Patent Application
20240342423
The present disclosure generally relates to a conduit connector assembly of a patient interface such as a face mask that covers at least one of a nose and a mouth of a user to supply respiratory gas under positive pressure. More particularly, the present disclosure relates to such conduit connector assemblies that have an anti-asphyxia valve (an AA valve) arranged to enable the user to continue to breathe, if the respiratory gas supply is switched off or stops for any reason. In some examples the conduit connector assembly is an elbow assembly. The disclosure also relates to a connector for connecting a conduit to a patient interface, such as via an elbow assembly, preferably the elbow assemblies disclosed herein.
Face masks can be used to provide respiratory gases to a user under positive pressure. In configurations in which both a mouth and a nose of a user are covered, the full face mask typically will overlie a bridge of the nose. Generally, a single seal will circumscribe the nose and the mouth of the user.
Such full face masks commonly are secured to a head of the user with headgear. In order to sufficiently reduce leakage, the headgear typically is tightened, which results in an elevated pressure being exerted on a bridge of a user's nose. In other words, as the headgear is tightened, the seal typically applies a progressively increasing load on the bridge of the nose. Such masks are typically provided with a conduit connector assembly typically comprising a tubular conduit, one end of the conduit being in fluid communication with the mask, the other end of the conduit being connected to a breathing gas delivery tube. Such a conduit connector assembly can comprise an elbow assembly comprising a tubular conduit which includes a bend. In some examples, the bend may extend through 90 degrees. It can be a problem that AA valves in such conduit connector assemblies do not open or close fully or reliably.
It is an object of the present disclosure to provide one or more constructions and/or methods that will at least go some way towards improving on the above or that will at least provide the public or the medical profession with a useful choice.
According to an aspect of the disclosure there is provided a conduit connector assembly for a respiratory therapy apparatus and configured to connect a patient interface to a gas delivery conduit, the elbow assembly comprising:
According to another aspect of the disclosure there is provided a conduit connector assembly for a respiratory therapy apparatus and configured to connect a patient interface to a gas delivery conduit, the conduit connector assembly comprising:
The valve body and/or conduit may be configured such that the supplementary gas flow path is permanently open.
The supplementary valve port may be formed on the valve body.
The supplementary valve port may comprise an array of valve ports formed on the valve body.
The supplementary valve port may be formed on a supplementary gas flow duct in communication with the valve body.
The supplementary valve port may be formed at one end of the supplementary gas flow duct distal from the valve body.
The supplementary gas flow duct may project from the valve body into the conduit. The supplementary gas flow duct may project from the valve body to a position adjacent the first port of the conduit. The supplementary gas flow duct may project from the valve body to a position projecting beyond the first port of the conduit, outside of the conduit.
The supplementary gas flow duct may comprise a relatively narrow diameter portion which extends from the valve body and along the conduit.
The supplementary valve port may be defined in a relatively wide mouth portion of the supplementary gas flow duct, the mouth portion being distal from the valve body.
The valve body may be elongate and comprises first and second end faces, the end faces comprising the first and second valve port respectively. The first end face may be planar, with the plane of the first end face being inclined relative to a longitudinal axis of the valve body. The second end face is planar, with the plane of the first end face being perpendicular to a longitudinal axis of the valve body.
The valve body may comprise a conduit insert mounted or at least located inside the conduit.
The supplementary valve port may comprise a single or a plurality of opening(s).
The valve flap may comprise an elongate bead which projects from the flap and is configured to contact an inner wall of the conduit when the flap is in the first position so as to space the flap from the inner wall of the conduit, the bead comprising at least one tapered portion configured such that part of the bead projects further from the flap than another part of the bead, when the flap is viewed from the side. The bead may extend around at least part of the periphery of the valve flap. The bead may extend around the entire periphery of the valve flap.
The flap may comprise a hinge which pivotally mounts the flap on the elbow, the bead extending around the periphery of the flap to the hinge.
The conduit connector assembly may comprise a diffuser configured to diffuse gas flow through the valve body and/or through the or each supplementary or expiratory flow port.
The diffuser may comprise a plurality of flow apertures.
The conduit connector assembly may further comprise a sleeve coupled with the conduit, the sleeve being configured to fluidly couple with the gas delivery conduit.
The valve body may comprise a sub-assembly removably mounted in the conduit.
The supplementary gas flow duct may be elongate and substantially tubular along its length.
The supplementary gas flow duct may extend along more than half the length of the conduit.
The supplementary gas flow duct may comprise a plurality of sub-passages extending along its length. The one or more sub-passage may be inclined relative to another. The one or more sub-passage may have a transverse cross sectional profile that is different to that of another sub-passage. The conduit connector assembly may comprise inlet and outlet sub-passages interconnected by an intermediate sub-passage. The inlet and outlet sub-passages may flare radially outwardly, and the intermediate sub passage may be narrower and substantially tubular.
The supplementary gas flow duct may comprise a relatively short duct positioned inside the conduit and projecting into the conduit. The duct may project across less than half the diameter of the conduit. The end of the duct may project into the conduit is closed by a duct end wall, the duct end wall being provided with at least one orifice configured to allow expiratory gas to flow from the conduit through the orifice and into the duct. The conduit connector assembly may comprise a plurality of orifices.
According to another aspect of this disclosure, there is provided a conduit connector assembly for a respiratory therapy apparatus and configured to connect a patient interface to a gas delivery conduit, the assembly comprising:
The supplementary valve port may be provided by a flow slot provided on or comprising part of the valve flap.
The slot may extend from a position radially inward of a perimeter of the valve flap to a position at the perimeter of the valve flap, such that the supplementary flow path extends through the perimeter of the valve flap.
A plurality of supplementary valve ports may be provided. The plurality of supplementary valve ports may be equispaced.
The plurality of supplementary valve ports are arranged in a symmetrical formation about a centre axis of the valve flap, when the flap is viewed from above.
The valve flap may comprise a substantially planar face, wherein the or each slot is defined between two upstanding portions of the valve flap that project away from the planar face. The planar face may comprise at least one recessed portion or region, each slot being in fluid communication with a recessed portion or region. A plurality of recessed portions or regions may be provided.
The valve flap may comprise a hinge or pivot about which the valve flap rotates in use, the supplementary valve port(s) being provided at a position distal from the hinge or pivot.
The distal position may comprise an arcuate part of a perimeter of the valve flap.
The valve flap may comprise one or more reinforced portions.
The valve flap may comprise a sealing face, the supplementary valve port extending through the sealing face.
The sealing face may be provided about the perimeter of the valve flap.
The sealing face may be tapered, when the valve flap is viewed from the side.
The conduit connector assembly may further comprise a flow restricting formation, configured to prevent or restrict the flow of gas across or along at least part of the valve flap. The conduit may comprise an internal support structure or feature, the flow restricting formation being configured to prevent or restrict the flow of gas into or over the internal support structure or feature.
The conduit connector assembly may comprise an elbow conduit connector assembly, the conduit comprising an elbow conduit.
According to a further aspect of this disclosure there is provided a respiratory therapy system comprising the conduit connector assembly of any one or more of the preceding statements.
The respiratory therapy system may further comprise any one or more of:
The respiratory therapy system may be configured to provide non-invasive ventilation, and be a single limb system comprising, or may be configured to be connected to, a single gas delivery conduit.
According to a further aspect of this disclosure there is provided a connector assembly for a respiratory therapy apparatus and configured to connect a patient interface to a gas delivery conduit, the connector assembly comprising:
The predetermined gas flow path may comprise any one of:
The gas flow directing structure may comprise a supplementary gas flow duct configured to be located in and extend at least partially into the flow channel, the flow duct having a first port open to the flow channel, and a second port, distal from the first port and configured to be in fluid communication with the expiratory flow port.
The supplementary gas flow duct may comprise a hollow body configured to be mounted in the connector in communication with the expiratory flow port, the hollow body projecting into the flow channel of the connector.
The hollow body may comprise a mouth opening configured to deliver inspiratory gas to the patient or to receive expiratory gas from the patient.
The mouth opening may comprise an array of openings.
The hollow body may be elongate and extends along at least part of the flow channel.
The mouth opening may be positioned adjacent the first flow port of the connector.
The hollow body may comprise a cap having a mouth opening which is positioned in the flow channel of the connector, remoted from the first flow port of the connector. The cap may be wedge shaped when viewed from the side, so as to have an inclined face, the mouth opening being provided in the inclined face.
The hollow body may comprise a hollow valve body configured to be mounted on or in the connector and having first and second valve ports, the first valve port being in communication with the interior of the connector, the second valve port being in communication with the first valve port and the expiratory flow port,
The gas flow directing structure may comprise a valve assembly comprising a valve flap; wherein
Each gas flow directing structure may be configured to be removably mounted in the second end of the connector assembly.
The connector assembly and/or the gas flow directing structure may be provided with at least one:
The connector assembly may further comprise a diffuser configured to diffuse the gas flow through the connector. The diffuser may be configured to diffuse gas flow through the expiratory flow port.
The connector may comprise an interior dividing wall, the flow channel being defined on one side of the dividing wall, the dividing wall comprising a valve opening, the valve opening being in fluid communication with a chamber on the other side of the dividing wall from the flow channel, the chamber being in communication with the expiratory flow porn; wherein each gas flow directing structure is configured to be mounted on the dividing wall such that the gas flow directing structure is in communication with the valve opening.
The connector assembly may further comprise a swivel connector at one or both of the first and second ends and configured to provide a rotatable connection with the patient interface or gas delivery conduit respectively.
The connector assembly may be an elbow connector assembly and the elongate connector comprises an elbow connector.
According to another aspect of this disclosure there is provided a connector assembly kit comprising:
According to another aspect of this disclosure there is provided a conduit connector assembly for a respiratory therapy apparatus and configured to connect a patient interface to a gas delivery conduit, the assembly comprising:
The supplementary valve port may be provided on, or comprise part of:
According to an aspect of the disclosure there is provided an elbow assembly configured to connect a mask assembly to an air and/or other gases conduit, the elbow assembly comprising:
In some embodiments, the bead extends around the periphery of the valve flap.
The flap may comprise a hinge which pivotally mounts the flap on the elbow, the bead extending around the periphery of the flap to the hinge.
The bead may comprise an arcuate bead portion distal from the hinge, the bead portion being arcuate when the flap is viewed in plan. The bead may additionally or alternatively comprise at least one linear bead portion adjacent the hinge, the bead portion being straight when the flap is viewed in plan. The linear bead portion may comprise a sealing surface which is wider than the width of the remainder of the bead. The width of the at least one linear bead portion may be substantially identical to a height of a surface of another part of the elbow assembly against which the at least one linear bead portion seals, when the flap is in the first position. A transitional wall may be defined between the at least one linear bead portion and the remainder of the flap, the transitional wall extending from the margin of the linear head portion to the body of the flap, the transitional wall being configured to provide structural stiffness to the flap. The transitional wall may be inclined relative to the plane of the valve flap. In one example, the bead is substantially n shaped when the flap is viewed in plan. In another example, the bead may be substantially ‘D’ shaped when the flap is viewed in plan.
The bead may taper inwardly towards the valve flap from a position distal from the hinge to a position adjacent the hinge, that is, the head projects further from the flap at a position distal from the hinge. The bead may taper such that the bead blends into the valve flap, at a position adjacent the hinge.
The bead preferably comprises a top surface which contacts the inner wall of the elbow when the flap is in the first position, and opposed side walls extending between the valve flap and the top surface. At least one side wall may be curved. At least one side wall may be straight. The profile shape of one side wall may be different from the shape of another side wall. In one example, the profile of one side wall is such that the side wall curves from the top surface into a plane of the valve flap. In one example, at least one side wall is substantially straight in profile so that that side wall extends in a straight line between the top surface and the valve flap. The straight side wall may be inclined relative to the plane of the valve flap.
The bead may be formed integrally with the valve flap. A plurality of beads may be provided.
The flap may comprise a flap support, the flap support being mounted on at least one of the elbow and the sleeve. An orientation feature may be provided and arranged to facilitate mounting the support and the valve flap in the desired orientation relative to the elbow and sleeve. The orientation feature may comprise a slot on one of the support and the elbow or sleeve and a protrusion on the other of the support and the elbow or sleeve, the protrusion being received in the slot when the support and the valve flap are mounted in the desired orientation.
The flow channel may comprise two flow channels.
The sleeve may further comprise a bump extending around an outer surface of the sleeve and a recess adjacent to the bump. The bump and the recess may be adapted to receive a swiveling component incorporating a ridge to engage with the bump.
The flap may be configured such that the flap is biased away from the elbow towards the sleeve, at least when the flap is in the second position. The flap may be configured such that the flap is biased away from the first position, at least when the flap is in the second position. The flap may be biased away from the second position in a direction also away from the first position. The flap may comprise a recess on an opposite face of the flap to the head.
The recess may be oblong. The recess may be adjacent a hinge of the flap.
According to another aspect of the disclosure there is provided an anti-asphyxiation valve for mounting in an elbow assembly configured to connect a mask assembly to an air and/or other gases conduit, the elbow assembly comprising:
According to another aspect, there is provided a connector for connecting an air and/or other gases conduit, directly or indirectly, to a patient interface, the connector comprising:
Preferably, the second end of the connector is dimensioned relative to the elbow connector so as to provide said prevention. More particularly, according to a preferred embodiment, an engaging portion of the elbow connector is configured to be received inside the connector and the inner dimension of the second end is greater than the external dimension of the engaging portion of the elbow connector.
Preferably, the connector is configured to releasably and sealably be secured to the elbow connector via a click or snap fit. To this end, a projection or recess may be provided on a surface (preferably an interior surface) of the connector and the engaging portion of the elbow connector may include a corresponding recess or projection. Thus the disclosure may further provide an elbow connector configured to engage the novel and inventive connector.
According to some embodiments, the connector comprises a projection on an outer surface thereof that is configured to act as a mechanical stop to limit the extent to which a respiratory tube may be pushed onto the connector. The external projection is preferably also configured to provide a grip for a user's fingers for facilitating removal of the connector from the elbow connector. It should be noted that this external projection may be used with or without the connector being configured to prevent engagement of the second end thereof with the engaging portion of the elbow connector (e.g. elbow 29 or 29a).
It will be appreciated that while air may be provided as respiratory assistance, this may be supplemented or replaced with other gases. Additionally or alternatively, medications may be provided to patients, such as via a nebulizer that is coupled to the patient interface or more typically, part of the breathing circuit feeding gases to the patient. As such references to “air” and even “gases” are not to be interpreted narrowly.
These and other features, aspects and advantages of embodiments of the present disclosure will be described with reference to the following drawings.
With reference initially to
The interface 100 can comprise any suitable mask configuration. For example, certain features, aspects and advantages of the present disclosure can find utility with nasal masks, full face masks, oronasal masks or any other positive pressure mask. The illustrated mask is a full face mask. The illustrated interface 100 generally comprises a mask assembly 102, a connection port assembly 104 and a headgear assembly 106.
With reference to
With reference to
The illustrated mask seal also comprises a generally central passage 144 that is defined by a wall 146. In the illustrated configuration, the wall 146 generally encloses the passage 144. Preferably, the wall 146 is generally cylindrical in configuration and extends through the wall 126. Other configurations are possible.
With reference to
The upper portion 154 is connected with a lower portion 156 of the seal member 110. The lower portion 156 extends laterally outward from the mask seal clip 112. In addition, the lower portion 156 wraps rearward and inward, as shown in
The upper portion 154 of the mask seal 110 is designed to roll over onto an outer surface 170 of the mask assembly 102. In the illustrated configuration, the outer surface of the mask seal 110 smoothly rolls into abutment with the outer surface of the mask seal clip 112 such that the outer surface of the mask seal clip 112 forms a support surface. In some configurations, the outer surface 170 onto which the upper portion 154 rolls comprises at least a portion of the outer surface of the mask seal clip 112. In some configurations, the outer surface 170 onto which the upper portion 154 rolls comprises almost exclusively the outer surface of the mask seal clip 112. In some configurations, the upper portion 154 rolls onto another portion of the mask seal 110. In some configurations, the upper portion 154 rolls onto the mask seal base 114.
With reference now to
Central passage 144 may be configured to connect to a conduit connector assembly. For example, central passage 144 may be radiused to receive a ball end 220 of a conduit comprising a swiveling elbow 222, such as that shown in
With reference to
The straps 260 can be connected to the back strap 280 in any suitable manner. In the illustrated configuration, the straps 260 connect to the upper arm 284 and the lower arm 286 respectively. Preferably, the upper arm 284 and the lower arm 286 are more rigid than the straps 260 such that the arms 284, 286 generally maintain shape as the headgear assembly 106 is being donned. In some configurations, each of the upper arm 284 and the lower arm 286 supports its own weight. In some configurations, each of the upper arm 284 and the lower arm 286 is structured to be tangle-free during donning. For example, the arms 284, 286 have sufficient torsion stiffness to reduce the likelihood of twisting when being put on.
Preferably, the straps 260 connect to at least one of the upper arm 284 and the lower arm 286 at a location forward of the ear. Such a configuration helps the user to locate the straps 260 without much difficulty. In addition, because the straps 260 in the illustrated configuration are embedded into the clips 252, the ends of the upper arms 284 and the lower arms 286 can comprise slots 290, 292 such that the straps 260 can be threaded through the slots 290, 292. In addition, the straps 260 can comprise an adjustment mechanism 294, such as a Velcro or buckle configuration. The adjustment mechanism 294 allows a force between the mask seal 110 and the face of the user U to be adjusted. Any suitable adjustment mechanism 294 can be used.
As shown in
Advantageously, as shown in
With reference again to
A sleeve 310 comprises a flange 312 that is received within the recess 308. The sleeve 310 can be secured into position within the elbow 222 using any suitable technique. The sleeve 310 comprises a generally cylindrical outer wall 314. The flange 312 comprises a section that extends outward to connect to a lever 316. Preferably, the flange 312 and the lever 316 are integrally formed. With reference to
A swivel 330 comprises a generally cylindrical inner wall 332. The inner wall 332 slides over the outer wall 314 of the sleeve 310 such that a sliding fit results between the swivel 330 and the sleeve 310. An upper portion 334 comprises a shoulder 336. The catch 320 of the lever 316 can secure the swivel 330 in axial position on the sleeve 310 by engaging with the shoulder 336. When the upper portion 322 of the lever 316 is depressed, the catch 320 moves away from the shoulder 336, which allows the swivel 330 to be removed from the sleeve 310.
A flap 350 can be mounted between the stem 304 and the sleeve 310. In the illustrated configuration, the flap 350 extends into a flow channel 352 from a base 354 that is sandwiched between the stem 304 and the sleeve 310. The flap 350 can pivot upward (as shown in
With reference to
In some configurations, the port 360 extends through a wall of the elbow 222 that comprises a generally planar inner wall 362. The generally planar inner wall 362 helps the flap 350 to generally seal the port 360 when the flap is moved upward away from the flange 312 of the sleeve 310.
In some configurations, the lever 316 overlies a majority of the port 360 such that the port 360 is generally obscured from view. As shown in
While not shown, the elbow 222 also can comprise one or more bias flow vent holes. The bias flow vent holes preferably are positioned in a forwardly directed orientation such that any bias flow does not directly impinge upon the user.
Another configuration of an elbow assembly 302 is illustrated in
With reference to
The swivel 330 preferably is generally cylindrical in configuration. As shown in
The elbow 222 comprises openings 420 at its sides that are in fluid communication with an air venting channel 422. The air venting channel 422 is formed by the spacing between the elbow's inner and outer walls 362, 424, as shown in
When the flap 350 drops to its closed position, as shown in
The configuration of
Referring additionally to
An anti-asphyxia valve (AA valve) 750 is provided and positioned over the sleeve 710 such that it at least partially obstructs the sleeve's flow channel 352. The elbow assembly 702 functions similar to the elbow assembly 302 of
The AA valve 750 comprises generally planar valve flap 752 which is hingedly mounted on a flap support 754. The flap support 754 may be integrally formed with the valve flap 752, and may comprise one or more orientation features which facilitate correct orientation and mounting of the valve 750 on the sleeve 710. In this example an orientation feature comprises a slot 756 formed in the underside of the flap support 754 which receives a corresponding protrusion 758 provided on an upper part of the sleeve 710. The engagement between the slot 756 and protrusion 758 helps retain the valve 750 on the sleeve 710 during assembly of the elbow assembly 702, and assists in correctly orientating the valve 750 relative to the sleeve 710 and elbow 722, and relative to the axis of the sleeve's flow channel 352. The slot 756 and protrusion 758 also prevent the valve 750 from being mounted on the sleeve 710 upside down, that is, with the flap 752 and flap support 754 rotated 180 degrees from the orientation illustrated in
The AA valve 750 comprises a hinge 760, pivotally mounting the flap 752 on the support 754. The hinge 760 may be integrally formed with both the flap 752 and the support 754. The hinge 760 comprises a relatively thin strip of material which is of greater flexibility than the flap 752 and the support 754, enabling the thicker flap 752 to pivot about the support 754 from a generally horizontal position in which the flap 752 closes the flow channel 352 through the sleeve 710, to a generally vertical position in which the flap 752 opens the flow channel 352 in the sleeve 710 but closes the air venting channels 422 formed in the elbow 722.
The valve flap 752 comprises a bead or ridge or protrusion 762 which protrudes from a planar upper surface 764 of the flap 752. The bead 762 thus projects from the upper surface 764 of the flap 752. When the flap 752 is in the generally vertical position in which the flap 752 opens the flow channel 352 in the sleeve 710 but closes the air venting channels 422 formed in the elbow 722, the bead 762 contacts the part of the elbow 722 surrounding the venting channels 422, and forms a discrete sealing surface 764 which seals against the elbow 722 and closes the venting channels 422. The bead 762 thus forms a sealing surface 764 having a relatively small sealing area relative to the area of the valve flap 752 itself. That is, the area 764 of the bead 762 which seals against the elbow 722 when the flap 752 is in the generally vertical condition is relatively small, but still sufficient to seal the venting channels 422 closed.
When the elbow 722 has gone through multiple cleaning cycles, the plastic surfaces of the elbow 722 can become degraded, allowing water to more easily stick to those surfaces. Thus, the wetting angle of the water/plastic interface increases with the result that water droplets can sit on the contact surfaces of the elbow 722, rather than forming beads and rolling off the contact surfaces.
It can be a problem with prior art AA valves that the relatively large sealing surface of a planar valve flap can trap water between the contact surfaces of the elbow and the valve flap. The surface tension of the water can cause the water to act as an adhesive, sticking the valve flap against the elbow contact surfaces, such that the valve flap sticks in the generally vertical condition, closing the venting channels 422.
Providing bead 762 on the valve flap 752 creates a much smaller relative sealing surface in contact with the internal sealing surfaces of the elbow. This results in the amount of water between the flap and the elbow being lower, lowering the force that the water's surface tension can resist, and allowing the valve flap 752 to release from the elbow contact surfaces more easily. The provision of the head 762 thus reduces or prevents the valve flap 752 sticking in the position where the venting channels 422 are closed.
In this example the bead 762 comprises an arcuate, curvilinear portion 765 which follows the curved periphery of the valve flap 752 distal from the hinge 760, and linear portions 766 which extend along the straight sides of the valve flap 752, towards the hinge 760. The bead 762 in this example therefore extends substantially around the entire periphery of the valve flap, to the hinge 760 and is substantially ‘n’ shaped when viewed in plan.
In this example, the bead 762 is tapered when viewed from the side. Thus, part of the bead 762 distal from the hinge 760 protrudes further from the planar upper surface of the flap 752 than the parts of the bead 762 nearer the hinge 760. In this example, the apex of the arcuate bead portion 764 projects further from the flap 752 than the linear bead portions 766. The bead tapers uniformly from the arcuate portion 764 to the linear portions 766, such that the bead 762 blends into the upper planar flap surface adjacent the hinge 760. This tapering along the longitudinal axis of the valve flap 752 allows the bead 762 to fully seal against the sealing surfaces of the elbow 722 around the entire periphery of the flap 752, to close the venting channels 422. The flap 752, when in the upright condition which closes the venting channels 422, is thus slightly inclined from the vertical when sealing against the elbow 722.
In this example, the profile of the bead 762 when viewed from the side, is rounded or chamfered. Thus, the sealing surface 764 of the bead 762, that is, the part of the bead 762 which protrudes the most from the valve flap 752 may be flat. However, the side walls of the bead which support the bead sealing surface 764 may be profiled, and may be rounded or chamfered for example. The profiled side walls 768, 770 of the bead 762 may extend all of the distance to the valve flap 752, or may be profiled only adjacent the sealing surface 764. As can be seen from
Other profiles and shapes of bead are envisaged. For example, the bead may simply comprise a square, rectangular, oblong or triangular cross sectional profile. For example the cross section of the bead may vary along the length of the bead. Part or all of the bead 762 may comprise a semi-circular or arcuate cross sectional profile. The side walls of the bead 762 may not be rounded or chamfered, and may simply be straight sides extending between the bead sealing surface 764 and the valve flap 752. The straight sides may be inclined, or substantially perpendicular relative to the plane of the valve flap 752.
Referring to
In this example, an alternative head profile is provided. In this example, the side walls of the bead are substantially straight, and are not inclined with respect to the plane of the valve flap 852. Likewise, the sealing surface 864A in this example is straight when the bead 862 is viewed from the side, that is the sealing surface 864 is a planar surface with the plane inclining downwardly from the distal part of the flap 862 towards the hinge 760. Thus the bead 862 is tapered as with the bead 762, but the sealing surface 864A is straight with no curved or inclined regions when viewed from the side. This may enhance the seal provided between the sealing surface 864A and the elbow, and may reduce the likelihood of leak paths forming. The bead 862 in this example is also more rigid, which may help prevent the flap edges from lifting and leaking at lower pressures, due to the flap 852 bending.
The patient interface of
A problem with the arrangement in
To address these problems, a new connector 270 has been devised, as shown in
Connector 270 has first end 271 and second end 272. First end 271 is configured to couple to an elbow (such as elbow 29 shown in
At least the exterior surface of the wall forming the connector 270 preferably tapers along at least part of the length thereof such that at least a portion of the connector 270 nearer the first end 271 has a greater exterior dimension than an exterior dimension of a portion of the connector 27 nearer the second end 272. This tapering refers to the substantially cylindrical body forming the connector 270 and not the rib or projection 273 proximate the first end 271 of the connector 270. Tapering is commonly used for tube connectors and is configured to couple to a respiratory tube or a collar terminating such a tube as would be apparent to those skilled in the art. Additionally or alternatively, tapering may be provided in the inside of the respiratory tube (or collar terminating said tube), the inside of the tube (or collar) narrowing from its mouth. The tapering facilitates insertion of the second end 272 of the connector 270 into the respiratory tube, with a seal being formed on continued insertion thereof.
As best seen in
The interior of the connector 270 extending from a point towards the second end 272 is preferably dimensioned to prevent engagement of the inside surface of the second end 272 of the connector 270 with the outer surface of the elbow connector 29a in the event a user attempts to incorrectly assemble the components together. In a preferred embodiment, this is realized by the inner dimension (generally diameter) of the connector 270 being greater than the external dimension of the elbow connector 29a that engages with the connector 270, such that it is readily apparent that the two are incorrectly assembled in view of the loose fit therebetween. Alternatively, the second end 272 of the connector 270 could have an inner dimension that prevents insertion of the elbow connector 29a therein i.e. it is too narrow or includes projections that act as stops.
Rib or projection 273 serves two functions. Firstly, it provides a grip for a user's fingers that may be used to remove the connector 270 from engagement with the elbow connector 29a. Secondly, it serves as a mechanical stop, limiting how far a respiratory tube may be pushed onto the second end 272 of the connector 270.
While the illustrated embodiment has the rib or projection 273 arcing in a sinusoidal pattern about the outer circumference of the connector 270 proximate the first end 271, the rib or projection 273 may be otherwise formed. For example, it may only extend part way around the circumference or comprise a number of discrete elements, each of which extends part way around the circumference. Further, the projection or rib may be substantially linear and/or comprise linear portions, in addition to or as an alternative to arcuate portions.
Referring additionally to
An anti-asphyxia valve (AA valve) 950 is provided and positioned over the sleeve such that it at least partially obstructs the sleeve's flow channel. AA valve 950 has similar features to valve 750 of
The AA valve 950 comprises generally planar valve flap 952 which is hingedly mounted on a flap support 954 which may be integrally formed with the valve flap 952. In this example, in contrast to the valve flap 752 as shown in
During assembly, the sleeve moves the downwardly inclined valve flap 952 upwardly to the generally horizontal position when the sleeve is fully assembled on the elbow 922. When the valve flap 952 is at rest in the generally horizontal position, the flap 952 is trying to pivot downwardly against the sleeve, that is, the flap 952 is biased downwardly, away from the vertical orientation, helping the flap 952 remain in the horizontal orientation with the flow channel through the sleeve closed and the air venting channels in the elbow 922 open. This biased flap 952 helps to ensure that the user of the elbow can still breathe, through the air venting channels in the elbow 922, when breathing gas is not being delivered through the flow channel in the sleeve.
The degree of biasing created by the flap 952 being initially downwardly inclined can be configured by the thickness of the hinge 960 between the support 954 and the flap 952, and the size of the angle of the flap 952 relative to the notional horizontal plane (which is parallel with the planar undersurface of the support 954) when the flap 952 is in a rest condition, prior to assembly with the sleeve. If the hinge thickness is too great, the flap 952 will not flex sufficiently easily for the flap 952 to pivot about the hinge 960 in the above described manner. If the hinge thickness is too thin, the flap 952 can be unstable in that it flexes, deforms and vibrates too much to perform an effective seal when in the vertical and/or horizontal positions.
In this example, the valve 950 is provided with further features, which features may also be used with the other examples of the valve 350, 750 described herein. One such feature is that in this example, the sealing bead 964 extends around the top surface of the valve flap 952 to form a ‘D’ shaped seal, as per the bead 764 of valve flap 752. However, at a part of the bead 964 adjacent the support 954, the bead 964 comprises a linear bead portion 964a of increased surface area, which seals against the vertical front face 954a of the support 954, when the flap 952 is in a vertical orientation. The portion 964a comprises an oblong, planar sealing face which extends across the flap 952 from one side to the other, adjacent the hinge 960. The width and length of sealing face 964a closely corresponds to, or is preferably identical to, the height and width of front face 954a of support block 954 such that when the flap 952 is in the vertical position, sealing face 964a is substantially matched in size and shape with, and seals against, all of front face 954a. This generates an improved seal between the part of the flap 952 that contacts the support 954.
A margin of the oblong sealing face 964a comprises an inclined, transitional wall 964b where the face 964a meets the upper planar surface 972 of the valve flap 952. The upper planar surface 972 is defined as a recessed planar region bounded by the sealing bead 964. The thickness of the wall 964b can be configured to control the stiffness of the flap 952, that is, the wall 964b functions as a stiffening rib or reinforcement member. The wall 964b can help prevent the valve flap 952 from ballooning or otherwise flexing and distorting under pressure in use, where otherwise the flap 952, and particularly the upper planar surface 972, may be too thin to resist the pressures generated in use.
Likewise, and with particular reference to
The dimensions and thicknesses of the features of the valve flap 952 and the support 954 may be configured as individual parameters, and/or relative to one another, to ensure that the valve flap 952 has the desired properties to achieve the best seal in both the horizontal and vertical positions, and also reacts appropriately to changes in pressure to move effectively from the horizontal to the vertical positions and vice versa. Additional reference is made to
The valve 950 may have the following properties, each of which may be provided as an individual feature or in combination with a property of another feature or features:
In accordance with the disclosure, the following ratios of properties of features of the valve 950, may be varied as follows:
The elbow 222 comprises a first end 1001 which comprises the swivel connector 220 and a first flow port 1003 configured to be connected to the patient interface 100, and a second end 1005 comprising a second flow port 1007 configured to be connected to the gas delivery conduit via a flow channel 1009 extending through the elbow 222 between the first and second ends 1001, 1005.
As can be more clearly seen in
Referring additionally to
In use, the valve flap 350 is movable between a first position, wherein the flap 350 at least partially blocks the first valve port 1019 and allows inspiratory gas from the gas delivery conduit to pass to a user via the elbow 222, and
The third valve port 1023 forms a supplementary gas flow path between the elbow flow channel 1009 and the expiratory flow ports 420. This supplementary gas flow path remains permanently open regardless of the position of the valve flap 350, and allows air to be drawn into the flow channel 1009 of the elbow 222 through the ports 420 during inspiration, and air to be expelled from flow channel 1009 through ports 420 during expiration. Thus the valve body 1017 forms part of the expiratory flow path when the system is pressurized, that is, when a pressurized flow of inspiratory gas enters elbow 222 via the gas delivery conduit.
Referring additionally to
Gas flow directing structure 2015 further comprises a snorkel arrangement 2031 depending from, and in communication with the interior of, valve body 2017. The snorkel arrangement 2031 comprises a first relatively narrow diameter tubular portion 2033 which projects upwardly from valve body 2017 and into the flow channel 1009. Tubular portion 2033 merges into an outwardly flared mouth portion 2035 adjacent first end 1001 of the elbow 222. The mouth portion 2035 in this example projects beyond first end 1001 of the elbow 222 and comprises a third valve port 2023 between the first and second valve ports 2019 and 2021. The narrow diameter tubular portion 2033 is relatively narrow so as to be relatively streamlined so that inspiratory gas flow can pass around it relatively easily. In other examples the mouth portion 2035 may terminate flush with the first end of elbow 222, or at a position inside the flow channel 1009, spaced from the first end of elbow 222.
The gas flow directing structure 2015 functions in a similar manner to gas flow directing structure 1015 except that the tubular portion 2033 and mouth portion 2035 together form a supplementary gas flow duct 2037 contained within, but separate from the flow channel 1009 through elbow 222. The supplementary flow duct 2037 can carry inspiratory air from the external environment to the patient, or carry expiratory gases from the patient, regardless of the position of the valve flap 350.
The inclined front face 1018, 2018 of valve body 1017, 2017 may comprise a plate face provided with an array of vent holes which together form the first valve port 1019, 2019. Likewise the perpendicular opposed face 1020, 2020 of valve body 1017, 2017 may comprise a plate face provided with an array of vent holes which together form the second valve port 1021, 2021.
Referring additionally to
The elbow assembly incorporating elbow 222 having first and second ends 1001, 1003, and expiratory flow passages 420, may comprise part of a common elbow assembly that can be configured differently depending on the function(s) to which the elbow assembly is put. The provision of the internal dividing wall and valve opening is such that different gas flow directing structures can be removably mounted in or at second end of elbow 222. One such gas flow directing structure may comprise an anti-asphyxia valve assembly comprising an anti-asphyxia valve flap as described above with reference to any of
The elbow assembly comprising a common elbow housing may be supplied in, or with, a kit with a plurality of different flow directing structures, allowing the common elbow housing to be used for different types of respiratory therapy, depending on the type of flow directing structure with which the elbow is used. For example, a flow directing structure incorporating a supplementary flow duct may be useful in non-invasive ventilation (NIV) therapy where a permanent vent path is required somewhere along the breathing circuit. Such an arrangement may enable NIV therapy to be provided using a breathing circuit comprising only one limb, that is, using only one gas delivery conduit, rather than requiring two limbs, that is, an inspiratory conduit and an expiratory conduit as with prior art arrangements. Single limb NIV can therefore be provided without requiring any additional vents being provided elsewhere in the breathing circuit. Further, the use of a common elbow assembly may have cost saving advantages, both during manufacture and for the end user, and can allow a single elbow assembly, with a common look and feel, to be used for multiple different therapies. Such a common elbow assembly may also make it easier for therapy providers to configure the apparatus, by incorporating the desired gas directing structure, to provide one or other therapy as required.
The supplementary gas flow duct has been described above as comprising part of, or being used in conjunction with, an anti-asphyxiation valve assembly. However, it is also envisaged that such a duct could be provided without a valve assembly, as shown in
Referring to
In these embodiments, by modifying the valve flap 350, an intentional leak path can be created to allow exhaled air to flow from the internal cavity of the elbow 222, through or via the existing flap 350, and out through the expiratory flow ports 420 of the elbow 220 into the ambient environment—thus achieving bias vent flow. This can be achieved by only modifying the tooling for the silicone valve flap 350, without further components being required. For example, any one or more of the following aspects of the AA valve flap can be modified:
A benefit of these embodiments is that because the valve flap is relatively well concealed within the elbow assembly, it is less likely for the nurses/caregiver to accidentally block any venting from the elbow 222. Aesthetic acceptance and/or patient compliance may also be improved because it appears to the user that no changes have been made to existing patient interfaces with which they are already comfortable/compliant with.
Referring to
When a flow of pressurized gas is travelling through the elbow housing 222 and into the patient interface, the flap 350 is sealingly pressed against the elbow housing 222 with the recessed regions 3025 in fluid communication with the external ambient environment. In this position the skits 3017 in combination with the elbow housing 222 create a four walled leak path through which flow can travel from the internal cavity of the elbow 3009, through the slots 3017, into the recessed regions 3025 of the flap 350 and out into the ambient environment.
In this example ten 0.5 mm wide slots 3017 are provided each with a 0.3 mm radius fillet on the external surfaces of the slots 3017 to allow the exhaled air to pass over a smooth surface which minimises the noise generated. The slots 3017 form a U shaped flow path through the AA flap 350 such that the top edges of the U shaped slots 3017 are configured to seal against the elbow housing to form an enclosed flow path through the AA flap 350.
Having the slots 3017 run laterally through the thickness of the flap 350, that is, to provide a vent flow path substantially parallel with the upper valve surface 350A, as opposed to apertures extending vertically through the flap 350, still allows the flap 350 to form a seal against the elbow housing in the closed position and prevent the patient from breathing up and down the breathing circuit under single fault conditions (loss of pressure supplied to the patient). The closed position can be seen with reference to
The slots 3017 in this example give a desired leak rate of approx. 16 L/min at 4 cmH2O. The number, size, shape and/or dimensions of the slots 3017 could be adjusted to achieve any desired leak rate. Elbows with pre-determined leak rates could be manufactured and distributed as single items, coupled to the masks, or be available in packs comprising multiple elbows of varying leak rates, that is, a pack or kit of elbows could be provided with each elbow having a valve flap 350 configured to provide a supplementary gas flow path of a different leak rate.
In this example, each slot 3017 is tapered towards the centre of the valve flap 350 in order to slow the velocity of the exhaled gas. In doing so, the overall noise level of the exhaled gas may decrease. One, some or all of the slots 3017 may taper in either direction, or both, to enable various transformations of the flow of air, for example, slowing velocity, increasing velocity, reducing turbulence, increasing turbulence.
Splitting the recessed region in the flap 350 into two sub regions 3025 with the centre column 3023 separating the two, provides the valve flap 350 with some reinforcing structure to prevent it from deforming under load from the pressure within the elbow and‘falling through’ the aperture of the elbow the flap 350 can pivot between closed and open positions without the flap 350 collapsing.
The length of the slots 3017 can represent the overlap of silicone on the valve to the polycarbonate on the elbow. This overlap could be increased (through changing the design of the elbow or flap 350) such that the exhaled air would travel down a longer silicone tunnel before exiting into the aperture of the elbow. In doing so, the noise and draft of the gas could be further reduced.
With reference to
This embodiment further comprises two upright stands or lugs 3031 which are configured to further reduce the sound level. Without the stands 3031, the exhaled air can catch a rigid AA valve support structure 3033 in the elbow 222 and the resultant turbulence generated can cause excess noise. The two stands 3031 on the flap are configured to be located in use on either side of this support structure 3033 when the valve flap 350 is in the open position, preventing the exhaled gas from flowing over the support structure 3033. The stands 3031 thus function as flow deflectors or flow restrictors to minimize unwanted flow across a certain part or parts of the elbow body 222.
In this example, each recessed region 3025 is relatively small, and located adjacent, and radially outward of, a respective stand 3031.
Referring now to
Referring now to
Referring now to
Referring now to
Referring now to
In these embodiments, the valve body 1017 is not required, and consequently second valve port 1021 and third valve port 1023 are not required. The elbow 222 is therefore substantially unmodified, with the valve flap 350 being movable between a first position, wherein the flap 350 at least partially blocks the part of the elbow body 222 which is in fluid communication with the expiratory flow ports 420 and allows inspiratory gas from the gas delivery conduit to pass to a user via the elbow 222 while still allowing bias flow to be achieved through the intentional leak paths (shown by the arrows in
The slots 3017 in the valve flap 350 form a supplementary gas flow path between the elbow flow channel 1009 and the expiratory flow ports 420. This supplementary gas flow path remains permanently open regardless of the position of the valve flap 350, and air to be expelled from flow channel 1009 through ports 420 during expiration. Thus the valve flap 350 forms part of the expiratory flow path when the system is pressurized, that is, when a pressurized flow of inspiratory gas enters elbow 222 via the gas delivery conduit.
A rigid component comprising the leak paths (slots, apertures, etc) could be overmoulded with silicone to create the valve flap 350. This could lead to an increased tolerance in the leak path dimensions as well as the leak path(s) not being deformed since the path(s) are created in a more rigid component or substrate.
In another embodiment the slots 3017 could be provided on the elbow housing 222, with the valve flap 350 not being provided with slots 3017. The international supplementary flow path would, as with the other described examples, be provide by a flow path defined between the elbow housing 222 and the sealing face of the valve flap 350.
It will be appreciated that whilst, for convenience, the above disclosure refers to an elbow assembly with non-aligned inlet and outlet ports, any aspect of this disclosure applies equally to any other configuration of conduit connector assembly comprising inlet and outlet ports configured to fluidly couple a patient interface with a breathing gas delivery conduit.
Although the present disclosure has been described in terms of certain embodiments, other embodiments apparent to those of ordinary skill in the art also are within the scope of this disclosure. Thus, various changes and modifications may be made without departing from the spirit and scope of the disclosure. For instance, various components may be repositioned as desired. Moreover, not all of the features, aspects and advantages are necessarily required to practice the present disclosure. Accordingly, the scope of the present disclosure is intended to be defined only by the claims that follow.
| Number | Date | Country | |
|---|---|---|---|
| 62492750 | May 2017 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16605634 | Oct 2019 | US |
| Child | 18651348 | US |
