Gas collector

Abstract

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

Description

[Technical Field]

[0001] The present disclosure relates to a gas collector for collecting gases in a patient. The gas collector is suitable for use in applications requiring the collection and monitoring of exhaled gases from the patient's nasal and / or oral passages while providing a flow of gas to the patient. It will be convenient to describe the gas collector with respect to exemplary, but non-limiting, applications. [Background technology]

[0002] Medical procedures may involve procedural sedation or general anesthesia (collectively known as procedural anesthesia). During procedural sedation, the patient may experience or be at risk of respiratory depression due to the anesthetic agent, which may cause apnea. During general anesthesia, the patient may require mechanical ventilation if apneic. Pre-oxygenation of the patient prior to administration of the anesthetic agent is encouraged. During pre-oxygenation, also known as denitrification, the patient is provided with oxygen to saturate the body's internal reservoirs, including the blood and lungs, and delay or prevent oxygen desaturation when the patient has respiratory depression or is apneic. Pre-oxygenation also reduces the patient's blood and lung carbon dioxide levels, as well as lung nitrogen levels, as these are replaced by oxygen.

[0003] Nasal high flow (NHF) can be used in anesthesia procedures to pre-oxygenate patients, maintain adequate oxygenation, and prevent desaturation, and in general anesthesia to extend safe apneic periods during anesthesia when the patient becomes apneic. NHF delivers breathable gases, such as oxygen or oxygen-enriched air, or air to the patient using a non-contact patient interface, such as a nasal cannula. NHF may also be used in other settings, such as hospital wards, emergency departments, and intensive care units (ICUs).

[0004] It is beneficial to monitor gases in patients receiving respiratory assistance. Such monitoring provides useful feedback to clinicians. For example, monitoring exhaled gases during the preoxygenation phase can be used to determine whether the patient has reached a desired end-tidal O2 level, indicating that preoxygenation is adequate, and / or whether the preoxygenation phase has been completed. Exhaled gas monitoring can be used to detect changes in the patient's condition, for example, whether a spontaneously breathing patient becomes apneic after being anesthetized or experiences an airway obstruction. Clinicians can provide better therapy by making decisions as a result of monitoring the patient's gases.

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

[0006] Monitoring exhaled gases also presents challenges due to the variability of exhalation pathways, i.e., through the patient's nose, mouth, or nose and mouth. Patients may switch between these pathways during the monitoring period. How a patient breathes can affect gas sampling results, as an inadequate amount of exhaled gas may be collected from the nose, for example, when the patient is primarily breathing through the mouth.

[0007] In particular, but not exclusively, it would be desirable to provide a gas collector for collecting gases in a patient's nasal and oral passages that improves or overcomes one or more disadvantages or inconveniences of known gas collectors in NHF applications. Furthermore, it would be desirable to provide a gas collector that allows for consistent sampling of exhaled gases despite variability in the exhalation pathway.

[0008] The above description of the background of the present disclosure is intended to facilitate understanding of the present disclosure. However, it should be understood that the description is not an acknowledgment or admission that any aspect of the description was part of the common general knowledge of those skilled in the art at the priority date of this application. Summary of the Invention [Means for solving the problem]

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

[0010] In one or more embodiments, the interface further comprises 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 nasal prongs for delivering gases to the patient's nasal passages, and the gas collector further includes one or more openings formed through the channel wall portion for receiving the nasal prongs.

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

[0015] In one or more embodiments, the spacer is positioned to connect to the patient's face on either side of the patient's upper lip.

[0016] In one or more embodiments, during 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 spacer has a thickness greater than 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 spacer has a higher Young's modulus than the channel wall portion.

[0021] In one or more embodiments, the channel wall portion is configured to bend when it contacts the patient's face.

[0022] In one or more embodiments, the gas collector further includes an interface that defines a gas collection region and includes first and second gas collection inlets in fluid communication with the gas collection region.

[0023] In one or more embodiments, the gas collector further includes a mouth-engaging portion configured to protrude 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-engaging portion includes a lower end that protrudes into the patient's mouth, the lower end of the mouth-engaging portion being 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-engaging portion has an inner surface that includes edge portions that, in use, are positioned at the sides of the patient's mouth and a central portion that, in use, is positioned in the center of the patient's mouth, further away from the patient's upper lip than the edge portions.

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

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

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

[0029] Another aspect of the present invention provides a gas collector for collecting gas in a patient, the gas collector including an interface configured to form channels in the patient's upper lip, the channels having open ends in fluid communication with the patient's nasal passages and oral passages, respectively, the channels 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 having a gas collection inlet and configured to deliver gas from the channel to a local gas collector region, and an outlet for bringing the collected gas from the local gas collector region to a gas analyzer.

[0031] In one or more embodiments, the channel is formed in part by the patient's upper lip.

[0032] In one or more embodiments, the gas collector further includes a gas flow diverter configured to funnel at least a portion of the gas exhaled by the patient into 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 channel wall portion from the patient's face, and the gas flow diverter is integrated with the channel 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 channel wall portion from the patient's face, and the gas flow diverter is formed separately from the channel wall portion.

[0035] In one or more embodiments, one or more of the gas sampling inlets form a nasal gas sampling inlet located closest to the patient's nasal passages.

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

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

[0038] In one or more embodiments, one of the gas sampling inlets forms an oral gas sampling inlet located closest to the patient's oral passage.

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

[0040] In some embodiments, the gas collector may further include an outlet for conducting the collected gases via a conduit to the gas analyzer, the outlet configured to allow connection to the conduit from one 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 the conduit. The receiving port may be oriented such that the open outlet end faces toward one of the lateral sides. The lateral sides 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 for the gas collector to provide collected gas to a gas analyzer.

[0043] In some embodiments, the gas collector may further include a single gas sampling inlet configured to bring the 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 snugly over a portion of the nasal cannula.

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

[0046] In some embodiments, the sleeve may define one or more slits that may allow for insertion of portions of a nasal cannula such that the portions of the nasal cannula can be received in the sleeve.

[0047] In some embodiments, the sleeve may have a resilient wall, allowing the width of one or more slits to be manually adjustable.

[0048] Another aspect of the present invention provides a gas collector for collecting gases in a patient, the gas collector including 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 protrude into the patient's mouth 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 bringing collected gas from the gas collection region to the gas analyzer, a nose gas collection channel fluidly communicating between the nose gas collection inlet and the gas collection region; and a mouth gas collection channel fluidly communicating between the mouth gas collection inlet and the gas collection region.

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

[0051] Another aspect of the present invention provides a gas collector for collecting gases in a patient, the gas collector including an interface configured to form a channel on the patient's upper lip, one or more gas sampling conduits each having a gas sampling inlet for drawing gases from the channel into a local gas collector area, and a gas flow diverter configured to direct at least a portion of gas exhaled by the patient to one or more of the gas sampling inlets, the gas flow diverter including an upper portion extending away from the patient's face.

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

[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, during use, is shaped to rest directly under the patient's nose and avoid creating a seal with the patient's nasal passages.

[0055] In one or more embodiments, the gas flow diverter has an inner surface that, during use, faces the patient's face and substantially conforms to 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 patient's upper lip during use; the gas collector further includes one or more nasal gas collection conduits formed within the spacer, each having a nasal gas collection inlet in fluid communication with the patient's nasal passages for delivering gases exhaled by the patient from the nasal passages to an outlet; an oral gas collection conduit formed within the spacer, each having an oral gas collection inlet in fluid communication with the patient's oral passages; and a gas flow diverter configured to direct at least a portion of gases exhaled by the patient from the oral passages to the oral gas collection inlet.

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

[0059] Another aspect of the present invention provides a gas collector for sampling gases in a patient, the gas collector including: 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 passages; and an oral gas collection conduit having an oral gas collection inlet and an oral outlet in fluid communication with the patient's oral passages, the one or more nasal gas sampling conduits and the oral gas sampling conduit forming a junction in a local gas collector region, and the one or more nasal gas sampling conduits and the oral gas sampling conduit configured such that a flow rate in the one or more nasal gas sampling conduits is a percentage of a 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.

[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 nose gas sampling conduits exceeds the flow rate in the mouth gas sampling conduit.

[0065] In one or more embodiments, one or more nose gas sampling conduits include a different resistance to flow than the mouth gas sampling conduit to achieve a percentage within a predetermined range.

[0066] In one or more embodiments, the resistance to flow 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 in the patient's upper lip, the nasal and oral gas collection conduits being formed within the spacer.

[0068] In one or more embodiments, the gas flow collector further includes a gas flow diverter configured to direct at least a portion of gases exhaled by the patient from the oral passageway 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 collector region, the luer connector including a structure that creates a tortuous flow path that increases resistance to flow in the oral gas sampling conduit.

[0070] In one or more embodiments, the gas collector is attachable to or integrally formed with a nasal cannula including nasal gas delivery prongs for delivering gas to the patient's nasal passages, and one or more of the nasal gas collection inlets are located proximate the patient's nasal passages, and the nasal gas collection inlets are positioned in one or more of the following positions: a first position in which the nasal gas collection inlets are substantially parallel to the length of the channel and point away from gas flow from the patient's nasal region; a second position in which the nasal gas collection inlets are substantially transverse to the length of the channel; and a third position between the first and second positions.

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

[0072] In one or more embodiments, the gas collection conduit is formed in a spacer, which rests against the patient's upper lip during use.

[0073] In one or more embodiments, the gas collector further includes an oral gas flow diverter configured to funnel at least a portion of the gas exhaled by the patient from the oral passage 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 according to any one of the claims, the gas collector being attached to or integral with the nasal cannula.

[0075] One or more embodiments of the present invention provide a gas collector having a structure that provides or creates one or more channels in a patient's upper lip, for example, in the patient's philtrum region, where the one or more channels are in fluid communication with the nose and mouth. Such a structure helps channel exhaled gases from the nose and / or mouth to the localized area, increasing the concentration of the gas sample. Such a structure in fluid communication with the nose and mouth also helps collect a gas sample regardless of whether the patient breathes through the nose or 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, for example, a nasal cannula.

[0077] Specific embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein, and with reference to the drawings. [Brief explanation of the drawings]

[0078] [Figure 1] 1 shows a respiratory support system. [Figure 2] A patient wearing a respiratory support system is shown. [Figure 3] 1 shows a patient wearing a first embodiment of a patient interface and face mask. [Figure 4] 4 shows a cross section of a portion of the patient interface of FIG. 3. [Figure 5-8] 1 shows a nasal cannula including a collapsible portion to which a gas collector may be attached or integrated. [Figure 9] 10 illustrates another embodiment of a patient interface. [Figure 10] 10 illustrates another embodiment of a patient interface. [Figure 11] 10 illustrates another embodiment of a patient interface. [Figure 12] Depicts facial features or areas of the patient. [Figure 13]1 shows different types of channel structures. [Figure 14] 1 shows different types of channel structures. [Figure 15] 1 shows different types of channel structures. [Figure 16] 1 shows a first embodiment of a gas collector. [Figure 17] 1 shows a first embodiment of a gas collector. [Figure 18] 1 shows a first embodiment of a gas collector. [Figure 19] 1 shows a first embodiment of a gas collector. [Figure 20] 1 shows a first embodiment of a gas collector. [Figure 21] 16-20 illustrate a nasal cannula equipped with a gas collector of the type shown in FIGS. [Figure 22] 16-20 illustrate a nasal cannula equipped with a gas collector of the type shown in FIGS. [Figure 23] 16-20 illustrate a nasal cannula equipped with a gas collector of the type shown in FIGS. [Figure 24] 21-23 show the gas collector of FIGS. 21-23 without the nasal cannula. [Figure 25] 21-23 show the gas collector of FIGS. 21-23 without the nasal cannula. [Figure 26] 21-23 show the gas collector of FIGS. 21-23 without the nasal cannula. [Figure 27] 1 shows a second embodiment of a gas collector. [Figure 28] 1 shows a second embodiment of a gas collector. [Figure 29] 1 shows a second embodiment of a gas collector. [Figure 30] 1 shows a second embodiment of a gas collector. [Figure 31] 1 shows a second embodiment of a gas collector. [Figure 32] 1 shows a second embodiment of a gas collector. [Figure 33] 1 shows a second embodiment of a gas collector. [Figure 34] 1 shows a second embodiment of a gas collector. [Figure 35] 1 shows a second embodiment of a gas collector. [Figure 36] 10 shows a third embodiment of a gas collector. [Figure 37] 10 shows a third embodiment of a gas collector. [Figure 38] 10 shows a third embodiment of a gas collector. [Figure 39] 10 shows a fourth embodiment of a gas collector. [Figure 40] 10 shows a fourth embodiment of a gas collector. [Figure 41] 10 shows a fifth embodiment of a gas collector. [Figure 42] 10 shows a fifth embodiment of a gas collector. [Figure 43] 10 shows a fifth embodiment of a gas collector. [Figure 44] 10 shows a fifth embodiment of a gas collector. [Figure 45] 10 shows a sixth embodiment of a gas collector. [Figure 46] 10 shows a sixth embodiment of a gas collector. [Figure 47] 10 shows a seventh embodiment of a gas collector. [Figure 48] 10A-10C illustrate different mechanisms for attaching the gas collector to the patient interface. [Figure 49] 10A-10C illustrate different mechanisms for attaching the gas collector to the patient interface. [Figure 50] 10A-10C illustrate different mechanisms for attaching the gas collector to the patient interface. [Figure 51] 10A-10C illustrate different mechanisms for attaching the gas collector to the patient interface. [Figure 52] 10A-10C illustrate different mechanisms for attaching the gas collector to the patient interface. [Figure 53] 10A-10C illustrate different mechanisms for attaching the gas collector to the patient interface. [Figure 54] 10A-10C illustrate different mechanisms for attaching the gas collector to the patient interface. [Figure 55]10A-10C illustrate different mechanisms for attaching the gas collector to the patient interface. [Figure 56] 12-26 show the gas collector of FIGS. 12-26 attached to a nasal cannula. [Figure 57] 12-26 show the gas collector of FIGS. 12-26 attached to a nasal cannula. [Figure 58] 12-26 show the gas collector of FIGS. 12-26 attached to a nasal cannula. [Figure 59] 12-26 show the gas collector of FIGS. 12-26 attached to a nasal cannula. [Figure 60] 1 shows a gas collector including an integral structural member. [Figure 61] 1 shows a gas collector including an integral structural member. [Figure 62] 1 shows a gas collector including an integral structural member. [Figure 63] 16-20, which shows a modification to the gas collector of FIGS. 16-20, including a hinge. [Figure 64] 16-20, which shows a modification to the gas collector of FIGS. 16-20, including a hinge. [Figure 65] 16-20, which shows a modification to the gas collector of FIGS. 16-20, including a hinge. [Figure 66] 16-20, which shows a modification to the gas collector of FIGS. 16-20, including a hinge. [Figure 67] 16-20, which shows another variation on the gas collector of FIGS. 16-20, including a bistable structure. [Figure 68] 16-20, which shows another variation on the gas collector of FIGS. 16-20, including a bistable structure. [Figure 69] 16-20, which shows another variation on the gas collector of FIGS. 16-20, including a bistable structure. [Figure 70] 16-20, which shows another variation on the gas collector of FIGS. 16-20, including a bistable structure. [Figure 71] 16-20, which includes an opening or removable portion for inserting and holding medical instrumentation. [Figure 72]16-20, which includes an opening or removable portion for inserting and holding medical instrumentation. [Figure 73] 16-20, which includes an opening or removable portion for inserting and holding medical instrumentation. [Figure 74] 16-20, which includes an opening or removable portion for inserting and holding medical instrumentation. [Figure 75] 16-20, which includes an opening or removable portion for inserting and holding medical instrumentation. [Figure 76] 16-20, which includes an opening or removable portion for inserting and holding medical instrumentation. [Figure 77] 16-20, which shows another variation to the gas collector of FIGS. 16-20, including an open channel for saliva capture. [Figure 78] 16-20, which shows another variation to the gas collector of FIGS. 16-20, including an open channel for saliva capture. [Figure 79] 16-20, which shows another variation to the gas collector of FIGS. 16-20, including an open channel for saliva capture. [Figure 80] 16-20, which shows another variation to the gas collector of FIGS. 16-20, including an open channel for saliva capture. [Figure 81] 16-20, which includes a modified center port engagement portion. [Figure 82] 16-20, which includes a modified center port engagement portion. [Figure 83] 16-20, which includes a modified center port engagement portion. [Figure 84] 16-20, which shows another variation to the gas collector of FIGS. 16-20, including a force absorbing section. [Figure 85] 16-20, which shows another variation to the gas collector of FIGS. 16-20, including a force absorbing section. [Figure 86] 74 and 75 show further variations to the gas collector of FIGS. 16-20, including variations to the force absorbing section. [Figure 87-89] 74 and 75 show further variations to the gas collector of FIGS. 16-20, including variations to the force absorbing section. [Figure 90] 16-20, which includes an enlarged or expandable mouth engagement portion. [Figure 91] 16-20, which includes an enlarged or expandable mouth engagement portion. [Figure 92] 16-20, which includes an enlarged or expandable mouth engagement portion. [Figure 93] 16-20, which includes an enlarged or expandable mouth engagement portion. [Figure 94] 16-20, which includes an enlarged or expandable mouth engagement portion. [Figure 95] 16-20, which includes an enlarged or expandable mouth engagement portion. [Figure 96] 16-20, which includes an enlarged or expandable mouth engagement portion. [Figure 97] 16-20, which includes an enlarged or expandable mouth engagement portion. [Figure 98] 16 shows another variation to the gas collector of 16-20, including means for attachment to a nasal cannula. [Figure 99] 16 shows another variation to the gas collector of 16-20, including means for attachment to a nasal cannula. [Figure 100] 16 shows another variation to the gas collector of 16-20, including means for attachment to a nasal cannula. [Figure 101] 16 shows another variation to the gas collector of 16-20, including means for attachment to a nasal cannula. [Figure 102] 16 shows another variation to the gas collector of 16-20, including means for attachment to a nasal cannula. [Figure 103-104] 16-20, which includes a recess in the base of the curved nasal prongs to create a channel with the patient's upper lip. [Figure 105] 95 shows another variation to the gas collector of FIGS. 93 and 94, including a tube in fluid communication with the channel. [Figure 106] 95 shows another variation to the gas collector of FIGS. 93 and 94, including a tube in fluid communication with the channel. [Figure 107] 95 shows another variation to the gas collector of FIGS. 93 and 94, including a tube in fluid communication with the channel. [Figure 108] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 109] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 110] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 111] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 112] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 113] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 114] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 115] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 116] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 117] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 118] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 119] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 120] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 121] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 122] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 123] 16-20 includes a sampling line to the outlet port and a series of single action mechanisms for connecting the sampling line. [Figure 124] 10 shows an eighth embodiment of the gas collector. [Figure 125] 10 shows an eighth embodiment of the gas collector. [Figure 126] 10 shows an eighth embodiment of the gas collector. [Figure 127] 10 shows an eighth embodiment of the gas collector. [Figure 128] A modification to the gas collector in Figures 124 to 127 is shown. [Figure 129] A modification to the gas collector in Figures 124 to 127 is shown. [Figure 130] A modification to the gas collector in Figures 124 to 127 is shown. [Figure 131] Further modifications to the gas collectors in Figures 124-127 are shown. [Figure 132] Further modifications to the gas collectors in Figures 124-127 are shown. [Figure 133] A modification of the gas collector in Figures 131-132 is shown. [Figure 134] This shows a modification of the gas collector shown in FIGS. [Figure 135] FIG. 135 is a schematic diagram showing the gas collector of FIG. 134 as worn by a patient. [Figure 136] 135 is a further schematic diagram showing the gas collector of FIG. 134 deforming when an instrument such as a laryngoscope is inserted into the patient's mouth. DETAILED DESCRIPTION OF THE INVENTION

[0079] Various embodiments will be described with reference to the drawings. The same reference numerals may be used throughout the drawings and the specification to designate the same or similar components, and redundant description thereof may be omitted.

[0080] As used herein, "high flow," "high flows," "high-flow," or other equivalent terms refer, without limitation, to any gas flow that is higher than normal / standard, e.g., higher than the standard inspiratory flow rate of a healthy patient. Alternatively, or in addition, it may be higher than some other threshold flow rate relevant to the context—for example, if a gas flow is provided to a patient at a rate that meets or exceeds inspiratory demand, that flow may be considered "high flow" because it is higher than the nominal flow rate that would otherwise be provided. Therefore, "high flow" is context-dependent, and what constitutes "high flow" depends on many factors, such as the patient's health status, the type of treatment / therapy / assistance provided, the nature of the patient (large, small, adult, child), etc. Those skilled in the art will know what constitutes "high flow" from the context. Another factor provided in addition to flow rate is the magnitude of the flow.

[0081] However, without limitation, some indications of high flow may be as follows:

[0082] In some embodiments, the delivery of gas to the patient at a rate of about 5 or 10 liters per minute (5 or 10 LPM or L / min) or greater.

[0083] In some embodiments, gas is delivered to the patient at a flow rate of about 5 or 10 LPM to about 150 LPM, or about 15 LPM to about 95 LPM, or about 20 LPM to about 90 LPM, or about 25 LPM to about 85 LPM, or about 30 LPM to about 80 LPM, or about 35 LPM to about 75 LPM, or about 40 LPM to about 70 LPM, or about 45 LPM to about 65 LPM, or about 50 LPM to about 60 LPM. For example, according to various embodiments and configurations thereof described herein, the flow rate of gas supplied or provided to the interface via the system or from a flow source or flow modulator may include, but is not limited to, flows of at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 LPM, or more, and a useful range may be selected to be any of these values ​​(e.g., about 20 LPM to about 90 LPM, about 40 LPM to about 70 LPM, about 40 LPM to about 80 LPM, about 50 LPM to about 80 LPM, about 60 LPM to about 80 LPM, about 70 LPM to about 100 LPM, about 70 LPM to about 80 LPM).

[0084] In "high flow" applications, the gas delivered will be selected depending on the intended use, e.g., therapy and / or respiratory support. The delivered gas may include a percentage of oxygen. In some embodiments, the percentage of oxygen in the delivered gas may be about 15% to about 100%, about 20% to about 100%, about 30% to about 100%, about 40% to about 100%, about 50% to about 100%, about 60% to about 100%, about 70% to about 100%, about 80% to about 100%, about 90% to about 100%, about 100%, or 100%.

[0085] In some embodiments, the delivered gas may include a percentage of carbon dioxide. In some embodiments, the percentage of carbon dioxide in the delivered gas may be greater than 0%, between about 0.3% and about 100%, between about 1% and about 100%, between about 5% and about 100%, between about 10% and about 100%, between about 20% and about 100%, between about 30% and about 100%, between about 40% and about 100%, between about 50% and about 100%, between about 60% and about 100%, between about 70% and about 100%, between about 80% and about 100%, between about 90% and about 100%, about 100%, or 100%.

[0086] "High flow" flow rates for premature infants / infants / children (ranging from about 1 kg to about 30 kg) can vary. Flow rates can be set at 0.4-8 L / min / kg, with a minimum of about 0.5 L / min and a maximum of about 70 L / min. The maximum flow rate for patients under 2 kg can be set at 8 L / min. For example, for a 2 kg patient, the flow rate is about 0.8 LPM to 16 LPM.

[0087] High flow has been shown to be effective in meeting or exceeding a patient's actual normal inspiratory flow to increase the patient's oxygenation and / or reduce the patient's work of breathing. Additionally, high flow therapy and / or respiratory assistance can create a flushing effect in the nasopharynx, causing the anatomical dead space of the upper airway to be flushed with a high inflow gas flow. This creates a pool of fresh gas available for each breath while minimizing rebreathing of carbon dioxide, nitrogen, etc.

[0088] By way of example, a high-flow breathing system 100 is described below with reference to Figure 1. High flow may be used as a means to enhance gas exchange and / or respiratory support by oxygen and / or other gas delivery and by removal of CO2 from the patient's airways. High flow may be particularly useful before, during, or after medical and / or anesthetic procedures.

[0089] When used before a medical procedure, a high gas flow rate can provide an oxygen buffer by pre-oxygenating the patient (i.e., increasing the pool of oxygen in the blood) so that the patient's blood oxygen saturation and volume of oxygen in the lungs are higher than normal, which is useful, for example, to reduce the risk or prevent desaturation when the patient is in an apneic phase during a medical procedure.

[0090] A continuous supply of oxygen is important for maintaining healthy respiratory function during medical procedures (e.g., during anesthesia) when respiratory function may be impaired (e.g., decreased or stopped). When this supply is impaired, conditions such as hypoxia and / or hypercapnia can occur. During medical procedures such as anesthesia and / or sedation, a patient's breathing is monitored to detect whether spontaneous breathing decreases or stops. If oxygen delivery and / or CO2 removal are impaired, the clinician interrupts the medical procedure and promotes oxygen delivery and / or CO2 removal. This may be accomplished by manually ventilating the patient, e.g., via bag-mask ventilation, or by providing a high flow of gas to the patient's airway using a high-flow breathing system or via jet ventilation. It will be further understood that masks (not necessarily limited to bag-masks) used for sedation / ventilation may also be used for preoxygenation and for monitoring patient parameters, such as end-tidal CO2.

[0091] Additional benefits of high gas flow rates may include providing pressure support that increases pressure within the patient's airways, thereby expanding the airways, trachea, lungs / alveoli, and bronchioles. Expanding these structures may enhance oxygenation, assist to some extent in the removal of CO2, and / or help support patients with collapsed areas of the lung.

[0092] When humidified, high gas flow rates may also prevent airway drying, reduce mucociliary damage, and reduce the risk of infection, as well as the risk of laryngospasm and risks associated with dry airways, such as nosebleeds, aspiration (as a result of nosebleeds), and airway obstruction, swelling, and bleeding. Another advantage of high gas flow rates is that the flow may clear smoke generated in the airways during surgery. For example, smoke may be generated by laser and / or cauterizing devices.

[0093] FIG. 1 illustrates a respiratory assistance system 100. The system 100 may be configured to provide high-flow respiratory assistance and / or high-flow therapy. The respiratory assistance system 100 includes a flow generator 102. The flow generator 102 is configured to generate a gas flow that is passed through the respiratory assistance 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 herein. The flow generator 102 passes air to a humidifier 104. The humidifier 104 is configured to heat and humidify the gas flow generated by the flow generator 102 (to a temperature and / or humidity as described elsewhere herein). In some embodiments, the flow generator 102 includes a blower adapted to receive gases from an environment outside the respiratory assistance system 100 and direct the gases through the respiratory therapy system 100. In some embodiments, the flow generator 102 may include some other gas generation means. For example, in some embodiments, the flow generator 102 may include a source available from a hospital gas outlet (e.g., oxygen or air), or one or more containers of compressed air and / or another gas, and one or more valve arrangements adapted to control the rate at which the gas leaves the one or more containers. As another example, in some embodiments, the flow generator 102 may include an oxygen concentrator. In some embodiments, the flow generator 102 may be adapted to perform high-flow respiratory assistance and / or high-flow therapy. In some embodiments, the flow source may include a compressed gas source, a device for modifying the flow from the compressed gas source and / or the flow generator that generates the gas flow.

[0094] The respiratory assistance system 100 includes a housing 106 that at least partially houses both the flow generator 102 and the humidifier 104 (e.g., the respiratory assistance system 100 may include an integrated flow generator / humidifier device). In other forms, the flow generator 102 and the humidifier 104 may have separate housings and / or be separate components. While the hardware controller 108 is shown in electronic communication with the flow generator 102 and the humidifier 104, in some forms the hardware controller 108 may communicate only with the flow generator 102 or the humidifier 104. In some forms, the flow generator 102 and the humidifier 104 may each have their own controller, which may or may not communicate with each other. The hardware controller 108 may include a microcontroller or some other architecture configured to direct the operation of controllable components of the respiratory assistance system 100, such as, but not limited to, the flow generator 102 and / or the humidifier 104.

[0095] An input / output module 110 is shown in electronic communication with the controller 108. The input / output module 110 may be configured to facilitate a user interfacing with the controller 108 to control controllable components of the respiratory assistance system 100, such as, but not limited to, the flow generator 102 and / or the humidifier 104, and / or to facilitate viewing data regarding the operation of the respiratory assistance system 100 and / or its components. The input / output module 110 may include, for example, one or more buttons, knobs, dials, switches, levers, a touchscreen, a speaker, a display, and / or other input or output peripherals that a user may use to view data and / or input commands to control components of the respiratory assistance system 100.

[0096] 1, a supplemental gas source 124 may be used to add one or more supplemental gases to the gas flowing through the respiratory assistance system 100. The one or more supplemental gases join 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 (O), carbon dioxide (CO), nitrogen (N), nitrous oxide (NO), an anesthetic, and / or heliox (a mixture of helium and oxygen). The supplemental gas source 124 may deliver one or more supplemental gases to or toward the flow generator 102 via a first supplemental gas conduit 128 and / or may deliver 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 one or more supplemental gases may flow from the supplemental gas source 124 through the first and / or second supplemental gas conduits 128, 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 may in turn control the operation and / or state of the one or more supplemental flow valves 126, 130. In other embodiments, the supplemental gas source 124 may be configured to add one or more supplemental gases downstream of the humidifier 104. In other embodiments, the supplemental gas source 124 may be configured to add one or more supplemental gases into the humidifier 104, for example, into a humidification chamber containing a body of water and engageable with a heater base, where the water to be heated by a heating element humidifies the flow of gas to the patient.

[0097] As shown in FIG. 1 , a conduit 112 extending from the humidifier 104 connects the humidifier 104 to a patient interface 200. The conduit 112 may include a conduit heater 114 adapted to heat gas passing through the conduit 112. In other embodiments, 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. While the patient interface 200 is shown to be a nasal cannula, it should be understood that other patient interfaces may be suitable in some embodiments. For example, in some embodiments, the patient interface 200 may include a tight-fitting or non-tight-fitting interface, and may include a nasal mask, an oral mask, an oral-nasal mask, a full-face mask, a nasal pillows mask, a nasal cannula, an endotracheal tube, a tracheostomy tube, a combination of the above, or some other gas delivery system. In some embodiments, the patient interface 200 is a non-tight-fitting interface, such as a nasal cannula, which allows gas to be exchanged with the environment. For example, a non-sealing cannula allows carbon dioxide to be removed and / or purged from the patient's airway while the patient receives gas flow from the system 100. Additionally, in some embodiments, the patient interface 200 is in the form of a nasal interface, preventing the system from interfering with other oral track equipment and / or devices in an intubation procedure, such as a tracheal tube.

[0098] Thus, the patient continues to receive gas flow throughout the intubation procedure. In other embodiments, the patient interface 200 is an oral interface, such as an oral interface that is received in the user's mouth. An oral interface may be preferred in situations involving medical procedures through the nose, ensuring that the interface does not interfere with nasal track instrumentation and / or equipment, such as tracheal tubes used in nasal intubation procedures. In other embodiments, the interface may be suitable for both nasal and oral placement, or may be conformed to a configuration between the nose and mouth.

[0099] As shown, in some forms, the patient interface 200 may also include a gas sensing module 120 adapted to measure properties of gas passing through the patient interface 200. In some forms, a gas collector (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 forms part of the sensing module 120. The gas sensing module 120 may be located elsewhere in the gas delivery system, for example, in a breathing conduit or a humidifier. In some embodiments, there may be more than one gas sensing module 120. In other embodiments, the gas sensing module 120 may be positioned and adapted to measure properties of gases present in or near other portions of the respiratory assistance system 100. The gas sensing module 120 may include one or more sensors adapted to detect the presence of gas and / or measure various properties of the gas, such as, but not limited to, pressure, flow rate, temperature, absolute humidity, relative humidity, enthalpy, gas composition, oxygen concentration, carbon dioxide concentration (e.g., to determine end-tidal CO), and / or nitrogen concentration. The gas properties 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 embodiments, flow rate data taken by the gas sensing module 120 may be used to determine instantaneous flow, which may in turn be used to determine the patient's respiratory cycle, facilitating flow delivery synchronized with portions of the respiratory cycle. The gas sensing module 120 may communicate with the controller 108 over a first transmission line 122. In some embodiments, the first transmission line 122 may include a data communication connection adapted to transmit a data signal. 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 embodiments, both power and data may be carried on the same first transmission line 122. For example, the gas sensing module 120 may include a modulator that may allow a data signal to be "overlaid" on top of the power signal. The data signal may be superimposed on the power signal, and the combined signal may be demodulated before being used by the controller 108. In other embodiments, the first transmission line 122 may include an air communication connection adapted to route the gas flow for analysis in a portion of the respiratory assistance system 100. In other embodiments, the transmission line 122 includes an air communication connection separate from the conduit 112 that is adapted to route the gas flow captured in the patient for analysis in a separate system or device, such as a capnograph.

[0100] Also shown, a physiological sensor module 121 may be present. The physiological sensor module 121 may be configured to detect various patient characteristics or health conditions, such as, but not limited to, heart rate, EEG signals, EKG / ECG signals, an inertial sensor attached to the patient (e.g., on the chest) to detect movement, blood oxygen level (e.g., via a pulse oximeter), blood CO2 level, transcutaneous CO2 (TcCO2), and / or blood glucose. Similarly, the physiological sensor module 121 may communicate with the controller 108 over a second transmission line 123. The second transmission line 123 may 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 patient's blood oxygen saturation. In some embodiments, the second transmission line 123 may include an air communication connection adapted to route fluid for analysis within the respiratory assistance system 100 or in a separate system or device.

[0101] FIG. 2 illustrates a user or patient P wearing a patient interface 200, such as the patient interface 200 of the respiratory system of FIG. 1. The illustrated patient is an adult, but the patient may also be an infant, newborn, or child. In the non-limiting form 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 assistance system 100 (e.g., via conduit 112 shown in FIG. 1) and channel the gas to the patient P. The first gas conduit 202 may include a reinforcing element 203 adapted to strengthen and / or add rigidity to the first gas conduit to prevent deformation or collapse of the first gas conduit 202 due to the application of force to the first gas conduit 202. The reinforcing element 203 may include several structures, such as, but not limited to, plastic or metal reinforcing beads within or on the wall of the first conduit lumen 202.

[0102] The first gases conduit 202 is in pneumatic communication with a flow manifold 206. The flow manifold 206 receives gases from the first gases conduit 202 and passes the gases 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-sealing (i.e., a gap exists between each nasal delivery element and the patient's nasal passages) when positioned within one or more nares of the patient P. As shown, the patient interface 200 includes two nasal prongs 208 adapted to be positioned in each of the patient's nostrils. Each nasal prong 208 may be shaped or angled to extend inward toward the patient's nasal septum. Alternatively, the first patient interface 200 may be a tight-fitting nasal interface.

[0103] In the embodiment shown in FIG. 2 , the flow manifold 206 receives flow from one lateral side of the flow manifold 206 (e.g., relative to an imaginary vertical plane bisecting the face of the patient P) and routes the flow through a channel into the manifold and to each of the nasal prongs 208. In some configurations, the flow manifold 206 receives flow from one side of the flow manifold 206 and routes the flow through a channel into the manifold and to each of the nasal prongs 208. The one side may be a single lateral side. In some embodiments, a conduit may extend from the left or right side of the manifold. In some situations, providing a conduit on the left side of the patient interface may be preferred for clinician access, e.g., for intubation. Alternatively, a conduit extending from the right side may be preferred, for example, in procedures such as endoscopy, where the patient is generally in the left lateral position. 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 embodiments, each nasal delivery element 208 may have a different configuration, size, shape, and / or properties. For example, one of a pair of nasal delivery elements 208 may be relatively long and the other nasal delivery element 208 may be relatively short.

[0104] In some configurations, the flow manifold 206 may be configured to receive flow from two lateral sides of the flow manifold 206 (e.g., from the "left" and "right" of the flow manifold 206, instead of only the patient's right side as shown in FIG. 2). In some such configurations, multiple gas conduits may be used to provide air communication between the flow manifold 206 and the respiratory assistance system 100. For example, the patient interface may include a dual conduit, with a first gas conduit 202 extending from a first side of the interface (in the example shown, the patient's right side) and a second gas conduit extending from a second, opposite side of the interface. In some configurations, the flow manifold 206 may 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 may receive flow from two or more gas conduits from one side, which may be from a single lateral side of the manifold 206. In some configurations, one prong may receive flow from one gas conduit and the other prong may receive flow from another separate gas conduit.

[0105] The patient interface may further include mounts and / or supports for attaching and / or supporting the one or more gas conduits 202 to the patient's face, such as cheek supports 210. Alternatively, or in addition, the patient interface may be held in place by one or more head straps or headgear.

[0106] The first gas conduit 202 may include a first portion 204 that is configured to transition from a first configuration that allows a first level of gas to pass through the first portion 204 to a second configuration that allows a second level of gas to pass through the first portion 204.

[0107] Figure 3 shows a non-limiting exemplary embodiment of a patient P wearing a patient interface 200 (first patient interface) as shown in Figure 2 underneath a face mask 300 assembly (second patient interface). Figure 3 shows the face mask schematically as a transparent structure to show the patient interface 200 underneath. The first patient interface 200 may be used with a first respiratory support subsystem, and the second patient interface 300 may be used with a second respiratory support subsystem. In some embodiments, the first patient interface 200 and the second patient interface 300 may be used in the same respiratory support system.

[0108] The system may find benefit in selectively delivering separate respiratory assistance and / or therapy to patients using different patient interfaces, and / or in pausing or ceasing delivery of respiratory assistance and / or therapy from an interface, and / or in being able to sample gases provided by the interface.

[0109] The systems and devices as described have particular application in emergency resuscitation, for intubation of patients receiving high-flow respiratory support and / or therapy, ear, nose and throat (ENT) surgery, in the pre-operative state before administration of anesthetic agents, and to assist in patient adjustment during recovery after extubation.

[0110] The face mask assembly 300 may be used as or in conjunction with a second respiratory support subsystem and / or may be used to deliver one or more substances to the patient other than the substance delivered by the cannula 200, such as an anesthetic or oxygen, or the same substance but at a different flow rate and / or pressure level. Alternatively, the face mask assembly 300 may be used to interrupt the delivery of respiratory support and / or therapy from the first respiratory support subsystem. The face mask assembly 300 may also be adapted to measure respiratory gases from the patient, such as exhaled carbon dioxide, measurements that may otherwise be affected by flow from the patient interface 200 of the first respiratory support subsystem.

[0111] 3 allows for alternation between two different respiratory support subsystems. Furthermore, this configuration allows the patient interface 200 to remain on the patient throughout the surgical procedure and / or until recovery (whether or not the patient continues to receive gas flow through the patient interface 200 throughout the procedure) without interfering with other clinical practice.

[0112] In the illustrated embodiment, the face mask assembly 300 includes a full face mask 302 configured to cover both the patient's nose and mouth. In other configurations, the face mask 300 may be a nasal mask that is placed over the patient interface 200 to cover only the patient's nasal region. In such configurations, a portion of the face mask 300 may be placed over a portion of the patient interface 200, such as the first portion 204.

[0113] As shown, the face mask 302 includes a sealing portion 304 adapted to seal against the patient's face. The face mask assembly 300 is connected to a second gas source, for example via a filter element 350 or a humidity / moisture exchanger (not shown), which supplies one or more other gases to the patient through the face mask. That is, the second gas source is preferably different from the source supply 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 face mask assembly 300 are connected to a common gas source.

[0114] In some embodiments, the face mask assembly 300 is connected to a separate gas source or a separate respiratory support device. For example, the respiratory support may be a ventilator or a CPAP or high-flow respiratory support and / or therapy device, or a manual resuscitator (e.g., a handheld face mask with a bag). Alternatively or additionally, the face mask assembly 300 may be connected to equipment for measuring the characteristics of the respiratory gas.

[0115] Alternatively, the mask assembly 300 may be connected to an anesthetic machine and anesthetic gas, or air, or oxygen, or a combination of gases may be delivered via the mask 302 .

[0116] The embodiment shown in FIG. 3 allows for the delivery of gas from multiple sources in at least two different respiratory assistance modes, and further allows a physician, clinician, or medical professional to quickly and easily change the type of respiratory assistance mode.

[0117] In one particular application, a patient being prepared for anesthesia may be pre-oxygenated by delivering high flow oxygen or humidified gas, or a mixture of both, via nasal cannulae. In some situations, an anesthesiologist administering a patient's sedation and / or anesthesia may wish to switch between delivering gas flow from one patient interface (e.g., nasal cannula 200) and via another patient interface, such as face mask 300.

[0118] Anesthesiologists also use a bag-mask to oxygenate patients, and in some cases find it more beneficial to use a bag-mask when the patient's vital signs begin to decline, for example to deliver more pressure or to have greater control over changes in the delivered pressure. In some situations, medical professionals may want to switch between different breathing systems or assist modes. In a first mode, respiratory assistance may be provided by a first respiratory assist system (e.g., via the patient interface 200), and in a second mode, respiratory assistance may be provided by a second respiratory assist system (e.g., via the patient interface 300), with assistance from the first system reduced or stopped. For example, because the additional flow from the high flow provided by the nasal interface 200 may also modify the expected behavior of the anesthetic circuit provided by the face mask 300, it may be advantageous to be able to reduce or stop the additional flow from the first breathing system.

[0119] In some forms, switching between the two respiratory assistance modes or subsystems is facilitated by the structure of the first gas conduit 202, which has a first portion 204 configured to transition from a first configuration that allows a first level of gas to pass through the first portion 204, to a second configuration that allows a second level of gas to pass through the first portion 204.

[0120] In some forms, first portion 204 is configured to be collapsible or otherwise better accommodate changes in gas flow through first portion 204 than other portions of conduit 202 (thus stopping or reducing gas flow through the conduit to the patient) and / or to allow sealing of the mask to seal over the top of the conduit. In other forms, the entire conduit may be configured to be collapsible. In some forms, a vent arrangement may be provided to vent gas from the conduit to atmosphere.

[0121] 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, i.e., the conduit 202 is configured to be more collapsible, deformable, or otherwise adapted to completely block flow in the first portion 204 than in other portions of the conduit 202. In the second condition, gas to the nasal delivery element 208 may be reduced or stopped.

[0122] FIG. 4 shows an example of this configuration, in which the conduit in the first portion 204 (e.g., the conduit 204 of the nasal cannula 200 of FIG. 3) is substantially closed by the seal 304 of the face mask 302. In such an embodiment, the length of the first portion (i.e., the more collapsible or deformable section) of the first gas conduit needs to be equal to or greater than the width of the section of the face mask seal that supports the first portion of the first gas conduit. This may result in the face mask seal not supporting the non-collapsible section of the first gas conduit. For example, the first portion may extend from 35 mm or less from a portion of the manifold 206 or the center of the user's nose to at least 50 mm from a portion of the manifold 206 or the center of the user's nose. The first portion 204 may be at least about 5 mm long, from about 1 mm to about 30 mm long, from about 5 mm to about 15 mm long, or about 10 mm long. In some embodiments, the length of the first portion may 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 more.

[0123] The first portion 204 may progress between the first and second configurations based on the relative level of force applied to the walls of the first portion 204. For example, as shown in Figure 3, the force may be applied by a 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.

[0124] Alternatively, force may be applied to first portion 204 by other means, such as a clamp (not shown), or alternatively, the physician may compress the conduit by pressing against the conduit wall with a finger or thumb.

[0125] 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. Furthermore, the face mask seal forms a seal or at least a partial seal across the first portion 204 of the gas conduit 202.

[0126] Therefore, switching between respiratory support therapies is accomplished by simply placing the mask on the patient's face and causing the mask seal to collapse (partially or completely) the first portion of the gas conduit of the first interface 200, interrupting or "stopping" or reducing the respiratory support and / or therapy delivered by the first interface 200, and providing a seal between the face mask 300 and the exterior surface of the first portion 204 of the conduit 202, allowing respiratory support and / or therapy to be delivered by the mask 300 while the respiratory support and / or therapy delivered by the first interface 200 is interrupted or reduced. As mentioned above, 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.

[0127] A cannula with a collapsible conduit portion allows a user, such as an anesthesiologist or nurse or clinician, to use a mask and prevent the delivery of gas from multiple sources (e.g., mask and cannula). The first interface 200 is structured and operative to reduce or terminate the delivery of high flow when the interface 200 is moved to the collapsed configuration, allowing the delivery of other respiratory assistance and / or respiratory therapy or anesthetic gases through the mass. In some embodiments, removal of the mask from the patient's face allows the conduit to return from the collapsed configuration to the open configuration, thereby allowing the resumption of respiratory assistance and / or therapy delivered by the first interface.

[0128] 5-8 illustrate a patient interface 1400 including a gas delivery member 1401 configured to deliver system gases (e.g., a flow of gas from a flow source) to a patient through a manifold 1406 that includes a nasal cannula and to a delivery outlet that includes a pair of nasal prongs 1408. The pair of nasal prongs 1408 extend from the manifold 1406. The gas delivery member 1401 extends from a first side of the manifold 1406, and the interface 1400 further includes a non-delivery member 1403 that extends from a second side of the manifold 1406 opposite the first side. The non-delivery member 1403 includes an end 1409 configured to connect to a head strap 1411.

[0129] Gas delivery side member 1401 includes a collapsible portion 1404 that is configured to move from a normally open configuration, as shown in Figures 5, 7, and 8, to a collapsed configuration in which system gas flow through collapsible portion 1404 is reduced or stopped. Collapsible portion 1404 is configured to move to the collapsed configuration upon application of a collapsible force, for example, from a patient mask placed on the patient's face, where the mask seal is forced down on collapsible portion 1404. Gas delivery side member 1401 also includes a non-collapsible portion 1407 that is configured to remain open during application of a collapsible force to collapsible portion 1404.

[0130] One end of the non-collapsible portion 1407 includes a delivery inlet 1407a for receiving system gas flow. The patient interface 1400 further includes a gas pathway connector 1413 having a rigid structure and including a delivery inlet 1413a and a delivery outlet 1413b. The gas pathway connector delivery inlet 1413a is connectable to a system gas supply via a conduit (not shown). The gas pathway connector delivery outlet 1413b is connected to the delivery inlet 1407a of the non-collapsible portion 1407. The gas pathway connector 1413 is also connected to the head strap 1411 at an end of the head strap opposite to the head strap end 1409 of the non-delivery member 1403.

[0131] FIG. 6 shows a cross-section of non-collapsible portion 1407 including walls 1412 of uniform thickness. FIGS. 7 and 8 show a cross-section of collapsible portion 1404 including walls 1404a of non-uniform thickness. Collapsible portion 1404 has an elongated cross-section, specifically a racetrack-shaped cross-section including a pair of longitudinal sides 1404b extending between a pair of ends 1404c. As shown in FIG. 8, a thin-walled portion 1404 is provided at each of ends 1404c. Thin-walled portions 1404d and 1404d are configured to provide creases that allow collapsible portion 1404 to bend or fold when a crushing force is applied.

[0132] The patient interface 400 shown in Figures 5-8 provides context for various embodiments of patient interfaces (or portions thereof) similar to the interface 1400 described herein.

[0133] Another example of a patient interface is shown in Figures 9-11. A nasal cannula 30 includes a face mount portion 32, a pair of nasal prongs 33, 34, a gas flow manifold portion 35, and a gas conduit 32. The face mount 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 patient's upper lip during use. The upper portion 32a and the face-contacting portion 32b are angled relative to each other and may be substantially perpendicular to each other. The face mount portion 32 and the pair of nasal prongs 33, 34 are preferably integrally molded as one piece from a soft plastic material such as silicone or a thermoplastic elastomer, although in other configurations, the face mount portion and prongs may be separate and attached for use. In some configurations, the face mount portion 32 and the nasal prongs 33, 34 may be formed from the same material or different materials. The nasal prongs 33, 34 may be tubular in shape and may be consistent in diameter but shaped to fit the contours of a person's nostrils. The prongs 33, 34 may be angled toward a central plane that bisects the face mount portion 32 between the prongs. The prongs 33, 34 may be curved to orient the prongs' outlets toward the back of the patient's head when in use. The prongs 33, 34 may include an internal and / or external cross-sectional shape transverse to the direction of flow through each prong when in use, which may be elliptical, e.g., circular, or substantially elliptical, e.g., oval. The shape and / or dimensions of each prong 33, 34 may be consistent or vary along its length. The prongs 33, 34 are configured to be non-sealing against the patient's nostrils during use, creating a gap between the prongs and the patient's nostrils. This allows for continuous gas flow between the prongs and the patient's nostrils during use.

[0134] The face mount portion 32 includes side arms 31 that extend laterally from the sides of the face mount portion 32. Together with head straps (not shown), the side arms 31 help hold the nasal cannula 30 in place on the patient's face. The end of each side arm 31 includes one or more slots through which the ends of the head straps can pass. This can provide an adjustable connection between the head straps and the side arms 31. Other attachment mechanisms besides slots, such as buckles and clips, are also envisioned.

[0135] The face mount portion 32 further includes a third portion 32c extending from the upper portion 32a and connecting to the face-contacting 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. Therefore, the gas flow manifold 35 can be inserted laterally into the recess 38 via one lateral side of the face mount portion 32 in a direction transverse to the length of the prongs 33, 34. Because the recess 38 includes two side openings, the gas manifold portion 35 can be inserted into the recess 38 from either the left or right side of the face mount portion 32. This allows the nasal cannula 30 to be configured so that gases can flow to 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 prongs 33, 34 include flow passages that extend through the face mount portion 32 and into the recess 38. The assembly of the face mount portion 32 and gas flow manifold 35 comprises a manifold. The gas flow manifold portion 35 is plugged 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 gas received from the gas conduit 3. The opening 37 is shown as an elongated opening, but other shapes are envisioned. The gas flow manifold 35 may be more rigid than the face mount portion 32 or may comprise a more rigid material. Due to the relative rigidity / flexibility of the gas manifold portion 35 and the face mount portion 32, the gas flow manifold portion 35 can be pushed through the recess 38 in the face mount portion 32, and the opening 37 in the gas flow manifold portion 35 interfaces with the flow passages of the prongs 33 and 34. Thus, during use, gases flowing through the gas conduit 3 into the gas flow manifold portion 35 exit through the openings 37 into the tubular passages in the prongs 33, 34 and then into the patient's nostrils.

[0136] 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 mount portion 32, the third portion 32c, which forms part of the recess 38, rests within the recessed portion 60, and the edges of the third portion 32c rest around the lips 58, 59 formed on the gas flow manifold portion 35. Additionally or alternatively, the gas flow manifold 35 includes one or more flanges 35a configured to engage a portion of the upper portion 32a to retain the gas flow manifold 35 with the face mount portion 32. The one or more flanges 35a are located around the periphery of the opening 37. In some forms, the one or more flanges 35a are a single flange that extends around the entire periphery of the opening 37.

[0137] The gas collector embodiments described below are attachable to or integral with nasal cannula 30, 200 and / or 1400.

[0138] Various embodiments of the gas collector provide or create one or more channels at or around the patient's upper lip 300. In some forms, the one or more channels may be formed partially by a portion of the gas collector and partially by the patient's upper lip when the gas collector is in use. The one or more channels are in fluid communication with the patient's nose 302 and mouth 304, as shown in FIG. 12 . The one or more channels provide a pathway for fluid communication between the patient's nasal region 302 and mouth region 304. In other words, the patient's nasal region 302 is in fluid communication with the patient's mouth region 304 through the one or more channels. The one or more channels are open to the atmosphere at least at the patient's nasal and / or mouth regions. In some embodiments, the one or more channels may be provided, more particularly, at or around the patient's philtrum region 306. The one or more channels assist in collecting gas from the nasal region 302 and / or mouth region 304 to a localized area for collection for sampling and analysis. In some forms, one or more channels collect exhaled gases from the nose 302 and / or mouth 304 to a localized area to help concentrate the exhaled gases before sampling and analysis. Having one or more channels that provide a path for fluid communication between the nose 302 and mouth 304 also helps collect gas samples regardless of whether the patient breathes through the nose or mouth. During use, a portion of the exhaled gases that exit the nose and mouth travels to the upper lip area; therefore, one or more channels create a collection area around the upper lip, which is beneficial for collecting gases from the nose and / or mouth area, especially during high-flow gas delivery.

[0139] In one or more embodiments, the one or more channels may be created, in part, by a portion of the preformed curve of the nasal cannula. Additionally or alternatively, a device that is integral with or removably attachable to the nasal cannula may be used to form these channels.

[0140] Figures 13, 14 and 15 respectively show three different types of channel configurations, labeled 400, 402 and 404. These images are shown looking up at the patient's chin, with the outline of the patient's nose 406 and nostrils 408 and 410, as well as nasal prongs 412 and 414 for delivering gases to the patient's nasal passages, shown by dashed lines.

[0141] The spacers, shown as solid blocks, maintain a portion of the channel wall away from the patient's upper lip 450, 452, 454. In some embodiments, the channel wall portion spaced away from the patient's upper lip may be formed by a portion of the nasal cannula to which the gas collector is attached or integrally formed, while in other embodiments, the channel wall portion may be a device formed separately from the nasal cannula.

[0142] Although the channels shown in Figures 13-15 are shown as being partially formed by the patient's upper lip, in other embodiments, the channels may simply be made by a preform having one or more gas collection conduits formed therein that rest against the patient's upper lip.

[0143] The first channel type 400 shown in FIG. 13 includes a channel 416 bounded 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 abut the lateral sides of the patient's upper lip, on either side of the philtrum region, during use. With respect to the nasal cannula, the spacers 418 and 420 are positioned laterally relative to the nasal prongs 412 and 414. In other words, from a top view, the prongs 412 and 414 are positioned between the spacers 418 and 420. The spacers 418 and 420 are configured to be positioned below the nasal prongs 412 and 414 as long as the upper lip is positioned below the nostrils. In some embodiments, the spacers 418 and 420 are positioned directly below the nasal prongs 412 and 414. Gases exhaled or delivered by the patient through the nasal cannula into the channel can be collected from multiple locations within the channel. The collected gases can then be analyzed in situ or delivered to a gas analyzer for analysis. The gas analyzer can include a negative flow source that draws the collected gases at a flow rate of about 40 ml / min to about 500 ml / min. In some embodiments, spacers 418 and 420 can be integral with or attachable to the nasal cannula.

[0144] The second channel type 404, shown in FIG. 15, includes a spacer 422 folded and positioned substantially along the central plane of the gas collector. In use, the spacer 422 is configured to contact the philtrum region of the patient's upper lip and to be positioned below and substantially between the patient's nostrils and between the prongs 412 and 414 of the nasal cannula. Positioning the spacer 422 in this manner creates 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 upper lip. The open channels 424 and 426 are also in fluid communication with the patient's oral passages and upper lip (not shown). The channels 424 and 426 are configured to facilitate fluid communication between these regions. Collected gas can be drawn from one or more locations within the channels so formed.

[0145] In the third channel type 402 shown in FIG. 14 , spacers 428 and 430 are configured to contact the patient's upper lip during use and may be positioned below the patient's nostrils and below the nasal prongs 412 and 414. Additionally, additional spacers 432 and 434 may be positioned below the patient's nostrils and on either side of the nasal prongs 412 and 414. These additional spacers 432 and 434 may contact a portion of the patient's nasolabial folds. This creates three separate channels 436, 438, and 440. Again, these open channels are created between the patient's nose, mouth, and upper lip area to allow gas collection at sampling regions. Samples of exhaled gas may be drawn from these sampling regions, for example, for further analysis.

[0146] In some embodiments, spacers 418, 420, 422, 432, 434, 428, and 430 are attachable to or integrally formed with a gas collector. 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.

[0147] It will be understood that the arrangements shown in Figures 13-15 are exemplary only and are intended to illustrate three non-exhaustive ways in which the channel wall portions can be spaced from the patient's face by the spacer to create an open channel to allow collection of gases exhaled by the patient from the nasal and oral passages.

[0148] 16-18 illustrate 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 channel with the patient's upper lip, the channel having open ends in fluid communication with the patient's nasal and oral passages, respectively. In this example, the interface 502 has a "scoop" portion including 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 necessary spacing. The spacers 506 and 508 are generic in this example and are integral with the channel wall portion 504. The spacers 506 and 508 are generic in this example and are positioned on either side of the nasal passages so as to contact the patient's face.

[0149] In this example, the gas collector 500 is configured to attach to a nasal cannula 510, which includes a gas delivery conduit 512 (or gas delivery member 512) and nasal prongs 514 and 516. The channel wall portion 504 includes apertures 518 and 520 that allow the gas collector 500 to be positioned over the nasal prongs 514 and 516. The channel wall portion 504 also includes two other apertures 522 and 524 therethrough, which form an oral gas inlet 522 (sometimes known as a first gas inlet 522) and a nasal gas inlet 524 (sometimes known as a second gas inlet 524), respectively. The nasal and oral gas inlets 522, 524 may be collectively referred to as gas inlets. In some forms, the oral gas inlet 522 may primarily collect gases from the patient's mouth region (e.g., exhaled gases from the patient's oral passage). In some embodiments, the nasal gas inlet 524 may primarily collect gases from the patient's nasal region (e.g., exhaled gases from the patient's nasal passages). In some embodiments, the oral gas inlet 522 and / or the nasal gas inlet 524 may collect gases from both the patient's nasal and oral regions. As best shown in FIGS. 17 and 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 region for collecting both oral and nasal gases 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, comprises a rigid structure. The adapter 530 and the channel wall portion 504 are configured to position a portion of the nasal cannula 510 therebetween, allowing the gas collector 500 to be attached to the nasal cannula 510. As shown particularly in FIGS. 17 and 18, a portion of the nasal cannula 510 is sandwiched between the channel wall portion 504 and the adapter 530 .

[0150] 16-18, the gas sampling points are shown as combined, however, in some embodiments, individual samples are sent back to two gas analyzers to sample each location and determine parameters from the patient, such as how the patient is breathing.

[0151] In some embodiments, gas collection inlets 522 and 524 may be a single inlet. In some embodiments, channel wall portion 504 includes an auxiliary channel fluidly connecting first gas inlet 522 and second gas inlet 524. Additionally, in some embodiments, gas collector 500 may have two or more gas collection inlets 524 for collecting gas from the nose and two or more gas collection inlets 522 for collecting gas from the mouth.

[0152] In this embodiment, the gas collector 500 is formed separately from the nasal cannula and then attached thereto, although in other embodiments the gas collector may be formed integrally with the nasal cannula. In such an arrangement, the nasal cannula may at least partially form a channel wall portion spaced from the patient's face by a suitable spacer to form an open channel that rests on the patient's upper lip.

[0153] The interface 502 can be made from a variety of materials. For example, the interface can be made from a soft polymer, such as silicone, that can conform to the contours of the user's face to minimize or avoid pressure points. The interface 502 can also include more than one material, such as a polymer and a metal, or a polymer with different properties.

[0154] Spacers 506 and 508 may take the form of thickened ribs that contact the patient's face on either side of nasal prongs 514 and 516. An open channel is created between the patient's nose, upper lip, and mouth by channel wall portion 504, which may form a thinned portion of interface 502 that is offset from the face with the aid of thickened ribs 506 and 508 that provide rigidity.

[0155] Thus, the thickness of spacers 506 and 508 may exceed that of channel wall portion 504, and spacers 506 and 508 may also be stiffer than channel wall portion 504. In some embodiments of the invention, the stiffness of the spacers may exceed that of the channel wall portion (e.g., the required stiffness may be achieved by shape / form and / or material, and in some embodiments, the Young's modulus of the spacers may exceed that of the channel wall portion).

[0156] The channel wall portion may be formed from or otherwise configured to bend when in contact with the patient's face. The gas collector may be capable of maintaining its shape during use. In some embodiments, the gas collector is adapted to maintain a preformed shape during use. In some embodiments, the gas collector may be configured to avoid precisely conforming to the contours of the patient's face to avoid creating a channel with the patient's upper lip during use. In some embodiments, the gas collector may include a preformed shape having a substantially different curvature in the channel wall portion compared to an average patient's upper lip (e.g., the channel wall portion is more convex in a direction away from the patient than an average patient's upper lip). In some embodiments, the gas collector is resilient and resists bending to conform the gas collector to the patient's face and avoid creating a channel. In other embodiments, the gas collector is configured to bend to accommodate medical scopes and other instruments that may be inserted into the patient's mouth.

[0157] It will be appreciated that the gas collector 500 shown in Figures 16-18 is non-sealing. That is, as best shown in Figure 18, the interface 500 includes a top surface 534 that, in use, resides directly under the patient's nose but does not create a seal with the nose, i.e., there is a gap between the nose and a portion of the top surface 534, allowing continuous gas passage between the nose and the atmosphere.

[0158] 16 , the gas collector 500 may include a mouth engaging portion 536 configured to protrude into the patient's mouth and maintain an open passage between the patient's mouth and the mouth gas collection inlet 522. In particular, the gas collector 500 is configured to protrude into the patient's mouth and engage only the patient's upper lip, prying open the patient's mouth and establishing an open passage for gases within the patient's mouth to exit to the atmosphere and / or into the channel created between the patient's nose, upper lip, mouth, and channel wall portion 504.

[0159] 16-18, the mouth-engaging portion includes a lower end that protrudes into the patient's mouth and is shaped to avoid creating 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, allowing continuous gas passage between the mouth and the atmosphere. In other words, the mouth-engaging portion is configured to protrude into the patient's mouth and maintain an open passage between the patient's mouth and the second gas collection inlet.

[0160] In particular, in this embodiment, the lower end of the mouth-engaging portion has an inner surface that includes edge portions 558 and 560 (best shown in FIG. 16) that, in use, rest against the sides of the patient's mouth. The inner surface of the lower end of the mouth-engaging portion also includes a central portion 542 that, in use, rests in the center of the patient's mouth and is further away from the patient's upper lip than the edge portions (see FIG. 17). In various embodiments of the present invention, the inner surface of the first end of the mouth-engaging portion may have a U- or V-shaped profile when viewing the gas collector 500 in the perspective view of FIG. 17. Other shapes for the mouth-engaging portion, such as a C-shaped profile or a W-shaped profile, may also be envisioned depending on the application.

[0161] 18 avoids creating a seal with the nose, it will be understood that this is only one example of the more common case in which the channel wall portion 504 includes an upper end that extends outwardly from the patient's face. In some embodiments, the outward extension of the upper end of the channel wall portion from the patient's face can result from the channel wall curving outwardly from the patient's face.

[0162] 16-18, it can be seen that interface 500, and in particular channel wall portion 504 and thickened ribs 506 and 508, form a gas flow diverter configured to direct at least a portion of gases exhaled by the patient toward gas collection inlets 522 and 524. Gas flow diverter 500 includes an upper portion 538 extending away from the patient's face, a lower portion 536 extending toward the patient's face, and an intermediate portion 540 interconnecting the lower and upper portions, as best shown in FIG. 18. Intermediate portion 540 extends in a direction substantially parallel to the patient's face.

[0163] From Figures 16-18 it can be seen that at least a middle portion of the gas flow diverter has an inner surface that faces the patient's face during use and substantially conforms to the shape of the patient's face from the tip of the nose (nasal tip point) to the upper lip area or below the upper lip area.

[0164] In certain embodiments, the interior surface of gas flow diverter 500, or a longitudinal cross section of gas flow diverter 500 along its length taken relative to the sagittal plane of the patient, has a substantially S-shaped configuration.

[0165] Images 600 and 602 of the gas collector 500 shown in Figures 16-18 in use are shown in Figures 19 and 20. In particular, the attachment of the gas collector to a nasal cannula (e.g., nasal cannula 200, 1400) and the non-sealing of the upper and lower portions of the interface to the patient's nasal and oral passages, respectively, can be seen.

[0166] 21-26 show a patient interface 2400 in the form of a nasal cannula similar to the nasal cannula 30 shown in FIGS. 9-11. The nasal cannula 2400 includes a patient conduit 2401 configured to deliver system gases (e.g., a gas flow from a flow source) to a patient through a manifold 2406 to a delivery outlet including a pair of nasal prongs 2408. The pair of nasal prongs 2408 extend from the manifold 2406. The patient conduit 2401 may extend from either the left or right side of the nasal cannula 2400. The interface 2400 further includes side arms 2403 and 2404 extending laterally from the sides of the manifold 2406. Side arms 2403 and 2404 include ends 2409 and 2410 configured to connect to head strap ends 2411 and 2412, respectively.

[0167] Unlike the embodiment shown in Figures 5-8, gas delivery side member 1401 does not include a collapsible portion configured to move from a normally open state to a collapsed configuration.

[0168] The gas collector 2415 may be formed separately from and removably attachable to the nasal cannula 2400. For example, as best shown in FIGS. 23 and 24, an adapter 2418 is engageable with the body 2420 of the gas collector 2415 to hold the gas collector 2415 on the nasal cannula 2400. When engaged, one or more flow channels within the adapter 2418 are in fluid communication with one or more passages in the conduits 2416 and 2417. In other embodiments, the gas collector 2415 is integrally formed with the nasal cannula. Features of the gas collector 2415 are shown in FIGS. 23-26. In many respects, the gas collector 2415 is substantially identical to the gas collector 500 shown in FIGS. 16-20. In some embodiments, gas collector 2415 is integrated with conduits 2416 and 2417 rather than attached to them, which in turn is integrated with adapter 2418 that forms a gas collection area for collecting gases from both the mouth and nose before sampling and further analysis.

[0169] FIGS. 27-35 illustrate further embodiments of a gas collector for collecting gases exhaled by a patient from the nasal and oral passages. The embodiment illustrated in these figures forms a second channel type, as shown in FIG. 15. In this embodiment, a gas collector 700 includes an interface 702 configured to form multiple channels in the patient's upper lip, the channels having open ends 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 during use. In one example, a portion of a nasal cannula 732 may contact a portion of the patient's upper lip during use, similar to the first channel type shown in FIG. 13. In such an example, the gas collector may form a combination of the first and second channel types shown in FIGS. 13 and 15. One or more nasal and oral gas collection conduits 706-710, as shown schematically in FIG. 29, are formed within the spacer 704. Arrows 734, 736 indicate the flow direction of redirected supply gas from nasal prongs 728, 730. Each nasal gas collection conduit 706 and 708 has a nasal gas collection inlet 712 and 714, respectively, that is in fluid communication with the patient's nasal passages and delivers gases exhaled by the patient from the nasal passages to an outlet. Oral gas collection conduit 710 formed in the spacer has an oral gas collection inlet 716 that is in fluid communication with the patient's oral passages.

[0170] The gas collector also includes a gas flow diverter 720, which in this embodiment has the form of a concave scoop configured to direct at least a portion of the gases exhaled by the patient from the oral passageway to the oral gas collection inlet. The gas flow diverter 720 may be integral with or attachable to the spacer 704.

[0171] The problem of dilution of exhaled gases from the nose and mouth is addressed in several ways. For exhaled gases from the mouth, a gas flow diverter limits the escape of exhaled gases or simple mixing with the atmosphere. For that matter, the gas flow diverter is in the form of a concave scoop having a central portion 722 extending toward the patient's face and side portions 724 and 726, which collectively act to minimize the escape of exhaled gases. Furthermore, for exhaled gases from the nose and mouth, the inlets 712-716 are positioned to maximize exhaled gas collection and minimize intake air from nasal prongs 728 and 730, which form part of a nasal cannula 732 to which the gas collector 700 is attached.

[0172] The problem of dilution becomes acute in NHF applications. Redirected gas delivered to the patient via nasal prongs 728 and 730 can dilute exhaled air and prevent exhaled air from the mouth from entering the gas collection inlets 712-716. In the embodiment shown in FIGS. 27-35, one measure used to address this problem is to position the nasal gas collection inlets 712 and 714 closest to the patient's nasal passages when in use. Furthermore, the nasal gas collection inlets 712, 714 are positioned transverse to the length of the created channel. This position minimizes the dynamic pressure for gas to enter the nasal gas collection conduits 706, 708. Thus, the nasal gas collection inlets 712 and 714 may be positioned in one or more of the following positions: a first position in which the nasal gas collection inlets 712, 714 are substantially parallel to the length of the channel and point toward the gas flow from the patient's nasal region; a second position in which 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. Nasal gas collection inlets 712, 714 pointing toward the gas flow from the patient's nasal region create a region of high pressure within the nasal gas collection conduits 706, 708 which, in embodiments where they are connected to the oral gas collection conduit 716, increases resistance to flow within the oral gas collection inlet 716 and conduit 710, thereby making it more difficult to collect gas from the patient's mouth region.

[0173] A further measure is to position the oral gas inlet 716 at the bottom of the spacer 704, when in use, closest to the patient's mouth. As can be seen in FIG. 29 , this allows the oral gas collection conduit 710 to form a path to a junction with the nasal gas collection conduits 706 and 708. The concave scoop configuration of the gas flow diverter 720 helps to guide exhaled air from the mouth to the oral gas collection inlet 716. The advantage of having such a junction is that it captures a significant amount of exhaled gas from the mouth, which may not be washed away by the redirected supply gas from the nasal prongs 728 and 730.

[0174] The problem of capturing exhaled gases when a patient switches between exhaling through the mouth and the nose is further addressed by providing a separate gas collection inlet for collecting exhaled gases, located at the junction, as shown schematically in Figure 29. The one or more nasal gas sampling conduits and the oral gas sampling conduit are configured such that the flow rate of the one or more nasal gas sampling conduits is a percentage of the total flow rate in the one or more nasal gas sampling conduits and the oral gas sampling conduit, where the percentage is within a predetermined range. This total flow rate includes the calculated total flow rate (i.e., the mathematical sum of the respective flow rates) of the flow rates in the one or more nasal gas sampling conduits and the oral gas sampling conduit, and the combined flow rate when the flow in the one or more nasal gas sampling conduits and the flow in the oral gas sampling conduit are combined, for example, at the junction.

[0175] In some embodiments with multiple nose gas sampling conduits, the multiple nose gas sampling conduits and the multiple mouth gas sampling conduits are configured such that the total flow rate in the multiple nose gas sampling conduits and the mouth gas sampling conduits is a percentage of the total flow rate in the multiple nose gas sampling conduits and the mouth gas sampling conduits, where the percentage is within a predetermined range. In some embodiments with multiple mouth gas sampling conduits, in such embodiments, the one or more nose gas sampling conduits and the multiple mouth gas sampling conduits are configured such that the flow rate in the one or more nose gas sampling conduits is a percentage of the total flow rate in the one or more nose gas sampling conduits and the multiple mouth gas sampling conduits, where the percentage is within a predetermined range. The predetermined range may be between about 1% and about 99% (e.g., the flow rate in the one or more nose gas sampling conduits is 1% of the total flow rate in the one or more nose gas sampling conduits and the mouth gas sampling conduits), preferably between about 5% and about 95%, and even more preferably between about 20% and about 80%. In some embodiments, the predetermined range is about 45% to about 55%. In some embodiments, the ratio may be about 50% so that the flow rate in the one or more nasal gas sampling conduits and the flow rate in the one or more oral gas sampling conduits are substantially balanced.

[0176] In some embodiments, the relative positions of the nose and / or mouth gas inlet openings may be configured to achieve the above-mentioned percentages within a predetermined range. For example, as shown in Figure 30, the nose gas inlet opening is positioned perpendicular to the flow direction through the channel from the patient's nose region to the patient's mouth region, while the mouth gas inlet opening is positioned facing the patient's mouth region and is substantially parallel to the flow direction through the channel from the patient's nose region to the patient's mouth region.

[0177] In some embodiments, to achieve the above-mentioned percentages within a predetermined range, the nasal gas sampling conduits 708 and 706 and the oral gas sampling conduit 710 may be configured such that the ratio of resistance to flow (RTF) within one or more of the 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 may be configured such that the ratio of the total RTF within one or more of the nasal gas sampling conduits to the RTF within the oral gas sampling conduit is within a predetermined range.

[0178] In one or more embodiments, the nose gas sampling conduit and the mouth gas sampling conduit may be configured such that the RTFs in each of these conduits are substantially equalized (i.e., are substantially the same). Having substantially equalized RTFs in each conduit may not result in substantially balanced flow rates in the nose gas sampling conduit and the mouth gas sampling conduit.

[0179] In one or more embodiments, the RTF in one or more of the nasal gas sampling conduits (or the total RTF in one or more nasal gas sampling conduits) may exceed the RTF in the oral gas sampling conduit by a predetermined amount. This predetermined amount may be based on the flow rate in one or more nasal gas sampling conduits and the total flow rate in one or more nasal gas sampling conduits and the oral gas sampling conduit as a percentage within a predetermined range, as described above. For example, the RTF in one or more of the nasal gas sampling conduits (or the total RTF in one or more nasal gas sampling conduits) may exceed the RTF in the oral gas sampling conduit by 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%. In some embodiments, the RTF in one or more of the nasal gas sampling conduits (or the combined RTF in one or more nasal gas sampling conduits) may exceed the RTF in the oral gas sampling conduit by about 200%, about 300%, about 400%, or more than about 400%, which may be beneficial when the patient is supplied with nasal high flow gas primarily from the nasal prongs 728 and 730 of the nasal cannula 732 and is primarily a mouth breather.

[0180] In other embodiments, the RTF in the nasal gas sampling conduit may be less than the RTF in the oral gas sampling conduit. In other words, the RTF in the oral gas sampling conduit may exceed the RTF in one or more of the nasal gas sampling conduits (or the total RTF in one or more nasal gas sampling conduits) by a predetermined amount. For example, the RTF in the oral gas sampling conduit may exceed the RTF in one or more of the nasal gas sampling conduits (or the total RTF in one or more nasal gas sampling conduits) by 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%. This can be beneficial when the patient is primarily supplied with nasal low-flow gases from the nasal prongs 728 and 730 of the nasal cannula 732 and primarily breathes through the nose.

[0181] Configuration of the nose and mouth gas sampling conduits to achieve a ratio in RTF between the nose and mouth gas sampling conduits can be achieved by configuring one or more parameters of the conduits or flow paths within the conduits (e.g., cross-sectional area, shape, length, surface roughness, etc.). In some embodiments, the mouth gas sampling conduit includes a more tortuous flow path and / or a longer flow path to a junction (e.g., where the flow paths within the conduits join) compared to one or more nose gas sampling conduits. In some embodiments, the cross-sectional shape and / or cross-sectional area of ​​the flow paths in one nose gas sampling conduit differs from the cross-sectional shape and / or cross-sectional area of ​​the flow paths in another nose gas sampling conduit and / or mouth gas sampling conduit.

[0182] In some embodiments, the inner surface of one or more nose sampling conduits exposed to the gas flow differs from the inner surface of the oral gas sampling conduit exposed to the gas flow; for example, the inner surface of one or more nose sampling conduits comprises a higher surface roughness than the inner surface of the oral gas sampling conduit (thereby causing one or more nose sampling conduits to have a higher RTF than the oral sampling conduit). In some embodiments, the RTF within one or more nose gas sampling conduits and / or oral gas sampling conduits may be variable. In some embodiments, such variable RTF is adjustable. In some embodiments, the cross-sectional area and / or cross-sectional shape of a portion of one or more sampling conduits may be adjustable, for example, by providing a valve that can be controlled to change parameters of the flow path through that portion. The valve may be automatically controlled or manually controlled, for example, by a rotary dial. In some embodiments, the portion may be configured to be collapsible, for example, less rigid than the rest of the conduit, such that forces acting on that portion change parameters of the flow path through that portion.

[0183] The RTF of the oral gas sampling conduit 710 can be increased by using a connector 740 (shown separately in FIG. 32) connected to the outlet to the gas collection region at the junction of the nose and mouth gas collection conduits 706-710, as shown in FIG. 31. As shown in the cross-section of the gas collector in FIG. 31, the connector 740 (which may be a Luer-type connector) includes a ledge 742 that, when inserted into the outlet, creates a tortuous path for exhaled air from the mouth. Thus, there is no or minimal flow bias, which favors exhaled air from the nose and redirected supply gas entering the nose gas inlets 712 and 714 over exhaled air from the mouth entering the mouth gas inlet 716. This means that if the patient is mouth breathing, the redirected flow entering the nose gas inlets will not wash out the exhaled air from the mouth entering the mouth gas inlets. That is, breaths exiting the mouth may also be captured.

[0184] 31 and 32, the connector 740 is a separate component, however, it will be appreciated that in other embodiments the connector may be integral with the remainder of the gas collector.

[0185] FIG. 33 shows an image 760 of the gas collector 700 when attached to a nasal cannula 732, where a tube 762 connects the connector 740 to a gas analyzer (not shown).

[0186] In some variations, the gas flow diverter may include a window to assist exhaled gases from the mouth into the oral gas collection inlet 716. As shown in FIG. 34 , the gas flow diverter 770 includes a window 772 located proximate the spacer 704 and the oral gas inlet 716. It will be understood that the window 772 may be of any desired shape. The window creates a path of negligible resistance for the flow of exhaled gases from the mouth. When this occurs, the gases from the mouth travel across the oral gas collection inlet 716.

[0187] Both embodiments of the gas flow diverter shown can be made of materials or structures that allow the gas flow diverter to be flexible and bendable or to make way for any oral appliance that needs to be inserted into a patient's mouth. Such an example is shown in image 780 of Figure 35, where gas flow diverter 770 can be seen bent to allow insertion into a patient's mouth to allow for insertion of oral conduit 782 or any other oral appliance into the patient's mouth.

[0188] It will be appreciated that in some embodiments of the gas collector, any portion of the gas collector may be flexible to allow for insertion of medical instruments into the patient's nose and / or mouth as needed.

[0189] Figures 36-38 show a variation of the embodiment shown in Figures 16-20 and 27-35. In this embodiment, connector 790 (e.g., a luer connector) is molded as one piece with gas flow diverter 792. The open channel created in this variation is a combination of that shown in Figures 13 and 15. That is, spacer 422 of Figure 15 is centered at either end with spacers 418 and 420 of Figure 13.

[0190] 39 and 40 illustrate an embodiment of a gas collector corresponding to the third type of open channel structure shown in FIG. 14 . For that matter, the gas collector 800 shown in these figures includes two spacers 802 and 804 positioned on either side of the patient's philtrum region when in use on the patient's upper lip to space the inner wall 806 of the nasal cannula 732 from the patient's upper lip. In this manner, multiple channels are formed in the patient's upper lip, with the nasal cannula 732 forming channel wall portions spaced, at least in part, 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, so that collected gas is delivered to a local gas collector area. In some embodiments, as described elsewhere herein, gas inlets 808 and 810 may be perpendicular to the flow of gas through the channel. For example, gas inlets 808 and 810 may be positioned as shown in the embodiment of Figures 27-35. An outlet 809 is provided in the local gas collector area to deliver collected gas to a sample analyzer (not shown) for analysis. Gas flow diverters 816 in the form of concave scoops are mounted around the oral gas inlets 812 and 814 and serve to funnel or direct at least a portion of gas exhaled by the patient from the oral passageway into the oral gas collection inlets 812 and 814.

[0191] In this arrangement, the nasal gas collection inlet and nasal gas collection conduit are aligned with the nasal prongs 728 and 730. The inlet diameter of the nasal gas collection inlet may be configured to be smaller than that of the oral gas collection inlet. In some embodiments, the nasal gas conduit, or a portion thereof, has a smaller cross-sectional diameter than the oral gas conduit, or a portion thereof. In this manner, the RTF of the passages for gases from the nose and mouth can be balanced as desired. This configuration may be particularly useful in low-flow respiratory therapy.

[0192] 41-44 show a further embodiment of a gas collector 831. In this embodiment, the gas collector is located on a non-patient-contacting portion of the nasal cannula 732. In some embodiments, a gas connector may be located on the patient-contacting portion of the nasal cannula 732. In this embodiment, the gas collector includes a mouth-engaging 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 herein. The mouth-engaging portion is in the form of a scoop including an elongated aperture 832. The scoop, in use, may project into or rest proximate the patient's mouth to capture gases at the patient, for example, gases exhaled through the patient's mouth, and deliver the gases to a gas collection area. An outlet 834 is formed at the rear of the gas collector to provide collected gases to a gas analyzer (not shown).

[0193] The mouth-engaging portion 830 rests proximate to or within the patient's mouth. Gas exiting the patient's mouth generally travels slower than gas exiting the patient's nostrils due to the larger cross-sectional area of ​​the mouth opening compared to the nostrils. Gas exiting the nose may have a higher velocity due to the smaller cross-sectional area of ​​the nostrils and / or the combined effect of the redirected supply flow from the prongs 728 and 730. Therefore, the mouth-gas aperture 832 may be configured to be positioned closer to the mouth than the nasal gas inlet 836 when the gas collector is positioned on the patient's face. The mouth-gas aperture 832 also includes a larger cross-sectional area than the nasal gas inlet 836. In the illustrated embodiment, the nasal gas inlet 836 is located adjacent to the non-patient-contacting portion of the nasal cannula 732, below its base, between the prongs 728 and 730. However, the nasal gas inlet 836 may be positioned elsewhere.

[0194] The nasal and oral gas inlets may be positioned to maximize gas collection in the patient's nasal and oral regions. For example, in high-flow applications, a high flow of gas from the nasal cannula 732 may be redirected into the nasal gas collection inlet. This high-flow gas flow rate may exceed the gas flow rate from the patient's oral region. Therefore, it may be beneficial to position the nasal inlet distal to the patient's nasal region and / or the prongs of the nasal cannula 732 and position the oral gas collection inlet proximal to the patient's oral region. Additionally or alternatively, it may be beneficial for the nasal gas inlet (or any portion of the conduit downstream of the nasal gas inlet) to include a smaller cross-section than the oral gas collection inlet (or portion of the conduit downstream of the oral gas inlet).

[0195] FIG. 45 shows a gas flow diverter 850 similar in form and function to the gas scoop 830, with some notable exceptions. The gas flow diverter 850 also has a large-opening inlet funnel 852 in the form of a scoop 868 that is located closest to the patient's mouth when in use. The gas flow diverter 850 also includes a top lip 854 that is placed directly under the patient's upper lip when in use. This ensures that an open channel is created between the patient's mouth and the inlet funnel 852. Keeping the mouth open encourages mouth breathing and exhaling through the mouth, which helps ensure the collection of target gas traces. The gas flow diverter 850 also includes nasal ports 862 and 864 located on opposite sides of the scoop 868, so that each nasal port is closest to one of the patient's nasal passages.

[0196] Consistent with previous embodiments, the embodiment shown in FIG. 45 is non-tight, has a low profile, and does not completely cover the mouth like a mask. The non-invasive nature of the device shown in FIG. 45 allows for other devices, such as a laryngoscope, to be inserted through the mouth. Exhaled gases are delivered through an inlet funnel 852 to an outlet port 856 that connects to a sampling conduit (not shown). The conduit then transports the sample gas to a gas analyzer (commonly known as sidestream capnography when the target gas is CO2). Additionally or alternatively, the conduit may include a gas analyzer.

[0197] The arrangement shown in Figure 45 is formed separately from and removably attachable to a nasal cannula, such as nasal cannula 30 as shown in Figures 9-11. For that matter, gas flow diverter 850 includes an attachment ring 858 and a corresponding latch 860 to enable mounting of gas flow diverter 850 around the nasal cannula. In such an arrangement, shown in Figure 46, the attachment ring and latch attach between nasal prongs 728 and 730 (or between nasal prongs 33 and 34 of nasal cannula 30 as shown in Figures 9-11).

[0198] Ideally, the attachment ring 858 has a profile that fits snugly against the base of the cannula prongs, creating a secure fit. The gas flow diverter 850 is preferably mounted, directly or indirectly, to a rigid manifold portion of the nasal cannula to provide a stable mounting base and enhance sampling stability and consistency. Any suitable shape of attachment ring may be used to accommodate a variety of patient interfaces.

[0199] A further embodiment of gas flow diverter 850 is shown in Figure 47. In this embodiment, gas flow diverter 862 has a similar form and function to gas flow diverter 850. However, a mounting ring 864 is shown having a shape adapted to fit a different patient interface, as well as a connector 866 inserted into the outlet port.

[0200] The various embodiments of gas collectors described above and shown in previous figures may be attached to the nasal cannula in any one of several ways. For example, as shown in FIG. 48, an exemplary gas collector 1000 may be attached to the nasal cannula 1002 by an adhesive, such as glue, adhesive tape, or any other type of adhesive, that may be applied to the facing surfaces of the gas collector 1000 and the nasal cannula 1002. Alternatively, the gas collector 1000 may be attached to the nasal cannula 1002 by other bonding means, such as solvent bonding or RF or ultrasonic welding.

[0201] A hook-and-loop or similar adhesive or sticky patch may also be attached to the patient's face. The opposing side of the sticky patch on the patient's face may have hook or loop material. The gas collector interface may have hook or loop material on the winglets that mate with the patch on the patient's face. This may allow the clinician to properly position the sampling interface on the patient's face. Additionally, hook-and-loop patches may also be used on nasal cannulae or other sampling interfaces to connect to the gas collector. This may also allow the clinician to adjust the position of the gas collector.

[0202] 49, another attachment method may include providing push-through buttons, otherwise known as barbs, on one or other of the gas collector 1000 and the nasal cannula 1002. The push-through buttons 1004 and 1006 engage corresponding apertures 1008 and 1010 to secure the gas collector to the nasal cannula. The use of multiple barbs or buttons and multiple corresponding apertures may be used to limit rotation of the gas collector relative to the nasal cannula.

[0203] A further attachment method is shown in FIG. 50 . In this example, clips 1112 and 1114, e.g., having C-shaped structures and protruding from the gas collector 1000, are provided to secure the gas collector 1000 to the nasal cannula 1002. The clips may be formed from a flexible material to allow the nasal cannula 1002 to deform and be pushed through the gaps in the clips' C-shaped structures. Once inserted into the C-shaped clips 1112 and 1114, the nasal cannula 1002 returns to its original geometric shape. A further such attachment method involving C-shaped clips is shown in FIG. 51 , where insertion of the nasal cannula 1002 through the gaps in the C-shaped clips 1116 and 1118 causes elastic deformation of the C-shaped clips and retention of the nasal cannula. Typically, the nasal cannula 1002 is hollow and made from a soft / flexible material. As such, the nasal cannula 1002 may be compressed to facilitate insertion into the C-shaped clips 1116, 1118. Once fully inserted into the C-shaped clips 1116, 1118, the nasal cannula 1002 returns to its original shape.

[0204] A further mounting arrangement is shown in FIG. 52. In this figure, the gas collection inlet formed in the gas collector 1000 includes integral "barbs" 1020 and 1022 that function as clips to lock the nasal cannula 1002 in place in a manner similar to the clip concepts described in previous figures. In a further embodiment shown in FIG. 53, a spring-loaded clip 1024 is provided on the gas collector 1000. A clinician can expand the clip to insert the nasal cannula 1002. The clip may be spring-loaded so that it regains the shape shown in the figure after elastic deformation. The clip 1024 wraps tightly around the manifold of the nasal cannula 1002.

[0205] 54, straps 1026 and 1028 may be provided on the gas collector 1000 to allow the nasal cannula 1002 to be secured to the gas collector 1000. The straps may be routed separately from or integral with the gas collector 1000. If separate, the straps may be secured across the gas collector 1000 and the nasal cannula 1002 to secure them together.

[0206] The straps integral with the gas collector 1000 may take the form of slits cut into extended winglets protruding from either side of the gas collector 1000. The gas collector 1000 is slid over the nasal cannula 1002.

[0207] Yet another method of attachment is shown in Figure 55. In this case, a length of strap material 1030 may be wrapped around the nasal cannula 1002. The terminal portion of the strap material 1030 may have a buckle, cable tie, pin connector, or the like that permanently or non-permanently attaches the gas collector 1000 (not shown) to the nasal cannula 1002.

[0208] 56-59 show 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 protrude into the patient's mouth to maintain an open passage between the patient's mouth and the oral gas collection inlet, may, in one embodiment, have a raised profile, moving the middle portion of the U-shaped channel section 1048 further away from the patient's upper lip. This creates a deeper opening / orifice channel in the mouth-engaging portion, which advantageously makes the opening / orifice less susceptible to blockage, for example, by saliva or by the patient's teeth or tongue.

[0209] The gas collector 1040, here in the form of a sampling scoop, may be transparent. As shown in FIG. 59, the gas collector body 1040 may be made of a transparent material, such as polymethyl methacrylate (PMMA), polycarbonate (PC), silicone, or a thermoplastic elastomer (TPE) (e.g., styrene-ethylene-butylene-styrene (SEBS)). Providing a transparent body of this nature allows medical personnel to view the patient's face, which is useful for ensuring proper placement of the nasal prongs within the patient's nose, as well as the overall alignment and good functioning of the gas collector and nasal cannula.

[0210] As shown in FIGS. 60-62, the body of the gas collector 1040 can be reinforced by incorporating structural members into or on the gas collector body. The structural members can be stronger in tension and compression relative to the gas collector body. In one or more embodiments, the gas collector and structural members can be the same material, but the reinforcement can be provided by thickening the areas where reinforcement is needed. In a first embodiment, shown in FIG. 60, the body of the gas collector 1060 is reinforced by a structural member 1062 extending around its perimeter to ensure it retains its shape. In a second embodiment, shown in FIG. 61, the body of the gas collector 1064 is reinforced by a structural member 1066 extending around the perimeter of the body, and further by horizontal stiffening members 1068 and 1070 to prevent the gas collector body 1064 from collapsing when the patient is in the supine position. In some embodiments, the structural member 1062 may not be present. In some embodiments, there may be multiple horizontal stiffeners 1068 and 1070 or a single horizontal stiffener. One or more of the horizontal stiffeners may not extend to the edge of the gas sampler 1040, but may terminate before the edge.

[0211] 62, the body of the gas collector 1072 includes a peripheral rigid structural member 1074 and further includes vertical stiffening members 1076 for resisting vertical forces applied to the body, preventing collapse of the gas collector 1072 when the instrument is inserted into a patient's mouth. In some embodiments, the structural member 1074 may be absent. In some embodiments, multiple vertical stiffening members 1076 may be present. One or more of the one or more vertical stiffening members may not extend to the edge of the gas sampler 1040, but may terminate before the edge.

[0212] It will be understood that the positioning of the rigid member dictates the direction in which the gas collector body in question will be rigid. For example, a gas collector body that can retain its shape when bent may be useful. This may be achieved by embedding a malleable member in the body, meaning that, instead of being resisted, upon application of a sufficiently high force, the malleable member (e.g., a malleable wire) will bend and the gas collector body will maintain its shape in the bent position. This means that the gas collector body can be adjusted to fit different facial contours.

[0213] In a further variation on the previously described embodiment, shown in FIGS. 63-66, it may be useful to gain access to a patient's mouth, for example, to insert medical instrumentation. In this case, the body of the gas collector 1080 may include a hinge 1082 that allows a first portion 1084 to pivotally rotate away from a second portion 1086 of the body of the gas collector 1080. One such way of creating a hinge is by creating an angled notch or slit through the body of the gas collector 1080. The angle of the slit allows the instrument to transition between a first position shown in FIGS. 63 and 65 and a second position shown in FIGS. 64 and 66.

[0214] Alternatively, as shown in FIGS. 67-70, the gas collector body may include a bistable structure. The concave structures are stable and retain their shape until a force is applied to them. In a first position, shown in FIGS. 67 and 69, the mouth-engaging portion 1092 of the gas collector 1090 is used to collect gas from the mouth. In a second position, shown in FIGS. 68 and 70, the mouth-engaging portion 1092 is folded and curved away from the patient's mouth to allow insertion of medical instrumentation into the patient's mouth. When switching from the first position to the second position, the intermediate positions are unstable, and the body of the gas collector 1090 assumes the most stable shape.

[0215] As can be seen in FIGS. 71-76, the body of the gas collector may include an opening for inserting and retaining medical instruments in a 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 FIGS. 71 and 72. As shown in these figures, the body of the gas collector 1110 may include a tear-away section 1112 that, when removed, reveals an aperture 1114 through the body of the gas collector 1110 to allow insertion of the medical instruments into the patient's mouth. In an alternative arrangement, shown in FIGS. 73 and 74, the body of the gas collector 1116 may include a slit 1118 that, when widened, creates an aperture 1120 to allow insertion of the medical instruments into the patient's mouth. The slit may or may not seal around the medical instruments.

[0216] A tear-away section, or two separate sections, may alternatively or additionally be added to the portion of the gas collector closest to the nasal prongs for delivering gases from the nasal cannula. As shown in Figures 75 and 76, the body of the gas collector 1122 may include tear-away sections 1124 and 1126 that are removable and provide access to one of the patient's nasal and oral passages, respectively, for insertion of medical instrumentation.

[0217] The gas collector body may also have grooves on the patient-facing side that form small open channels. As shown in FIGS. 77-80, the small open channels may be formed within a larger open channel formed with the patient's upper lip. The small open channels may be formed on the patient-facing side of the gas collector body. The grooves are configured to capture the patient's bodily fluids, such as saliva. Any gas then migrates across the fluid captured in the small open channels and enters the gas inlet. In FIGS. 77-79, three grooves 1130, 1132, and 1134 are provided on the patient-facing side 1136 of the gas collector 1138. In some embodiments, there may be a single groove or two or more grooves. Additional grooves—three grooves are shown in this exemplary embodiment—are provided for redundancy. While one of the grooves extends to the gas collection inlet, this is not necessary in other embodiments.

[0218] In FIG. 80 , a groove is provided on the patient-facing side 1140 of the gas collector 1142. The groove has several branches that lead to a dead end 1144. Any bodily fluid, such as saliva, may resist a change in flow direction within the groove and become trapped at the dead end. In other words, saliva may take the path of least resistance and become trapped at the dead end. This reduces the chance of the gas collection inlet being blocked by saliva.

[0219] Additionally or alternatively, the patient-facing side 1140 of the gas collector 1142 may be lined with a moisture-absorbing or hydrophilic material to reduce the likelihood of the gas collection inlet becoming blocked.

[0220] In the arrangement shown in FIGS. 81-83 , the U-shaped mouth-engaging portion described above may be modified so that the central portion 1150 of the U-shaped section is recessed to rest away from the patient's face. Other shapes for the mouth-engaging portion, such as a V-shape, may also be envisioned. 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 the patient's upper lip, forming two channels in fluid communication with the patient's mouth. This creates an open channel between the patient's mouth and the upper lip area. This avoids covering the patient's upper lip while still creating a channel with the upper lip that allows the patient to close their mouth in place. The central portion 1150 allows access to the patient's mouth by the medical instrument without the medical instrument striking the gas collector with a force that could affect gas sampling.

[0221] In a further variation, as shown in FIGS. 84 and 85 , it may be beneficial to decouple the forces transmitted between the gas collector body and the nasal cannula. This means that when the gas collector body is moved or bumped into the position of the nasal cannula, it remains largely unaffected, and vice versa. This effect can be achieved by altering the mechanical properties of the gas collector so that the areas most susceptible to bumping or force absorption occur instead of transmitting the force to the nasal cannula. Forces may be applied to the outer edge of the gas collector 1170 by the patient's facial features or external appliances. Therefore, by making the outer edge flexible, the gas collector absorbs some of the applied force as it bends. This can minimize the amount of force transmitted from the sampling device to the nasal cannula. An example of how this can be achieved is by varying the hardness, e.g., Shore A 20-80, from the outer edge to the inner portion.

[0222] The decoupling effect can also be achieved by making the central section of the gas collector around the oral gas collection inlet thinner. Thinner material flexes and absorbs forces, meaning less force is transferred to the nasal cannula. FIGS. 86-89 show various representations of a gas collector 1180 coupled to a nasal cannula 1182 and including a thin central section 1184. An applied force "F" deforms the thin central section 1184 of the gas collector 1180. Some of this force (energy) is absorbed by the thin central section as it deforms. This minimizes the amount of force transferred from the gas collector to the nasal cannula.

[0223] As shown in FIGS. 90-97, the mouth-engaging portion of the gas collector may have an enlarged mouth-engaging portion and / or the mouth-engaging portion may be adjustable to enlarge the mouth-engaging portion. The enlarged mouth-engaging portion may have a lateral dimension relative to one or more of the lateral dimensions of the nasal cannula (e.g., cannula body), the distance between the mouth joints, or the lateral dimensions of the nose. A gas collector 1190 having a wider than normal mouth-engaging portion 1192 is shown in FIGS. 90 and 91 and is adapted to fit a patient 1194 with a wide mouth. The mouth-engaging portion may be expandable from a first, unextended position 1196 shown in FIG. 92 to a second, extended position 1198 shown in FIG. 93. As shown in FIG. 94, the mouth-engaging portion may include a series of telescoping sections. In particular, FIG. 94 shows a view of the mouth-engaging portion from below in its unextended condition 1196 and extended condition 1198, respectively.

[0224] The gas collector may be secured to the patient's face using adhesive. As shown in Figures 95-97, the adhesive is placed over the top of flexible tabs 1200 and 1202, which are angled upwards, away from the patient's mouth area, to minimize the effects of movement of the mouth area from removal of the gas collector and nasal cannula. Alternatively, or in addition, adhesive is applied to flexible tab 1204, which is secured to the patient's nose.

[0225] 98-102, the lower end, or mouth-engaging portion, of the gas collector body 1220 may receive additional support by being secured to the nasal cannula 1222 using a strap. The strap may keep the body of the gas collector 1220 stable when the patient is moved or when the body of the gas collector 1220 is accidentally bumped.

[0226] 98 , in one embodiment, straps 1224 and 1226 may be attached between the nasal cannula 1222 and opposite sides of the gas collector 1220 through slots or other attachment mechanisms formed in the gas collector 1220. By tightening one strap and loosening the other, the gas collector 1220 can be manipulated to one side or the other of the patient's mouth. This may be useful if a medical instrument needs to be inserted into the patient's nose or mouth.

[0227] Further details are provided in Figures 99-102. In Figure 99, it can be seen that an aperture 1228 is provided in the nasal cannula 1222 to allow a first end of the strap 1224 to be attached to the nasal cannula. Figure 100 shows an aperture 1230 in the body of the gas collector 1220 through which the strap may be attached.

[0228] As shown in Fig. 101, each of the straps may be secured at its other end to an aperture in the nasal cannula, through which the strap is pulled and attached to itself by stitching or by heat or chemical bonding. As shown in Fig. 102, one or more regions of the body of the gas collector 1220, such as the region marked 1232 adjacent the aperture 1234, may be made from a thin material so that as the straps are tightened, the body of the gas collector 1220 stretches and prevents the nasal cannula 1222 from being removed during the tightening process.

[0229] The nasal cannula geometry described in the above-referenced embodiment is curved at the base of the nasal prongs to conform to the patient's upper lip.

[0230] However, in the variation shown in Figures 103 and 104, a nasal cannula 1240 has a recess 1242 at the base of curved nasal prongs 1244 and 1246 to create a channel with the patient's upper lip for collecting gas.

[0231] In a further variation on the above-described embodiment, as shown in FIGS. 105-107, sampling of collected gas may additionally or alternatively be performed by a small diameter tube 1250 in fluid communication with the channel created by the recess 1242 and the patient's upper lip. The small diameter tube 1250 is configured to be positioned within the created channel, as more clearly shown in FIG. 106, with the inlet of the tube 1250 facing below or toward the mouth scoop portion of the gas collector 1254, when in use. In such a position, the inlet of the tube 1250 is positioned parallel to the flow within the created channel and facing away from the gas flow from the patient's nasal region. In other embodiments, the inlet may be positioned differently, for example, transverse to the length of the created channel. The small diameter tube 1250 may be hooked or otherwise connected to a nasal cannula 1252 with which the gas collector 1254 is mounted or integrally formed.

[0232] As an alternative to the above-described embodiment, as shown in Figures 108-110, the nasal and oral gas collection inlets may be formed by multiple channels 1260. Multiple channels 1260 may replace one or both of the nasal and oral gas collection inlets formed through the body of gas collector 1262. The multiple channels provide redundancy in case one or more channels are blocked by, for example, material 1261, such as saliva and / or nasal mucus / secrets from the patient as shown in Figure 110.

[0233] As shown in FIGS. 111-123, in a further variation on the above-described embodiment, it may be convenient to connect a sampling line 1270 to an outlet port 1272 of a gas collector 1274 with a single action, e.g., by pushing to create the connection. Several single-action connection mechanisms are possible. The outlet port 1272 that receives the sampling line 1270 may have multiple tapered members 1276 that flare when the sampling line 1270 is inserted. Friction between the flared thin members and the sampling line causes the thin members to bend and bite into the sampling line when attempting to pull the sampling line away from the outlet port. Various examples of such tapered members are shown in FIGS. 112-116. As shown in FIG. 117, two or more outlet ports 1276 and 1278 may be provided for redundancy.

[0234] Additionally, the outlet port of the gas collector 1282 may have an extension sampling line connector attached to it. The extension sampling line connector may be integral with the gas collector or removably attachable thereto. A connector (e.g., a twist-lock mechanism or a push-fit type, such as a Luer connector) may be used to connect the sampling line (not shown) to the extension sampling line connector. Such an extension may move the connection point to the sampling line away from the patient's face. Therefore, when attaching the sampling line, force is not applied directly to the patient's face or the nasal cannula.

[0235] An example is shown in FIG. 118 , which shows an outlet port 1280 forming part of a gas collector 1282 attached to a nasal cannula 1284. An extension sampling line connector 1286 and tubing 1288 can be seen to be connected to the outlet port 1280. The extension sampling line and connector can be attached to the gas pathway connector of the nasal cannula 1284.

[0236] Alternatively, as shown in Figures 119 and 120, the extension sampling connector 1290 and line 1292 may be flexible and free-floating, allowing them to be oriented in a variety of ways. Tabs 1294 and 1296 may be provided on the sampling line connector 1290 to assist in gripping the sampling line connector during assembly.

[0237] In a further variation on the above-described embodiment, visual information may be provided on the body of the gas collector to assist in proper device selection and device orientation. Representative indicia 1300 indicating the size of the body of the gas collector 1302 is shown in Fig. 121, while Figs. 122 and 123 include exemplary indicia 1304 and 1306, for example, in the form of an arrow 1304 and / or text (e.g., "this way up") 1306 to assist in orienting the gas collector during use.

[0238] A gas collector 2000 for collecting gases exhaled from the nasal and / or oral passages by a patient, according to a further embodiment, is shown in Figures 124-127. Similar to several previous embodiments described herein, the gas collector 2000 includes an interface 2002 configured to form a channel at the patient's upper lip. In particular, an inner wall 2004 of the interface 2002 generally extends between the patient's nasal and oral passages during use, effectively providing a volume for collecting gases (e.g., exhaled from the patient's nasal and / or oral passages) to be analyzed.

[0239] The position of the inner wall 2004 may be slightly offset from the patient's face during use. The top portion of the interface 2002 is configured to be positioned below the patient's nasal passages. At the base of the interface 2002, the gas collector 2000 includes a mouth-engaging portion 2010 for engaging with the patient's mouth. In particular, the mouth-engaging portion 2010 includes a pair of extensions 2006, 2008. Each extension 2006, 2008 is adapted to fit under opposite sides of the patient's upper lip to move the corners of the patient's upper lip away from the patient's lower lip during use, ensuring an open oral passage for the patient. As such, the "channels" created by the inner wall 2004 may be considered to have open ends that are in fluid communication with the patient's nasal and oral passages, respectively.

[0240] 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) gases from the patient's nasal passages into the single sampling inlet 2016. The sampling inlet 2016 may be approximately centrally located on the interface 2002. The elongated guide protrusions 2012, 2014 may also act as spacers to space the inner wall 2004 of the interface 2002 away from the patient's face during use.

[0241] 125-127, the gas collector 2000 further includes an outlet 2018 for providing 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 gas collected via the sampling inlet 2016 can be provided to the gas analyzer via the outlet 2018.

[0242] The interface 2002 includes a pair of opposing lateral sides 2020, 2022. The lateral sides 2020, 2022 may be configured to extend generally in a direction aligned with an imaginary vertical plane that bisects the patient's face.

[0243] 125, 126, and 127, the outlet 2018 defines a receiving port 2024 having an open outlet end 2026 for receiving a portion of a gas analyzer conduit. The receiving port 2024 of the outlet 2018 is oriented such that its open outlet end 2026 faces towards 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.

[0244] As shown in Figures 126 and 127, the receiving port 2024 has a low profile, which advantageously minimizes the risk of accidentally disconnecting the conduit during use.

[0245] Gas collector 2000 further includes a mounting portion 2028 for mounting gas collector 2000 to a nasal cannula (e.g., as shown in FIGS. 5-8 ) for delivery of breathable gas to a patient. Mounting portion 2028 defines a sleeve 2030 configured to fit snugly over and receive a portion of the nasal cannula. The inner wall of sleeve 2030 generally follows the outer contour of that portion of the nasal cannula, thereby allowing for stable mounting of gas collector 2000 on the nasal cannula during use.

[0246] As shown more clearly in FIGS. 126 and 127 , the sleeve 2030 defines a pair of slits 2032, 2034 along its top. The sleeve 2030 further defines an opening 2036 that allows the nasal prongs of a nasal cannula to protrude therethrough. The slits 2032, 2034 and the opening 2036 allow for insertion of a portion of the nasal cannula into the sleeve 2030. In this embodiment, the nasal cannula is securely received in the sleeve 2030 during use. The walls of the nasal cannula may be flexible and may be pressed together to fit through the slits 2032, 2034. In some embodiments, the walls of the sleeve 2030 may be elastic such that the width of the slits 2032, 2034 is manually adjustable, allowing for easy loading of the nasal cannula. The nasal cannula may be loaded into the gas collector 2000 in any suitable manner. For example, in other embodiments, any one or more of the features described above for mounting a nasal cannula to a gas collector may be included in place of mounting portion 2028, in any suitable combination.

[0247] 126 and 127, the gas collector 2000 has a relatively low profile so that it does not become occluded during use. This can be particularly beneficial in procedures where time is of the essence and the clinician needs to carefully navigate around various medical instruments placed in the patient's airway.

[0248] A further gas collector 2050, which is a variation of the gas collector 2000 in Figures 124 to 127, will now be described with reference to Figures 128 to 130, in which like features refer to those previously described.

[0249] The gas collector 2050 further includes a pair of nasal guides 2052, 2054. Each nasal guide 2052, 2054 extends outward from the inner wall 2004 of the interface 2002 at the upper end of the gas collector 2050. The nasal guides 2052, 2054 guide and facilitate the movement of gases from the patient's nasal passages into the channels created by the inner wall 2004, which act as funnels by the elongated guide protrusions 2012, 2014.

[0250] In the gas collector 2050, the slits 2032, 2034 of the sleeve 2030 of the mounting portion 2028 are provided below the nasal guides 2052, 2054. As described above, a nasal cannula may be deformed to pass through the slits 2032, 2034 and thus be received by the sleeve 2030.

[0251] A further gas collector 2100, which is another variation of the gas collector 2000 in Figures 124 to 127, will now be described with reference to Figures 131 to 132. In Figures 131 and 132, like features refer to those previously described.

[0252] The gas collector 2100 provides a plurality of ribs 2102 extending from the inner wall 2004 of the interface. A first group of ribs 2102 and / or rib portions 2104 are arranged in a generally V-shaped configuration to funnel gas from the nasal passages toward the sampling inlet 2016, thereby creating a first generally V-shaped funnel 2110 in an upper central region of the interface. In some embodiments, the ribs 2102 may be longer, such as the elongated guide protrusions 2012, 2014 shown in FIG. 128. In some embodiments, the ribs 2102 may be shorter.

[0253] The second group of ribs 2106 and / or rib portions 2108 extend generally diagonally downward from each side of the V-shaped funnel 2110 to a corresponding lateral side 2020, 2022 of the interior wall 2004. A pair of bottom ribs 2116, 2118 from the second group of ribs 2106 also form a generally V-shaped configuration to funnel gases from the oral passage toward the sampling inlet 2016, thereby creating a second generally V-shaped funnel 2114 in the lower central region of the interface.

[0254] The ribs 2102 advantageously funnel gases from both the patient's nasal and oral passages toward the single sampling inlet 2016 (it is envisioned that in some embodiments, as discussed above, the ribs 2102 may funnel gases from the nasal and oral passages toward multiple sampling inlets). Additionally, the ribs 2102 function as a spacer, creating an offset between the patient's face and the inner wall 2004 of the interface during use. Additionally, the second group of ribs 2106 and / or rib portions 2108 encourage drainage of fluids from the patient and downwash from the nasal cannula away from the sampling inlet 2016, thereby minimizing dilution of exhaled gases from the patient's nasal and oral passages that enter the sampling inlet 2016.

[0255] The lower edge 2112 of the interface may extend below the patient's upper lip or below the patient's lower lip during use. As shown in FIGS. 131 and 132 , 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 shown more clearly in FIG. 132 , the distance that the ribs 2106 extend from the inner wall 2004 (also referred to herein as the "extension distance") may vary. For example, the portion of the ribs 2106 closest to the lower portion of the interface may extend further outward than the portion of the ribs configured to rest on the patient's upper lip. This variation in the extension distance of the ribs 2106 may accommodate the contours of the patient's lips while maintaining an overall low profile for the gas collector 2100 (e.g., relative to the patient's face during use).

[0256] A further gas collector 2200, which is a variation of the gas collector 2100 in FIGS. 131 and 132, will now be described with reference to FIG. 133. In FIG. 133, like features refer to those previously described. In this embodiment, the gas collector 2200 does not include any ribs to funnel gases from the patient's nasal or oral passages. The inner wall 2004 of the interface may be sufficient to effectively channel gases from the patient's nasal and / or oral passages to the sampling inlet 2016.

[0257] In some embodiments, the gas collector may generally take the form of the gas collector shown in FIG. 18 as previously described, where the outlet 532 may be oriented such that the open end of the outlet 532 faces towards one of the lateral sides of the gas collector, similar to that shown in FIGS. 125-127.

[0258] A further gas collector 2300, which is a variation of the first embodiment of the gas collector shown in Figures 16 to 20, will now be described with reference to Figures 134 to 136, in which like features refer to those previously described.

[0259] The gas collector 2300 includes a mouth-engaging portion 2302 configured to extend farther than the first embodiment of the gas collector shown in FIGS. 13-20 such that the mouth-engaging portion 2302 extends below the patient's front teeth during use. In some embodiments, the mouth-engaging portion 2302 may wrap around the patient's teeth. Thus, the mouth-engaging portion 2302 may function as a mouth guard to protect the patient's teeth during a medical procedure. For example, as shown in FIGS. 135 and 136 , a laryngoscope 2304 may be used when intubating a patient in some medical procedures. In such procedures, there is a risk that the patient's teeth may be chipped due to the force applied by the laryngoscope. Therefore, the mouth-engaging portion 2302 provides protection for the patient's teeth.

[0260] Although the present disclosure has been described in terms of several embodiments, other embodiments that are apparent to those skilled in the art are also within the scope of the present disclosure. Accordingly, various changes and modifications may be made without departing from the spirit or scope of the present disclosure.

[0261] interpretation The specification, including the claims, is intended to be interpreted as follows.

[0262] The embodiments or examples described herein are intended to illustrate the present invention without limiting its scope. The present invention can be realized with various modifications and additions that will readily occur to those skilled in the art. It should therefore be understood that the scope of the present invention is not limited to the exact construction and operation described or illustrated, but is limited only by the scope of the following claims.

[0263] The mere disclosure of a method step or product element herein should not be considered essential to the invention claimed herein unless expressly stated as such or expressly recited in the claims.

[0264] The terms in the claims have the broadest meaning that would be given to them by a person skilled in the art at the relevant date.

[0265] The terms "a" and "an" mean "one or more" unless expressly specified otherwise.

[0266] Neither the title nor the abstract of this application should be construed as limiting the scope of the claimed invention in any way.

[0267] If the preamble of a claim recites a purpose, benefit, or use of the claimed invention, it does not limit the claimed invention to having only that purpose, benefit, or use.

[0268] It should be noted that terms of degree, such as "generally, entirely, approximately," "substantially," "about," and "approximately," as used herein, refer to a reasonable amount of deviation from the modified term that does not materially change the end result. These terms of degree should be considered to include deviations from the modified term if such deviations do not negate the meaning of the term they modify.

[0269] In this specification, including the claims, the term "comprise" and variations of that term, such as "comprises" or "comprising," mean "including, but not limited to," unless expressly stated otherwise or unless the context or usage requires an exclusive interpretation of the term.

[0270] Additionally, the recitation herein of any numerical ranges by endpoints includes all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, and 5). It is also understood that all numerical values ​​and fractions thereof are presumed to be modified by the term "about," which implies variation of the referenced numerical value up to a certain amount where the end result would not change significantly.

[0271] As used herein, the phrase "and / or" is intended to represent an inclusive or. That is, for example, "X and / or Y" is intended to mean 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.

[0272] Throughout this specification, like reference numerals refer to like features described herein. As such, whenever a feature or component is designated with the same numeral, a direct correlation to a similar or identical feature or component as previously described herein is implied.

[0273] The disclosure of any documents mentioned herein is for specification and enablement purposes only and is incorporated by reference into this patent application as part of this disclosure, and should not be used to in any way limit, define, or otherwise interpret any terms of this application, which would necessarily have an understandable meaning without such incorporation by reference. Any incorporation by reference does not, in itself, constitute an admission or authorization of any statements, opinions, or discussions contained in any incorporated document.

Claims

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

2. The gas collector of claim 1 , wherein the interface further comprises the channel wall portion.

3. 3. The gas collector of claim 1 or 2, wherein the interface is configured to be attached to or integral with a nasal cannula.

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

5. 5. The gas collector of claim 3 or 4, wherein the nasal cannula includes nasal prongs for delivering gases to the patient's nasal passages, and the gas collector further includes one or more openings formed through the channel wall portion for receiving the nasal prongs.

6. A gas collector according to any preceding claim, wherein the channel is formed in part by the patient's upper lip.

7. A gas collector according to any one of claims 1 to 6, wherein the spacer is arranged to connect to the patient's face on either side of the patient's upper lip.

8. A gas collector according to any preceding claim, wherein, in use, the spacer extends from the channel wall portion to the face of the patient.

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

10. 10. The gas collector of claim 8 or 9, wherein the spacer has a thickness greater than the channel wall portion.

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

12. The gas collector of claim 11 , wherein the spacer has a higher Young's modulus than the channel wall portion.

13. A gas collector according to any preceding claim, wherein the channel wall portion is configured to bend when in contact with the patient's face.

14. moreover, an interface defining a gas collection region and including first and second gas collection inlets in fluid communication with the gas collection region; The gas collector according to any one of claims 1 to 13, comprising:

15. moreover, a mouth-engaging portion configured to protrude into the patient's mouth to maintain an open passage between the patient's mouth and the second gas collection inlet; 15. The gas collector of claim 14, comprising:

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

17. The lower end of the mouth-engaging portion has an inner surface, the inner surface comprising: a rim portion that, in use, is positioned at the side of the patient's mouth; and a central portion located in the center of the patient's mouth when in use and further away from the patient's upper lip than the edge portions; 17. The gas collector of claim 16, comprising:

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

19. A gas collector according to any preceding claim, wherein the channel wall portion includes an upper end that, in use, extends outwardly from the patient's face.

20. 16. A gas collector according to claim 15, wherein the upper end of the channel wall curves outwardly from the patient's face in use.

21. 1. A gas collector for collecting gases exhaled from nasal and oral passages by a patient, said gas collector comprising: an interface configured to form a channel in the patient's upper lip, the channel having open ends in fluid communication with the patient's nasal and oral passages, respectively; Including, The channel provides a volume for collecting the gas to be analyzed, a gas collector.

22. moreover, one or more gas collection conduits each having a gas collection inlet and configured to deliver gas from the channel to a localized gas collector area; an outlet for bringing collected gas from said local gas collector area to a gas analyzer; 22. The gas collector of claim 21, comprising:

23. 23. The gas collector of claim 22, wherein the channel is partially defined by the patient's upper lip.

24. 24. The gas collector of any one of claims 21 to 23, further comprising a gas flow diverter configured to funnel at least a portion of the gas exhaled by the patient into one or more of the gas sampling inlets.

25. 25. The gas collector of 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 the gas flow diverter is integrated with the channel wall portion.

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

27. 27. A gas collector according to claim 25 or 26, wherein one or more of the gas sampling inlets form a nasal gas sampling inlet located closest to the patient's nasal passages.

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

29. 28. The gas collector of claim 27, wherein the one or more nose gas sampling inlets are formed in the spacer.

30. 30. A gas collector according to any one of claims 21 to 29, wherein one of the gas sampling inlets forms an oral gas sampling inlet located closest to the patient's oral passage.

31. 31. The gas collector of claim 30, wherein the mouth gas sampling inlet is formed in the channel wall portion.

32. 1. A gas collector for collecting gas in a patient, comprising: an interface defining a gas collection region and including at least one nose gas collection inlet and one mouth gas collection inlet in fluid communication with the gas collection region; a mouth engaging portion configured to protrude into the patient's mouth to maintain an open passage between the patient's mouth and the mouth gas collection inlet; a gas collector.

33. 1. A gas collector for collecting gas in a patient, the gas collector comprising: an interface configured to form a channel in the patient's upper lip; one or more gas sampling conduits, each having a gas sampling inlet, for drawing gas from the channel into a local gas collector region; and a gas flow diverter configured to direct at least a portion of the gas exhaled by the patient to one or more of the gas sampling inlets. Including, The gas flow diverter comprises: an upper portion extending away from the patient's face a gas collector.

34. The spacer rests against the patient's upper lip during use; and The gas collector further comprises: one or more nasal gas collection conduits formed within the spacer, each nasal gas collection conduit having a nasal gas collection inlet in fluid communication with the patient's nasal passages for delivering gases exhaled by the patient from the nasal passages to an outlet; an oral gas collection conduit formed within the spacer, the oral gas collection conduit 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 a portion of the gases exhaled by the patient from the patient's oral passage to the oral gas collection inlet; A gas collector according to any one of claims 1 to 20, comprising:

35. 1. A gas collector for sampling gas in 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 passages; an oral gas collection conduit having an oral gas collection inlet and an outlet in fluid communication with the patient's oral passage; Including, the one or more nose gas sampling conduits and the mouth gas sampling conduit form a junction at a local gas collector region; and a gas collector, wherein the one or more nose gas sampling conduits and the mouth gas sampling conduit are configured such that a flow rate in the one or more nose gas sampling conduits is a percentage of a total flow rate in the one or more nose gas sampling conduits and the mouth gas sampling conduit, wherein the percentage is within a predetermined range.

36. a nasal cannula for delivering breathable gas to the patient; and 36. A gas collector according to any one of claims 1 to 35, which is removably attachable to or integral with the nasal cannula. a patient interface including:

37. 22. The gas collector of claim 21, further comprising an outlet for conducting collected gases via a conduit to a gas analyzer, the outlet configured to allow connection to the conduit from one side of the patient's face.

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

39. 40. The gas collector of claims 21, 37 and 38, wherein the outlet is a single outlet of the gas collector for conducting collected gas to the gas analyzer.

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

41. 41. A gas collector as described in claim 21 or 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 snugly over a portion of the nasal cannula.

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

43. 43. A gas collector according to claim 41 or 42, wherein the sleeve defines one or more slits, the one or more slits allowing insertion of the portion of the nasal cannula so that the portion of the nasal cannula can be received in the sleeve.

44. 44. The gas collector of claim 43, wherein the sleeve has a resilient wall to allow the width of the one or more slits to be manually adjustable.

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