 4640. The cutouts 4640 can receive the interface tubes 4800 through the cutouts 4640. The cutouts 4640 can be fitted over the interface tubes 4800 and secured in place. In some embodiments, the arms 4642 can be positioned around the interface tubes 4800 when the tubes 4800 are extended through the cutouts 4640. In some embodiments, the arms 4642 can be flexed or fitted around the tubes 4800. The arms 4642 may be configured to ‘hug’ or lie adjacent the tubes 4800. This configuration may assist in reducing the thickness or bulk of the interface assembly while still allowing the bridging portion 4630 the freedom to hinge or flex. The cutouts 4640 of the bridging portion 4630 provide the passage for the interface tubes 4800 to pass through the cutouts 4640 and connect to the housing 4400. In some cases, the interface tubes 4800 can be integral with the housing 4400. In some cases, the interface tubes 4800 can be detachably coupled to the housing 4400.
As shown in
In some embodiments, the cutouts 4640 of the bridging portion 4630 may allow passage of interface tubes, such as the interface tube 4800 through the first securement member 4600 as shown in
In the illustrated embodiment of
In some cases, the arms of the bridging portion 4630 may have a recessed region with hook or loop fasteners which can also assist in management of the interface tubes or conduits. In some occasions, it may be desirable that there is some way to hold and manage the interface tubes 4800 of the patient interface assembly 4000. In such arrangements, the tubes 4800 may be flexible enough to promote tube movement and fixation by a clinician or a user. Being able to move the tubes 4800 and fix as desired may allow more comfort for the patient, for example side sleeping.
In some embodiments, the bridging portion 4630 of the first securement member 4600 may have cutout or recessed regions for receiving the tubes 4800 as described herein. The cutout or recessed regions may further include hook or loop material for attaching to a corresponding material on the tubes 4800. In some embodiments, there may be one or more cutout or recessed regions on the bridging portion 4630 or the support pad 4660. The cutout regions may be located at any suitable location along the bridging portion 4630 or the support pad 4660. In some embodiments, there may be a cutout or recessed region having hook or loop on the front side (non-patient facing side) of each support pad 4660 or the bridging portion 4630. In some embodiments, the hook or loop material may be overmoulded onto the bridging portions 4630 or the support pad 4660, or attached by adhesive.
In some embodiments, the rear side and patient facing hook or loop pieces of material may be formed as a single piece to form a double-sided hook or loop material, which can be overmoulded into a cutout or opening in the support pad 4660. The use of the double-sided hook or loop material may be advantageous, since it can be overmoulded more easily to the first securement member 4600 than separate pieces of hook or loop on each side. Further, the support pad 4660 may be more flexible when a single double-sided piece of hook or loop material is used, as opposed to multiple pieces of hook or loop materials, thereby conforming to the user’s face better.
The tube 4800 may have a strip of hook or loop material to be attached with a corresponding material on the patient interface assembly 4000. For example, the strip of hook or loop may be wrapped around the outside of the tube 4800 or attached to a part of the tube 4800. In some embodiments, the tube 4800 may include the engagement portion 4840 where the strip of hook or loop or any other attachment mechanism is attached to. The engagement portion 4840 may be wrapped or moulded or placed around the outside of the tube 4800. The piece of loop material may attach to a corresponding hook material on the bridging portions 4630 of the patient interface assembly 4000 to secure the tube 4800. Alternatively, or additionally there may be an overmoulded portion on the tube where part of this portion comprises loop material.
In some embodiments, magnets may be used to hold the conduit or tube 4800 on the patient interface assembly 4000. For example, there may be a magnet on the support pad 4660 or the bridging portion 4630, or placed on a piece of material that wraps around the tube 4800 or overmoulded into the tube 4800. This magnet can interact with a corresponding ferromagnetic material on the other component to secure the tube 4800 and patient interface assembly 4000. Any other suitable detachable coupling mechanisms, such as mechanism described elsewhere herein regarding attachment of the securement members and the interface bodies, may be used to attach the tubes 4800 to the first securement member 4600.
The first securement member 4600 may have a mechanism to be retained by or otherwise coupled to the housing 4400. The first securement member 4600 may be coupled to the housing 4400 by coupling the central portion 4610 to the housing 4400. The first securement member 4600 may be coupled to the housing 4400 by coupling with one or more attachment elements on the housing 4400. For example, the first securement member 4600 may include an opening 4426 for coupling the first securement member 4600 to the housing 4400 at the attachment elements. The opening 4426 may couple to the housing 4400 at the side protrusions 4420. In some embodiments, the first securement member 4600 can be detachably coupled with the housing 4400. The first securement member 4600 may have a mechanism to be retained by or couple with the housing 4400. The opening 4426 may be sized and shaped to be received and retained by or engage with the side protrusion 4420. For example, the opening 4426 may be sized and shaped to be retained at the stem 4424 of the side protrusion 4420.
In some embodiments, the first securement member 4600 can be made of a soft flexible material (e.g. TPE/silicone) or any other material described herein for the securement member. In some embodiments, the first securement member 4600 can have one or more openings or recesses 4426. The first securement member 4600 can have two openings or recesses 4426. The openings or recesses 4426 can be located in a central portion of the first securement member 4600. The openings or recesses 4426 can be pushed over or otherwise engaged with the two side protrusions 4420 of the housing 4400 to secure the first securement member 4600 in place. In some embodiments, the openings 4426 and side protrusions 4420 can allow the first securement member 4600 and the housing to be secured by a push-fit mechanism. The openings 4426 of the first securement member 4600 can be pushed over the enlarged head 4422 of the side protrusion 4420. The inner diameter of the opening 4426 of the first securement member 4600 can sit around the stem 4424 of the side protrusion 4420 when the first securement member 4600 is positioned on the housing 4400. The uniform indentation of the stem 4424 all the way around the side protrusion 4420 can prevent detachment of the first securement member 4600 from the housing 4400.
In some embodiments, the first securement member 4600 may be attached to the housing 4400 through any other mechanism where the side protrusions 4420 can receive and retain or otherwise engage one or more complementary components. For example, the side protrusions 4420 can engage with a hole which fits to the enlarged head of the side protrusion 4420. In some embodiments, the first securement member 4600 may be detachably coupled to the housing 4400. In some embodiments, the first securement member 4600 may be coupled to the housing 4400 with a clip. In some embodiments, the first securement member 4600 may be permanently coupled to the housing 4400. In some embodiments, the first securement member may not have the central portion 4610 and/or the bridging portion 4630 and may include the support pads 4660 directly coupled with the housing 4400 or the interface body detachably or permanently.
In some embodiments, the bridging portion 4630, or the entire first securement member 4600 are made of a flexible material, such that the bridging portion 4630 is flexible or deformable, as described above. In some embodiments, the bridging portion 4630 is made of the same material as the central portion 4610 in an assembled or unitary construction. In some embodiments, the first securement member 4600 may be made of one or more elastomer materials, such as silicone, rubber, polyethylene, or any other flexible material. In some embodiments, the first securement member 4600 may be made of a single material. In some embodiments, the first securement member 4600 may be made of two or more materials, such that a region of the bridging portion 4630 has a different flexibility relative to another region of the first securement member 4600. In some embodiments, at least a region of the bridging portions 4630 may be made of flexible but tensile material, such that the bridging portions 4630 are stiff enough to resist torsion forces and prevent rotation of the central portion with respect to the housing, while being able to hinge or flex to assist to minimize translation of forces and/or movements from the patient’s cheeks to the sealing region. In some embodiments, the first securement member 4600 may be constructed from a same material as the interface body (e.g. the cannula body 3200a, the mask body 3200b) and/or the housing 4400.
The first securement member 4600 can have a material thickness that may be defined as the distance from the rear side 4645 of the first securement member 4600 to the front side 4647 of the first securement member 4600. The first securement member 4600 can have different thicknesses at different regions thereof. In some embodiments, the first securement member 4600 can have a thickened region at the bridging portion 4632 where the material thickness at the bridging portion 4632 is greater than the material thickness at other portions of the first securement member 4600. For example, the material thickness at the bridging portion 4632 may be greater than the material thickness at one or more of the support pads 4660, the other portions of the arms of the bridging portion 4630, and/or the central portions 4610 as described previously in relation to
The torsional stiffness of the first securement member 4600 can resist movement of, and hence disruption of the seal when a force is applied to the interface, e.g. by pulling on tubes or touching of the housing and/or interface body. The torsional stiffness of the first securement member 4600 may assist to resist vertical rotation or movement of the interface body seals, minimizing impact on the seal when a force is applied.
The portion of the first securement member 4600 with or connected to the support pads 4660 may be flexible for attachment of the first securement member 4600 to the patient. The flex of the support pads 4660 can also accommodate the contour of the patient’s face.
In some embodiments, the first securement member 4600 can include perforated areas or indications where a clinician may cut off a portion of the support pads 4660 to alter the size of the support pads 4660 e.g. to achieve a smaller size support pad for a smaller patient.
The attachment portion 4910 can be used to attach the second securement member 4900 to the housing 4400. The attachment portion 4910 is formed to couple with a corresponding structure on the housing 4400. In some embodiments, the corresponding structure can be located on the central portion of the housing 4400. The central portion of the housing 4400 can have a central protrusion 4440 such as shown in
In one embodiment, the attachment portion 4910 can be a soft, deformable or flexible material that can be attached or detached from the housing 4400. This may be desired for example, when switching between different interface bodies. The attachment portion 4910 can be a flexible barb 4912. The flexible barb 4912 can have a pair of tabs 4914 on opposing sides of the barb 4912. The pair of tabs 4914 may be configured to catch onto or otherwise engage with the opening 4442 of the housing 4400. The pair of tabs 4914 may be a pair of lower laterally protruding tabs 4914. The flexible barb 4912 can include the pair of lower laterally protruding tabs 4914 and an extended top portion 4918, and a connecting portion 4915 therebetween. The connecting portion 4915 can include a cutout 4916 in the center of the connecting portion 4915. The cutout 4916 can allow for compression or deformation of at least part of the flexible barb 4912 during attachment and detachment. The flexible barb 4912 can be compressed or deformed and the connecting portions 4915 can move inward toward each other. The flexible barb 4912 in the compressed state can be passed through the opening 4442 in the housing 4400. The flexible barb 4912 can then be allowed to relax and the connection portions 4915 move back to their expanded resting position when the laterally protruding tabs 4914 are through the opening 4442. After insertion, the pair of lower laterally protruding tabs 4914 may be located on one side of the central protrusion 4440 and the extended top portion 4918 may be on the other side of the central protrusion 4440 as shown in
The flexible material of the flexible barb 4912 can allow for a low insertion force and a strong separation force unless intentionally being removed from where it is attached. The flexible barb 4912 can be compressed and collapsed or otherwise deformed easily to be pushed and fit through the opening 4442 then returning to original configuration when the flexible barb 4912 is through the opening 4442. The cutout 4916 in the center of the flexible barb 4912 promotes this compression and collapsing. In some cases, the attachment portion 4910 can be made of a soft or flexible material, for example, the attachment portion 4910 can be made of TPE or silicone.
In some embodiments, the flexible barb 4912 can have a low insertion force and strong separation force. The flexible barb 4912 can be easy to disassemble from the housing 4400. The flexible barb 4912 can be removed by moving or pivoting the second securement member 4900 to one side or laterally and pulling the second securement member 4900 and flexible barb 4912 away and out from the housing 4400. In some embodiments, the flexible barb 4912 can be removed by collapsing in a similar but opposing manner to the insertion. In some embodiments, the length, size and/or configuration of the protruding tabs 4914 can be chosen such that when the second securement member 4900 is moved laterally to a certain degree, the tabs 4914 can fold in and allow the second securement member 4900 to be removed. In some embodiments, the protruding tabs 4914 can have a length that is 1.5 mm (about 1.5 mm) long. In some embodiments, the protruding tabs 4914 can have a length that is between 0.5 mm - 10.0 mm, 1.0 -5.0 mm, 1.0 - 2.5, 1.0 - 2.0 mm, 1.5 - 5.0 mm, 1.5 mm - 2.5 mm, or 1.5 mm - 2.0 mm.
The flexible barb 4912 can have an extended top portion 4918 that extends outwardly from the flexible barb 4912. The extended top portion 4918 can prevent the flexible barb 4912 from being over-inserted into the opening 4442 of the housing 4400. The extended top portion 4918 can extend outwardly from the connecting portion 4915 of the flexible barb 4912 and can sit above the opening in the housing 4400 such as shown in
In some cases, the flexible barb 4912 can be beneficial as it can prevent rigid, sharp, or potentially damaging portions from potentially interacting with the patient. Additionally, the flexible barb 4912 can withstand the compressive forces for assembly and disassemble without breaking.
The central portion 4920 can be a rigid central portion that connects the attachment portion 4910 to the support pad 4980. In some embodiments, the attachment portion 4910 can be integrally formed or molded as one integral piece with the central portion 4910. In other embodiments, the attachment portion 4910 can be formed separately and attached to the central portion 4920. In some embodiments, the attachment portion 4910 can be overmoulded onto central portion 4920 of the second securement member 4900. In some embodiments, the attachment portion 4910 can be attached to the central portion 4920 through crimping or deforming one or both of the portions to join them together. Additionally, in some embodiments, the support pad 4980 can also be overmoulded. In some embodiments, the support pads 4980 can be flexible. In some embodiments, the support pads 4980 can be rigid. The rigid central portion can have a Shore hardness between 30A to 100D. In some embodiments, the attachment portion 4910 and/or a support pad 4980 can have a Shore hardness between 20A - 80A. In some embodiments, the Shore hardness of the central portion 4920 can be the same or greater (or even below) then the Shore hardness of the attachment portion 4910 and/or a support pad 4980.
In some embodiments, the central portion 4920 can work in tension and compression. In some embodiments, the central portion 4920 can prevent over-rotation upwards of the interface body and housing 4400 which can add further added pressure to the nose when compared to a flexible second securement member. In some embodiments, the central portion 4920 can be formed from an optically clear or transparent material which can assist to allow visibility of the patient’s face. In some embodiments, the profile of the second securement member 4900 may be shaped to avoid the interface body in use which may give the second securement member 4900 and particularly the central portion 4920 some slight curvature. However, the central portion 4920 can be generally relatively straight. In some embodiments, the central portion 4920 can be rigid. In other cases, the central portion 4920 can be flexible.
Pivoting of the support pad 4980 relative to the central portion 4920 can help provide the intended vertical stability of the second securement member 4900 by allowing adjustment of the position of the support pad 4980 of the second securement member 4900. This adjustment can be important as a support pad 4980 may connect to a patient at, for example the patient’s forehead, or may connect to different devices (for example, headgear) which may locate the support pad 4980 at a different height from the forehead of the patient. The second securement member 4900 can therefore accommodate for these different heights (for example, headgear bulk) and different forehead angles by having the hinging or pivoting connection 4982 of the support pad 4980. The compensation for the different heights and/or forehead angle can assist to minimize impacting the seal of the interface body with the patient. In some embodiments, the support pad 4980 can be flexible. The support pad 4980 can have a means to attach and secure to a headgear, a chinstrap, a patient interface patch or a dermal patch on the patient’s face, or otherwise on the patient’s face by any suitable mechanisms.
The second securement member 4900 can have a hinge connection between the support pads 4980 and the rest of the second securement member 4900. In some embodiments, the hinging or pivoting connection 4982 can permit a 180 degree pivot, a greater than 180 degree pivot, or any other pivot angle that can allow the second securement member 4900 to be maintained on the patient (and also the rest of the assembly) whilst a caregiver or clinician is tending to a patient or removing/moving the assembly, for example, cleaning the patient’s nares. For example, the housing 4400 and interface body can be flipped up and above the support pad 4980 via the pivot or hinge 4982 to move it out of the way. With this configuration, assembly of the housing 4400 and interface body do not have to be fully removed. This can be beneficial because the assembly of the housing 4400 and interface body can be easily flipped up and down. For example, if during care the patient begins to desaturate and requires therapy again, the mask can easily be flipped back down and into place.
In other embodiments, the second securement member 4900 may not have a pivotable connection. The support pad 4980 may instead be integral with the second securement member 4900 as described in relation to
The wide base 4986 can be compressed to bring the barbed fingers 4987 closer together. The cutout profile 4972 of the wide base 4986 can contribute to the deformation of the base 4986 when compressed. The barb catch 4988 can catch on the central protrusion 4440 and/or a lip of the central protrusion 4440 of the housing 4400. The wide base 4986 above the barbed fingers 4987 can be pinched to compress the attachment portion 4910 and to fit the barbed fingers 4987 into the opening 4442 (or openings) of the housing 4400. The attachment portion 4910 can provide tactile feedback to the user.
Similar to the attachment of the second securement member 4900, the second securement member 4900a can be attached by compressing and subsequent expansion of the barb. Once compressed and fit through the opening, the compression force is released and the barbed fingers 4987 can spring out and catch on the central protrusion 4440 of the housing 4400 and remain in place.
To remove the second securement member 4900a a similar mechanism can be used. The attachment portion 4910 can have a low insertion force but high removal force. The removal of the attachment portion 4910 can require the user to actively compress the barb to remove it easily. The second securement member 4900a has an attachment rod 4984 that allows connection of a support pad or any other pad or patch that can be attached to a device for securing the assembly to the patient (such as a headgear or patches) similar to the attachment described in relation to
Additionally, second securement member 4900b can have a protrusion 4985 on the rear side of each barbed finger 4987 which can provide an additional catchment which can secure the second securement member 4900b in the central protrusion 4440 of a housing, for example, the housing 4400 described in relation to
A second or upper anterior barb portion 4950b may be located on the attachment portion 4910 above the first anterior barb portion 4950a. In the embodiment shown, the second barb portion 4950b includes a protrusion extending outwardly from a front surface of the attachment portion 4910. The protrusion may be configured such that it is unable to pass through the opening 4442. The second barb portion 4950b thus prevents the attachment portion 4910 and hence second securement member 4900 from being over-inserted into the opening 4442.
In some embodiments, the housing may have one opening in the central protrusion at the front side of the housing 4400 (shown in
The attachment portion 4910 can provide tactile feedback to the user. With tactile feedback of the attachment portion 4910 the user can tell when the attachment portion 4910 is inserted properly within the housing 4400 or under the first securement member 4600. In some cases, the attachment portion 4910 can control the angle of the second securement member 4900 to the seal assembly to the patient.
In some embodiments, the attachment portion 4910 can be rigid. In some embodiments, the attachment portion 4910 can be a flexible material.
The embodiments of the second securement member 4900 described in relation to
The patient interface assembly includes an interface body which can form a seal with at least part of the user’s airway and allow gas flow from and to the user, and a housing which can be coupled with the interface body. The housing and the interface body can be coupled in various configurations. The mating of these two components can be optimized for the functionality of the patient interface assembly and/or carer usability. The interface body can be in sealing engagement with the housing to allow the gas flow from and to the user.
In some embodiments, the coupling of the interface body with the housing can be complementary fit as described herein. The coupling of the interface body and housing can allow for assembly and disassembly of the patient interface as well as switching between different interface bodies. The coupling is configured to also assist in preventing unintentional disconnect of the interface body from the housing. The housing and the interface body can be a complementary fit that is difficult to assemble incorrectly and/or provides visual indication of an incorrect and a correct assembly. The interface body can have a manifold 4240 that connects to the interior cavity of the housing 4400 at the tube engaging portion 4460 of the housing 4400.
The manifold 4240 may include a housing coupling portion 4244 on the rear side of the manifold 4240. The housing coupling portion 4244 can be received by the interface body receiving portion 4480 (shown in
The interface body and the housing can have an engagement surface 4889 (shown in
The manifold 4240 of the cannula body 4200a and the mask body 4200a may define one or more openings 4246 (shown in
The lateral openings 4246 may be in fluid communication with each other via the manifold4240. When the cannula body is engaged with the housing, except for the openings 4246 and the lumens of the nasal prongs 4220, the manifold 4240 may be sealed when coupled with the housing. When a mask body is engaged with the housing, except for the openings in the manifold and the mask cavity, the manifold may be sealed when coupled with the housing.
As shown in
In some embodiments, the housing coupling portion 4244 of the interface body and manifold 4240 can have a width measured from one end of the raised portion 4247 of the housing coupling portion 4244 to a second end of the raised portion 4247 of the housing coupling portion 4244 along the lumen of the manifold 4240. When the raised portion 4247 of the housing coupling portion 4244 is an angled raised portion 4247 as shown in
The angle 4847 of the opening 4845 can be balanced with the width w of the housing. The angled opening 4845 can prevent and discourage incorrect orientation of the manifold 4240 within the housing 4400. As shown in
In some embodiments, the angled opening 4845 can help with the alignment and removal of the manifold 4240 from the housing 4400. In some embodiments, a narrow or smaller angle at the angled opening (for example, from 0 to 30 degrees, from 0 to 45 degrees, or from 0 to 60 degrees) could discourage incorrect assembly. A smaller angle could require the width of the housing to be extended due, for example, to the fixed location of the prongs on the interface body. In some embodiments, the angled opening 4845 and the raised portion 4247 of the housing coupling portion 4244 with a larger angle (for example, from 30 to 180 degrees, from 45 to 180 degrees, from 60 to 180 degrees) can allow the housing width to be shorter. A larger angle may, however, lose the advantage of the angle preventing or discouraging incorrect orientation. In some embodiments, at a 90-degree angle, the orientation assistance from the angle can be lost. Therefore, it can be desirable to have the housing 4400 as narrow as possible to improve patient comfort when they are lying on their side, as well as reducing bulkiness and improving aesthetics. However, the width of the housing 4400 is desirably balanced with an angle that can assist to prevent incorrect orientation of the manifold 4240 within the housing 4400. In some embodiments, the raised portion 4247 of the housing coupling portion 4244 can have an angled opening with a 60-degree angle 4847 measured from the rear portion 4843 of the manifold 4240 as shown in
In some embodiments, the manifold 4240 can have a horizontal axis, h1, that extends through the center of the inner lumen of the manifold 4240. The housing 4400 can have a horizontal axis, h2, that extends through the housing 4400 through the center of the tube engaging portions 4460 on each side of the housing 4400. In some cases, the horizontal axis, h1, can be the same as the horizontal axis, h2. In other embodiments, the horizontal axis, h1, can be off-set or off-center from the horizontal axis, h2, of the housing 3400. Therefore, the annular ridge 4248 of the manifold 4240 can be off-center of the horizontal axis h2. The annular ridge 4248 of the manifold 4240 may be substantially the same size or smaller in size than the inner diameter of the housing 4400.
The key feature 4286 is shown on the rear side (or patient facing side) of the housing 4400. However, the key feature 4286 can be positioned on the front or rear side of the housing 4400 or any location that can allow for a complementary fit between a protrusion and corresponding indentation. Additionally, while the manifold is shown with the protrusion and the housing 4400 is shown with the indentation, a key feature can be used where the protrusion is present on the housing and the indentation is present on the manifold. The key feature shown in
The angled raised portion 4247 of the manifold can be a substantially trapezoidal configuration when viewed from the top view of the housing 4400 and manifold 4240 as shown in the top view in
The housing 4400 can have an angled interface body receiving portion 4480 with a complementary configuration, as shown in
The angled raised portion 4247 of the housing coupling portion 4244 and angled interface body receiving portion 4480 as illustrated in
As shown in
The manifold 4240 can be folded, flexed, bent or otherwise suitably manipulated while being inserted into the housing 4400. For example, upon insertion, the manifold 4240 can be folded through the center of the housing 4400 in order to manipulate the annular ridge 4248 through the narrowest point of the housing 4400. Once the annular ridges 4248 are concentrically located in the housing, the manifold can straighten and return to the resting shape. During this process, the angled faces 4849 and angled openings 4284 can act to align the manifold 4240 in the correct orientation relative to the housing 4400.
In some embodiments, the seal between the manifold 4240 and the housing 4400 can be broken when the annular ridge 4248 moves beyond distance “y” as shown on
The manifolds 4240 of both the mask body and cannula body have annular ridges 4248 on both sides of the manifold 4240. The annular ridges 4248 can be an integral sealing o-ring portion. These annular ridges 4248 of the manifold 4240 can fit in the housing 4400 and seal with the housing 4400 so that either side is respectively in fluid communication with one of the tubes. The annular ridges 4248 are the intended point of contact between the manifold 3240 and the housing 4400. Having a single point of contact can reduce friction of the manifold 4240 with the housing 4400 so that the interface body can slide in easier when fitting to the housing and self-aligns easier. The amount of rotation of each side of the interface body or each annular ridge relative to each other can be controlled by the amount of interference between the components (for example, the amount of interference between the housing 4400 and manifold 4240). This rotation (and thus the interference) is ideally minimized because a small amount of rotation of one side can distort the seal between the housing 4400 and manifold 4240. Therefore, it can be important to assure and confirm proper alignment of the manifold 4240 within the housing 4400. The manifold 4240 can include a self-aligning feature to help to prevent this rotation and maintain each side of the manifold 4240 in the same location in the housing 4400 relative to the other.
As shown in
The width at the shoulder portion 4628 can create a region at the base of the interface body that can act to prevent rotation of the manifold within the housing once assembled. In some embodiments, the shoulder portion 4628 only extends along a portion of the manifold. In some embodiments, the shoulder portion 4628 can extend the width of the manifold from one side of the manifold to the other. The shoulder portion 4628 can also give the nasal prongs or mask some structure or stiffness which can assist with the insertion of the device as described previously. Additionally, the increased thickness at this shoulder portion 4628 can also increase the necessary removal force thereby reducing the chance of accidental disassembly.
In some embodiments, the surface finish of the material of the housing and interface body or manifold can assist with the manifold’s placement within the housing and thus improve fitting of the manifold to the housing. In some embodiments, to achieve this, the surface finish of the housing and manifold or interface body can result in a low friction or slippery surface. In some embodiments, the low friction surface of the housing or interface body can be a characteristic of the material that forms the housing or interface body or a portion of the housing or interface body. In some embodiments, the low friction surface can be achieved during the manufacturing process. For example, a material coating can be added to the material of the housing or interface body. For example, a parylene coating can be applied to the external surfaces of the housing or interface body to achieve a low friction surface. Alternatively, the surface can be treated by a process, such as a blasting process (e.g. bead blasting) to provide the low friction surface. The coating or treatment can reduce the friction and adherence of the housing or interface body to other materials which can improve sliding the interface body into the housing. Furthermore, the low friction surface also reduces friction of the parts of the interface body which contact the patients face and can improve comfort. In some embodiments, other components of the patient interface assembly can also have the low friction surface or be formed from a low friction material.
The colored ring 5604 can be provided on both opposing annular ridges of the manifold. In some embodiments, the color indicator can be provided only on the manifold, only on the housing, or on both the manifold and the housing.
Additionally or alternatively, the interface assembly may include a second visual indicator, such as a second color indicator, on an angled corner of either the housing 5400 and/or the manifold 5420.
A further embodiment of visual indicator is shown in
In some embodiments, the color indicator on the housing and/or manifold can be used as a sizing indicator as well as an alignment indicator. For example, the housing and manifold can be provided in various sizes and different sizes can use different color indicators so that the correct size housing could be paired with the correct size manifold. This could assist the user in correctly pairing the housing and manifold components. While the color indicators illustrated with reference to
The one or more interface tubes and connectors of the patient interface assembly allows fluid communication to and from the patient from an external device or gas flow source.
The housing can connect to the tubing at the tube engaging portion (shown in
In some embodiments, the locking fingers 4822 can extend away from the connector 4820. The locking fingers 4822 can be spaced apart and narrowing along their length away from the connector. The locking fingers can have locking recesses that are formed at least on outer surfaces of each of the locking fingers. The locking recesses can lock with portions of a gas delivery tube connector or other connector. The locking fingers can interact with recesses of the gas delivery tube connector or other connector to align the connector 4820 and the gas delivery tube connector or other connector.
Unless the context clearly requires otherwise, throughout the description and the claims, the words “comprise”, “comprising”, and the like, are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense, that is to say, in the sense of “including, but not limited to”. Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or states. Thus, such conditional language is not generally intended to imply that features, elements and/or states are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or states are included or are to be performed in any particular embodiment.
The term “plurality” refers to two or more of an item. Recitations of quantities, dimensions, sizes, formulations, parameters, shapes and other characteristics should be construed as if the term “about” or “approximately” precedes the quantity, dimension, size, formulation, parameter, shape or other characteristic. The terms “about” or “approximately” mean that quantities, dimensions, sizes, formulations, parameters, shapes and other characteristics need not be exact, but may be approximated and/or larger or smaller, as desired, reflecting acceptable tolerances, conversion factors, rounding off, measurement error and the like and other factors known to those of skill in the art. Recitations of quantities, dimensions, sizes, formulations, parameters, shapes and other characteristics should also be construed as if the term “substantially” precedes the quantity, dimension, size, formulation, parameter, shape or other characteristic. The terms “approximately,” “about,” and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, in some embodiments, as the context may dictate, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than or equal to 10% of the stated amount. The term “generally” as used herein represents a value, amount, or characteristic that predominantly includes, or tends toward, a particular value, amount, or characteristic. For example, as the context may dictate, the term “generally linear” can mean something that departs from exactly parallel by less than or equal to 15°.
Numerical data may be expressed or presented herein in a range format. It is to be understood that such a range format is used merely for convenience and brevity and thus should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also interpreted to include all of the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. As an illustration, a numerical range of “1 to 5” should be interpreted to include not only the explicitly recited values of about 1 to about 5, but should also be interpreted to also include individual values and sub-ranges within the indicated range. Thus, included in this numerical range are individual values such as 2, 3 and 4 and sub-ranges such as “1 to 3,” “2 to 4” and “3 to 5,” etc. This same principle applies to ranges reciting only one numerical value (e.g., “greater than 1”) and should apply regardless of the breadth of the range or the characteristics being described.
A plurality of items may be presented in a common list for convenience. However, these lists should be construed as though each member of the list is individually identified as a separate and unique member. Thus, no individual member of such list should be construed as a de facto equivalent of any other member of the same list solely based on their presentation in a common group without indications to the contrary. Furthermore, where the terms “and” and “or” are used in conjunction with a list of items, they are to be interpreted broadly, in that any one or more of the listed items may be used alone or in combination with other listed items. The term “alternatively” refers to selection of one of two or more alternatives, and is not intended to limit the selection to only those listed alternatives or to only one of the listed alternatives at a time, unless the context clearly indicates otherwise.
Reference to any prior art in this specification is not, and should not be taken as, an acknowledgement or any form of suggestion that that prior art forms part of the common general knowledge in the field of endeavor in any country in the world.
The invention may also be said broadly to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, in any or all combinations of two or more of said parts, elements or features.
Where, in the foregoing description reference has been made to integers or components having known equivalents thereof, those integers are herein incorporated as if individually set forth.
It should be noted that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the spirit and scope of the invention and without diminishing its attendant advantages. For instance, various components may be repositioned as desired. It is therefore intended that such changes and modifications be included within the scope of the invention. Moreover, not all of the features, aspects and advantages are necessarily required to practice the present invention. Accordingly, the scope of the present invention is intended to be defined only by the claims that follow.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2021/051707 | 3/2/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63117044 | Nov 2020 | US | |
| 62984718 | Mar 2020 | US |
