Improved gas collector and gas delivery patient interface
The gas collector with angled inlet openings and mouth sampling part addresses inconsistent sampling in high-flow gas delivery by ensuring reliable collection and analysis of exhaled gases, improving patient monitoring accuracy.
Patent Information
- Application Number
- PCT/IB2025/051579
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-10-17
- Filing Date
- 2025-02-14
- Publication Date
- 2025-08-21
AI Technical Summary
Existing gas collectors and patient interfaces for monitoring exhaled gases during high-flow gas delivery to patients face challenges such as gas dilution, enhanced gas concentrations, and variability in exhalation pathways, leading to inconsistent sampling results.
A gas collector with a nose sampling part positioned between nasal prongs of a gas delivery patient interface, featuring inlet openings angled differently from the exhalation direction, and a mouth sampling part for consistent gas collection, connected to a conduit for analysis.
Enables consistent sampling of exhaled gases regardless of exhalation variability, providing accurate monitoring of patient conditions during high-flow gas delivery.
Smart Images

Figure IB2025051579_21082025_PF_FP_ABST
Abstract
Description
Improved Gas Collector and Gas Delivery Patient InterfaceTechnical Field
[0001] This disclosure relates to a gas collector for collecting gases at a patient, and a gas delivery patient interface having a gas collector. The gas collector and gas delivery patient interface are suitable for use in applications requiring the collection and monitoring of gases exhaled by a patient from their nasal passages and / or oral passage whilst providing gas flow to a patient. It will be convenient to describe the gas collector and the gas delivery patient interface in relation to that exemplary but non-limiting application.Background of Invention
[0002] Medical procedures may involve procedural sedation or general anaesthesia, collectively known as anaesthetic procedures. In procedural sedation, a patient may have diminished respiratory function or risk thereof due to the anaesthetic agents and may become apnoeic. In general anaesthesia, patients will likely require mechanical ventilation if they become apnoeic. Pre-oxygenation of the patient prior to administration of anaesthetic agents is encouraged. During pre-oxygenation, also known as de-nitrogenation, the patient is provided with oxygen to saturate their body's stores, including blood and lungs, to delay or avoid oxygen desaturation when the patient has diminished respiratory function or is apnoeic. Pre-oxygenation also reduces the patient's blood and lung carbon dioxide levels, and nitrogen levels in the lungs due to replacement by oxygen.
[0003] Nasal High Flow (NHF) can be used in anaesthetic procedures to pre-oxygenate a patient, maintain adequate oxygenation and prevent desaturation, and in general anaesthesia when the patient becomes apnoeic, extend safe apnoea time. NHF utilises a nonsealing patient interface such as a nasal cannula to deliver breathable gases, for example oxygen or oxygen enriched air or air, to a patient. NHF may also be used in other environments, such as wards, emergency departments and intensive care units (ICUs).
[0004] The above discussion of the background to the disclosure is intended to facilitate an understanding of the disclosure. However, it is to be appreciated that the discussion is notan acknowledgement or admission that any aspect of the discussion was part of the common general knowledge of a skilled addressee as at the priority date of any of the claims.Summary of Invention
[0005] According to one aspect of the invention, there is provided a gas collector for collecting gases at a patient, the gas collector including a gas sampling portion for sampling gases at the patient, and a coupling mechanism for coupling the gas sampling portion to a gas delivery patient interface, the gas delivery patient interface having a body having a flow manifold for receiving a flow of gases for delivery to the patient, and a pair of nasal prongs extending from the body for delivering the flow of gases to the patient via the patient's nares, the gas sampling portion having a nose sampling part configured for positioning above the body and between the nasal prongs of the gas delivery patient interface, the nose sampling part defining at least one inlet opening to sample gases at the patient's nose, wherein the position of the at least one inlet opening is fixed relative to the coupling mechanism.
[0006] Optionally, the nose sampling part may be configured for positioning above the flow manifold between the nasal prongs of the gas delivery patient interface.
[0007] The at least one inlet opening of the nose sampling part may enable sampled gases exhaled from the patient's nose to enter the nose sampling portion at an inlet flow entry direction. The inlet flow entry direction may be generally different to a direction of exhaled gases from the patient's nose.
[0008] The inlet flow entry direction may be generally perpendicular to a surface of the nose sampling part on which the at least one inlet is defined.
[0009] The inlet flow entry direction may be generally perpendicular to the direction of exhaled gases from the patient's nose.
[0010] The inlet flow entry direction may be different to a flow direction of gases delivered to the patient's nares via the nasal prongs.
[0011] The nose sampling part may define at least two inlet openings. Each inlet opening may be positioned on an opposite side of the nose sampling part.
[0012] The nose sampling part may define a plurality of inlet openings.
[0013] The nose sampling part may be configured for positioning under the patient's septum or columella in use.
[0014] The nose sampling part may be configured for positioning in a space between the gas delivery patient interface and the patient's septum or columella in use.
[0015] The body and / or flow manifold may have a bridging portion extending between the nasal prongs. The nose sampling part may be configured for positioning over the bridging portion of the body and / or flow manifold of the patient interface.
[0016] The nose sampling part may be configured for positioning in a space between the patient's septum, the bridging portion and the nasal prongs.
[0017] The nose sampling part may be configured such that the at least one inlet opening is located proximal to a base of the nasal prongs adjacent the body of the patient interface when the gas collector is mounted to the patient interface.
[0018] The body of the patient interface may have an inner wall for facing the patient in use, and an outer wall opposite the inner wall, the outer wall facing away from the patient in use. The nose sampling part may be configured such that the at least one inlet opening is located proximate any one of the inner wall, the outer wall, a central region between the inner wall and outer wall of the body.
[0019] The nasal prongs may have opposing inner side wall portions, and the at least one inlet opening may be located on a face of the nose sampling part facing and offset from an inner side wall portion of a respective nasal prong.
[0020] The at least one inlet opening may be offset from a central plane of the gas delivery patient interface. The central plane may extend between the nasal prongs such that the nasal prongs are spaced at generally equal distances from the central plane.
[0021] The coupling mechanism may be configured for releasable attachment to the body of the gas delivery patient interface.
[0022] The coupling mechanism may include a loop configured for attachment around the bridging portion of the gas delivery patient interface.
[0023] The coupling mechanism may be configured for attachment to one or both of the nasal prongs of the gas delivery patient interface.
[0024] The coupling mechanism may include one or more rings configured for attachment to one or both of the nasal prongs of the gas delivery patient interface.
[0025] The coupling mechanism may include a pair of rings. Each ring may be configured for attachment to a respective one of the pair of nasal prongs.
[0026] The coupling mechanism may define one or more further inlet openings thereon to sample gases at the patient's nose.
[0027] Each of the one or more rings may comprise a conduit.
[0028] Each conduit may define one or more further inlet openings thereon to sample gases exhaled from the patient's nose.
[0029] The coupling mechanism may include one or more C-shaped or U-shaped portions for mounting to the body and / or nasal prongs of the gas delivery patient interface.
[0030] The sampling portion may further include a mouth sampling part configured to extend below the body of the gas delivery patient interface for placement adjacent the patient's mouth in use. The mouth sampling part may define at least one inlet aperture to sample gases at the patient's mouth.
[0031] The mouth sampling part may include a mouth sampling guide configured to extend below the body of the gas delivery patient interface. The mouth sampling guide mayhave a mouth sampling end portion defining the at least one inlet aperture to sample gases at the patient's mouth. The mouth sampling end portion may be located at one end of the mouth sampling guide.
[0032] The mouth sampling guide may be pliable so as to allow selective repositioning of the mouth sampling end portion.
[0033] The mouth sampling guide may be selectively removable.
[0034] The mouth sampling guide may be offset from a central plane of the gas delivery patient interface. Typically, the central plane extends between the nasal prongs such that the nasal prongs are spaced at generally equal distances from the central plane.
[0035] The mouth sampling guide may be oriented at an angle relative to the central plane.
[0036] The angle may be a predetermined angle.
[0037] In one embodiment, the angle may be generally between -100° and 100°.
[0038] The gas collector may further include an outlet portion defining an outlet. Gases collected by the gas sampling portion may exit the gas collector via the outlet.
[0039] The outlet may be configured to connect with a conduit for delivering the gases collected by the gas sampling portion to one or more sensor units.
[0040] The gas collector may further include one or more flow guides for guiding gases from the patient towards the gas sampling portion.
[0041] The flow guides may be configured to guide gases from the patient's nose towards the at least one inlet opening of the nose sampling part.
[0042] The gas collector may include a pair of flow guides. Each flow guide may extend from an opposite side of the nose sampling part.
[0043] The pair of flow guides may be configured for positioning between the nasal prongs in use. Each flow guide may define a curved surface for guiding a flow of gases from the patient's nose towards the at least one inlet opening of the nose sampling part.
[0044] The gas sampling portion may be rigid.
[0045] The gas sampling portion may be generally fixed relative to the coupling mechanism.
[0046] The coupling mechanism may allow coupling to a malleable portion of the gas delivery patient interface.
[0047] According to another aspect of the invention, there is provided a gas collector for collecting gases at a patient, the gas collector including a gas sampling portion for sampling gases at the patient, and a coupling mechanism for coupling the gas sampling portion to a gas delivery patient interface, the gas delivery patient interface having a body having a flow manifold for receiving a flow of gases for delivery to the patient, and a pair of nasal prongs extending from the body for delivering the flow of gases to the patient via the patient's nares, the gas sampling portion having a nose sampling part configured for mounting above the body and between the nasal prongs of the gas delivery patient interface, the nose sampling part defining at least one inlet opening to sample gases at the patient's nose.
[0048] According to yet another aspect of the invention, there is provided a gas delivery patient interface for delivering gases to a patient, the gas delivery patient interface including a body having a flow manifold for receiving a flow of gases for delivery to the patient, and a pair of nasal prongs extending from the body for delivering the flow of gases to the patient via the patient's nares, a gas sampling portion for sampling gases at the patient, the gas sampling portion having a nose sampling part provided above the body and between the nasal prongs of thegas delivery patient interface, the nose sampling part defining at least one inlet opening to sample gases from the patient's nose.
[0049] In some embodiments, the nose sampling part may be configured for positioning above the flow manifold between the nasal prongs of the gas delivery patient interface.
[0050] The gas sampling portion may be integral with the body and / or nasal prongs.
[0051] The at least one inlet opening of the nose sampling part may enable sampled gases from the patient to enter the nose sampling portion at an inlet flow entry direction. The inlet flow entry direction may be different to a direction of exhaled gases from the patient's nose.
[0052] The inlet flow entry direction may be generally perpendicular to a surface of the nose sampling part on which the at least one inlet is defined.
[0053] The inlet flow entry direction may be generally perpendicular to the direction of exhaled gases from the patient's nose.
[0054] The inlet flow entry direction may be different to a flow direction of gases delivered to the patient's nares via the nasal prongs.
[0055] The nose sampling part may define at least two inlet openings. Each inlet opening may be positioned on an opposite side of the nose sampling part.
[0056] The nose sampling part may define a plurality of inlet openings.
[0057] The nose sampling part may be configured for positioning under the patient's septum in use.
[0058] The body may have a bridging portion extending between the nasal prongs. The nose sampling part may project from the bridging portion of the body. The nose sampling part may be positioned in a space between the patient's septum, the bridging portion of the body and the nasal prongs in use.
[0059] The sampling portion may further includes a mouth sampling part configured to extend below the body for placement adjacent the patient's mouth in use. The mouth sampling part may define at least one inlet aperture to sample gases at the patient's mouth.
[0060] The mouth sampling part may include a mouth sampling guide configured to extend below the body of the gas delivery patient interface. The mouth sampling guide may have a mouth sampling end portion defining the at least one inlet aperture to sample gases at the patient's mouth. The mouth sampling end portion may be located at one end of the mouth sampling guide.
[0061] The mouth sampling guide may be pliable so as to allow selective repositioning of the mouth sampling end portion.
[0062] The mouth sampling guide may be selectively removable.
[0063] The mouth sampling guide may be offset from a central plane of the gas delivery patient interface. Typically, the central plane may extend between the nasal prongs such that the nasal prongs are spaced at generally equal distances from the central plane.
[0064] The mouth sampling guide may be oriented at an angle relative to the central plane.
[0065] The angle may be predetermined angle.
[0066] The angle may be generally between -100° and 100°.
[0067] The gas delivery patient interface may further include an outlet portion defining an outlet. The gases collected by the gas sampling portion may exit the gas collector via the outlet.
[0068] The outlet may be configured to connect with a conduit so as to deliver gases collected by the gas sampling portion to one or more sensor units.
[0069] The gas delivery patient interface may further include one or more flow guides for guiding gases exhaled from the patient towards the gas sampling portion.
[0070] The flow guides may be configured to guide gases from the patient's nose towards the at least one inlet opening of the nose sampling part.
[0071] The gas collector may include a pair of flow guides. Each flow guide may extend from an opposite side of the nose sampling part.
[0072] The pair of flow guides may be configured for positioning between the nasal prongs.
[0073] Each flow guide may define a curved surface for guiding a flow of gases from the patient's nose towards the at least one inlet opening of the nose sampling part.
[0074] The gas sampling portion may be rigid.
[0075] According to another aspect of the invention, there is provided a patient interface assembly including a gas delivery patient interface for delivering a flow of gases to the patient, and a gas collector according to any one of the embodiments described herein.
[0076] The patient interface assembly may include a gas delivery patient interface according to any one of the embodiments described herein.
[0077] The patient interface assembly may further include a filter for filtering a backflow of gases from the patient. The filter may be mounted upstream of the gas delivery patient interface.
[0078] The patient interface assembly may further include a conduit for connecting the gas delivery patient interface and the filter.
[0079] According to a further aspect of the invention, there is provided a kit including a gas delivery patient interface for delivering a flow of gases to the patient, and a gas collector according to any one of the embodiments described herein.
[0080] According to a further aspect of the invention, there is provided a kit including a gas delivery patient interface having an integral gas collector as described herein.
[0081] The kit may further include any one or more of at least one gas flow conduit, an inspiratory limb, and a humidification chamber.
[0082] According to a further aspect of the invention, there is provided a gas collector for collecting gases at a patient, the gas collector including a gas collection portion for collecting at least a portion of gases exhaled from the patient via the patient's nose and / or mouth, and a coupling mechanism for coupling the gas collection portion to a gas delivery patient interface, the gas delivery patient interface being adapted to deliver gases to the patient, wherein the gas collection portion is configured to provide damping of external forces applied to the gas collection portion so as to reduce the transfer of forces between the gas collection portion and the coupling mechanism.
[0083] The gas collection portion may include a resilient material to facilitate damping of the external forces applied thereto. The coupling mechanism may include a rigid material to facilitate stabilising the gas delivery patient interface.
[0084] The coupling mechanism may include an engagement portion for engagement with the gas delivery patient interface.
[0085] The engagement portion may include a U-shaped holder for receiving the gas delivery patient interface therein.
[0086] The gas delivery patient interface may include a nasal cannula.
[0087] The gas collector may further include a gas collection inlet in fluid communication with the gas collection portion such that at least a portion of gases collected by the gas collection portion flows into the gas collection inlet.
[0088] The gas collection portion may include a nasal flow guide configured to extend under the patient's nose in use so as to facilitate collection of gases from the patient's nose towards the gas collection inlet.
[0089] The nasal flow guide may include a neck for accommodating nasal prongs of the gas delivery patient interface on either side of the neck.
[0090] The gas collection portion may include a mouth portion configured to extend under or adjacent the patient's upper lip and / or upper teeth in use so as to facilitate collection of gases from the patient's mouth towards the gas collection inlet.
[0091] The gas collection portion may further include an offset region proximate the mouth portion. The offset region may be configured to be situated away from the patient's mouth in use so as to facilitate gas flow between the patient's mouth and the gas collection inlet.
[0092] The gas collector may further include a channel in fluid communication with the gas collection inlet to facilitate gas flow from the patient's nose and / or mouth towards the gas collection inlet.
[0093] The channel may include a rigid material.
[0094] The channel may be integrally formed with the coupling mechanism.
[0095] The gas collection portion may define a narrowed portion adjacent the mouth portion. The narrowed portion may provide a hinge to enable movement of the mouth portion relative to the narrowed portion.
[0096] The gas collection portion may further include a pair of guide members projecting from the gas collection inlet toward an edge of the mouth portion so as to guide at least a portion of the gas flow from the patient's mouth towards the gas collection inlet.
[0097] The mouth portion may include a scooped portion between the guide members. The scooped portion may have an edge configured to extend below the patient's upper lip in use to facilitate gas flow from the patient's mouth towards the gas collection inlet.
[0098] The mouth portion may include a pair of mouth flow guide projections. Each mouth flow guide projection may be configured to extend under or adjacent an opposite side or corner of the patient's upper lip in use so as to facilitate collection of gases from the patient's mouth towards the gas collection inlet.
[0099] The gas collection portion may include a pair of nasal flow guide projections. Each nasal flow guide projection may be configured to extend adjacent an opposite side of the patient's nose in use so as to facilitate collection of gases from the patient's nose towards the gas collection inlet.
[0100] According to another aspect of the invention, there is provided a patient interface assembly including a gas delivery patient interface for delivering a flow of gases to the patient, and a gas collector according to any one of the embodiments described herein.
[0101] The patient interface assembly may further include a filter for filtering a backflow of gases from the patient. The filter may be mounted upstream of the gas delivery patient interface.
[0102] The patient interface may further include a conduit for connecting the gas delivery patient interface and the filter.
[0103] According to a further aspect of the invention, there is provided a kit including a gas delivery patient interface for delivering a flow of gases to the patient, and a gas collector according to any one of the embodiments as described herein.
[0104] The kit may further include any one or more of at least one gas flow conduit, an inspiratory limb, and a humidification chamber.
[0105] According to a further aspect of the invention, there is provided a system comprising a gas delivery patient interface for delivering a flow of gases to the patient, a gas collector as described herein, the gas collector being mounted to the gas delivery patient interface, and a humidifier for humidifying the flow of gases delivered to the patient.
[0106] According to yet another aspect of the invention, there is provided a system comprisinga gas delivery patient interface for delivering a flow of gases to the patient, a gas collector as described herein, the gas collector being mounted to the gas delivery patient interface, and a flow generator for generating the flow of gases for delivery to the patient.
[0107] The system may further include one or more gas analysers coupled to the gas collector for analysing gases from the gas collector.
[0108] According to another aspect of the invention, there is provided a system comprising a gas delivery patient interface as described herein, and a humidifier for humidifying the flow of gases delivered to the patient.
[0109] According to another aspect of the invention, there is provided a system comprising a gas delivery patient interface as described herein, and a flow generator for generating the flow of gases for delivery to the patient.
[0110] The system may further include one or more gas analysers coupled to the gas delivery patient interface for analysing gases from the gas sampling portion.
[0111] According to another aspect of the invention, there is provided a gas delivery patient interface for delivering gases to a patient, the gas delivery patient interface including: a body having a flow manifold for receiving a flow of gases for delivery to the patient, and a pair of nasal prongs extending from the body for delivering the flow of gases to the patient via the patient's nares, a gas sampling portion for sampling gases at the patient, the gas sampling portion having a nose sampling part positioned between the nasal prongs, the nose sampling part defining at least one inlet opening to sample gases at the patient's nose, and a sampling gas conduit for providing fluid communication between the gas sampling portion and a sensing apparatus, wherein the sampling gas conduit extends along the flow manifold.
[0112] Optionally, the gas sampling portion and the sampling gas conduit are integrally formed with the flow manifold.
[0113] In one embodiment, the gas sampling portion and the sampling gas conduit may be selectively attachable to, and detachable from the body.
[0114] In one embodiment, the body may have an inner surface for facing towards the patient's face when the gas delivery patient interface is mounted to the patient, and an outer surface opposite the inner surface for facing away from the patient's face when the gas delivery patient interface is mounted to the patient. The at least one inlet opening may be oriented generally transversely to the inner surface of the body.
[0115] The nose sampling part may define two inlet openings to sample gases at the patient's nose. The body may have an inner surface for facing towards the patient's face when the gas delivery patient interface is mounted to the patient, and an outer surface opposite the inner surface for facing away from the patient's face when the gas delivery patient interface is mounted to the patient. Each of the inlet openings may be oriented generally transversely to the inner surface of the body.
[0116] In one embodiment, the position of the at least one inlet opening of the nose sampling part may be fixed relative to the body.
[0117] In one embodiment, the nose sampling part may be generally fixed relative to the body and / or nasal prongs.
[0118] In some embodiments, the position of the at least one inlet opening of the nose sampling part may be fixed relative to the body and / or nasal prongs.
[0119] Typically, the nose sampling part is located adjacent at least one of the nasal prongs. The nose sampling part may be located centrally to the body of the gas delivery patient interface.
[0120] In some embodiments, the flow manifold may be collapsible.
[0121] In some embodiments, the sampling portion may further include a mouth sampling part configured to extend below the body for placement adjacent the patient'smouth in use. The mouth sampling part may define at least one inlet aperture to sample gases at the patient's mouth.
[0122] In some embodiments, the mouth sampling part may be moveable relative to the body and / or nasal prongs.
[0123] In some embodiments, the mouth sampling part may include a mouth sampling guide configured to extend below the body. The mouth sampling guide may have a mouth sampling end portion defining the at least one inlet aperture to sample gases at the patient's mouth. The mouth sampling end portion may be located at one end of the mouth sampling guide.
[0124] In some embodiments, the mouth sampling guide may be pliable so as to allow selective repositioning of the mouth sampling end portion. In some embodiments, the mouth sampling guide may be selectively removable. Optionally, the mouth sampling guide may be offset from a central plane of the gas delivery patient interface. The central plane may extend between the nasal prongs such that the nasal prongs are spaced at generally equal distances from the central plane. The mouth sampling guide may be oriented at an angle relative to the central plane. In some embodiments, the angle may be a predetermined angle. More specifically, the angle may be generally between -100° and 100°.
[0125] In some embodiments, the nose sampling part may define one or more nasal gas sampling passages providing fluid communication between each of the at least one inlet opening of the nose sampling part and the sampling gas conduit. The mouth sampling part may define one or more oral gas sampling passages providing fluid communication between each of the at least one inlet aperture of the mouth sampling part and the sampling gas conduit. A resistance to flow in the one or more nasal gas sampling passages may be lower than a resistance to flow in the one or more oral gas sampling passages.
[0126] In another embodiments, the nose sampling part may define one or more nasal gas sampling passages providing fluid communication between each of the at least one inlet opening of the nose sampling part and the sampling gas conduit. The mouth sampling part may define one or more oral gas sampling passages providing fluid communication between each of the at least one inlet aperture of the mouth sampling part and the sampling gasconduit. A resistance to flow in the one or more nasal gas sampling passages may be higher than a resistance to flow in the one or more oral gas sampling passages.
[0127] In some embodiments, the nose sampling part may be positioned above the body of the patient interface.
[0128] In some embodiments, a surface covering at least a portion of the sampling gas conduit may be a curved surface. The curved surface may define a protrusion that accommodates a portion of the sampling gas conduit.
[0129] According to another aspect, there is provided a gas collector for collecting gases at a patient, the gas collector including a gas sampling portion for sampling gases at the patient, and a sampling gas conduit for providing fluid communication between the gas sampling portion and a sensing apparatus, wherein the gas collector is configured for attachment to a gas delivery patient interface, the gas delivery patient interface having a body having a flow manifold for receiving a flow of gases for delivery to the patient, and a pair of nasal prongs extending from the body for delivering the flow of gases to the patient via the patient's nares, the gas sampling portion having a nose sampling part for positioning between the nasal prongs of the gas delivery patient interface, the nose sampling part defining at least one inlet opening to sample gases at the patient's nose, wherein the sampling gas conduit extends along the flow manifold.
[0130] In some embodiments, the gas collector may further include a coupling mechanism for coupling the gas sampling portion to the gas delivery patient interface. The gas sampling portion and the sampling gas conduit may be selectively attachable to, and detachable from the body of the gas delivery patient interface.
[0131] In some embodiments, the nose sampling part may be configured such that the at least one inlet opening is oriented generally transversely to an inner surface of the body of the gas delivery patient interface when the gas collector is attached to the gas deliverypatient interface. The inner surface may be a surface of the body for facing towards the patient's face when the gas delivery patient interface is mounted to the patient.
[0132] In some embodiments, the nose sampling part may define two inlet openings to sample gases at the patient's nose. Each of the inlet openings may be oriented generally transversely to an inner surface of the body of the gas delivery patient interface when the gas collector is attached to the gas delivery patient interface. The inner surface may be a surface of the body for facing towards the patient's face when the gas delivery patient interface is mounted to the patient.
[0133] In some embodiments, the sampling portion may further include a mouth sampling part configured to extend below the body of the gas delivery patient interface for placement adjacent the patient's mouth in use. The mouth sampling part may define at least one inlet aperture to sample gases at the patient's mouth.
[0134] In some embodiments, the mouth sampling part may include a mouth sampling guide configured to extend below the body of the gas delivery patient interface. The mouth sampling guide may have a mouth sampling end portion defining the at least one inlet aperture to sample gases at the patient's mouth. The mouth sampling end portion may be located at one end of the mouth sampling guide.
[0135] The mouth sampling guide may be pliable so as to allow selective repositioning of the mouth sampling end portion. The mouth sampling guide may be selectively removable.
[0136] In some embodiments, the mouth sampling guide may be offset from a central plane of the nose sampling part. The central plane may extend between a pair of inlet openings of the nose sampling part such that the pair of inlet openings are spaced at generally equal distances from the central plane. The mouth sampling guide may be oriented at an angle relative to the central plane. The angle may be a predetermined angle. In some embodiments, the angle may be generally between -100° and 100°.
[0137] The nose sampling part may define one or more nasal gas sampling passages providing fluid communication between each of the at least one inlet opening of the nose sampling part and the sampling gas conduit. The mouth sampling part may define one or more oral gas sampling passages providing fluid communication between each of the at leastone inlet aperture of the mouth sampling part and the sampling gas conduit. In some embodiments, a resistance to flow in the one or more nasal gas sampling passages may be lower than a resistance to flow in the one or more oral gas sampling passages. In other embodiments, a resistance to flow in the one or more nasal gas sampling passages may be higher than a resistance to flow in the one or more oral gas sampling passages.
[0138] In some embodiments, the nose sampling part may be configured for positioning above the body and flow manifold.
[0139] In some embodiments, a surface covering at least a portion of the sampling gas conduit may be a curved surface.
[0140] In order that the invention may be more readily understood and put into practice, one or more preferred embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings.
[0141] It will be appreciated that for simplicity and clarity of illustration, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.Brief Description of Drawings
[0142] FIGURE 1 illustrates a respiratory support system for delivery a gas flow treatment to a patient.
[0143] FIGURE 2 illustrates a gas collector mounted to a gas delivery patient interface according to one embodiment.
[0144] FIGURE 3 is a perspective view of the gas collector of Figure 2.
[0145] FIGURE 4 is another perspective view of the gas collector of Figure 2.
[0146] FIGURE 5 is a partial A-A cross sectional view of the gas collector of Figure 3 in which the view of one of the optional flow guides is omitted.
[0147] FIGURE 6 illustrates a gas collector mounted to a gas delivery patient interface according to another embodiment.
[0148] FIGURE 7 is a perspective view of the gas collector of Figure 6.
[0149] FIGURE 8 is the B-B cross sectional view of the gas collector of Figure 7.
[0150] FIGURE 9 is a perspective view of a gas collector according to another embodiment.
[0151] FIGURE 10 is a further perspective view of the gas collector of Figure 9.
[0152] FIGURE 11 illustrates the gas collector of Figures 9 and 10 mounted to a gas delivery patient interface.
[0153] FIGURE 12 illustrates a gas collector mounted to a gas delivery patient interface according to another embodiment.
[0154] FIGURE 13 is a perspective view of a gas collector according to another embodiment.
[0155] FIGURE 14 is the C-C cross sectional view of the gas collector of Figure 13.
[0156] FIGURE 15 illustrates a gas collector mounted to a gas delivery patient interface according to another embodiment.
[0157] FIGURE 16 is a perspective view of the gas collector of Figure 15.
[0158] FIGURE 17 is a D-D cross sectional view of the gas collector of Figure 16.
[0159] FIGURE 18 illustrates a gas collector mounted to a gas delivery patient interface according to another embodiment.
[0160] FIGURE 19 is a perspective view of the gas collector of Figure 18.
[0161] FIGURE 20 is the E-E cross sectional view of the gas collector of Figure 19.
[0162] FIGURE 21 is one side view of a gas collector according to another embodiment.
[0163] FIGURE 22 is another side view of the gas collector of Figure 21.
[0164] FIGURE 23 is a perspective view of the gas collector of Figures 21 and 22.
[0165] FIGURE 24 is an internal side of the gas collector of Figures 21 to 23 for facing the patient in use.
[0166] FIGURE 25 is a perspective view of a gas collector according to another embodiment.
[0167] FIGURE 26 is an internal side of the gas collector of Figure 25 for facing the patient in use.
[0168] FIGURE 27 is a perspective view of a gas collector according to a further embodiment.
[0169] FIGURE 28 is a schematic diagram illustrating a kit including a conduit, an inspiratory tube, a patient interface, a gas collector and a humidification chamber.
[0170] FIGURE 29 illustrates a patient wearing a respiratory support system.
[0171] FIGURE 30 illustrates a patient wearing one embodiment of a gas delivery patient interface and a face mask.
[0172] FIGURE 31 illustrates a cross-section of a portion of the patient interface of Figure 30.
[0173] FIGURES 32 to 35 illustrates a nasal cannula including a collapsible portion to which a gas collector can be attached or integrated with.
[0174] FIGURES 36 to 38 illustrate another embodiment of a gas delivery patient interface.
[0175] FIGURE 39A is a schematic diagram illustrating a gas delivery patient interface according to one embodiment.
[0176] FIGURE 39B is a schematic diagram illustrating a top view of the gas delivery patient interface of Figure 39A.
[0177] FIGURE 40 is a partial cross-sectional view through section A-A of the gas delivery patient interface of Figure 39A illustrating the sampling gas conduit.
[0178] FIGURE 41A illustrates a gas delivery patient interface according to another embodiment.
[0179] FIGURE 41B illustrates a gas delivery patient interface according to a further embodiment.
[0180] FIGURE 42 is a schematic diagram illustrating a cross-sectional view through section B-B of the gas delivery patient interface of Figure 39A.
[0181] FIGURE 43 illustrates a portion of the mouth sampling guide of the gas delivery interface of Figure 41.
[0182] FIGURES 44 to 47 illustrates a mouth sampling tip of the gas delivery patient interface of Figure 41.
[0183] FIGURES 48 and 49 are detailed views of the mouth sampling part including and mouth sampling tip of Figures 44 to 47 mounted to a mouth sampling guide such as the one illustrated in Figure 43.
[0184] FIGURE 50 is a schematic diagram illustrating nasal gas passages and oral gas passage of the gas sampling portion of the gas delivery patient interface or gas collector according to an embodiment.
[0185] FIGURE 51 illustrates a patient's face.Detailed Description
[0186] It is beneficial to monitor gases at the patient when the patient is receiving respiratory support. Such monitoring provides useful feedback to clinicians. For example, monitoring exhaled gases during the pre-oxygenation phase can be used to determine whether the patient has reached a desired end expiratory 02 level which indicates preoxygenation is adequate and / or that the pre-oxygenation phase could be complete. Exhaled gas monitoring can be used to detect a change in patient condition, for example, a spontaneously breathing patient becoming apnoeic after being anaesthetised or when experiencing a blocked airway. Clinicians can provide better care by making decisions as a result of patient gas monitoring.
[0187] Unfortunately, monitoring of a target gas at a patient while providing a gas flow to the patient can affect the sampling results because the provided gas flow may taint the actual value (e.g. concentration) of the target gas. For example, exhaled CO2 (carbon dioxide) may be diluted by the provided gases or end tidal 02 may be enhanced by a higher concentration of 02 in the provided gas flow. NHF exacerbates this problem due to the high gas flow rates involved.
[0188] Difficulties also arise in monitoring exhaled gases due to the variability of the exhalation pathways, that is, via the patient's nose, mouth or nose and mouth. A patient can alternate between these pathways during a period of monitoring. How a patient breathes can affect the gas sampling results as an inadequate amount of exhaled gases may be collected from, say, the nose when the patient is predominantly breathing out of the mouth.
[0189] It would be desirable to provide a gas collector or patient interface for collecting gases at the nasal passages and oral passage of a patient, that ameliorates or overcomes one or more disadvantages or inconveniences of known gas collectors, in particular but not limited to NHF applications. Moreover, it would be desirable to provide a gas collector or patient interface that enables consistent sampling of the exhaled gases regardless of variability in the exhalation pathways.
[0190] 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.
[0191] 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. For example, 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 such 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 knowfrom 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.
[0192] But, without limitation, some indicative values of high flow can be as follows.
[0193] 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).
[0194] 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).
[0195] 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%.
[0196] 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. Also for example, for a 2kg patient the flow rates would be about 0.8LPM to 16LPM.
[0197] 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.
[0198] By example, a high flow respiratory system 10 is described below with reference to Figure 1. High flow may be used as a means to promote gas exchange and / or respiratory support through the delivery of oxygen and / or other gases, and facilitating the removal of CO2 from the patient's airways. High flow may be particularly useful prior to, during or after a medical and / or anaesthetic procedure.
[0199] 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, which would be useful in reducing the risk or preventing desaturation for example when the patient is in an apnoeic phase during the medical procedure.
[0200] 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 or by jet ventilation. 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.
[0201] 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 opensairways, 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.
[0202] 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.
[0203] Figure 1 shows a respiratory support system 10. The system 10 may be configured to provide high flow respiratory support and / or high flow therapy. The respiratory support system 10 comprises a flow generator 12. The flow generator 12 is configured to generate gas flows that are passed through the respiratory support system 10. The flow generator 12 is configured to generate gas flows that are provided to a patient at flow rates described elsewhere in the present specification. The flow generator 12 passes the air to a humidifier 14. The humidifier 14 is configured to heat and humidify gas flows (to temperatures and / or humidities as described elsewhere in the present specification) generated by the flow generator 12. In some configurations, the flow generator 12 comprises a blower adapted to receive gases from the environment outside of the respiratory support system 10 and propel them through the respiratory therapy system 10. In some configurations, the flow generator 12 may comprise some other gas generation means. For example, in some configurations, the flow generator 12 may comprise a source available from a hospital gas outlet (e.g. oxygen or air), or one or more containers of compressed air and / or another gas and one or more valve arrangements adapted to control the rate at which gases leave the one or more containers. As another example, in some configurations, the flow generator 12 may comprise an oxygen concentrator. In some configurations, the flow generator 12 may be adapted to deliver a high flow respiratory support and / or high flow therapy. In some embodiments, the flow source may include a compressed gas source, a device that modifies the flow from a compressed gas source and / or a flow generator which generates a gas flow.
[0204] The respiratory support system 10 comprises a housing 16 that at least partially houses both the flow generator 12 and the humidifier 14 (e.g. the respiratory support system10 may comprise an integrated flow generator / humidifier apparatus). In other configurations the flow generator 12 and humidifier 14 may have separate housings, and / or be separate components. A hardware controller 18 is shown to be in electronic communication with the flow generator 12 and the humidifier 14, although in some configurations the hardware controller 18 might only communicate with the flow generator 12 or the humidifier 14. In some configurations, the flow generator 12 and the humidifier 14 may each have their own controller, which may or may not be in communication with one another. The hardware controller 18 may comprise a microcontroller or some other architecture configured to direct the operation of controllable components of the respiratory support system 10, including but not limited to the flow generator 12 and / or the humidifier 14.
[0205] An input / output module 20 is shown to be in electronic communication with the controller 18. The input / output module 20 may be configured to allow a user to interface with the controller 18 to facilitate the control of controllable components of the respiratory support system 10, including but not limited to the flow generator 12 and / or the humidifier 14, and / or view data regarding the operation of the respiratory support system 10 and / or its components. The input / output module 20 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 10.
[0206] As further shown in Figure 1, a supplementary gas source 22 may be used to add one or more supplementary gases to the gases flowing through the respiratory support system 10. The one or more supplementary gases join the gas flow generated by the flow generator 12. The supplementary gas source 22 may be configured to deliver one or more supplementary gases including but not limited to air, oxygen (O2), carbon dioxide (CO2), nitrogen (N2), nitrous oxide (NO), anaesthetic agents and / or heliox (a mixture of helium and oxygen). The supplementary gas source 22 may deliver the one or more supplementary gases via a first supplementary gas conduit 24 to or towards the flow generator 12, and / or may deliver the one or more supplementary gases via a second supplementary gas conduit 26 to a location in the flow passage between the flow generator 12 and the humidifier 14. One or more supplementary flow valves 28, 30 may be used to control the rates at which the one or more supplementary gases can flow from the supplementary gas source 22 and through thefirst and / or second supplementary gas conduits 24, 26. One or more of the supplementary flow valves 28, 30 may be in electronic communication with the controller 18 or a separate controller, which may in turn control the operation and / or state of the one or more supplementary flow valves 28, 30.
[0207] In some embodiments, the supplementary flow valves 28, 30 may be provided by and / or integrated with the flow generator 12. At least one of the supplementary flow valves 28, 30 may be a proportional valve. In one example, the user may set a flow rate and / or oxygen concentration via the input / output module 20. The flow generator 12 and supplementary flow valves 28, 30 may work together to achieve the user set flow and / or oxygen concentration.
[0208] In other configurations, the supplementary gas source 22 may be configured to add one or more supplementary gases downstream of the humidifier 14. In other configurations, supplementary gas source 22 may be configured to add one or more supplementary gases into the humidifier 14, e.g. into a humidification chamber containing a body of water and engageable with a heater base, the water to be heated by a heating element to humidify a flow of gases to the patient.
[0209] As shown in Figure 1, a conduit 32 extending from the humidifier 14 links the humidifier 14 to a gas delivery patient interface 102 (also referred to herein as patient interface). The conduit 32 may comprise a conduit heater 34 adapted to heat gases passing through the conduit 32. In other configurations the conduit heater 34 may not be present. The conduit 32 and conduit heater 34 form an inspiratory limb 37 delivering humidified gases from the humidifier 14 to the patient via patient interface 102.
[0210] In some embodiments, an optional filter 36 is arranged between conduit 32 and patient interface 102. The filter 36 may prevent a backflow of gases from the patient into the conduit 32. In some cases, micro-organisms may accompany gases from the patient when the patient breathes out or coughs. The filter 36 may prevent any micro-organisms accompanying any gases from the patient from entering the conduit 32. This serves to keep the respiratory support system 10 upstream of the filter 36 sanitary for reuse. An inspiratory limb 37 may be provided for coupling the filter 36 to the humidification chamber 14.
[0211] The gas delivery patient interface 102 in Figure 1 is shown to be a nasal cannula, although it should be understood that in some configurations, other patient interfaces may be suitable. For example, in some configurations, the patient interface 102 may comprise a sealing or non-sealing interface, and may comprise a nasal mask, an oral mask, an oro-nasal mask, a full face mask, a nasal pillows mask, a nasal cannula, an endotracheal tube, tracheostomy tube, a combination of the above or some other gas conveying system. In an embodiment, the patient interface 102 is a non-sealing interface such as a nasal cannula, which allows gases to be exchanged with the environment. For example, the non-sealing cannula allows carbon dioxide to be removed and / or cleared from the patient's airways while the patient receives a gas flow from the system 10. Further, in some embodiments, the patient interface 102 is in the form of a nasal interface, such that the system does not interfere with other oral airway equipment and / or devices, for example, a tracheal tube in an intubation procedure.
[0212] Accordingly, the patient may continue to receive gas flow throughout the intubation procedure. In other embodiments, the patient interface 102 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.
[0213] As shown, in some configurations the patient interface 102 may also comprise a gas sensing module 38 adapted to measure a characteristic of gases passing through the patient interface 102. In some configurations, a gas collector 100 (for example in accordance with any one of the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 as described herein) of the present disclosure is mounted on the patient interface 102 to measure and monitor patient gases. In some configurations, a gas delivery patient interface 3000, 3500 providing gas sampling capabilities may be used as patient interface 102. In some configurations, the patient interface 3000, 3500 and / or the gas collector 100 (or any one of 200, 300, 400, 500, 600, 700, 800, 900, 1000) may be integral with the patient interface 102. The gas collector 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 may be coupled to one or more sensor units 39 via sampling line 41 to sense expired gases from the patient. The sensorunit 39 may be separate stand-alone unit from the respiratory support system 16. The one or more sensor units 39 may include one or more gas analysers. Moreover, the one or more sensor units 39 may comprise sensors to determine gases concentration. More specifically, the one or more sensor units 39 may include a capnography machine. The sampling line 41 may be a pneumatic line. The sampling line 41 facilitates fluid communication between the patient and the one or more sensor units 39.
[0214] The one or more gas analyser (e.g. the capnography machine) may have a suction flow rate of less than 500mL / min, or more specifically a suction flow rate between 50mL / min to 300mL / min. The suction flow rate of the one or more gas analyser (e.g. capnography machine) is typically lower than the flow rate of gases delivered to the patient via the nasal cannula 102.
[0215] The gas sensing module 38 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 38. In other configurations the gas sensing module 38 could be positioned and adapted to measure the characteristics of gases at or near other parts of the respiratory support system 10. The gas sensing module 38 may comprise one or more sensors adapted to detect the presence of gases and / or 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 38 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 38 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 38 may communicate with the controller 18 over a first transmission line 40. In some configurations, the first transmission line 40 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 becommunicated over the same first transmission line 40. For example, the gas sensing module 38 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 18. In other configurations the first transmission line 40 may comprise a pneumatic communication connection adapted to transmit a gas flow for analysis at a portion of the respiratory support system 10. In other configurations, the transmission line 40 comprises a pneumatic communication connection separate from the conduit 32, adapted to transmit a captured gas flow at or near the patient for analysis at a separate system or device such as a capnograph.
[0216] Additionally, as shown a physiological sensor module 42 may be present. The physiological sensor module 42 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 (TcCCh) and / or blood glucose. Similarly, the physiological sensor module 42 may communicate with the controller 18 over a second transmission line 44. The second transmission line 44 may comprise wired or wireless data communication connections similarly to the first transmission line 40, and power and data may be communicated similarly. The physiological sensor module 42 may be used, for example, to determine the blood oxygen saturation of the patient. In some embodiments, the second transmission line 44 may comprise a pneumatic communication connection adapted to transmit a fluid for analysis at a portion of the respiratory support system 10 or at separate system or device.
[0217] Figure 29 shows a user or patient P wearing a patient interface 102, for example the patient interface 102 of the respiratory system 10 of Figure 1. The patient depicted is an adult, however, the patient may be an infant, a neonate or a child. In the illustrated nonlimiting configuration, the patient interface 102 is a nasal cannula 104. The patient interface 102 comprises a first gas conduit 136. The first gas conduit 136 is adapted to receive gases from the respiratory support system 10 (for example, via the conduit 32 shown in Figure 1) and channel the gases to the patient P. The first gas conduit 136 may comprise a reinforcement element 138 adapted to strengthen and / or add rigidity to the first gas conduitto prevent deformation or collapse of the first gas conduit 136 arising due to the application of forces against the first gas conduit 136. The reinforcement element 138 may include a number of structures, including but not limited to plastic or metallic reinforcing beads that lie in or on the wall of the first conduit lumen 136.
[0218] The first gas conduit 136 is in pneumatic communication with a flow manifold 106. The flow manifold 106 receives gases from the first gas conduit 136 and passes them to one or more nasal delivery elements 108, 110 (e.g. nasal prongs). The one or more nasal delivery elements 108, 110 extend outwardly from the flow manifold 106. The one or more nasal delivery elements 108, 110 are adapted to be non-sealing (i.e. a gap exists between each nasal delivery element and the patient's nasal passage) when positioned in one or more nares of the patient P. As shown, the patient interface 102 comprises two nasal prongs 108, 110 adapted to be positioned one in each of the patient's nares. Each nasal prong 108, 110 may be shaped or angled such that it extends inwardly towards a septum of the patient's nose. Alternatively, the gas delivery patient interface 102 may be a sealing nasal interface.
[0219] In the embodiment shown in Figure 29, the flow manifold 106 receives flow from one lateral side of the flow manifold 106 (e.g. with respect to an imaginary vertical plane bisecting the face of the patient P) and channels flow to the manifold and each of the nasal prongs 108, 110. In some configurations, the flow manifold 106 receives flow from a single side of the flow manifold 106 and channels flow to the manifold and each of the nasal prongs 108, 110. The single side may be a single lateral side. In some embodiments a conduit may extend from the left-hand side or from the right-hand side of the manifold. In some situations, providing the conduit on the left-hand side of the patient interface may be preferred for access for a clinician, for example for intubation. Alternatively, a conduit extending from the right-hand side may be preferred, for example in procedures such as endoscopies where the patient is typically lying on his or her left-hand side. In other configurations, the patient interface 102 may comprise greater (for example, three or four) or fewer (for example, one) nasal delivery elements 108, 110. In other configurations, each nasal delivery elements 108, 110 can have different structures, dimensions, shapes and / or properties. For example, one of a pair of nasal delivery elements 108, 110 can be relatively long and the other nasal delivery elements 108, 110 can be relatively short.
[0220] In some configurations, the flow manifold 106 may be configured to receive flow from two lateral sides of the flow manifold 106 (e.g. from a 'left' and 'right' of the flow manifold 106 instead of just the patient's right-hand side of the flow manifold 106 as seen in Figure 29). In some such configurations, multiple gas conduits may be used to provide for pneumatic communication between the flow manifold 106 and the respiratory support system 10. For example, the patient interface 102 may comprise dual conduits, the first gas conduit 136 extending from a first side of the interface (in the illustrated example the righthand side of the patient) and a second gas conduit extending from a second opposite side of the interface. In some configurations, the flow manifold 106 may be configured to receive flow from a non-lateral side of the flow manifold 106 (e.g. from a 'bottom' or 'top' of the flow manifold 106). In some configurations, the flow manifold 106 may receive flow from more than one gas conduit from a single side, optionally a single lateral side of the manifold 106. In some configurations, one prong may receive flow from one gas conduit and the other prong may receive flow from another separate gas conduit.
[0221] The patient interface 102 may further comprise mounts and / or supports, e.g., cheek supports 140, for attaching and / or supporting the gas conduit 136 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.
[0222] The first gas conduit 136 may comprise a first portion 142 configured to transition from a first configuration in which a first level of gases is able to pass through the first portion 142 to a second configuration in which a second level of gases is able to pass through the first portion 142.
[0223] Figure 30 shows a non-limiting exemplary embodiment of a patient P wearing the patient interface 102 as shown in Figure 29 (a first patient interface) underneath a face mask 144 assembly (a second patient interface). Figure 30 schematically shows the face mask 144 as a transparent structure in order to illustrate the patient interface 102 under it. The first patient interface 102 may be used with a first respiratory support subsystem and the second patient interface 144 may be used together with a second respiratory support subsystem. In some embodiments, the first patient interface 102 and second patient interface 144 may be used with the same respiratory support system.
[0224] 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.
[0225] 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.
[0226] Face mask assembly 144 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 102, 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 144 may be used to stop the delivery of respiratory support and / or therapy from a first respiratory support subsystem. The face mask assembly 144 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 144 of the first respiratory support subsystem.
[0227] Accordingly, the embodiment shown in Figure 30 allows for the alternation between the two different respiratory support subsystems. Additionally, this configuration may allow the patient interface 102 to be left on the patient throughout the surgical procedure and / or into recovery (whether or not the patient continues to receive a gas flow through the patient interface 102 throughout the procedure) without interfering with other clinical practices.
[0228] In the embodiment shown, face mask assembly 144 comprises a full face mask 146 configured to cover both the patient's nose and mouth. In other configurations, the face mask 144 may be a nasal mask which is placed over the patient interface 102 to cover only the patient's nasal region. In such configurations, a portion of the face mask 144 may be placed upon a portion of the patient interface 102, such as first portion 142.
[0229] As shown, the face mask 146 comprises a seal region 148 adapted to seal against the patient's face. The face mask assembly 144 is connected to a second gas source, for example via a filter element 150 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 22 / flow generator 12) to the patient interface 102. In other embodiments, the patient interface 102 and the face mask assembly 144 are connected to a common gas source.
[0230] In an embodiment, the face mask assembly 144 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 144 may be connected to a device for measuring a characteristic of respiratory gases.
[0231] Alternatively, the mask assembly 144 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 146.
[0232] The embodiment shown in Figure 30 allows for the delivery of gas from multiple sources via at least two different respiratory support modes, and further allows a doctor, clinician or medical professional to quickly and easily change the type of respiratory support mode.
[0233] In one particular application, a patient preparing for anaesthesia can be preoxygenated 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 102) and delivery of gas flow from another patient interface, such as via a face mask 144.
[0234] Anaesthesiologists also use a mask in fluid communication with a bag ('bag mask') 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 greatercontrol 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 102) and in a second mode respiratory support may be provided by a second respiratory support system (for example via the patient interface 144), with the support from the first system reduced or stopped. For example, the additional flow from a high flow provided by nasal interface 102 may also modify the expected behaviour of the anaesthetic circuit provided by the face mask 144, and therefore it may be advantageous to be able to reduce or stop the additional flow from the first respiratory system.
[0235] In some configurations, the switching between two respiratory support modes or subsystems may be facilitated by a structure of the first gas conduit 136, which has first portion 142 configured to transition from a first configuration in which a first level of gases is able to pass through the first portion 142 to a second configuration in which a second level of gases is able to pass through the first portion 142.
[0236] In some configurations, the first portion 142 is configured to be more collapsible or otherwise better adapted at changing the flow of gas through the first portion 142 (therefore stopping or reducing the flow of gas through the conduit and to the patient) than other portions of the conduit 136, 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.
[0237] 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 136 is configured to be more collapsible, deformable or otherwise adapted to fully close off the flow at the first portion 142 than at other portions of the conduit 136. In the second condition, gases to the nasal delivery elements 108 may be reduced or stopped.
[0238] Figure 31 shows one example of this configuration, in which the conduit (for example the conduit 142 of the nasal cannula 104 of figure 30) at a first portion 142 is substantially closed by the seal 148 of face mask 146. In such an embodiment, the firstportion (i.e. the more collapsible or deformable section) of the first gas conduit should be of a length that is greater or equal to a width of a section of a seal of the face mask that bears over the first portion of the first gas conduit. This may provide that the seal of the face mask does not bear over a non-collapsible section of the first gas conduit. For example, the first portion may extend from a distance of 35mm or less from a portion of the manifold 106 or the centre of a user's nose to at least 50mm from a portion of the manifold 106 or the centre of a user's nose, The first portion 142 may have a length of at least about 5mm, about 1mm to about 30mm in length, or about 5mm to about 15mm in length, or about 10mm in length. In some embodiments the length of the first portion may be at least 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 20mm, 25mm, 30mm, 35mm, 40mm, 45mm, 50mm or greater.
[0239] The first portion 142 may progress between the first and second configurations based on a relative level of force applied to a wall of the first portion 142. For example, as shown in Figure 30, the force may be applied by the seal 148 of face mask 146. In this example, first portion 142 is configured to be positioned under the seal 148 of the face mask 146.
[0240] Alternatively, the force may be applied to first portion 142 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.
[0241] In some embodiments, the seal of the face mask acting on the first portion 142 of the gas conduit causes the first portion 142 to form a seal or at least an occlusion between the nasal outlets of the first patient interface 102 and the flow generator 12. Additionally, the seal of the face mask forms a seal or at least a partial seal over the first portion 142 of the gas conduit 136.
[0242] 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 102 to stop or 'turn off' or reduce the respiratory support and / or therapy supplied by the first interface 102 and also provides a seal between the face mask 144 and the external surface of the first portion 142 of the conduit 136 such that respiratory support and / or therapy can be provided by the mask144 with the respiratory support and / or therapy provided by the first interface 102 is stopped or reduced. As noted, the first portion 142 of the patient interface 102 is configured to be collapsible and will hereinafter be referred to as collapsible portion 142.
[0243] 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 102 is structured and functions in a manner to reduce or close the delivery of high flow and allow delivery of other respiratory support and / or respiratory therapy or anaesthesia gases through a mask when the interface 102 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.
[0244] Figures 32 to 35 exemplify a patient interface 1400 comprising a nasal cannula and including a gases delivery side member 1401 configured to deliver apparatus gases (for example gas flow from a flow source) to a patient via a manifold 1406 to a delivery outlet comprising a pair of nasal prongs 1408. The pair of nasal prongs 1408 extend from the manifold 1406. The gases delivery side member 1401 extends from a first side of the manifold 1406 and the interface 1400 further includes a non-delivery side member 1403 extending from a second side of the manifold 406 which is opposite to the first side. The nondelivery side member 1403 includes an end 1409 configured for connection to a headstrap 1411.
[0245] The gases delivery side member 1401 includes a collapsible portion 1404 configured to move from the normally open configuration shown in Figures 32, 34 and 35 to a collapsed configuration in which apparatus gas flow through the collapsible portion 1404 is reduced or stopped. The collapsible portion 1404 is configured to move to the collapsed configuration upon application of a collapsing force such as from a patient mask placed over the patient's face and wherein a seal of the mask is pressed down upon the collapsed portion 1404. The gases delivery side member 1401 also includes a non-collapsible portion 1407 configured to remain open during application of the collapsing force onto the collapsible portion 1404.
[0246] One end of the non-collapsible portion 1407 comprises a delivery inlet 1407a for receiving apparatus gas flow. The patient interface 1400 further includes a gas path connector 1413 which has a rigid structure and includes a delivery inlet 1413a and a delivery outlet 1413b. The gas path connector delivery inlet 1413a is connectable to an apparatus gas supply via a conduit (not shown). The gas path connector delivery outlet 1413b is connected to the delivery inlet 1407a of the non-collapsible portion 1407. The gas path connector 1413 is also connected to the headstrap 1411. The headstrap 1411 at an opposite end is connected to the headstrap end 1409 of the non-delivery side member 1403.
[0247] Figure 33 illustrates a cross-section of the non-collapsible portion 1407 which includes wall 1412 of uniform thickness. Figures 34 and 35 illustrate a cross-section of the collapsible portion 1404 which includes a wall 1404a of non-uniform thickness. The collapsible portion 1404 has an elongate cross-section and in particular a stadium-shaped cross section which includes a pair of longitudinal sides 1404b extending between a pair of ends 1404c. As shown in Figure 35, a thin-walled portion 1404 is provided at each of the ends 1404c. The thin wall portions 1404d are configured to provide fold lines at which the collapsible portion 1404 bends or folds upon application of the collapsing force.
[0248] In some embodiments, each of the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 as described herein may be configured to be mounted to a respective nasal cannula 104 such that the nasal cannula 104 and the corresponding gas collector 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 fits under the face mask assembly 144 when the face mask assembly 144 is applied over the nasal cannula 104 as shown in Figure 31. As described in further detail herein, the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 may be generally configured to fit between the nasal prongs 106, 108 of a nasal cannula. In some configurations, the gas collectors 300, 500, 600, 700, 800, 900 may fit around the nasal prongs 106, 108 of a nasal cannula 104. Such a configuration allows a clinician to seamlessly transition between the two different respiratory support modes either via the nasal cannula 104 or the face mask assembly 144 as described herein, whilst maintaining uninterrupted sampling of gases from the patient and / or gases delivered to the patient when a face mask assembly 144 is placed over the nasal cannula 104 as shown in Figure 31.
[0249] A sampling line 41 (see Figure 1) connecting the gas collector 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 to one or more gas analysers / sensor units 39 may be configured such that it remains open when the face mask assembly 144 is applied over the nasal cannula 104 and the first portion 142 of the gas conduit 136 is collapsed. Example configurations are described in further detail below with reference to sampling gas conduit 3018 and gas delivery patient interface 3000 as shown in Figures 39A to 40. This allows the one or more gas analysers / sensor units 39 (e.g. a capnography machine) to continue sampling gases from the patient when the face mask assembly 144 is applied. In some examples, the geometry of the sampling line 41 provides more structural support for the sampling line 41 so as to prevent it from collapsing when the face mask assembly 144 is applied over the nasal cannula 104. In some embodiments, the sampling line 41 may have a smaller cross section than the gas conduit 136. In some embodiments, the sampling line 41 may have thicker walls than that of the first portion 142 of the gas conduit 136.
[0250] In some embodiments, the one or more gas analysers / sensor units 39 (e.g. a capnography machine) may form part of the respiratory support system as illustrated in Figure 1. For example, the one or more gas analysers / sensor units 39 may be provided within or outside housing 16. In some embodiments, the one or more gas analysers / sensor units 39 (e.g. a capnography machine) may form part of a separate system or apparatus to the respiratory support system as illustrated in Figure 1.
[0251] The patient interface 1400 illustrated in Figures 32 to 35 provides context for various embodiments of patient interfaces (or parts thereof) similar to interfaces 2030 and 104 described herein.
[0252] Another example of a patient interface is shown in Figures 36 to 38. The nasal cannula 2030 comprises a face mount part 2032, a pair of nasal prongs 2033, 2034, gases flow manifold part 2035 and gas conduit 2003. The face mount part 2032 comprises an upper (first) portion 2032a from which the prongs 2033, 2034 extend and a face contacting (second) portion 2032b that is configured to contact the patient's upper lip in use. The upper portion 2032a and face contacting portion 2032b are at an angle to one another and are optionally substantially perpendicular to one another. The face mount part 2032 and pair of nasal prongs 2033, 2034 are preferably integrally moulded as one piece from a soft plasticsmaterial such as silicone or thermoplastic elastomer, although in other forms the face mount part and prongs may be separate, but capable of attachment together for use. In some configurations, the face mount part 2032 and the nasal prongs 2033, 2034 may be formed from the same or different material. The nasal prongs 2033, 2034 may be tubular in shape and may be consistent in diameter but may be shaped to fit the contours of the human nares. The prongs 2033, 2034 may be angled towards a central plane bisecting the face mount part 2032 between the prongs. The prongs 2033, 2034 may be curved to point the outlets of the prongs 2033, 2034 toward the back of the patient's head when in use. The prongs 2033, 2034 may comprise an internal and / or external cross-sectional shape transverse to a direction of flow through each prong when in use, that is elliptical, for example a circle or substantially elliptical, for example an oval. The shape and / or dimensions of each prong 2033, 2034 may be consistent or may change along its length. The prongs 2033, 2034 are configured to be non-sealing with the patient's nares in use such that there is a gap between the prongs and the patient's nares. This allows continuous flow of gas between the prongs and the patient's nares when in use.
[0253] The face mount part 2032 comprises side arms 2031 that extend laterally from the sides of the face mount part 2032. Together with a headstrap (not shown), the side arms 2031 help hold the nasal cannula 2030 in place on a patient's face. The ends of each side arm 2031 comprises one or more slots to allow an end of a headstrap to thread through. This may provide for an adjustable coupling between the headstrap and the side arm 2031. Other attachment mechanisms other than slots are also envisaged, such as buckles and clips.
[0254] The face mount part 2032 further comprises a third portion 2032c extending from the upper portion 2032a and connects to the face contacting portion 2032b to form a recess 2038 that is capable of receiving the gases flow manifold part 2035. In the embodiment shown, the recess 2038 provides for a horizontal side entry of the gases flow manifold 2035. The gases flow manifold 2035 may therefore be laterally inserted into the recess 2038 via one lateral side of the face mount part 2032, in a direction that is transverse to the length of the prongs 2033, 2034. As the recess 2038 comprises two lateral openings, the gases manifold part 3205 may be inserted into the recess 2038 via a left or a right side of the face mount part 2032. This allows the nasal cannula 2030 to be configured to allow gases flow to the patient from either the left or right side of the nasal cannula. The gases flow manifold2035 may be attached to or integrally formed with gas conduit 2003. The nasal prongs 2033, 2034 comprise flow passages that extend through the face mount part 2032 and into the recess 2038. The assembly of the face mount part 2032 and the gases flow manifold 2035 comprises a manifold. The gases flow manifold part 2035 is blocked at one end 2039 but attached to the gas conduit 2003 at the other end. The gases flow manifold 2035 has an opening 2037 that acts as an exit for gases received from the gas conduit 2003. The opening 2037 is shown as an elongate opening but other shapes are also envisaged. The gases flow manifold 2035 may be more rigid or comprise a material that is more rigid than the face mount part 2032. Due to the relative rigidities / flexibilities of the gases manifold part 2035 and face mount part 2032, the gases flow manifold part 2035 can be pushed through the recess 2038 in the face mount part 2032 and the opening 2037 in the gases flow manifold part 2035 meets with the flow passages of the prongs 2033, 2034. Therefore, in use, gases flowing through the gas conduit 2003 and into the gases flow manifold part 2035 exit through the opening 2037 and into the tubular passageways in the prongs 2033, 2034, then into the patient's nares.
[0255] In order to assist with maintaining the gases flow manifold part 2035 within the recess 2038, the gases flow manifold part 2035 is provided with a recessed portion 2060 and lip areas 2058, 2059. When engaged with the face mount part 2032, the third portion 2032c forming part of the recess 2038 sits within the recessed portion 2060 and the edges of the third portion 2032c about the lips 2058, 2059 formed on the gases flow manifold part 2035. Additionally, or alternatively, the gases flow manifold 2035 comprises one or more flanges 2035a that is configured to engage with a part of the upper portion 2032a to retain the gases flow manifold 2035 with the face mount part 2032. The one or more flanges 2035a is located about a periphery of opening 2037. In some configurations, the one or more flanges 2035a is a single flange that extends about the entirety of the periphery of opening 2037.
[0256] Embodiments of the gas collector 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 described below may be attachable to or integral with the nasal cannula 2030, 104 and / or 1400. Embodiments of the gas collector 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 may be configured for mounting to any suitable patient interface comprising a portion (such as a bridging portion between nasal elements) for positioning below the patient's septum, and in particular the patient's columella in use.
[0257] Referring to Figure 51 which illustrates a patient's face, the patient's nasal septum 4000 (also referred to herein as septum) is the structure separating the two nostrils 4002, 4004, positioned generally vertically between them. The columella 4006 is the most anteroinferior portion of the nasal septum 4000 and forms the external, central fleshy portion between the two nostrils 4002, 4004, which is visible at the lower end of the nose 4008. The columella 4006 is a midline structure composed of cartilage and overlying skin, extending posteriorly from the tip of the nose 4008. As referred to herein, the columella 4006 is the external visible part of the nasal septum 4000. Throughout the specification, a position 4010 below the patient's septum 4000 or columella 4006 may be used interchangeably. This position 4010 as illustrated in Figure 51 refers to a position outside the patient's nose 4008, under the patient's septum 4000 and columella 4006, generally aligned with the philtrum 4012 which extends along the patient's midsagittal plane between the patient's nostrils 4002, 4004.
[0258] Below the columella 4006, the philtrum 4012 refers to the vertical groove located on the upper lip, extending from the base of the columella 4006 to the central point of the upper lip. These features are situated in relative alignment along the midline of the patient's face (and the patient's midsagittal plane), with the columella 4006 forming a boundary between the nose 4008 above and the philtrum 4012 below.
[0259] Figures 2 to 5 illustrates a gas collector 100 for collecting gases at a patient according to one embodiment. In some embodiments, the gas collector 100 may be separately provided and releasably attachable to a gas delivery patient interface 102. The gas delivery patient interface 102 may include a non-sealing nasal cannula 104 for providing a flow of gases to the patient via the patient's nares.
[0260] In the present specification, gases sampled or collected at the patient by the gas collector 100 may include gases exhaled from the patient's lungs, redirected gases from gases delivered to the patient via the gas delivery patient interface 102, ambient gases proximate the patient, or any combination thereof. Occasionally, redirected gases from gases delivered to the patient via the gas delivery patient interface 102 may be referred to herein as downwash. In some instances, downwash may include redirected gases from gasesdelivered to the patient via the gas delivery patient interface 102 and / or other discharge (e.g. mucus) from the patient.
[0261] Typically, the gas delivery patient interface 102 includes a body 101 having a flow manifold 106 for receiving a flow of gases for delivery to the patient, and a pair of nasal prongs 108, 110 extending from the body 101 and flow manifold 106 for delivering the flow of gases to the patient via the patient's nares. In some embodiments, a suitable alternative gas delivery patient interface may include two separate flow manifolds extending from opposite sides of the body 101, each flow manifold delivering gases to a respective one of the nasal prongs 108, 110. In some embodiments of the patient interface 102, the body 101 includes a bridging portion 120 extending between nasal prongs 108, 110.
[0262] It will be appreciated that the gas delivery patient interface 102 (e.g. nasal cannula 104) can be stored and used in any suitable orientation. In the context of the present disclosure, a first side 107 (also referred herein as a top side 107) of the flow manifold 106 from which the nasal prongs 108, 110 extend and an area spanning from the first side 107 of the flow manifold 106 away from the flow manifold 106 may be referred to as a region 105 above the flow manifold 106. A second side 109 (also referred to herein as a bottom side 109) of the flow manifold 106 opposite the first side 107 and an area spanning from the second side 109 of the flow manifold 106 away from the flow manifold 106 may be referred to as a region 103 below the flow manifold 106.
[0263] Any suitable gas delivery patient interface 102 may be used. For example, the gas delivery patient interface 102 may include a collapsible non-sealing nasal cannula 1400 as described above and in PCT application no. PCT / IB2023 / 058268 entitled 'Gas Collector', the entire contents of which are incorporated herein by reference. The non-sealing nasal cannula 104 may deliver high flow gas treatment to the patient. A gas delivery patient interface similar to the gas delivery patient interface 2030 as described herein with reference to Figures 36 to 38 may also be used.
[0264] The gas collector 100 may include a gas sampling portion 111 for sampling gases at the patient. The gas sampling portion 111 may include a nose sampling part 112 defining at least one opening 114 to sample gases at the patient's nose. In the particular embodiment shown in Figures 2 to 5, the nose sampling part 112 defines a pair of openings 114, 116 (seeFigures 4 and 5). Each inlet opening 114, 116 may be positioned on an opposite side 122, 124 of the nose sampling part 112 such that each one of the inlet openings 114, 116 faces a respective nasal prong 108, 110 when the gas collector 100 is mounted to the gas delivery patient interface 102. In some embodiments, the nose sampling part 112 may include a single opening 114 to sample gases at the patient's nose. The single opening 114 may be positioned to face either one of the nasal prongs 108, 110 when the gas collector 100 is mounted to the gas delivery patient interface 102.
[0265] As more clearly shown in Figure 2, the one or more inlet openings 114 may be configured such that when the gas collector 100 is mounted to the patient interface 102, the one or more inlet openings 114 are located proximal to a base of the respective nasal prongs 108, 110. The base of each nasal prong 108, 110 may be opposite an opening of the respective nasal prong 108, 110, and connected to the body 101 of the patient interface 102. More specifically, the one or more inlet openings 114 may be configured for location adjacent and proximate the top side 107 of the body 101 and flow manifold 106 when the gas collector 100 is mounted to the patient interface 102.
[0266] Moreover, the body 101 of the patient interface 102 may comprise an inner wall 113 for facing the patient's face in use, and an outer wall (hidden in Figure 2) opposite the inner wall 113. The outer wall faces away from the patient's face when the patient interface 102 is mounted to the patient.
[0267] The one or more inlet openings 114 may be configured for location adjacent and proximate the inner wall 113 of the body 101 when the gas collector 100 is mounted to the patient interface 102. Alternatively, or in combination, the one or more inlet openings 114 may be configured for location adjacent and proximate a central region between the inner wall 113 and outer wall of the body 101, and / or adjacent and proximate the outer wall of the body 101 when the gas collector 100 is mounted to the patient interface 102.
[0268] The gas collector 100 further includes a coupling mechanism 118 for coupling the gas sampling portion 112 to the nasal cannula 104. In particular, coupling mechanism 118 may be configured for releasable attachment to the body 101 of the patient interface, for example as shown in Figure 2. In some embodiments, the coupling mechanism 118 may be configured for releasable attachment to the body 101. In the particular embodiment shown,the coupling mechanism 118 is a ring-shaped portion, a loop or band configured to fit around the periphery of the of the body 101. More specifically, as previously described, the body 101 includes a bridging portion 120 extending between the nasal prongs 108, 110. In other words, the bridging portion 120 is situated between the nasal prongs 108 and 110. The bridging portion 120 may be a wall portion of the body 101 and / or flow manifold 106. In some embodiments, a single flow manifold 106 may extend across one side of the body 101 of the patient interface 102 and the bridging portion 120 to deliver gases to both nasal prongs 108, 101. In these embodiments, the coupling mechanism 118 may be configured for releasable attachment to the portion of the flow manifold 106 which coincides with the bridging portion 120. In some embodiments, the bridging portion 120 may include a recess in the wall of the body 101 to accommodate the septum and columella. In some embodiments, the bridging portion 120 may include a flat surface between the nasal prongs 108, 110 and at the base of the nasal prongs 108, 110.
[0269] The ring-shaped coupling mechanism 118 may be configured to fit around or encircle the bridging portion 120 of the body 101. In practice, the ring-shaped coupling mechanism 118 may be attached to the nasal cannula 104 by sliding the coupling mechanism 118 over the body 101 and either one of the nasal prongs 108 or 110 such that the coupling mechanism 118 is positioned around the bridging portion 120 between the nasal prongs 108 as shown in Figure 2. The coupling mechanism 118 may allow coupling to a malleable portion of the nasal cannula 104. At least a portion of the body 101 and / or nasal prongs 108, 110 may be flexible to facilitate attachment of the coupling mechanism 118. In some embodiments, all components of the nasal cannula 102 may be flexible and malleable. For example, the nasal cannula 102 may be moulded in one piece using soft plastic material. In some embodiments, the nasal prongs 108, 110 may be flexible and malleable and remaining features of the nasal cannula 102 may be relatively rigid and less flexible and malleable when compared with the nasal prongs 108, 110. As such, the body 101 including the bridging portion 120 and / or the flow manifold 106 of the nasal cannula 104 may be flexible or collapsible to allow the ring-shaped coupling mechanism 118 to slide over the body 101 and at least one of the nasal prongs 108, 110. After inserting the body 101 and at least one of the nasal prongs 108, 110 through the ring-shaped coupling mechanism 118, the body 101 returns to its original shape. Alternatively, or in combination, the coupling mechanism 118may be flexible and / or resilient so that it can be stretched to fit over the body 101 and nasal prongs 108, 110 for attachment to the bridging portion 120. In some embodiments, the gas collector 100 may be manufactured using the same or a similar material as the nasal cannula 104.
[0270] As it will be appreciated, a component's rigidity, flexibility or malleability are intended to be relative terms, and these relative properties may be achieved via any one or more of specific structures, geometries and materials used for or associated with the specific features described.
[0271] In some embodiments, the coupling mechanism 118 may be generally U or C- shaped, or have any suitable loop or partially enclosed / partially open loop shaped cross section to facilitate releasable mounting of the gas collector 100 to the bridging portion 120 of the patient interface 102.
[0272] When the gas collector 100 is mounted to the nasal cannula 104, the nose sampling part 112 may be positioned in a space between the patient's septum / columella, the bridging portion 120 of the body 101 and the nasal prongs 108, 110. Typically, the nose sampling part 112 is positioned underneath the patient's septum / columella in use.
[0273] The at least one (e.g. pair) of inlet openings 114, 116 of the nose sampling part 112 enables some of the expired gases from the patient's nose to enter the nose sampling portion 112 at an inlet flow entry direction Finiet- Generally, the inlet flow entry direction Finiet is different to a direction of exhaled gases from the patient's nose FnOse. In some cases, the direction of exhaled gases from the patient's nose FnOse may change as the gases travel away from the patient's nose. As such, in the context of the present disclosure, the direction of exhaled gases from the patient's nose FnOse may be defined by the initial direction of gases exiting the patient's nares. In the embodiment shown in Figures 2 to 5, inlet flow entry direction Finiet may be generally perpendicular to the direction of exhaled gases from the patient's nose F nose-
[0274] In some embodiments, the inlet flow entry direction Finiet for each opening 114,116 may be generally perpendicular to a surface of the respective side 122, 124 of the nose sampling portion 112 that defines the opening 114, 116. Each of the sides 122, 124 may facea respective nasal prong 108, 110 when the gas collector 100 is mounted to the nasal cannula 104. As such, the one or more inlet openings 114 may face a respective one of the nasal prongs 108, 110 when the gas collector 100 is mounted to the nasal cannula 104. Moreover, the one or more inlet openings 114 may be oriented in a sagittal plane of the patient when the gas collector is mounted to the nasal cannula 104 and the nasal cannula 104 is applied to a patient. Moreover, the inlet flow entry direction Finiet may be different to a flow direction of gases delivered to the patient's nares via the nasal prongs 108, 110. The inlet flow entry direction Finiet may be perpendicular to a central axis of each of the nasal prongs 108, 110.
[0275] It has been found that the orientation of the inlet openings 114, 116 may affect the quality of sampling and gas monitoring. More specifically, when the one or more inlet openings 114, 116 are oriented to face the septum / columella such that gases expired from the patient directly enter the inlet opening 114, 116 without changing direction, increased dilution of exhaled gases can be observed. Elaborating further, downwash from the nasal prongs 108, 110 (which typically includes redirected gases from the nasal cannula 102) may more readily enter the inlet openings 114, 116 when the inlet flow entry direction Finiet is the same as the direction of exhaled gases from the patient's nose FnOse. The downwash may undesirably dilute the sampled gas trace detected using the gas collector 100.
[0276] As previously mentioned, the suction rate of a capnography machine coupled to the gas collector 100 via sample line 41 may have a suction rate which is lower than the flow rate of the supplied gases via the nasal cannula 104. In some cases, this difference in flow rate and suction rate may exacerbate the problem of dilution when the inlet flow entry direction Finiet is generally the same as the direction of exhaled gases from the patient's nose F nose-
[0277] As such, improved quality sampling and gas monitoring may be achieved when the inlet flow entry direction Finiet is different to the direction of exhaled gases from the patient's nose FnOse, and in particular, the inlet flow entry direction Finiet is as described above e.g. generally perpendicular to the direction of exhaled gases from the patient's nose FnOse. This positioning of the gas sampling portion 112 and the inlet openings 114, 116 allows expired gases from the patient to flow past the gas sampling portion 112 without creating undesirable gas pockets and facilitates the monitoring of the cyclic breathing pattern of thepatient. When in fluid communication with a capnography machine, a portion of gases at or near the patient's nose may be removed / sampled via suction through the inlet openings 114, 116.
[0278] The one or more inlet openings 114, 116 may be of any suitable geometry and size. In some embodiments, the one or more inlet openings 114, 116 may be generally circular having a diameter of about 0.5mm to 1.5mm, 0.6mm to 1.5mm, 0.7mm to 1.5mm, 0.7mm to 1.4mm, 0.7mm to 1.3mm, 0.7mm to 1.2mm, 0.7mm to 1.1mm, 0.7mm to 1.0mm, or 0.7mm to 0.9mm. In one embodiment, the one or more inlet openings 114, 116 may be generally circular having a diameter of about 0.8mm.
[0279] In some instances where the gas collector samples gases from the patient's mouth, arranging the inlet flow entry direction Finiet such that it is different to the direction of exhaled gases from the patient's nose FnOse, may also improve the ability of the gas collector to sample from the mouth, as described in further detail below with reference to Figure 14.
[0280] In some procedures, the gases may be supplied to the patient at high flow rates via the nasal cannula 104. The gas collector 100 may be coupled to a capnography machine and may collect / sample gases at the patient continuously at a suction flow rate much lower than the flow rate of gases delivered to the patient via the nasal cannula 104. It can sometimes be difficult to capture a trace using the capnography machine representing the patient's breathing if the patient's breath is washed out or substantially diluted by redirected gases from the nasal cannula 104 gas supply. The orientation and position of the one or more inlet openings 114, 116 on opposite sides 122, 124 of the nose sampling part 112, and facing the nasal prongs 108, 110 so that Finiet is generally perpendicular to FnOse may further improve the nose sampling part's 112 ability to sample at least some of the exhaled gases and redirected gases when a level of suction is applied via the capnography machine. The orientation and positioning of the inlet openings 114, 116 may also minimise the downwash from substantially blocking or occupying the inlet openings 114, 116 and hindering the sampled exhaled gases from entering the inlet openings 114 and 116. In other words, due to the high flow rate and pressure of the redirected gases from the nasal prongs 108, 110, exhaled gases from the patient may be prevented or blocked from entering the inlet openings 114, 116 if the inlet openings 114 and 116 were positioned and oriented in such away that Finiet is generally parallel with FnOse (e.g. if the inlet openings 114, 116 faced the patient's septum / columella in use). Moreover, positioning the inlets 114, 116 on opposite sides 122, 124 of the nose sampling part 112 reduces changes of blockage due to discharge (such as mucous fluid and / or particles) from the patient's nose.
[0281] The compact configuration of gas collector 100 with the positioning of the nose sampling part 112 under the patient's septum / columella may further provide improved gas sampling functionality to more effectively monitor patient breathing. In particular, the nose sampling part 112 can be positioned directly under, and in close proximity to, the patient's septum / columella where it has been found that expired gases from the patient's nose momentarily accumulate. More specifically, positioning of the nose sampling part 112 proximate the patient's septum / columella and above the bridging portion 120 provides improved sampling as exhaled gases from the patient's nose momentarily accumulates near the septum / columella before dissipating. This positioning may improve exposure of the nose sampling part 112 to expired gases from the patient's nose to enable better sampling and measurement. Positioning the nose sampling part 112 directly in a position where exhaled gases from the patient's nose is most likely to temporarily accumulate improves sampling outcomes.
[0282] In some embodiments, such as the gas collector 100 as illustrated in Figures 2 to 5, at least a substantial part of the gas collector 100 including the coupling mechanism 118 and the nose sampling part 112 fits generally between the nasal prongs 108, 110. More specifically, the nose sampling part 112 is also above the bridging portion 120.
[0283] Moreover, by positioning the nose sampling part 112 directly under, and proximal to the patient's septum / columella further enables the gas collector 100 to sample gases from either one or both of the left and right nares.
[0284] The streamlined and low-profile design of the gas collector 100 may provide a low resistance to flow gas collector that more effectively enables expired gases from the patient to enter the gas collector 100. Moreover, the gas collector 100 may be seamlessly mounted to the nasal cannula 104, without impeded gas flow for the patient or obstructing medical professionals' procedures. As previously mentioned, a second respiratory support via a face mask assembly 144 may be provided by placing the face mask assembly 144 over the nasalcannula 104 and collapsing a portion of the flow manifold 106, whilst maintaining open fluid communication of the sampling line 41 which connects the gas collector 100 to one or more gas sensors 39. More specifically, the gas collector 100 does not substantially protrude beyond the existing framework and boundaries of the nasal cannula 104. In other words, when attached, the gas collector 100 is compact and does not significantly increase the size or bulkiness of the overall nasal cannula 104 and gas collector 100 assembly. Indeed, the overall profile of the nasal cannula 104, particularly on the patient facing side, remains relatively unchanged when the gas collector 100 is mounted thereto, thereby allowing the nasal cannula 104 to be positioned relatively flush against the patient's face. This minimises discomfort to the patient and also minimises movement or displacement of the nasal prongs 108, 110 away from the patient's face in the coronal plane, which minimises disruption to the supply of gases to the patient via the nasal cannula 104.
[0285] In addition, the coupling mechanism 118 provides secure and stable attachment of the gas collector 100 to the nasal cannula 106 so as to avoid unintentional movement of the gas collector 100 relative to the nasal cannula 106 during use.
[0286] The position of the nose sampling portion 112 and thus the one or more inlet openings 114, 116 is generally fixed relative to the coupling mechanism 118. In some embodiments, the nose sampling portion 112 may be integrally formed with, or rigidly attached to, the coupling mechanism 118 so that there is essentially no movement of the nose sampling portion 112 and inlet openings 114, 116 relative to the coupling mechanism 118. The secure and stable positioning of the nose sampling portion 112 after mounting to the nasal cannula 104 via the coupling mechanism 118 further facilitates improved measurement and patient monitoring outcomes. The configuration of the gas collector 100 also avoids the need for any readjustment of positioning of the nose sampling portion 112 during a medical procedure, which in some instances may lead to sub-optimal positioning and reduced effectiveness in patient monitoring.
[0287] In some embodiments, an additional inlet opening (e.g. similar to inlet opening 3015 as shown in Figure 39B) may be provided on a top face of the nose sampling part 112 in addition to the one or more inlet openings 114, 116. In some scenarios, the additional inlet opening (e.g. 3015) on the top face of the nose sampling part 112 may be blocked by thepatient's columella when the nasal cannula 104 and gas collector 100 is in use. Occasionally, the nasal cannula 104 and / or gas collector 100 may move or be positioned such that the additional inlet opening (e.g. 3015) is not entirely blocked by the patient's columella (e.g. due to patient and / or clinician movement, differences between patient facial geometry). When the additional inlet opening (e.g. 3015) is not entirely blocked by the patient's columella, a level of patient gas sampling may be achieved via additional inlet opening (e.g. 3015). Patient gases may enter the additional inlet opening (e.g. 3015) at an angle to the general direction of exhaled gases from the patient's nose FnOse.
[0288] In some embodiments, the gas collector 100 may be integral with the nasal cannula 104. For example, the gas collector 100, 200, 300, 400, 500, 600, 700, 800 may be comoulded with the nasal cannula.
[0289] The gas collector 100 may further include a pair of flow guides 126, 128 for guiding gases from the patient towards the gas sampling portion 112. As more clearly shown in Figures 3 and 4, the flow guides 126, 128 are generally wing-shaped and disposed on opposite sides of the nose sampling part 112. The flow guides 126, 128 are configured to guide gases from the patient's nose towards the pair of inlet openings 114, 116 of the nose sampling part 112. In some embodiments, the flow guides 126, 128 may be rigid components located adjacent the inlet openings 114, 116 and may further serve to maintain the vicinity of the inlet openings 114, 116, for example by preventing a flexible part of the nasal cannula 104 (e.g. nasal prong 108, 110) or other medical instrument from collapsing or moving into or covering the nose sampling part 112 and obstructing the inlet openings 114, 116. As mentioned, relative rigidity or flexibility in a feature may be achieve via any one or more of structure, geometry and material of the relevant feature. In this example, the desired rigidity of the flow guides 126, 128 may be achieved in any suitable manner, for example by using a more rigid material or providing a thickness of the flow guides that is sufficient to provide the required rigidity, or a combination of both. In some embodiments, the flow guides 126, 128, any other part of the gas collector 100 and the patient interface 104 may be manufactured using the same material or similar materials.
[0290] As shown in Figure 2, the pair of flow guides 126, 128 are configured for positioning between the nasal prongs 108, 110 when the gas collector 100 is mounted to thenasal cannula 104. Each flow guide 126, 128 defines a curved surface for guiding a flow of gases from the patient's nose towards the inlet openings 114, 116 of the nose sampling part 112. As described below with reference to gas collector 200 which does not include flow guides 126, 128, inner side walls of nasal prongs 108, 110 may serve as flow guides to guide a flow of gases from the patient's nose towards the inlet openings of the nose sampling part. More specifically, the inner side walls of the nasal prongs 108, 110 and an upper surface of the bridging portion 120 may form a generally U-shaped curved wall, which may serve as flow guides to guide a flow of gases from the patient's nose towards the inlet openings of the nose sampling part.
[0291] As more clearly shown in the cross-sectional view in Figure 5, the gas collector 100 further includes an outlet portion 130 defining an outlet 132 in fluid communication with the inlet openings 114, 116. Gases collected via the inlet openings 114, 116 move through an internal channel 134 of the gas collector 100 and exits the gas collector 100 via the outlet 132. The outlet portion 130 may be configured for connection with a conduit (also referred to herein as a sampling line 41) for delivering the gases collected by the gas sampling portion to one or more sensor units 39 to analyse the collected gases. The connection between the outlet portion 130 and the conduit 41 may be achieved in any suitable manner. For example, the outlet portion 130 may be threaded, including one or more tapered portions, protrusions, projections, notches or grooves for secure attachment to the conduit.
[0292] The one or more sensor units 39 may include one or more gas analysers for analysing gases from the gas collector 100. Output from the sensor units 39 may be used to generate one or more traces to monitor patient breathing. In some embodiments, output from the sensor units 39 may be used to generate one or more visual / graphical representations of the patient breath. For example, one or more line graphs may represent one or more gas parameters plotted against time. For example, an output graphical representation may include a line graph (trace) representing a concentration or relative concentration of CO2 plotted against time. As such, the visual representation may provide an indication of changes in CO2 concentration over time to provide effective monitoring of patient breathing.
[0293] Another embodiment of a gas collector 200 is illustrated in Figures 6 to 8. In the gas collector 200, like components refer to those previously described in relation to Figures 2 to 5, and elsewhere in the present specification.
[0294] Gas collector 200 functions in a similar manner to the gas collector 100 illustrated in Figures 2 to 5. As illustrated in Figure 6, the gas collector 200 is configured for releasably attachment to a gas delivery patient interface 102 such as a non-sealing nasal cannula 104.
[0295] The gas sampling portion 202 includes a nose sampling part 204 including one or more (e.g. a pair of) inlet openings 214, 216 disposed on opposite sides of the nose sampling part 204 for sampling expired gases from the patient's nose. The gas collector 200 further includes a coupling mechanism 218 for releasably coupling the gas sampling portion 202 to the bridging portion 120 of the nasal cannula 104. As previously mentioned, gas collector 200 may be integrally provided with the patient interface 102. Moreover, the gas collector 200 may be manufactured from the same material as, a similar material or different material to the patient interface 102.
[0296] In the particular embodiment shown in Figures 6 to 8, the gas collector 200 may not include any flow guides. However, side walls of the nasal prongs 108, 110 adjacent the nose sampling part 204 may act as flow guides to facilitate guiding gases from the patient towards the one or more inlet openings 214, 216.
[0297] The gas sampling portion 202 may further include a mouth sampling part 206 configured to extend below the body 101 and flow manifold 106 for placement adjacent the patient's mouth in use. As more clearly shown the cross-sectional view in Figure 8, the mouth sampling part 206 defines an inlet aperture 208 to sample gases at the patient's mouth. In practice, some of the expired gases from the patient's nose may be captured via the pair of inlet openings 214, 216 defined by the nose sampling part 204 and some of the expired gases from the patient's mouth may be captured via the inlet aperture 208 defined by the mouth sampling part 206. The captured gases via the inlet openings 214, 216, and inlet aperture 208 move through internal channels 210, 212 of the gas collector 200 towards an outlet 232 defined by an outlet portion 230 of the gas collector 200. The outlet portion 230 may be threaded to facilitate attachment to a conduit, which couples the gas collector 200 to one or more gas analysers to analyse the captured gases from the patient.
[0298] The outlet portion 230 may extend laterally with respect to the patient and nasal cannula 104 so as to maintain a low profile for the gas collector 200 to avoid obstructing the patient and / or operations of clinicians.
[0299] A gas collector 300 according to another embodiment is illustrated in Figures 9 to 11. The gas collector 300 includes a nose sampling part 302 for sampling gases at the patient's nose. The nose sampling part 302 defines a plurality of inlet openings 304. Any suitable number of inlet openings 304 in any suitable arrangement can be provided. In the particular embodiment shown in Figures 9 to 11, two rows of inlet openings 304 are provided. In some embodiments, only one row of inlet openings 304 may be provided. For example, a second row of inlet openings 306 having the inlet flow entry direction Finiet which is different to a direction of exhaled gases from the patient's nose FnOse may be provided. A first row of inlet openings 304 having the inlet flow entry direction Finiet which is the same as a direction of exhaled gases from the patient's nose FnOse may be omitted.
[0300] In various embodiments, for at least some of the inlet openings 306 the inlet flow entry direction Finiet may be different to a direction of exhaled gases from the patient's nose Fnose. More specifically, the inlet flow entry direction Finiet for at least some of the inlet openings 304 may be disposed at roughly 10° to 90° to the direction of exhaled gases from the patient's nose FnOse. The angle of the inlet openings 304 may be varied to vary the amount of downwash entering the gas collector 300.
[0301] Similar to the embodiments shown in Figures 1 to 8, the nose sampling part 302 is compact and configured for positioning in a space between the patient's septum / columella, the bridging portion 120 of the body 101 and the nasal prongs 108, 110 when the gas collector 300 is mounted to the nasal cannula 104. An outlet 330 is provided on a side of the nose sampling part facing away from the patient in use. A sampling line 41 may be connected to the nose sampling part 302 via the outlet 330 so that gases captured by the nose sampling part 302 moves through the conduit for analysis by one or more gas analysers.
[0302] The gas collector 100 further includes a coupling mechanism in the form of two C- shaped or U-shaped gripping portions 308, 310 for mounting to the nasal prongs 108, 110 of the nasal cannula 104 as illustrated in Figure 11. Each of the gripping portions 308, 310 isconfigured for releasable attachment to a respective one of the nasal prongs 108, 110 via a friction fit.
[0303] The inlet openings 304, 306 can be any suitable shape. In the alternative embodiment of the gas collector 400 shown in Figure 12, the rows of inlet openings 304, 306 of gas collector 300 are replaced by two parallel slots 402, 404. Like features of the gas collector 400 refer to those previously described with reference to the gas collector 300 in Figures 9 to 11.
[0304] Figures 13 and 14 illustrate a gas collector 500 for collecting gases at a patient according to yet another embodiment. The gas collector 500 may include a gas sampling portion 502 for sampling gases at the patient. The gas sampling portion 502 includes a nose sampling part 504 and a mouth sampling part 506. The nose sampling part 504 defines one or more (e.g. a pair of) openings 522 (only one shown in Figure 13) disposed on one or opposite sides of the nose sampling part 504 to sample expired gases from the patient's nose. The mouth sampling part 506 defines an aperture 510 for sampling expired gases from the patient's mouth. Similar to the previously described embodiments, the nose sampling part 504 is positioned proximate and under the patient's septum / columella, above the bridging portion 120 of the nasal cannula 104, and between the nasal prongs 108, 110 in use. The mouth sampling part 506 extends downwardly below the bridging portion 120 and is configured for positioning adjacent the patient's mouth. The mouth sampling part 506 defines a mouth sampling aperture 510 for sampling gases (including exhaled gases) from the patient's mouth. The sampled gases at the patient's mouth may include exhaled gases and / or ambient gases.
[0305] The coupling mechanism of the gas collector 500 comprises a pair of rings 512, 514. Each ring 512, 514 may be configured for attachment to a respective one of the nasal prongs 108, 110 of the nasal cannula 104. More specifically, each of the nasal prongs 108, 110 may be inserted into a respective one of the rings 512, 514 such that the nose sampling part 504 is positioned above the bridging portion 120 of the body 101 and between the nasal prongs 108, 110 in use. In some embodiments, the rings 512, 514 may be replaced by C- shaped or U-shaped portions, or any suitable partially open / partially closed looped portions for attachment to the nasal prongs 108, 110.
[0306] As more clearly shown in Figure 14, the gas collector 500 includes an outlet portion 518 defining an outlet 518. The sample line 41 may be connected to the outlet portion 518 for coupling the outlet 518 to the one or more sensor units 39.
[0307] Whilst it is shown in Figure 14 that the outlet portion 518 extends in a direction away from the nasal cannula 104 when the gas collector 500 is mounted thereon, it will be appreciated that the outlet portion 518 of gas collector 500 (and any outlet portion of any of the gas collector embodiment) may extend in any suitable direction. For example, the outlet portion 518 may extend towards either side of the body 101 of the nasal cannula 104, such as towards the flow manifold 106 as illustrated by outlet 232 of gas collector 200 as shown in Figures 6 and 7. Advantageously, providing an outlet portion 232 that extends to one side of the body 101 allows the sample line 41 and the outlet portion 232 to more effectively maintain a low profile. For example, arranging the sample line 41 such that it extends along the flow manifold 106 may also allow continuous sampling when the flow manifold 106 is collapsed when a face mask assembly 144 is applied over the nasal cannula 104 (e.g. as described with reference to Figures 39A to 40).
[0308] A further aperture 520 may be provided adjacent the mouth sampling aperture 510. Sampled gases at the patient's mouth may be received via either one or both of the apertures 510, 520.
[0309] In some instances where the gas collector 500 samples gases from the patient's mouth, arranging the inlet flow entry direction Finiet of the inlet openings 522 at the nose sampling part 504 such that it is different to the direction of exhaled gases from the patient's nose Fnose, may also improve the ability of the gas collector to sample from the patient's mouth. By orienting the inlet openings 522 such that Finiet is generally perpendicular to FnOse, any redirected gases from the nasal cannula 104 having a high flow flow rate would be less likely to enter the inlet openings 522, pass through internal channels 524, 526 of the gas collector 500 and out of apertures 510, 520 at high pressure. The flow of such redirected gases (downwash) out of apertures 510, 520 may undesirably preventing gases from mouth from entering the gas collector 500 via 510 and 520 to enable effective sampling and patient monitoring.
[0310] In an alternative embodiment of the gas collector 600 as shown in Figures 15 to 17, the coupling mechanism comprises a pair of rings 602, 604. Similar to the embodiment shown in Figures 13 and 14, each of the rings 602, 604 is configured to fit around a respective one of the nasal prongs 108, 110 for releasable attachment to thereto. As more clearly shown in the cross-sectional view in Figure 17, each of the rings 602, 604 is hollow. In other words, each of the rings 602, 604 of the coupling mechanism comprises a conduit or channel.
[0311] Each of the rings 602, 604 defines a plurality of inlet openings 606, 608 radially spaced around its external periphery. Each of the rings 602, 604 may further define a plurality of inlet opening 610, 612 radially spaced around its internal periphery. In other embodiments, the inlet openings may be provided anywhere on either one or both of the hollow rings 602, 604. The nose sampling portion 616 is provided between the rings 602, 604 and positioned between the nasal prongs 108, 110 and above the bridging portion 120 in use as shown in Figure 15. Similar to the previously described embodiments, the nose sampling portion 616 may provide a pair of inlet openings 622 (partially hidden in the figures) on opposite sides of the nose sampling portion.
[0312] An outlet portion 618 defining an outlet 620 may be provided on one side of the gas collector facing away from the patient when the gas collector 600 is mounted to the nasal cannula 104. The outlet portion 618 may be connected to a sampling line 41 and coupled to one or more gas analysers to analyse patient gases collected via the gas collector 600. More specifically, inlet openings 614, 622, 606, 608, 610, 612 provided by the nose sampling part 616 and the coupling mechanism 602, 604 are connected to the outlet 620 via internal flow paths of the gas collector 600 (Figure 17). As such, gases collected via the inlet openings inlet openings 614, 622, 606, 608, 610, 612 exit the gas collector 600 via outlet 620 for analysis via the one or more gas analysers.
[0313] Optionally, the inlet openings 606, 608, 610, 612 may vary in size to facilitate flow balancing across the gas collector 600. For example, inlet openings located closer to the outlet 620 may be smaller than those located further from the outlet 620.
[0314] It will be appreciated, in the embodiment of the gas collector 600, the specific configuration and orientation of the outlet portion 618 may vary. Similarly, in other embodiments of the gas collector 100, 200, 300, 400, 500, 700, 800, 900, 1000 as describedherein, or embodiments having a combination of the features of the gas collectors described herein, the specific configuration and orientation of the outlet portion 618 may vary. As previously mentioned, the outlet 620 may project towards one side of the body 101 of the nasal cannula 104 when mounted thereon to facilitate maintaining a low profile.
[0315] In some embodiments, a mouth sampling part 702 may be provided as shown in the gas collector 700 of Figures 18 and 19. The mouth sampling part 702 is configured to extend below the body 101 and bridging portion 120 of the nasal cannula 104 in use for positioning adjacent the patient's mouth. Like features of the gas collector 700 refer to those previously described with reference to Figures 13 to 17. In the embodiment of the gas collector 700 illustrated in Figures 18 and 19, additional inlet openings may or may not be provided in the coupling mechanism 704, 708. Moreover, one or more mounting stabilisers 706 may be provided on an inner side of each ring-shaped coupling mechanism 704, 708. Each mounting stabiliser 706 may take the form of a protrusion for abutment against a respective nasal prong 108, 110 so as to provide additional stability for the coupling mechanism 704, 708.
[0316] Typically, in the embodiments described herein with reference to Figures 2 to 20, the gas sampling portion may be fixed relative to the coupling mechanism. More specifically, the nose sampling part may be fixed relative to a body of the gas collector, so that its relative position to the body of the gas collector or coupling mechanism is generally fixed / stationary and does not change during operation. As such, when the gas collector is mounted to the patient interface 102, location of the nose sampling part may be in a generally stable position relative to the bridging portion 120 and nasal prongs 108, 110 of the nasal cannula 104, and does not require manual adjustment during the course of a medical procedure.
[0317] In some embodiments, the gas collectors may have a degree of flexibility and resilience. For example, the gas collectors may be moulded using a plastic material which may be soft plastic or hard plastic. In some embodiments, the gas collectors may be formed from a material that is similar to or same as a material of the patient interface 102. In any event, the position of the nose sampling part is fixed relative to the coupling mechanism. This facilitates accurate positioning of the nose sampling part under the patient's septum / columella, above the bridging portion 120 of the nasal cannula 104 and between thenasal prongs 108, 110, which provides effective patient gas monitoring that does not rely on manual adjustment of the positioning of the nose sampling part by a clinician.
[0318] In some embodiments, the gas collector may be integral with the nasal cannula. In particular, the gas collector 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 may be integrally formed with the nasal cannula 104.Gas collector having rigid and flexible portions
[0319] A gas collector 800 according to another embodiment for collecting gases at a patient is illustrated in Figures 21 to 24. The gas collector 800 includes a gas collection portion 802 for collecting at least a portion of gases exhaled from the patient via the patient's nose and / or mouth. During operation, the gas collection portion 802 faces the patient and is positioned generally between and proximate the patient's nose and mouth so as to collect expired gases from the patient's nose and / or mouth. Generally, the gas collector 800 is configured to extend from beneath the patient's nose to adjacent the top of the patient's mouth, upper lip and / or teeth in use. The geometry of the gas collector 800 may roughly follow a contour of the patient's face from adjacent the patient's septum / columella to the patient's mouth.
[0320] The gas collector 800 further includes a coupling mechanism 804 for coupling the gas collection portion 802 to a gas delivery patient interface 102 such as a nasal cannula 104. In some embodiments, the coupling mechanism 802 includes an engagement portion in the form of a U-shaped holder 806 for engagement with the nasal cannula 104. In particular, the U-shaped holder may receive the body 101 of the nasal cannula 104 therein. The body 101 of the nasal cannula may be flexible or collapsible to allow insertion into the U-shaped holder. After insertion, the body 101 returns to its original shape. Advantageously, the U-shaped holder may allow removal of the gas collector 800 without removal of the nasal prongs 108, 110 from the patient's nares.
[0321] The gas collection portion 802 may be configured to provide damping of external forces applied to the gas collection portion 802 so as to reduce the transfer of forces between the gas collection portion 802 and the coupling mechanism 804. More specifically, the gas collection portion 802 may include a resilient material to facilitate damping of theexternal forces applied thereto, for example from the patient. Elaborating further, the gas collection portion 802 may be made from a resilient material and the damping properties of the resilient material may serve to decouple forces applied thereto. For example, forces may be applied to the gas collection portion 802 by contact with the patient in use. These forces may be absorbed by the gas collection portion 802, or cause the gas collection portion 802 to flex, bend, and / or deform. The decoupling of these forces reduces the transfer of forces from the gas collection portion 802 to the coupling mechanism 804, thereby reducing the risk of undesirable movement and / or dislodgement of the nasal cannula 104 during a medical procedure.
[0322] The coupling mechanism 804 may include a rigid material to further facilitate stabilising the nasal cannula 104. In the embodiment shown in Figure 21 to 23, a base of the coupling mechanism forms a central portion 808 of the gas collector 800. The U-shaped holder extends from one side of the central portion 808 facing away from the patient in use. The coupling mechanism 804 may be made from a rigid material. The rigidity of the coupling mechanism may provide structural integrity and stability to the gas collector 800 and the nasal cannula 104 when the two are attached to one another. It will be appreciated when describing the physical properties of a material, terms such as rigid, flexible and resilient are relative terms. A person skilled in the art would understand that in the context of present embodiments, the coupling mechanism 804 is more rigid, less flexible and less resilient than the gas collection portion 802, and vice versa.
[0323] The gas collector 800 further includes an outlet portion 810 defining an outlet 812 through which gases collected by the gas collector 800 can exit the gas collector 800. The outlet portion 810 is configured for attachment with a conduit / sampling line 41, which provides a pathway for the sampled gases to the one or more gas analysers 39. The outlet portion 810 extends from the central portion 808 and may be integral with the central portion 808. The outlet portion 810 may be made from the same rigid material as the central portion 808. The rigidity of the outlet portion 810 may further provide structural integrity to ensure secure and stable attachment with the sampling line 41, which may also be decoupled from external forces applied to the gas collector 802 due to the damping effect of the gas collector 802.
[0324] As more clearly shown in Figure 24, the gas collector 800 further includes a gas collection inlet 814 in fluid communication with the gas collection portion 802 such that at least a portion of gases collected by the gas collection portion 802 flows into the gas collection inlet 814. The rigidity of the outlet portion 810 also ensures that the flow path between the inlet 814 and the outlet 812 remains open.
[0325] The gas collector 800 may further include a channel 816 in fluid communication with the gas collection inlet 814 to facilitate gas flow from the patient's nose and / or mouth towards the gas collection inlet. The channel 816 may extend substantially across an inner side of the central portion 808 facing the patient in use such that the length of the channel 816 generally extends from proximate the patient's septum / columella to the patient's mouth or upper lips. In other words, the channel 816 may generally extend along the patient's philtrum to the patient's mouth or upper lips in use. The inlet 814 is in fluid communication with the outlet 812 so that gases collected by the gas collection portion 802 enters the inlet 814 and passes through the outlet 814 the sampling line 41 for analysis by one or more gas analysers 39. The channel 816 may include a rigid material. In some embodiments, the channel 816 may be integral with and made from the same rigid material as the central portion 808. The channel 816 may be integrally formed with the coupling mechanism 804. The rigidity of the channel 816 may prevent deformation of the channel 816 and facilitate maintaining the fluid communication between the gas collecting portion 802, the channel 816 and the inlet 814.
[0326] The gas collection portion 802 may include a nasal flow guide 818 configured to extend under the patient's nose in use so as to facilitate collection of gases from the patient's nose towards the gas collection inlet 814. The nasal flow guide may take any suitable shape or form. In the particular embodiment shown in Figures 21 to 24, the nasal flow guide 818 is shaped to generally follow a contour of a lower part of the patient's nose. Moreover, the nasal flow guide 818 may include a neck 820 for accommodating nasal prongs 108, 110 of the nasal cannula 104 on either side of the neck 820.
[0327] The gas collection portion 802 may further include a mouth portion 822 configured to extend under or adjacent the patient's upper lip and / or upper teeth in use so as to facilitate collection of gases from the patient's mouth towards the gas collection inlet814. As more clearly shown in Figures 21 and 22, the gas collector 800 has a generally sigmoid shaped profile. In other words, the general sigmoid shape may be apparent when a vertical cross section is taken through a center line of the gas collector 800. More specifically, the gas collection portion 802 further includes an offset region 824 proximate the mouth portion 822. The offset region 824 may be configured to be situated away from the patient's mouth in use so as to facilitate gas flow between the patient's mouth and the gas collection inlet 814. The offset region 824 may facilitate the maintenance of a distance between the gas collection portion 802 and the patient in use so as to minimise the risk of the patient's upper lip from blocking a portion of the gas collection portion and / or the inlet 814 in use.
[0328] Now referring to a gas collector 900 according to another embodiment as illustrated in Figures 25 and 26. In the gas collector 900, like features refer to those previously described with reference to Figures 21 to 24.
[0329] The gas collector 900 includes a gas collection portion 902 for collecting at least a portion of gases exhaled from the patient via the patient's nose and / or mouth. The gas collector 900 further includes a coupling mechanism 904 having a U-shaped holder 906 for receiving the flow manifold 106 of a nasal cannula 104 therein.
[0330] In some embodiments, the gas collection portion 902 may be made from a resilient material to provide damping of external forces applied to the gas collection portion 902 so as to reduce the transfer of forces between the gas collection portion 902 and the coupling mechanism 904. The coupling mechanism 904 may be made from a rigid material to further facilitate stabilising the nasal cannula 104 and sample line in use.
[0331] As more clearly shown in Figure 26, the gas collector 800 may further include a channel 916 in fluid communication with the gas collection inlet 814 to facilitate gas flow from the patient's nose and / or mouth towards the gas collection inlet 914.
[0332] The gas collection portion 902 includes a mouth portion 922 for placement adjacent the patient's mouth. In some embodiments, the mouth portion 922 may extend partially into the patient's mouth, for example under the patient's upper lip, or under the patient's upper row of teeth. The gas collection portion 902 may define a narrowed portion 940 adjacent the mouth portion 922. The narrowed portion 940 may provide a hinge toenable movement of the mouth portion 922 relative to the narrowed portion 940. This additional flexibility in the movement of the mouth portion 922 relative to the narrowed portion may allow the gas collector 900 to better conform with the contours of a patient's mouth and facial features in use so that the gas collector 900 may have a more streamlined and low-profile shape when mounted to the nasal cannula 104 and placed over a patient's face.
[0333] As more clearly shown in Figure 26, the gas collection portion 902 may further include a pair of guide members 944, 946 each projecting from the gas collection inlet 914 toward an edge of the mouth portion 946 so as to guide at least a portion of the gas flow from the patient's mouth towards the gas collection inlet 914.
[0334] The mouth portion 922 may include a scooped portion 942 between the guide members 944, 946. The scooped portion 942 may have an edge configured to extend below the patient's upper lip in use to facilitate gas flow from the patient's mouth towards the gas collection inlet. The scooped portion 942 may prevent the patient's upper lip from blocking the mouth portion 922 from collecting gases from the patient's mouth.
[0335] A further embodiment of a gas collector 1000 is shown in Figure 27. In the gas collector 1000, like feature refer to those previously described with reference to Figures 21 to 26. In the gas collector 1000, the mouth portion includes a pair of mouth flow guide projections 1002, 1004. Each of the mouth flow guide projections 1002, 1004 is configured to extend under or adjacent an opposite side or corner of the patient's upper lip in use so as to facilitate collection of gases from the patient's mouth towards the gas collection inlet (hidden).
[0336] The gas collection portion may further include a pair of nasal flow guide projections 1006, 1008. Each nasal flow guide projection 1006, 1008 is configured to extend adjacent an opposite side of the patient's nose in use so as to facilitate collection of gases from the patient's nose towards the gas collection inlet (hidden in Figure 27).
[0337] As illustrated in Figure 28, various single use components of the respiratory support system 10 as shown in Figure 1 may be provided in a kit. For example, a gas delivery patient interface 102 such as a non-sealing patient interface such as nasal cannula 104 maybe provided in a kit with a gas collector (e.g. gas collector 500 as shown in Figures 13 and 14) for mounting to the non-sealing patient interface e.g. nasal cannula 104. The gas collector in the kit may be any one of the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 as described herein or may be an alternative gas collector having a combination of the different features described in relation to the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 as disclosed herein.
[0338] In some embodiments, the kit may include a gas delivery patient interface 102 such as a non-sealing patient interface e.g. nasal cannula 104 integrally formed with a gas collector according to any one of the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 as described herein or an alternative gas collector having a combination of the different features described in relation to the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 as disclosed herein.
[0339] In some embodiments, the kit may further include any one or more of a gas flow conduit 31, an inspiratory limb 37, filter 36 and a humidification chamber 14, for example as shown in Figure 28. The gas flow conduit 31 may be any supplementary gas conduit, such as the first or second supplementary gas conduit 24, 26 as illustrated in Figure 1.
[0340] A schematic of a gas delivery patient interface 3000 for delivering gases to a patient P according to another embodiment is illustrated in Figure 39A. The gas delivery patient interface 3000 includes a body 3002 having a flow manifold 3004 for receiving a flow of gases for delivery to the patient P similar to patient interface 1400 previously described with reference to Figures 32 to 35. The gas delivery patient interface 3000 also includes a pair of nasal prongs 3006, 3008 extending from the body 3002 for delivering the flow of gases to the patient P via the patient's nares. For simplicity, only a part of the gas delivery patient interface 3000 is shown in Figure 39A. It will be understood that the gas delivery patient interface 3000 may include similar inlets, outlets, ports, connectors, straps and the like for coupling to an apparatus gas supply via any suitable conduit, and attaching the gas delivery patient interface 3000 to the patient P.
[0341] The gas delivery patient interface 3000 includes a gas sampling portion 3010 for sampling gases at the patient P. The gas sampling portion 3010 may be integral with, or selectively attachable to and removable from, the body of the patient interface 3000. Anysuitable coupling mechanism may be provided to enable selective attachment of the gas sampling portion 3010 to the body of the patient interface 3000. For example, any one of the coupling mechanisms in various gas collector embodiments as described herein, or similar coupling mechanisms may be used.
[0342] The gas sampling portion 3010 includes a nose sampling part 3012 positioned between the nasal prongs 3006, 3008 so as to provide a low profile whilst effectively capturing exhaled gases at or near the philtrum from the patient's nose. The nose sampling part 3012 defines at least one opening. In the specific embodiment illustrated in Figure 39A, the nose sampling part 3012 defines two inlet openings 3014, 3016 to sample gases at the philtrum. Similar to gas collectors previously described such as gas collectors 100, 200 illustrated in Figures 2 to 8, each of the inlet openings 3014, 3016 may be oriented to face a respective nasal prong 3006, 3016. Moreover, each inlet opening 3014, 3016 may be oriented generally transversely (or perpendicularly) to an inner surface 3025 or an outer surface 3020 of the body 3002 (as more clearly shown in Figure 42). The inlet openings 3014, 3016 are also generally perpendicular to a top face 3021 of the nose sampling part 3012 (see Figure 39B). In some embodiments, one or more alternative or additional inlet openings may be provided parallel and aligned, or parallel and offset from the inner surface 3025 and / or outer surface 3020 (e.g. generally parallel with the patient's coronal plane in use). In some embodiments, one or more alternative or additional inlet openings 3015 may be oriented generally transversely (or perpendicularly) to an inner surface 3025 or an outer surface 3020 of the body 3002 for example as shown in Figure 39B (e.g. generally parallel with the patient's transverse plane in use). As shown in Figure 39B, one or more inlet openings 3015 may be provided on a top face 3021 of the nose sampling part 3012. The one or more inlet openings 3015 may be provided adjacent an inner side 3023 of the nose sampling part 3012 facing the patient in use. The inner surface 3025 of the body 3002 of the gas delivery patient interface 3000 may be the surface of the body 3002 that faces the patient P in use. The outer surface 3020 of the body 3002 of the gas delivery patient interface 3000 may be the surface 3020 of the body 3002 opposite the inner surface 3025 and facing away from the patient P in use.
[0343] As illustrated in the B-B cross sectional view of the gas delivery patient interface3000 in Figure 42, one or more inlet openings 3014, 3016 (only one shown) are orientedgenerally perpendicularly to an inner surface 3025 and outer surface 3020 of the body 3002 of the patient interface 3000. The inlet openings 3014, 3016 are on a plane that is parallel to a flow direction of gases exiting the patient's nares 3734, 3736 in use (also see Figure 50). In this orientation, the inlet openings 3014, 3016 are placed to pick up a sample of the gases exiting the patient's nares 3734, 3736 indirectly.
[0344] On the contrary, if inlet openings 3014, 3016 were placed on a plane perpendicular to the flow direction of gases exiting the patient's nares 3734, 3736 (that is, directly under and facing the patient's nare openings) the gases would enter the inlet openings 3014, 3014 with high dynamic pressure. The dynamic pressure may be the result of redirected high flow gases delivered to the patient via the nasal prongs and / or the pressure generated by the patient on exhalation. Thus, it has been found that placement of the inlet openings 3014, 3016 on a plane parallel to the general gases flow direction indicated by 3734, 3736 may allow more effective gas sampling at the patient's mouth in some embodiments as described in further detail below.
[0345] Similar to the gas collector embodiments as previously described, the one or more inlet openings 3014, 3016 may be generally located above the body 3002 of the interface 3000. Specifically, the one or more inlet openings 3014, 3016 may be located above a bridging portion of the body 3002 of the interface 3000 between the nasal prongs 3006, 3008. In some embodiments, the one or more inlet openings 3014, 3016 may be located above the bridging portion of the body 3002 of the interface 3000 between the nasal prongs 3006, and laterally positioned adjacent the outer surface 3020, inner surface 3025, or generally centred between the inner and outer surfaces 3020, 3025.
[0346] In some embodiments, the one or more inlet openings of the nose sampling part 3012 may be positioned and oriented in any suitable manner on the nose sampling part 3012. For example, one or more inlet openings may be defined on a sloping surface that meets the body 3002 of the patient interface 3000 at an angle, such as a 30°, 45°, 50°, 70° angle, or any suitable angle between 10° to 100°. Typically, one or more inlet openings of the nose sampling part 3012 are configured for positioning generally under the nasal septum / columella area, and oriented away from gas flow exiting the patient's nares 3734, 3736 (also see Figure 50). In other words, the one or more inlet openings of the nosesampling part 3012 are positioned at an angle that is not approximately 90° to the direction of the gas flow exiting the patient's nares 3734, 3736. It has been found that orienting the inlet openings 3014, 3016 away from the gas flow exiting the patient's nose in this manner prevents excessive dynamic pressure from the gases exiting the patient's nares 3734, 3736 from entering the nose sampling part 3012 (often as a result of the delivered high flow from the gas delivery patient interface 3000) and flushing out via any oral sampling passages 3710 (see Figure 50), for example as provided by an optional mouth sampling part 3052 as described below with reference to Figure 41. When gases exiting the patient's nose flow through the oral sampling passages 3710, it may be difficult to obtain a useful gas sample via the mouth sampling part 3052. It has therefore been found that by providing the inlet openings 3014, 3016 away from the gas flow exiting the patient's nares 3734, 3736 in the manner described above, a useful amount of gas sampling from the nose may be obtained without adversely affecting the effectiveness of the mouth sampling portion 3052 to sample gases from the patient's mouth. A top view of the gas delivery patient interface 3000 is shown in Figure 39B. As mentioned, in some embodiments of the gas delivery patient interface 3000, one or more inlet openings 3015 may be optionally provided on a top face 3021 of the nose sampling part 3012. To prevent gases with a high dynamic pressure exiting the patient's nose from entering the inlet openings 3015, it would be preferable to position the inlet openings 3015 on the top face 3021 closer to the inner side 3023 of the nose sampling part 3012 and under the patient's nasal septum / columella such that the inlet openings 3015 are not directly aligned with the flow path of gases exiting the patient's nares 3734, 3736.
[0347] Now returning to Figure 39A, the gas delivery patient interface 3000 further includes a sampling gas conduit 3018 for providing fluid communication between the gas sampling portion 3010 and a sensing apparatus such as a capnography machine, respiratory gas monitor or other gas sensing apparatus. It will be appreciated that in practice, the sampling gas conduit 3018 may connect to another conduit which connects to the sensing apparatus.
[0348] In the specific embodiment shown in Figure 39A, the sampling gas conduit 3018 extends along the flow manifold 3004. More particularly, the sampling gas conduit 3018 is positioned externally of the flow manifold 3004. As more clearly shown in the A-A partialcross-sectional view of the interface 3000 in Figure 40, the sampling gas conduit 3018 protrudes from the outer surface 3020 of the body 3002 of the patient interface 3000. A surface 3022 covering at least a portion of the sampling gas conduit 3018 may be a curved surface. In particular, the curved surface 3022 defines a protrusion 3024 that accommodates the portion of the sampling gas conduit 3018. The curved surface 3022 may have a gentle gradient as shown in Figure 40. More specifically, the curved surface 3022 may have two sloping sides 3026, 3028 meeting at a rounded peak 3030. In particular, an angle |3 where each of the sloping sides 3026, 3028 of the protrusion 3024 meet the outer surface 3020 of the body 3002 of the patient interface 3000 may be generally between 0° and 89°.
[0349] In some embodiments, the surface 3022 may include a central curve section defining the rounded peak 3030 having a higher curvature (smaller radius) than the two adjacent side curve sections defining the two sloping sides 3026, 3028. The direction the curvature of the central curve section may be opposite to the curvatures of the two side curve sections.
[0350] In some embodiments, the sampling conduit 3018 may be integrally formed with the body 3020 of the interface 3000. For example, the sampling conduit 3018 may be formed as a hole, channel or any suitable recess in a wall of the body 3020. The sampling conduit 3018 may be formed by removing material from the body 3020 of the interface 3000.
[0351] In embodiments whereby the flow manifold 3004 is collapsible during application of a face mask 144, the sampling gas conduit 3018 may remain open to allow continuous patient gas sampling. As previously discussed particularly with reference to Figures 29 to 35, in some scenario, it may be desirable to switch from a nasal cannula to face mask 144 for delivering gases to a patient, and the flow manifold 3004 may be collapsible by application of a face mask over the patient's face. By keeping the sampling gas conduit 3018 open, the clinician can continuously keep track of patient parameters even after a mode of respiratory support has changed (e.g. from a nasal cannula to a face mask). In some other scenarios, a clinician may manually collapse the flow manifold 3004 to allow the patient to breath from ambient air. In this scenario, the sampling gas conduit 3018 remains open to sample gases from the patient.
[0352] More specifically, the gentle gradient of the curved surface 3022, the structure of the protrusion 3024, the geometry and / or the rigidity of the sampling gas conduit 3018 walls may facilitate retaining the structural integrity of the sampling gas conduit 3018, whilst allowing the seal 148 of the face mask 144 to collapse the flow manifold 3004 and seal against the patient's face. In other words, the protrusion 3024 acts as a tunnel under the mask seal 148 to allow the sampling gas conduit 3018 to remain open when the flow manifold 3004 is collapsed, so as to allow continuous patient gas sampling when the face mask 144 is applied to the patient's face.
[0353] In particular, the gentle gradient of the curved surface 3022 (e.g. in which an angle |3 where each of the sloping sides 3026, 3028 of the protrusion 3024 meet the outer surface 3020 of the body 3002 of the patient interface 3000 may be generally between 0° and 89°) effectively facilitates an effective seal of the face mask 144 over the sampling gas conduit 3018 and protrusion 3024. The gentle gradient of the protrusion 3024 avoids any steep turns and / or sharp edges which may form gaps with the face mask 144 and prevent proper sealing between the face mask 144 and the sampling gas conduit 3018 and protrusion 3024.
[0354] Moreover, the gentle gradient of the curved surface 3002 and the sloping sides 3026, 3028 facilitates distribution of the load from the application of a face mask 144 to be evenly distributed across the entire curved surface 3002 thereby further reducing the likelihood of closing the sampling gas conduit 3018 when a force is applied to collapse the flow manifold 3004 (e.g. by application of a face mask 144).
[0355] Furthermore, the geometry of the sampling gas conduit 3018 (being smaller than the flow manifold 3004 of the body 3002 of the interface 3000) may also facilitate maintaining the open state of the sampling gas conduit 3018 when the flow manifold 3004 is collapsed. In some embodiments the material used to form the flow manifold 3004 and the sampling gas conduit 3018 may be the same or similar. In some embodiments, thicker walls or a relatively harder material may be provided on the sampling gas conduit 3018 to facilitate maintaining the open state of the sampling gas conduit 3018 during use, particularly when the flow manifold 3004 is collapsed.
[0356] As illustrated in Figure 40, a bulk of the material 3027 in the protrusion 3024 covered by each sloping side 3026, 3028 may have a height 3029 that is about 80% the height or diameter of the sampling gas conduit 3018, and a width 3031 of about 1.25 of the width or diameter of the sampling gas conduit 3018. The protrusion 3024 may be generally symmetrical about the peak 3030 of the protrusion 3024. The bulk of the material 3027 under each sloping side 3026, 3028 may occupy roughly 80% to 99% of the total volume of material under each sloping side 3026, 3018. The bulk of the material 3027 provides structural integrity and may contribute to keeping the gas conduit 3018 open in the case a face mask is applied over it.
[0357] As previously described with reference to Figures 32 to 35, the flow manifold 3004 may collapse along fold lines located at opposite ends (equivalent to ends 1404c as shown in Figures 34 and 35) of the flow manifold 3004 when a face mask 144 is applied. The protrusion 3024 extends along the flow manifold 3004 without interfering with the fold lines at opposite ends of the flow manifold 3004 so that the flow manifold 3004 can collapse without hinderance by the protrusion 3024 or the sampling gas conduit 3018 when the face mask 144 is applied to the patient's face. In particular, the sampling gas conduit 3018 extends along the outer surface 3020 of the flow manifold 3004 and does not interfere with the fold lines of the flow manifold 3004.
[0358] The size of the gas flow passage provided by the sampling gas conduit 3018 is also much smaller than the gas flow passage provided by the flow manifold 3004 (also see Figure 42), which further facilitates maintaining an open position for the sampling gas conduit 3018 when the flow manifold 3004 is collapsed.
[0359] Typically, the sampling gas conduit 3018 and / or the protrusion 3024 may be formed using relatively rigid material (particularly when compared with the material of the flow manifold 3004). The rigidity of the material facilitates maintaining the structural integrity and open shape of the sampling gas conduit 3018 when a force / face mask 144 is applied to collapse the flow manifold 3004. The gas sampling conduit 3018 and / or the protrusion 3024 may be formed from the same material as the flow manifold 3004.
[0360] In some embodiments, the sampling gas conduit 3018 may be located on a noncollapsing side of the body 3002 of the gas delivery patient interface 3000.
[0361] In some embodiments, the gas sampling portion 3010 and / or the sampling gas conduit 3018 may be integrally formed with the body 3002 and / or flow manifold 3004. In some embodiments, the gas sampling portion 3010 and / or the sampling gas conduit 3017 may be selectively attachable to, and detachable from the body 3002 and / or flow manifold 3004.
[0362] In any event, when the gas sampling portion 3010 is provided on the body 3002, the one or more (e.g. two) inlet openings 3014 and 3016 of the nose sampling part 3012 is fixed relative to the body 3002 and nasal prongs 3006, 3008. By providing fixed gas sampling locations for sampling at the philtrum, reliability of patient gas sampling may be improved by preventing relative movement between the body 3002 of patient interface 3000 and the nose sampling part 3012, particularly when the patient and / or the patient interface 3000 is moved during therapy. Moreover, after placement of the gas delivery patient interface 3000, the nose sampling part 3012 does not require separate adjustment for correct positioning under the patient's nasal septum / columella for gas sampling at the patient's philtrum. As the position of the nose sampling part 3012 and the inlet opening(s) 3014, 3016 are fixed relative to the nasal prongs 3006, 3008, proper placement of the gas delivery patient interface 3000 including the nasal prongs 3006, 3008 provides proper positioning of the nose sampling part 3012 and the inlet openings 3014, 3016.
[0363] In some embodiments, the sampling gas conduit 3018 may be attachable to the outer surface 3020 of the body 3002 of the patient interface 3000 when protrusion 3024 is applied over the sampling gas conduit 3018 and fastened to the outer surface 3020 of the body 3002 of the patient interface 3000 in any suitable manner, such as moulding or adhesive or via one or more mechanical fastening mechanisms.
[0364] In some embodiments, the protrusion 3024 may be formed with hollow sleeve therein to provide a portion of the sampling gas conduit 3018, and the protrusion 3024 may be fastened to the outer surface 3020 of the body 3002 of the patient interface 3000 in any suitable manner, such as moulding or adhesive or via one or more mechanical fastening mechanisms.
[0365] In some embodiments, the protrusion 3024 may define an elongate groove therethrough. When the protrusion is fastened to the outer surface 3020 of the body 3002 ofthe patient interface 3000 in any suitable manner as mentioned above, the groove and the outer surface 3020 of the body 3002 of the patient interface 3000 may provide the portion of the sampling gas conduit 3018. In some embodiments, the groove in the protrusion 3024 may align with a groove on the outer surface 3020 of the body 3002 of the patient interface 3000 to provide the sampling gas conduit 3018.
[0366] In some embodiments, at least a section of the sampling gas conduit 3018 may be provided within a wall of the body 3002. In particular, a section of the sampling gas conduit 3018 may be provided within a wall of the flow manifold 3004. As such, in some embodiments, the interface 3000 may not include a protrusion 3024 above the outer surface 3020 to accommodate the sampling gas conduit 3018.
[0367] Now turning to Figure 41, which illustrates a gas delivery patient interface 3500 according to another embodiment. In the gas delivery patient interface 3500 of Figure 41, like numerals refer to like features previously described with reference to the gas delivery patient interface 3000 of Figures 39A and 40. Similarly to previous embodiments, the gas sampling portion 3010 may be integrally formed with or separately provided to the body 3002 of the patient interface 3500.
[0368] The gas sampling portion 3010 of the gas delivery patient interface 3500 further includes a mouth sampling part 3052 in addition to the nose sampling part 3012. The mouth sampling part 3052 is configured to extend below the body 3002 of the patient interface 3500 and flow manifold 3004 for placement adjacent the patient's mouth in use. In particular, the mouth sampling part 3012 includes a mouth sampling guide 3054 extending from the body 3002 of the patient interface 3500. The mouth sampling guide 3054 may include a tube defining an oral sampling passage therethrough. An example configuration of the mouth sampling guide 3054 will be described in more detail below with reference to Figure 43. The mouth sampling guide 3054 may be insertable and removable from a mounting portion 3056 of the gas sampling portion 3010. The mounting portion 3056 may include a sleeve, protrusion, recesses or grooves or other suitably shaped configuration to allow selective mounting and removal of the mouth sampling guide 3054. In some embodiments, the mounting portion 3056 may define a gas flow path having a non- return / one-way valve therein such that fluid communication with the mouth sampling guide3054 may be established through the gas flow path when the mouth sampling guide 3054 is attached to the mounting portion 3056. The non-return / one-way valve prevents fluid communication of the gas flow path with the atmosphere when the mouth sampling guide 3054 is not attached to the mounting portion 3056. In some embodiments, a cap may be attached to the mounting portion 3056 when the mouth sampling guide 3054 is not attached to the mounting portion 3056. In some embodiments, the mouth sampling guide 3054 may be integrally formed with the gas sampling portion 3010.
[0369] The mouth sampling part 3052 further includes a mouth sampling end portion 7050 defining one or more inlet apertures to sample gases at the patient's mouth. The mouth sampling end portion 7050 is located at one end of the mouth sampling guide 3054. Typically, the mouth sampling guide may be pliable so as to allow selective repositioning of the mouth sampling end portion. One example embodiment of the mouth sampling end portion 7050 defining three inlet apertures 7230 will be described in further detail below with reference to Figures 44 to 47. However, it will be understood, that the mouth sampling end portion 7050 may define any suitable number of inlet apertures. For example, the sampling end portion 7050 may define, one, two, three, four, five or more inlet apertures to sample gases at the patient's mouth.
[0370] Beneficially, having a generally fixed and low-profile nose sampling part 3012 provides stable nasal sampling at or near the patient's philtrum may increase the accuracy and reliability of nasal sampling at the patient. As previously mentioned, the nose sampling part 3012 may remain in place during therapy without interfering with the medical procedure, such as application of a face mask 144 as discussed, and / or use of various medical instrumentation. In combination with a movable mouth sampling guide 3054, the interface 3500 may provide more comprehensive patient sampling than previously known solutions. During therapy, a clinician is often required to insert various medical instrumentation into the patient's mouth (e.g. a tracheostomy tube). As such, it may be beneficial to provide a movable / selectively positionable mouth sampling guide 3054 so that a clinician can move the mouth sampling guide 3054 into and out of position as required to carry out the medical procedure and sample patient gases at or near the mouth to compliment the nasal sampling. Providing both nasal and oral sampling options as exemplified in interface 3500 may further improve the accuracy and reliability of gas sampling at the patient. Thus, this novelcombination of fixed nasal and adjustable oral sampling provides improved ability to sample from both the patients nose and mouth at the same time, thereby improving overall sampling accuracy, particularly during high flow respiratory support.
[0371] As shown in Figure 41, the mouth sampling guide 3054 is offset from a central plane 3058 of the gas delivery patient interface 3500. The central plane 3054 may be defined as an imaginary plane that extends between the nasal prongs 3006, 3008 or the pair of inlet openings 3014, 3016 such that the nasal prongs 3006, 3008 and inlet openings 3014, 3016 are spaced at generally equal distances from the central plane 3058. When the interface 3500 is placed on the patient, the central plane 3054 may be parallel with the sagittal plane of the patient. In practice, the offset positioning of the mouth sampling guide 3054 may provide clinicians with improved access to the patient's mouth during a medical procedure, and / or better compatibility with the placement of a face mask 144 over the gas delivery patient interface 3500.
[0372] In some embodiments, a base portion of the mouth sampling guide 3054 may be oriented at an angle a relative to the central plane. The angled orientation of the mouth sampling guide 3054 may further provide clinicians with improved access to the patient's mouth during a medical procedure, and / or better compatibility with the placement of a face mask 144 over the gas delivery patient interface 3500.
[0373] Typically, the angle a is a predetermined angle. For example, the angle a may be generally between 100° and -100°.
[0374] The inlet openings 3014, 3016 are generally located on a plane parallel to and offset from central plane 3058. In previous embodiments of the gas collectors 100, 200, 300, 400, 500, 700, 800, 900, 1000 described herein, the respective one or more inlet openings maybe similarly positioned when mounted to a nasal cannula 104.
[0375] In some embodiments, the mouth sampling guide 3054 may be offset from a coronal plane 3057 of the gas delivery patient interface 3600 as illustrated in Figure 41b. The coronal plane 3057 may be defined as an imaginary plane that extends across the patient interface 3600 in a direction perpendicular to the central plane 3054. When the interface3600 is placed on the patient, the coronal plane 3057 may be parallel with the coronal plane of the patient.
[0376] As illustrated in Figure 41b, a base portion of the mouth sampling guide 3054 may be oriented at an angle |3 relative to the coronal plane 3057. The angled orientation of the mouth sampling guide 3054 may further provide clinicians with improved access to the patient's mouth during a medical procedure, and / or better compatibility with the placement of a face mask 144 over the gas delivery patient interface 3600.
[0377] Typically, the angle P is a predetermined angle. For example, the angle |3 may be generally between 100° and -100°.
[0378] Now turning to Figure 43, which illustrates a detailed view of a portion of the mouth sampling guide 3054 according to one example embodiment. In the particular example embodiment shown, the mouth sampling guide 3054 includes a dual lumen conduit 3201 (also referred to herein as a mouth sampling conduit 3201). The dual lumen conduit 3201 has a conduit body 3203. The conduit body 3203 has a generally circular cross-section along its entire length. The conduit 3201 comprises a flexibly resilient support structure that allows the conduit 3201 to be manipulated or bent to any desired shape so that the mouth sampling end portion 7050 can be selectively positioned and repositioned at any desired location in, around or adjacent the patient's mouth. In the specific embodiment of the gas delivery patient interface 3500 shown in Figure 41, significant repositioning of the mouth sampling end portion 7050 may not be required due to the offset and / or angled positioning of the mounting portion 3056 as previously described. The mouth sampling end portion 7050 may be positioned generally in the desired position in or adjacent and to one side of the patient's mouth after the patient interface 3500 is mounted to the patient's face, so as to be more compatible with face mask 144 application and / or variations in patient facial geometry, and allow sufficient space for a clinician to access the patient's respiratory pathways including the mouth area.
[0379] The support structure may take many different forms. For example, the support structure may comprise a wire, rod, or strip of flexible resilient material (such as a metallic or polymer material) that extends along at least a portion of the conduit 3201, or throughout the entire length of the conduit 3201. In one form, the conduit 3201 comprises a first,support lumen in which the support structure, such as a wire, may be located. The wire may be inserted into the lumen or co-extruded with the conduit 3201 or a portion of the conduit 3201 may be over-moulded around the wire. In other forms, the support structure may be formed around an external wall of the conduit 3201 or the external wall may be made from a suitable material (e.g. a flexible resilient or pliable material) that provides a support structure.
[0380] In the embodiment shown in Figure 43, the conduit 3201 comprises a first, support lumen 3204, for housing a support structure in the form of a wire 3210 within the first lumen. The first, support lumen or wire lumen 3204 has a substantially circular crosssection along its entire length. A second, gas lumen 3202 for receiving expired and / or exhaled gas, has a substantially crescent-shaped cross-section along its entire length. The first lumen 3204 lies within and at one side of the second lumen 3202, such that the crescent shaped cross-section of the second, gas lumen 3202 is formed by the shape of the open space around the first, wire lumen 3204.
[0381] In alternative embodiments, an outer wall of the gas lumen 3202 may include a flexi ble / plia ble material such as metal, thereby allowing the conduit 3201 to be pliable without the need for a separate wire lumen 3204 and wire 3210.
[0382] In some embodiments, the cross-sectional area of the gas lumen 3202, is greater than about 1.3 mm2. In some embodiments, the nominal cross-sectional area of the gas lumen 3202 may be 0.75mm2, for example, having a diameter of about 1mm. In some embodiments, the cross-sectional area of the gas lumen 3202, may be greater than or equal to about 0.3 mm2. In some embodiments, the cross-sectional area of the gas lumen 3202, may be smaller than or equal to about 30mm2.
[0383] In some embodiments, the height of the gas lumen 3202 is greater than about 1.5 mm. In some embodiments, the width of the gas lumen 3202 is greater than about 1.5 mm. Typically, the height and width of the gas lumen 3202 refer to the diameter of the gas lumen 3202.
[0384] As mentioned, in one form, the flexible, resilient support structure may comprise a length of malleable wire, such as a cable or rod for example, that is located within theconduit 3201. The wire is preferably a metallic wire. The wire may extend along one or more portions of the conduit 3201 or the wire may extend along substantially the entire length of the conduit 3201. A distal end or patient end of the wire may be coated in a soft material so as to not graze or scratch the patient's face. Alternatively, the patient end of the wire may be positioned sufficiently far back in the conduit 3201 so that it does not extend beyond the distal end of the conduit 3201. In a further alternative, the end of the wire may be sealed inside the conduit wall. In a further alternative, the wire may be located within the support lumen / wire lumen 3204 of a dual lumen conduit 3201 and the patient end of the wire may be fixed at one or more points along the inner wall of the wire lumen to hold the wire in place and prevent the wire from moving out of the lumen.
[0385] In another form, the conduit 3201 may comprise at least one lumen that acts as both a wire / support lumen and a gas lumen. In this form, the conduit may comprise a wire having a smaller diameter than the internal diameter of the lumen. The wire may be held inside the lumen at one or more locations. In this arrangement, the conduit may bend around the wire, but one or more gaps are provided between the wire and the internal wall of the lumen so that gas can pass along the lumen to be sampled by the respiratory gas monitor. The lumen cannot completely seal around the wire, which is non-compressible, preventing full obstruction.
[0386] A length of malleable wire may occupy at least a portion of the conduit 3201 or the wire may extend along substantially the entire length of the conduit 3201. For example, in the dual lumen conduit shown in Figure 43, the wire 3210 may occupy one or more portions of the first lumen 3204 of the dual lumen conduit 3201, or the wire may extend along substantially the entire length of the first lumen 3204. The presence of the wire 3210 provides rigidity to the conduit 3201 and the mouth sampling part 3052. The wire 3210 is also flexible to allow the first, support conduit 3204, and therefore the conduit 3201, some degree of adjustment to further customise positioning of the mouth sampling end portion 7050 based on geometries of the patient's face, respiratory behaviour and requirements of a particular medical procedure.
[0387] The wire may comprise a stainless steel wire that can be bent / reshaped multiple times without breaking. The wire may be between about 0.4 mm to 1.0mm in diameter andis optionally about 0.6 mm or 0.7 mm in diameter. Optionally, the wire is grade 304. These properties create suitable malleability to allow the user to reshape / bend the conduit by hand easily. In another form, the wire comprises aluminium wire. In another form, the wire comprises nickel titanium wire.
[0388] In one form, the wire 3210 is positioned on an inside curve of the conduit 3201 when the conduit 3201 is curved. This may reduce the risk of kinking the mouth sampling conduit 3201 when bent. Alternatively, the wire 3210 may be positioned on the outside curve of the curved conduit 3201 or along a side or at any other orientation or position with respect to the length of the conduit 3201.
[0389] Using a flexibly resilient mouth sampling conduit 3201 having a support structure, such as a wire, as described above allows the mouth sampling part 3052 to be selectively positionable (resiliently bendable / formable) to be placed at any suitable location in or near the patient's mouth. In practice, the mouth sampling end portion 7050 may be placed in the mouth generally at the position of the teeth or near the mouth.
[0390] Figures 44 to 47 illustrate an example embodiment of a mouth sampling end portion 7050 that may be connected to a mouth sampling conduit 3201 to receive gases exiting from a patient P. The mouth sampling end portion 7050 may be integrally formed with the mouth sampling conduit 3201 or formed separately and then attached to a free end / gas inlet end of the mouth sampling conduit 3201. The mouth sampling end portion 7050 may be attached to the free end of the mouth sampling conduit 3201 using any suitable form of attachment. For example, a mouth sampling end portion 7050 may be welded to the mouth sampling conduit 3201; attached via threaded engagement to a free end of the mouth sampling conduit 3201; glued or otherwise adhered to the free end of the mouth sampling conduit 3201; or the mouth sampling end portion 7050 and the mouth sampling conduit 3201 may be attached together in a snap fit arrangement, friction fit arrangement, or the like.
[0391] Optionally, the mouth sampling end portion 7050 is formed of a soft or semi-soft compressible material. In some instances, it has been found that a mouth sampling end portion 7050 formed from a rigid or hard material may cause injury to a patient or could damage the patient's teeth, especially if the mouth sampling end portion 7050 is placedbetween the teeth and the patient inadvertently bites down on the mouth sampling end portion 7050. These risks may be avoided or at least mitigated by providing a sampling tip that may comprise a compressible material that is less likely to cause injury or harm to the patient.
[0392] In one embodiment, the mouth sampling end portion 7050 comprises a body 7060 comprising a substantially hollow interior region 7061 configured to be in fluid communication with the inlet 3206 of a mouth sampling conduit 3201 when the mouth sampling end portion 7050 is connected to the mouth sampling conduit 3201. The body 7060 comprises one or more side walls forming an outer side surface of the body, a proximal connection end 7062 for connecting to the free end (inlet 3206) of the mouth sampling conduit 3201 such that the hollow interior region is in fluid communication with the mouth sampling conduit 3201 and a distal end portion 7063 that terminates in a distal end 7064 of the mouth sampling end portion 7050.
[0393] In one form, the connection end 7062 may be glued onto the mouth sampling conduit 3201. In another form, the connection end 7062 may be threaded for connecting to a corresponding threaded end of the mouth sampling conduit 3201 so that the mouth sampling end portion 7050 may be threaded onto and off from the free end of the mouth sampling conduit 3201. In yet another form, the connection end 7062 may comprise a lip configured to fit onto a collar of the inlet 3206 end of the mouth sampling conduit 3201 to connect the mouth sampling end portion 7050 and conduit 3201 in a snap fit arrangement. Alternatively, the inlet end 3206 of the mouth sampling conduit 3201 may comprise a lip that fits onto a collar of the connection end 7062 of the mouth sampling end portion 7050.
[0394] The mouth sampling end portion 7050 comprises at least one inlet / gas receiving aperture 7230. Gases exhaled or expired by a patient may be received by the inlet / gas receiving aperture 7230, which is in fluid communication with the substantially hollow interior region 7061 of the body 7060, so that the received gases can pass through the body 7060 of the mouth sampling end portion 7050 and into inlet 3206 of the mouth sampling conduit 3201. In the embodiment illustrated in Figures 44 to 47, three inlet apertures 7230 are provided the mouth sampling end portion 7050. Each inlet / gas receiving aperture 7230forms an opening to the hollow interior region 7061 of the body 7060 of the mouth sampling end portion 7050.
[0395] In one form, the inlet aperture 7230 may extend from the distal end 7064 of the mouth sampling end portion 7050 along a side of the body 7060. Optionally, the inlet aperture 7230 forms an elongate opening in the distal end portion 7063 of the mouth sampling end portion 7050.
[0396] In one form, the sampling end portion 7050 comprises an end wall at its distal end 7064 and one or more inlet apertures 7230 located on one or more side walls of the sampling end portion 7050. In one form, the inlet aperture 7230 may extend around substantially the entire outer periphery of the sampling end portion 7050, such as around the entire outer periphery of the outer side surface. Where the sampling end portion 7050 has a substantially round / circular cross-section, the inlet aperture 7230 may extend around the circumferential outer surface of the sampling end portion 7050 to form an annular ring-like aperture. In another form, the inlet aperture 7230 may extend around the circumferential outer surface of the sampling end portion 7050 in a substantially helical arrangement, similar to the helical thread of a corkscrew.
[0397] In some embodiments, the sampling end portion 7050 may comprise multiple inlets / gas receiving apertures 7230. For example, the sampling end portion 7050 may comprise a pair of gas receiving apertures 7230 extending from the distal end of the sampling tip and along the sides of the distal end portion 7063 of the body 7060. The apertures 7230 may or may not be evenly spaced from each other. For example, the apertures 7230 may be located on substantially opposing sides of the body 7060 or the apertures 7230 may be located closer to each other in at least one direction. In other embodiments, the sampling end portion 7050 may comprise two, three, four or more gas receiving apertures 7230. The apertures 7230 may or may not be evenly spaced from each other.
[0398] In the specific embodiment shown in Figures 44 to 47, the sampling end portion 7050 comprises three inlet apertures 7230 that are evenly spaced around the distal end and sides of the sampling end portion 7050. The spacing of the apertures 7230 can be more clearly seen in Figure 46.
[0399] Each portion of the body 7060 located between the inlet apertures 7230 forms a flute 7240 that terminates at the distal end of the sampling end portion 7050. A central support 7250 may be located at the distal end of the sampling end portion 7050 and may be connected to the flutes 7240. The central support 7250 provides the flutes 6240 with additional strength and positional integrity to prevent the flutes 7240 from crushing together and at least partially blocking the inlet apertures 7230. The central support 7250, flutes 7240, and body 7060 of the sampling end portion 7050 together define edges of the inlet apertures 7230.
[0400] The body 7060 of the sampling end portion 7050 may have a substantially cylindrical form and the flutes 7240 may be substantially evenly spaced around the circumference of the distal end portion 7063 of sampling end portion 7050. In one form, an inner portion of each flute may comprise a cut out region to form an enlarged opening within the sampling end portion 7050.
[0401] In the embodiment shown in Figure 44, the distal end 7064 of sampling end portion 7050 (comprising the central support and distal ends of the flutes) is outwardly curved or convex to form a protruding shield that prevents the end opening of the inlet apertures 7230 from suctioning against the patient's face, mouth or lip. The side surfaces of the flutes 7240 at the distal end portion of the sampling end portion 7050 may also be outwardly curved to form a substantially bulbous distal end.
[0402] Figures 48 and 49 further illustrate detailed views of the mouth sampling part 3052 according to one embodiment. As mentioned, the mouth sampling part 3052 includes a mouth sampling guide 3054 which may be provided by pliable mouth sampling conduit 3201 and a sampling end portion 7050 coupled to an inlet 3206 end thereof. An opposite end 3060 of the mouth sampling guide 3054 may be selectively attachable and removable from the mounting portion 3056 of the gas sampling portion 3010.
[0403] Now referring back to the embodiment of the gas delivery patient interface 3500 as shown in Figure 41, the nose sampling part 3012 defines nasal gas sampling passages 3706, 3708 providing fluid communication between each of the inlet openings 3014, 3016 of the nose sampling part 3012 and the sampling gas conduit 3018. The mouth sampling part 3052 defines an oral gas sampling passage 3710 providing fluid communication betweeneach of the at least one inlet aperture 7230 of the mouth sampling part 3052 and the sampling gas conduit 3018.
[0404] The schematic diagram in Figure 50 is a simplified illustration of the nasal and oral gas sampling passages 3706, 3708, 3710 (outlet connection to gas sensing apparatus not shown). Gases leaving the patient's nares may flow in the direction of arrows 3734, 3736. The orientation of the inlet openings 3014, 3016 of the nose sampling art 3012 are generally perpendicular to the direction of gas flow 3734, 3736 leaving the patient's nares.
[0405] During a medical procedure, a patient may switch between oral and nasal exhalation. Moreover, to accommodate for effects of high flow therapy, differences in patient anatomy, respiratory habits and behaviour, and requirements of different procedures, characteristics of nasal and oral gas sampling passages of the gas sampling portion 3010 may be varied or fine-tuned to provide the desired gas sampling outcomes.
[0406] In particular, the one or more nasal gas sampling passages and the oral gas sampling passage may be configured so that a flow rate in the one or more nasal gas sampling passages is a percentage of a total flow rate in the one or more nasal gas sampling passages and the oral gas sampling passage, where said percentage is within a predetermined range. This total flow rate includes a calculated total flow rate of a flow rate in the one or more nasal gas sampling passages and a flow rate in the oral gas sampling passage (i.e. mathematically adding up their respective flow rates), or a flow rate of a combined flow when the flow in the one or more nasal gas sampling passages and the flow in the oral gas sampling passage are combined, e.g. at a junction.
[0407] In some configurations where there is a plurality of nasal gas sampling passages, the plurality of nasal gas sampling passages and the oral gas sampling passage are configured so that a combined flow rate in the plurality of nasal gas sampling passages is a percentage of a total flow rate in the plurality of nasal gas sampling passages and the oral gas sampling passage, where the percentage is within a predetermined range. In some configurations, there is a plurality of oral gas sampling passages. In such configurations, the one or more nasal gas sampling passages and the plurality of oral gas sampling passages are configured so that a flow rate in the one or more nasal gas sampling passages is a percentage of a total flow rate in the one or more nasal gas sampling passages and the plurality of oral gas samplingpassages, where the percentage is within a predetermined range. The predetermined range may be from about 1% to about 99% (for example, the flow rate in one or more nasal gas sampling passages is 1% of the total flow rate in the one or more nasal gas sampling passages and the oral gas sampling passage), and preferably from about 5% to about 95%, and even more preferably from about 20% to about 80%. In some embodiments, the predetermined range is from about 45% to about 55%. In some embodiments, this ratio may be about 50% such that the flow rates in the one or more nasal gas sampling passages and one or more oral gas sampling passages are substantially balanced.
[0408] In some embodiments, the relative positions of the nasal and / or oral gas inlet openings (e.g. inlet openings 3014, 3016 of the nose sampling part 3012 and inlet apertures 7230 of the mouth sampling part 3052) may be configured to achieve the abovementioned percentage in the predetermined range. For example, as shown in Figure 41, inlet openings 3014, 3016 of the nose sampling part 3012 are positioned perpendicular to a flow direction from the patient's nasal region to the patient's oral region, while the inlet apertures 7230 of the mouth sampling part 3052 are positioned to generally face the patient's oral region. In practice, as the position and orientation of the mouth sampling end portion 7050 can be moved and repositioned as required. The movement and repositioning of the mouth sampling end portion 7050 may further allow adjustment relative flow rate percentages mentioned above.
[0409] In some embodiments, to achieve the abovementioned percentage in the predetermined range, the nasal gas sampling passages 3708 and 3706 and the oral gas sampling passage 3710 may be configured so that the ratio of resistance to flow (RTF) in one or more nasal gas sampling conduits and the oral gas sampling conduit is within a predetermined range. In some embodiments, the nasal gas sampling passages 3708 and 3706 and the oral gas sampling passage 3710 may be configured so that the ratio of a combined RTF in the one or more nasal gas sampling passages 3706, 3708 and the RTF in the oral gas sampling passage 3710 is within a predetermined range.
[0410] In one or more embodiments, the nasal gas sampling passages and oral gas sampling passages may be configured so that the RTF in these respective passages is substantially equalised (i.e. substantially the same). Having substantially equalised RTF in therespective passages may result in substantially balanced flow rates in the nasal gas sampling passages and oral gas sampling passages.
[0411] In other situations, having substantially equalised RTF in the respective passages may not result in substantially balanced flow rates in the nasal gas sampling passages and oral gas sampling passages. For example, a blockage in the nasal gas sampling passage or oral gas sampling passage could cause imbalanced flow rates through the respective passages. In another example, a mouth sampling portion attached to the oral gas sampling passage may increase the RTF of the oral gas sampling passage which may result in imbalanced flow rates through the respective passages.
[0412] In one or more embodiments, the RTF in one or more of the nasal gas sampling passages (or combined RTF in the one or more nasal gas sampling passages) may be greater than the RTF in the oral gas sampling passage by a predetermined amount. This predetermined amount may be based on the abovementioned percentage in the predetermined range of the flow rate in one or more nasal gas sampling passages and a total flow rate in the one or more nasal gas sampling passages and the oral gas sampling passage. For example, the RTF in one or more of the nasal gas sampling passages (or combined RTF in the one or more nasal gas sampling passages) may be about 1%, about 2%, about 3%, about 4%, about 5%, about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, about 100% or more than about 100% greater than the RTF in the oral gas sampling passage. In some embodiments, the RTF in one or more of the nasal gas sampling passages (or combined RTF in the one or more nasal gas sampling passages) may be about 200%, about 300%, about 400% or more than about 400% greater than the RTF in the oral gas sampling passage. This may be beneficial when the patient is predominantly supplied with nasal high flow gas from the nasal prongs 3006, 3008 of the patient interface 3500 and the patient is predominantly mouth breathing.
[0413] In other embodiments, the RTF in the nasal gas sampling passages may be less than the RTF in the oral gas sampling passage. In other words, the RTF in the oral gas sampling passage may be greater than the RTF in one or more of the nasal gas sampling passages (or combined RTF in the one or more nasal gas sampling passages) by a predetermined amount. For example, the RTF in the oral gas sampling passage may be about1%, about 2%, about 3%, about 4%, about 5%, about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, about 100% or more than about 100% greater than the RTF in the one or more of the nasal gas sampling passages (or combined RTF in the one or more nasal gas sampling passages). In some embodiments, it may be desirable for the RTF in the oral gas sampling passage to be greater than the nasal gas sampling passages if a nasal gas sampling trace is expected to be weaker (e.g. if a proportion of CO2 to exhaled breath is lower in the nasal gas sampling trace due to dilution of exhaled breath that may be caused by redirection of gases flow delivered to the patient via the nasal prongs) when compared to the oral gas sampling trace. Typically, gases sampled via the oral gas sampling passage may not be diluted by a flow of gases delivered via the nasal prongs. As such, when providing nasal gas sampling passages with a lower RTF when compared to the oral gas sampling passage, the gas sampling portion 3010 may sample about the same absolute volume of exhaled gas in the nasal and oral gas sampling passages.
[0414] A pressure required to generate a predetermined gas flow rate in the nasal and oral gas sampling passages may be related to the RTF. In particular, the higher the RTF in a passage, the greater the pressure required to generate the same gas flow rate through the passage. Various properties of the nasal and oral gas sampling passages may be varied as discussed above to achieve any target pressure ratio between the nasal and oral gas sampling passages. In some embodiments, a pressure ratio between the oral gas sampling passage 3710 and the combination of the two nasal gas sampling passages 3014, 3016 to generate a predetermined gas flow rate (e.g. 200mL / min) therethrough may be 2:1, or anywhere between 1:10 to 10:1. For embodiments in which a single nasal gas sampling passage is provided, a pressure ratio between the oral gas sampling passage and the single nasal gas sampling passage to generate a predetermined gas flow rate (e.g. 200mL / min) therethrough may be 2:1, or anywhere between 1:10 to 10:1, or anywhere between 1:100 to 100:1.
[0415] Configuration of the nasal and oral gas sampling passages to achieve a ratio of RTF between the nasal gas sampling passages and the oral gas sampling passage may be achieved by configuring one or more of parameters (e.g. cross-sectional area, shape, length, surface roughness etc) of the passages or a flow path in the passages. In some embodiments, the oral gas sampling passage comprises a more tortuous flow path and / or comprises alonger flow path to a junction (for example where the flow paths in the conduits combine) compared to the one or more nasal gas sampling passages. In some embodiments, a cross- sectional shape and / or area of a flow path in one nasal gas sampling passage is different from a cross-sectional shape and / or area of a flow path of another nasal gas sampling passage and / or the oral gas sampling passage. Moreover, introducing bends / kinks in the nasal and / or oral gas sampling passages can also increase the RTF in the respective passages.
[0416] In some embodiments, an internal surface of the one or more nasal sampling passages exposed to a gas flow is different from an internal surface of the oral gas sampling passage exposed to a gas flow, for example, the internal surface of the one or more nasal sampling passages comprises a surface roughness greater than an internal surface of the oral gas sampling passage (thereby causing the one or more nasal sampling passages to have a higher RTF than the oral sampling passage). In some embodiments, the RTF in the one or more nasal gas sampling passages and / or the oral gas sampling passage may be variable. In some embodiments, such variable RTF is adjustable. In some embodiments, the cross- sectional area and / or shape of a portion of one or more sampling conduits may be adjustable, for example, by providing a valve that may be controlled to alter a parameter of the flow path through that portion. The valve may be controlled automatically or manually e.g. by a rotary dial.
[0417] In one example as illustrated in Figure 42, a flow obstruction 3037 may extend from an internal wall of the oral gas sampling passage 3710 to increase the RTF therein. In other examples, RTF may be increased by making the flow path of the oral gas sampling passage 3710 tortuous or by reducing the opening area of the flow path.
[0418] Whilst not specifically illustrated in the Figures 39A and 41, in some embodiments, the gas sampling portion 3010, sampling gas conduit 3018, and optionally the mouth sampling part 3052 may be provided as a separate gas collector for selectively mounting to any suitable gas delivery patient interface such as patient interface 102, 1400, and 2030 as previously described herein. The separate gas collector may be configured for attachment to the gas delivery patient interface 102, 1400, and 2030 via any suitable manner, for example by adhesive or any suitable mechanical attachment mechanism. Themechanical attachment mechanism may include loops, clips, clamps, mating portions and the like, or any combination thereof.
[0419] The gas delivery patient interfaces 3000, 3500 (or separately provided gas collector attachable to a gas delivery patient interface 102, 1400, and 2030) combines the reliability of philtrum sampling at the patient's nose by providing a low profile nose sampling part 3012 between the nasal prongs 3006, 3008 and above the body 3002 and flow manifold 3004 with the flexibility of optionally providing a selectively repositionable mouth sampling part 3052 for sampling gases at the mouth. The placement of the gas sampling conduit 3018 over the flow manifold 3004 also offers reliable and continuous gas sampling when switching between different patient interfaces such as between a nasal cannula and face mask.Interpretation
[0420] This specification, including the claims, is intended to be interpreted as follows:
[0421] Embodiments or examples described in the specification are intended to be illustrative of the invention, without limiting the scope thereof. The invention is capable of being practised with various modifications and additions as will readily occur to those skilled in the art. Accordingly, it is to be understood that the scope of the invention is not to be limited to the exact construction and operation described or illustrated, but only by the following claims.
[0422] Moreover, any feature or element described within one embodiment may be combined with any feature or element as described with respect to any other embodiment detailed within this specification, as deemed suitable and appropriate by those skilled in the art.
[0423] The mere disclosure of a method step or product element in the specification should not be construed as being essential to the invention claimed herein, except where it is either expressly stated to be so or expressly recited in a claim.
[0424] The terms in the claims have the broadest scope of meaning they would have been given by a person of ordinary skill in the art as of the relevant date.
[0425] The terms "a" and "an" mean "one or more", unless expressly specified otherwise.
[0426] Neither the title nor the abstract of the present application is to be taken as limiting in any way as the scope of the claimed invention.
[0427] Where the preamble of a claim recites a purpose, benefit or possible use of the claimed invention, it does not limit the claimed invention to having only that purpose, benefit or possible use.
[0428] It should be noted that terms of degree such as "generally", "substantially", "about" and "approximately" as used herein mean a reasonable amount of deviation of the modified term such that the end result is not significantly changed. These terms of degree should be construed as including a deviation of the modified term if this deviation would not negate the meaning of the term it modifies.
[0429] In the specification, including the claims, the term "comprise", and variants of that term such as "comprises" or "comprising", are used to mean "including but not limited to", unless expressly specified otherwise, or unless in the context or usage an exclusive interpretation of the term is required.
[0430] Furthermore, the recitation of any numerical ranges by endpoints herein includes all numbers and fractions subsumed within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, and 5). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term "about" which means a variation up to a certain amount of the number to which reference is being made if the end result is not significantly changed.
[0431] As used herein, the wording "and / or" is intended to represent an inclusive-or. That is, "X and / or Y" is intended to mean X or Y or both, for example. As a further example, "X, Y, and / or Z" is intended to mean X or Y or Z or any combination thereof.
[0432] Throughout the specification, like reference numerals refer to like features described herein. As such, any instance where features or components are indicated with thesame references implies a direct correlation to the similar or identical features or components as previously described in the specification.
[0433] The disclosure of any document referred to herein is incorporated by reference into this patent application as part of the present disclosure, but only for purposes of written description and enablement and should in no way be used to limit, define, or otherwise construe any term of the present application where the present application, without such incorporation by reference, would not have failed to provide an ascertainable meaning. Any incorporation by reference does not, in and of itself, constitute any endorsement or ratification of any statement, opinion or argument contained in any incorporated document.
Claims
The claims defining the invention are as follows:
1. A gas collector for collecting gases at a patient, the gas collector including a gas sampling portion for sampling gases at the patient, and a coupling mechanism for coupling the gas sampling portion to a gas delivery patient interface, the gas delivery patient interface having a body having a flow manifold for receiving a flow of gases for delivery to the patient, and a pair of nasal prongs extending from the body for delivering the flow of gases to the patient via the patient's nares, the gas sampling portion having a nose sampling part configured for positioning above the body and between the nasal prongs of the gas delivery patient interface, the nose sampling part defining at least one inlet opening to sample gases at the patient's nose, wherein the position of the at least one inlet opening is fixed relative to the coupling mechanism.
2. The gas collector of claim 1, wherein the nose sampling part is configured for positioning above the flow manifold between the nasal prongs of the gas delivery patient interface.
3. The gas collector of claim 1 or 2, wherein the at least one inlet opening of the nose sampling part enables sampled gases exhaled from the patient's nose to enter the nose sampling portion at an inlet flow entry direction, wherein the inlet flow entry direction is generally different to a direction of exhaled gases from the patient's nose.
4. The gas collector of claim 3, wherein the inlet flow entry direction is generally perpendicular to a surface of the nose sampling part on which the at least one inlet is defined.
5. The gas collector of claim 3 or 4, wherein the inlet flow entry direction is generally perpendicular to the direction of exhaled gases from the patient's nose.
6. The gas collector of any one of claims 3 to 5, wherein the inlet flow entry direction is different to a flow direction of gases delivered to the patient's nares via the nasal prongs.
7. The gas collector of any one of the preceding claims, wherein the nose sampling part defines at least two inlet openings, each inlet opening being positioned on an opposite side of the nose sampling part.
8. The gas collector of any one of the preceding claims, wherein the nose sampling part defines a plurality of inlet openings.
9. The gas collector of any one of the preceding claims, wherein the nose sampling part is configured for positioning under the patient's septum in use.
10. The gas collector of any one of the preceding claims, wherein the nose sampling part is configured for positioning in a space between the gas delivery patient interface and the patient's columella in use.
11. The gas collector of any one of the preceding claims, wherein the body of the patient interface has a bridging portion extending between the nasal prongs, and wherein the nose sampling part is configured for positioning over the bridging portion of the patient interface.
12. The gas collector of claim 11, wherein the nose sampling part is configured for positioning in a space between the patient's septum, the bridging portion and the nasal prongs.
13. The gas collector of any one of the preceding claims, wherein the nose sampling part is configured such that the at least one inlet opening is located proximal to a base of the nasal prongs adjacent the body of the patient interface when the gas collector is mounted to the patient interface.
14. The gas collector of any one of the preceding claims, wherein the body of the patient interface has an inner wall for facing the patient in use, and an outer wall opposite the inner wall, the outer wall facing away from the patient in use, and wherein the nose sampling part is configured such that the at least one inlet opening is located proximate any one of: the inner wall, the outer wall, a central region between the inner wall and outer wall of the body.
15. The gas collector of any one of the preceding claims, wherein the nasal prongs have opposing inner side wall portions, and the at least one inlet opening is located on a face of the nose sampling part facing and offset from an inner side wall portion of a respective nasal prong.
16. The gas collector of any one of the preceding claims, wherein the at least one inlet opening is offset from a central plane of the gas delivery patient interface, wherein the central plane extends between the nasal prongs such that the nasal prongs are spaced at generally equal distances from the central plane.
17. The gas collector of any one of the preceding claims, wherein the coupling mechanism is configured for releasable attachment to the body of the gas delivery patient interface.
18. The gas collector of claim 17, wherein the coupling mechanism includes a loop configured for attachment around the bridging portion of the gas delivery patient interface.
19. The gas collector of any one of the preceding claims, wherein the coupling mechanism is configured for attachment to one or both of the nasal prongs of the gas delivery patient interface.
20. The gas collector of any one of the preceding claims, wherein the coupling mechanism includes one or more rings configured for attachment to one or both of the nasal prongs of the gas delivery patient interface.
21. The gas collector of claim 20, wherein the coupling mechanism includes a pair of rings, each ring being configured for attachment to a respective one of the pair of nasal prongs.
22. The gas collector of any one of the preceding claims, wherein the coupling mechanism defines one or more further inlet openings thereon to sample gases at the patient's nose.
23. The gas collector of claim 20 or 21, wherein each of the one or more rings comprises a conduit.
24. The gas collector of claim 23, wherein each conduit defines one or more further inlet openings thereon to sample gases exhaled from the patient's nose.
25. The gas collector of any one of claims 1 to 17, wherein the coupling mechanism includes one or more C-shaped or U-shaped portions for mounting to the body and / or nasal prongs of the gas delivery patient interface.
26. The gas collector of any one of the preceding claims, wherein the sampling portion further includes a mouth sampling part configured to extend below the body of the gas delivery patient interface for placement adjacent the patient's mouth in use, the mouth sampling part defining at least one inlet aperture to sample gases at the patient's mouth.
27. The gas collector of claim 26, wherein the mouth sampling part includes a mouth sampling guide configured to extend below the body of the gas delivery patient interface, the mouth sampling guide having a mouth sampling end portion defining the at least one inlet aperture to sample gases at the patient's mouth, the mouth sampling end portion being located at one end of the mouth sampling guide.
28. The gas collector of claim 26 or 27, wherein the mouth sampling guide is pliable so as to allow selective repositioning of the mouth sampling end portion.
29. The gas collector of any one of claims 26 to 28, wherein the mouth sampling guide is selectively removable.
30. The gas collector of any one of claims 26 to 29, wherein mouth sampling guide is offset from a central plane of the gas delivery patient interface, wherein the central plane extends between the nasal prongs such that the nasal prongs are spaced at generally equal distances from the central plane.
31. The gas collector of claim 30, wherein the mouth sampling guide is oriented at an angle relative to the central plane.
32. The gas collector of claim 31, wherein the angle is a predetermined angle.
33. The gas collector of claim 30 or 31, wherein the angle is generally between -100° and100°.
34. The gas collector of any one of the preceding claims, further including an outlet portion defining an outlet, wherein gases collected by the gas sampling portion exit the gas collector via the outlet.
35. The gas collector of claim 34, wherein the outlet is configured to connect with a conduit for delivering the gases collected by the gas sampling portion to one or more sensor units.
36. The gas collector of any one of the preceding claims, further including one or more flow guides for guiding gases from the patient towards the gas sampling portion.
37. The gas collector of claim 36, wherein the flow guides are configured to guide gases from the patient's nose towards the at least one inlet opening of the nose sampling part.
38. The gas collector of claim 36 or 37, wherein the gas collector includes a pair of flow guides, each flow guide extending from an opposite side of the nose sampling part.
39. The gas collector of claim 38, wherein the pair of flow guides are configured for positioning between the nasal prongs in use.
40. The gas collector of any one of claims 36 to 38, wherein each flow guide defines a curved surface for guiding a flow of gases from the patient's nose towards the at least one inlet opening of the nose sampling part.
41. The gas collector of any one of the preceding claims, wherein the gas sampling portion is rigid.
42. The gas collector of any one of the preceding claims, wherein the gas sampling portion is generally fixed relative to the coupling mechanism.
43. The gas collector of any one of the preceding claims, wherein the coupling mechanism allows coupling to a malleable portion of the gas delivery patient interface.
44. A gas delivery patient interface for delivering gases to a patient, the gas delivery patient interface including:a body having a flow manifold for receiving a flow of gases for delivery to the patient, and a pair of nasal prongs extending from the body for delivering the flow of gases to the patient via the patient's nares, a gas sampling portion for sampling gases at the patient, the gas sampling portion having a nose sampling part provided above the body and between the nasal prongs of the gas delivery patient interface, the nose sampling part defining at least one inlet opening to sample gases from the patient's nose.
45. The gas collector of claim 44, wherein the nose sampling part is configured for positioning above the flow manifold between the nasal prongs of the gas delivery patient interface.
46. The gas delivery patient interface of claim 44 or 45, wherein the gas sampling portion is integral with the body and / or nasal prongs.
47. The gas delivery patient interface of any one of claims 44 to 46, wherein the at least one inlet opening of the nose sampling part enables sampled gases from the patient to enter the nose sampling portion at an inlet flow entry direction, wherein the inlet flow entry direction is different to a direction of exhaled gases from the patient's nose.
48. The gas delivery patient interface of claim 47, wherein the inlet flow entry direction is generally perpendicular to a surface of the nose sampling part on which the at least one inlet is defined.
49. The gas delivery patient interface of claim 47 or 48, wherein the inlet flow entry direction is generally perpendicular to the direction of exhaled gases from the patient's nose.
50. The gas delivery patient interface of any one of claims 47 to 49, wherein the inlet flow entry direction is different to a flow direction of gases delivered to the patient's nares via the nasal prongs.
51. The gas delivery patient interface of any one of claims 44 to 50, wherein the nose sampling part defines at least two inlet openings, each inlet opening being positioned on an opposite side of the nose sampling part.
52. The gas delivery patient interface of any one of claims 44 to 51, wherein the nose sampling part defines a plurality of inlet openings.
53. The gas delivery patient interface of any one of claims 44 to 52, wherein the nose sampling part is configured for positioning under the patient's septum in use.
54. The gas delivery patient interface of any one of claims 44 to 53, wherein the body has a bridging portion extending between the nasal prongs, and wherein the nose sampling part projects from the bridging portion of the body, and the nose sampling part is positioned in a space between the patient's septum, the bridging portion of the body and the nasal prongs in use.
55. The gas delivery patient interface of any one of claims 44 to 53, wherein the sampling portion further includes a mouth sampling part configured to extend below the body for placement adjacent the patient's mouth in use, the mouth sampling part defining at least one inlet aperture to sample gases at the patient's mouth.
56. The gas delivery patient interface according to claim 55, wherein the mouth sampling part includes a mouth sampling guide configured to extend below the body of the gas delivery patient interface, the mouth sampling guide having a mouth sampling end portion defining the at least one inlet aperture to sample gases at the patient's mouth, the mouth sampling end portion being located at one end of the mouth sampling guide.
57. The gas delivery patient interface of claim 55 or 56, wherein the mouth sampling guide is pliable so as to allow selective repositioning of the mouth sampling end portion.
58. The gas delivery patient interface of any one of claims 55 to 57, wherein the mouth sampling guide is selectively removable.
59. The gas delivery patient interface of any one of claims 55 to 58, wherein mouth sampling guide is offset from a central plane of the gas delivery patient interface, wherein the central plane extends between the nasal prongs such that the nasal prongs are spaced at generally equal distances from the central plane.
60. The gas delivery patient interface of claim 59, wherein the mouth sampling guide is oriented at an angle relative to the central plane.
61. The gas delivery patient interface of claim 60, wherein the angle is a predetermined angle.
62. The gas delivery patient interface of claim 60 or 61, wherein the angle is generally between -100° and 100°.
63. The gas delivery patient interface of any one of claims 44 to 62, further including an outlet portion defining an outlet, wherein gases collected by the gas sampling portion exit the gas collector via the outlet.
64. The gas delivery patient interface of claim 63, wherein the outlet is configured to connect with a conduit so as to deliver gases collected by the gas sampling portion to one or more sensor units.
65. The gas delivery patient interface of any one of claims 44 to 64, further including one or more flow guides for guiding gases exhaled from the patient towards the gas sampling portion.
66. The gas delivery patient interface of claim 65, wherein the flow guides are configured to guide gases from the patient's nose towards the at least one inlet opening of the nose sampling part.
67. The gas delivery patient interface of claim 65 or 66, wherein the gas collector includes a pair of flow guides, each flow guide extending from an opposite side of the nose sampling part.
68. The gas delivery patient interface of claim 67, wherein the pair of flow guides are configured for positioning between the nasal prongs.
69. The gas delivery patient interface of any one of claims 65 to 68, wherein each flow guide defines a curved surface for guiding a flow of gases from the patient's nose towards the at least one inlet opening of the nose sampling part.
70. The gas delivery patient interface of any one of claims 44 to 69, wherein the gas sampling portion is rigid.
71. A patient interface assembly including a gas delivery patient interface for delivering a flow of gases to the patient, and a gas collector according to any one of claims 1 to 43.
72. A patient interface assembly including a gas delivery patient interface according to any one of claims 44 to 70.
73. The patient interface assembly of claim 71 or 72, further including a filter for filtering a backflow of gases from the patient, wherein the filter is mounted upstream of the gas delivery patient interface.
74. The patient interface assembly of claim 73, further including a conduit for connecting the gas delivery patient interface and the filter.
75. A kit including a gas delivery patient interface for delivering a flow of gases to the patient, and a gas collector according to any one of claims 1 to 43.
76. A kit including a gas delivery patient interface according to any one of claims 44 to 70.
77. The kit of claim 75 or 76, further including any one or more of at least one gas flow conduit, an inspiratory limb, and a humidification chamber.
78. A system comprising a gas delivery patient interface for delivering a flow of gases to the patient, a gas collector according to any one of claims 1 to 43, the gas collector being mounted to the gas delivery patient interface, and a humidifier for humidifying the flow of gases delivered to the patient.
79. A system comprising a gas delivery patient interface for delivering a flow of gases to the patient, a gas collector according to any one of claims 1 to 43, the gas collector being mounted to the gas delivery patient interface, and a flow generator for generating the flow of gases for delivery to the patient.
80. The system of claim 78 or 79, further including one or more gas analysers coupled to the gas collector for analysing gases from the gas collector.
81. A system comprising a gas delivery patient interface according to any one of claims 44 to 70, and a humidifier for humidifying the flow of gases delivered to the patient.
82. A system comprising a gas delivery patient interface according to any one of claims 44 to 70, and a flow generator for generating the flow of gases for delivery to the patient.
83. The system of claim 81 or 82, further including one or more gas analysers coupled to the gas delivery patient interface for analysing gases from the gas sampling portion.
84. A gas delivery patient interface for delivering gases to a patient, the gas delivery patient interface including: a body having a flow manifold for receiving a flow of gases for delivery to the patient, and a pair of nasal prongs extending from the body for delivering the flow of gases to the patient via the patient's nares, a gas sampling portion for sampling gases at the patient, the gas sampling portion having a nose sampling part positioned between the nasal prongs, the nose sampling part defining at least one inlet opening to sample gases at the patient's nose, and a sampling gas conduit for providing fluid communication between the gas sampling portion and a sensing apparatus, wherein the sampling gas conduit extends along the flow manifold.
85. The gas delivery patient interface of claim 84, wherein gas sampling portion and the sampling gas conduit are integrally formed with the flow manifold.
86. The gas delivery patient interface of claim 84, wherein gas sampling portion and the sampling gas conduit are selectively attachable to, and detachable from the body.
87. The gas delivery patient interface according to any one of the preceding claims, wherein the body has an inner surface for facing towards the patient's face when the gas delivery patient interface is mounted to the patient, and an outer surface opposite the inner surface for facing away from the patient's face when the gas delivery patient interface is mounted to the patient, wherein the at least one inlet opening is oriented generally transversely to the inner surface of the body.
88. The gas delivery patient interface according to any one of claims 84 to 86, wherein the nose sampling part defines two inlet openings to sample gases at the patient's nose body, and wherein the body has an inner surface for facing towards the patient's face when the gas delivery patient interface is mounted to the patient, and an outer surface opposite the inner surface for facing away from the patient's face when the gas delivery patient interface is mounted to the patient, and wherein the each of the inlet openings is oriented generally transversely to the inner surface of the body.
89. The gas delivery patient interface according to any one of claims 84 to 88, wherein the position of the at least one inlet opening of the nose sampling part is fixed relative to the body and / or nasal prongs.
90. The gas delivery patient interface according to any one of claims 84 to 89, wherein the nose sampling part is generally fixed relative to the body and / or nasal prongs.
91. The gas delivery patient interface according to any one of claims 84 to 90, wherein the flow manifold is collapsible.
92. The gas delivery patient interface according to any one of claims 84 to 91, wherein the sampling portion further includes a mouth sampling part configured to extend below thebody for placement adjacent the patient's mouth in use, the mouth sampling part defining at least one inlet aperture to sample gases at the patient's mouth.
93. The gas delivery patient interface of 92, wherein the mouth sampling part is moveable relative to the body and / or nasal prongs.
94. The gas delivery patient interface of claim 92 or 93, wherein the mouth sampling part includes a mouth sampling guide configured to extend below the body, the mouth sampling guide having a mouth sampling end portion defining the at least one inlet aperture to sample gases at the patient's mouth, the mouth sampling end portion being located at one end of the mouth sampling guide.
95. The gas delivery patient interface of claim 94, wherein the mouth sampling guide is pliable so as to allow selective repositioning of the mouth sampling end portion.
96. The gas delivery patient interface of claim 94 or 95, wherein the mouth sampling guide is selectively removable.
97. The gas delivery patient interface of any one of claims 94 to 96, wherein mouth sampling guide is offset from a central plane of the gas delivery patient interface, wherein the central plane extends between the nasal prongs such that the nasal prongs are spaced at generally equal distances from the central plane.
98. The gas delivery patient interface of claim 97, wherein the mouth sampling guide is oriented at an angle relative to the central plane.
99. The gas delivery patient interface of claim 98, wherein the angle is a predetermined angle.
100. The gas delivery patient interface of claim 98 or 99, wherein the angle is generally between -100° and 100°.
101. The gas delivery patient interface of any one of claims 92 to 100, wherein the nose sampling part defines one or more nasal gas sampling passages providing fluid communication between each of the at least one inlet opening of the nose sampling part and the sampling gas conduit, andwherein the mouth sampling part defines one or more oral gas sampling passages providing fluid communication between each of the at least one inlet aperture of the mouth sampling part and the sampling gas conduit, and wherein a resistance to flow in the one or more nasal gas sampling passages is lower than a resistance to flow in the one or more oral gas sampling passages.
102. The gas delivery patient interface of any one of claims 92 to 100, wherein the nose sampling part defines one or more nasal gas sampling passages providing fluid communication between each of the at least one inlet opening of the nose sampling part and the sampling gas conduit, and wherein the mouth sampling part defines one or more oral gas sampling passages providing fluid communication between each of the at least one inlet aperture of the mouth sampling part and the sampling gas conduit, and wherein a resistance to flow in the one or more nasal gas sampling passages is higher than a resistance to flow in the one or more oral gas sampling passages.
103. The gas delivery patient interface according to any one of claims 92 to 102, wherein the nose sampling part is positioned above the body.
104. The gas delivery patient interface according to any one of claims 92 to 103, wherein a surface covering at least a portion of the sampling gas conduit is a curved surface.
105. The gas delivery patient interface of claim 104, wherein the curved surface defines a protrusion that accommodates a portion of the sampling gas conduit.
106. A gas collector for collecting gases at a patient, the gas collector including a gas sampling portion for sampling gases at the patient, and a sampling gas conduit for providing fluid communication between the gas sampling portion and a sensing apparatus, wherein the gas collector is configured for attachment to a gas delivery patient interface, the gas delivery patient interface having a body having a flow manifold for receiving a flow of gases for delivery to the patient, anda pair of nasal prongs extending from the body for delivering the flow of gases to the patient via the patient's nares, the gas sampling portion having a nose sampling part for positioning between the nasal prongs of the gas delivery patient interface, the nose sampling part defining at least one inlet opening to sample gases at the patient's nose, wherein the sampling gas conduit extends along the flow manifold.
107. The gas collector of claim 106, further including a coupling mechanism for coupling the gas sampling portion to the gas delivery patient interface.
108. The gas collector of claim 106 or 107, wherein gas sampling portion and the sampling gas conduit are selectively attachable to, and detachable from the body of the gas delivery patient interface.
109. The gas collector of any one of claims 106 to 108, wherein the nose sampling part is configured such that the at least one inlet opening is oriented generally transversely to an inner surface of the body of the gas delivery patient interface when the gas collector is attached to the gas delivery patient interface, the inner surface being a surface of the body for facing towards the patient's face when the gas delivery patient interface is mounted to the patient.
110. The gas collector of any one of claims 106 to 108, wherein the nose sampling part defines two inlet openings to sample gases at the patient's nose, and wherein each of the inlet openings is oriented generally transversely to an inner surface of the body of the gas delivery patient interface when the gas collector is attached to the gas delivery patient interface, the inner surface being a surface of the body for facing towards the patient's face when the gas delivery patient interface is mounted to the patient.
111. The gas collector of any one of claims 106 to 110, wherein the sampling portion further includes a mouth sampling part configured to extend below the body of the gas delivery patient interface for placement adjacent the patient's mouth in use, the mouth sampling part defining at least one inlet aperture to sample gases at the patient's mouth.
112. The gas collector of claim 111, wherein the mouth sampling part includes a mouth sampling guide configured to extend below the body of the gas delivery patient interface, themouth sampling guide having a mouth sampling end portion defining the at least one inlet aperture to sample gases at the patient's mouth, the mouth sampling end portion being located at one end of the mouth sampling guide.
113. The gas collector of claim 112, wherein the mouth sampling guide is pliable so as to allow selective repositioning of the mouth sampling end portion.
114. The gas collector of claim 112 or 113, wherein the mouth sampling guide is selectively removable.
115. The gas collector of any one of claims 112 to 114, wherein mouth sampling guide is offset from a central plane of the nose sampling part, wherein the central plane extends between a pair of inlet openings of the nose sampling part such that the pair of inlet openings are spaced at generally equal distances from the central plane.
116. The gas collector of claim 115, wherein the mouth sampling guide is oriented at an angle relative to the central plane.
117. The gas collector of claim 116, wherein the angle is a predetermined angle.
118. The gas collector of claim 116 or 117, wherein the angle is generally between -100° and 100°.
119. The gas collector of any one of claims 111 to 118, wherein the nose sampling part defines one or more nasal gas sampling passages providing fluid communication between each of the at least one inlet opening of the nose sampling part and the sampling gas conduit, and wherein the mouth sampling part defines one or more oral gas sampling passages providing fluid communication between each of the at least one inlet aperture of the mouth sampling part and the sampling gas conduit, and wherein a resistance to flow in the one or more nasal gas sampling passages is lower than a resistance to flow in the one or more oral gas sampling passages.
120. The gas collector of any one of claims 111 to 118, wherein the nose sampling part defines one or more nasal gas sampling passages providing fluid communication betweeneach of the at least one inlet opening of the nose sampling part and the sampling gas conduit, and wherein the mouth sampling part defines one or more oral gas sampling passages providing fluid communication between each of the at least one inlet aperture of the mouth sampling part and the sampling gas conduit, and wherein a resistance to flow in the one or more nasal gas sampling passages is higher than a resistance to flow in the one or more oral gas sampling passages.
121. The gas collector of any one of claims 106 to 120, wherein the nose sampling part is configured for positioning above the body and flow manifold.
122. The gas collector of any one of claims 106 to 121, wherein a surface covering at least a portion of the sampling gas conduit is a curved surface.
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