Patent Application
20250186730
This disclosure relates to a patient interface for delivering respiratory support to a patient.
Patients may lose respiratory function during anaesthesia, or sedation, or more generally during certain medical procedures. Prior to a medical procedure a patient may be pre-oxygenated by a medical professional to provide a reservoir of oxygen saturation, and this pre-oxygenation and CO2 flushing/washout may be carried out with high flow respiratory support via a nasal cannula or other patient interface.
In various clinical situations it can be desirable to monitor patient gases such as exhalation gases to monitor O2 content and to monitor whether a patient has become apnoeic. One example situation is where a patient is spontaneously breathing under general anaesthesia or under deep sedation where a patient may drift into and out of apnoea. Another example is where a patient is required to be intubated. In some cases, intubation is completed in 30 to 60 seconds, but in other cases, particularly if the patient's airway is difficult to traverse (for example, due to cancer, severe injury, obesity or spasm of the neck muscles), intubation will take significantly longer. While pre-oxygenation provides a buffer against declines in oxygen saturation, for long intubation procedures, it is necessary to interrupt the intubation process and increase the patient's oxygen saturation to adequate levels. The interruption of the intubation process may happen several times for difficult intubation processes, which is time consuming and puts the patient at serious health risk. After approximately three attempts at intubation the medical procedure, such as an intubation method will be abandoned.
In the event that manual ventilation of the apnoeic, non-intubated, patient is urgently required (such as due to unsuccessful intubation of the patient or a sedated patient that has drifted into apnoea) it is necessary to quickly remove the high flow patient interface and then apply a non-invasive ventilation mask, e.g. a face mask and bag, to the patient. A cannula may be difficult to remove quickly from the patient, for example connectors between headgear and a cannula may be difficult to release quickly or manipulate. Failure to remove the patient interface may result in the seal of the face mask overlying the patient interface or patient interface gases supply tube, disrupting the seal between the face mask and the patient's face. Gases may consequently leak from the face mask during ventilation, rendering ventilation ineffective or inefficient.
In procedures where multiple respiratory support systems are required, there may be a concern that the combination(s) of support systems could cause excessive pressure delivery (for example when a cannula is in place on a patient and an anaesthetist wishes to deliver support through a mask over the top of the cannula). Furthermore, switching between different support systems may be time consuming or difficult.
The above discussion of the background to the disclosure is intended to facilitate an understanding of the disclosure. However, it should be appreciated that the discussion is not an acknowledgement or admission that any aspect of the discussion was part of the common general knowledge as at the priority date of the application.
Before turning to a description of the present disclosure, it is useful to provide an explanation of some of the terms that will be used to define the spatial relationship of various parts thereof. Spatial references throughout this specification will generally be based upon a patient interface fitted to a patient's face and configured to deliver respiratory gases from a flow source and through a gases delivery conduit to the patient's nares or mouth. With this environment as the basis, some terms may be defined with reference to the patient such as ‘patient-facing’ and ‘non-patient-facing’. Terms such as ‘inwards’ and ‘outwards’ may be defined with reference to the patient's face. Some terms may be defined with reference to the gases delivery conduit such as ‘behind’ and ‘in front’.
In view of the issues noted in the foregoing, the Applicant has previously developed a patient interface having a collapsible conduit, as described in International Patent application PCT/IB2019/051137 (International Patent Publication WO2019159063). The patient interface provides a means for pre-oxygenating the patient and maintaining the apnoeic window of the patient such as during sedation or under use of general anaesthesia (whether or not intubation is required). The collapsible conduit includes a collapsible portion configured to collapse and temporarily interrupt the (high flow or low flow) respiratory gas flow when, for example, a mask is placed onto a patient's face and a portion of the mask, e.g. the mask cuff, is overlaid across (and pressed onto) the collapsible portion. This allows a clinician to easily apply a non-invasive ventilation mask to the patient over the patient interface when needed and which simultaneously interrupts the high flow patient interface gas flow during application of the ventilation mask.
During use of a patient interface such as the collapsible patent interface described in International Patent application PCT/IB2019/051137 (International Patent Publication WO2019159063), it is beneficial to monitor gases at the patient where the patient is receiving respiratory support. Gas monitoring provides useful feedback to clinicians and, for example, during the pre-oxygenation phase to determine whether the patient has reached a desired end expiratory O2 level to indicate that pre-oxygenation is complete. Patent gas monitoring may also include monitoring of CO2 and/or volatiles. Such gas monitoring may also be useful to determine the patient condition or a change in the patient condition when the patient has diminished respiratory function or a risk of diminished respiratory function, for example during a medical procedure when anaesthetic agents are used as described above. Such change in patient condition can include a spontaneously breathing patient becoming apnoeic or experiencing a blocked (non-patent) airway, such that an interruption of the high flow respiratory support is required as discussed above.
The Applicant has previously developed a gas sampling device, as described in International Patent application PCT/NZ2017/050134 (International Patent Publication WO2018070885). This device includes a moveable inlet which can be positioned near a patient's nose or mouth to sample patient gases. A conduit may connect the sampling device to a respiratory gases monitor (for example, a capnography device) which provides a monitor of the sampled gases. The sampling device has been designed to be attachable to a standard nasal cannula but is not configured to operate with a collapsible patient interface of the type disclosed in International patent application PCT/IB2019/051137 (International Patent Publication WO2019159063).
Accordingly, it is desirable to provide a new or alternative patient interface with a collapsible portion and which can also facilitate patient gas sampling.
According to an aspect of the disclosure, there is provided a patient interface comprising:
The patient interface according to the first aspect of the disclosure may advantageously facilitate sampling of patient gases whilst the collapsible gases delivery interface is concurrently operated. In particular, the sampling conduit is able to continue sampling whilst the apparatus gases of the gases delivery interface are reduced or stopped during movement of the collapsible portion to the collapsed configuration. The sampling conduit may be configured for delivering patient gases to a gas sensor or gas monitoring device. The sampling conduit may be configured for delivering patient gases to a sensor or monitoring device located within the patient gas flow. The sensor may be located within the sampling conduit. The sampling conduit could be configured to deliver patient gases to a respiratory gas monitor in fluid communication with the sampling conduit via the sampling outlet.
A patient interface according to the first aspect of the disclosure thereby facilitates continuous monitoring of the patient gases to provide feedback for clinicians both during respiratory support (for example high-flow respiratory support) provided via the gases delivery interface and also during interruption of the apparatus gas flow through the gases delivery interface (for example, during application of a patient face mask onto the patient's face).
It will be appreciated that references herein to “apparatus gas flow” refers to a gas flow from an apparatus such as a respiratory support system which could comprise a flow generator or a wall source, a compressed air source or any other suitable respiratory gas source. Apparatus gas flow may therefore include a respiratory gas flow. Apparatus gas flow could also include anaesthetic agents or oxygen delivered to the patient.
The sampling inlet is configured to receive a patient gas flow at the patient which may include expiratory gases from the patient and/or inhalation gases for the patient and/or apparatus gases from the apparatus gas flow and/or atmospheric gases or a combination of two or more thereof. The atmospheric gases which may be sampled via the sampling inlet could include entrained atmospheric gases contained within the patient's expiratory gases and/or atmospheric gases present in front of the patient's face or within the patient's airway that have not been exhaled from the patient. The patient gases sampled may include apparatus gases which have been delivered to the patient and which are yet to be inhaled. The patient gases could also include other gases such as anaesthetic agents being delivered to the patient.
It will be appreciated that atmospheric gases, expiratory gases, apparatus gases and anaesthetic gases may become mixed at the sampling inlet and therefore the patient gases received by the sampling inlet may typically comprise a mixture of two or more of these or other gases. Similarly, it will be appreciated that the patient gas flow received by the sampling inlet could in some instances comprise only one of these types of gases. The patient gas flow can vary with time (for example, between patient exhalations) and therefore the composition of the patient gas flow received by the sampling inlet can vary with time.
The patient gas flow received at the patient may be received from a patient's airway. The patient gas flow received at the patient may be received in front of a patient's mouth and/or nose. The patient gas flow received at the patient may be received internally of the patient. For example, the patient gas flow may be received from inside the patient's mouth and/or nose.
The sampling outlet may be configured for fluid communication with a respiratory gas monitor. For example, the sampling outlet may be connected via a tube or other conduit to a gas monitoring device capable of analysing the patient gases received through the sampling inlet. The gas sampling interface may therefore be configured for sidestream capnography. In this instance, the sampling outlet may therefore facilitate delivery of the patient gas flow away from the patient and towards the respiratory gas monitor.
In an embodiment, the gas sampling interface may include a gas sensor in or at the sampling conduit and/or in or at the sampling outlet. For example, the gas sampling interface may be configured for mainstream capnography. The gas sensor may be connected via a wired or wireless data communication to an appropriate receiver capable of displaying the sensor data to a clinician. In this instance, the sampling outlet may vent patient gas flow to ambient once downstream of the sensor and in this manner the sampling outlet is configured to deliver the patient gas flow away from the patient in order to enable flow through the conduit and past the sensor.
In another alternative embodiment, the gas sampling interface could include a passive sampling configuration and, for example, could be configured to sample the patient gases via colourimetry. In this instance, the sampling conduit could be configured to deliver patient gases to an assay of colorimetric reagents or to another form of colourimeter configured to indicate the presence or concentration of one or more particular gases in the patient gas flow. In some configurations, the gas sampling interface may include the colourimetry means in the sampling conduit or at the sampling outlet.
The collapsible portion of the gases delivery side member may be moved from a normally open configuration to a collapsed configuration. An open configuration will be understood as meaning a configuration in which the collapsible portion is capable of delivering apparatus gases to the patient at the desired flow rate. For example, the open configuration may involve a lumen of the gases delivery member being sufficiently open and/or unobstructed to allow for the required apparatus gas flow rate to be delivered to the patient. The collapsible portion is configured to be in a ‘normally’ open configuration which will be understood as meaning the collapsible portion will default to the open configuration or is in the open configuration ‘at rest’. For example, the collapsible portion can remain in (and will return to) the open configuration in the absence of an external force urging the collapsible portion away from the open configuration. In other embodiments, the collapsible portion may be self-collapsing or be in a ‘normally’ closed configuration. That is, it may be partially or fully collapsed (collapsed configuration) when there is no apparatus gas or a low flow of apparatus gas flowing through it, and expands (open configuration) when there is some level of apparatus gas flowing through it. However, a ‘normally’ open collapsible portion (in an open configuration in the absence of an external force urging the collapsible portion away from the open configuration) can be beneficial in that a substantial amount of flow and/or pressure is not needed to first open or maintain the collapsible portion in an open configuration for delivery of the apparatus gas to the patient.
The normally open configuration of the collapsible portion may be achieved via inherent material properties of the collapsible portion or via geometry or other structural configuration of the collapsible portion. For example, the collapsible portion may be formed of a flexibly resilient material which can be folded, flattened or otherwise temporarily manipulated by an external force but urges toward its original state, position or configuration upon cessation or release of the external force.
The ‘collapsed configuration’ of the collapsible portion will be understood as meaning a configuration in which the collapsible portion is physically manipulated or affected so as to reduce the path of apparatus gases through the collapsible portion. Upon movement to the collapsed configuration, the collapsible portion may undergo a change in cross-section. For example, a reduction in cross-section to as to produce a more restricted or convoluted flow path. The collapsed configuration may involve an internal passageway such a lumen becoming reduced in cross-section so as to occlude, obstruct or otherwise reduce flow.
Movement of the collapsible portion to the collapsed configuration may involve the collapsible portion being folded, bent, kinked, flattened, compressed or twisted into the collapsed configuration. The collapsed configuration may involve one or more side portions of the collapsible portion moving toward or against each other so as to occlude or obstruct the apparatus gas flow path. The collapsed configuration could reduce the flow of apparatus gases to substantially zero or, alternatively, could reduce the flow of apparatus gases as compared to the open configuration but with some residual flow still occurring in the collapsed configuration.
In an embodiment of the disclosure, the collapsible portion is resiliently deformable from the normally open configuration to the collapsed configuration. For example, two or more side portions of the collapsible portion may be configured for resilient deformation towards or against each other under influence of the collapsing force and to return to a normal position spaced from one another upon removal of the collapsing force. The movement towards or against each other may be relative movement towards one another. That is, one of the side portions may remain static relative to the patient interface (and to the patient) and the other of the side portions may move toward or against the static side portion. In an alternative embodiment of the disclosure, the collapsible portion comprises a side portion configured for resilient deformation towards or against another side portion of the collapsible portion.
The side portions may be located adjacent to or may be connected to one another. For example, side portions may be connected at a fold line and may be folded toward or against one another. Alternatively, the side portions may be opposite to one another. For example, opposite sides of the collapsible portion could be moved toward one another.
The resilient deformation of the collapsible portion may comprise bending or folding or one or more sides of the collapsible portion. The collapsible portion may comprise a wall of non-uniform thickness. For example, the collapsible portion may include a thin-walled portion which facilitates folding or bending of the collapsible portion at the thin-walled portion. The collapsible portion may include a single thin-walled portion. The thin-walled portion may comprise a relative thin section of the wall which forms a hinge portion or collapsing portion of the wall which induces folding to occur at the thin-walled portion upon application of the collapsing force to the collapsible portion. The relatively thin section of the thin-walled portion allows the section of wall to be particular adapted to fold or bend at the fold points so as to transition between the open and closed configurations. In this way, the collapsible portion preferentially bends or folds at the fold points to move between the open and closed configurations.
According to an embodiment of the disclosure, the collapsible portion comprises a pair of thin-walled portions configured to provide fold lines at which the collapsible portion folds or bends upon application of the collapsing force. The pair of thin-walled portions may be located on opposite sides of the collapsible portion or could be otherwise relatively located, for example adjacent to one another.
The collapsible portion comprises a portion of the gases delivery side member which may comprise a conduit. The collapsible portion may therefore itself comprise a conduit, tube or other structure configured to deliver gases. The collapsible portion could have a circular cross-section. The collapsible portion could have an elongate cross section such as an oval or ovoid cross-section or a stadium cross-section. According to an embodiment of the disclosure, the collapsible portion has an elongate cross-section which comprises a pair of longitudinal sides extending between a pair of ends and wherein the thin-walled portions are located at the ends. In a particular embodiment, each of the ends comprises a single thin-walled portion. Each of the ends may include more than one thin-walled portion.
The provision of a thin-walled portion at the ends of the elongate cross-section may advantageously promote folding or bending at the ends resulting in one or both of the longitudinal sides moving toward the other longitudinal side. The collapsible force may be applied to a first of one of the longitudinal sides and in the direction of the other longitudinal side which results in a flattening of the collapsible portion as the first of longitudinal sides is moved toward or against the second longitudinal side.
Various embodiments of possible collapsible portion configurations are discussed in Applicant's previous international patent publications WO2018/029638 and WO2019159063.
According to the first aspect of the disclosure, the gas sampling interface could be provided to the gases delivery side member or could be separate to the gases delivery side member. In an embodiment of the disclosure, the sampling conduit extends from a second side of the delivery outlet that is opposite to the first side. For example, the gases delivery conduit may be separate from the gases delivery side member and may extend from the opposite side of the delivery outlet and/or toward an opposite side of the patient's face as compared to the gases delivery side member.
The sampling conduit may have a dual function in that it may also be used as a structural component to support part of the patient interface. For example, the sampling conduit may be used with or as part of a head strap which connects with the patient's head to secure the patient interface in position relative to the patient's face. In an embodiment, the sampling conduit has an end configured for coupling to a headstrap and comprises an internal passageway providing the fluid communication between the sampling inlet and sampling outlet, the sampling conduit also comprising a patient-facing wall and a non-patient-facing wall.
Alternatively, the sampling conduit may not contribute to securing of the patient interface and the delivery outlet may be supported by a component other than the sampling conduit. For example, in an embodiment, the patient interface further comprises a non-delivery side member extending from a second side of the delivery outlet that is opposite to the first side and the non-delivery side member having a headstrap end that is configured for coupling to a headstrap, the non-delivery side member also comprising a patient-facing wall and a non-patient-facing wall.
The “non-delivery” side member will be understood as meaning a side member which is not configured for delivering the apparatus gases to the patient. That is, the non-delivery side member does not form part of the apparatus gases flow path which is provided by the gases delivery side member.
Whilst the non-delivery side member is unassociated with the apparatus gas flow, the non-delivery side member may be associated with the patient gas flow. For example, the sampling conduit may be associated with the non-delivery side member. In an embodiment, the sampling conduit is provided on the non-delivery side member.
The provision of the sampling conduit to the non-delivery side member can be provided by various configurations.
In an embodiment, the sampling conduit extends through a portion of the non-delivery side member.
In an embodiment, the sampling conduit extends through an internal passage of the non-delivery side member.
In an embodiment, the sampling conduit extending between a pair of spaced apart openings in one or more walls of the non-delivery side member.
In an embodiment, the spaced apart openings comprising an inlet port proximate to the delivery outlet and an outlet port proximate to the headstrap end.
In an embodiment, the inlet port and/or the outlet port is located in the patient-facing wall of the non-delivery side member.
In an embodiment, the inlet port and/or the outlet port is located in the non-patient-facing wall of the non-delivery side member.
In an embodiment, the sampling inlet is located at or adjacent the inlet port and the sampling outlet located at or adjacent the outlet port.
In an embodiment, the sampling conduit comprises a tube extending through both the inlet port and the outlet port and through the internal passage which extends between the inlet and outlet ports.
In an embodiment, the sampling conduit comprises the internal passage of the non-delivery member and wherein the inlet and/or outlet ports are configured for connection to respective sampling tubes configured to extend from the inlet and outlet ports to the sampling inlet and sampling outlet respectively.
In an embodiment, the inlet and/or outlet ports are configured for connection to sampling tubes via a luer lock or threaded connection or plug-fit or barb.
In an embodiment, the non-delivery member comprises a sampling inlet tube moulded to the sampling inlet and/or a sampling outlet tube moulded to the sampling outlet.
In an embodiment, the sampling conduit is integrally formed with the non-delivery side member.
In an embodiment, the sampling conduit being attachable with the non-delivery side member. In an embodiment, the non-delivery side member comprising a channel configured to receive the sampling conduit and permitting removable attachment between the sampling conduit and the non-delivery side member.
In an embodiment, the channel being located in the patient-facing wall of the non-delivery side member. In an embodiment, the channel being is located in the non-patient-facing wall of the non-delivery side member.
In an embodiment, the sampling inlet is proximate to the delivery outlet and the sampling outlet is proximate to the headstrap end of the non-delivery side member.
In an embodiment, the sampling inlet and sampling outlet are separated by a distance that is greater than a width of a section of a face mask seal that is configured for placement on the patient's face and to bear over a portion of the non-delivery side member.
In an embodiment, the non-delivery side member is configured to resist deformation upon bearing of the face mask seal over the non-delivery member.
In an embodiment, the non-delivery side member is configured to deform upon bearing of the face mask seal over the non-delivery side member and wherein the sampling conduit remains open during deformation of the non-delivery side member.
In an embodiment, the patient-facing wall has a more pronounced curve as compared to the non-patient-facing wall.
In an embodiment, the non-delivery side member has an elongate cross-section which is asymmetric in at least one axis.
In an embodiment, the cross-section is asymmetric in an axis substantially parallel with the patient-facing wall.
In an embodiment, the patient-facing wall has a different curvature configuration to the non-patient-facing wall.
In an embodiment, the non-delivery side member has an asymmetric lens cross section.
In an embodiment, the non-delivery side member cross-section comprises a pair of opposite and spaced apart edges and wherein the patient-facing wall and the non-patient-facing wall extend between the pair of edges.
In an embodiment, the patient-facing wall has a substantially convex formation extending between the pair of opposite edges.
In an embodiment, the non-patient-facing wall has a substantially planar formation extending between the pair of opposite edges.
For example, in an embodiment, the sampling conduit extends through a portion of the non-delivery side member. The sampling conduit may extend through an internal passage of the non-delivery side member. As noted above, the non-delivery side member may be unassociated with the apparatus gas flow and therefore the internal passage of the non-delivery side member may be unconfigured for delivering apparatus gases.
The sampling conduit may have any suitable diameter or profile. For example, any suitable diameter or profile internal or external to the non-delivery side member. The sampling conduit may have a uniform cross-section. The sampling conduit may have a varying cross-section. The varying cross-section could increase or decrease along the length of the sampling conduit.
In an embodiment, the sampling conduit may extend between a pair of spaced apart openings in one or more walls of the non-delivery side member. The spaced apart openings may comprise an inlet port proximate to the delivery outlet and an outlet port proximate to the headstrap end of the non-delivery side member. The inlet and outlet ports could be provided in a common wall, side or side portion of the non-delivery side member or could alternatively be on different walls, sides or side portions of the non-delivery side member. The inlet and/or the outlet port may be located in the patient-facing wall of the non-delivery side member. The inlet and/or the outlet port may be located in the non-patient-facing wall of the non-delivery side member.
The sampling inlet may be located sufficiently close to the patient's airway so as to receive the patient airflow which can include expiratory gases. The sampling outlet may be located to facilitate connection with a respiratory gas monitor.
In an embodiment, the sampling inlet is located at or adjacent the inlet port and the sampling outlet is located at or adjacent the outlet port. In an embodiment, the sampling inlet consists of the inlet port and/or the sampling outlet consists of the outlet port. In an alternative embodiment, the sampling conduit comprises a tube extending through both the inlet port and the outlet port and through the internal passage which extends between the inlet and outlet ports.
In an embodiment, the sampling conduit comprises the internal passage of the non-delivery member and wherein the inlet and/or outlet ports are configured for connection to respective sampling tubes configured to extend from the inlet and outlet ports to the sampling inlet and sampling outlet respectively.
In an embodiment, the sampling inlet could be located at (or consist of) the inlet port in which case there may only an outlet tube connecting the sampling outlet to the outlet port.
In an alternative embodiment, the sampling outlet could be located at (or consist of) the outlet port in which case there may only an inlet tube connecting the sampling outlet to the outlet port.
In an embodiment, the inlet and/or outlet ports are configured for connection to sampling tubes via a luer lock or threaded connection or plug-fit or a barb. The inlet port could utilise a different type of connection from the outlet port. This may advantageously improve usability by preventing components or tubes from being incorrectly connected to the wrong port.
In an embodiment, the non-delivery member comprises a sampling inlet tube moulded to the sampling inlet and/or a sampling outlet tube moulded to the sampling outlet. The sampling inlet tube may be integrally formed with the sampling inlet and or the inlet port. The sampling outlet tube may be integrally formed with the sampling outlet and/or the sampling outlet.
In an embodiment, the sampling conduit is integrally formed with the non-delivery side member. In an alternative embodiment, the sampling conduit is attachable with the non-delivery side member. The sampling conduit may be removably attached or connected with the non-delivery side member. The non-delivery side member may be configured for removable connection with the sampling conduit. For example, the non-delivery side member may comprise a channel configured to receive the sampling conduit and permitting removable attachment between the sampling conduit and the non-delivery side member. The channel may be located in an external surface of the non-delivery side member. The channel may have a formation which corresponds to the formation of the sampling conduit. For example, the channel may have a width or diameter approximately commensurate with a diameter of the sampling conduit so as to snugly receive and retain the sampling conduit in the channel. The channel may have a semi-circular cross-section. The sampling conduit may be frictionally retained with the channel. The channel may be configured in geometry to retain the sampling conduit in the channel. For example, the channel may have a width or diameter slightly less than a diameter of the sampling conduit such that the channel is resiliently expanded when the sampling conduit is fitted in the channel and retained therein by resilient ‘squeezing’ of the channel onto the sampling conduit. The sampling conduit may be formed of a more rigid material than the portion of the non-delivery member in which the channel is formed so as to avoid deformation of the sampling conduit when fitted into a channel of slightly smaller size than the sampling conduit.
In an embodiment, the channel is located in the patient-facing wall of the non-delivery side member. In an alternative embodiment, the channel is located the non-patient-facing wall of the non-delivery side member. The channel advantageously allows for convenient attachment and detachment of the sampling conduit and whereby the sampling conduit can be fitted to the non-delivery side member when required and removed when not required and/or to facilitate maintenance, cleaning or replacement of certain components.
In an embodiment, the sampling inlet is proximate to the delivery outlet and the sampling outlet is proximate to the headstrap end of the non-delivery side member. The spacing between the sampling inlet and sampling outlet may of course vary. In an embodiment, the sampling inlet and sampling outlet are separate by a distance that is greater than a width of a section of a face mask seal that is configured for placement on the patient's face and to bear over a portion of the non-delivery side member. This may advantageously allow for a patient face mask to be positioned over the delivery outlet and the sampling inlet and for the sampling outlet to be located outside of the patient face mask. The positioning of the face mask onto the non-delivery side member may therefore not interfere with the sampling outlet and its fluid connection with the respiratory gas monitor.
As noted, the sampling conduit of the first aspect of the disclosure is configured to remain open when the collapsible portion is moved to the collapsed configuration. The bearing of the face mask seal over the non-delivery member applies a force to the non-delivery side member which may be transmitted or directly applied to the sampling conduit. Accordingly, the sampling conduit may be configured to remain open under application or influence of the face mask force. The sampling conduit may therefore allow for continuous patient gas sampling.
In an embodiment, the non-delivery side member may itself be configured to resist deformation upon bearing of the face mask seal over the non-delivery side member. Alternatively, the non-delivery side member may be configured to deform upon bearing of the face mask seal over the non-delivery side member and wherein the sampling conduit remains open during deformation of the non-delivery side member. The deformation of the non-delivery side member may involve a flattening of the non-delivery side member. This may advantageously help to form a seal between the face mask and the patient's face and/or between the face mask and the non-delivery side member. For example, the non-delivery side member may be configured to move to a flattened configuration and the face mask can resiliently deform around the flattened configuration to form a seal with the patient's face. The patient interface may be configured to reduce or avoid leaks when a face mask is placed over the patient interface, which could lead to undesirable dilatation of the respiratory support and/or the patient gas flow which is being sampled.
The non-delivery side member may be hollow (e.g. tubular) or may be non-hollow. The non-delivery side member could comprise a conduit or tube. The non-delivery side member could have a circular cross-section or could have a non-circular cross section. The non-delivery side member could have an elongate cross section such as an oval or ovoid cross-section or a stadium cross-section. According to an embodiment of the disclosure, the non-delivery side member has an elongate cross-section which comprises a pair of longitudinal sides extending between a pair of ends. The ends may be rounded for example semi-circular. Alternatively, the ends may comprise edges (for example, angular edges) and at which the longitudinal sides meet one another.
The non-delivery side member may have a symmetrical cross-section. For example, a circular, oval or stadium cross-section which is symmetrical about a length axis and/or a width axis.
Alternatively, in an embodiment the non-delivery side member has an elongate cross-section which is asymmetric in at least one axis. In an embodiment, the elongate cross-section may comprise a length axis and a width axis and the cross-section is asymmetric about the length axis. The cross-section may include a pair of longitudinal sides extending between a pair of end edges and wherein the longitudinal sides are asymmetric. For example, one of the side portions may include a channel configured to receive the sampling conduit. One of the sides may have a different curve configuration from the other side. In an embodiment, the patient-facing wall has a different curvature configuration to the non-patient-facing wall. In an embodiment, the patient-facing wall of the non-delivery side member has a more pronounced curve as compared to the non-patient-facing wall. In an embodiment, the cross-section is asymmetric in an axis substantially parallel with the patient-facing wall.
The non-delivery side member cross-section may have an asymmetric lens shaped or an air foil shape. For example, the cross-section may comprise two longitudinal sides having different levels of curvature and which meet at opposite end edges. Each of the longitudinal sides may have a convex configuration (i.e. bulging outward). The two longitudinal curved sides may comprise the patient-facing side and the non-patient-facing side. In an embodiment, the non-patient-facing side has a low level of curvature and may be substantially flat and the patient-facing side has a higher level of curvature.
In an embodiment, the non-delivery side member cross-section comprises a pair of opposite and spaced apart edges and wherein the patient-facing wall and the non-patient-facing wall extend between the pair of edges. In an embodiment, the patient-facing wall has a substantially convex formation extending between the pair of opposite edges. In an embodiment, the non-patient-facing wall has a substantially flat or planar formation extending between the pair of opposite edges.
The non-delivery side member may be configured to be partially sunken or recessed into a patient's face so as to facilitate formation of an undisrupted seal between a patient mask and the patient's face. The non-delivery side member may be slightly recessed into the patient's skin such the non-patient-facing wall is approximately flush or aligned with the patient's skin. The non-patient-facing wall may thereby form a substantially continuous surface with the patient's skin and onto which the face mask may form a substantially undisrupted seal.
The above discussion contains various embodiments and examples of the gas sampling interface being provided to a non-delivery side member. However, as noted in earlier discussion, a patient interface according to the first aspect of the disclosure may also be configured with the gases sampling interface provided to the gases delivery side member. The gases sampling interface may therefore be located at, on, within or be otherwise physically associated with the gases sampling interface.
In an embodiment, the gas sampling interface is provided to the gases delivery side member the gases delivery side member comprising a delivery inlet at one end to receive the apparatus gas flow and the gases delivery side member comprising a patient-facing wall and a non-patient-facing wall. In an embodiment, the sampling inlet is proximate to the delivery outlet and the sampling outlet is proximate to the delivery inlet.
In an embodiment, the sampling conduit comprises a sampling lumen for the patient gas flow and the gases delivery side member comprising a gases delivery lumen for the apparatus gas flow. In an embodiment, the patient interface comprises a single sampling conduit. According to an embodiment, all of the patient gas flow that is communicated from the sampling inlet to the sampling outlet is communicated through the single sampling conduit. The physical association between the sampling lumen and the gases delivery lumen can be configured in a variety of ways.
In an embodiment, the sampling conduit is integrated with the gases delivery side member.
In an embodiment, the sampling conduit extends through the gases delivery lumen.
In an embodiment, a portion of the sampling conduit is free to move within the gases delivery lumen.
In an embodiment, the sampling conduit extends through the collapsible portion and the sampling conduit having a cross-section configured to minimise obstruction of apparatus gas flow and to minimise interference with moving of the collapsible portion to the collapsed configuration.
In an embodiment, the cross-section of the sampling conduit has a geometry configured to facilitate occlusion of the gases delivery lumen when the collapsible portion is in the collapsed configuration.
In an embodiment, the sampling conduit has a cross-section with a curved exterior surface configured for a wall the collapsible portion to bend or fold around the curved exterior surface.
In an embodiment, the sampling conduit has a cross-sectional area that is less than a cross-sectional area of the gases delivery lumen.
In an embodiment, the gases delivery side member extends through the sampling lumen.
In an embodiment, the sampling conduit comprises a sleeve that surrounds the gases delivery side member.
In an embodiment, the sampling inlet comprises a funnel portion at an end of the sleeve proximate to the delivery outlet, the funnel portion configured to receive patient gas flow from the nose and/or mouth.
In an embodiment, the funnel portion is configured to receive a portion of the apparatus gas flow.
In an embodiment, the gases delivery lumen and the sampling lumen are substantially concentric.
In an embodiment, the gases delivery lumen and the sampling lumen are substantially co-axial.
In an embodiment, the gases delivery lumen and the sampling lumen have parallel longitudinal axes.
In an embodiment, the gases delivery lumen and sampling lumen are integrally formed within the gases delivery side member and spaced apart from one another.
In an embodiment, the sampling lumen is formed within a wall of the gases delivery side member which surrounds the gases delivery lumen.
In an embodiment, the sampling conduit is integrated with the gases delivery side member. The sampling conduit may be integrally formed with the gases delivery side member. The sampling lumen and gases delivery lumen may therefore also be integrally formed. For example, the sampling lumen and gases delivery lumen may be simultaneously moulded during manufacture of the delivery side member.
In an embodiment, the sampling conduit comprises a sampling lumen with an elongate cross-sectional shape. The cross-section of the sampling lumen could be circular.
In an embodiment, the sampling conduit extends through the gases delivery lumen. The sampling lumen (inside of the sampling conduit) may therefore also be located within the gases delivery lumen. In an embodiment, a portion of the sampling conduit is free to move within the gases delivery lumen. For example, the sampling conduit may be fed through the gases delivery lumen so as to be loosely contained by the gases delivery lumen and capable of movement therein. Alternatively, the sampling conduit may extend through the gases delivery lumen but be fixed in a particular position therein. For example, by one or more ribs or webs which connect an outer surface of the sampling conduit to an peripheral surface of the gases delivery lumen. The sampling conduit may be fixed at certain portions relative to the gases delivery lumen but has other portions permitted to move within the gases delivery lumen.
In an embodiment, the sampling conduit extends through the collapsible portion and the sampling conduit has a cross-section configured to minimise obstruction of apparatus gas flow and to minimise interference with moving of the collapsible portion to the collapsed configuration. The sampling conduit may have a configuration which facilitates a reduction in apparatus gas flow through the collapsible portion when the collapsible portion is moved to the collapsed configuration. The cross-section of the sampling conduit can have a geometry configured to facilitate occlusion of the gases delivery lumen when the collapsible portion is in the collapsed configuration. For example, the sampling conduit can have a cross-section with a curved exterior surface configured for a wall portion of the collapsible portion to bend or fold around the curved exterior surface.
The sampling conduit may be configured so to facilitate formation of a seal around the sampling conduit which restricts the flow of apparatus gases through the collapsible portion. For example, a seal between an exterior surface of the sampling conduit and an interior surface of the collapsible portion. The sampling conduit may have a substantially curved cross-section such as a circular cross-section. The sampling conduit may have a cross-section without angular edges. The sampling conduit may therefore be configured to minimise or avoid interference with the collapsed configuration of the collapsible portion. That is, minimise or avoid interference with the reduction of stopping of apparatus gas flow when the collapsible portion is moved to the collapsed configuration.
The sampling conduit may be configured so as not to obstruct gas flow through the collapsible portion when the collapsible portion is in the open configuration. For example, an exterior surface of the sampling conduit may have a substantially smooth configuration (for example, a curved configuration) so as not to cause a choke point, blockage or other obstruction in the apparatus gas flow.
The sampling conduit may be configured in its size to minimise interference with the apparatus gas flow through the gases delivery lumen. The sampling conduit may have a cross-sectional area that is less than a cross-sectional area of the gases delivery lumen. In an embodiment, the sampling conduit has a width that is less than a width of the collapsible portion. A flow volume required of the gases delivery lumen may typically be higher than a flow volume required of the sampling lumen and therefore the gases delivery lumen may have a cross-sectional area that is larger than the cross-sectional area of the sampling lumen. For example, in some embodiments, a sampling flow rate of 40-500 mL/min of patient gases are provided through the sampling conduit. The sampling lumen may therefore be configured in its cross-section to facilitate a flow of approximately 40-500 mL/min. The gases delivery lumen may be configured for a significantly greater flow rate. In a particular embodiment, in the normally open configuration, the gases delivery interface is configured to allow an apparatus gas flow rate of about 20 L/min to 90 L/min through the apparatus gases flow path. In another particular embodiment, in the normally open configuration, the gases delivery interface is configured to allow an apparatus gas flow rate of between 5-70 L/min through the apparatus gases flow path.
In a particular embodiment, in the collapsed configuration, the patient interface is configured to allow an apparatus gas flow rate through the apparatus gases flow path that is at least 20 times greater than a patient gas flow rate through the gas sampling interface. For example, a flow rate through the gas sampling interface may be less than about 500 ml/min and a flow rate through the gases delivery interface when in the closed configuration may be less than about 10 L/min. In a particular embodiment, in the collapsed configuration, the gases delivery interface is configured to allow an apparatus gas flow rate of less than about 10 L/min through the apparatus gases flow path and the gas sampling interface is configured to allow a patient gas flow rate of less than about 500 mL/min, optionally about 40 mL/min to about 500 mL/min.
In an alternative embodiment, the gases delivery side member extends through the sampling lumen. For example, the gases delivery lumen may be provided in a gases delivery conduit which extends through the sampling conduit. In this instance, the sampling conduit may itself provide the gases delivery side member. Alternatively, the sampling conduit (with the gases delivery conduit extended therethrough) may be attached to or extend through the gases delivery side member.
In an embodiment, the sampling conduit comprises a sleeve that surrounds the gases delivery side member. In an embodiment, the sampling inlet is provided by a funnel portion at an end of the sleeve proximate to the delivery outlet, the funnel portion configured to receive patient gas flow from the nose and/or mouth. The funnel portion may include an opening which comprises the sampling inlet. The funnel portion could comprise a flared or enlarged portion of the sleeve. The funnel could have various configurations, for example a frustoconical or elongated-frustoconical or oval-frustoconical in configuration. In an embodiment, the funnel portion is configured to receive a portion of the apparatus gas flow.
In an embodiment, the gases delivery lumen and the sampling lumen are substantially concentric. For example, one of the gases delivery lumen and the sampling lumen extends through the other of the gases delivery lumen and the sampling lumen such that each shares a common central axis and (in cross-section) each shares a common central point. The gases delivery lumen and the sampling lumen may be substantially co-axial.
In an embodiment, the gases delivery lumen and the sampling lumen have parallel longitudinal axes. This configuration could be provided in a number of ways. In a first example, one of the gases delivery lumen and the sampling lumen may extend through the other of the gases delivery lumen or the sampling lumen. In a second example, the gases delivery lumen and the sampling lumen may extend alongside (and externally of) one another. In a third example, the gases delivery lumen and the sampling lumen are both formed internally within the gases delivery side member but also have parallel longitudinal axes.
In an embodiment, the gases delivery lumen and sampling lumen are integrally formed within the gases delivery side member and are spaced apart from one another. For example, spaced apart by an internal portion of the gases delivery side member. In an embodiment, the sampling lumen is formed within a wall of the gases delivery side member which surrounds the gases delivery lumen. In an embodiment, the gases delivery lumen is formed within a wall of the gases delivery side member which surrounds the sampling lumen. The wall-formed lumen (which could be either the sampling lumen or the gases delivery lumen) within the wall of the gases delivery side member could be localised to one side of wall-surrounded lumen. Alternatively, the wall-formed lumen could partially or completely surround the wall-surrounded lumen.
Some of the above embodiments relate to the sampling lumen and gases delivery lumen being each contained within an external surface of the gases delivery member. In an alternative embodiment, the sampling conduit extends alongside an external surface of the gases delivery side member. For example, the gases delivery lumen may be provided inside the gases delivery side member and the sampling conduit is located outside of the gases delivery side member. In an embodiment, the sampling conduit is connected with an external surface of the gases delivery side member.
In an embodiment, the sampling conduit integrally is connected with an external surface of the gases delivery side member.
In an embodiment, the sampling conduit is integrally connected with the external surface via a connection web and the sampling conduit is spaced apart from the gases delivery side member by a width of the connection web.
In an embodiment, the collapsible portion has an elongate cross-section which includes a pair of longitudinal sides extending between a pair of ends and wherein the connection web extends between the sampling conduit and one of the ends of the collapsible portion.
In an embodiment, the patient interface further comprises an accessory located at or proximate the collapsible portion and configured to facilitate the collapsible portion moving to the collapsed configuration.
In an embodiment, the accessory comprising a rigid member extending along the patient-facing wall of the gases delivery side member and is configured to provide a reaction force to a load applied to the collapsible portion.
In an embodiment, the accessory comprises a portion extending along the non-patient-facing wall of the gases delivery side member and configured to move towards the patient in response to a load applied to the accessory.
In an embodiment, the accessory comprises a conduit connector for connecting a portion of the sampling conduit to the accessory.
In an embodiment, the sampling conduit extends through the accessory.
In an embodiment, the accessory comprises pair of spaced apart openings comprising a patient gas inlet port configured for location proximate the delivery outlet and a patient gas outlet port configured for location proximate the delivery inlet, the sampling conduit extending internally through the accessory between the patient gas inlet and outlet.
In an embodiment the patient interface comprises a rigid gas path connector connectable with the delivery inlet and the patient interface further comprising a conduit connector for removably connecting a portion of the sampling conduit to the gas path connector.
In an embodiment, the conduit connector comprises a first attachment configuration comprising a pair of resilient arms configured for removable attachment to the gas path connector and a second attachment configuration configured for removable attachment to the sampling conduit.
In an embodiment, the second attachment configuration comprises a pair of hooks defining a pair of recesses corresponding to an external diameter of the sampling conduit and configured to receive and retain the sampling conduit.
In an embodiment, the sampling conduit is connected to both the conduit connector of the accessory and the conduit connector in connection with gas path connector.
In an embodiment, the gases delivery side member comprising a channel configured to receive the sampling conduit and permitting removable attachment between the sampling conduit and the gases delivery side member.
In an embodiment, the channel is located in the patient-facing wall of the gases delivery side member.
In an embodiment, the channel is located in the non-patient-facing wall of the gases delivery side member.
In an embodiment, the sampling conduit comprising a sampling lumen and the sampling conduit configured to retain the shape of the sampling lumen in response to the collapsing force applied to the collapsible portion.
The sampling conduit may be integrally connected with the external surface of the gases delivery side member. For example, the sampling conduit may be integrally connected with the external surface via a connection web and the sampling conduit is spaced apart from the gases delivery side member by a width of the connection web.
In an embodiment, the collapsible portion has an elongate cross-section which comprises a pair of longitudinal sides extending between a pair of ends and wherein the connection web extends between the sampling conduit and one of the ends of the collapsible portion.
The above-noted spacing between the sampling conduit and the gases delivery side member may advantageously facilitate movement of the collapsible portion to the collapsed configuration whilst not affecting the sampling conduit. For example, the sampling conduit may be spaced from the gases delivery side member so that flattening or compression of the collapsible portion during application of a patient face mask does not impact, deform, collapse or otherwise interfere with the patient gas flow through the sampling conduit.
In some embodiments, the patient interface further comprises an accessory located at or proximate the collapsible portion and configured to facilitate the collapsible portion moving to the collapsed configuration. Various examples of a suitable accessory are described in Applicant's U.S. Provisional application 63/362,486filed 4 Apr. 2022. It will be appreciated that an accessory described in U.S. provisional application 63/362,486 may be used with a patient interface according to the present disclosure. For example, an accessory disclosed in U.S. 63/362,486 may be used in conjunction with a gas sampling interface including a gas sampling conduit. A sampling conduit could be integrated with an accessory according to 63/362,486. In an embodiment, the accessory comprises a rigid member extending along the patient-facing wall of the gases delivery side member and configured to provide a reaction force to a load applied to the collapsible portion. In an embodiment, the accessory comprises a portion extending along the non-patient-facing wall of the gases delivery side member and configured to move towards the patient in response to a load applied to the accessory. The accessory may operate to enhance, focus, amplify or supplement a collapsing force applied to the collapsible portion.
The sampling conduit may be located external of the accessory but may be associated with the accessory. For example, in an embodiment the accessory comprises a conduit connector for connecting a portion of the sampling conduit to the accessory. Alternatively, in an embodiment the sampling conduit extends through the accessory. The sampling conduit may comprise a tube extending through a passageway integrally formed in the accessory. Alternatively, the sampling conduit may be provided by a passageway integrally formed in the accessory.
In an embodiment, the accessory includes pair of spaced apart openings comprising a patient gas inlet port configured for location proximate the delivery outlet and a patient gas outlet port configured for location proximate the delivery inlet, the sampling conduit extending internally through the accessory between the patient gas inlet and outlet.
In an embodiment, the patient interface further includes a rigid gas path connector connectable with the delivery inlet and the patient interface further comprising a conduit connector for removably connecting a portion of the sampling conduit to the gas path connector. The gas path connector may be configured for connecting the gases delivery side member to a flow supply conduit, for example a conduit connected to the apparatus supplying the apparatus gas flow. The gas path connector may include a connection configuration for connecting the gas path connector to a headstrap.
In an embodiment, the conduit connector in connection with the gas path connector includes a first attachment configuration comprising a pair of resilient arms configured for removable attachment to the gas path connector and a second attachment configuration configured for removable attachment to the sampling conduit. In a particular embodiment, the second attachment configuration comprises a pair of hooks defining a pair of recesses corresponding to an external diameter of the sampling conduit and configured to receive and retain the sampling conduit.
The above-noted conduit connector of the accessory may cooperate with the above-noted conduit connector in connection with the gas path connector. For example, in an embodiment, the sampling conduit is connected to both the conduit connector of the accessory and the conduit connector that is connected to the gas path connector.
As noted, the sampling conduit according to the first aspect of the disclosure is configured to remain open to maintain fluid communication between the sampling inlet and sampling outlet when the collapsible portion is moved to the collapsed configuration. This can be achieved in a variety of ways some of which were noted in the foregoing. For example, the sampling conduit being connected to the gases delivery member but spaced therefrom by a connection web such that the sampling conduit is not contacted or affected by a collapsing force applied to the collapsible portion. Various other configurations which maintain the sampling conduit in an open state are envisaged.
For example, in an alternative configuration, the sampling conduit can be located with respect to the collapsible portion such that the sampling conduit receives or is exposed to or influenced by the collapsing force applied to the collapsible portion. This could occur directly (for example a face mask directly contacting and pressing onto the sampling conduit) or could occur indirectly (for example a face mask force being applied to the collapsible portion and transmitted through the collapsible portion onto the sampling conduit). In either of these or other scenarios, the sampling conduit can be configured to remain open in response to direct or indirect application of the collapsing force to the sampling conduit.
For example, in an embodiment, the sampling conduit comprises a sampling lumen and the sampling conduit is configured to retain the shape of the sampling lumen in response to the collapsing force applied to the collapsible portion. In an embodiment, the sampling conduit is configured to be stiffer than the collapsible portion to maintain the shape of the sampling lumen upon application of the collapsing force. In a particular embodiment, the sampling conduit is formed of a material having sufficient material stiffness to retain the shape of the sampling lumen. In an embodiment, the gas sampling interface is formed of a different material than the collapsible portion. In an embodiment, the sampling conduit is formed of a different material than the collapsible portion. In an embodiment, the sampling conduit is formed of a material that has greater material stiffness than a material of the collapsible portion. In an embodiment, the gas sampling interface comprises silicone. In an embodiment, the collapsible portion comprises thermoplastic elastomer. In an embodiment, the gas sampling interface comprises silicone and the collapsible portion comprises thermoplastic elastomer.
In an embodiment, the sampling conduit is configured via geometric features to be stiffer than the collapsible portion. For example, the sampling conduit may have a thicker wall than the collapsible portion. The sampling conduit may comprise a wall of uniform (i.e. consistent) thickness whereas the collapsible portion may include thin-walled portions configured to facilitate bending or folding and thereby facilitate movement of the collapsible portion to the collapsed configuration. The sampling conduit may include an internal reinforcement structure such as struts or cross-members which help to resist closure of the sampling conduit.
According to a second aspect of the disclosure, there is provided a patient interface comprising:
According to the second aspect of the disclosure, the gas sampling interface is therefore provided to the gases delivery side member. The various embodiments and features of the disclosure discussed above with respect to the first aspect of the disclosure will be understood as being applicable to the second aspect of the disclosure also, with the exception of the above-discussed embodiments which relate to the gases delivery interface being provided to the non-delivery side member.
In contrast to the first aspect of the disclosure, the sampling conduit of the second aspect of the disclosure is not necessarily configured to remain open when the collapsible portion is moved to the collapsed configuration. However, it is to be appreciated that the sampling conduit of the second aspect of the disclosure could be configured to remain open in the same manner as the first aspect of the disclosure.
The various embodiments and features of the disclosure discussed above with respect to the first aspect of the disclosure which relate to the sampling conduit remaining open when the collapsible portion is moved to the collapsed configuration may therefore also be applicable and/or implemented to the second aspect of the disclosure.
However, in an embodiment of the second aspect of the disclosure, the sampling conduit may be configured such that the patient gases flow can be selectively reduced or stopped. This may be desired in applications where a second respiratory support system (for example a face mask applied to a patient's face) also has gas sampling functionality and wherein a gas sampling interface on the collapsible cannula could introduce a leak to during use of the second respiratory support. Accordingly, in some situations, it may be desirable to stop patient gas flow through the gas sampling interface in order to not disrupt the secondary respiratory support system.
According to an embodiment of the second aspect of the disclosure, the sampling conduit is movable from a normally open configuration to a collapsed configuration in which the patient gas flow through the sampling conduit is reduced or stopped. The sampling conduit may have a configuration similar to that of the collapsible portion which is discussed in the foregoing and which facilitates closure, occlusion or restriction of the sampling conduit in response to a collapsing force. For example, a collapsing force applied to the collapsible portion by a patient face mask. The sampling conduit may be configured such that no patient gas flow occurs when in the collapsed configuration. Alternatively, the sampling conduit may be configured such that some residual patient gas flow still occurs through the sampling conduit when in the collapsed configuration. For example, one or more residual openings, channels or passageways may remain of a sampling lumen inside the sampling conduit when the sampling conduit is moved to the collapsed configuration and some residual patient gas flow may still flow through these residual openings, channels or passageways.
In an embodiment, the sampling conduit includes one or more side portions configured to move toward or against each other upon application of the collapsing force to reduce or stop the patient gas flow through the sampling conduit. The sampling conduit may comprise a material or geometry that is configured to facilitate movement of the side portions toward or against each other. In an embodiment, the sampling conduit moving from the open configuration to the closed configuration comprises bending or folding of one or more sides of the sampling conduit. The sampling conduit may include one or more thin-walled portions configured to provide folding lines at which the sampling conduit folds or bends upon application of the collapsing force. In an embodiment, the sampling conduit is resiliently deformable from the normally open configuration to the collapsed configuration.
The foregoing discussion relates to possible embodiments and features of the disclosure which relate to one or both of the first and second aspects of the disclosure. Various other possible embodiments and/or features of the disclosure may be applicable to both aspects of the disclosure and some of which are discussed below.
In an embodiment, the sampling inlet is located adjacent to the delivery outlet or within the delivery outlet. The sampling inlet may comprise a mouth scoop configured for location in front of the patient's mouth. The mouth scoop may comprise an opening configured to capture patient gases exhaled from the patient's mouth and/or nares. The mouth scoop may therefore form part of the sampling interface. In an embodiment, the mouth scoop is configured for removable attachment to the sampling conduit. In an embodiment the sampling inlet may be provided by the mouth scoop. For example, the mouth scoop may be configured for removable attachment to the sampling inlet and whereupon selective attachment of the mouth scoop to the sampling inlet, the sampling inlet is then provided by or at the mouth scoop. In an embodiment the mouth scoop may be non-removably attached to the sampling conduit and wherein the sampling inlet is provided by the mouth scoop.
The delivery outlet may comprise one or more nasal delivery prongs configured for location in one or both of the patient's nares. In an embodiment, the sampling inlet comprises a nasal and a mouth inlet.
In an embodiment, the sampling inlet is provided by a sampling nasal prong configured for insertion into a patient's nares. The sampling inlet could be provided by a pair of nasal prongs. The sampling conduit may extend beyond a distal end of the nasal delivery prongs such that the sampling nasal prong is configured to locate deeper in the patient's nares than the nasal delivery prongs.
The positioning of the sampling nasal prong relative to the nasal delivery prong could vary. In an embodiment, the sampling nasal prong extends through the nasal delivery prong. The sampling nasal prong may be located substantially centrally in the nasal delivery prong. For example, the sampling nasal prong and the nasal delivery prong may be concentric. Alternatively, the sampling nasal prong may be located externally of the nasal delivery prong and extending alongside the nasal delivery prong.
In an embodiment, the sampling conduit has a flexibly resilient support structure allowing the sampling conduit to be manipulated into a desired shape and/or allowing the sampling inlet to be located at a desired position. The support structure could comprise a wire located within the sampling conduit or associated with a wall of the sampling conduit. The wire may be formed of steel and may be flexible so as to allow selectively positioning of the wire into a desired shape or position.
In an alternative embodiment, the sampling conduit is provided without the above-noted flexibly resilient support structure. For example, the sampling conduit may be provided without a wire located within the sampling conduit. In an embodiment, the sampling conduit is provided with a single lumen and the single lumen is a sampling lumen for the patient gas flow. According to this embodiment, the sampling conduit does not include a support wire and therefore does not include any additional lumen for a support wire. In an embodiment, the sampling conduit has a homogenous material composition. For example, the sampling conduit may be formed only of a silicone or silicone-type material and not of a silicone material with an embedded support wire formed of a metallic or non-silicone material, as per the previously-mentioned alternative embodiment. The provision of a sampling interface with a single lumen that is the sampling lumen (i.e. without a flexibly resilient support wire accommodated in a wire lumen) may advantageously save material and reduce manufacturing complexity.
In an embodiment, the sampling conduit has an outer surface configured to seal against a mask cuff of a patient face mask. The sampling conduit may include a non-patient-facing surface which could be configured to seal against the mask cuff. The non-patient-facing surface may be provided with a stiffer configuration than the mask cuff such that the mask cuff is resiliently deformed around the non-patient-facing surface so as to form a seal between the mask cuff and the sampling conduit.
In an embodiment, the sampling inlet is located proximate the delivery outlet so as to be located within a cavity formed between a patient face mask and the patient's face during application of the face mask to the patient and wherein the sampling outlet is spaced from the delivery outlet so as to be outside of the cavity during the application of the mask to the patient. In this manner, a patient face mask applied to a patient's face will cover the sampling inlet but not the sampling outlet which is in (or available for) fluid communication with a respiratory gas monitor.
It will be appreciated from the above discussion that the present disclosure provides a patient interface configured to allowing sampling and monitoring of patient gases when the collapsible portion is moved to the collapsed configuration. For example, when a patient face mask is placed over the patient interface. The patient interface therefore allows for respiratory systems to be switched (for example, from a high-flow nasal canula to a face mask). It will also be appreciated from the above discussion that the patient interface can be configured so as not to disrupt (or to minimise disruption) of a mask seal placed against the patient's face.
Patient Interface and Accessory therefor
This disclosure also relates to a patient interface and an accessory therefor.
As discussed in the foregoing, the collapsible conduit includes a collapsible portion configured to collapse and restrict respiratory gas flow when, for example, a mask is placed onto a patient's face and a portion of the mask, e.g. the mask cuff, is overlaid across (and pressed onto) the collapsible portion. This allows a clinician to easily apply a non-invasive ventilation mask to the patient over the patient interface when needed and with a restriction of gas flow through the collapsed conduit
When a clinician wishes to provide manual ventilation using a bag and mask to a patient, the clinician may need to apply a considerable amount of pressure on the collapsible portion to cause sufficient collapse. Insufficient collapse may result in a residual gas flow through the collapsible portion.
An accessory according to this aspect of the disclosure may be provided in order to reduce residual flow and/or to otherwise improve the consistency or ease with which sufficient collapse is achieved.
The accessory may be configured in a variety of different ways to help facilitate or promote improved collapse of the collapsible portion. For example, the accessory may be configured to be located in a particular position with respect to the collapsible portion in order to promote sufficient collapse. Alternatively, or in addition, the accessory may include geometric features that provide a localised concentration of force on the collapsible portion to amplify a pressure applied to the collapsible portion. In another example, the accessory may be configured to amplify a force applied to the collapsible portion. Various embodiments of these and other concepts will be discussed below.
According to an aspect of the disclosure, there is provided an accessory for a patient interface configured to deliver respiratory gases to a patient via a gases delivery conduit which includes a collapsible portion, the accessory comprising: an attachment configuration configured to attach the accessory to the patient interface; and a contact portion configured to facilitate collapse of the collapsible portion at a collapse location in fixed relation to the attachment configuration, when a collapsing force is applied to the contact portion and/or to the collapsible portion.
The accessory may advantageously improve collapse consistency by promoting or otherwise facilitating collapse of the collapsible portion at a predetermined collapse location in fixed relation to the attachment configuration. This configuration may provide the user with control over the collapse location by altering the position of the accessory and the attachment configuration.
The accessory may include a platform, bar or plate locatable behind the collapsible portion (i.e. between the patient's face and a patient-facing side of the collapsible portion) to provide a rigid surface against which the collapsible portion is compressed when a collapsing force is applied to the collapsible portion. For example, the accessory may provide a backing plate configured to support the collapsible portion and provide a firm surface against which the collapsible portion is squeezed and compressed when a bag mask is applied to the patient's face.
The contact portion of the accessory may provide a surface against which the collapsible portion is pressed such that the collapsible portion is pinched or sandwiched between the mask cuff and the accessory. The contact portion may be configured to engage the collapsible portion in order to facilitate collapse of the collapsible portion. For example, the contact portion may be configured to contact the collapsible portion. The contact portion may be configured to deliver a force to the collapsible portion in order to cause or assist in collapsing the collapsible portion.
The contact portion may contact the patient interface at the collapsible portion. Alternatively, the contact portion may contact the patient interface at a location other than the collapsible portion for example, at a position on the gases delivery conduit that is upstream or downstream of the collapsible portion. In this instance, the contact portion may still facilitate collapse of the collapsible portion. For example, the contact portion may contact part of the gases delivery conduit adjacent to the collapsible portion and may provide a hinge or pivot point about which the gases delivery conduit may fold or kink to promote or induce collapse of the collapsible portion.
The contact portion may contact and support one or more parts of the gases delivery conduit adjacent to the collapsible portion and whereby at least a section of the collapsible portion is unsupported by the accessory. An unsupported section of the collapsible portion may span between a supported section of the collapsible portion or of the gases delivery conduit. The accessory may be configured to promote collapse at the unsupported section spaning between one or more supported sections.
According to a particular embodiment, the accessory includes a backing plate locatable, in use, between a patient-facing surface of the collapsible portion and the patient's face, the backing plate having a patient-facing surface and an opposite conduit-facing surface for facing the patient-facing surface of the collapsible portion.
The contact portion of the accessory may be configured in various ways. According to one embodiment, the contact portion comprising the conduit-facing surface of the backing plate. The conduit-facing surface of the backing plate may be configured to promote collapse of the collapsible portion at the collapse location. For example, the conduit-facing surface of the backing plate may comprise a concentration formation configured to concentrate force onto the patient-facing surface of the collapsible portion.
According to an embodiment, the concentration formation comprises at least one rib on the conduit-facing surface of the backing plate. The concentration formation may comprise a plurality of ribs. The concentration formation may comprise a serrated surface. The concentration formation could comprise other configurations such as a protrusion or a tapered protrusion. The concentration formation may be configured to contact the collapsible portion at a single position which corresponds to the collapse location.
In a particular embodiment, the backing plate is shaped with a pre-formed curve configured to conform with a contour of the gases delivery conduit and/or of the patient's face. The pre-formed curve may advantageously match or conform with a patient's face so as to direct or arrange the gases delivery conduit in a desired position with respect to the patient's face and/or to improve comfort for the patient.
The accessory may be provided in a variety of sizes to accommodate a variety of patient face sizes or shapes. For example, the accessory may be provided with a backing plate sized and/or shaped to accommodate a child's face and could also be provided with a backing plate sized and/or shaped to accommodate an adult's face. In this manner, a healthcare provider such as a nurse may select an appropriately sized accessory on the basis of characteristics of the patient's face.
In some embodiments of the disclosure, the accessory is not provided with a backing plate but may be provide with an alternative component. For example, the accessory may include a support member extending between the attachment configuration and the contact portion, the support member configured to support the contact portion in fixed relation to the attachment configuration.
In an embodiment, the support member may include a pre-formed curve to conform with a contour of the gases delivery conduit and/or the patient's face.
In an embodiment, the contact portion comprises a tapered configuration configured to concentrate force onto a patient-facing surface of the collapsible portion.
In an embodiment, the tapered configuration comprises a tapered rib located at a distal end of the support member.
In an embodiment, the tapered rib comprises an edge configured to concentrate force onto a patient-facing surface of the collapsible portion. The edge may comprise a linear or planar or straight edge. The edge may comprise a rounded or non-linear or non-planar edge.
In an embodiment, the edge is substantially transverse to a length of the collapsible portion.
In an embodiment, the contact portion comprises a first member locatable, in use, between a patient-facing surface of the collapsible portion and the patient's face; and a second member connected in movable association with the first member and configured to move toward the first member and facilitate collapse of the collapsible portion in response to application of the collapsing force. In use, the accessory may be fitted or otherwise located at or on the collapsible portion such that the collapsible portion is positioned between the first and second members. The movable association between the first and second members may be configured to squeeze, compress, sandwich, pinch or clamp the collapsible portion between the first and second members in order to promote collapse of the collapsible portion.
In an embodiment, the attachment configuration comprising an opening configured to receive the collapsible portion and to locate the collapse location of the collapsible portion between the first and second members. The first and second members may be configured to apply a clamping load at the collapse location of the collapsible portion upon application of the collapsing force.
In an embodiment, the second member includes an application surface configured to receive the collapsing force and whereby application of the collapsing force onto the application surface induces movement of the second member toward the first member. The application surface may comprise a portion of the second member located on a non-patient facing side (i.e. an outer side) of the collapsible portion. For example, a portion of the second member first contacted by a bag mask applied to a patient's face. The application surface may be located at or adjacent the collapse location or could be spaced therefrom, depending on the particular configuration and length of the second member.
In an embodiment, each of the first and second members include a proximal end, a distal end and a clamping portion located between the proximal and distal ends, wherein the proximal and distal ends are hinged together and, in use, the collapsible portion is locatable between the respective clamping portions.
The movable association between the first and second members could involve a variety of different configurations. In a particular embodiment, the first and second members are hingedly connected and, in use, the collapsible portion is locatable between the first and second members. The hinged connection could comprise a pin extending between corresponding openings in ends of the first and second members. Alternatively, the hinged connection could comprise any other suitable configuration. For example, the hinged connection could comprise a flexible hinge portion connecting the first and second members.
In an embodiment, the first member comprises a backing plate and the second member comprises a cantilever member hinged or pivoted to the backing plate. In use, the backing plate is located behind the collapsible portion i.e. between the patient's face and the patient-facing side of the collapsible portion. At least a portion of the second member may be positioned in front of the collapsible portion i.e. on a non-patient-facing side of the collapsible portion such that a bag mask will contact the second member when applied to the patient's face. The back plate and/or the cantilever member may include one or more ribs for concentrating force onto the collapsible portion. In use, the collapsible portion may be compressed or pinched between a rib of the backplate and a rib of the cantilever member. This configuration may advantageously provide a reliable collapse location and a localised concentration of force provided by the ribs may decrease the force required to achieve sufficient collapse of the collapsible portion.
The attachment configuration of the accessory may be provided in a variety of configurations and may be advantageously configured to allow selective positioning or adjustment of the accessory location in order to achieve a desired collapse location. According to an embodiment, positional adjustment of the attachment configuration allows for positional adjustment of the collapse location. The attachment configuration may be attachable at an attachment location on the patient interface and wherein the collapse location is predetermined by selection of the attachment location. In use, a user may select (for example, visually) a desired collapse location on the collapsible portion and position the attachment configuration accordingly so as to achieve the desired collapse location. This configuration may also advantageously provide a consistent collapse location relative to the attachment configuration. That is, the accessory may enable a user to accurately predict where collapse of the collapsible portion will occur upon application of the collapsing force.
According to a particular embodiment, the attachment configuration is attachable to the collapsible portion. The attachment configuration may be attachable to a part of the patient interface other than the collapsible portion. For example, the attachment configuration may be attachable to a portion of the gases delivery conduit upstream and/or downstream of the collapsible portion.
In an embodiment, the attachment configuration is attachable to a rigid part of the patient interface. In a particular embodiment, the rigid part of the patient interface is a rigid part of the gases delivery conduit upstream of the collapsible portion, with respect to a flow direction of respiratory gases in the gases delivery conduit.
In an embodiment, the contact portion is co-located with the collapse location. The contact portion may induce collapse of the collapsible portion at an interface between the contact portion and the collapsible portion. Accordingly, the user can advantageously anticipate a consistent collapse location based on the location of the contact portion.
In one embodiment, the and the collapse location are spaced from the attachment configuration. For example, the contact portion and attachment configuration may be located on generally opposite ends of the accessory such that the contact portion and the collapse location are spaced from the attachment configuration by approximately the length of the accessory.
In one embodiment, the contact portion and the collapse location are co-located with the attachment configuration. For example, the attachment configuration may be positioned generally at or adjacent the same position on the collapsible portion as the contact portion. The collapse location may therefore be at approximately the same location as the attachment configuration. Accordingly, the user may expect collapse to occur at the same location as the attachment configuration.
In an embodiment, the attachment configuration comprises at least one of a mount, clamp, coupling, connector, fastener, clip, snap-fit attachment or a recess.
In an embodiment, the attachment configuration is configured to attach or detach from the patent interface without disrupting a flow of respiratory gases to the patient through the gases delivery conduit. This embodiment may advantageously allow a user to fit or install the accessory or to remove the accessory while a patient is still receiving respiratory support through the patient interface.
In an embodiment, the attachment configuration comprises an opening configured to receive the collapsible portion and whereby, in use, the collapsible portion extends through the opening. The opening may comprise an aperture or passageway through a portion of the accessory. The opening may comprise a recess, trough, groove or a cut-away portion. The collapsible portion may, in use, be surrounded by the opening for example, where the opening comprises an aperture. Alternatively, the collapsible portion may, in use, be only partially-surrounded by the opening for example, where the opening comprises a cut-away, trough, groove or recess.
In an embodiment, the attachment configuration is configured to maintain location of the contact portion relative to the collapsible portion.
In an embodiment, the collapse location is in fixed relation to the attachment configuration, regardless of where the collapsing force is applied on the collapsible portion and/or the contact portion.
In an embodiment, the contact portion is configured to cooperate with the collapsing force to provide a compressive force onto the collapsible portion at the collapse location.
In an embodiment, the contact portion is configured to provide force onto at least one discrete position at the collapse location. The discrete position may comprise a discrete point or edge or side of the collapsible portion.
In an embodiment, the contact portion is configured to provide force onto a plurality of discrete positions at the collapse location.
In an embodiment, the contact portion is configured to provide a reaction force onto the collapsible portion in response to application of the collapsing force. The reaction force may act on the collapsible portion in an opposite direction to the direction of the collapsing force. In an embodiment, the contact portion applies a reaction force onto the collapsible portion in a direction away from the patient's face.
In an embodiment, the collapsing force is an external force applied to the contact portion and/or the collapsible portion. In an embodiment, the collapsing force is an external force applied by a cuff of a patient mask.
In an embodiment, the accessory comprises a plurality of contact portions. For example, the accessory may include a pair of spaced apart contact portions configured to locate the collapsible portion in between the pair of contact portions. Alternatively, the accessory may include a series of contact portions comprise a plurality of tapered protrusions configured to produce a plurality of collapse locations in the collapsible portion.
In an embodiment, the contact portion is configured to provide a force to the collapsible portion when a mask is applied to the patient and whereby a cuff of the mask overlies the collapsible portion.
In an embodiment, the contact portion has a contact surface configured to contact the collapsible portion and to concentrate the collapsing force at an interface of the contact surface and the collapsible portion. In an embodiment, the contact surface has a relatively small area configured to concentrate the collapsing force at the interface. According to a particular embodiment, the contact surface is located at the tip of a tapered protrusion. The collapsing force applied to the collapsible portion and/or to the contact portion may be concentrated onto the collapse location by the tip of the tapered protrusion. According to a particular embodiment, the tapered protrusion comprises a tapered rib.
According to a particular embodiment, the collapse of the collapsible portion provides a reduced flow rate of respiratory gases through the patient interface.
According to another aspect of the disclosure, there is provided an accessory for a patient interface configured to deliver respiratory gases to a patient via a gases delivery conduit which includes a collapsible portion, the accessory comprising: an attachment configuration configured to attach the accessory to the patient interface; a contact portion configured to contact and facilitate collapse of the collapsible portion when a collapsing force is applied to the contact portion and/or to the collapsible portion; and an indicator configured to locate the application of the collapsing force.
This aspect of the disclosure may advantageously facilitate effective positioning of the collapsing force. For example, the indicator may enable more accurate and effective positioning of the bag mask onto the collapsible portion and/or positioning of the accessory with respect to the collapsible portion. The indicator may indicate to a user an optimum application site for the collapsing force so as to achieve optimum collapse of the collapsible portion.
According to an embodiment, the indicator comprising a visual indicator. According to a particular embodiment, the visual indicator comprises coloured indicia.
In an embodiment, the visual indicator comprises indicia of symbols or
markings.
In an embodiment, the visual indicator is configured to be visualised through a transparent or translucent part of the collapsible portion.
In an embodiment, the indicator comprises a tactile indicator.
In an embodiment, the tactile indicator comprises a tactile formation in a surface of the accessory. In an embodiment, the tactile indicator comprising at least one of a ribs, bar, indentation, depression, rebate, notch, cavity channel, slit, groove, opening, protrusions, bump or raised portion.
In an embodiment, the accessory includes a patient-facing surface and an opposing non-patient-facing surface and the indicator is located on the non-patient-facing surface. According to a particular embodiment, the indicator is located on the contact portion.
In an embodiment, the indicator is configured to provide a location guide for a user to apply the collapsing force onto the collapsible portion or onto the contact portion.
According to another aspect of the disclosure, there is provided an accessory for a patient interface configured to deliver respiratory gases to a patient via a gases delivery conduit which includes a collapsible portion, the accessory comprising: an attachment configuration configured to attach the accessory to the patient interface; and a contact portion configured to deliver a collapsing load to the collapsible portion when an external load is applied to the contact portion and/or to the collapsible portion, the accessory configured to amplify the external load such that the force and/or pressure of the collapsing load delivered to the collapsible portion is higher than the force and/or pressure of the applied external load.
In an embodiment, the accessory is configured to deliver a higher pressure to the collapsible portion than a pressure of the applied external load.
In an embodiment, the contact portion has a contact area configured to deliver the collapsing load at an interface between the contact portion and the collapsible portion. According to a particular embodiment, the contact area of the contact portion is relatively small. For example, the contact area may be smaller than an application area of the contact portion or collapsible portion onto which the external load is applied. It will be appreciated that an equivalent force applied to a smaller area results in an increase in the pressure applied to that area. Accordingly, when a collapsing load of a particular force and pressure is applied to the application area and resulting in an equivalent force delivered to the collapsible portion at the contact area, the pressure at the contact area is increased by virtue of the contact area being smaller than the application area.
In an embodiment, the accessory is configured to deliver a higher force to the collapsible portion than a force of the applied external load. In an embodiment, the accessory is configured to amplify the force of the applied external load by a predetermined multiple. According to an embodiment, the predetermined multiple is greater than 1. According to an embodiment, the predetermined multiple is between 1-20. According to an embodiment, the predetermined multiple is between 5-20. According to an embodiment, the predetermined multiple is between 5-15.
In an embodiment, the applied external load is the force or pressure of a bag mask being applied to the collapsible portion and the accessory is configured to deliver a force and/or pressure to the collapsible portion that is larger than the force and/or pressure at which the bag mask is applied.
In an embodiment, the lever mechanism includes a pivot and the lever mechanism is configured to produce a turning moment about the pivot in response to the applied external load. In an embodiment, the lever mechanism may be configured to receive the force of the applied external load at a first portion of the lever mechanism and to deliver an amplified force to the collapsible portion at a second portion of the lever mechanism which is spaced apart from the first portion of the lever mechanism. In an embodiment, the second portion of the lever mechanism being positioned closer to the pivot than the first portion of the lever mechanism.
In an embodiment, the accessory comprises a lever mechanism configured to amplify the force of the applied external load. The lever mechanism may comprise a second-class lever configuration. That is, a configuration where the load delivered to the collapsible portion is positioned between a fulcrum and the force applied to the lever mechanism.
In an embodiment, the second-class lever configuration comprises a pair of clamping arms pivotally connected at a fulcrum, the pair of clamping arms providing a pair of opposed clamping surfaces positioned between the fulcrum and a distal end of each clamping arm and a clamping region provided between the pair of opposed clamping surfaces configured to receive the collapsible portion.
In an embodiment, the accessory is configured for the external load to be applied to at least one of the clamping arms in a position at or adjacent the distal end of the clamping arm.
In an embodiment, a distance between the delivered collapsing load to the fulcrum is less than a distance between the applied external load to the fulcrum. It will be appreciated that the force of the applied external load creates a torque or moment in the clamping arm about the fulcrum. The moment will induce a larger force at positions along the clamping arm that are closer to the fulcrum. In this manner, the force delivered to the collapsible portion at its position closer to the fulcrum than the applied external force will be an amplification of the applied external force. The multiple of amplification may be predetermined by the fulcrum-to-delivered load distance and the fulcrum-to-applied load distance. By way of example, clamping surfaces positioned 1 cm from the fulcrum and the applied load positioned 3 cm from the fulcrum will result in a force amplification multiple of 3.
The accessory may be configured to amplify both force and pressure of the applied external load or may be configured to amplify just one of force or pressure. For example, the accessory may be configured to delivery approximately the same force to the collapsible portion as was applied by the external load but over a smaller area, resulting in an increase in pressure. In other words, the accessory may concentrate the same force over a smaller area to increase the pressure of the collapsing load applied to the collapsible portion.
According to another aspect of the disclosure there is provided an accessory for a patient interface configured to deliver respiratory gases to a patient via a gases delivery conduit which includes a collapsible portion, the accessory comprising: an attachment portion configured to attach the accessory to the patient interface; and a support locatable, in use, between the gases delivery conduit and the patient's face and configured to facilitate collapse of the collapsible portion when a collapsing force is applied to the collapsible portion.
In an embodiment, the support comprises a rigid support. The support may include a rigid surface configured to provide a resisting force to a patient-facing side of the collapsible portion in response to application of the collapsing force to a non-patient-facing side of the collapsible portion. In a particular embodiment, the support is rigid yet has some resilient flexibility.
In an embodiment, the support is shaped to conform to a contour of the collapsible portion and/or the patient's face. The support may be shaped with a curve. In an embodiment, the support includes a pre-formed curve configured to conform to a contour of the collapsible portion and/or the patient's face.
According to an embodiment, the attachment portion is in fixed relation to the support. For example, the support may be rigidly connected to or integrally formed with the attachment portion. In this manner, the position of the support may be adjusted or determined based on the position of the attachment portion.
In an embodiment, the attachment portion comprises at least one of a mount, clamp, coupling, connector, fastener, clip, snap-fit attachment or a recess. The attachment portion could comprise any suitable means of attachment and it will be appreciated that other forms of attachment may be suitable for use as the attachment portion. According to a particular embodiment, the attachment portion comprises a clip in fixed relation to the support. The clip may be formed of a rigid material. The clip may be formed of a resilient material. The clip may be formed of a deformable material.
In an embodiment, the clip is configured to provide a removable snap-fit connection to a rigid part of the patient interface. In one embodiment, the clip is configured to provide a connection to a rigid part of gases delivery conduit located upstream of the collapsible portion, with respect to a flow direction of gases in the gases delivery conduit.
In an embodiment, the clip comprises a C-shaped clip or U-shaped clip. For example, the clip could comprise a resiliently flexible C-shaped clip configured to snap-fit onto a rigid part of the gases delivery conduit. In an embodiment, the support extends from the clip. In an embodiment, the clip is configured to connect to a rigid part of the gases delivery conduit at a position upstream of the collapsible portion and the support extends from the clip in a downstream direction between the patient's face and the collapsible portion.
In an embodiment, the support comprises a backing plate. The backing plate may be configured to be located, in use, such that a longitudinal axis of the backing plate is approximately parallel with a longitudinal axis of the collapsible portion. The backing plate may have a width direction perpendicular to the longitudinal axis of the backing plate and the backing plate has a width along the width direction which is at least equal to a width of the collapsible portion. In an embodiment, the backing plate has a width that is larger than a width of the collapsible portion. According to an embodiment, the backing plate has a substantially planar configuration.
In one embodiment, the support includes a proximal end, a distal end and a curved portion located intermediate of the proximal and distal ends. In an embodiment, the attachment configuration located at or adjacent to the proximal end of the support.
In an embodiment, the patient interface comprises a nasal cannula comprising one or more prongs configured for insertion into the patient's nasal passages and the support is sized such that the distal end of the backing plate is, in use, spaced from the one or more prongs.
In an embodiment, the support comprises a contact portion configured to contact a patient-facing surface of the gases delivery conduit. The contact portion may be configured to contact a patient-facing surface of the collapsible portion. In an embodiment, the contact portion is configured to contact a patient-facing surface of the gases delivery conduit upstream or downstream of the collapsible portion, with respect to a flow direction in the gases delivery conduit.
In an embodiment, the contact portion is configured to provide a space or cavity between the support and the patient-facing surface of the gases delivery conduit in a region upstream of the contact portion, with respect to a flow direction of respiratory gases in the gases delivery conduit.
In an embodiment, the accessory is configured to allow the collapsible portion to collapse into the space or cavity upon application of the collapsing force. In an embodiment, the accessory is configured to allow the collapsible portion to kink into the space or cavity upon application of the collapsing force. For example, the accessory may be configured to engage with the collapsible portion so as to produce a kink in the collapsible portion. The accessory may be configured to produce more than one kink in the collapsible portion. The accessory may be configured to collapse and/or kink the collapsible portion so as produce a tortuous path for the respiratory gases and reduce flow rate by increasing flow resistance through the tortuous path.
In an embodiment, the support includes an outwardly-facing surface configured to, in use, face the patient-facing surface of the collapsible portion and wherein the contact portion extends from the outwardly-facing surface of the support in an outward direction away from the patient's face.
In an embodiment, the support includes a patient-facing side for facing the patient's face and an outwardly-facing side for facing the patient-facing surface of the collapsible portion and a concentration formation located at the outwardly-facing side of the support for concentrating a resisting force onto the collapsible portion. In an embodiment, the resisting force occurs in response to application of the collapsing force. That is, the support resists movement of the collapsible portion toward the patient's face by applying a resisting force to the patient-facing side of the collapsible portion which is concentrated by the concentration formation. In an embodiment, the concentration formation is configured to increase the pressure of the resisting force.
In an embodiment, the contact portion comprises at least one of a rib, bump, bar, serration, protrusion or raised portion. In an embodiment, the contact portion is located at or adjacent a distal end of the support.
In an embodiment, the contact portion comprises one or more ribs. In an embodiment, the one or more ribs extend at least partially between a pair of opposing longitudinal edges of the support. In an embodiment, the one or more ribs are orientated parallel with a longitudinal axis of the support.
In an embodiment, the support includes a first rib and a second rib spaced apart from the first rib by a seat configured to receive the collapsible portion. In an embodiment, the first and second ribs extend along opposing raised edges of the support. In an embodiment, the opposing raised edges comprise a pair of opposite first and second longitudinal edges, the first rib located adjacent the first longitudinal edge the second rib located adjacent the second longitudinal edge.
According to a particular embodiment, the first rib is configured to contact an upper portion of the collapsible portion and the second rib is configured to contact a lower portion of the collapsible portion. For example, in use the support may be orientated such that the first rib is at a higher position than the second rib. The first rib may therefore make contact with the collapsible portion at a higher position on the collapsible portion than the second rib which makes contact with a lower position on the collapsible portion.
According to an embodiment, the first and second ribs are pivotally connected to locate the collapsible portion in the seat.
According to an embodiment, the first and second ribs are movable toward or away from one another and between an open configuration configured to receive the collapsible portion and a closed configuration configured to engage the collapsible portion between the first and second ribs.
In an embodiment, the first and second ribs are biased toward the open configuration and movable toward the closed configuration upon application of the collapsing force.
In an embodiment, the accessory is attachable to the patient interface with the attachment configuration positioned upstream of the support, with respect to a flow direction of respiratory gases in the gases delivery conduit.
In an embodiment, the support comprises a backing plate comprising a conduit-facing surface which comprises an elongate protrusion and the accessory comprising a pair of attachment portions comprising a pair of flanges extending from opposing sides of the backing plate, each flange comprising an opening configured for the collapsible portion to extend therethrough.
In an embodiment, the backing plate is configured to protect or shield the patient's face from the applied the collapsing force. For example, the backing plate may be rigidly connected to the patient interface via the attachment configuration such that the applied collapsing force is not transmitted to the patient's face.
In an embodiment, the attachment configuration comprises a clip and the backing plate extends from the clip. The clip may attach to a headstrap-pneumatic connector of the patient interface which acts as a support for the accessory. The backplate may be shaped with a curve along its length. The curve may allow for a substantial portion of the backplate to seat between the patient's face and the collapsible portion. In an embodiment, the backplate is more rigid than the collapsible portion. The rigidity of the backplate may be achieved via the backplate material and/or via the geometric configuration of the backplate.
In an embodiment, the clip comprises a C-shaped clip. In an embodiment, the clip comprises a U-shaped clip. In an embodiment, the attachment configuration may comprise alternative attachment means such as adhesive, over moulding or integral moulding.
In an embodiment of the disclosure, the backplate provides a hard surface behind the collapse location of the collapsible portion. The hard surface of the backing plate thereby provides a resisting force against the applied collapsing load, for example the collapsing force applied by a bag mask. In this manner, the backing plate helps facilitate an optimum collapse of the collapsible portion.
The backing plate may be elongated or generally rectangular and may have a larger width than the collapsible portion. According to a particular embodiment the backing plate may be provided in a range of sizes to suit a range of patient face sizes or shapes. The backing plate could be customised to fit a particular patient's face.
According to an embodiment, the backing plate includes a visual or tactile indicator to assist a user in applying a force to collapse the collapsible portion. The backing plate may be configured to indicate an optimised collapse location. For example, the backing plate may include a visual or tactile indicator of the position of the contact portion. In particular, the indicator may indicator to a user where the contact portion is positioned underneath the collapsible portion so that the user can apply a load at a position on the collapsible portion which overlies the contact portion.
According to another aspect of the disclosure there is provided, an accessory for a patient interface configured to deliver respiratory gases to a patient via a gases delivery conduit which includes a collapsible portion, the accessory comprising: a clamping configuration comprising first and second clamping members configured to receive the collapsible portion between the first and second clamping members, the first clamping member locatable, in use, between a patient-facing surface of the collapsible portion and the patient's face, the second clamping member connected in movable association with the first clamping member and configured to move toward the first clamping member and facilitate collapse of the collapsible portion in response to application of a collapsing force.
In an embodiment, at least one of the first and second clamping members includes a concentration formation configured to concentrate force onto the collapsible portion.
In an embodiment, the concentration formation comprises one or more ribs.
In an embodiment, the first clamping member includes a first rib extending toward the second clamping member and the second clamping member includes a second rib extending toward the first clamping member.
In an embodiment, one of the first or second clamping members includes a rib extending toward the other of the first or second clamping members.
In an embodiment, the second clamping member is configured to overlie a non-patient-facing surface of the collapsible portion. That is, the second clamping member is configured to overlie an outer or outward-facing side of the collapsible portion which faces away from the patient's face. The said non-patient-facing surface of the collapsible portion may, in use, be the surface which is contacted by the applied collapsing force, for example contacted by the cuff of a bag mask applied to the patient's face.
In an embodiment, the second clamping member includes a non-patient-facing surface which defines an application surface configured to receive the applied collapsing force and whereby application of the collapsing force onto the application surface induces movement of the second clamping member toward the first clamping member.
In an embodiment, the application surface is located at or adjacent a distal end of the second clamping member.
In an embodiment, the first and second clamping members are pivotally connected. The first and second clamping members may be hingedly connected at a hinged connection. The hinged connection may comprise a multi-part hinge mechanism such as a pin engaged with apertures in the clamping members. Alternatively, the hinge connection may comprise an integrally formed hinge such as a flexible portion of material connecting the first and second clamping members. It will be appreciated that other pivotal or hinge configurations may be suitable.
In an embodiment, the first and second ribs are located between the hinged connection and a distal end of the clamping members.
In an embodiment, the first and second clamping members have a second-class lever configuration configured to amplify the applied collapsing force which is delivered to the collapsible portion. It will be appreciated that a second-class lever configuration is a lever configuration wherein the load delivered by the lever is positioned between a fulcrum and the force applied to the lever mechanism. According to this embodiment, the load delivered to the collapsible portion is positioned between a fulcrum (the pivotal or hinged connection) and the force applied to the lever mechanism.
In an embodiment, the second clamping member includes an opening configured for the collapsible portion to extend through.
In an embodiment, at least one of the clamping members is formed of a flexibly resilient or soft material.
In an embodiment, the accessory further includes an attachment configuration configured to attach the accessory to the patient interface. The attachment configuration may be connected to the first clamping member. In an embodiment, the attachment configuration comprises a C-shaped clip or U-shaped-clip configured to provide a snap-fit connection to a portion of the patient interface.
In an embodiment, the clamping configuration is movable between an open position configured to allow unrestricted flow within the collapsible portion and a clamped position configured to apply restriction to the flow within the collapsible portion. In an embodiment, the clamping configuration is biased toward the open position and movable toward the clamped position upon application of the collapsing force.
According to an embodiment, the first and second clamping members include respective clamping surfaces biased apart by a biasing configuration. The biasing configuration may comprise, for example, a spring or a flexibly resilient linkage or strut.
In an embodiment, the first and second clamping members are configured to create a series of pinch points in the collapsible portion when in the clamped configuration. The first and second clamping members may be configured to create a series of kinks in the collapsible portion. In an embodiment, the first and second clamping members are connected via at least one linkage movable with respect to at least one of the clamping members. In a particular embodiment, the clamping members Are connected via a plurality of linkages. In an embodiment, each linkage in the plurality of linkages is flexibly resilient.
In an embodiment, the accessory includes four flexibly resilient linkages extending between the clamping members and configured to maintain the clamping members in a normally spaced apart configuration. That is, the linkages are configured to urge the clamping members to the spaced apart configuration. The resilient flexibility of the linkages allows the clamping members to be moved together under a load, for example a compressive load such as a force applied by application of a bag mask to one of the clamping members. The linkages are configured to return the clamping members to their normally spaced apart configuration when the force is removed.
In an embodiment, the linkages are configured to flexibly deform upon application of the collapsing force and allow the clamping members to collapse toward one another. In an embodiment, the clamping members have a square or rectangular profile and the four linkages extend from each of the four corners of the clamping members. In an embodiment, the four corners of the clamping members are each connected by one of the linkages. In an embodiment, the linkages are oriented approximately parallel with one another when the clamping members are in the normally spaced apart configuration. In an alternative embodiment, the linkages may have a crossed configuration wherein one or more linkages cross over at least one of the other linkages.
In an embodiment, the linkages have a normally linear formation. In an embodiment, the linkages having a normally non-linear formation. In an embodiment, the linkages having a diamond-shaped configuration.
In an embodiment, the clamping members have a plate or planar configuration. In an embodiment, each clamping member comprises a bar. In an embodiment, each clamping member has a cylindrical formation.
According to another aspect of the disclosure, there is provided an accessory for a patient interface configured to deliver respiratory gases to a patient via a gases delivery conduit which includes a collapsible portion, the accessory comprising: a first portion configured to apply a force to collapse a first region of the collapsible portion; a second portion spaced apart from the first portion and with a fulcrum located between the first and second portions, wherein application of a collapsing force in a first direction to the first portion causes movement of the second portion in a second direction to collapse a second region of the collapsible portion.
In an embodiment, the first and second portions are angled with respect to one another. The first and second portions may be angled at an obtuse angle with respect to one another. In a particular embodiment, the first portion is located on a first lever arm and the second portion is located on a second lever arm and wherein each of the lever arms extend from the fulcrum.
According to an embodiment, the accessory is rigid such that the first lever arm, the second lever arm and the fulcrum are in fixed relation to one another.
In an embodiment, the fulcrum comprises a rigid corner at an intersection or convergence of the first and second lever arms.
In an embodiment, the first portion includes an opening configured to receive the collapsible portion therethrough.
In an embodiment, the accessory further includes a support locatable between the patient's face and the fulcrum.
In an embodiment, the support comprises a backing plate. The backing plate may include a rigid surface configured to act as a pivot surface for the fulcrum.
In an embodiment, the fulcrum comprises a pivot connected to the backing plate.
In an embodiment, the first direction is a direction toward the patient's face and the second direction is a direction away from the patient's face.
In an embodiment, the first and second portions are spaced unequally from the fulcrum. According to a particular embodiment, the second portion is spaced farther from the fulcrum than the first portion. As noted above, the first portion may be located on a first lever arm and the second portion may be located on a second lever arm. According to this embodiment, the second lever arm may be longer than the first lever arm, relative to the fulcrum. That is, the second lever arm may extend from the fulcrum farther than the first lever arm extends from the fulcrum.
According to an embodiment, the accessory may comprise a see-saw configuration wherein each of the first and second lever arms extend from opposite sides of the fulcrum. In an embodiment, the accessory may have a generally ‘V’ shape.
According to another aspect of the disclosure, there is provided, an accessory for a patient interface configured to deliver respiratory gases to a patient via a gases delivery conduit which includes a collapsible portion, the accessory comprising:
a gripping portion configured to apply a force in a direction away from the patient's face to facilitate collapse or folding of the collapsible portion.
This aspect of the disclosure may advantageously provide a relatively simple and reliable means by which to promote collapse of the collapsible portion by providing a gripping portion which allows a user to pull on the collapsible portion in a direction away from the patient's face. This action may occur simultaneously with a mask being applied to the patient's face and overlaid on the collapsible portion. In this instance, the collapsible portion would be pulled outwardly away from the patient's face by the gripping portion and simultaneously pushed inwardly toward the patient's face by the mask. This simultaneous and opposing forces may thereby promote improved collapse of the collapsible portion.
In an embodiment, the accessory comprises a connector configured to connect a tube of the gases delivery conduit to the collapsible portion. For example, the accessory may be integrally formed with a connector of the patient interface.
According to an alternative embodiment, the accessory further includes an attachment configuration to attach the accessory to the patient interface. For example, the accessory may be removably connectable to the patient interface.
It will be appreciated from the foregoing that the gripping portion may be integrally formed with the connector or may be discrete and selectively attachable to the connector.
In an embodiment, the attachment configuration comprises an opening, clip or recess. In an embodiment, the attachment configuration includes a C-shaped or U-shaped clip.
According to an embodiment, the attachment configuration is configured to attach to a rigid portion of the gases delivery conduit.
In an embodiment, the attachment configuration is configured to attach to a rigid connector located between a gas delivery tube and the collapsible portion.
In an embodiment, the gripping portion extends from the connector and is configured to allow digital application of a pulling force away from the patient's face.
In an embodiment, the gripping portion comprises a hook, loop, ring or strap.
In an embodiment, the gripping portion comprises a rigid hook or ring.
In an embodiment, the gripping portion comprises a flexible finger loop or finger strap.
The accessory of any one of the foregoing aspects of embodiments of the disclosure may be formed of at least one of thermoplastic elastomer, thermoset or thermoplastic elastomer or metal. The accessory may be formed of titanium, steel, copper or nitinol. The accessory may be formed of other metallic materials, polymers or ceramics. The accessory may be formed of polyethylene.
It will be appreciated that the force required to achieve a sufficient or desirable level of collapse of the collapsible portion may vary depending on various factors such as the resilience of the collapsible portion as well as the respiratory gas pressure passing through the collapsible portion. However, according to a particular embodiment, the collapsible portion is collapsible upon application of a collapsing force of greater than 5N and more particularly a collapsing force of greater than 7N. In another embodiment, the collapsible portion is collapsible upon application of a minimum collapsing force of between 5N to 30N.
The accessory in the foregoing discussion may be configured for use with a patient mask such as a bag mask. The accessory may be configured to configured to cooperate with the patient mask when overlaid across the collapsible portion or a portion of the accessory. The accessory may be configured to cooperate with the mask whereby the mask seals over the accessory and the patient interface to form a seal with the patient's face.
According to an embodiment, the accessory is configured to amplify, concentrate or increase a collapsing load applied by a cuff of the patient mask.
In an embodiment, the accessory is operable to create a tortuous flow path in the collapsible portion.
In an embodiment, the accessory is operable to increase flow path resistance in the collapsible portion.
According to an aspect of the disclosure, there is provided a respiratory system which includes an accessory as discussed in any of the above-noted aspects or embodiments.
According to another aspect of the disclosure, there is provided a patient interface which includes an accessory as discussed in any of the foregoing aspects or embodiments.
In an embodiment, the patient interface includes a gases delivery conduit for delivering respiratory gases to a patient, the gases delivery conduit comprising a collapsible portion configured to collapse and restrict or occlude flow through the collapsible portion upon a collapsing force being applied to the collapsible portion.
In an embodiment of the patient interface, the collapsible portion comprises a portion of conduit formed of a resilient material and is configured to collapse under application of a collapsing force applied from a mask overlaid across the collapsible portion. Said patient interface may include an accessory according to any one of the foregoing aspects or embodiments.
In an embodiment, the patient interface comprises a nasal cannula. The nasal cannula may comprise a non-sealing nasal canula. The nasal cannula may comprise a cannula body and prongs extending from the cannula body and configured to provide respiratory gases to the patients' nares.
According to another aspect of the disclosure, there is provided a respiratory system configured to deliver respiratory gases to a patient via a gases delivery conduit which includes a collapsible portion, the system comprising: a respiratory gases flow source; a patient interface comprising a gases delivery conduit which has a collapsible portion; and an accessory configured to reduce flow of respiratory gases through the collapsible portion to less than a threshold flow rate.
In an embodiment, the respiratory system further includes a humidifier.
In an embodiment, the respiratory system includes a heated inspiratory tube.
In an embodiment, the accessory of the respiratory system is configured to reduce the flow of respiratory gases in response to application of a collapsing force applied to the accessory and/or to the collapsible portion.
In an embodiment, the respiratory system is configured to provide flow of the respiratory gases at flow rates of at least 20 L/min. In an embodiment, the respiratory system is configured to provide flow of the respiratory gases at flow rates of 20-90 L/min. In an embodiment, the respiratory system is configured to provide flow of the respiratory gases at flow rates of 40-70 L/min.
In an embodiment of the respiratory system, the accessory is configured to reduce the flow rate from an initial flow of 40-70 L/min to less than the threshold flow rate. In an embodiment of the respiratory system, the accessory is configured to reduce the flow rate an initial flow of approximately 70 L/min to less than the threshold flow rate. In an embodiment, the threshold flow rate is less than 10 L/min.
According to an embodiment of the respiratory system, the collapsible portion is collapsible from an open configuration to a collapsed configuration, the open configuration allowing an unrestricted flow of respiratory gases through the collapsible portion and the collapsed configuration providing a restricted flow of respiratory gases through the collapsed portion.
In an embodiment of the respiratory system, the unrestricted flow of respiratory gases ranges between 40-70 L/min and the restricted flow is less than the threshold flow rate.
In an embodiment of the respiratory system, the accessory is provided according to any one of the above-discussed aspects of embodiments of an accessory for use with a patient interface.
According to another aspect of the disclosure, there is provided a respiratory system configured to deliver respiratory gases to a patient via a gases delivery conduit which includes a collapsible portion, the system comprising: a respiratory gases flow source; a patient interface comprising a gases delivery conduit which has a collapsible portion; and an accessory configured to reduce the cross-sectional area of the collapsible portion by a minimum multiple.
In an embodiment of the respiratory system, the accessory is configured to reduce the cross-sectional area of the collapsible portion in response to application of a collapsing force applied to the accessory and/or the collapsible portion.
In an embodiment of the respiratory system, the accessory is configured to facilitate collapse of the collapsible portion to reduce the cross-sectional area.
In an embodiment of the respiratory system, the minimum multiple is at least 90%. In an embodiment, the minimum multiple is at least 95%.
In an embodiment of the respiratory system, the respiratory system includes an accessory according to any one of the above discussed aspects or embodiments for an accessory for use with a patient interface.
According to another aspect of the disclosure, there is provided a patient interface configured to deliver respiratory gases to a patient via a gases delivery conduit which includes a collapsible portion, the patient interface comprising an accessory configured to facilitate of the collapsible portion when a collapsing force is applied to the accessory and/or to the collapsible portion.
In an embodiment of the patient interface, the accessory is non-removably connected or integrally formed with the patient interface.
In an embodiment of the patient interface, the accessory is integrally formed with a portion of the gases delivery conduit.
In an embodiment of the patient interface, the accessory is removably connected to the patient interface. In an embodiment of the patient interface, the accessory includes an attachment configuration configured to attach the accessory to the patient interface.
In an embodiment of the patient interface, the accessory is provided according to any of the above-discussed aspects or embodiments of an accessory for use with a patient interface.
Specific embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein having reference to the figures that follow, of which:
showing a cross-section of the non-delivery side member;
Various embodiments are described with reference to the Figures.
Throughout the Figures and specification, the same reference numerals may be used to designate the same or similar components, and redundant descriptions thereof may be omitted.
In this specification, “high flow”, “high flows”, “high-flow” or other equivalent terminology means, without limitation, any gas flow with a flow rate that is higher than usual/normal, such as higher than the normal inspiration flow rate of a healthy patient. Alternatively, or additionally, it can be higher than some other threshold flow rate that is relevant to the context—for example, where providing a gas flow to a patient at a flow rate to meet or exceed inspiratory demand, that flow rate might be deemed “high flow” as it is higher than a nominal flow rate that might have otherwise been provided.
“High flow” is therefore context dependent, and what constitutes “high flow” depends on many factors as the health state of the patient, type of procedure/therapy/support being provided, the nature of the patient (big, small, adult, child) and the like. Those skilled in the art know from context what constitutes “high flow”. It is a magnitude of flow rate that is over and above a flow rate that might otherwise be provided.
But, without limitation, some indicative values of high flow can be as follows.
In some configurations, delivery of gases to a patient at a flow rate of greater than or equal to about 5 or 10 litres per minute (5 or 10 LPM or L/min).
In some configurations, delivery of gases to a patient at a flow rate of about 5 or 10 LPM to about 150 LPM, or about 15 LPM to about 95 LPM, or about 20 LPM to about 90 LPM, or about 25 LPM to about 85 LPM, or about 30 LPM to about 80 LPM, or about 35 LPM to about 75 LPM, or about 40 LPM to about 70 LPM, or about 45 LPM to about 65 LPM, or about 50 LPM to about 60 LPM. For example, according to those various embodiments and configurations described herein, a flow rate of gases supplied or provided to an interface via a system or from a flow source or flow modulator, may comprise, but is not limited to, flows of at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 LPM, or more, and useful ranges may be selected to be any of these values (for example, about 20 LPM to about 90 LPM, about 40 LPM to about 70 LPM, about 40 LPM to about 80 LPM, about 50 LPM to about 80 LPM, about 60 LPM to about 80 LPM, about 70 LPM to about 100 LPM, about 70 LPM to about 80 LPM).
In “high flow” the gas delivered will be chosen depending on for example the intended use of a therapy and/or respiratory support. Gases delivered may comprise a percentage of oxygen. In some configurations, the percentage of oxygen in the gases delivered may be about 15% to about 100%, about 20% to about 100%, or about 30% to about 100%, or about 40% to about 100%, or about 50% to about 100%, or about 60% to about 100%, or about 70% to about 100%, or about 80% to about 100%, or about 90% to about 100%, or about 100%, or 100%.
In some embodiments, gases delivered may comprise a percentage of carbon dioxide. In some configurations, the percentage of carbon dioxide in the gases delivered may be more than 0%, about 0.3% to about 100%, about 1% to about 100%, about 5% to about 100%, about 10% to about 100%, about 20% to about 100%, or about 30% to about 100%, or about 40% to about 100%, or about 50% to about 100%, or about 60% to about 100%, or about 70% to about 100%, or about 80% to about 100%, or about 90% to about 100%, or about 100%, or 100%.
Flow rates for “high flow” for premature/infants/paediatrics (with body mass in the range of about 1 to about 30 kg) can be different. The flow rate can be set to 0.4-8 L/min/kg with a minimum of about 0.5 L/min and a maximum of about 70 L/min. For patients under 2 kg maximum flow may be set to 8 L/min.
High flow has been found effective in meeting or exceeding the patient's normal real inspiratory flow, to increase oxygenation of the patient and/or reduce the work of breathing. Additionally, high flow therapy and/or respiratory support may generate a flushing effect in the nasopharynx such that the anatomical dead space of the upper airways is flushed by the high incoming gas flows. This creates a reservoir of fresh gas available of each and every breath, while minimising re-breathing of carbon dioxide, nitrogen, etc.
By example, a high flow respiratory system 100 is described below with reference to
When used prior to a medical procedure, high gas flow can pre-load the patient with oxygen (i.e. increase the reservoir of oxygen in the blood) so that their blood oxygen saturation level and volume of oxygen in the lungs is higher than normal in order to provide an oxygen buffer while the patient is in an apnoeic phase during the medical procedure.
A continuous supply of oxygen is important to sustain healthy respiratory function during medical procedures (such as during anaesthesia) where respiratory function might be compromised (e.g. diminishes or stops). When this supply is compromised, conditions such as hypoxia and/or hypercapnia can occur. During medical procedures such as anaesthesia and/or sedation, patient breathing is monitored to detect if spontaneous breathing is diminished or ceases. If oxygen supply and/or CO2 removal is compromised, the clinician stops the medical procedure and facilitates oxygen supply and/or CO2 removal. This can be achieved for example by manually ventilating the patient for example through bag mask ventilation, or by providing a high flow of gases to the patient's airway using a high flow respiratory system. Further, it will be appreciated that a mask that is used for sedation/ventilation (not necessarily limited to a bag mask) may also be used for pre-oxygenation and also for monitoring patient parameters such as end tidal CO2, etc.
Further advantages of high gas flow can include that the high gas flow increases pressure in the airways of the patient, thereby providing pressure support that opens airways, the trachea, lungs/alveolar and bronchioles. The opening of these structures enhances oxygenation, and to some extent assists in removal of CO2 and/or can help support patients with collapsed areas of the lung.
When humidified, the high gas flow can also prevent airways from drying out, mitigating mucociliary damage, reducing risk of infection and reducing risk of laryngospasms and risks associated with airway drying such as nose bleeding, aspiration (as a result of nose bleeding), and airway obstruction, swelling and bleeding. Another advantage of high gas flow is that the flow can clear smoke created during surgery in the air passages. For example, smoke can be created by lasers and/or cauterizing devices.
The respiratory support system 100 comprises a housing 106 that at least partially houses both the flow generator 102 and the humidifier 104 (e.g. the respiratory support system 100 may comprise an integrated flow generator/humidifier apparatus). In other configurations the flow generator 102 and humidifier 104 may have separate housings. A hardware controller 108 is shown to be in electronic communication with the flow generator 102 and the humidifier 104, although in some configurations the hardware controller 108 might only communicate with the flow generator 102 or the humidifier 104. The hardware controller 108 may comprise a microcontroller or some other architecture configured to direct the operation of controllable components of the respiratory support system 100, including but not limited to the flow generator 102 and/or the humidifier 104.
An input/output module 110 is shown to be in electronic communication with the controller 108. The input/output module 110 may be configured to allow a user to interface with the controller 108 to facilitate the control of controllable components of the respiratory support system 100, including but not limited to the flow generator 102 and/or the humidifier 104, and/or view data regarding the operation of the respiratory support system 100 and/or its components. The input/output module 110 might comprise, for example, one or more buttons, knobs, dials, switches, levers, touch screens, speakers, displays and/or other input or output peripherals that a user might use to view data and/or input commands to control components of the respiratory support system 100.
As further shown in
As shown in
Accordingly, the patient may continue to receive gas flow throughout the intubation procedure. In other embodiments, the patient interface 200 is an oral interface, for example an oral interface that is received in a user's mouth. An oral interface may be preferred in situations involving medical procedures via the nose, such that the interface does not interfere with nasal airway equipment and/or devices, for example a tracheal tube used in a nasal intubation procedure. In other embodiments the interface may be suitable for both nasal and oral placement or may be adapted between a nasal and an oral configuration.
As shown, in some configurations the patient interface 200 may also comprise a gas sensing module 120 adapted to measure a characteristic of gases passing through the patient interface 200. The gas sensing module 120 could be located elsewhere within the gas delivery system and, for example, at the breathing conduit or humidifier. In some embodiments, there may be one or more gas sensing modules 120. In other configurations the gas sensing module 120 could be positioned and adapted to measure the characteristics of gases at or near other parts of the respiratory support system 100. The gas sensing module 120 may comprise one or more sensors adapted to measure various characteristics of gases, including but not limited to pressure, flow rate, temperature, absolute humidity, relative humidity, enthalpy, gas composition, oxygen concentration, carbon dioxide concentration (e.g. for determining end tidal CO2), and/or nitrogen concentration. Gas properties determined by the gas sensing module 120 may be utilized in a number of ways, including but not limited to closed loop control of parameters of the gases. For example, in some configurations flow rate data taken by a gas sensing module 120 may be used to determine the instantaneous flow, which in turn may be used to determine the respiratory cycle of the patient to facilitate the delivery of flow in synchronicity with portions of the respiratory cycle. The gas sensing module 120 may communicate with the controller 108 over a first transmission line 122. In some configurations, the first transmission line 122 may comprise a data communication connection adapted to transmit a data signal. The data communication connection could comprise a wired data communication connection such as but not limited to a data cable, or a wireless data communication connection such as but not limited to Wi-Fi or Bluetooth. In some configurations, both power and data may be communicated over the same first transmission line 122. For example, the gas sensing module 120 may comprise a modulator that may allow a data signal to be ‘overlaid’ on top of a power signal. The data signal may be superimposed over the power signal and the combined signal may be demodulated before use by the controller 108. In other configurations the first transmission line 122 may comprise a pneumatic communication connection adapted to transmit a gas flow for analysis at a portion of the respiratory support system 100.
Additionally as shown a physiological sensor module 121 may be present. The physiological sensor module 121 may be configured to detect various characteristics of the patient or of the health of the patient, including but not limited to heart rate, EEG signal, EKG/ECG signal, inertial sensors attached to the patient (e.g. to the chest) to detect movement, blood oxygen concentration (via, for example, a pulse oximeter), blood CO2 concentration, transcutaneous CO2 (TcC02) and/or blood glucose. Similarly, the physiological sensor module 121 may communicate with the controller 108 over a second transmission line 123. The second transmission line 123 may comprise wired or wireless data communication connections similarly to the first transmission line 122, and power and data may be communicated similarly. The physiological sensor module 121 may be used, for example, to determine the blood oxygen saturation of the patient.
The first gas conduit 202 is in pneumatic communication with a flow manifold 206. The flow manifold 206 receives gases from the first gas conduit 202 and passes them to one or more nasal delivery elements 208 (e.g. nasal prongs). The one or more nasal delivery elements 208 extend outwardly from the flow manifold 206. The one or more nasal delivery elements 208 are adapted to be non-sealing when positioned in one or more nares of the patient P. As shown, the patient interface 200 comprises two nasal prongs 208 adapted to be positioned one in each of the patient's nares. Each nasal prong 208 may be shaped or angled such that it extends inwardly towards a septum of the patient's nose. Alternatively the first patient interface 200 may be a sealing nasal interface.
In the embodiment shown in
In some configurations, the flow manifold 206 may be configured to receive flow from two lateral sides of the flow manifold 206 (e.g. from a ‘left’ and ‘right’ of the flow manifold 206 instead of just the patient's right hand side of the flow manifold 206 as seen in
The patient interface may further comprise mounts and/or supports, e.g., cheek supports 210, for attaching and/or supporting the gas conduit 202 or conduits on the patient's face. Alternatively or additionally, the patient interface may be held in place via one or more headstraps or headgear.
The first gas conduit 202 of the patient interface 200 comprises a first portion 204 configured to transition from a first configuration in which a first level of gases is able to pass through the first portion 204 to a second configuration in which a second level of gases is able to pass through the first portion 204.
A system may find benefit in the selective delivery of separate respiratory supports and/or therapies to a patient using different patient interfaces, and/or in stopping or ceasing the delivery of a respiratory support and/or therapy from an interface and/or allowing gases provided by an interface to be sampled.
The system and devices as described find particular application in emergency resuscitation, around intubation of a patient receiving high flow respiratory support and/or therapy, ear, nose, and throat (ENT) surgery, in assisting with conditioning of a patient in a pre-operative state prior to administration of anaesthetics, and during post-extubation and recovery.
Face mask assembly 300 may be used as or with a second respiratory support subsystem and/or to deliver one or more substances other than a substance delivered by the cannula 200, for example anaesthetic agents or oxygen, to the patient, or the same substance but at different flow and/or pressure levels. Alternatively, the face mask assembly 300 may be used to stop the delivery of respiratory support and/or therapy from a first respiratory support subsystem. The face mask assembly 300 may also be adapted to measure respiratory gases, for example exhaled carbon dioxide from the patient, the measurements of which may otherwise be affected by flow from the patient interface 200 of the first respiratory support subsystem.
Accordingly, the embodiment shown in
In the embodiment shown, face mask assembly 300 comprises a full face mask 302 configured to cover both the patient's nose and mouth. In other configurations, the face mask 300 may be a nasal mask which is placed over the patient interface 200 to cover only the patient's nasal region.
As shown, the face mask 302 comprises a seal region 304 adapted to seal against the patient's face. The face mask assembly 300 is connected to a second gas source, for example via a filter element 350 or a humidity moisture exchanger (not shown), which supplies the one or more other gases to the patient via the face mask. That is, the second gas source is preferably different from the source supplying gas (for example, supplementary gas source 124/flow generator 102) to the patient interface 200. In other embodiments, the patient interface 200 and the face mask assembly 300 are connected to a common gas source.
In an embodiment, the face mask assembly 300 is connected to a separate gas source or a separate respiratory support device. For example, the respiratory support can be a ventilator or a CPAP or a high flow respiratory support and/or therapy device or a manual resuscitator (for example a hand-held face mask with bag). Alternatively or in addition, the face mask assembly 300 may be connected to a device for measuring a characteristic of respiratory gases.
Alternatively, the mask assembly 300 could be connected to an anaesthetic device and anaesthetic gas, or air, or oxygen, or a combination of gases, can be delivered via the mask 302.
The embodiment shown in
In one particular application, a patient preparing for anaesthesia can be pre-oxygenated by delivering a high flow of oxygen or humidified gases or mixture of both via a nasal cannula. In some circumstances, anaesthesiologists managing the sedation and/or anaesthesia of a patient may want to switch between delivery of gas flow from one patient interface (for example a nasal cannula 200) and delivery of gas flow from another patient interface, such as via a face mask 300.
Anaesthesiologists also use a mask with a bag to oxygenate a patient, and in some instances find it more beneficial to use a bag mask if a patient's vital signs begin to drop for example to deliver more pressure or have greater control over the variation in delivered pressure. In some situations a medical professional may wish to switch between different respiratory systems or support modes. In a first mode respiratory support may be provided by a first respiratory support system (for example via the patient interface 200) and in a second mode respiratory support may be provided by a second respiratory support system (for example via the patient interface 300), with the support from the first system reduced or stopped. For example, the additional flow from a high flow provided by nasal interface 200 may also modify the expected behaviour of the anaesthetic circuit provided by the face mask 300, and therefore it may be advantageous to be able to reduce or stop the additional flow from the first respiratory system.
In some configurations, the switching between two respiratory support modes or subsystems may be facilitated by a structure of the first gas conduit 202, which has first portion 204 configured to transition from a first configuration in which a first level of gases is able to pass through the first portion 204 to a second configuration in which a second level of gases is able to pass through the first portion 204.
In some configurations, the first portion 204 is configured to be more collapsible or otherwise better adapted at changing the flow of gas through the first portion 204 (therefore reducing the flow of gas through the conduit and to the patient) than other portions of the conduit 202, and/or allowing a seal of a mask to seal over the top of the conduit. In other configurations the entire conduit may be configured to be collapsible. In some configurations a vent arrangement may be provided to vent gases from the conduit to atmosphere.
In some embodiments, the first configuration or first condition is a substantially open configuration and the second configuration or second condition is a substantially closed configuration. That is, the conduit 202 is configured to be more collapsible, deformable or otherwise adapted to fully close off the flow at the first portion 204 than at other portions of the conduit 202. In the second condition, gases to the nasal delivery elements 208 may be reduced or stopped.
The first portion 204 may progress between the first and second configurations based on a relative level of force applied to a wall of the first portion 204. For example, as shown in
Alternatively, the force may be applied to first portion 204 by other means, e.g., clamps (not shown), or alternatively a medical practitioner may compress the conduit by pressing on the conduit wall with a finger or thumb.
In some embodiments, the seal of the face mask acting on the first portion of the gas conduit causes the first portion to form a seal or at least a partial seal between the nasal outlets of the first patient interface 200 and the flow generator 102. Additionally, the seal of the face mask forms a seal or at least a partial seal over the first portion of the gas conduit.
Switching between respiratory support therapies is therefore achieved simply by applying a mask to the patient's face so that the seal of the mask collapses (partially or completely) the first portion of the gas conduit of the first interface 200 to ‘stop’ or ‘turn off’ or reduce the respiratory support and/or therapy supplied by the first interface 200 and also provides a seal between the face mask 300 and the external surface of the first portion 204 of the conduit 202 such that respiratory support and/or therapy can be provided by the mask 300 with the respiratory support and/or therapy provided by the first interface is stopped or reduced. As noted, the first portion 204 of the patient interface 200 is configured to be collapsible and will hereinafter be referred to as collapsible portion 204.
The cannula with a collapsible conduit portion allows a user, e.g. an anaesthetist or a nurse or a clinician to use a mask and prevent delivery of gases from multiple sources (e.g. the mask and cannula). The first interface 200 is structured and functions in a manner to reduce or close the delivery of high flow and other respiratory support and/or respiratory therapy or anaesthesia gases through a mask when the interface 200 is moved to a collapsed configuration. In some embodiments the removal of the mask from the patient's face allows the respiratory support and/or therapy supplied by the first interface to recommence, as the conduit returns from the collapsed configuration to the open configuration.
The gas sensing module 120 shown in
The gas sensing module 120 could be a separate component to the gas sampling interface and could be located elsewhere on the patient interface. The gas sensing module 120 could comprise a gas composition sensor and could be located in or at the sampling conduit and/or in or at the sampling outlet.
Alternatively, the gas sampling interface may include no sensors at the manifold portion nor any sensors at the patient. For example, the gas sampling interface may be configured for only the sampling inlet to be located at the patient and for the patient gas analysis to occur away from the patient, for example at a respiratory gas monitor. The gas sampling interface may therefore be used in the application of sidestream capnography. In this instance, the sampling outlet may facilitate delivery of the patient gas flow away from the patient and towards a respiratory gas monitor. The omission of sensors at the patient may in some instances improve accessibility for medical instruments.
In alternative embodiment (not illustrated), the gas sampling interface could include a passive sampling configuration and, for example, could be configured to sample the patient gases via colourimetry. In this instance, the sampling conduit could be configured to deliver patient gases to an assay of colorimetric reagents or to another form of colourimeter configured to indicate the presence or concentration of one or more particular gases in the patient gas flow. In some configurations, the gas sampling interface may include the colourimetry means in the sampling conduit or at the sampling outlet.
The gases delivery side member 401 includes a collapsible portion 404 configured to move from the normally open configuration shown in
One end of the non-collapsible portion 407 comprises a delivery inlet 407a for receiving apparatus gas flow. The patient interface 400 further includes a gas path connector 413 which has a rigid structure and includes a delivery inlet 413a and a delivery outlet 413b. The gas path connector delivery inlet 413a is connectable to an apparatus gas supply via a conduit (not shown). The gas path connector delivery outlet 413b is connected to the delivery inlet 407a of the non-collapsible portion 407. The gas path connector 413 is also connected to the headstrap 411 at an opposite end of the headstrap to that which is connected to the headstrap end 409 of the non-delivery side member 403.
The patient interface 400 illustrate in
In particular,
The gas sampling interface 515 includes a pair of spaced apart openings formed in a non-patient-facing wall 516 of the non-delivery member 503. The pair of spaced apart openings comprise an inlet port 517 and an outlet port 518 which is in fluid communication with the inlet port 517 via a sampling conduit 520 extending internally through the non-delivery side member 503.
The outlet port is located toward a headstrap end 509 of the non-delivery side member 503 which is configured for coupling to a headstrap. The inlet port 517 is positioned at or near the delivery outlet comprising nasal delivery prongs 508. The sampling conduit 520 extends along a length direction of the non-delivery side member 503. The inlet port 517 provides a sampling inlet through which patient gases can be received at the patient. The outlet port 518 provides a sampling outlet which is configured for fluid connection to a respiratory gas monitor.
In an embodiment, the sampling outlet may be connected in fluid communication with a respiratory gas monitor. The respiratory gas monitor (not shown) may apply suction or pressure or a vacuum through the sampling conduit 520 in order to draw and receive patient gas flow for analysis. In another embodiment, the respiratory gas monitor may passively receive the patient gas flow through the sampling conduit 520 i.e. the respiratory gas monitor may receive patient gas flow without drawing the patient gas flow via suction or pressure or a vacuum etc.
The patient-facing wall 514 and the non-patient-facing wall 516 extend between a pair of edges comprising an upper edge 522 and a lower edge 523.
As shown in
The cross-section of the non-delivery side member 503 is substantially symmetrical about the width axis Aw. In other embodiments, the cross-section may be asymmetrical and, for example, the sampling conduit 520 could be located closer to one of the upper or lower edges 522, 523. As seen in
The cross-section of the non-delivery side member 503 is asymmetric about the length axis AL. The asymmetry about the length axis AL is due to the patient-facing-wall 514 having greater curvature as compared to the non-patient-facing wall 516 which is substantially planar. The substantially planar configuration of the non-patient-facing wall 516 may help provide a seal between the non-patient-facing wall 516 and a seal of a patient face mask, which will be discussed in further detail below with reference to
Turning to
The inlet port 517 and outlet port 518 are positioned such that the mask 302 covers only the inlet port 517. In other words, the inlet port 517 lies within the cavity formed by the patient's face and the mask 302 when the mask 302 is applied over the patient interface 500 onto the patient's face. A sampling device (for example a sampling tube comprising the sampling inlet) may connect to the inlet port 517 and fit within the area under the mask 302. Alternatively, the inlet port 517 may not be connected to a sampling device and may itself provide the sampling inlet. The sampling lumen 520 acts as a tunnel under the mask seal 304 so as to provide fluid communication between the inlet port 517 and outlet port 518 and making available at the outlet port 518 a sample of the patient gas flow taken at the inlet port 517 which is located at the patient and also inside of the mask 302.
As will be appreciated from
This has usability benefits. For example, this may allow a user to continue monitoring a gas at the patient when a mask 302 is applied over the patient interface 500 without having to disconnect the gas sampling interface 515 from a respiratory gas monitor (e.g. capnography device) and reconnecting the respiratory gas monitor to another sampling interface (for example to a sampling port (not shown) in the mask 302. Additionally or alternatively, this may allow a user to monitor output from a single respiratory gas monitor rather than several monitors connected to various sampling interfaces (for example the gas sampling interface 515 and a sampling port on the mask 302), which could be confusing and thereby increase the risk of incorrect or inaccurate measurements.
The sampling device 827 comprises the sampling inlet for the gas sampling interface. The sampling device 827 is located at an end of the inlet sampling line 825 and is configured for positioning in front of the patient's face and/or around the face and/or inside the patient's mouth. The sampling device 827 could comprise a gas sampling tip equivalent or similar to that which has been previously described by the Applicant in International Patent Publication WO/2018/070885. In an alternative embodiment, the inlet sampling line 825 and outlet sampling line 828 are non-removably connected to the non-delivery side member 803 and could, for example, be moulded to the inlet 817 and outlet 818 respectively.
The inlet sampling lines 825, 925 shown in
The scoop 1032 has a substantially flat profile allowing it to fit under a patient mask applied over the top of the interface 1000. The scoop 1032 may be sized to cover a relatively small portion of the mouth in order to enable expiratory gas catchment but also allowing room for other medical equipment. The sampling conduit 1020 extends beneath an internal wall 1029 which separates the scoop 1032 from the gases delivery passage 1036 such that the sampling conduit 1020 does not interfere with the gas delivery passage 1036 providing gases to the nasal delivery prongs 1008. In other embodiments, the sampling conduit could extend within the gases delivery passage 1036. The mouth scoop 1032 may be made from or formed of a soft material allowing it to bend around instruments if necessary. The mouth scoop 1032 could be any suitable shape so as to limit interference with instruments which require mouth access.
The configurations shown in
The patient interface 1200 could also be provided with a mouth sampling scoop 1332 as is shown in
The patient interface 1400 further comprises a gases delivery side member 1401 which comprises a collapsible portion 1404
A variation to patient interface 1500 is shown in
The channel 1742 may be sufficiently deep so as to receive most or all of the diameter of the conduit 1720 and in order that the periphery of the non-delivery side member cross-section 1721 is not substantially increased or altered when the sampling conduit is fitted within the channel 1742. This may advantageously minimise disruption to the mask seal when placed over the top of the patient interface.
A variation to patient interface 1800 is shown in
The embodiments exemplified in
The preceding description of
The alternative configurations of the sampling conduit remaining open or becoming closed (i.e. the alternative configurations shown in
It will be appreciated that
A variation to patient interface 2600 is shown in
A variation to patient interface 2800 is shown in
The gas sampling interface may be formed of a different material than the collapsible portion. For example (and with reference to
As exemplified in various embodiments and including
The attachment ring 6140 further comprises a pair of clips 6167 forming hooks which comprise arms 6168 extending from the clip body 6141. The clips 6167 provide a concave receiving region 6170 within which a portion of the gas sampling conduit 6120 is received and held. The gas sampling conduit 6120 is threaded through the receiving regions 6170 as shown in
The ring 3258 shown in
The accessory 3358 further includes an attachment configuration 3372 for attaching the accessory 3358 to the patient interface 400. The attachment configuration 3372 includes an opening 3374 configured to receive and engage with the headstrap flange 3164 on the gas path connector 3113 shown in
The contact element 3370 includes a connection ring 3360 configured for connection with a sampling line such as the sampling line 3220 of
The sampling inlet 3417 may be configured for connection to a sampling device or sampling line. For example, via a luer lock, threaded connection, plug fit, barb fit. The sampling inlet 3417 may be integrally connected, for example moulded, to a sampling device or sampling line. The sampling outlet 3418 may be configured for connection with or may be integrally connected with an outlet line in fluid communication with a respiratory gas monitor. The sampling conduit 3420 is formed within the rigid material of the accessory 3458 and is therefore prevented from collapse during collapse of the collapsible portion thus enabling sampling to continue when apparatus gas flow through the collapsible portion is reduced or stopped.
Various embodiments of a patient interface are described above with reference to the accompanying Figures. It will be appreciated that the patient interface comprises a gases delivery interface which includes an apparatus gases flow path configured to provide apparatus gases to a patient. According to a particular embodiment, in the normally open configuration, the gases delivery interface is configured to allow an apparatus gas flow rate of about 20 L/min to about 90 L/min through the apparatus gases flow path. By way of example, with reference to the patient interface 500 illustrated in
In a particular embodiment, when the collapsible portion 504 is moved to the collapsed configuration, the patient interface 500 is configured to allow an apparatus gas flow rate through the apparatus gas flow path of the gases delivery member 501 that is at least 20 times greater than a patient gas flow rate through the gas sampling interface 515. For example, a flow rate through the gas sampling interface 515 (and through the sampling conduit 520) may be less than about 500 ml/min and a flow rate through the gases delivery member 501 when the collapsible portion 504 is in the closed configuration, may be less than about 10 L/min.
In a particular embodiment, when the collapsible portion 504 is in the collapsed configuration, the gases delivery member 501 is configured to allow an apparatus gas flow rate of less than about 10 L/min through the apparatus gases flow path and the gas sampling interface 515 is configured to allow a patient gas flow rate of less than about 500 mL/min, optionally about 40 mL/min to about 500 mL/min through the gas sampling interface 515.
It will be appreciated from the various illustrated embodiments that the patient interface can comprise a single sampling conduit. The provision of a single conduit only may advantageously minimise the number of conduits associated with the patient interface.
The sampling conduit 520 of
As noted, the first portion 204 of the patient interface 200 is configured to be collapsible and will hereinafter be referred to as collapsible portion 204. The accessory according to the various embodiments is configured to facilitate or otherwise enhance or promote collapse of the collapsible portion 204 in order to reduce or stop respiratory gas flow through the patient interface 200. In an example, the accessory according to the various embodiments is configured to facilitate or otherwise enhance or promote collapse of the collapsible portion 204 in order to reduce or stop respiratory gas flow to an outlet of the patient interface 200, e.g. prongs 208. The various accessory embodiments shown in
With reference to
The clip 3502 comprises a flexibly resilient c-clip configured to attach onto a portion of the patient interface 200. For example, the clip 3502 may attach to the gas conduit 202 of the patient interface 200 or to a gas connector. In an embodiment, the clip couples with a rigid support for increased stability. For example, the clip may couple with a rigid support of a gas connector. The clip 3502 includes a pair of flexibly resilient clip arms 3506 which are pre-formed with a curve conforming to the opposite curved sides 212 of the gas conduit 202, as best shown in
Returning to
Turning to
In use, the patient-facing surface 3514 of the straight portion 3508 faces toward (and may typically also be in contact with) the patient's face. As shown in
The contact surface 3512 defines a contact portion of the accessory which, in use, contacts the collapsible portion 204 and provides a rigid supporting surface between the collapsible portion 204 and the patient's face. The contact surface 3512 facilitates collapse of the collapsible portion 204 when a collapsing force is applied to the collapsible portion 204. For example, a collapsing force applied by a face mask which is overlaid across the collapsible portion 204 as shown in
As shown in
Turning to
In some configurations the flow of respiratory gases G towards the patient may be completely prevented. In other configurations there may remain a residual flow of respiratory gases from an upstream side 220 of the obstruction 3518 to a downstream side 222 of the obstruction 3518. In instances where a residual flow traverses the obstruction 3518 the total flow rate through the collapsible portion 204 is still significantly reduced as compared to the uncollapsed configuration shown in
As shown in
The accessory 3500 illustrated in
Turning to
The accessory 3600 includes a C-shaped clip 3602 which is equivalent to clip 3502 in the preceding embodiment. The clip 3602 includes a pair of resilient clip arms 3606 extending, in use, away from the patient's face. Clip 3602 allows removable attachment of accessory 3600 with the patient interface 200. The accessory 3600 includes a support member 3604 extending between the clip 3602 and a contact element 3616. The contact element 3620 has an elongate profile orientated generally perpendicular to the support member 3604. The contact element includes a flat base 3622 defining a portion of the patient-facing surface 3614. A tapered rib 3618 is located on an opposite side of the contact portion 3620 from the flat base 3622. The tapered rib 3618 extends a non-patient-facing direction and, in use, extends outwardly from the patient's face. In particular embodiments, the rib may not necessarily be tapered and may have a non-tapered configuration such as generally flat contact surface.
The support member 3604 comprises an elongate bar with a pre-formed curve to conform the support member 3604 with a contour of the patient's face and/or of the gas delivery conduit 202 shown in
As shown in
As will be appreciated from the collapsed configurations illustrated in
Turning to
The plurality of ribs 3618 are configured to concentrate force onto a plurality of discrete interfaces at the tip of each rib 3618. The valleys between adjacent ribs 3618 may also provide a series of cavities 3728 into which the patient-side 224 of the collapsible portion 204 may be collapsed into. This may assist in transforming lumen 205 into a tortuous or kinked passage of having flow resistance and thereby lowering or preventing residual flow through the collapsible portion 204 when in the collapsed configuration. The backing plate 3708 therefore provides a rigid support surface which contributes a reaction force onto the collapsible portion, as described above with reference to accessory 3500. Furthermore, the ribs 3718 may act to concentrate the reaction force and thereby amplify the pressure applied to the patient-facing surface of the collapsible portion. These combined effects thereby facilitate collapse of the collapsible portion.
Turning to
In use, the ribs 3818 help locate the collapsible portion 204 onto the saddle 3832 such that the collapsible portion is restricted from movement in a direction perpendicular to axis L during application of pressure onto a non-patient side of the collapsible portion. The configuration of ribs 3818 and saddle 3832 therefore help maintain the collapsible potion in a desired position on contact surface 3812. Furthermore, the ribs 3818 promote a higher pressure applied to the edges of the collapsible portion along a longitudinal direction. This may help promote a more complete collapse of (and achieve greater occlusion of) the collapsible portion. In particular, this configuration may reduce or prevent the formation of longitudinally extending residual channels formed in one or more edge regions of the collapsible portion, when in the collapsed configuration. The longitudinal orientation of ribs 3818 and the positioning of ribs so as to engage opposing edge regions of the collapsible portion may increase pressure applied to the regions of the collapsible portion where said channels may be most likely to occur. Positioning ribs 3818 at these positions and in the longitudinal orientation may promote a higher pressure applied to the channels and thereby promoting sealing or narrowing of the channels or may prevent or reduce the formation of the channels.
The above-noted advantages of the accessory 3800 will be further described with reference to
With reference to
Turning to
Turning to
The residual channels 209 may not necessarily form at edge regions of the collapsible portion 204 in the collapsed configuration, and could form anywhere along the width of the collapsed collapsible portion 204. Therefore, the accessory 3800 may be configured such that ribs 3818 may be located anywhere along the width of seat 3832 to facilitate collapse of such residual channels 209. In such instances, the seat 3832 may no longer be saddle-shaped and may comprise other shape profiles.
Turning to
The abutment surface 3918 provides a rigid surface against which the non-patient side of the collapsible portion can be compressed by the applied external force (e.g. by a cuff of a patient mask or by a user's hand) and thereby facilitating collapse of the collapsible portion. The contact element 3920 extends in the non-patient facing direction from the support element such that a corner cavity 3928 is formed between the support member 3904 and the contact element 3920. In use, the corner cavity provides a volume for the patient-side of the collapsible portion to collapse into forming a tortuous or kinked flow path within the collapsible portion and thereby further reducing residual gas flow in the collapsed configuration.
An applied force FA is applied to the non-patient-facing surface 216 of the collapsible portion 204. The contact element 3920 provides a pivot point about which the collapsible portion 204 may be folded upon application of the applied force FA. The applied force FA may induce a double bending moment in the collapsible portion. As indicated by arrows B1 and B2, the double bending comprising a first bending moment B1 occurring about the contact element 3920 and a second bending moment B2 occurring about the clip 3902 and/or the inside edge 3911 of the curved portion 3910 of the support member 3904. The collapsible portion may be caused to collapse, fold or kink in at least one position (and potentially two or more positions) and with the collapsible portion collapsing into the space 3929. As exemplified in
Still referring to
Turning to
Turning to
Each of the first and second lever arms 4102, 4104 include a contact portion comprising a rib 4118 for concentrating force onto the collapsible portion. The second lever arm 4104 includes an opening 4114 configured to receive the collapsible portion and whereby, in use, the collapsible portion extends through the opening and is located between the first and second lever arms 4102, 4104. In an alternative embodiment, the first level arm 4102 includes the opening 4114 configured to receive the collapsible portion and whereby, in use, the collapsible portion extends through the opening and is located between the first and second lever arms 4102, 4104.
A distal end of the second lever arm 4104 provides a force-application portion 4120 for receiving the applied force from a bag mask applied to the patient's face. The force-application portion includes an application surface 4122 onto which the force is applied and whereupon the second lever arm 4104 is rotated about the hinge arrangements 4106 toward the first lever arm 4102 causing the collapsible portion to become clamped and squeezed between the ribs 4118 of the first and second lever arms 4102, 4104.
The rib 4118 of the second lever arm 4104 is positioned between the application surface 4122 and the hinge arrangements 4106 such that the accessory 4100 comprises a second-class lever configuration i.e. a ‘nut-cracker’ lever configuration. The force delivered to the collapsible portion at the ribs 4118 is therefore an amplification of the force applied to the application surface 4122. The extent of the force amplification will be dependent on the particular configuration of the lever arms and, in particular, the distance between the application surface 4122 and the rib 4118 on the second lever arm 4104. It will be appreciated that the greater the distance between the rib 4118 on the second lever arm 4104 and the application surface 4122, the greater the degree of force amplification. For example, the degree of force amplification may be increased by either positioning rib 4118 closer to hinge arrangement 4106 and/or by increasing the length of the second lever arm 4104 such that the distance between application surface 4122 and the rib 4118 is increased.
Turning to
The accessory 4200 also differs from the accessory 4100 in that the hinge arrangement 4206 of accessory 4200 has an open configuration whereby hinge pins 4208 are snap-fitted into a pin recess 4210 formed in hinge portions 4212. This configuration allows for the second lever arm 4204 to be disconnected from the first lever arm 4202 and subsequently reconnected by snap-fitting the hinge pins 4208 into the recesses 4200. In use, the accessory 4200 may be installed onto the gas delivery conduit during operation of the patient interface by temporarily disconnecting the first and second lever arms 4202, 4204 from each other such that the first lever arm 4202 is located between the patient's face and a patient-facing surface of the collapsible portion. The second lever arm 4204 may then be fitted over the gases delivery conduit which is received within the open-ended opening 4214 and the second lever arm 4204 then snap-fitted together with the first lever arm 4202 at the hinge arrangements 4206. The accessory 4200 may be connected onto an operational patient interface and then slid along the gases delivery conduit until the collapsible portion is located between the ribs 4218. This configuration may also allow for the accessory to be conveniently removed from an operational patient interface, if required.
It will be appreciated that the accessory 4100 in
Turning to
As shown in
Turning to
As shown in
In some embodiments, the base plate 4302 may be provided by the backing plate of one of the above-discussed embodiments of the disclosure. Returning briefly to
An earlier embodiment of an accessory intended to facilitate collapse of a collapsible portion was disclosed in Applicant's International Patent Application PCT/IB2019/051137.
In the embodiment illustrated in
Whilst
In an alternative embodiment (not illustrated) a variation of the pivot arm 4480 includes only a single side member 4482 such that the pair of cylindrical bars 4484 and a single side member 4482 form a U-shape.
The combination of a backing plate 4404 and pivot ring 4430 provides a significant improvement over the ring 215 disclosed in Applicant's earlier patent application PCT/IB2019/051137. In particular, the backing plate 4403 enables the ring 4430 to be properly located at a desired position. Furthermore, the recess 4406 provides improved rotational movement of the pivot ring 4430 which further enhances the collapse achieved during use.
Turning to
The backing plate 4404B is equivalent in configuration to the backing plate 4404 illustrated in
Furthermore, a distance D1 between the outer edges of the side projections 4401B is larger than a distance D2 between the inner edges of the side members 4482B. When accessory 4400B is not attached to a patient interface, pivoting movement of the pivot arm 4430B toward the contact surface 4412B will therefore result in contact between the side members 4482B and the side projections 4401B. In use, when accessory 4400B is attached to a patient interface and wherein the collapsible portion of a gases delivery conduit extends through the opening 4415B, pivoting movement of the pivot arm 4430B toward the contact surface 4412B causes the collapsible portion to become pinched between the pivot member 4430B and the contact surface 4412B. In particular, the longitudinal side portions (for example side portions 207 illustrated in
Turning to
This configuration may urge part of the collapsible portion to kink or fold into the recess 4421C. This configuration may also provide two pinch points in that the collapsible portion is pinched between, firstly, the top member 4483C and a first of the ribs 4418C and, secondly, the top member 4483C and a second of the ribs 4418C. The contact portion 4420C is configured to contact a patient-facing-surface of the collapsible portion at a collapse location and to thereby facilitate collapse of the collapsible portion when the collapsible portion is pinched between ribs 4418C and a top member 4483C of the pivot member 4430C.
Turning to
As with accessory 4400 illustrated in
Turning to
The first lever arm 4502 comprises a C-shaped member extending outwardly from the fulcrum 4506. The first lever arm 4502 defines an opening 4514 which provides an attachment configuration allowing attachment of the accessory to the collapsible portion. In particular, the opening 4514 is configured for the collapsible portion 204 to, in use, extend therethrough.
The second lever arm 4504 comprises an elongate bar 4508 extending from the fulcrum 4506 and a cylindrical bar 4510 at the distal end of elongate bar 4508. The cylindrical bar 4510 has a longitudinal axis perpendicular to a longitudinal axis of the elongate bar 4508. The angle α between the longitudinal axes of the first and second lever arms 4502, 4504 may depend on the length or other configuration of the first and second lever arms. According to a particular embodiment the angle α is an obtuse angle i.e. between 90-180°.
The first lever arm 4502 has a longitudinal axis A1. The second lever arm 4504 has a longitudinal axis A1. The fulcrum comprises a rigid corner 4506 extending along an interface of the first and second lever arms 4502, 4504 and perpendicularly to the longitudinal axes A1, A2. The corner 4506 provides a tilt edge and defines an axis of rotation AR about which the first and second lever arms 4502, 4504 can rotate when the corner 4506 is located on a surface.
The first lever arm 4502 includes a contact section 4503 extending generally parallel with the corner 4506. The contact section 4503 and the cylindrical bar 4510 provide a pair of distinct contact portions configured to apply a collapsing force to the collapsible portion, as will be discussed in further detail below with reference to
In use, the application of a force such as a force from a bag mask is applied to the contact portion 4503 of the first lever arm 4502 and in a direction toward the patient's face. The applied force causes the accessory 4500 to pivot about the corner 4506 and causing movement of the second lever arm 4504 in a direction away from the patient's face and toward the collapsible portion 204. The movement of the second lever arm 4504 causes the cylindrical bar 4510 to press into the patient-facing surface 214 of the collapsible portion 204. Simultaneously, the pivoting movement of the accessory 4500 causes the contact portion 4503 of the first lever arm 4502 to press into the non-patient-facing surface 216 of the collapsible portion 204. The collapsible portion 204 is therefore caused to collapse at least at two separate and spaced apart locations and in two different directions by the contact portion 4503 and cylindrical bar 4510 respectively.
Turning to
The upper and lower bars 4618, 4620 are connected to one another in spaced apart relation by a biasing arrangement comprising four flexibly resilient linkages 4606. The linkages 4606 have a normally non-linear formation and, in particular, have a V-shaped configuration. In alternative embodiments the linkages may have a C-shaped or U-shaped configuration. The linkages 4606 each comprise an upper portion 4640 and a lower portion 4642 connected at a corner 4640. The upper portions 4640 extend between the upper bar 4618 and the corner 4640. The lower portions 4642 extend between the corner 4640 and the lower bar 4620. As shown in
The linkages 4606 have a normal configuration shown in
Turning to
The diameter of the upper and lowers bars 4618 and 4620 is relatively small and, in particular, is smaller than the width of the mask cuff 304. The force from the mask cuff 304 is thereby concentrated onto the collapsible portion 204 at the upper and lowers bars 4618 and 4620 which consequentially delivers a pressure onto the collapsible portion 204 which is greater than the pressure applied by the mask cuff 304. As shown in
Upon release of the load applied by the mask cuff 304, the resiliency of the linkages 4606 will urge the accessory 4600 to return to the normal configuration shown in
The resiliency of linkages 4606 may be due to material and/or geometry. The accessory 4600 may be formed of more than one material and whereby different parts of the accessory are formed of material which contributes to the desired characteristics of that part. For example, the linkages 4606 may be formed of a resilient material to enable their flexibly resilient function whereas the upper and lower bars 4618, 4620 may be formed of a rigid material.
Turning to
The upper clamping plate 4918 includes a concentration formation 4930 comprising a plurality of ribs on the patient-facing surface 4918b. The lower clamping plate 4920 includes an equivalent concentration formation 4930 on the non-patient-facing surface 4920a. In some embodiments, only one of the upper or lower clamping plates 4918, 4920 comprises a concentration formation 4930. The void between the opposing clamping plates 4918 and 4920 is bounded by the linkages 4906 and defines an opening 4946 configured for the collapsible portion to extend therethrough. In an alternative embodiment (not illustrated) the concentration formation 4930 comprises a series of discrete protrusions such as a series of teeth which creates multiple tortuous paths in the collapsed configuration.
Turning to
Upon release of the applied force from the mask cuff 304, the resiliency of the linkages 4906, the resiliency of the collapsible portion 204 and/or the pressure of the respiratory airflow provided through the collapsible portion 204 will urge the accessory 4900 to return to the normal configuration shown in
According to a particular embodiment, the opposing concentration formations 4930 may be configured such that the peaks of the ribs on one of the concentration formations 4930 are aligned for receipt with the troughs of the opposing concentration formations. For example, with reference to
Turning to
The accessory 5000 further includes a curved portion 5074 extending from the lower clamping plate 5020. The curved portion is configured to conform and nest with the curved portion 3510 of the backing plate 3504 when backing plate 3504 is inserted into the opening 5070. In some embodiments, the curved portion 5074 is formed of a flexibly resilient material which is soft, and may act as a cushion between the rigid backing plate 3504 and the patient's face.
The assembly and cooperation of accessory 3500 and accessory 5000, as illustrated in
The cooperative combination of accessory 3500 and accessory 5000 may also enable the convenient use of different materials having different material properties. In this manner, various material properties can be utilised in an advantageous way but also allowing for each accessory to be formed of a single material. For example, the accessory 3500 may be formed of a relatively rigid material providing a rigid support and responsive when the external force is applied. The accessory 3500 may therefore be formed of a single rigid material which improves manufacturing efficiency and reduces cost. Similarly, the accessory 5000 may be formed of a single material that is flexibly resilient. That is, the upper and lower clamping members 5018 and 5020 may be formed of the same material as the flexible linkages 5006. The use of a single material in each of the two accessories may reduce and simplify manufacturing costs as well as improve article quality insofar as the manufacturing process is simplified. In other embodiments, the accessory may be produced using over moulding to make part or all of the accessory from different materials.
The lower clamping member 5120 includes a neck 5171 which includes an opening 5170 leading to an internal void (not shown) inside the lower clamping member 5120. The neck 5171 includes a pre-formed curve corresponding to a pre-formed curve of the backing plate 3504 of accessory 3500. The internal void and the opening 5170 are configured to receive a distal end of backing plate 3504 of accessory 3500. In use, the distal end of the backing plate 3504 (i.e. the end opposite to the clip 3502) is inserted through opening 5170 such that the accessory 5100 is fitted onto the backing plate 3504. The lower clamping member 5120 may be formed of a resilient material which allows resilient deformation of the curved neck 5171 to assist in locating the backing plate 3504 within the internal void.
In use, the accessory 5100 of
Turning to
In use, the accessory 5200 is fitted onto the backing plate 3504 of accessory 3500 in a similar configuration to that which is illustrated in
Turning to
Turning to
Turning to
Turning to
The second clip 5603 includes a pair of resilient U-shaped arms 5605 configured to clip onto longitudinal edges 5681 of the projection 5680 on the gas path connector 5640. The second clip 5603 is configured to help retain accessory 5600 in position with respect to the gases delivery conduit. In particular, the second clip 5603 is configured to resist rotational movement of the accessory 5600 around the circumference of the gases delivery conduit.
In other embodiments, the second clip 5603 may connect with another region of the same portion to which the C-shaped clip 5602 connects, where the second clip 5603 may be spaced away from the C-shaped clip 5602. In such embodiments, the second clip 5603 may comprise a shape that is substantially similar to that of the C-shaped clip 5602, i.e. the accessory 5600 comprises two C-shaped clips. In other embodiments, the second clip 5603 comprises a shape that corresponds to the portion of the patient interface to which it connects. In other embodiments, the C-shaped clip 5602 and/or second clip 5603 may be an attachment means which include but are not limited to adhesives, hook-and-loop fasteners, plug and socket attachments, etc.
It will be appreciated that certain embodiments of an accessory according to the present disclosure may have a one-part or unitary configuration whereas other embodiments comprise a multi-part or assembly configuration. For example, the embodiments of accessory 3500, accessory 3600, accessory 3600A, accessory 3700, accessory 3800, accessory 3900, accessory 4000, accessory 4500, accessory 4600, accessory 4700, accessory 4800, accessory 4900, accessory 5000 and accessory 5500 may comprise a single component and might be produced via a single manufacturing technique such as injection moulding. Other embodiments such as accessory 4100, accessory 4200, accessory 4300, accessory 4400, accessories 4400A-D and accessory 5300 may include multiple and/or moving parts or assemblies of parts and may therefore require production in different or separate manufacturing techniques.
The accessory of the present disclosure may be produced using one or more of manufacturing techniques including injection molding, overmolding, and additive manufacturing such as 3D printing. In some embodiments, injection moulding could be used to produce an accessory made from more than one material. In embodiments where a part is formed of metallic material then this part may be producing using machining.
The inventions 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.
Where any or all of the terms “comprise”, “comprises”, “comprised” or “comprising” are used in this specification (including the claims) they are to be interpreted as specifying the presence of the stated features, integers, steps or components, but not precluding the presence of one or more other features, integers, steps or components or group thereof.
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 | Kind |
|---|---|---|---|
| 2021221742 | Aug 2021 | AU | national |
This disclosure claims priority from U.S. provisional patent application 63/362,486 filed on 5 Apr. 2022 and from Australian Patent Application No. 2021221742 filed on 25 Aug. 2021, the contents of each should be understood to be incorporated herein by this reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2022/057911 | 8/24/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63362486 | Apr 2022 | US |
