Gas collector

Abstract

The present invention is directed to a gas collector for collecting gas at a patient. The gas collector may include an interface configured to form at least one channel at an upper lip of a patient. The channel may be in fluid communication with a nose region and a mouth region of the patient. The interface may include one or more spacers configured to contact the patient's face to space the channel wall portion from the patient's face.

Description

Technical Field

[0001] The present disclosure relates to a gas collector for collecting gas at a patient. The gas collector is suitable for use in applications where a gas flow is provided to a patient while it is desired to collect and monitor the gas exhaled by the patient from their nasal and / or oral passages. It will be convenient to describe the gas collector in connection with this exemplary but non-limiting application. Background Art

[0002] Medical procedures can involve procedural sedation or general anesthesia (collectively referred to as anesthesia procedures). During procedural sedation, the patient's respiratory function may be impaired or at risk of impairment due to the anesthetic agent, and apnea may occur. In general anesthesia, if the patient becomes apneic, the patient will most likely require mechanical ventilation. Pre-oxygenation of the patient is encouraged prior to administration of the anesthetic agent. During pre-oxygenation (also known as denitrogenation), oxygen is provided to the patient to saturate the reserves of their body (including blood and lungs), thereby delaying or avoiding a decrease in oxygen saturation when the patient's respiratory function has been impaired or the patient is apneic. Due to oxygen displacement, pre-oxygenation also reduces the carbon dioxide level in the patient's blood and lungs, as well as the nitrogen level in the lungs.

[0003] Nasal high flow (NHF) can be used in anesthesia procedures for pre-oxygenating patients, maintaining adequate oxygenation and preventing desaturation, and in general anesthesia, when the patient becomes apneic, NHF can extend the safe apnea time during anesthesia. NHF uses a non-sealed patient interface (such as a nasal cannula) to deliver breathable gas, such as oxygen or oxygen-enriched air or air, to the patient. NHF can also be used in other settings, such as wards, emergency departments, and intensive care units (ICUs).

[0004] Monitoring the gas at the patient while providing a gas flow to the patient is beneficial. Such monitoring provides useful feedback to the clinician. For example, monitoring the exhaled gas during the pre-oxygenation phase can be used to determine whether the patient has reached the desired end-tidal O2 level, which indicates that the pre-oxygenation is sufficient and / or the pre-oxygenation phase can be completed. Exhaled gas monitoring can be used to detect changes in the patient's condition, for example, an awake patient becoming apneic after receiving anesthesia or when experiencing airway obstruction. The clinician can make decisions as a result of the patient gas monitoring to provide better care.

[0005] Unfortunately, monitoring the target gas at the patient while providing a gas flow to the patient can affect the sampling results because the provided gas flow may disrupt the actual value (e.g., concentration) of the target gas. For example, exhaled CO2 (carbon dioxide) may be diluted by the provided gas, or a higher concentration of O2 in the provided gas flow may increase the end-tidal O2. Due to the high gas flow rates involved, NHF exacerbates this problem.

[0006] Due to the variability of the exhalation path (i.e., via the patient's nose, mouth, or both nose and mouth), difficulties also arise in monitoring exhaled gas. The patient may alternate between these paths during the monitoring period. The patient's breathing pattern can affect the gas sampling results because when the patient breathes primarily through the mouth, insufficient exhaled gas may be collected, for example, from the nose.

[0007] It would be desirable to provide a gas collector for collecting gas at a patient's nasal and oral passages that improves or overcomes one or more disadvantages or inconveniences of known gas collectors, particularly but not limited to NHF applications. Additionally, it would be desirable to provide a gas collector that achieves consistent sampling of exhaled gas regardless of the variability of the exhalation path.

[0008] The foregoing discussion of the background of the disclosure is intended to facilitate understanding of the disclosure. However, it will be understood that the discussion is not an admission or acknowledgment that any aspect of the discussion was part of the common general knowledge of a person skilled in the art (skilled addressee) at the priority date of the present application. Summary of the Invention

[0009] One aspect of the invention provides a gas collector for collecting gas at a patient, the gas collector comprising: an interface configured to form at least one channel at the patient's upper lip, the channel being in fluid communication with the patient's nose region and mouth region, wherein the interface includes one or more spacers configured to contact the patient's face to space the channel wall portion from the patient's face.

[0010] In one or more embodiments, the interface further includes a channel wall portion.

[0011] In one or more embodiments, the interface is configured to be attached to or integral with a nasal cannula.

[0012] In one or more embodiments, the nasal cannula at least partially forms the channel wall portion.

[0013] In one or more embodiments, the nasal cannula includes a nasal prong for delivering gas to the patient's nasal passage, and the gas collector further includes one or more openings formed through the channel wall portion for receiving the nasal prong.

[0014] In one or more embodiments, the channel is partially formed by the patient's upper lip.

[0015] In one or more embodiments, the spacers are arranged to contact the patient's face on either side of the patient's upper lip.

[0016] In one or more embodiments, in use, the spacer extends from the channel wall portion to the patient's face.

[0017] In one or more embodiments, the spacer is integral with the channel wall portion.

[0018] In one or more embodiments, the thickness of the spacer is greater than that of the channel wall portion.

[0019] In one or more embodiments, the spacer is more rigid than the channel wall portion.

[0020] In one or more embodiments, the Young's modulus of the spacer is greater than that of the channel wall portion.

[0021] In one or more embodiments, the channel wall portion is configured to be flexible when in contact with the patient's face.

[0022] In one or more embodiments, the gas collector further includes an interface that forms a gas collection area and includes a first gas collection inlet and a second gas collection inlet that are in fluid communication with the gas collection area.

[0023] In one or more embodiments, the gas collector further includes a mouth engagement portion configured to project into the patient's mouth to maintain an open passage between the patient's mouth and the second gas collection inlet.

[0024] In one or more embodiments, the mouth engagement portion includes a lower end that projects into the patient's mouth, and the lower end of the mouth engagement portion is shaped to maintain an open passage between the patient's mouth and the second gas collection inlet.

[0025] In one or more embodiments, the lower end of the mouth engagement portion has an inner surface that includes: an edge portion that, when in use, is located at the side of the patient's mouth; and a central portion that, when in use, is located at the center of the patient's mouth and is spaced further from the patient's upper lip than the edge portion.

[0026] In one or more embodiments, the inner surface of the first end of the mouth engagement portion has a C, U, or V-shaped profile.

[0027] In one or more embodiments, the channel wall portion includes an upper end that extends outwardly from the patient's face when in use.

[0028] In one or more embodiments, when in use, the upper end of the channel wall bends outwardly from the patient's face.

[0029] Another aspect of the present invention provides a gas collector for collecting gas at a patient, the gas collector including an interface configured to form a passage at the patient's upper lip, the passage having open ends in fluid communication with the patient's nasal and oral passages respectively, the passage providing a volume for collecting gas to be analyzed.

[0030] In one or more embodiments, the gas collector further includes: one or more gas collection conduits, each gas collection conduit having a gas collection inlet configured to deliver gas from the passage to a local gas collection region; and an outlet for providing the collected gas from the local gas collection region to a gas analyzer.

[0031] In one or more embodiments, the passage is partially formed by the patient's upper lip.

[0032] In one or more embodiments, the gas collector further includes a gas flow diverter configured to direct at least some of the gas exhaled by the patient to one or more of the gas sampling inlets.

[0033] In one or more embodiments, the interface includes one or more spacers for contacting the patient's face to space the passage wall portion from the patient's face, and wherein the gas flow diverter is integrated with the passage wall portion.

[0034] In one or more embodiments, the sampler body includes one or more spacers for contacting the patient's face to space the passage wall portion from the patient's face, and wherein the gas flow diverter is separately formed from the passage wall portion.

[0035] In one or more embodiments, one or more of the gas sampling inlets form a nasal gas sampling inlet positioned proximate the patient's nasal passage.

[0036] In one or more embodiments, the one or more nasal gas sampling inlets are formed in the passage wall portion.

[0037] In one or more embodiments, the one or more nasal gas sampling inlets are formed in the spacer.

[0038] In one or more embodiments, one gas sampling inlet or one or more of the gas sampling inlets form an oral gas sampling inlet positioned proximate the patient's oral passage.

[0039] In one or more embodiments, the oral gas sampling inlet is formed in the passage wall portion.

[0040] In some embodiments, the gas collector may further include an outlet for providing the collected gas to the gas analyzer via a conduit, the outlet being configured to allow connection to the conduit from a side of the patient's face.

[0041] The interface may have a pair of opposing lateral sides. The outlet may define a receiving port having an open outlet end for receiving a portion of a conduit therein. The receiving port may be oriented so that the open outlet end faces one of the lateral sides. The lateral side may be configured to extend generally in a direction aligned with an imaginary vertical plane bisecting the patient's face.

[0042] In some embodiments, the outlet may be a single outlet of a gas collector to provide the collected gas to a gas analyzer.

[0043] In some embodiments, the gas collector may further include a single gas sampling inlet configured to provide collected gas from the channel to the outlet.

[0044] In some embodiments, the gas collector may further include a mounting portion for mounting the gas collector to a nasal cannula for delivering breathable gas to a patient, the mounting portion defining a sleeve configured to fit over a portion of the nasal cannula.

[0045] In some embodiments, the sleeve generally follows the outer contour of the portion of the nasal cannula.

[0046] In some embodiments, the sleeve may define one or more slots. The one or more slots may allow the portion of the nasal cannula to be inserted through the slots so that the portion of the nasal cannula can be received in the sleeve.

[0047] In some embodiments, the sleeve may have resilient walls to allow the width of the one or more slots to be manually adjustable.

[0048] Another aspect of the present invention provides a gas collector for collecting gas from a patient, the gas collector comprising: an interface forming a gas collection area and comprising at least one nasal gas collection inlet and an oral gas collection inlet fluidly connected to the gas collection area; and a mouth engaging portion configured to protrude into the patient's mouth so as to maintain an open passage between the patient's mouth and the oral gas collection inlet.

[0049] In one or more embodiments, the gas collector further includes: an outlet for providing the collected gas from the gas collection region to a gas analyzer; a nasal gas collection flow path that provides fluid communication between a nasal gas collection inlet and the gas collection region; and an oral gas collection flow path that provides fluid communication between an oral gas collection inlet and the gas collection region.

[0050] In one or more embodiments, the gas collector is removably attachable to a non-sealed nasal interface.

[0051] Another aspect of the present invention provides a gas collector for collecting gas at a patient, the gas collector including: an interface configured to form a passage at the patient's upper lip; one or more gas sampling conduits, each gas sampling conduit having a gas sampling inlet for drawing gas from the passage into a local gas collection region; and a gas flow diverter configured to direct at least some of the gas exhaled by the patient to one or more of the gas sampling inlets, wherein the gas flow diverter includes an upper portion extending away from the patient's face.

[0052] In one or more embodiments, the gas collector further includes: a lower portion extending towards the patient's face; and an intermediate portion interconnecting the upper portion and the lower portion.

[0053] In one or more embodiments, the intermediate portion extends in a direction substantially parallel to the patient's face.

[0054] In one or more embodiments, the upper portion includes a top surface that seats under the patient's nose in use and is shaped to avoid forming a seal with the patient's nasal passages.

[0055] In one or more embodiments, the gas flow diverter has an inner surface that faces the patient's face in use and substantially follows the shape of the patient's face from the tip of the nose to the upper lip.

[0056] In one or more embodiments, the inner surface has a substantially S-shaped configuration.

[0057] In one or more embodiments, the spacer rests against the upper lip of the patient in use; and wherein the gas collector further comprises: one or more nasal gas collection ducts formed within the spacer, each nasal gas collection duct having a nasal gas collection inlet in fluid communication with the patient's nasal passage for delivering gas exhaled by the patient from their nasal passage to an outlet; an oral gas collection duct formed within the spacer, the oral gas collection duct having an oral gas collection inlet in fluid communication with the patient's oral passage; and a gas flow diverter configured to direct at least some of the gas exhaled by the patient from their oral passage to the oral gas collection inlet.

[0058] In one or more embodiments, the gas flow diverter is integrated with or attachable to the spacer.

[0059] Another aspect of the present invention provides a gas collector for sampling gas at a patient, the gas collector comprising: one or more nasal gas collection ducts, each nasal gas collection duct having a nasal gas collection inlet in fluid communication with the patient's nasal passage; and an oral gas collection duct having an oral gas collection inlet in fluid communication with the patient's oral passage and an outlet, wherein the one or more nasal gas sampling ducts and the oral gas sampling duct form a junction at a local gas collection region, and wherein the one or more nasal gas sampling ducts and the oral gas sampling duct are configured such that the flow rate in the one or more nasal gas sampling ducts is a certain percentage of the total flow rate in the one or more nasal gas sampling ducts and the oral gas sampling duct, wherein the percentage is within a predetermined range.

[0060] In one or more embodiments, the predetermined range is from about 1% to about 99%.

[0061] In one or more embodiments, the predetermined range is from about 5% to about 95%.

[0062] In one or more embodiments, the predetermined range is from about 20% to about 80%.

[0063] In one or more embodiments, the predetermined range is from about 45% to about 55%.

[0064] In one or more embodiments, the flow rate in the one or more nasal gas sampling ducts is greater than the flow rate in the oral gas sampling duct.

[0065] In one or more embodiments, the one or more nasal gas sampling ducts include a flow resistance different from that of the oral gas sampling duct to achieve a percentage within a predetermined range.

[0066] In one or more embodiments, the flow resistance in the gas sampling conduit is achieved by modifying one or more of the length, cross-sectional area, cross-sectional shape, or angled flow path of the gas sampling conduit.

[0067] In one or more embodiments, the gas collector further includes a spacer configured to form a plurality of channels at the upper lip of the patient, within which the nasal gas collection conduit and the oral gas collection conduit are formed.

[0068] In one or more embodiments, the gas flow collector further includes a gas flow diverter configured to direct at least some of the gas exhaled by the patient from their oral tract to the oral gas collection inlet.

[0069] In one or more embodiments, the gas flow collector further includes a connector interconnecting the oral gas sampling conduit and the local gas collection region, the Luer connector including a structure forming a tortuous fluid path that increases the flow resistance of the oral gas sampling conduit.

[0070] In one or more embodiments, the gas collector is attachable to or integrally formed with a nasal cannula, the nasal cannula including a nasal gas delivery forked tube for delivering gas to the patient's nasal passage, wherein one or more of the nasal gas collection inlets are positioned proximate the patient's nasal passage, and wherein the nasal gas collection inlets are disposed in one or more of the following positions: a first position where the nasal gas collection inlet is substantially parallel to the length of the channel and facing away from the gas flow from the patient's nasal region; a second position where the nasal gas collection inlet is substantially transverse to the length of the channel; and a third position intermediate the first and second positions.

[0071] In one or more embodiments, there are two nasal gas collection inlets and two gas sampling conduits in fluid communication with the two nasal gas sampling inlets, and one oral gas collection inlet and one gas collection conduit in fluid communication with the one oral gas sampling inlet, and the gas collection conduits from the two nasal gas collection inlets and the one oral gas collection inlet form a junction at the local gas collection region.

[0072] In one or more embodiments, the gas collection conduits are formed within a spacer that rests against the patient's upper lip in use.

[0073] In one or more embodiments, the gas collector further includes an oral gas flow diverter configured to converge at least some of the gas exhaled by the patient from their oral tract to the at least one oral gas sampling inlet.

[0074] Another aspect of the present invention provides a patient interface comprising: a nasal cannula for delivering breathable gas to a patient; and a gas collector as described in any one of the preceding claims, the gas collector being attached to or integrated with the nasal cannula.

[0075] One or more embodiments of the present invention provide a gas collector having a structure that provides or forms one or more channels at the upper lip of a patient (e.g., in the philtrum region of the patient), the one or more channels being in fluid communication with the nose and mouth. Such a structure helps to direct exhaled gas from the nose and / or mouth to a local area to increase the gas sample concentration. Such a structure in fluid communication with the nose and mouth also helps to collect a gas sample, whether the patient is breathing through the nose or the mouth. The collected gas sample can then be provided to a gas analyzer.

[0076] In one or more embodiments, the gas collector may be attachable to or integral with a patient interface (such as a nasal cannula). Brief Description of the Drawings

[0077] From the detailed description herein with reference to the following drawings, specific embodiments and modifications thereof will become apparent to those skilled in the art, in which: Figure 1 shows a respiratory support system; Figure 2 shows a patient wearing a respiratory support system; Figure 3 shows a patient wearing a first embodiment of a patient interface and a face mask; Figure 4 shows Figure 3 a cross-section of a portion of the patient interface; Figures 5 to 8 shows a nasal cannula including a collapsible portion to which the gas collector may be attached or integrated; Figures 9 to 11 shows another embodiment of the patient interface; Figure 12 shows features or regions of a patient's face; Figures 13 to 15 shows three different types of channel structures; Figures 16 to 20 shows a first embodiment of the gas collector; Figures 21 to 23 shows a nasal cannula having a gas collector of the type shown in Figures 16 to 20 ; Figures 24 to 26 shows Figures 21 to 23 ​​​​​​​​​​​a gas collector without a nasal cannula; Figures 27 to 35 shows a second embodiment of the gas collector; Figures 36 to 38 shows a third embodiment of the gas collector; Figure 39 and Figure 40 shows a fourth embodiment of the gas collector; Figures 41 to 44 shows a fifth embodiment of the gas collector; Figure 45 and Figure 46 shows a sixth embodiment of the gas collector; Figure 47 shows a seventh embodiment of the gas collector; Figures 48 to 55 shows different mechanisms for attaching the gas collector to a patient interface; Figures 56 to 59 shows the Figures 12 to 26 gas collector attached to a nasal cannula; Figures 60 to 62 shows a gas collector including an integrated structural member; Figures 63 to 66 shows the Figures 16 to 20 variant of the gas collector, which includes a hinge; Figures 67 to 70 shows the Figures 16 to 20 another variant of the gas collector, which includes a bistable structure; Figures 71 to 76 shows the Figures 16 to 20 another variant of the gas collector, which includes an opening or a detachable part for inserting and retaining medical equipment; Figures 77 to 80 shows the Figures 16 to 20 another variant of the gas collector, which includes an open channel for saliva interception; Figures 81 to 83 shows the Figures 16 to 20 another variant of the gas collector, which includes a modified central mouth engaging part; Figure 84 and Figure 85 shows the Figures 16 to 20 another variant of the gas collector, which includes a force absorption section; Figures 86 to 89 shows the Figures 16 to 20 another variant of the gas collector, which includes the Figure 74 and Figure 75 variant of the force absorption section; ​​​​​​​​​​​​​​​​Figures 90 to 97 shows another variant of the Figures 16 to 20 gas collector, which includes an enlarged or expandable mouth engaging portion; Figures 98 to 102 shows another variant of the Figures 16 to 20 gas collector, which includes means for attachment to a nasal cannula; Figure 103 and Figure 104 show another variant of the Figures 16 to 20 gas collector, which includes a recess at the base of a curved nasal prong to form a passage with the patient's upper lip; Figures 105 to 107 show another variant of the Figure 93 and Figure 94 gas collector, which includes a tube in fluid communication with the passage; Figures 108 to 123 show another variant of the Figures 16 to 20 gas collector, which includes a sampling line to an outlet port and a series of single-acting mechanisms for connecting the sampling line; Figures 124 to 127 show the eighth embodiment of the gas collector; Figures 128 to 130 show a variant of the Figures 124 to 127 gas collector therein; Figure 131 and Figure 132 show a further variant of the Figures 124 to 127 gas collector therein; and Figure 133 show a variant of the Figures 131 to 132 gas collector therein. Figure 134 show a variant of the Figures 16 to 20 gas collector shown therein. Figure 135 is a schematic diagram showing the Figure 134 gas collector as worn by a patient. Figure 136 is a further schematic diagram which shows the Figure 134 gas collector deforming when an instrument (such as a laryngoscope) is inserted into the patient's mouth. DETAILED DESCRIPTION

[0078] Various embodiments are described with reference to the accompanying drawings. Throughout the drawings and the specification, the same reference numerals may be used to denote the same or similar components, and redundant descriptions thereof may be omitted.

[0079] ​​​​​​​​​​​​In this specification, "high flow" (or other equivalent terms) means, but is not limited to, any gas flow having a flow rate higher than normal / typical values (e.g., higher than the normal inspiratory flow rate of a healthy patient). Alternatively or additionally, high flow can be higher than some other threshold flow rate that is relevant to the context of delivering a gas flow to a patient at a rate that meets or exceeds the inspiratory demand (which may be considered "high flow" because it is higher than the nominal flow rate that may have been provided otherwise). Thus, "high flow" is context-dependent, and what constitutes "high flow" depends on many factors such as the patient's health status, the type of procedure / treatment / support being provided, the nature of the patient (large, small, adult, child), etc. One of ordinary skill in the art will know what constitutes "high flow" from the context. Its magnitude of flow rate exceeds and is higher than the flow rate that may have been provided otherwise.

[0080] However, without limitation, some indicative values of high flow can be as follows.

[0081] In some configurations, gas is delivered to the patient at a flow rate greater than or equal to about 5 or 10 liters per minute (5 or 10 LPM or L / min).

[0082] In some configurations, gas is delivered to the patient at the following flow rates: from about 5 or 10 LPM to about 150 LPM, or from about 15 LPM to about 95 LPM, or from about 20 LPM to about 90 LPM, or from about 25 LPM to about 85 LPM, or from about 30 LPM to about 80 LPM, or from about 35 LPM to about 75 LPM, or from about 40 LPM to about 70 LPM, or from about 45 LPM to about 65 LPM, or from about 50 LPM to about 60 LPM. For example, according to the various embodiments and configurations described herein, the flow rate of gas supplied or provided to the interface via the system or from a flow source or flow modulator can include, but is not limited to, at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 LPM or greater, and the available range can be selected as any value within that range (e.g., from about 20 LPM to about 90 LPM, from about 40 LPM to about 70 LPM, from about 40 LPM to about 80 LPM, from about 50 LPM to about 80 LPM, from about 60 LPM to about 80 LPM, from about 70 LPM to about 100 LPM, from about 70 LPM to about 80 LPM).

[0083] In "high flow", the gas to be delivered will be selected depending on the intended use, such as treatment and / or respiratory support. The delivered gas may include a certain percentage of oxygen. In some configurations, the percentage of oxygen in the delivered gas may be from about 15% to about 100%, from about 20% to about 100%, or from about 30% to about 100%, or from about 40% to about 100%, or from about 50% to about 100%, or from about 60% to about 100%, or from about 70% to about 100%, or from about 80% to about 100%, or from about 90% to about 100%, or about 100%, or 100%.

[0084] In some embodiments, the delivered gas may include a certain percentage of carbon dioxide. In some configurations, the percentage of carbon dioxide in the delivered gas may be greater than 0%, from about 0.3% to about 100%, from about 1% to about 100%, from about 5% to about 100%, from about 10% to about 100%, from about 20% to about 100%, or from about 30% to about 100%, or from about 40% to about 100%, or from about 50% to about 100%, or from about 60% to about 100%, or from about 70% to about 100%, or from about 80% to about 100%, or from about 90% to about 100%, or about 100%, or 100%.

[0085] The flow rate for "high flow" for premature infants / infants / toddlers (weighing in the range of about 1 kg to about 30 kg) may vary. The flow rate can be set from 0.4 L / min / kg to 8 L / min / kg, where the minimum value is about 0.5 L / min and the maximum value is about 70 L / min. For patients under 2 kg, the maximum flow rate can be set to 8 L / min. Again, for a 2 kg patient, the flow rate will be about 0.8 LPM to 16 LPM.

[0086] It has been found that high flow rates are effective in meeting or exceeding the patient's normal actual inspiratory flow rate to increase patient oxygenation and / or reduce the work of breathing. Additionally, high flow treatment and / or respiratory support can create a flushing effect in the nasopharynx such that the anatomic dead space of the upper airway is flushed by the incoming high gas flow. This creates a reserve of fresh gas available for each breath while minimizing rebreathing of carbon dioxide, nitrogen, etc.

[0087] By way of example, a high flow respiratory system 100 is described below with reference to Figure 1 High flow can be used as a means to facilitate gas exchange and / or respiratory support by delivering oxygen and / or other gases and by removing CO2 from the patient's airway. High flow can be particularly useful before, during, or after a medical procedure and / or an anesthetic procedure.

[0088] When used prior to a medical procedure, a high gas flow can pre-load the patient with oxygen (i.e., increase the oxygen reserve in the blood), such that their blood oxygen saturation level and the volume of oxygen in the lungs are above normal values to provide an oxygen buffer, which will be useful in reducing the risk or preventing a decrease in saturation (e.g., when the patient is in an apnea phase during the medical procedure).

[0089] During a medical procedure where respiratory function may be impaired (e.g., weakened or stopped), such as during anesthesia, a continuous oxygen supply is important for maintaining healthy respiratory function. When this supply is impaired, conditions such as hypoxia and / or hypercapnia can occur. During a medical procedure (such as anesthesia and / or sedation), the patient's respiration is monitored to detect whether spontaneous respiration has weakened or stopped. If the oxygen supply and / or CO2 removal is impaired, 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 (e.g., by bag-mask ventilation) or by providing a high gas flow to the patient's airway using a high-flow respiratory system, or by jet ventilation. Further, it will be appreciated that a mask for sedation / ventilation (not necessarily limited to a bag-mask) can also be used for pre-oxygenation and also for monitoring patient parameters (such as end-tidal CO2, etc.).

[0090] Further advantages of a high gas flow can include: the high gas flow increases the pressure in the patient's airway, thereby providing pressure support to open the airway, trachea, lungs / alveoli, and bronchioles. The opening of this structure improves oxygenation and to some extent assists in removing CO2 and / or can help support patients with areas of lung collapse.

[0091] When humidified, a high gas flow can also prevent airway drying, thereby reducing mucociliary damage, the risk of infection, and the risk of laryngospasm, as well as risks associated with airway drying (such as epistaxis, aspiration (caused by epistaxis), and airway obstruction, swelling, and bleeding). Another advantage of a high gas flow is that the flow can clear the smoke formed in the airway during surgery. For example, the smoke may be formed by a laser and / or cautery device.

[0092] Figure 1FIG. 0 shows a respiratory support system 100. The system 100 can be configured to provide high-flow respiratory support and / or high-flow therapy. The respiratory support system 100 includes a flow generator 102. The flow generator 102 is configured to generate a gas flow through the respiratory support system 100. The flow generator 102 is configured to generate a gas flow that is delivered to a patient at a flow rate described elsewhere in this specification. The flow generator 102 delivers air to a humidifier 104. The humidifier 104 is configured to heat and humidify the gas flow generated by the flow generator 102 (heated and humidified to a temperature and / or humidity as described elsewhere in this specification). In some configurations, the flow generator 102 includes a blower that is adapted to receive gas from the ambient environment external to the respiratory support system 100 and to propel the gas through the respiratory therapy system 100. In some configurations, the flow generator 102 can include certain other gas generating devices. For example, in some configurations, the flow generator 102 can include a source obtainable 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 gas exits the one or more containers. As another example, in some configurations, the flow generator 102 can include an oxygen concentrator. In some configurations, the flow generator 102 can be adapted to deliver high-flow respiratory support and / or high-flow therapy. In some embodiments, the flow source can include a compressed gas source, means for modifying the flow from the compressed gas source, and / or a flow generator that generates a gas flow.

[0093] The respiratory support system 100 includes a housing 106 that at least partially houses both the flow generator 102 and the humidifier 104 (e.g., the respiratory support system 100 can include an integrated flow generator / humidifier device). In other configurations, the flow generator 102 and the humidifier 104 can have separate housings, and / or can be separate components. A hardware controller 108 is shown in electronic communication with the flow generator 102 and the humidifier 104, although in some configurations, the hardware controller 108 may communicate only with the flow generator 102 or the humidifier 104. In some configurations, the flow generator 102 and the humidifier 104 can each have their own controller, which may or may not communicate with each other. The hardware controller 108 can include a microcontroller or some other architecture that is configured to direct the operation of the controllable components of the respiratory support system 100, including but not limited to the flow generator 102 and / or the humidifier 104.

[0094] The input / output module 110 is shown as being in electronic communication with the controller 108. The input / output module 110 may be configured to allow a user to interface with the controller 108 to facilitate control of the controllable components of the respiratory support system 100, including but not limited to the flow generator 102 and / or the humidifier 104, and / or to view data regarding the operation of the respiratory support system 100 and / or its components. The input / output module 110 may include, for example, one or more buttons, knobs, dials, switches, levers, touchscreens, speakers, displays, and / or other input or output peripherals that a user may use to view data and / or enter commands to control the respiratory support system 100.

[0095] As Figure 1 Further shown, a supplemental gas source 124 may be used to add one or more supplemental gases to the gas flowing through the respiratory support system 100. The one or more supplemental gases are combined with the gas flow generated by the flow generator 102. The supplemental gas source 124 may be configured to deliver one or more supplemental gases, including but not limited to air, oxygen (O2), carbon dioxide (CO2), nitrogen (N2), nitric oxide (NO), anesthetic agents, and / or heliox (a mixture of helium and oxygen). The supplemental gas source 124 may deliver or direct the one or more supplemental gases to the flow generator 102 via a first supplemental gas conduit 128, and / or may deliver the one or more supplemental gases to a location in the flow path between the flow generator 102 and the humidifier 104 via a second supplemental gas conduit 132. One or more supplemental flow valves 126, 130 may be used to control the rate at which the one or more supplemental gases may flow from the supplemental gas source 124 through the first supplemental gas conduit 128 and / or the second supplemental gas conduit 132. One or more of the supplemental flow valves 126, 130 may be in electronic communication with the controller 108 or a separate controller, which in turn may control the operation and / or status of the one or more supplemental flow valves 126, 130. In other configurations, the supplemental gas source 124 may be configured to add one or more supplemental gases downstream of the humidifier 104. In other configurations, the supplemental gas source 124 may be configured to add one or more supplemental gases to the humidifier 104, such as to a humidification chamber that contains a body of water and that may be engaged with a heater base, the water to be heated by a heating assembly to humidify the gas flow directed to the patient.

[0096] As Figure 1As shown, a conduit 112 extending from the humidifier 104 links the humidifier 104 to the patient interface 200. The conduit 112 may include a conduit heater 114 adapted to heat the gas passing through the conduit 112. In other configurations, the conduit heater 114 may not be present. In some embodiments, an optional filter (not shown) is disposed between the conduit 112 and the patient interface 200. The patient interface 200 is shown as 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 200 may include a sealed or non-sealed interface and may include a nasal mask, a face mask, a nasal-oral mask, a full face mask, a nasal pillow mask, a nasal cannula, an endotracheal adapter, a tracheostomy tube, a combination of the foregoing, or some other gas delivery system. In an embodiment, the patient interface 200 is a non-sealed interface (e.g., a nasal cannula) that allows gas exchange with the environment. For example, when a patient receives a gas flow from the system 100, the non-sealed cannula allows removal and / or clearance of carbon dioxide from the patient's airway. Further, in some embodiments, the patient interface 200 is in the form of a nasal interface such that the system does not interfere with other oral airway equipment and / or devices (e.g., an endotracheal adapter in an intubation procedure).

[0097] Accordingly, the patient can continuously receive a gas flow throughout the intubation procedure. In other embodiments, the patient interface 200 is an oral interface, such as an oral interface received in the user's mouth. In cases involving a medical procedure via the nose, an oral interface may be preferred such that the interface does not interfere with nasal airway equipment and / or devices, such as an endotracheal adapter used in a nasal intubation procedure. In other embodiments, the interface may be suitable for both nasal and oral placement, or may be adaptable between a nasal configuration and an oral configuration.

[0098] As shown, in some configurations, the patient interface 200 may also include a gas sensing module 120 that is adapted to measure characteristics of the gas passing through the patient interface 200. In some configurations, the gas collectors (500; 700; 800; 850; 1000; 1040; 1060; 1080; 1090; 1110; 1116; 1122; 1138; 1140; 1150; 1170; 1180; 1190; 1200; 1220; 1254; 1362; 1274; 1282; 1300) of the present disclosure form part of the sensing module 120. The gas sensing module 120 may be located elsewhere within the gas delivery system and, for example, at a breathing conduit or a humidifier. In some embodiments, there may be one or more gas sensing modules 120. In other configurations, the gas sensing module 120 may be positioned and adapted to measure gas characteristics at or near other parts of the respiratory support system 100. The gas sensing module 120 may include one or more sensors that are adapted to detect the presence of the gas and / or measure various characteristics of the gas, 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. The gas performance determined by the gas sensing module 120 may be utilized in several ways, including but not limited to closed-loop control of gas parameters. For example, in some configurations, the flow rate data obtained by the gas sensing module 120 may be used to determine an instantaneous flow rate, which in turn may be used to determine the patient's respiratory cycle to facilitate synchronization with portions of the respiratory cycle for flow delivery. The gas sensing module 120 may communicate with the controller 108 via a first transmission line 122. In some configurations, the first transmission line 122 may include a data communication connection that is adapted to transmit data signals. The data communication connection may include a wired data communication connection (such as but not limited to a data cable) or a wireless data communication connection (such as but not limited to Wi-Fi or Bluetooth). In some configurations, both power and data may be conveyed via the same first transmission line 122. For example, the gas sensing module 120 may include a modulator that may allow the data signal to "ride" on top of the power signal. The data signal may be superimposed on the power signal, and the combined signal may be demodulated by the controller 108 before use. In other configurations, the first transmission line 122 may include a pneumatic connection that is adapted to transmit a gas stream for analysis to a part of the respiratory support system 100. In other configurations, the transmission line 122 includes a pneumatic connection that is separate from the conduit 112 and is adapted to transmit a gas stream captured at the patient for analysis to a separate system or device (such as, a carbon dioxide monitor).

[0099] Additionally, as shown, a physiological sensor module 121 may be present. The physiological sensor module 121 may be configured to detect various characteristics of a patient or the patient's health condition, including but not limited to heart rate, EEG signals, EKG / ECG signals, inertial sensors attached to the patient (e.g., chest) to detect movement, blood oxygen concentration (e.g., via a pulse oximeter), blood CO2 concentration, transcutaneous CO2 (TcC02), and / or blood glucose. Similarly, the physiological sensor module 121 may communicate with the controller 108 via a second transmission line 123. The second transmission line 123 may include a wired or wireless data communication connection similar to the first transmission line 122, and power and data may be transmitted similarly. The physiological sensor module 121 may be used, for example, to determine the blood oxygen saturation of a patient. In some embodiments, the second transmission line 123 may include a pneumatic connection adapted to transfer a fluid for analysis to a part of the respiratory support system 100 or to a separate system or device.

[0100] Figure 2 A user or patient P wearing the patient interface 200 (e.g., Figure 1 the patient interface 200 of the respiratory system) is shown. The depicted patient is an adult; however, the patient may be an infant, neonate, or child. In the non-limiting configuration shown, the patient interface 200 is a nasal cannula. The patient interface 200 includes a first gas conduit 202. The first gas conduit 202 is adapted to receive gas from the respiratory support system 100 (e.g., via Figure 1 the conduit 112 shown therein) and direct the gas to the patient P. The first gas conduit 202 may include a reinforcement assembly 203 adapted to enhance and / or increase the stiffness of the first gas conduit to prevent deformation or collapse of the first gas conduit 202 due to a force being applied against the first gas conduit 202. The reinforcement assembly 203 may include several structures, including but not limited to plastic or metal beads located within or on the wall of the first conduit lumen 202.

[0101] The first gas conduit 202 is pneumatically connected to the flow manifold 206. The flow manifold 206 receives gas from the first gas conduit 202 and passes the gas to one or more nasal delivery elements 208 (e.g., nasal prongs). The one or more nasal delivery elements 208 extend outward from the flow manifold 206. The one or more nasal delivery elements 208 are adapted to be non-sealed when positioned in one or more nostrils of the patient P (i.e., there is a gap between each nasal delivery element and the patient's nasal passage). As shown, the patient interface 200 includes two nasal prongs 208, which are adapted to position one nasal prong in each nostril of the patient. Each nasal prong 208 can be shaped or angled so that it extends inwardly toward the septum of the patient's nose. Alternatively, the first patient interface 200 can be a sealed nasal interface.

[0102] exist Figure 2 In the embodiment shown in , the flow manifold 206 receives flow from one lateral side of the flow manifold 206 (e.g., relative to an imaginary vertical plane that bisects the face of the patient P) and directs the flow to the manifold and to each of the nasal prongs 208. In some configurations, the flow manifold 206 receives flow from a single side of the flow manifold 206 and directs the flow to the manifold and to each of the nasal prongs 208. The single side can be a single lateral side. In some embodiments, the catheter can extend from the left-hand side or the right-hand side of the manifold. In some cases, it may be preferred to provide the catheter on the left-hand side of the patient interface for access by the clinician (e.g., for intubation). Alternatively, a catheter extending from the right-hand side may be preferred, such as in procedures where the patient typically lies on his or her left-hand side (e.g., endoscopy). In other configurations, the patient interface 200 may include more (e.g., three or four) or fewer (e.g., one) nasal delivery elements 208. In other configurations, each nasal delivery element 208 can have a different structure, size, shape and / or performance. For example, one of a pair of nasal delivery elements 208 can be relatively long, and the other nasal delivery element 208 can be relatively short.

[0103] In some configurations, the flow manifold 206 can be configured to receive flow from both lateral sides of the flow manifold 206 (e.g., from the “left side” and the “right side” of the flow manifold 206, rather than from the “left side” and the “right side” of the flow manifold 206, as shown in FIG. Figure 2The flow from the flow manifold 206 (only the patient's right hand side as seen in the figure). In some such configurations, multiple gas conduits can be used to provide pneumatic communication between the flow manifold 206 and the respiratory support system 100. For example, the patient interface can include a dual conduit: a first gas conduit 202 extending from the first side of the interface (the patient's right hand side in the illustrated example), and a second gas conduit extending from the second opposite side of the interface. In some configurations, the flow manifold 206 can be configured to receive flow from a non-lateral side of the flow manifold 206 (e.g., from the "bottom" or "top" of the flow manifold 206). In some configurations, the flow manifold 206 can receive flow from more than one gas conduit on a single side (optionally a single lateral side) of the manifold 206. In some configurations, one manifold can receive flow from one gas conduit, and another manifold can receive flow from another separate gas conduit.

[0104] The patient interface can further include mounts and / or supports (e.g., cheek support 210) for attaching and / or supporting one or more gas conduits 202 on the patient's face. Alternatively or additionally, the patient interface can be held in place via one or more headstraps.

[0105] The first gas conduit 202 can include a first portion 204 configured to transition from a first configuration in which a first level of gas can pass through the first portion 204 to a second configuration in which a second level of gas can pass through the first portion 204.

[0106] Figure 3 It is shown that the patient P will wear the patient interface 200 (the first patient interface) as shown in Figure 2 a non-limiting exemplary embodiment below the mask assembly 300 (the second patient interface). Figure 3 The mask is schematically shown as a transparent structure to show the patient interface 200 below it. The first patient interface 200 can be used with a first respiratory support subsystem, and the second patient interface 300 can be used with a second respiratory support subsystem. In some embodiments, the first patient interface 200 and the second patient interface 300 can be used with the same respiratory support system.

[0107] The system may find benefits in aspects such as selectively delivering separate respiratory support and / or treatment to the patient using different patient interfaces, and / or stopping or terminating the delivery of respiratory support and / or treatment from the interface, and / or allowing sampling of the gas provided by the interface.

[0108] The described systems and devices are found to be particularly suitable for peri-intubation, ENT surgery, preoperative states prior to administration of anesthesia, and during extubation and resuscitation of patients undergoing emergency resuscitation, receiving high-flow respiratory support, and / or treatment.

[0109] The mask assembly 300 can be used as a second respiratory support subsystem or used in conjunction with a second respiratory support subsystem, and / or for delivering one or more substances to the patient in addition to, or at a different flow and / or pressure level than, the substances (e.g., anesthetic or oxygen) delivered by the intubation 200. Alternatively, the mask assembly 300 can be used to discontinue the delivery of respiratory support and / or treatment from the first respiratory support subsystem. The mask assembly 300 can also be adapted to measure respiratory gases (e.g., carbon dioxide exhaled from the patient), the measurement of which may otherwise be affected by the flow from the patient interface 200 of the first respiratory support subsystem.

[0110] Accordingly, Figure 3 the illustrated embodiments allow for alternation between two different respiratory support subsystems. Additionally, this configuration can allow the patient interface 200 to remain on the patient throughout the surgical procedure and / or during entry into resuscitation (regardless of whether the patient continuously receives a gas flow through the patient interface 200 throughout the procedure) without interfering with other clinical practices.

[0111] In the illustrated embodiment, the mask assembly 300 includes a full face mask 302 that is configured to cover both the patient's nose and mouth. In other configurations, the mask 300 can be a nasal mask that is placed over the patient interface 200 to cover only the patient's nasal region. In such configurations, a portion of the mask 300 can be placed on a portion of the patient interface 200 (e.g., the first portion 204).

[0112] As shown, the mask 302 includes a sealing region 304 that is adapted to seal against the patient's face. The mask assembly 300 is connected to a second gas source (e.g., via a filter assembly 350 or a humidity moisture exchanger (not shown)), which supplies the one or more other gases to the patient via the mask. That is, the second gas source is preferably different from the source that supplies gas to the patient interface 200 (e.g., the supplemental gas source 124 / flow generator 102). In other embodiments, the patient interface 200 and the mask assembly 300 are connected to a common gas source.

[0113] In an embodiment, the face mask assembly 300 is connected to a separate gas source or a separate respiratory support device. For example, the respiratory support can be a ventilator or a CPAP or a high flow respiratory support and / or treatment device or a manual resuscitator (e.g., a handheld face mask with a bag). Alternatively or additionally, the face mask assembly 300 can be connected to a device for measuring the characteristics of respiratory gases.

[0114] Alternatively, the face mask assembly 300 can be connected to an anesthesia device and can deliver anesthetic gas or air or oxygen or a combination of gases via the face mask 302.

[0115] Figure 3 The embodiment shown allows for the delivery of gases 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.

[0116] In one particular application, a patient being prepared for anesthesia can be pre-oxygenated by delivering high flow oxygen or humidified gas or a mixture of both via a nasal cannula. In some cases, an anesthesiologist managing the sedation and / or anesthesia of a patient may wish to switch between delivering a gas flow from one patient interface (e.g., the nasal cannula 200) and delivering a gas flow from another patient interface (such as via the face mask 300).

[0117] An anesthesiologist also uses a face mask with a bag to oxygenate a patient and in some cases finds it more beneficial to use the bag-valve mask when the patient's vital signs start to decline, e.g., to deliver greater pressure or have more control over the change in the delivered pressure. In some cases, a medical professional may wish to switch between different respiratory systems or support modes. In a first mode, respiratory support can be provided by a first respiratory support system (e.g., via the patient interface 200); and in a second mode, respiratory support can be provided by a second respiratory support system (e.g., via the patient interface 300) while support from the first system is reduced or stopped. For example, the additional flow from high flow provided by the nasal interface 200 can also modify the expected behavior of the anesthesia circuit provided by the face mask 300, and thus it can be advantageous to be able to reduce or stop the additional flow from the first respiratory system.

[0118] In some configurations, the switching between two respiratory support modes or subsystems can be facilitated by the structure of the first gas conduit 202, which has a first portion 204 configured to transition from a first configuration to a second configuration, in the first configuration, a first level of gas can pass through the first portion 204, and in the second configuration, a second level of gas can pass through the first portion 204.

[0119] In some configurations, the first portion 204 is configured to be more collapsible than other portions of the conduit 202 or otherwise better adapted to alter the gas flow through the first portion 204 (and thus stop or reduce the gas flow through the conduit and to the patient), and / or to allow the seal of the face mask to seal over the top of the conduit. In other configurations, the entire conduit can be configured to be collapsible. In some configurations, a vent arrangement can be provided to vent gas from the conduit to the atmosphere.

[0120] In some embodiments, the first configuration or first condition is a substantially open configuration, and the second configuration or second condition is a substantially closed configuration. That is, the conduit 202 is configured to be more collapsible, deformable, or otherwise adapted to completely block the flow at the first portion 204 than other portions of the conduit 202. Under the second condition, the gas reaching the nasal delivery element 208 may be reduced or stopped.

[0121] Figure 4 An example of such a configuration is shown, where the conduit (e.g., Figure 3 the conduit 204 of the nasal cannula 200) is substantially blocked by the seal 304 of the face mask 302 at the first portion 204. In such embodiments, the length of the first portion (i.e., the more collapsible or deformable section) of the first gas conduit should be greater than or equal to the width of the section of the face mask seal that bears on the first portion of the first gas conduit. This can be achieved such that the face mask seal does not bear on a non - collapsible section of the first gas conduit. For example, the first portion can extend from a distance of 35 mm or less from a portion of the manifold 206 or the center of the user's nose to a distance of at least 50 mm from a portion of the manifold 206 or the center of the user's nose. The first portion 204 can have a length of at least about 5 mm, a length of about 1 mm to about 30 mm, or a length of about 5 mm to about 15 mm, or a length of about 10 mm. In some embodiments, the length of the first portion can be at least 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm or greater.

[0122] The first portion 204 can transition between the first configuration and the second configuration based on the relative level of the force applied to the wall of the first portion 204. For example, as Figure 3 shown, the force can be applied by the seal 304 of the face mask 302. In this example, the first portion 204 is configured to be positioned below the seal 304 of the face mask 302.

[0123] Alternatively, force may be applied to the first portion 204 by other devices (e.g., a clamp (not shown)), or alternatively, a medical practitioner may compress the catheter by pressing with a finger or thumb against the catheter wall.

[0124] In some embodiments, the face mask seal acting on the first portion 204 of the gas conduit causes the first portion 204 to form a seal or at least an occlusion between the nasal outlet of the first patient interface 200 and the flow generator 102. Additionally, the face mask seal forms a seal or at least a partial seal over the first portion 204 of the gas conduit 202.

[0125] Thus, switching between respiratory support therapies can be simply achieved by applying the face mask to the patient's face such that the face mask seal collapses (partially or fully) the first portion of the gas conduit of the first interface 200 to stop or "cut off" or reduce the respiratory support and / or therapy supplied by the first interface 200, and also provides a seal between the face mask 300 and the outer surface of the first portion 204 of the conduit 202 such that respiratory support and / or therapy can be provided by the face mask 300 and the respiratory support and / or therapy provided by the first interface 200 is stopped or reduced. As noted, the first portion 204 of the patient interface 200 is configured to be collapsible and will hereinafter be referred to as the collapsible portion 204.

[0126] An endotracheal tube having a collapsible conduit portion allows a user (e.g., an anesthesiologist or nurse or clinician) to use a face mask and prevent delivery of gas from multiple sources (e.g., the face mask and the endotracheal tube). The first interface 200 is constructed and operative to reduce or shut off the delivery of high flow and allow delivery of other respiratory support and / or respiratory therapy or anesthetic gas through the face mask when the interface 200 is moved to a collapsed configuration. In some embodiments, when the conduit is restored from the collapsed configuration to the open configuration, removing the face mask from the patient's face allows the respiratory support and / or therapy supplied by the first interface to resume.

[0127] Figures 5 to 8 A patient interface 1400 is illustrated that includes a nasal endotracheal tube and includes a gas delivery side member 1401 configured to deliver device gas (e.g., a gas stream from a flow source) to a patient via a manifold 1406 to a delivery outlet that includes a pair of nasal prongs 1408. The pair of nasal prongs 1408 extends from the manifold 1406. The gas 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, the second side being opposite the first side. The non-delivery side member 1403 includes an end 1409 configured to connect to a head strap 1411.

[0128] The gas delivery side member 1401 includes a collapsible portion 1404 that is configured to move from the normally open configuration shown in Figure 5 , Figure 7 and Figure 8 to a collapsed configuration in which the device gas flow through the collapsible portion 1404 is reduced or stopped. The collapsible portion 1404 is configured to move to the collapsed configuration when a collapsing force is applied, such as from a patient mask placed over the patient's face, and wherein the mask seal is pressed down onto the collapsible portion 1404. The gas delivery side member 1401 also includes a non - collapsible portion 1407 that is configured to remain open when a collapsing force is applied to the collapsible portion 1404.

[0129] One end of the non - collapsible portion 1407 includes a delivery inlet 1407a for receiving the device gas flow. The patient interface 1400 further includes a gas path connector 1413 that has a rigid structure and includes a delivery inlet 1413a and a delivery outlet 1413b. The gas path connector delivery inlet 1413a is connectable via a conduit (not shown) to a device gas supply. 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 head strap 1411 at an end opposite the end of the head strap to which the head strap end 1409 connected to the non - delivery side member 1403 is attached.

[0130] Figure 6 A cross - section of the non - collapsible portion 1407 is shown, which includes a wall 1412 of uniform thickness. Figure 7 and Figure 8 A cross - section of the collapsible portion 1404 is shown, which includes a wall 1404a of non - uniform thickness. The collapsible portion 1404 has an elongated cross - section and particularly a cross - section in the shape of a stadium, which includes a pair of longitudinal sides 1404b extending between a pair of ends 1404c. As Figure 8 shown, thin - walled portions 1404 are provided at each of the ends 1404c. The thin - wall portions 404d and 1404d are configured to provide fold lines at which the collapsible portion 1404 bends or folds when a collapsing force is applied.

[0131] Figures 5 to 8 The patient interface 400 shown provides a background for various embodiments of a patient interface (or portions thereof) similar to the interface 1400 described herein.

[0132] Figures 9 to 11Another example of a patient interface is shown. The nasal cannula 30 includes a face mounting portion 32, a pair of nasal prongs 33, 34, a gas flow manifold portion 35, and a gas conduit 32. The face mounting portion 32 includes an upper (first) portion 32a from which the prongs 33, 34 extend, and a face contacting (second) portion 32b configured to contact the upper lip of the patient in use. The upper portion 32a and the face contacting portion 32b are angled with respect to each other and are optionally substantially perpendicular to each other. The face mounting portion 32 and the pair of nasal prongs 33, 34 are preferably integrally molded as a single piece from a soft plastic material such as silicone or thermoplastic elastomer, although in other forms the face mounting portion and the prongs may be separate but attachable together for use. In some configurations, the face mounting portion 32 and the nasal prongs 33, 34 may be made of the same or different materials. The nasal prongs 33, 34 may be tubular in shape and may have a uniform diameter, but may be shaped to conform to the contour of a human nostril. The prongs 33, 34 may be angled toward a central plane that bisects the face mounting portion 32 between the prongs. The prongs 33, 34 may be curved so that when in use the outlets of the prongs 33, 34 point toward the back of the patient's head. The prongs 33, 34 may include an internal and / or external cross-sectional shape that is transverse to the flow direction through each prong when in use, the cross-sectional shape being oval (e.g., circular) or substantially oval (e.g., ovoid). The shape and / or size of each prong 33, 34 may be uniform or may vary along its length. The prongs 33, 34 are configured to be non-sealing with respect to the patient's nostrils in use such that there is a gap between the prongs and the patient's nostrils. This allows for continuous gas flow between the prongs and the patient's nostrils when in use.

[0133] The face mounting portion 32 includes side arms 31 that extend laterally from the sides of the face mounting portion 32. The side arms 31, together with a head strap (not shown), assist in holding the nasal cannula 30 in place on the patient's face. The end of each side arm 31 includes one or more slots to allow the end of the head strap to pass through. This may provide an adjustable coupling between the head strap and the side arms 31. Other attachment mechanisms besides slots are also contemplated, such as buckles and clips.

[0134] The face mounting portion 32 further includes a third portion 32c that extends from the upper portion 32a and connects to the face contact portion 32b to form a recess 38 capable of receiving the gas flow manifold portion 35. In the illustrated embodiment, the recess 38 provides a horizontal side inlet for the gas flow manifold 35. Thus, the gas flow manifold 35 can be laterally inserted into the recess 38 via one lateral side of the face mounting portion 32 in a direction transverse to the length of the fork tubes 33, 34. Since the recess 38 includes two lateral openings, the gas manifold portion 35 can be inserted into the recess 38 via the left or right side of the face mounting portion 32. This allows the nasal cannula 30 to be configured to allow gas flow to reach the patient from either the left or right side of the nasal cannula. The gas flow manifold 35 can be attached to or integrally formed with the gas conduit 3. The nasal fork tubes 33, 34 include flow channels that extend through the face mounting portion 32 and into the recess 38. The assembly formed by the face mounting portion 32 and the gas flow manifold 35 includes a manifold. The gas flow manifold portion 35 is blocked at one end 39 but is attached to the gas conduit 35 at the other end. The gas flow manifold 35 has an opening 37 that serves as an outlet for the gas received from the gas conduit 3. The opening 37 is shown as an elongated opening, but other shapes are also contemplated. The gas flow manifold 35 can be more rigid than the face mounting portion 32 or include a material that is more rigid than the face mounting portion. Due to the relative stiffness / flexibility of the gas flow manifold portion 35 and the face mounting portion 32, the gas flow manifold portion 35 can be pushed through the recess 38 in the face mounting portion 32, and the opening 37 in the gas flow manifold portion 35 meets the flow channels of the fork tubes 33, 34. Thus, in use, the gas flowing through the gas conduit 3 and into the gas flow manifold portion 35 exits through the opening 37 and enters the tubular passages in the fork tubes 33, 34 and then into the patient's nostrils.

[0135] To assist in maintaining the gas flow manifold portion 35 within the recess 38, the gas flow manifold portion 35 is provided with a recessed portion 60 and lip regions 58, 59. When engaged with the face mounting portion 32, the third portion 32c, which forms part of the recess 38, seats within the recessed portion 60, and the edges of the third portion 32c around the lips 58, 59 are formed on the gas flow manifold portion 35. Additionally, or alternatively, the gas flow manifold 35 includes one or more flanges 35a that are configured to engage a portion of the upper portion 32a to retain the gas flow manifold 35 to the face mounting portion 32. The one or more flanges 35a are positioned around the perimeter of the opening 37. In some configurations, the one or more flanges 35a are a single flange that extends around the entire perimeter of the opening 37.

[0136] The embodiments of the gas collector described below can be attached to or integral with the nasal cannulas 30, 200, and / or 1400.

[0137] Various embodiments of the gas collector provide or form one or more channels at or around the patient's upper lip 300. In some configurations, when the gas collector is in use, the one or more channels may be formed partially by a portion of the gas collector and partially by the patient's upper lip. The one or more channels are in fluid communication with the patient's nose 302 and the patient's mouth 304, as Figure 12 shown. The one or more channels provide a path for fluid communication between the patient's nose region 302 and the patient's mouth region 304. In other words, the patient's nose region 302 is in fluid communication with the patient's mouth region 304 via the one or more channels. The one or more channels are open to the atmosphere at least at the patient's nose region and / or the patient's mouth region. In certain embodiments, the one or more channels may be more particularly disposed at or around the patient's philtrum region 306. The one or more channels facilitate the collection of gas from the nose region 302 and / or the mouth region 304 to a local area for sampling and analysis. In some configurations, the one or more channels facilitate the collection of exhaled gas from the nose 302 and / or the mouth 304 to a local area to increase the concentration of exhaled gas prior to sampling and analysis. Having one or more channels that provide a path for fluid communication between the nose 302 and the mouth 304 also assists in collecting gas samples, whether the patient is breathing through the nose or the mouth. In use, a portion of the exhaled gas leaving the nose and mouth travels to the upper lip region, so the one or more channels form an accumulation area around the upper lip, which is beneficial for collecting gas from the nose region and / or the mouth region, especially during periods of high flow gas delivery.

[0138] In one or more embodiments, the one or more channels may be formed partially by a portion of the preformed curvature of a nasal cannula. Additionally or alternatively, a device integral with or removably attachable to the nasal cannula may be used to form the channel.

[0139] Figure 13 、 Figure 14 and Figure 15 respectively depict three different types of channel structures (referred to as 400, 402, and 404 respectively). These images are depicted as looking up from the patient's chin towards their head, and the outline of the patient's nose 406 and nostrils 408 and 410 and the nasal prong tubes 412 and 414 for delivering gas to the patient's nasal passages are depicted with dashed lines.

[0140] The spacer (depicted as a solid block) maintains a portion of the channel wall away from the patient's upper lip 450, 452, and 454. In some embodiments, the portion of the channel wall spaced from the patient's upper lip may be formed by a portion of a nasal cannula (to which the gas collector is attached or formed integrally therewith). However, in other embodiments, the portion of the channel wall may be a device formed separately from the nasal cannula.

[0141] Although Figures 13 to 15 the channel depicted in is shown as being partially formed by the patient's upper lip, in other embodiments, the channel may be formed by a preformed body that includes one or more gas collection conduits formed therein, the one or more gas collection conduits merely resting against the patient's upper lip.

[0142] Figure 13 The first channel type 400 shown in includes a channel 416 constrained by two spacers 418 and 420, the channel including a first open end facing the patient's nose and a second open end facing the patient's mouth. The spacers 418 and 420 are configured to rest against the lateral sides of the patient's upper lip on either side of the philtrum region in use. In terms of the nasal cannula, the spacers 418 and 420 are laterally positioned relative to the nasal forks 412 and 414. In other words, in a top planar view, the forks 412 and 414 are positioned between the spacers 418 and 420. Insofar as the upper lip is positioned below the nostrils, the spacers 418 and 420 are configured to be positioned below the nasal forks 412 and 414. In some embodiments, the spacers 418 and 420 are positioned directly below the nasal forks 412 and 414. Gas exhaled by the patient or gas provided to the patient via the nasal cannula and entering the channel may be collected at multiple locations within the channel. The collected gas may then be analyzed in situ or delivered to a gas analyzer for analysis. The gas analyzer may include a negative flow source that aspirates the collected gas at a flow rate of from about 40 ml / min to about 500 ml / min. In some embodiments, the spacers 418 and 420 may be integral with or attachable to the nasal cannula.

[0143] Figure 15The second channel type 404 shown in [Figure 0] includes a spacer 422 that is positioned substantially along the central plane of the gas collector. When in use, the spacer 422 is configured to contact the philtrum region at the patient's upper lip and is positioned below the patient's nostrils and substantially between the patient's nostrils and between the fork tubes 412 and 414 of the nasal cannula. Positioning the spacer 422 in this manner forms two open channels 424 and 426 on either side of the spacer 422, both of which are in fluid communication with the nasal passages and the upper lip. The open channels 424 and 426 are also in fluid communication with the patient's oral cavity and upper lip (not shown). The channels 424 and 426 are formed to facilitate fluid communication between these regions. The collected gas can be aspirated from one or more locations within the channels thus formed.

[0144] In Figure 14 the third channel type 402 shown in [Figure 0], when in use, the spacers 428 and 430 are configured to contact the patient's upper lip and may be positioned below the patient's nostrils and optionally below the nasal fork tubes 412 and 414. Further, additional spacers 432 and 434 may be positioned below the patient's nostrils and disposed on either side of the nasal fork tubes 412 and 414. These additional spacers 432 and 434 may contact a portion of the patient's nasolabial fold. This results in the formation of three separate channels 436, 438, and 440. Again, these open channels are formed between the patient's nose, mouth, and upper lip regions to enable collection of gas at the sampling area. A sample of exhaled gas can be aspirated, for example, from this sampling area for further analysis.

[0145] In some embodiments, the spacers 418, 420, 422, 432, 434, 428, and 430 may be attached to the gas collector or formed integrally therewith. In some embodiments, the gas collector may be a separate device that is removably attachable to or integral with a nasal interface (such as the nasal cannula shown at 30 and / or 200).

[0146] It will be appreciated that Figures 13 to 15 the arrangements depicted in [Figure 0] are merely exemplary and are intended to illustrate three non-exclusive ways in which channel wall portions can be spaced from the patient's face by means of spacers to form open channels, thereby enabling collection of gas exhaled by the patient from the nasal and oral passages.

[0147] Figures 16 to 18Shows a first embodiment of a gas collector 500 for collecting gases exhaled by a patient from the nasal and oral passages. The gas collector 500 includes an interface 502 configured to form a passage with the patient's upper lip, the passage having an open end that is in fluid communication with the patient's nasal and oral passages, respectively. In this example, the interface 502 has a "scoop" portion that includes a curved channel wall portion 504 spaced from the patient's face by two spacers 506 and 508. In this example, the spacers 506 and 508 are in the form of ribs that extend along the length of the curved channel wall portion 504 and project from the channel wall portion 504 toward the patient's face to provide the required spacing. It is common in this example that the spacers 506 and 508 are integral with the channel wall portion 504. It is common in this example that the spacers 506 and 508 are arranged to contact the patient's face on either side of the nasal passage.

[0148] In this example, the gas collector 500 is configured to be attached to a nasal cannula 510, which includes a gas delivery catheter 512 (or a gas delivery side member 512) and nasal prongs 514 and 516. The channel wall portion 504 includes apertures 518 and 520 such that the gas collector 500 can be positioned over the nasal prongs 514 and 516. The channel wall portion 504 further includes two additional apertures 522 and 524 that pass through the channel wall portion and form an oral gas inlet 522 (which may also be referred to as a first gas inlet 522) and a nasal gas inlet 524 (which may also be referred to as a second gas inlet 524), respectively. The nasal gas inlet 524 and the oral gas inlet 522 may be collectively referred to as gas inlets. In some configurations, the oral gas inlet 522 may primarily collect gases from the patient's mouth area (e.g., exhaled gases from the patient's oral passage). In some configurations, the nasal gas inlet 524 may primarily collect gases from the patient's nasal area (e.g., exhaled gases from the patient's nasal passage). In some configurations, the oral gas inlet 522 and / or the nasal gas inlet 524 may collect gases from both the patient's nasal area and the patient's oral area. As best seen in Figure 17 and Figure 18 , the oral gas inlet 522 and the nasal gas inlet 524 are connected to an adapter 530 via conduits 526 and 528 to form a gas collection area for collecting both oral gas and nasal gas prior to sampling and further analysis. In this embodiment, the adapter 530 includes a single outlet 532 that is in fluid communication with a gas analyzer (not shown). In some embodiments, the adapter 530 or a portion thereof includes a rigid structure. The adapter 530 and the channel wall portion 504 are configured to position a portion of the nasal cannula 510 therebetween such that the gas collector 500 is mounted to the nasal cannula 510. In particular, as Figure 17 and Figure 18As shown, a portion of the nasal cannula 510 is clamped between the channel wall portion 504 and the adapter 530.

[0149] In Figures 16 to 18 the embodiment shown, the gas sampling points are shown to be combined. However, in some embodiments, the individual samples can be returned to two gas analyzers to sample each location and determine parameters from the patient, such as the patient's breathing pattern.

[0150] In some embodiments, the gas collection inlets 522 and 524 can be a single inlet. In some embodiments, the channel wall portion 504 includes an auxiliary channel that fluidly connects the first gas inlet 522 and the second gas inlet 524. Additionally, in some embodiments, the gas collector 500 can have more than one gas collection inlet 524 for collecting nasal gas and more than one gas collection inlet 522 for collecting oral gas.

[0151] Although in this embodiment the gas collector 500 is formed separately from the nasal cannula and subsequently attached to the nasal cannula, in other embodiments, the gas collector can be integrally formed with the nasal cannula. In such an arrangement, the nasal cannula can at least partially form the channel wall portion, which is spaced from the patient's face by a suitable spacer to form an open channel at the patient's upper lip.

[0152] The interface 502 can be made of a variety of materials. For example, it can be made of a soft polymer (such as silicone), which can flex with the user's facial profile to minimize or avoid pressure points. The interface 502 can also include one or more materials, such as polymers and metals or polymers with different properties.

[0153] The spacers 506 and 508 can take the form of thickened ribs that contact the patient's face on either side of the nasal forks 514 and 516. The channel wall portion 504 forms an open channel between the patient's nose, upper lip, and mouth, and this open channel can form a thinner region of the interface 502, which is offset from the face by the thickened ribs 506 and 508 that provide stiffness.

[0154] Thus, the thickness of the spacers 506 and 508 can be greater than that of the channel wall portion 504, and the spacers 506 and 508 can also be more rigid than the channel wall portion 504. In some embodiments of the present invention, the hardness of the spacers can be greater than the hardness of the channel wall portion (e.g., the desired hardness can be achieved via shape / configuration and / or material, and in some embodiments, the Young's modulus of the spacers can be greater than the Young's modulus of the channel wall portion).

[0155] The channel wall portion can be formed of a material or otherwise configured such that it can flex when in contact with the patient's face. When in use, the gas collector can be capable of maintaining its shape. In some embodiments, when in use, the gas collector is adapted to maintain a preformed shape. In several embodiments, the gas collector can be configured to avoid precisely matching the contour of the patient's face such that no channel is formed with the patient's upper lip when in use. In some embodiments, the gas collector can include a preformed shape that has a substantially different curvature in the channel wall portion compared to the upper lip of a typical patient (e.g., the channel wall portion is more convex in a direction away from the patient than the upper lip of a typical patient). In some embodiments, the gas collector is elastic and resists flexure, which would cause the gas collector to conform to the patient's face and avoid forming a channel. In other embodiments, the gas collector is configured to flex and deform to accommodate a medical mirror and other instruments that may be inserted into the patient's mouth.

[0156] It will be appreciated that Figures 16 to 18 the gas collector 500 shown in is non-sealed. That is, and as best seen in Figure 18 the interface 500 includes a top surface 534 that, when in use, seats under the patient's nose but does not form a seal with the nose, i.e., there is a gap between the nose and a portion of the top surface 534 to allow gas to continuously pass between the nose and the atmosphere.

[0157] Similarly, and as best appreciated in Figure 16 the gas collector 500 can include a mouth engaging portion 536 that is configured to project into the patient's mouth to maintain an open passage between the patient's mouth and the oral gas collection inlet 522. In particular, the gas collector 500 is configured to project into the patient's mouth and engage only the patient's upper lip to pry open the patient's mouth to establish an open pathway for gas in the patient's mouth to exit to the atmosphere and / or enter the channel formed between the patient's nose, upper lip, mouth, and the channel wall portion 504.

[0158] In Figures 16 to 18 the embodiment shown in, the mouth engaging portion includes a lower end that projects into the patient's mouth and is shaped to avoid forming a seal with the patient's upper lip, i.e., there is a gap between a portion of the patient's upper lip and the mouth engaging portion to allow gas to continuously pass between the mouth and the atmosphere. In other words, the mouth engaging portion is configured to project into the patient's mouth to maintain an open passage between the patient's mouth and the second gas collection inlet.

[0159] In particular, in this embodiment, the lower end of the mouth engaging portion has an inner surface that includes edge portions 558 and 560 that, when in use, are located at the sides of the patient's mouth (inFigure 16 as best seen in ). The inner surface of the lower end of the mouth engagement portion also includes a central portion 542 that, when in use, is located at the center of the patient's mouth and is spaced from the patient's upper lip by a greater distance than the edge portion (see Figure 17 ). In various embodiments of the present invention, when the gas collector 500 is viewed from the Figure 17 angle shown in, the inner surface of the first end of the mouth engagement portion may have a U-shaped or V-shaped profile. Depending on the application, other shapes of the mouth engagement portion may be envisioned, such as a C-shaped profile or a W-shaped profile.

[0160] Although Figure 18 the flat top surface 534 depicted in avoids forming a seal with the nose, it will be understood that this is just one example of a more general case where the channel wall portion 504 includes an upper end that extends outward from the patient's face. In some embodiments, the upper end of the channel wall portion extending outward from the patient's face may be caused by the channel wall bending outward from the patient's face.

[0161] From Figures 16 to 18 it will be understood that the interface 500 (and in particular the channel wall portion 504 and the thickened ribs 506 and 508) forms a gas flow diverter that is configured to direct at least some of the gas exhaled by the patient to the gas collection inlets 522 and 524. As can be best seen in Figure 18 , the gas flow diverter 500 includes an upper portion 538 that extends away from the patient's face, a lower portion 536 that extends toward the patient's face, and an intermediate portion 540 that interconnects the lower portion and the upper portion. The intermediate portion 540 extends in a direction that is substantially parallel to the patient's face.

[0162] It can be seen from Figures 16 to 18 that at least the intermediate portion of the gas flow diverter has an inner surface that, in use, faces the patient's face and substantially follows the shape of the patient's face from the tip of the nose (nasion) to the upper lip region or below the upper lip region.

[0163] In a particular embodiment, the inner surface of the gas flow diverter 500 or a vertical cross-section of the gas flow diverter 500 taken along its length and relative to the patient's sagittal plane has a substantially S-shaped shape.

[0164] Figure 19 and Figure 20 show images 600 and 602 of the gas collector 500 as shown in Figures 16 to 18 when in use. In particular, the attachment of the gas collector to the nasal cannula (e.g., nasal cannulas 200, 1400) can be seen, as well as the unsealed conditions of the upper and lower portions of the interface to the patient's nasal and oral passages, respectively.

[0165] Figures 21 to 26 illustrates a patient interface 2400 in the form of a nasal cannula similar to the nasal cannula 30 shown in Figures 9 to 11 The nasal cannula 2400 includes a patient conduit 2401 configured to deliver device gas (e.g., a gas stream from a flow source) to a patient via a manifold 2406 to a delivery outlet, the delivery outlet including a pair of nasal prongs 2408. The pair of nasal prongs 2408 extends from the manifold 2406. The patient conduit 2401 extends from a first side of the manifold 2406. The patient conduit 2401 may extend from the left or right side of the nasal cannula 2400. The interface 2400 further includes side arms 2403 and 2404 that extend laterally from a side portion of the manifold 2406. The side arms 2403 and 2404 include ends 2409 and 2410 configured to be connected to head strap ends 2411 and 2412, respectively.

[0166] Unlike Figures 5 to 8 the embodiment shown in

[0167] the gas delivery side member 1401 does not include a collapsible portion configured to move from a normally open configuration to a collapsed configuration. Figure 23 and Figure 24 As can be best seen in Figures 23 to 26 The gas collector 2415 may be formed separately from the nasal cannula 2400 and removably attachable to the nasal cannula. For example, as can be best seen in Figures 16 to 20 and

[0168] Figures 27 to 35 An adapter 2418 may engage the body 2420 of the gas collector 2415 to secure the gas collector 2415 to the nasal cannula 2400. When engaged, one or more flow channels in the adapter 2418 are in fluid communication with one or more channels of conduits 2416 and 2417. In other embodiments, the gas collector 2415 is integrally formed with the nasal cannula. Figure 15As shown. In this embodiment, the gas collector 700 includes an interface 702 configured to form a plurality of channels at the patient's upper lip, the channels having open ends that are in fluid communication with the patient's nasal and oral passages, respectively. The interface 702 includes a spacer 704 that rests against the patient's upper lip in use. In an example, similar to the first channel type as shown in Figure 13 , a portion of the nasal cannula 732 can contact a portion of the patient's upper lip in use. In such examples, the gas collector can form a combination of the first channel type and the second channel type as shown in Figure 13 and Figure 15 . One or more nasal gas collection conduits and oral gas collection conduits 706 to 710 (schematically shown in Figure 29 ) are formed within the spacer 704. Arrows 734, 736 show the flow direction of the redirected supply gas from the nasal forks 728, 730. Each nasal gas collection conduit 706 and 708 has a nasal gas collection inlet (referenced as 712 and 714, respectively) in fluid communication with the patient's nasal passage for delivering the gas exhaled by the patient from its nasal passage to the outlet. The oral gas collection conduit 710 formed within the spacer has an oral gas collection inlet 716 in fluid communication with the patient's oral passage.

[0169] The gas collector further includes a gas flow diverter 720 (in the form of a concave spoon in this embodiment), which is configured to direct at least some of the gas exhaled by the patient from its oral passage to the oral gas collection inlet. The gas flow diverter 720 can be integrated with or attachable to the spacer 704.

[0170] The problem of dilution of exhaled gas through the nose and exhaled gas through the mouth can be addressed in several ways. For exhaled gas through the mouth, the gas flow diverter restricts the exhaled gas from leaking out or mixing with the atmosphere easily. In that regard, the gas flow diverter is in the form of a concave spoon having a central portion 722 extending towards the patient's face and side portions 724 and 726 that act together to minimize the leakage of exhaled gas. Additionally, for exhaled air through the nose and through the mouth, the inlets 712 to 716 are positioned to maximize the collection of exhaled gas and minimize the entry of the supplied air from the nasal forks 728 and 730, which form part of the nasal cannula 732 (to which the gas collector 700 is attached).

[0171] In NHF applications, the dilution problem is exacerbated. The redirected gas supplied to the patient via the nasal forks 728 and 730 dilutes the exhaled air and prevents the exhaled air through the mouth from entering the gas collection inlets 712 to 716. For use in Figures 27 to 35One measure to address this issue in the illustrated embodiment is to position the nasal gas collection inlets 712 and 714 close to the patient's nasal passages when in use. Additionally, the nasal gas collection inlets 712, 714 are arranged in a position where they are transverse to the length of the formed channel. This position minimizes the dynamic pressure used for gas to enter the nasal gas collection ducts 706, 708. Thus, the nasal gas collection inlets 712 and 714 can be arranged in one or more of the following positions: a first position where the nasal gas collection inlets 712, 714 are substantially parallel to the length of the channel and face the gas flow from the patient's nasal region; a second position where the nasal gas collection inlets 712, 714 are substantially transverse to the length of the channel; and a third position between the first and second positions. The nasal gas collection inlets 712, 714 facing the gas flow from the patient's nasal region will form a high-pressure region within the nasal gas collection ducts 706, 708, which in embodiments where the nasal gas collection ducts are connected to the oral gas collection duct 716, increases the flow resistance in the oral gas collection inlet 716 and duct 710, thereby making it more difficult to collect gas from the patient's oral region.

[0172] A further measure is to position the oral gas inlet 716 at the bottom of the spacer 704 close to the patient's mouth when in use. As can be seen in Figure 29 this enables the oral gas collection duct 710 to form a path leading to the junction with the nasal gas collection ducts 706 and 708. The concave spoon form of the gas flow diverter 720 assists in guiding the exhaled gas through the oral cavity to the oral gas collection inlet 716. The advantage of having such a junction is that there is substantial capture of the exhaled gas through the oral cavity, which may not be flushed out by the redirected supply gas from the nasal prongs 728 and 730.

[0173] By providing different gas collection inlets for collecting exhaled gas placed at the junction schematically depicted in Figure 29 the problem of capturing exhaled gas when the patient switches between oral and nasal exhalation is further addressed. The one or more nasal gas sampling ducts and the oral gas sampling duct are configured such that the flow rate in the one or more nasal gas sampling ducts is a certain percentage of the total flow rate in the one or more nasal gas sampling ducts and the oral gas sampling duct, where the percentage is within a predetermined range. The total flow rate includes the calculated total flow rate of the flow rate in the one or more nasal gas sampling ducts and the flow rate in the oral gas sampling duct (i.e., adding their respective flow rates mathematically), as well as the flow rate of the combined flow (when the flow in the one or more nasal gas sampling ducts and the flow in the oral gas sampling duct are combined, such as at the junction).

[0174] In some configurations in which there are multiple nasal gas sampling conduits, the multiple nasal gas sampling conduits and the oral gas sampling conduit are configured such that the combined flow rate in the multiple nasal gas sampling conduits is a certain percentage of the total flow rate in the multiple nasal gas sampling conduits and the oral gas sampling conduit, where the percentage is within a predetermined range. In some configurations, there are multiple oral gas sampling conduits. In such configurations, the one or more nasal gas sampling conduits and the multiple oral gas sampling conduits are configured such that the flow rate in the one or more nasal gas sampling conduits is a certain percentage of the total flow rate in the one or more nasal gas sampling conduits and the multiple oral gas sampling conduits, where the percentage is within a predetermined range. The predetermined range can be from about 1% to about 99% (e.g., the flow rate in the one or more nasal gas sampling conduits is 1% of the total flow rate in the one or more nasal gas sampling conduits and the oral gas sampling conduit), 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, the ratio can be about 50% such that the flow rates in the one or more nasal gas sampling conduits and the one or more oral gas sampling conduits are substantially balanced.

[0175] In some embodiments, the relative positions of the nasal gas inlet opening and / or the oral gas inlet opening can be configured to achieve the above percentages within a predetermined range. For example, as Figure 30 shown, the nasal gas inlet opening is positioned perpendicular to the flow direction from the patient's nasal region through the channel to the patient's oral region, while the oral gas inlet opening is positioned to face the patient's oral region and is substantially parallel to the flow direction from the patient's nasal region through the channel to the patient's oral region.

[0176] In some embodiments, to achieve the above percentages within a predetermined range, the nasal gas sampling conduits 708 and 706 and the oral gas sampling conduit 710 can be configured such that the ratio of the resistance to flow (RTF) in the 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 conduits 708 and 706 and the oral gas sampling conduit 710 can be configured such that the ratio of the combined RTF in the one or more nasal gas sampling conduits to the RTF in the oral gas sampling conduit is within a predetermined range.

[0177] In one or more embodiments, the nasal gas sampling conduit and the oral gas sampling conduit can be configured such that the RTF in these respective conduits is substantially equal (i.e., substantially the same). Making the RTF in the respective conduits substantially equal may not result in the flow rates in the nasal gas sampling conduit and the oral gas sampling conduit being substantially balanced.

[0178] In one or more embodiments, the RTF in one or more of the nasal gas sampling conduits (or the combined RTF in one or more of the nasal gas sampling conduits) can be a certain predetermined amount greater than the RTF in the oral gas sampling conduit. The predetermined amount can be based on the percentage of the flow rate in one or more of the nasal gas sampling conduits to the total flow rate in one or more of the nasal gas sampling conduits and the oral gas sampling conduit within a predetermined range. For example, the RTF in one or more of the nasal gas sampling conduits (or the combined RTF in one or more of the nasal gas sampling conduits) can 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 conduit. In some embodiments, the RTF in one or more of the nasal gas sampling conduits (or the combined RTF in one or more of the nasal gas sampling conduits) can be about 200%, about 300%, about 400% or more than about 400% greater than the RTF in the oral gas sampling conduit. This can be beneficial when the patient is primarily supplied with nasal high-flow gas from nasal prongs 728 and 730 of nasal cannula 732 and is primarily breathing through the mouth.

[0179] In other embodiments, the RTF in the nasal gas sampling conduit can be less than the RTF in the oral gas sampling conduit. In other words, the RTF in the oral gas sampling conduit can be a certain predetermined amount greater than the RTF in one or more of the nasal gas sampling conduits (or the combined RTF in one or more of the nasal gas sampling conduits). For example, the RTF in the oral gas sampling conduit can 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 one or more of the nasal gas sampling conduits (or the combined RTF in one or more of the nasal gas sampling conduits). This can be beneficial when the patient is primarily supplied with nasal low-flow gas from nasal prongs 728 and 730 of nasal cannula 732 and is primarily breathing through the nose.

[0180] By configuring one or more of the parameters of the conduit or the flow path in the conduit (e.g., cross-sectional area, shape, length, surface roughness, etc.), it is possible to configure the nasal gas sampling conduit and the oral gas sampling conduit to achieve the RTF ratio between the nasal gas sampling conduit and the oral gas sampling conduit. In some embodiments, the oral gas sampling conduit includes a more tortuous flow path to the junction and / or includes a longer flow path (e.g., where the flow paths in the conduits are combined) compared to the one or more nasal gas sampling conduits. In some embodiments, the cross-sectional shape and / or area of the flow path in one nasal gas sampling conduit is different from the cross-sectional shape and / or area of the flow path in another nasal gas sampling conduit and / or the oral gas sampling conduit.

[0181] In some embodiments, the inner surface of the one or more nasal sampling conduits exposed to the gas flow is different from the inner surface of the oral gas sampling conduit exposed to the gas flow. For example, the inner surface of the one or more nasal sampling conduits includes a surface roughness greater than that of the inner surface of the oral gas sampling conduit (thereby causing the RTF of the one or more nasal sampling conduits to be higher than that of the oral sampling conduit). In some embodiments, the RTF in the one or more nasal gas sampling conduits and / or the oral gas sampling conduit can 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 can be adjustable, e.g., by providing a valve that can be controlled to change the parameters of the flow path through that portion. The valve can be controlled automatically or manually (e.g., by a rotary dial). In some embodiments, the portion can be configured to be collapsible (e.g., less rigid compared to the rest of the conduit) such that a force acting on that portion can change the parameters of the flow path through that portion.

[0182] The RTF of the oral gas sampling conduit 710 can be increased by using a connector 740 ( Figure 32 shown separately in Figure 31 and shown in Figure 31As seen in the cross-section of the gas collector depicted, the connector 740 (which can be a Luer connector) includes a boss 742 that will create a tortuous path for the exhaled air through the mouth when inserted into the outlet. Thus, there is no or minimal flow deviation compared to the exhaled gas through the oral gas inlet 716, which is beneficial for the exhaled nasal gas and redirected supply gas entering the nasal gas inlets 712 and 714. This means that in the case where the patient breathes through the mouth, the redirected flow into the nasal gas inlet will not disrupt the exhaled flow through the oral gas inlet. That is, the breath leaving the mouth can also be captured.

[0183] In Figure 31 and Figure 32 In the images shown, the connector 740 is a separate component. However, it will be appreciated that in other embodiments, the connector can be integral with the rest of the gas collector.

[0184] Figure 33 An image 760 of the gas collector 700 attached to the nasal cannula 732 is shown, where the tube 762 couples the connector 740 to a gas analyzer (not shown).

[0185] In a variant, the gas flow diverter can include a window to facilitate the entry of exhaled air through the mouth into the oral gas collection inlet 716. As Figure 34 shown, the gas flow diverter 770 includes a window 772 that is positioned close to the spacer 704 and the oral gas inlet 716. It will be appreciated that the window 772 can have any desired shape. The window forms a path with negligible resistance for the exhaled gas through the mouth to flow through. When this occurs, the oral gas will travel through the oral gas collection inlet 716.

[0186] Both of the illustrated embodiments of the gas flow diverter can be made of a material or structure that enables the gas flow diverter to be flexible and fold or yield to any oral instrument that needs to be inserted into the patient's mouth. Figure 35 Such an example is shown in the image 780 of

[0187] In some embodiments of the gas collector, it will be understood that any part of the gas collector can be flexible to enable the insertion of medical instruments into the patient's nose and / or mouth as needed.

[0188] Figures 36 to 38 depicts Figures 16 to 20 as well as Figures 27 to 35Variations of the embodiment shown. In this embodiment, the connector 790 (e.g., a Luer connector) is molded as a one-piece with the gas flow diverter 792. The open channels formed in this variation are Figure 13 and Figure 15 a combination of the channels shown in Figure 15 . That is, the spacer 422 of Figure 13 is in the middle, and the spacers 418 and 420 of

[0189] Figure 39 and Figure 40 are at either end. Figure 14 Figures Figures 27 to 35 depict an embodiment of a gas collector corresponding to the third type of open channel structure depicted in Figure 14 . In that regard, the gas collector 800 shown in that figure includes two spacers 802 and 804 that are positioned at the patient's upper lip and, when in use, on either side of the patient's philtrum region to space the inner wall 806 of the nasal cannula 732 from the patient's upper lip. In this way, a plurality of channels are formed at the patient's upper lip, and the nasal cannula 732 at least partially forms a channel wall portion that is spaced from the patient's upper lip by the spacers 802 and 804. The spacers 802 and 804 include nasal gas collection inlets 808 and 810, respectively. A tubing arrangement is provided to interconnect the nasal gas collection inlets 808 and 810 with the oral gas inlets 812 and 814 such that the collected gas is supplied at the local gas collector region. In some embodiments, the gas inlets 808 and 810 can be perpendicular to the gas flow through the channels, as described in other parts of the specification. For example, the gas inlets 808 and 810 can be arranged in place as described in the embodiment of Figures 27 to 35 . An outlet 809 is provided at the local gas collector region to supply the collected gas to a sample analyzer (not shown) for analysis. A gas flow diverter 816 in the form of a concave spoon is fitted around the oral gas inlets 812 and 814 and serves to collect or direct at least some of the gas exhaled by the patient from their oral passageway to the oral gas collection inlets 812 and 814.

[0190] In this arrangement, the nasal gas collection inlets and nasal gas collection ducts are in line with the nasal forks 728 and 730. The inlet diameter of the nasal gas collection inlets can be configured to be smaller than the inlet diameter of the oral gas collection inlets. In some embodiments, the cross-sectional diameter of the nasal gas duct or a portion thereof is smaller than the cross-sectional diameter of the oral gas duct or a portion thereof. In this way, the RTF of the paths of the nasal gas and oral gas can be balanced to a desired state. This configuration can be particularly useful for low-flow respiratory therapy.

[0191] Figures 41 to 44Depicts a further embodiment of the gas collector 831. In this embodiment, the gas collector is located on the non-patient contact portion of the nasal cannula 732. In some embodiments, the gas connector may be located on the patient contact portion of the nasal cannula 732. In this embodiment, the gas collector includes a mouth engagement portion 830 and is integrally formed with the nasal cannula 732. In some embodiments, the gas collector may be removably attached to the nasal cannula 732 by methods described elsewhere in this specification. The mouth engagement portion is in the form of a spoon and includes an elongated aperture 832. When in use, the spoon may project into or be seated proximate to the patient's mouth to capture gas at the patient (e.g., gas exhaled by the patient from their mouth) and deliver the gas to the gas collection area. An outlet 834 is formed at the rear of the gas collector to provide the collected gas to a gas analyzer (not shown).

[0192] The mouth engagement portion 830 is seated proximate to or within the patient's mouth. Due to the larger cross-sectional area of the mouth opening compared to the nostrils, gas leaving the patient's mouth typically travels more slowly than gas leaving the patient's nostrils. Due to the combined effect of the smaller cross-sectional area of the nostrils and / or the redirected supply flow from the Y-tubes 728 and 730, the gas leaving the nose may be at a higher velocity. Thus, when the gas collector is positioned on the patient's face, the oral gas aperture 832 may be configured to be positioned closer to the mouth relative to the nasal gas inlet 836. The oral gas aperture 832 will also include a cross-sectional area greater than the cross-sectional area of the nasal gas inlet 836. In the illustrated embodiment, the nasal gas inlet 836 is seated between the Y-tubes 728 and 730 and below the base of the Y-tube, adjacent to the non-patient contact portion of the nasal cannula 732. However, the nasal gas inlet 836 may be positioned at other locations.

[0193] The nasal gas inlet and the oral gas inlet may be positioned to maximize the collection of gas at the patient's nasal and oral regions. For example, in high flow applications, the high flow gas from the nasal cannula 732 may be redirected into the nasal gas collection inlet. The flow rate of this high flow gas may be greater than the flow rate of the gas from the patient's oral region. Thus, it will be beneficial for the nasal inlet to be positioned distal to the patient's nasal region and / or the Y-tubes of the nasal cannula 732, and for the oral gas collection inlet to be positioned proximal to the patient's oral region. Additionally or alternatively, it will be beneficial for the nasal gas inlet (or any portion of the conduit downstream of the nasal gas inlet) to include a cross-sectional area smaller than the cross-sectional area of the oral gas collection inlet (or any portion of the conduit downstream of the oral gas inlet).

[0194] Figure 45Shown is a gas flow diverter 850, which is similar in form and function to the gas scoop 830, but with some significant exceptions. The gas flow diverter 850 also takes the form of a scoop 868, which has a large open inlet funnel portion 852 that, when in use, is positioned close to the patient's mouth. The gas flow diverter 850 further includes a top lip 854 that, when in use, rests under the patient's upper lip. This ensures an open channel is formed between the patient's mouth and the inlet funnel portion 852. Keeping the mouth open facilitates mouth breathing and exhalation through the mouth, which helps to ensure that target gas traces are collected. The gas flow diverter 850 further includes nasal ports 862 and 864 that are located on opposite sides of the scoop 868 such that each nasal port is close to one of the patient's nasal passages.

[0195] Consistent with the previous embodiments, Figure 45 the embodiment shown in is unsealed, has a low profile, and does not fully cover the mouth in a manner that a face mask would cover the mouth. Figure 45 The non-invasive nature of the device shown in allows other devices (such as a laryngoscope) to be inserted through the mouth. Exhaled gas is diverted through the inlet funnel portion 852 until it reaches the outlet port 856, which is connected to a sampling catheter (not shown). The catheter then transports the sample gas to a gas analyzer (typically referred to as a sidestream capnograph when the target gas is CO2). Additionally, or alternatively, the catheter can include a gas analyzer.

[0196] Figure 45 the arrangement shown in is formed separately from and removably attachable to a nasal cannula (e.g., the nasal cannula 30 as shown in Figures 9 to 11 ). In that regard, the gas flow diverter 850 includes an attachment ring 858 and a corresponding latch 860 to enable the gas flow diverter 850 to be mounted around the nasal cannula. In Figure 46 such an arrangement as shown in, the attachment ring and latch are attached between the nasal forks 728 and 730 (or the nasal forks 33, 34 of the nasal cannula 30 as shown in Figures 9 to 11 ).

[0197] Ideally, the attachment ring 858 will have a profile to fit snugly around the base of the forks of the cannula, thereby forming a secure attachment. The gas flow diverter 850 is preferably mounted directly or indirectly to a rigid manifold portion of the nasal cannula, which provides a stable mounting base to improve stability and sampling consistency. Any suitable shaped attachment ring can be used to mate with various patient interfaces.

[0198] Figure 47A further embodiment of the gas flow diverter 850 is shown. In this embodiment, the gas flow diverter 862 has a similar form and function to the gas flow diverter 850. However, an attachment ring 864 having a shape adapted to fit different patient interfaces and a connector 866 inserted into the outlet port are depicted.

[0199] The various embodiments of the gas collector previously described and shown in the previous figures can be attached to the nasal cannula in any of several ways. For example, as Figure 48 shown, the exemplary gas collector 1000 can be attached to the nasal cannula 1002 by means of an adhesive, such as glue, sticky tape, or any other type of adhesive that can be applied to the facing surfaces of the gas collector 1000 and the nasal cannula 1002. Alternatively, the gas collector 1000 can be attached to the nasal cannula 1002 by other bonding means, such as solvent bonding or RF welding or ultrasonic welding.

[0200] Hook-and-loop fasteners or similar sticky or adhesive patches can also be attached to the patient's face. The opposite side of the sticky patch on the patient's face can have hook or loop material. The gas collector interface can have hook or loop material on a winglet that mates with the patch on the patient's face. This can allow the clinician to correctly position the sampling interface on the patient's face. Additionally, hook-and-loop patches can also be used on the nasal cannula or other sampling interfaces to connect to the gas collector. This also allows the clinician to adjust the position of the gas collector.

[0201] As Figure 49 shown, another attachment method can include providing push-through buttons (otherwise known as barbs) on one or the other of the gas collector 1000 and the nasal cannula 1002. The push-through buttons 1004 and 1006 engage in corresponding apertures 1008 and 1010 to secure the gas collector to the nasal cannula. Multiple barbs or buttons and the use of multiple corresponding apertures can be used to constrain the relative rotation of the gas collector with respect to the nasal cannula.

[0202] Figure 50 A further attachment method is shown. In this example, clips 1112 and 1114 (e.g., having a C-shaped configuration) protruding from the gas collector 1000 are provided to enable the gas collector 1000 to be fixed to the nasal cannula 1002. The clip can be formed of a flexible material to allow the nasal cannula 1002 to deform and be pushed through a slit in the C-shaped configuration of the clip. Once inserted into the C-shaped clips 1112 and 1114, the nasal cannula 1002 will return to its original geometry. Figure 51Another such attachment method involving C-shaped structure clips is shown, where the insertion of the nasal cannula 1002 through the slits in the C-shaped structure clips 1116 and 1118 causes elastic deformation of the C-shaped structure clips and secures the nasal cannula. Typically, the nasal cannula 1002 is hollow and made of a soft / flexible material. Thus, the nasal cannula 1002 can be compressed to facilitate insertion into the C-shaped structure clips 1116, 1118. Once fully inserted into the C-shaped structure clips 1116, 1118, the nasal cannula 1002 returns to its original shape.

[0203] Figure 52 A further attachment arrangement is depicted in. In this figure, the gas collection inlets formed in the gas collector 1000 are provided with integral "barbs" 1020 and 1022 that act as clips to lock the nasal cannula 1002 in place in a manner similar to the clip concept explained in the previous figures. In Figure 53 In a further embodiment shown in, a spring-loaded clip 1024 can be provided on the gas collector 1000. The clinician can open the clip to insert the nasal cannula 1002. The clip can be spring-loaded such that it will return to the shape shown in the drawing after elastic deformation. The clip 1024 will tightly wrap around the manifold of the nasal cannula 1002.

[0204] In Figure 54 In yet another attachment method shown in, straps 1026 and 1028 can be provided on the gas collector 1000 to enable the nasal cannula 1002 to be fixed to the gas collector 1000. The straps can be separate paths or integral with the gas collector 1000. If separate, the straps can be fixed over the gas collector 1000 and the nasal cannula 1002 to hold them together.

[0205] A strap integral with the gas collector 1000 can take the form of a slot cut into an extension fin protruding from the side of the gas collector 1000. The gas collector 1000 will slide onto the nasal cannula 1002.

[0206] Figure 55 Yet another attachment method is depicted in. In this case, a length of strap material 1030 can be wrapped around the nasal cannula 1002. The terminating portion of the strap material 1030 can have a buckle, plastic strip, pin connector, etc. that ties the gas collector 1000 (not shown) to the nasal cannula 1002 either permanently or non-permanently.

[0207] Figures 56 to 59Depicts a gas sampler 1040 attached to a nasal cannula 1042. In this embodiment, the edges 1044 and 1046 of the U-shaped channel section 1048 of the gas collector 1040 (i.e., the mouth engaging portion configured to project into the patient's mouth to maintain an open channel between the patient's mouth and the oral gas collection inlet) may have a raised profile in one embodiment, which will cause the middle portion of the U-shaped channel section 1048 to be further away from the patient's upper lip. This forms a deeper opening / aperture channel at the mouth engaging portion, thus advantageously making the opening / aperture more difficult to occlude, for example, more difficult to be occluded by saliva or by the patient's teeth or tongue.

[0208] The gas collector 1040 (shown here in the form of a sampling spoon) can be transparent. As Figure 59 shown, the body of the gas collector 1040 can be made of a transparent material such as polymethyl methacrylate (PMMA), polycarbonate (PC), silicone, thermoplastic elastomer (TPE) (e.g., styrene-ethylene-butene-styrene (SEBS)). Providing a transparent body of this nature will enable healthcare workers to see the patient's face, which will be useful for ensuring the correct placement of the nasal prong tube inside the patient's nose and the overall alignment and proper functioning of the gas collector and nasal cannula.

[0209] As Figures 60 to 62 shown, the body of the gas collector 1040 can be strengthened by integrating structural members within or on the body of the gas collector. The structural member can have greater tensile and compressive strength relative to the body of the gas collector. In one or more embodiments, the gas collector and the structural member can have the same material, but the strengthening can be provided by making the area to be strengthened thicker. In Figure 60 the first embodiment shown, the body of the gas collector 1060 is strengthened by a structural member 1062 extending around the perimeter to ensure it maintains its shape. In Figure 61 the second embodiment shown, the body of the gas collector 1064 is strengthened both by a structural member 1066 extending around the perimeter of the body and additionally by horizontal strengthening members 1068 and 1070 to prevent the body of the gas collector 1064 from collapsing when the patient is lying supine. In some embodiments, there may be no structural member 1062. In some embodiments, there may be multiple horizontal strengthening members 1068 and 1070 or a single horizontal strengthening member. One or more of the horizontal strengthening members may not extend to the edge of the gas sampler 1040 and may terminate before the edge.

[0210] In Figure 62In a further embodiment as shown, the body of the gas collector 1072 includes a peripheral rigid structural member 1074 and further includes vertical strengthening members 1076 to resist vertical forces applied to the body so as to prevent the gas collector 1072 from collapsing when the instrument is inserted into the patient's mouth. In some embodiments, the structural member 1074 may not be present. In some embodiments, there may be multiple vertical strengthening members 1076. One or more of the vertical strengthening member or members may not extend to the edge of the gas sampler 1040 and may terminate before the edge.

[0211] It will be appreciated that the positioning of the rigid members determines the direction in which the body of the gas collector in question will be rigid. For example, it may be useful for the body of the gas collector to be able to maintain its shape when flexed. This can be achieved by embedding a ductile member within the body, which means that, instead of the force being resisted, in the case of a sufficiently high force being applied, the ductile member (e.g., a ductile wire) will flex and the body of the gas collector will maintain its shape in the flexed position. This means that the body of the gas collector can be adjusted to fit different facial profiles.

[0212] In Figures 63 to 66 a further variant of the previously described embodiment as shown, it may be beneficial to be close to the patient's mouth, for example to insert medical equipment. In this case, the body of the gas collector 1080 may include a hinge 1082 to enable a first part 1084 to pivotally rotate away from a second part 1086 of the body of the gas collector 1080. One such method of forming the hinge is by forming a cut-out or slot through the body of the gas collector 1080 at an angle. The angle of the slot allows the device to transition between a first position as shown in Figure 63 and Figure 65 and a second position as shown in Figure 64 and Figure 66 .

[0213] Alternatively, and as depicted in Figures 67 to 70 , the gas collector body may include a bistable structure. The concave structure is stable and will maintain its shape until a force is applied to the concave structure. In a first position as shown in Figure 67 and Figure 69 , the mouth engaging portion 1092 of the gas collector 1090 is used to collect oral gas. However, in Figure 68 and Figure 70In the second position shown, the mouth engagement portion 1092 has been folded and bent away from the patient's mouth so that medical equipment can be inserted into the patient's mouth. The intermediate position when switching from the first position to the second position will be unstable, and the body of the gas collector 1090 will assume the shape closest to stable.

[0214] As can be seen in Figures 71 to 76 the body of the gas collector may include an opening for the purpose of inserting and securing medical equipment in the patient's mouth. The opening may be in the form of a tear-away section that is part of the body of the gas collector, as shown in Figure 71 and Figure 72 As can be seen in this figure, the body of the gas collector 1110 may include a tear-away section 1112 that, when removed, exposes an orifice 1114 through the body of the gas collector 1110 to enable insertion of medical equipment into the patient's mouth. In the alternative arrangement shown in Figure 73 and Figure 74 the body of the gas collector 1116 may include a slot 1118 that, when opened to form an orifice 1120, enables insertion of the medical equipment into the patient's mouth. The slot may or may not seal around the medical equipment.

[0215] Alternatively or additionally, a tear-away section or a section that can bifurcate may be added to the portion of the gas collector near the nasal prong tube for delivering gas from the nasal cannula. As shown in Figure 75 and Figure 76 the body of the gas collector 1122 may include tear-away sections 1124 and 1126 that are removable and provide access to the patient's nasal and oral passages respectively, thus providing for insertion of medical equipment.

[0216] The body of the gas collector may also have a groove on the patient-facing side that forms a smaller open channel. As shown in Figures 77 to 80 a smaller open channel may be formed within a larger open channel formed with the patient's upper lip. The smaller open channel may be formed in the patient-facing side of the body of the gas collector. The groove is configured to intercept the patient's body fluid, such as saliva. Then, any gas can travel over the body fluid trapped in the smaller open channel and enter the gas inlet. In Figures 77 to 79 three grooves 1130, 1132, and 1134 are provided in the patient-facing side 1136 of the gas collector 1138. In some embodiments, there may be a single groove or more than one groove. Additional grooves (three grooves are shown in this exemplary embodiment) are provided for redundancy. Although one of the grooves extends to the gas collection inlet, this need not be the case in other embodiments.

[0217] In Figure 80 this, a groove is provided in the patient-facing side 1140 of the gas collector 1142. The groove has some branches leading to a dead end 1144. Any body fluid (e.g., saliva) is likely to resist a change in the flow direction within the groove and become trapped at the dead end. In other words, saliva is likely to take the path of least resistance and become trapped in the dead end. This reduces the probability that the gas collection inlet becomes blocked by saliva.

[0218] Additionally, or alternatively, the patient-facing side 1140 of the gas collector 1142 can be lined with a hygroscopic or hydrophilic material to reduce the likelihood that the gas collection inlet becomes blocked.

[0219] In Figures 81 to 83 the arrangement depicted, the above-described U-shaped mouth engagement portion can be modified such that the central portion 1150 of the U-shaped section is recessed to seat away from the patient's face. Other shapes of the mouth engagement portion are also conceivable, such as a V shape. The edges 1152 and 1154 of the body of the gas collector 1156 that extend into the patient's mouth include channels 1158 and 1160 that engage with the patient's upper lip to form two channels in fluid communication with the patient's mouth. This forms an open channel between the patient's mouth and the upper lip region. This avoids covering the patient's upper lip while still forming a channel with the upper lip such that the patient can close their mouth in place. The central portion 1150 can permit a medical instrument to enter the patient's mouth without the medical instrument hitting the gas collector with a force that may affect gas sampling.

[0220] In a further variant, and as Figure 84 and Figure 85 seen, it can be beneficial to decouple the forces transmitted between the body of the gas collector and the nasal cannula. This means that when the body of the gas collector is moved or impacted, the positioning of the nasal cannula will largely remain unaffected, and vice versa. This effect can be achieved by changing the mechanical properties of the gas collector such that the areas most likely to be hit or have a force applied to them will absorb the applied force rather than transmit the force to the nasal cannula. Forces can be applied to the outer edge of the gas collector 1170 by the patient's facial features or external equipment. Thus, by making the outer edge flexible, the gas collector will absorb some of the applied force when it flexes. This can minimize the magnitude of the force transferred from the sampling device to the nasal cannula. An example of how this can be achieved is by changing the hardness from the outer edge to the inner part (e.g., from Shore A 20 to 80) respectively.

[0221] The decoupling effect can also be achieved by making the middle section of the gas collector around the oral gas collection inlet thinner. The thin material will flex and absorb force. This will mean that less force will be transmitted to the nasal cannula. Figures 86 to 89 are various representations of a gas collector 1180 that is coupled to a nasal cannula 1182 and includes a thinner middle section 1184. The applied force “F” will cause the thinner middle section 1184 of the gas collector 1180 to deform. The thinner middle section absorbs some of the force (energy) as it deforms. This minimizes the magnitude of the force transmitted from the gas collector to the nasal cannula.

[0222] As Figures 90 to 97 seen, the mouth engaging portion of the gas collector can have a large mouth engaging portion, and / or the mouth engaging portion can be adjustable to expand the mouth engaging portion. The large mouth engaging portion can include a lateral dimension relative to one or more of: the lateral dimension of the nasal cannula (e.g., the cannula body), the distance between the corners of the mouth, or the lateral dimension of the nose. Figure 90 and Figure 91 shows a gas collector 1190 having a mouth engaging portion 1192 that is wider than normal, and the gas collector is adapted to fit a patient 1194 with a wide mouth. The mouth engaging portion can be expandable from a first unexpanded position 1196 as shown in Figure 92 to a second expanded position 1198 as shown in Figure 93 . In that regard, the mouth engaging portion can include a series or bellows telescoping sections, as depicted in Figure 94 . In particular, Figure 94 shows top views of the mouth engaging portion in its unexpanded state 1196 and expanded state 1198, respectively.

[0223] The gas collector can be fixed to the patient's face using an adhesive. As seen in Figures 95 to 97 , the adhesive can be laid on flexible tabs 1200 and 1202 that are angled upward and away from the patient's mouth area. This is done to minimize the effect of movement in the mouth area on the detachment of the gas collector and the nasal cannula. Alternatively or additionally, the adhesive can be applied to flexible tabs 1204 that are fixed to the patient's nose.

[0224] As can be in Figures 98 to 102 seen, the lower end or mouth engaging portion of the gas collector body 1220 can receive additional support by securing it to the nasal cannula 1222 using a strap. The strap can keep the body of the gas collector 1220 stable when the patient moves around or if the body of the gas collector 1220 is accidentally struck.

[0225] As Figure 98As seen, in one embodiment, straps 1224 and 1226 can be attached between opposite sides of nasal cannula 1222 and gas collector 1220 by slots or other attachment mechanisms formed in gas collector 1220. By tightening one strap and loosening the other, gas collector 1220 can be maneuvered to one side or the other of the patient's mouth. This can be useful in situations where it is necessary to insert a medical instrument into the patient's nose or mouth.

[0226] Figures 99 to 102 Further details are provided in Figure 99 wherein, it can be seen that orifice 1228 can be provided on nasal cannula 1222 to attach the first end of strap 1224 to the nasal cannula. Figure 100 An orifice 1230 is depicted in the body of gas collector 1220 through which the strap can be attached.

[0227] As Figure 101 seen, each of the straps can be fixed at the other end to an orifice in the nasal cannula, and the strap is pulled through and attached to itself by suturing or thermal or chemical bonding. As Figure 102 shown, one or more regions of the body of gas collector 1220 (such as the region labeled 1232 adjacent to orifice 1234) can be made of a thin material such that when the straps are tightened, the body of gas collector 1220 stretches to prevent nasal cannula 1222 from falling off during the tightening process.

[0228] The geometry of the nasal cannula described in the above-cited embodiment is curved at the base of the nasal prong to conform to the patient's upper lip.

[0229] However, in Figure 103 and Figure 104 the variant shown, nasal cannula 1240 has a recess 1242 at the base of curved nasal prongs 1244 and 1246 to form a channel with the patient's upper lip for the purpose of collecting gas.

[0230] In a further variant of the above-described embodiment, and as Figures 105 to 107 shown, sampling of the collected gas can additionally or alternatively be implemented by a small-diameter tube 1250 that is in fluid communication with the channel formed by recess 1242 and the patient's upper lip. Small-diameter tube 1250 is configured such that when in use, the inlet of tube 1250 is positioned in the formed channel, and as Figure 106As shown more clearly therein, the inlet is arranged to point below the oral spoon portion of the gas collector 1254 or to point to the oral spoon portion. In such a position, the inlet of the tube 1250 is arranged to be parallel to the flow in the formed channel and against the gas flow from the patient's nasal region. In other embodiments, the inlet can be arranged in a different manner, for example, transverse to the length of the formed channel. The small-diameter tube 1250 can be hooked or otherwise connected to the nasal cannula 1252, on which the gas collector 1254 is mounted or integrally formed therewith.

[0231] As an alternative to the above-described embodiment, the nasal gas collection inlet and the oral gas collection inlet can be formed by a plurality of channels 1260, as Figures 108 to 110 shown therein. The plurality of channels 1260 can instead be formed to pass through one or both of the nasal gas collection inlet and the oral gas collection inlet in the body of the gas collector 1262. This plurality of channels provides redundancy in case one or more channels become blocked, for example, by material 1261 (such as, saliva and / or nasal mucus / secretions from the patient), as Figure 110 depicted therein.

[0232] As Figures 111 to 123 shown therein, in a further variant of the above-described embodiment, it can be convenient to connect the sampling line 1270 to the outlet port 1272 of the gas collector 1274 by a single action, for example, by pushing the sampling line to effect the connection. Several single-action connection mechanisms are possible. The outlet port 1272 that receives the sampling line 1270 can have a plurality of tapered members 1276 that expand outward when the sampling line 1270 is inserted. When an attempt is made to pull the sampling line away from the outlet port, the friction between the expanded tapered members and the sampling line will cause the tapered members to flex and drill into the sampling line. Figures 112 to 116 Various examples of such tapered members are shown therein. As Figure 117 depicted therein, two or more outlet ports 1276 and 1278 can be provided to achieve redundancy.

[0233] In addition, the outlet port of the gas collector 1282 can have an extended sampling line connector attached thereto. The extended sampling line connector can be integral with the gas collector or capable of being removably attached to the gas collector. A connector (such as, a twist-and-lock mechanism or a push-fit type, such as a Luer connector) can be used to connect a sampling line (not shown) to the extended sampling line connector. Such an extension allows the connection point to the sampling line to be away from the patient's face. Thus, when attaching the sampling line, force is not directly applied to the patient's face or the nasal cannula.

[0234] Figure 118Examples are shown in which an outlet port 1280 is shown, which forms part of a gas collector 1282 attached to a nasal cannula 1284. An extended sampling line connector 1286 and tubing 1288 can be seen connected to the outlet port 1280. The extended sampling line and connector can be fixed to the gas path connector of the nasal cannula 1284.

[0235] Alternatively, as Figure 119 and Figure 120 shown, the extended sampling connector 1290 and line 1292 can be flexible and freely movable such that it can be oriented in a variety of ways. Tabs 1294 and 1296 can be provided on the sampling line connector 1290 to assist in gripping the sampling line connector during assembly.

[0236] In a further variant of the above-described embodiment, visual information can be provided to the body of the gas collector to assist in selecting an appropriate device and the orientation of the device. Figure 121 Representative markings 1300 indicating the body size of the gas collector 1302 are shown, while Figure 122 and Figure 123 include exemplary markings 1304 and 1306, for example in the form of arrows 1304 and / or text (e.g., "this side up") 1306, to assist in orienting the gas collector during use.

[0237] Figures 124 to 127 A gas collector 2000 for collecting gas exhaled by a patient from their nasal and / or oral passages is shown in accordance with a further embodiment. Similar to some of the previous embodiments described herein, the gas collector 2000 includes an interface 2002 configured to form a passage at the patient's upper lip. In particular, the inner wall 2004 of the interface 2002 generally extends between the patient's nasal and oral passages in use and effectively provides a volume for collecting the gas to be analyzed (e.g., gas exhaled from the patient's nasal and / or oral passages).

[0238] In use, the position of the inner wall 2004 may be slightly offset from the patient's face. The top portion of the interface 2002 is configured to be positioned below the patient's nasal passage. At the base of the interface 2002, the gas collector 2000 includes a mouth engaging portion 2010 for engaging the patient's mouth. In particular, the mouth engaging portion 2010 includes a pair of extensions 2006, 2008. Each extension portion 2006, 2008 is adapted to fit under opposite sides of the patient's upper lip such that in use the corners of the patient's upper lip are separated from the patient's lower lip to ensure an open oral passage for the patient. Thus, the "passage" formed by the inner wall 2004 can be considered to have open ends that are in fluid communication with the patient's nasal and oral passages, respectively.

[0239] The interface 2002 further includes a pair of elongated guide protrusions 2012, 2014. The elongated guide protrusions 2012, 2014 are arranged in a generally V-shaped configuration to more effectively guide (e.g., funnel) gas from the patient's nasal passages to a single sampling inlet 2016. The sampling inlet 2016 can be located generally centrally on the interface 2002. The elongated guide protrusions 2012, 2014 can also serve as spacers for spacing the inner wall 2004 of the interface 2002 from the patient's face during use.

[0240] like Figures 125 to 127 As shown more clearly in FIG. 2 , the gas collector 2000 further includes an outlet 2018 for providing the collected gas to a gas analyzer via a conduit (not shown). The outlet 2018 is in fluid communication with the sampling inlet 2016, so that the gas collected via the sampling inlet 2016 can be provided to the gas analyzer via the outlet 2018.

[0241] The interface 2002 includes a pair of opposing lateral sides 2020, 2022. The lateral sides 2020, 2022 can be configured to extend generally in a direction aligned with an imaginary vertical plane that bisects the patient's face.

[0242] like Figure 125 , Figure 126 and Figure 127 , the outlet 2018 defines a receiving port 2024 having an open outlet end 2026 for receiving a portion of a gas analyzer conduit therein. The receiving port 2024 of the outlet 2018 is oriented such that its open outlet end 2026 faces one of the lateral sides 2020. Advantageously, the receiving port 2024 of the outlet 2018 is configured to allow connection to the conduit from one side of the patient's face.

[0243] like Figure 126 and Figure 127 As shown in , the receiving port 2024 has a low profile, which advantageously minimizes the risk of accidental disconnection of the catheter during use.

[0244] The gas collector 2000 further includes a device for mounting the gas collector 2000 to a nasal cannula (e.g., Figures 5 to 8 2000 is a nasal cannula for delivering breathable gas to a patient. The mounting portion 2028 defines a sleeve 2030 that is configured to fit over and receive a portion of the nasal cannula. The inner wall of the sleeve 2030 generally follows the outer contour of the portion of the nasal cannula, thereby providing a stable mounting of the gas collector 2000 on the nasal cannula during use.

[0245] like Figure 126 and Figure 127As shown more clearly therein, the sleeve 2030 defines a pair of slots 2032, 2034 along its top portion. The sleeve 2030 further defines an opening 2036 for allowing the nasal prong tube of the nasal cannula to project through the opening. The slots 2032, 2034 and the opening 2036 allow a portion of the nasal cannula to be inserted into the cannula 2030. In this embodiment, the nasal cannula is securely received in the cannula 2030 during use. The wall of the nasal cannula may be flexible and may be pressed together to fit through the slots 2032, 2034. In some embodiments, the wall of the cannula 2030 may be elastic to allow the width of the slots 2032, 2034 to be manually adjusted to facilitate installation onto the nasal cannula. The nasal cannula may be mounted to the gas collector 2000 in any suitable manner. For example, in other embodiments, any one or more of the previously described features for mounting the nasal cannula to the gas collector may be included in any suitable combination to replace the mounting portion 2028.

[0246] As Figure 126 and Figure 127 shown more clearly therein, the gas collector 2000 has a relatively low profile such that the gas collector 2000 is non - obstructive during use. This may be particularly beneficial in procedures where a clinician needs to carefully navigate around various medical devices mounted to a patient's airway in a time - critical manner.

[0247] Now reference will be made to Figures 128 to 130 describe a further gas collector 2050 which is a Figures 124 to 127 variant of the gas collector 2000 in Figures 128 to 130 which, similar features refer to the previously described features.

[0248] The gas collector 2050 further includes a pair of nasal guides 2052, 2054. Each nasal guide 2052, 2054 extends outwardly from the inner wall 2004 of the interface 2002 to the upper end of the gas collector 2050. The nasal guides 2052, 2054 are used to guide and facilitate the movement of gas from the patient's nasal passages towards the channels formed by the inner wall 2004 and converged by the elongated guide protrusions 2012, 2014.

[0249] In the gas collector 2050, the slots 2032, 2034 of the sleeve 2030 of the mounting portion 2028 are provided below the nasal guides 2052, 2054. As mentioned, the nasal cannula can be deformed to fit through the slots 2032, 2034 such that it can be received in the sleeve 2030.

[0250] Now reference will be made to Figures 131 to 132 describe a further gas collector 2100 which is a Figures 124 to 127Another variant of the gas collector 2000 in. In Figure 131 and Figure 132 Similar features refer to the features described previously.

[0251] The gas collector 2100 provides a plurality of ribs 2102 extending from the inner wall 2004 of the interface. The first set of ribs 2102 and / or rib portions 2104 are arranged in a generally V-shaped configuration to direct gas from the nasal passages towards the sampling inlet 2016, thereby forming a first generally V-shaped funnel-shaped portion 2110 in the upper central region of the interface. In some embodiments, the ribs 2102 may be longer, such as Figure 128 the elongated guiding protrusions 2012, 2014 shown in. In some embodiments, the ribs 2102 may be shorter.

[0252] A second set of ribs 2106 and / or rib portions 2108 extend generally diagonally downward from the respective sides of the V-shaped funnel-shaped portion 2110 to the corresponding lateral sides 2020, 2022 of the inner wall 2004. A bottom pair of ribs 2116, 2118 from the second set of ribs 2106 also form a generally V-shaped configuration to direct gas from the oral passages towards the sampling inlet 2016, thereby forming a second generally V-shaped funnel-shaped portion 2114 in the central region of the lower portion of the interface.

[0253] The ribs 2102 advantageously direct gas from both the nasal and oral passages of the patient towards a single sampling inlet 2016. (It is contemplated that in some embodiments, as previously described, the ribs 2102 may direct gas from the nasal and oral passages towards multiple sampling inlets). Additionally, in use, the ribs 2102 serve as spacers to create an offset between the patient's face and the inner wall 2004 of the interface. Further, the second set of ribs 2106 and / or rib portions 2108 facilitate the discharge of liquid from the patient and the downwash airflow from the nasal cannula away from the sampling inlet 2016, thereby minimizing the dilution of the exhaled gas entering the sampling inlet 2016 from the patient's nasal and oral passages.

[0254] In use, the lower edge 2112 of the interface may extend below the upper lip of the patient or below the lower lip of the patient. As Figure 131 and Figure 132 shown, the lower edge 2112 is generally flat. During use, the lower edge 2112 may be offset and spaced from the patient's mouth by the ribs 2106. As Figure 132As shown more clearly therein, the distance that the rib 2106 extends from the inner wall 2004 (also referred to herein as the "extension distance") can vary. For example, the portion of the rib 2106 proximate the lower part of the interface can extend further outward than the portion of the rib configured to seat on top of the patient's upper lip. This variation in the extension distance of the rib 2106 can accommodate the contour of the patient's lips while maintaining the overall low profile of the gas collector 2100 (e.g., relative to the patient's face in use).

[0255] Reference will now be made to Figure 133 to describe a further gas collector 2200, which is Figure 131 and Figure 132 a variation of the gas collector 2100 in Figure 133 In, like features refer to the previously described features. In this embodiment, the gas collector 2200 does not include any ribs for collecting gases from the patient's nasal and oral passages. The inner wall 2004 of the interface may be sufficient to effectively direct gases from the patient's nasal and / or oral passages to the sampling inlet 2016.

[0256] In some embodiments, the gas collector may generally take the form of the gas collector as shown in Figure 18 previously described, wherein the outlet 532 may be oriented such that the open end of the outlet 532 faces one of the lateral sides of the gas collector (similar to the gas collector shown in 125 to Figure 127 in).

[0257] Reference will now be made to Figures 134 to 136 to describe a further gas collector 2300, which is Figures 16 to 20 a variation of the first embodiment of the gas collector shown in Figures 134 to 136 In, like features refer to the previously described features.

[0258] The gas collector 2300 includes a mouth engaging portion 2302 that is configured to extend further than Figures 13 to 20 the first embodiment of the gas collector shown in, such that the mouth engaging portion 2302 extends beneath the patient's front teeth in use. In some embodiments, the mouth engaging portion 2302 may wrap around the patient's teeth. Thus, the mouth engaging portion 2302 can serve as a dental guard to protect the patient's teeth during a medical procedure. For example, as shown in Figure 135 and Figure 136 in, during some medical procedures, a laryngoscope 2304 may be used when intubating a patient. During such procedures, there is a risk that the patient's teeth may become chipped due to the force exerted by the laryngoscope. Thus, the mouth engaging portion 2302 provides protection for the patient's teeth.

[0259] Although the present disclosure has been described with respect to certain embodiments, other embodiments that are obvious to those skilled in the art are also within the scope of the present disclosure. Accordingly, various changes and modifications can be made without departing from the spirit and scope of the present disclosure. Interpretation

[0260] This specification (including the claims) is intended to be interpreted as follows:

[0261] The embodiments or examples described in the specification are intended to illustrate the invention and not to limit the scope of the invention. The invention can be practiced with various modifications and additions that would be readily apparent to those skilled in the art. Accordingly, it will be understood that the scope of the invention is not limited to the exact construction and operation described or illustrated, but is only limited by the appended claims.

[0262] The disclosure of only method steps or product elements in the specification should not be construed as essential to the invention claimed herein, unless either expressly stated to be so or expressly recited in the claims.

[0263] The terms in the claims have the broadest scope of meaning that has been given to them by those skilled in the art since the relevant date.

[0264] Unless otherwise expressly specified, the terms "a" and "an" mean "one or more".

[0265] Neither the title nor the abstract of the present application shall be regarded as limiting the scope of the claimed invention in any way.

[0266] Where the preamble of a claim recites the 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.

[0267] It should be noted that degree terms such as "substantially", "essentially", "about", and "approximately" as used herein mean a reasonable amount of deviation from the modified term such that the end result is not significantly changed. If such deviation does not negate the meaning of the term it modifies, these degree terms shall be construed to include the deviation of the modified term.

[0268] In the specification (including the claims), the term "comprising" and variations thereof (such as "comprises" or "comprising") are used to mean "including but not limited to", unless otherwise expressly specified, or unless an exclusive interpretation of the term is required by the context or usage.

[0269] In addition, the recitation of any numerical range 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 will also be understood that all numbers and their fractions are assumed to be modified by the term "about", which means up to a certain amount of variation of the recited number (if the final result is not significantly changed).

[0270] As used herein, the phrase "and / or" is intended to mean an inclusive or. That is, "X and / or Y" is intended to mean, for example, X or Y or both. As a further example, "X, Y, and / or Z" is intended to mean X or Y or Z or any combination thereof.

[0271] Throughout the specification, like reference numerals refer to like features described herein. Thus, any instance of using the same reference numeral to indicate a feature or component implies a direct correlation to a similar or identical feature or component previously described in the specification.

[0272] The disclosure of any document mentioned herein is hereby incorporated by reference as part of this patent application, but solely for purposes of written description and implementation, and shall in no way be used to limit, define, or otherwise interpret any term of this application (in cases where the application would not otherwise be without a determinable meaning without such incorporation by reference). Any content incorporated by reference does not itself constitute any endorsement or approval of any statement, opinion, or argument contained in any incorporated document.

Claims

1. A gas collector for collecting gas at a patient, the gas collector comprising: An interface configured to form at least one channel at the upper lip of the patient, the channel being in fluid communication with the patient's nose region and mouth region, wherein the interface includes one or more spacers configured to contact the patient's face to space the channel wall portion from the patient's face.

2. The gas collector according to claim 1, wherein, The interface further includes the channel wall portion.

3. The gas collector according to any one of claims 1 or 2, wherein, The interface is configured to be attached to or integral with a nasal cannula.

4. The gas collector according to claim 3, wherein, The nasal cannula at least partially forms the channel wall portion.

5. The gas collector according to any one of claims 3 or 4, wherein, The nasal cannula includes a nasal prong for delivering gas to the patient's nasal passage, and the gas collector further includes one or more openings formed through the channel wall portion for receiving the nasal prong.

6. The gas collector according to any one of the preceding claims, wherein, The channel is partially formed by the patient's upper lip.

7. The gas collector according to any one of the preceding claims, wherein, The spacer is arranged to contact the patient's face on either side of the patient's upper lip.

8. The gas collector according to any one of the preceding claims, wherein, In use, the spacer extends from the channel wall portion to the patient's face.

9. The gas collector according to claim 8, wherein The spacer is integral with the channel wall portion.

10. The gas collector according to any one of claims 8 or 9, wherein, The thickness of the spacer is greater than that of the channel wall portion.

11. The gas collector according to any one of claims 8 to 10, wherein, The spacer is more rigid than the channel wall portion.

12. The gas collector according to claim 11, wherein, The Young's modulus of the spacer is greater than that of the channel wall portion.

13. The gas collector according to any one of the preceding claims, wherein, The channel wall portion is configured such that it can flex when in contact with the patient's face.

14. The gas collector according to any one of the preceding claims, and the gas collector further comprises: An interface that forms a gas collection area and includes a first gas collection inlet and a second gas collection inlet in fluid communication with the gas collection area.

15. The gas collector according to claim 14, and the gas collector further comprises: A mouth engagement portion configured to project into the patient's mouth to maintain an open passage between the patient's mouth and the second gas collection inlet.

16. The gas collector according to claim 15, wherein, The mouth engagement portion includes a lower end that projects into the patient's mouth, and the lower end of the mouth engagement portion is shaped to maintain an open passage between the patient's mouth and the second gas collection inlet.

17. The gas collector according to claim 16, wherein, The lower end of the mouth engagement portion has an inner surface that includes: An edge portion that, when in use, is located at the side of the patient's mouth, and A central portion that, when in use, is located at the center of the patient's mouth and is spaced further from the patient's upper lip than the edge portion.

18. The gas collector according to claim 17, wherein, The inner surface of the first end of the mouth engagement portion has a U or V-shaped profile.

19. The gas collector according to any one of the preceding claims, wherein, The channel wall portion includes an upper end that extends outward from the patient's face when in use.

20. The gas collector according to claim 15, wherein, When in use, the upper end of the channel wall bends outward from the patient's face.

21. A gas collector for collecting gas exhaled by a patient from their nasal passage and oral passage, the gas collector comprising: An interface configured to form a channel at the upper lip of the patient, the channel having open ends in fluid communication with the patient's nasal passage and oral passage respectively, The channel provides a volume for collecting the gas to be analyzed.

22. The gas collector according to claim 21, and the gas collector further comprises: One or more gas collection ducts, each gas collection duct having a gas collection inlet configured to deliver gas from the passageway to a local gas collection region, and an outlet for providing the collected gas from the local gas collection region to a gas analyzer.

23. The gas collector according to claim 22, wherein, The passageway is partially formed by the upper lip of the patient.

24. The gas collector according to any one of claims 21 to 23, and the gas collector further includes a gas flow diverter configured to converge at least some of the gas exhaled by the patient into one or more of the gas sampling inlets.

25. The gas collector according to claim 24, wherein, The interface includes one or more spacers for contacting the patient's face to space the channel wall portion from the patient's face, and wherein the gas flow diverter is integrated with the channel wall portion.

26. The gas collector according to claim 25, wherein, The sampler body includes one or more spacers for contacting the patient's face to space the channel wall portion from the patient's face, and wherein the gas flow diverter is formed separately from the channel wall portion.

27. The gas collector according to any one of claims 25 or 26, wherein, One or more of the gas sampling inlets form nasal gas sampling inlets positioned close to the patient's nasal passages.

28. The gas collector according to claim 27, wherein, The one or more nasal gas sampling inlets are formed in the channel wall portion.

29. The gas collector according to claim 27, wherein, The one or more nasal gas sampling inlets are formed in the spacer.

30. The gas collector according to any one of claims 21 to 29, wherein, One gas sampling inlet or the gas sampling inlet forms an oral gas sampling inlet positioned close to the patient's oral cavity.

31. The gas collector according to claim 30, wherein, The oral gas sampling inlet is formed in the channel wall portion.

32. A gas collector for collecting gas at a patient, the gas collector comprising: an interface that forms a gas collection region and includes at least one nasal gas collection inlet and an oral gas collection inlet in fluid communication with the gas collection region, and a mouth engagement portion configured to project into the patient's mouth to maintain an open passageway between the patient's mouth and the oral gas collection inlet.

33. A gas collector for collecting gas at a patient, the gas collector comprising: an interface configured to form a passageway at the upper lip of the patient, one or more gas sampling ducts, each gas sampling duct having a gas sampling inlet for sucking gas from the passageway into a local gas collection region, and a gas flow diverter configured to direct at least some of the gas exhaled by the patient to one or more of the gas sampling inlets, wherein the gas flow diverter includes: an upper portion extending away from the patient's face.

34. The gas collector according to any one of claims 1 to 20, wherein the spacer rests against the upper lip of the patient in use; and wherein the gas collector further includes: one or more nasal gas collection ducts formed within the spacer, each nasal gas collection duct having a nasal gas collection inlet in fluid communication with the patient's nasal passages for delivering gas exhaled by the patient from their nasal passages to the outlet; an oral gas collection duct formed within the spacer, the oral gas collection duct having an oral gas collection inlet in fluid communication with the patient's oral cavity; and A gas flow diverter configured to direct at least some of the gas exhaled by a patient from their oral tract to the oral gas collection inlet.

35. A gas collector for sampling gas at a patient, the gas collector comprising: One or more nasal gas collection conduits, each nasal gas collection conduit having a nasal gas collection inlet in fluid communication with the patient's nasal passage; And An oral gas collection conduit having an oral gas collection inlet in fluid communication with the patient's oral tract and an outlet, Wherein the one or more nasal gas sampling conduits and the oral gas sampling conduit form a junction at a local gas collector region, and Wherein the one or more nasal gas sampling conduits and the oral gas sampling conduit are configured such that the flow rate in the one or more nasal gas sampling conduits is a certain percentage of the total flow rate in the one or more nasal gas sampling conduits and the oral gas sampling conduit, wherein the percentage is within a predetermined range.

36. A patient interface comprising: A nasal cannula for delivering breathable gas to a patient; And The gas collector according to any one of the preceding claims, the gas collector being removably attachable to or integrated with the nasal cannula.

37. The gas collector according to claim 21, further comprising an outlet for providing the sampled gas to a gas analyzer via a conduit, the outlet being configured to allow connection to the conduit from one side of the patient's face.

38. The gas collector according to claim 37, wherein, The interface has a pair of opposing lateral sides, and Wherein the outlet defines a receiving port having an open outlet end for receiving a portion of the conduit therein, the receiving port being oriented such that the open outlet end faces one of the lateral sides.

39. The gas collector according to any one of claims 21, 37, and 38, the outlet being a single outlet of the gas collector for providing the sampled gas to the gas analyzer.

40. The gas collector according to any one of claims 37 to 39, further comprising a single gas sampling inlet configured to provide the sampled gas from the channel to the outlet.

41. The gas collector according to claim 21 and any one of claims 37 to 40, further comprising a mounting portion for mounting the gas collector to a nasal cannula for delivering breathable gas to a patient, the mounting portion defining a sleeve configured to fit over a portion of the nasal cannula.

42. The gas collector according to claim 41, wherein, The sleeve generally follows the outer contour of the portion of the nasal cannula.

43. The gas collector according to claim 41 or 42, wherein The sleeve defines one or more slots that allow the portion of the nasal cannula to be inserted through the slots such that the portion of the nasal cannula can be received in the sleeve.

44. The gas collector according to claim 43, wherein, The sleeve has an elastic wall to allow the width of the one or more slots to be manually adjustable.

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