Patent Application
20220211962
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 flexible breathing tube. The patient interface can be a nasal cannula, nasal mask, full face, oral mask 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.
It would be advantageous to provide a system for an alternative or improved interface location or operational positioning of the interface, such as a nasal cannula, nasal mask, or oro-nasal mask. Such an alternative or improved system may further assist with improved compliance of gas delivery treatment.
An aspect of the disclosure involves a patient interface comprising a mask seal body defining 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 interface also comprises a pair of facial pads, each of the facial pads configured to engage the face of a user on opposing sides of the mask seal body. The interface further comprises a pair of bridging portions, each of the bridging portions connecting the mask seal body and a respective one of the facial pads. Each of the bridging portions has a curved shape configured in use to urge the mask seal body toward the user's face to create or maintain sealing engagement between the user-contacting surface and the user's face.
In some configurations, the bridging portion comprises one or more cutouts.
In some configurations, a mechanical fastener component is positioned within the cutout(s).
In some configurations, the mechanical fastener component is a hook or loop material.
In some configurations, the bridging portion comprises one or more locating features.
In some configurations, as the one or more locating features are grooves.
In some configurations, a mechanical fastening material, such as a hook or loop material is positioned within the locating feature(s) such as groove(s).
In some configurations, a mechanical fastener component is positioned within the groove(s).
In some configurations, the bridging portion comprises a portion having a mechanical fastener component.
In some configurations, the mechanical fastener component is a hook or loop material.
In some configurations, the bridging portion comprises a clip configured to retain a respiratory tube.
In some configurations, each of the bridging portions is split into an upper section and a lower section that are separate from one another.
In some configurations, the bridging portions are constructed integrally with the mask seal body.
In some configurations, the bridging portions are constructed separately from the mask seal body and connected thereto.
In some configurations, the bridging portion comprises an S-shape, a U-shape or a C-shape as viewed from above.
In some configurations, the patient interface further comprises a reinforcing element configured to support the structure of the mask seal body.
In some configurations, the reinforcing element is an elongated strip overmoulded on or within the mask seal body.
In some configurations, the reinforcing element is a clip positioned at a front surface of the mask seal body.
In some configurations, the bridging portion is integrally constructed with the clip.
In some configurations, the reinforcing element is a hardened interface tube connection attached to the mask seal body.
In some configurations, the reinforcing element is a thickened portion of the mask seal body.
In some configurations, the reinforcing element is at least one of (i) an elongated strip overmoulded on or within the mask seal body; (ii) a clip positioned at a front surface of the mask seal body; (iii) a hardened interface tube connection attached to the mask seal body; and (iv) a thickened portion of the mask seal body.
In some configurations, the bridging portion is integrally constructed with the clip.
In some configurations, the mask seal body comprises an upper region, wherein at least part of the upper region is configured to roll when the mask seal body is positioned on a user's face.
In some configurations, the upper region comprises a portion with a thinner wall located between portions having thicker walls.
In some configurations, the mask seal body is configured to be placed around an alar region of a user.
In some configurations, the mask seal body includes an under-nose support configured to be placed under a nose of a user when the interface is worn by the user.
In some configurations, the interface includes one or more respiratory tubes configured to deliver gas.
In some configurations, the respiratory tubes comprise an inspiratory tube configured to deliver gas to a user.
In some configurations, the respiratory tubes comprise an expiratory tube configured to deliver gas from a user.
In some configurations, the mask seal body includes a tube receiving portion configured to receive the one or more respiratory tubes.
In some configurations, the tube receiving portion comprises elongate tube extensions extending from the mask seal body.
In some configurations, the elongate tube extensions vary in cross-sectional size or shape along a length of the elongate tube extensions.
In some configurations, the elongate tube extensions further comprise regions with a first part of a releasable connector for connection with a second part of a releasable connector on the respective bridging portion.
In some configurations, the bridging portion is configured to receive the respiratory tube.
In some configurations, the tube receiving portion comprises one or more swivel connectors.
In some configurations, the mask is overmolded to the respiratory tubes.
In some configurations, the one or more swivel connectors comprise elbows having an angle of less than 90 degrees, preferably about 45 degrees.
In some configurations, the one or more respiratory tubes connect to the mask seal body at an angle of between 0-90 degrees, preferably about 45 degrees.
In some configurations, at least one of the bridging portions defines an internal flow path.
In some configurations, the patient interface further comprises a patch assembly coupled to each of the facial pads for securing the facial pads to the user.
In some configurations, the patch assembly comprises a first portion coupled to the facial pad and a second portion configured to be coupled to the user, wherein the patch assembly is configured for releasable connection between the first portion and the second portion.
In some configurations, the patient interface further comprises a third facial pad configured to engage the forehead of the user above the mask seal body and a third bridging portion connecting the mask seal body and the third facial pad.
In some configurations, the mask seal body comprises a reduced stiffness region.
In some configurations, the reduced stiffness region is located in an upper portion of the mask seal body.
In some configurations, the reduced stiffness region comprises a reduced thickness relative to portions of the mask seal body above and/or below the reduced stiffness region.
In some configurations, the reduced stiffness region has a triangular or substantially triangular profile.
In some configurations, the triangular or substantially triangular profile has a rounded apex.
In some configurations, an upper edge of the reduced stiffness region defines a dip.
In some configurations, the reduced stiffness region is a rolling region configured to roll onto another portion of the mask seal body.
An aspect of the present disclosure involves a patient interface comprising a mask seal body defining 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 patient interface also comprises a pair of facial pads, each of the facial pads configured to engage the face of a user on opposing sides of the mask seal body. The facial pads are coupled to the mask seal body.
In some configurations, a sealing mechanism is configured to urge the mask seal body toward the user's face to create or maintain sealing engagement between the user-contacting surface and the user's face.
In some configurations, the sealing mechanism is integral with the mask seal body.
In some configurations, the sealing mechanism is formed separately from the mask seal body.
In some configurations, the sealing mechanism comprises a strap.
In some configurations, the sealing mechanism comprises a bridging portion that extends between the mask seal body and each of the facial pads.
In some configurations, the bridging portion defines a curved shaped configured to roll in response to movement between the facial pad and the mask seal body.
In some configurations, the bridging portion comprises one or more hinges.
In some configurations, the bridging portion comprises one or more cutouts.
In some configurations, a hook or loop material is positioned within the cutout(s).
In some configurations, a mechanical fastener component is positioned within the cutout(s).
In some configurations, the bridging portion comprises one or more locating features, such as grooves.
In some configurations, a hook or loop material is positioned within the locating feature(s) such as groove(s).
In some configurations, a mechanical fastener component is positioned within the groove(s).
In some configurations, the bridging portion comprises a portion having a mechanical fastener component.
In some configurations, the mechanical fastener component is a hook or loop material.
In some configurations, the bridging portion comprises a clip configured to retain a respiratory tube.
In some configurations, each of the bridging portions is split into an upper section and a lower section that are separate from one another.
In some configurations, wherein the patient interface further comprises a reinforcing element configured to support the structure of the mask seal body.
In some configurations, the reinforcing element is an elongated strip overmoulded on or within the mask seal body.
In some configurations, the reinforcing element is a clip positioned at a front surface of the mask seal body.
In some configurations, the bridging portion is integrally constructed with the clip.
In some configurations, the reinforcing element is a hardened interface tube connection attached to the mask seal body.
In some configurations, the reinforcing element is a thickened portion of the mask seal body.
In some configurations, the mask seal body comprises an upper region, wherein at least part of the upper region is configured to roll when the mask seal body is positioned on a user's face.
In some configurations, the upper region comprises a portion with a thinner wall located between portions having thicker walls.
In some configurations, the mask seal body is configured to be placed around an alar region of a user.
In some configurations, the mask seal body includes an under-nose support configured to be placed under a nose of a user when the interface is worn by the user.
In some configurations, the patient interface further comprises one or more respiratory tubes configured to deliver gas.
In some configurations, the respiratory tubes comprise an inspiratory tube configured to deliver gas to a user.
In some configurations, the respiratory tubes comprise an expiratory tube configured to deliver gas from a user.
In some configurations, the mask seal body includes a tube receiving portion configured to receive the one or more respiratory tubes.
In some configurations, the tube receiving portion comprises elongate tube extensions extending from the mask seal body.
In some configurations, the elongate tube extensions vary in cross-sectional size or shape along a length of the elongate tube extensions.
In some configurations, the tube receiving portion comprises one or more swivel connectors.
In some configurations, the one or more swivel connectors comprise elbows having an angle of less than 90 degrees, preferably about 45 degrees.
In some configurations, the one or more respiratory tubes connect to the mask seal body at an angle of between 0-90 degrees, preferably about 45 degrees.
In some configurations, at least one of the bridging portions defines an internal flow path.
In some configurations, the patient interface further comprises a patch coupled to each of the facial pads for securing the facial pads to the user.
In some configurations, the patch comprises a first portion coupled to the facial pad and a second portion configured to be coupled to the user, wherein the patch assembly is configured for releasable connection between the first portion and the second portion.
In some configurations, a third facial pad configured to engage the forehead of the user above the mask seal body and a third bridging portion connecting the mask seal body and the third facial pad.
In some configurations, the mask seal body comprises a reduced stiffness region.
In some configurations, the reduced stiffness region is located in an upper portion of the mask seal body.
In some configurations, the reduced stiffness region comprises a reduced thickness relative to portions of the mask seal body above and/or below the reduced stiffness region.
In some configurations, the reduced stiffness region has a triangular or substantially triangular profile.
In some configurations, the triangular or substantially triangular profile has a rounded apex.
In some configurations, an upper edge of the reduced stiffness region defines a dip.
In some configurations, the reduced stiffness region is a rolling region configured to roll onto another portion of the mask seal body.
Further aspects and advantages of the present disclosure will become apparent from the ensuing description which is given by way of example only.
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.
In the illustrated arrangement, each of the facial pads 250 includes a base or connecting portion 235 that is coupled directly to the respective bridging portion 230. In some configurations, the base or connecting portion 235 is configured to provide support to a face-contacting portion of the facial pad 250. For example, the base or connecting portion 235 can assist in maintaining a shape (e.g., a curved shape) of the face-contacting portion of the facial pad 250. In the illustrated arrangement, the base or connecting portion 235 is generally triangular in shape as viewed from above (see, e.g.,
In some embodiments, the seal body 210 is permanently or semi-permanently connected with the bridging portions 230. In some embodiments, the seal body 210 and the bridging portions 230 are integrally formed in a single, unitary piece. In some embodiments, the seal body 210, the bridging portions 230, and the facial pads 250 may be integrally formed in a single, unitary piece. For example, the seal body 210, the bridging portions 230 and the facial pads 250 may be molded as a single piece from a single material, or co-molded as a single piece from different materials. In some embodiments, the seal body 210 and the bridging portions 230 are removably or releasably coupled such that the seal body 210 may be removed for cleaning or replacement if required. Additionally, the ease of manufacturing may be improved if the seal body 210 and the bridging portions 230 are individually formed and subsequently assembled or coupled.
As shown in
The seal body 210 comprises a cushion portion 215 that defines a face-contacting surface 220 having an inner peripheral edge 222 that defines a nose-receiving opening into the mask cavity 260 for receiving the user's nose in use. In some embodiments, the tube receiving portion 214 may be located generally opposite the face-contacting surface 220. In use, the patient interface 100 is secured against the user's face such that the contacting surface 220 of the seal body 210 envelops or circumscribes a portion of the user's nose defining the nares and sealingly engages about the user's nose such as against 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 seal body 210 may be substantially hollow and generally shaped to provide or define the seal cavity 260 for receiving the flow of gases from the tube receiving portion 214. The seal cavity 260 may be fluidically connected with the openings 216 and 218, such that gas from and to the patient flows through the cavity 260.
The seal body 210 may include an upper portion 212 at the top of the seal body 210. The upper portion 212 may be configured to extend over a nasal bridge and/or nasal tip and/or ala of the user. In some embodiments, the upper portion 212 may be designed to roll over onto an outer surface the seal body 210. In some embodiments, the upper portion 212 may roll onto another portion of the seal body 210. To assist with the rolling of the upper portion 212, the upper portion 212 may have a varying thickness or a varying stiffness. In some embodiments, to induce the upper portion 212 to roll, a reduced stiffness region 211 can be incorporated. The reduced stiffness region 211 can reduce or eliminate the likelihood of the seal body 210 buckling or adversely deforming in a region other than the desired region for rolling. In some embodiments, other means for providing the reduced stiffness region 211 also can be used to induce rolling of the upper portion 212. For example, the material of the upper portion 212 can be configured to have a reduced stiffness through material selection or material properties. In addition, a composite of materials can be used to provide a region of reduced stiffness or rigidity. Moreover, a combination of any suitable techniques can be used.
When the upper portion 212 comprises the reduced stiffness region 211, the upper portion 212 of the seal body 210 may tend to balloon outward under internal pressures, such as those encountered during positive pressure therapy regimens, which ballooning is believed to be caused by the reduced stiffness region 211 that defines a large area of silicone or flexible materials without significant structure. With reference to
In some embodiments, the band 224 can be a separately formed component that is at least partially encased by the material of the seal body 210. For example, the band 224 can be a preformed plastic component and the seal body 210 can be overmoulded onto or around the band 224. In some configurations, the band 224 can be defined by a portion of the upper portion 212 that has enhanced stiffness relative to surrounding regions. For example, but without limitation, the band 224 can be defined by one or both of a portion of increased thickness, a portion of differing materials or material properties that result in increased stiffness or the like. The band 224 may extend along at least a portion of the upper portion 212 of the seal body 210.
In some embodiments, the face-contacting surface 220 may be shaped such that the face-contacting surface 220 substantially corresponds to or can accommodate the contour of the face of the user and form a fluid-tight seal or a substantially fluid-tight seal during normal use. For example, as illustrated in
As shown in
In some embodiments, the bridging portions 230 may be connected to the seal body 210 at a region other than the rolling region 213 of the upper portion 212 of the seal body 210, such that the movement of the bridging portions 230 do not interfere with the rolling of the rolling region 213. For example, the bridging portions 230 may be connected to a side portion, a bottom portion, or a front portion of the seal body 210.
In some embodiments, the inner peripheral edge 222 of the seal body 210 is shaped and/or sized such that the face-contacting surface 220 does not touch the alar region of the nose of the user. As a result, as shown in
In some embodiments, the seal body 210 may include an under-nose support, which can contact or engage under the user's nose to generate an opposing downward force that at least partially counteracts, resists or otherwise mitigates the resultant force generated by the patient interface and exhalation force to thereby stabilize the nasal mask in place over the user's nose during use and/or inhibit or prevent its tendency to slide or otherwise move up the user's face from its initially secured position prior to gas delivery being initiated. An under-nose support may also help to resist rocking of the mask against the patient's face, in particular, vertical or chin to forehead rocking.
Reinforcing Element
In some embodiments, a seal body of a mask, such as the seal body 210 or the seal body 510, may include a reinforcing element, which can provide additional support to the structure of the seal body and thus the nasal mask. The reinforcing element may reduce movement of the mask or seal body caused by the exertion of external force, thereby facilitating the maintenance of a suitable seal with the face of the user. For example, the reinforcing element may inhibit or at least partially prevent the movement of the seal body when the bridging portions 230 move, such as movement caused by movement of the facial pads 250. The movement of the bridging portions 230 are further described elsewhere herein. The reinforcing element may have any suitable shape or form, but the reinforcing element preferably provides sufficient stiffness such that it can prevent the seal body from folding, collapsing or buckling.
The reinforcing element may be positioned such that the reinforcing element does not contact the user when the mask is applied to the user. For example, the reinforcing element may be positioned at the anterior, non-patient facing side of the seal body, and/or within an interior space of the seal body. In some embodiments, the reinforcing element may be constructed from the same material as the seal body, but as a thickened portion. In some embodiments, the reinforcing element may be constructed from a different material than the seal body. In some embodiments, the reinforcing element may be formed integrally with the seal body (e.g. overmoulded). In some embodiments, the reinforcing element may be formed as a separate structure with the seal body and attached or otherwise installed to the seal body (e.g., removably or non-removably attached). The reinforcing element may be placed on the outer surface of the seal body, on the internal surface of the seal body, or within the seal body. The reinforcing element may be placed on an upper, lower, side portion, or any suitable location of the seal body.
In some embodiments, the seal body 1010 may not include a separate or distinct reinforcing element. In some such arrangements, certain regions of the seal body 1010 may be thickened, hardened or otherwise structured to reinforce the seal body 1010. For example, in some embodiments, a tube-receiving portion 1015 of the seal body 1010 and/or the end of the interface tubes is thickened or hardened and may function as the reinforcing element or in a manner similar to the reinforcing element. In some embodiments, the tube-receiving portion 1015 and/or a portion of the seal body 1010 adjacent to or surrounding the tube-receiving portion 1015 defines a reinforced region 1026 that is thicker, harder or otherwise reinforced relative to other regions of the seal body 1010, such that the reinforced region 1026 is stiffer than other regions of the seal body 1010. In some embodiments, the tube-receiving portion 1015 can be made of a stiffer material than other regions of the seal body 1010. In the illustrated arrangement, the reinforced region 1026 corresponds with a portion of the seal body 1010 bounded by the reinforcing clip 1020. With such an arrangement, the reinforced region 1026 of the seal body 1010 can assist the reinforcing clip 1020 in maintaining a desired shape of the seal body 1010. In other configurations, the reinforced region 1026 of the seal body 1010 can be configured to provide some or all of the desired reinforcement of the seal body 1010 such that the clip 1020 can be made more flexible, such as to reduce material costs and/or ease assembly.
As illustrated in
The backing or facial pads 250 may be pre-formed to be of a contour that is substantially curved to fit a user's face, cheek or upper lip region. In some embodiments with a point of contact in the forehead region, the contour could be selected to match or accommodate the contour of the user's forehead, which may be the same as, flatter, or more curved than a cheek region, for example. The enlarged end of the bridging portions 230 may be also contoured to accommodate the contour of the facial pads 250. The facial pads 250 may be anatomically shaped with a distribution and scale of curvature that reflects the facial geometry of the intended user. The anatomical shape of the facial pads 250 can give the interface a positive engagement with a user's face at a predetermined position where the contour of the facial pads 250 matches the user's facial contour. Pre-shaping or contouring the facial pads 250 to the user's facial features reduces the pressure applied to the user's face by any retention mechanism (adhesive tape, headgear or other means). This reduces the likelihood of pressure sores, head forming, or other injury. The positive engagement promoted by the anatomical shape of the facial pads 250 increases the stability of the mask 200 and therefore improves comfort and efficacy of the treatment being administered.
The patient interface may be secured to the patient's face using a securement system. The securement system may include a two-part releasable attachment or connection arrangement. The two-part releasable attachment or connection arrangement may be a two-part releasable attachment or connection arrangement as described in PCT application PCT/NZ2011/000218, published as WO2012/053910, the contents of which are incorporated herein by reference. The reference herein to a patient interface, patient interface patch, and similar terms, will be understood to be similar to the reference to a user interface or user interface patch in WO2012/053910. Such two-part releasable attachment or connection arrangement enables securement of the patient interface without use of a headgear or a bonnet, thereby preventing potential head forming by the headgear or the bonnet on babies or young children with still-developing skull structure and/or active fontanelles. The releasable connection arrangement includes a pair of patches that are affixed to the patient and the patient interface, respectively. The first patch is a dermal patch that is adhered or otherwise attached to the patient's skin. The dermal patch has a user side that faces the user's skin and an interface side that faces the patient interface. The user side of the dermal patch may be attached to the skin of a user by a dermatologically sensitive adhesive, such as a hydrocolloid. The patient interface side of the dermal patch is provided with the first part of the two-part releasable attachment or connection system.
The second patch is a patient interface patch. The patient interface patch also has a patient side and an interface side. The patient side of the patient interface patch is disposed adjacent the dermal patch when the system is engaged. The complimentary second part of the two-part releasable attachment or connection system is affixed to the patient side of the patient interface patch so that the respective parts of the two-part releasable attachment or connection system are easily engageable when the patches are brought together. The interface side of the patient interface patch is affixed to the patient interface (e.g. at the backing or facial pads 250). The patient interface patch may be integrated with, formed integrally with (i.e., by overmolding or other methods as are known in the art), or suitably adhered to the patient interface.
The two-part releasable attachment or connection arrangement may comprise a mechanical fastener, such as a hook and loop material (such as VELCRO™), a magnet (or ferrous material to attract with a magnet) or an array of magnets disposed on the respective patches with the poles suitably arranged, an adhesive arrangement that is activated when the patches are urged together or another suitable releasable coupling. The interface side of the dermal patch may have one of a hook or a loop material, and the patient side of the patient interface patch may have the other of the hook or loop material, such that the dermal and patient interface patches are releasably attachable or connectable to each other.
Turning back to
In some situations, a chinstrap may be used in conjunction with the two-part releasable attachment or connection arrangement. This chinstrap may be a standard or conventional chinstrap that is used to keep the patient's mouth closed during CPAP therapy. The chinstrap helps ensure a sealed system (by biasing the patient's mouth closed or substantially closed for eliminated, or at least reduced, mouth leak) and thus more effective treatment. In some embodiments, the chinstrap may be a part of a headgear or connected to the headgear which can be secured around the patient's head.
Additionally, or alternatively, a chinstrap may be part of the patient interface and may be used without a two-part releasable attachment or connection arrangement to secure the device.
In one example embodiment, the chinstrap comprises a material that is soft on the patient's face. Advantageously, the material may also be a stretchable fabric, such as a knit fabric, or a fabric comprising elastic material or elastic fibres. The chinstrap may have one or more regions of hook or loop material/fasteners, and/or may be substantially made up of or covered by hook or loop material. In one preferred embodiment, this is loop material, which is soft on the patient's face. In another example, this may be a hook material, so that any overlap of the user interface patch over the footprint of the strap does not cause any damage or scratching of the patient's face due to hooks on the interface patch. In an embodiment, the strap includes at least one region of hook material, and at least one region of loop material. The chinstrap may connect to a region of hook or loop fasteners on a connecting portion on the patient interface (e.g., the patient interface patch). This securement system secures the patient interface on the patient's face without having to apply any adhesive to the face. In one example embodiment, the chinstrap is used in combination with a continuous loop headgear that extends around the back and/or top of the patient's head. In a further example embodiment, the chinstrap comprises a slit or bifurcation to allow it to conform to the patient's curved chin region. In one embodiment, the chin strap may comprise, or may additionally comprise, an opening, slit, or bifurcation to hold a nasogastric or endotracheal tube.
The securement system may include a bonnet, such as an adjustable bonnet, which may include one or more sections of loop material. In some embodiments, the patient interface patch may be connected to the adjustable bonnet using a suitable structure, such as buttons, snaps, adhesive, magnets, ties, elastic, or other mechanical attachments. In some embodiments, the chinstrap may be attached to the bonnet via hook or loop fasteners. In some embodiments, the hook or loop fasteners on the bonnet or the chinstrap are movable or the bonnet or the chinstrap includes multiple hook or loop fasteners, such that the position where the patient interface or tube is secured on the bonnet or the chinstrap can be changed or adjusted as desired by the user or the clinician.
Furthermore, instead of extending over the chin, in one embodiment the at least one headgear strap may extend down the side of the patient's cheek. This type of strap may again comprise hook or loop material to attach to the patient interface and also to the bonnet (in an embodiment where the side strap portions and bonnet are not integral). In one preferred embodiment, this is loop material to be soft on the patient's face. In another example, this may be hook material, so that any overlap of the user interface patch over the footprint of the strap does not cause any damage or scratching of the patient's face due to hooks on the interface patch. In one embodiment, the strap comprises at least one region of hook material, and at least one region of loop material. An embodiment of these side strap portions may attach to the bonnet. The strap may have a longitudinal body that extends down the side of the patient's cheek.
Further examples of the securement system and its components are further described in PCT application PCT/NZ2011/000218, published as WO2012/053910, the contents of which are incorporated herein by reference.
As described herein, the facial pads (e.g. the facial pads 250) can rest directly or indirectly on a user's face when the mask (e.g. the mask 200) is worn by the user. Accordingly, the bridging portions (e.g. the bridging portion 230), which is connected to the facial pads, may be moved or deflected when the user's face moves. For example, when a portion of the user's face where the facial pads rest on moves, such external force or movement may be conducted to the bridging portion, and to the seal body (e.g. the seal body 210) eventually. In some instances, the bridging portions themselves may move or deflect when an external force is exerted on them. For example, the user of the mask may lay on the bridging portions, exerting force to the bridging portions, and thus to the seal body. Accordingly, it is desirable for the bridging portion to be constructed such that the seal body can maintain its seal with the user's face even when the user's face and/or the facial pads move.
To apply the mask 200 to the user, the seal body 210 may be first positioned on the face of the user, such as on the user's nose as described herein with reference to
When the facial pads 250 and the bridging portions 230 are in position (B) illustrated in
Advantageously, if the first configuration of the bridging portion 230 spaces the respective facial pad 250 away from the user's face in position (A) as illustrated in
In some configurations, the deformable configuration of the bridging portions 230 provides some degree of de-coupling of the facial pads 250 from the seal body 210, preferably while maintaining the downward force on the seal body 210 toward the face of the user. For example, deformation of the bridging portions 230 may allow cheek movement of the user to have a reduced or minimal effect on the downward pressure between the seal body 210 and the bridging portions 230 in comparison to a straight or substantially straight bridging portion. Preferably, the deformation of the bridging portions 230 at least reduces or possibly eliminates disruption of the seal between the seal body 210 and the user's face as a result of cheek movements of the user's face.
Some or all of these advantages may be provided by the shape of the bridging portions 230, the orientation of the bridging portions 230 or the material(s) used to construct the bridging portions 230. In some embodiments, the bridging portions 230 may be made of a flexible or elastically-deformable material, such that at least a portion of a length of the bridging portion 230 has flexibility and/or elasticity. In some embodiments, the bridging portions 230 are each shaped such that its curved geometry facilitates the flexibility of the bridging portions 230. The flexibility of the bridging portions 230 preferably allows the bridging portions 230 to absorb forces exerted on them, for example caused by the movement of the user's cheek. Accordingly, as described above, only some of the force exerted on the facial pads 250 and, thus, the bridging portions 230 is transferred to the seal body 210. Advantageously, such an arrangement assists in maintaining the seal between the seal body 210 and the user's face during movement of the user's cheeks.
As illustrated in, for example,
In the illustrated arrangement, the path 300 has an initial outward trajectory when moving along the path 300 in a direction from the first end 302 toward the second end 304. The path 300 then extends in a substantially forward direction. In some configurations, the initial outward trajectory can be omitted and the path 300 can initially extend in a substantially forward direction from the first end 302. In the illustrated arrangement, the path 300 continues in a forward direction while moving inwardly toward a centerline 306 of the mask 200. The path 300 then moves outwardly away from the centerline 306 while still moving in a forward direction. The illustrated path 300 then reverses course and moves rearwardly. In addition, the path 300 also moves outwardly away from the centerline 306 while moving rearwardly to the second end 304. Overall, the illustrated path 300 extends greater in a forward direction than in a rearward direction, thereby the second end 304 of the illustrated path 300 is positioned at least partially forwardly than the first end 302. Accordingly, an imaginary straight line extending from the first end 304 to the second end 302 forms an angle 308 smaller than 90°. In some embodiments, the angle 308 can be between about 30°-80° inclusive, and including any and all values within this range (such as about 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75° or 80°). However, the angle 308 can be changed when the bridging portions 230 are extended or deformed. For example, at the second or adjusted or deflected position (B) of
Thus, the illustrated path 300 changes direction at least once in a fore-aft direction or a direction along the centerline 306 (e.g., moves forwardly and then moves rearwardly). Preferably, the path 300 also changes direction at least once in a direction toward and away from the centerline 306. In particular, the illustrated path 300 changes direction twice in the direction toward and away from the centerline 306 (e.g., moves away from, then toward and then away from the centerline 306).
Such an arrangement increases the length of the path 300 or the effective length of the bridging portion 230, in a space-efficient manner, thereby lessening the bulkiness of the mask 200 and improving the comfort of the user. A greater effective length of the bridging portions 230 can provide the bridging portions 230 a greater range of movement or adjustment, such that the mask 200 can be applied to users with a wider range of face sizes. In addition or in the alternative, a greater effective length provides the bridging portions 230 with a flatter force-extension curve, which may inhibit or prevent the seal body 210 from exerting too much force on the user's face even when the bridging portions 230 are significantly stretched while in use. A flatter force-extension curve provides a more constant sealing force on a patient's face during cheek movement.
In some configurations, the effective length of the bridging portion 230 or length of the path 300 is significantly greater than one or both of a linear distance 310 between the first end 302 and the second end 304 of the bridging portion 230 and a lateral distance 312 between the first end 302 and the second end 304 of the bridging portion 230 (in a direction perpendicular to the centerline 306). In general, the larger the ratio between the effective length or length of the path 300 and the linear distance 310 or lateral distance 312, the larger the adjustment range, the flatter the force-extension curve and/or the greater the de-coupling of movement between the facial pads 250 and the seal body 210. In some embodiments, each of the bridging portions 230 may have a length or arclength (length of the path 300) of between about 150%-300%, inclusive, and including any and all values within this range (such as about 170%, 175%, 200%, 210%, 225%, 250% or 275%), of either of the linear distance 310 or the lateral distance 312. In some embodiments, ratio of the length of the path 300 to either of the linear distance 310 or the lateral distance 312 can be greater.
As shown in
In some embodiments, the bridging portions 230 may be made of a flexible material, such that the bridging portions 230 are flexible or deformable, as described above. In some embodiments, the bridging portions 230 may be made of the same material as the seal body 210 in an assembled or unitary construction. In some embodiments, the bridging portions 230 may be made of one or more elastomer materials, such as silicone, rubber, polyethylene, etc. In some embodiments, the bridging portions may be made of a single material. In some embodiments, the bridging portions 230 may be made of two or more materials, such that a region of the bridging portion 230 has a different flexibility relative to another region.
In some embodiments, each of the bridging portions 230 may be shaped such that its geometry contributes to the flexibility. In some embodiments, the bridging portions 230 may have a constant or substantially constant cross-sectional area throughout their length. In some embodiments, the bridging portions 230 may have a varying cross-sectional area along their length, such that, for example a region of the bridging portion 230 has greater cross-sectional area and, assuming the same material, is stiffer than another region.
In some embodiments, as illustrated in
Other configurations of bridging portions are also possible, many of which share some or all of the characteristics and/or provide similar functionality as described above. For example, the mask 1000 illustrated in
As described with regard to the mask 200, forces may be exerted to the facial pad 1050 and the bridging portions 1030, for instance, when the patient is lying on the side of his or her face or when the patient's face is squeezed. When such forces are exerted on the facial pads 1050, the bridging portions 1030 are inclined to fold inward at the hinges 1032, labeled in
In some embodiments, a strap may be used in place of the bridging portions. The strap may be integrally formed with the seal body, or may be a separate piece and can be attached to the seal body. In some embodiments, the strap may have regions of hook or loop material for securing the mask to the securement system described elsewhere herein. In some embodiments, the strap can be made of, or covered in, fabric or a fabric/foam laminate such as neoprene or breath-o-prene.
In some embodiments, the tube extensions 1340 may be integrally formed with the seal body 1310. In some embodiments, the tube extensions 1340 may be connected to the seal body 1310. The seal body 1310 may include openings at the front portion, such that the tube extensions 1340 can be connected at the openings. In some embodiments, each of the seal ends 1344 may have elliptical or circular shape. In some embodiments, the tube extensions 1340 may be removably attached to the seal body 1310, such that the tube extensions 1340 can be attached or removed as desired. When the tube extensions 1340 are removed, the seal body 1310 may have a tube-receiving portion such as the tube-receiving portion 214, such that the seal body 1310 can receive interface tubes. In some embodiments, the seal end 1344 can be connected to the seal body 1310 at the tube-receiving portion. In some embodiments, the seal end 1344 can be connected to the seal body 1310 by suitable connection mechanisms, such as friction-fitting, snap-fitting, screw-fitting or barbed connections. The connection between the seal end 1344 and the seal body 1310 preferably is sealed such that the gas passing to or from the seal body 1310 does not leak.
The tube end 1342 of each of the tube extensions 1344 can be connected to any suitable interface tubes. In some embodiments, the interface tubes are breathable, being permeable to water vapor while being impermeable to liquid or bulk flow of gases. Further examples of interface tubes which can be used with the patient interfaces described herein are described in U.S. patent application Ser. No. 15/514,221, published as U.S. 2017/0304578, the contents of which are incorporated herein by reference. In some embodiments, an adaptor or connecter may be placed between the tube end 1342 and the interface tube, such that various interface tubes can be connected to the tube extensions 1340. The tube extensions 1340 may be removably attached to the interface tubes by any suitable connection mechanisms, for example friction-fitting, snap-fitting, interference-fitting, screw-fitting or barbed connections.
In some embodiments, each of the tube extensions 1340 taper towards the seal end 1344 and have a smaller diameter at a region adjacent the seal end 1344 than a region adjacent the tube end 1342. In some embodiments, each of the tube extensions 1340 may taper away from the seal body 1310 and have a greater diameter at a region adjacent to the seal end 1344 than a region adjacent to the tube end 1342. The tapered shape of the tube extensions 1310 may allow connection of larger interface tubes than what could be or is desirable for accommodated directly on the seal body 1310. For example, interface tubes having a large diameter can be connected to a smaller mask via tube extensions 1340. In other arrangements, the tube extensions 1340 may have a constant or substantially constant diameter throughout their length. In some embodiments, the seal end 1344 and the tube end 1342 of the tube extensions 1340 can have the same or substantially the same size and shape.
The tube extensions 1340 may be flexible such that the tube extensions can be moved or positioned or bent (without occluding) towards locating features which may be provided in the form of grooves 1332. The flexibility of the tube extensions 1340 can facilitate comfort of the user and thereby facilitates more sleeping positions, and kangaroo care positions. At the same time, the tube extensions 1340 may have some structural integrity, such that the tube extensions 1340 do not collapse or kink in use. In some embodiments, the tube extensions 1340 may have ribs or supports internally and/or externally to prevent collapse while maintaining flexibility.
In some embodiments, to reduce the bulkiness of the patient interface, the tube extensions 1340 can be bent and placed at least partially along the bridging portions 1330. In some embodiments, each of the bridging portions 1330 includes a locating feature, which in some embodiments is a groove 1332 extending at least partially along its front surface. The groove 1332 is configured to receive a portion of the tube extensions 1340. In some embodiments, the bridging portions 1330 may further include cutouts 1334 at the groove 1332. The tube extensions 1340 may be long enough to fit into the grooves 1332 and the cutouts 1334. In some embodiments, the tube extensions 1340 are shorter, and interface tubes connected to the tube extensions 1340 are received in the groove 1332. In some embodiments, the tube extensions 1340 or the interface tubes may further extend over a front, non-face side of the facial pads 1352. In some embodiments, the front, non-face side 1352 of the facial pads 1350 include hook or loops which can receive hook or loops attached to the tube extensions 1340 or the interface tubes to retain them in a desired position. In some embodiments, the facial pads 1350 may include hook or loop material or adhesives on both sides (patient-facing and away-from-patient facing), such that the facial pads 1350 can be attached to the tube extensions 1340 or the interface tubes at one side, and the securement system described elsewhere herein on the other side.
In some embodiments, the tube extensions 1440 can each include openings for venting of exhaust gases from the mask 1400. For example, the openings can take the place of the recessed portions 1442. The openings 1442 can form a bias flow vent, as is known in the art. In some configurations, the openings 1442 can also facilitate bending of the tube extensions 1440 in a manner similar to the recessed portions 1442 described above. In addition or in the alternative, a suitable vent arrangement can be provided on another portion of the mask 1400, such as the seal body 1410.
In some embodiments, the interface tubes may be connected to bridging portions, instead of being directly connected to the seal body or via the tube extensions.
In some embodiments, each of the bridging portions 1530 includes or defines a substantially U-shaped portion as viewed from above. Preferably, the bridging portions 1530 are configured to provide similar functionality and one or more of the advantages of the other bridging portions described herein. For example, the bridging portions 1530 can generate a sealing force on the seal body 1510 in use. The bridging portions 1530 can provide at least some de-coupling of the facial pads 1550 from the seal body 1510. Each of the bridging portions 1530 can define a path length or an effective length that is greater than a (e.g., lateral or linear) distance between the seal body 1510 and the associated facial pad 1550. Such an arrangement can provide the bridging portion 1530 with a relatively flat force-extension curve, as described above.
In some embodiments, each of the bridging portions 1530 includes a tube receiving opening 1532 as illustrated in
In some embodiments, the bridging portions 1530 may have overall contoured shapes as described with respect to the bridging portions 230, but to accommodate the interface tube at the tube receiving opening 1532, the bridging portions 1530 may have greater height along their lengths than the bridging portions 230. In some embodiments, the bridging portions 1530 have a height substantially similar to the diameter of the tube receiving openings 1532. In some embodiments, the bridging portions 1530 have a height greater than the diameter of the tube receiving opening 1532. The bridging portions 1530 may have a substantially similar or smaller height than the seal body 1510. At the same time, the bridging portions 1530 may have similar thickness with the bridging portions 230, such that the bridging portions 1530 have laterally rolling movement of the bridging portions described elsewhere herein. Accordingly, the bridging portions 1530 may have a flatter cross-section than the bridging portions 230.
The internal gas pathway 1534 may have small width/diameter, such that it does not interfere with the movement of the bridging portion 1530. For example, the internal gas pathway 1534 may have a diameter of about 2 mm-1 cm or greater. As illustrated in
In some embodiments, a swivel connector, such as a swivel elbow, may be attached or overmoulded to the interface tubes to provide a connection (e.g., a curved connection) between the interface tube and a mask and to facilitate adjusting the position of the interface tube relative to the mask.
In some embodiments, the connection between any of the interface tube, the mask, the tube extension, and the swivel elbow described in the specification may be permanent (e.g. overmoulded, attached by adhesive). Such permanent connection may be beneficial as it may withstand a stronger force.
As shown in
The cutouts or grooves may have any suitable shape, and be placed at any suitable region along the bridging portions and/or the facial pads. In some embodiments, as illustrated in
In some embodiments, each of the bridging portions 2130 includes or defines a substantially U-shaped or C-shaped portion as viewed from above. Preferably, the bridging portions 2130 are configured to provide similar functionality and one or more of the advantages of the other bridging portions described herein. For example, the bridging portions 2130 can generate a sealing force on the seal body 2110 in use. The bridging portions 2130 can provide at least some de-coupling of the facial pads 2150 from the seal body 2110. Each of the bridging portions 2130 can define a path length or an effective length that is greater than a (e.g., lateral or linear) distance between the seal body 2110 and the associated facial pad 2150. Such an arrangement can provide the bridging portion 2130 with a relatively flat force-extension curve, as described above.
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/IB2020/051704 | 2/28/2020 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62812823 | Mar 2019 | US |
