Gas collector, gas delivery patient interface, patient interface assembly, kit, system
By designing a gas collector on the gas delivery patient interface, the problem of gas sampling results being diluted under high flow rates was solved, enabling accurate collection and monitoring of gas from the patient's nasal and oral passages, and improving the accuracy of sampling results.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- FISHER & PAYKEL HEALTHCARE LTD
- Filing Date
- 2025-02-14
- Publication Date
- 2026-07-10
AI Technical Summary
While providing airflow to patients, existing technologies struggle to effectively monitor and collect the gas exhaled from the nasal and oral passages, especially at high flow rates, where gas sampling results are easily diluted or inconsistent, affecting monitoring accuracy.
A gas collector was designed, including a gas sampling unit and a connecting mechanism. The gas sampling unit is located above the main body of the gas delivery patient interface and between the nose forks. It has a fixed inlet opening, which can effectively collect gas from the patient's nose and mouth. The gas is introduced into the sampling unit through an airflow guide to ensure that the inlet airflow direction is different from the exhaled gas direction, thereby reducing the dilution effect.
It enables effective collection and monitoring of gas from the patient's nasal and oral passages under high flow conditions, reducing the impact of airflow contamination and improving the accuracy and consistency of gas sampling results.
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Figure CN224474440U_ABST
Abstract
Description
Technical Field
[0001] This disclosure relates to a gas collector for collecting gases from a patient and a gas delivery patient interface having the gas collector. The gas collector and gas delivery patient interface are suitable for applications that require collecting and monitoring gases exhaled by a patient from a nasal and / or oral passage while providing airflow to the patient. Conveniently, the gas collector and gas delivery patient interface are described in conjunction with this exemplary but non-limiting application. Background Technology
[0002] Medical procedures can include procedural sedation or general anesthesia, collectively referred to as anesthetic procedures. In procedural sedation, the patient has impaired respiratory function or is at risk of respiratory arrest due to the anesthetic agent. In general anesthesia, if the patient becomes respiratoryly arrested, the patient will most likely require mechanical ventilation. Pre-oxygenation of the patient before administration of anesthetic agents is encouraged. During pre-oxygenation, also known as denitrification, the patient is provided with oxygen to saturate the body's reserves, including the blood and lungs, to delay or prevent a drop in oxygen saturation if the patient's respiratory function is impaired or respiratory arrest occurs. Pre-oxygenation also reduces the patient's blood and lung carbon dioxide levels, as well as the nitrogen levels in the lungs, due to the replacement with oxygen.
[0003] High-flow nasal cannula (NHF) can be used in anesthesia procedures to pre-oxygenate patients, maintain adequate oxygenation, and prevent a drop in saturation; and in general anesthesia, it can prolong the safe duration of apnea when the patient becomes apnea. NHF uses an open-system patient interface, such as a nasal cannula, to deliver breathable gases, such as oxygen or oxygen-enriched air or air, to the patient. NHF can also be used in other settings, such as wards, emergency rooms, and intensive care units (ICUs).
[0004] The foregoing discussion of the background art of this disclosure is intended to facilitate understanding of this disclosure. However, it should be understood that this discussion is not an admission or endorsement that any aspect thereof is part of common general knowledge to those skilled in the art prior to the priority date of any claim. Utility Model Content
[0005] According to one aspect of the present invention, a gas collector is provided for collecting gas from a patient, the gas collector comprising:
[0006] A gas sampling unit is used to sample the gas from the patient's area, and
[0007] A coupling mechanism is used to connect the gas sampling unit to the gas delivery patient interface, the gas delivery patient interface having:
[0008] The main body has an airflow manifold for receiving the gas flow delivered to the patient, and
[0009] A pair of nose forks, extending from the body, are used to deliver a flow of air to the patient through the patient's nostrils.
[0010] The gas sampling unit has a nasal sampling unit configured to be positioned above the main body of the gas delivery patient interface and between the nasal forks. The nasal sampling unit defines at least one inlet opening for sampling gas from the patient's nose.
[0011] The position of the at least one inlet opening is fixed relative to the connecting mechanism.
[0012] Optionally, the nasal sampling unit can be configured to be positioned above the airflow manifold between the nasal forks of the gas delivery patient interface.
[0013] The at least one inlet opening of the nasal sampling unit allows sampling gas exhaled from the patient's nose to enter the nasal sampling unit in an inlet airflow direction. This inlet airflow direction may be substantially different from the direction of the gas exhaled from the patient's nose.
[0014] The inlet airflow direction can be approximately perpendicular to the surface of the nasal sampling section that defines at least one inlet.
[0015] The direction of the airflow entering the inlet can be roughly perpendicular to the direction of the air exhaled from the patient's nose.
[0016] The direction of airflow entering the inlet can be different from the direction of airflow delivered to the patient's nostrils via the nasal fork.
[0017] The nasal sampling unit may define at least two inlet openings. Each inlet opening may be located on one side of the nasal sampling unit.
[0018] The nasal sampling unit can be configured with multiple inlet openings.
[0019] The nasal sampling unit can be configured to be positioned below the patient's nasal septum or columella during use.
[0020] The nasal sampling unit can be configured to be positioned in the space between the gas delivery patient interface and the patient's nasal septum or columella during use.
[0021] The body and / or airflow manifold may have a bridging portion extending between the nasal forks. The nasal sampling portion may be configured to be positioned over the bridging portion of the body and / or airflow manifold of the patient interface.
[0022] The nasal sampling unit can be configured to be positioned in the space between the patient's nasal septum, bridging portion, and nasal fork.
[0023] The nasal sampling unit can be configured such that when the gas collector is installed on the patient interface, the at least one inlet opening is close to the base of the nasal fork adjacent to the body of the patient interface.
[0024] The patient interface body may have an inner wall facing the patient during use and an outer wall opposite to the inner wall, with the outer wall facing away from the patient during use. The nasal sampling section may be configured such that the at least one inlet opening is close to any one of the inner wall, outer wall, or central region between the inner and outer walls of the body.
[0025] The nose fork may have inner sidewalls facing each other, and the at least one inlet opening may be located on the surface of the nose sampling portion facing the inner sidewall of the corresponding nose fork and offset from the inner sidewall of the corresponding nose fork.
[0026] The at least one inlet opening may be offset from the central plane of the gas delivery patient interface. The central plane may extend between the nasal forks such that the nasal forks are spaced apart by approximately equal distances relative to the central plane.
[0027] The coupling mechanism can be configured for releasable attachment to the body of the gas delivery patient interface.
[0028] The connection mechanism may include a ring configured for attachment around a bridging portion of the gas delivery patient interface.
[0029] The coupling mechanism can be configured to attach to one or both of the nose forks of the gas delivery patient interface.
[0030] The coupling mechanism may include one or more rings configured for attachment to one or both of the nose forks of the gas delivery patient interface.
[0031] The coupling mechanism may include a pair of rings. Each ring may be configured to attach to a corresponding nose fork in a pair of nose forks.
[0032] The connecting mechanism may define one or more additional inlet openings thereon to sample the gas from the patient's nose.
[0033] Each of the one or more rings may include a conduit.
[0034] Each catheter may define one or more additional inlet openings to sample the gas exhaled from the patient's nose.
[0035] The coupling mechanism may include one or more C-shaped or U-shaped portions for mounting to the body and / or nose fork of the gas delivery patient interface.
[0036] The sampling unit may also include a mouth sampling unit configured to extend below the body of the gas delivery patient interface for placement adjacent to the patient's mouth during use. The mouth sampling unit may define at least one inlet hole for sampling gas at the patient's mouth.
[0037] The mouth sampling unit may include a mouth sampling guide configured to extend below the body of the gas delivery patient interface. The mouth sampling guide may have a mouth sampling end that defines the at least one inlet orifice for sampling gas at the patient's mouth. The mouth sampling end may be located at one end of the mouth sampling guide.
[0038] The mouth sampling guide can be flexible to allow for selective repositioning of the mouth sampling tip.
[0039] The mouth sampling guide can be selectively removable.
[0040] The mouth sampling guide can be offset from the center plane of the gas delivery patient interface. Typically, the center plane extends between the nasal forks, such that the nasal forks are spaced approximately equidistant from the center plane.
[0041] The mouth sampling guide can be oriented at a certain angle relative to the central plane.
[0042] The angle can be a predetermined angle.
[0043] In one embodiment, the angle can be approximately between -100° and 100°.
[0044] The gas collector may also include an outlet section that defines the outlet. The gas collected by the gas sampling section can leave the gas collector through the outlet.
[0045] The outlet can be configured to connect to a conduit for delivering gas collected by the gas sampling unit to one or more sensor units.
[0046] The gas collector may also include one or more airflow guides for directing gas from the patient toward the gas sampling unit.
[0047] The airflow guide can be configured to guide gas from the patient's nose toward at least one inlet opening of the nasal sampling section.
[0048] The gas collector may include a pair of airflow guides. Each airflow guide may extend from the opposite side of the nasal sampling section.
[0049] A pair of airflow guides may be configured for positioning between the nasal forks in use. Each airflow guide may define a curved surface for guiding airflow from the patient's nose toward the at least one inlet opening of the nasal sampling section.
[0050] The gas sampling unit can be rigid.
[0051] The gas sampling unit can be roughly fixed relative to the connecting mechanism.
[0052] The coupling mechanism allows for connection to an extendable section of the gas delivery patient interface.
[0053] According to another aspect of the present invention, a gas collector for collecting gas from a patient is provided, the gas collector comprising:
[0054] A gas sampling unit is used to sample the gas from the patient's area, and
[0055] A coupling mechanism is used to connect the gas sampling unit to the gas delivery patient interface, the gas delivery patient interface having:
[0056] The main body has an airflow manifold for receiving the gas flow delivered to the patient, and
[0057] A pair of nose forks, extending from the body, are used to deliver a flow of air to the patient through the patient's nostrils.
[0058] The gas sampling unit has a nasal sampling unit configured to be mounted above the body of the gas delivery patient interface and between the nasal forks, the nasal sampling unit defining at least one inlet opening for sampling gas from the patient's nose.
[0059] According to another aspect of the present invention, a gas delivery patient interface for delivering gas to a patient is provided, the gas delivery patient interface comprising:
[0060] The main body has an airflow manifold for receiving the gas flow delivered to the patient, and
[0061] A pair of nose forks, extending from the body, are used to deliver a flow of air to the patient through the patient's nostrils.
[0062] A gas sampling unit for sampling gas from a patient, the gas sampling unit having a nasal sampling section disposed above the main body of the gas delivery patient interface and between the nasal forks, the nasal sampling section defining at least one inlet opening for sampling gas from the patient's nose.
[0063] In some embodiments, the nasal sampling unit may be configured to be positioned above the airflow manifold between the nasal forks of the gas delivery patient interface.
[0064] The gas sampling unit can be integrated with the main body and / or the nose fork.
[0065] The at least one inlet opening of the nasal sampling unit allows sampling gas from the patient to enter the nasal sampling unit in the inlet airflow inlet direction. The inlet airflow inlet direction may differ from the direction of the gas exhaled from the patient's nose.
[0066] The inlet airflow direction may be approximately perpendicular to the surface defining at least one inlet of the nasal sampling section.
[0067] The direction of the airflow entering the inlet can be roughly perpendicular to the direction of the air exhaled from the patient's nose.
[0068] The direction of airflow entering the inlet can be different from the direction of airflow delivered to the patient's nostrils via the nasal fork.
[0069] The nasal sampling unit may define at least two inlet openings. Each inlet opening may be located on one side of the nasal sampling unit.
[0070] The nasal sampling unit can be configured with multiple inlet openings.
[0071] The nasal sampling unit can be configured to be positioned below the patient's nasal septum during use.
[0072] The main body may have a bridging portion extending between the nasal bifurcations. The nasal sampling portion may protrude from the bridging portion of the main body. The nasal sampling portion can be positioned during use within the space between the patient's nasal septum, the bridging portion of the main body, and the nasal bifurcation.
[0073] The sampling unit may also include a mouth sampling unit configured to extend below the main body for placement adjacent to the patient's mouth during use. The mouth sampling unit may define at least one inlet hole for sampling gas at the patient's mouth.
[0074] The mouth sampling unit may include a mouth sampling guide configured to extend below the body of the gas delivery patient interface. The mouth sampling guide may have a mouth sampling end that defines at least one inlet orifice for sampling gas at the patient's mouth. The mouth sampling end may be located at one end of the mouth sampling guide.
[0075] The mouth sampling guide can be flexible to allow for selective repositioning of the mouth sampling tip.
[0076] The mouth sampling guide can be selectively removable.
[0077] The mouth sampling guide can be offset from the center plane of the gas delivery patient interface. Typically, the center plane extends between the nasal forks such that the nasal forks are spaced approximately equidistant from the center plane.
[0078] The mouth sampling guide can be oriented at a certain angle relative to the central plane.
[0079] The angle can be a predetermined angle.
[0080] The angle can be roughly between -100° and 100°.
[0081] The gas delivery patient interface may also include an outlet section that defines the exit. Gas collected by the gas sampling section can exit the gas collector via the outlet.
[0082] The outlet can be configured to connect to a conduit to deliver the gas collected by the gas sampling unit to one or more sensor units.
[0083] The gas delivery patient interface may also include one or more airflow guides for guiding the gas exhaled by the patient toward the gas sampling unit.
[0084] The airflow guide can be configured to guide gas from the patient's nose toward at least one inlet opening of the nasal sampling section.
[0085] The gas collector may include a pair of airflow guides. Each airflow guide may extend from the opposite side of the nasal sampling section.
[0086] A pair of airflow guides can be configured to be positioned between the nose forks.
[0087] Each airflow guide may define a curved surface for guiding airflow from the patient’s nose to the at least one inlet opening of the nasal sampling section.
[0088] The gas sampling unit can be rigid.
[0089] According to another aspect of the present invention, a patient interface component is provided, including...
[0090] A gas delivery patient interface for delivering a gas stream to a patient, and
[0091] Gas collector according to any embodiment described herein.
[0092] The patient interface component may include the gas delivery patient interface as described in any of the embodiments described herein.
[0093] The patient interface component may also include a filter for filtering return gas from the patient. The filter may be installed upstream of the gas delivery patient interface.
[0094] The patient interface component may also include a catheter for connecting the gas delivery patient interface and the filter.
[0095] According to another aspect of the present invention, a kit is provided, comprising:
[0096] A gas delivery patient interface for delivering gas streams to a patient, and
[0097] Gas collector according to any embodiment described herein.
[0098] According to another aspect of the present invention, a kit is provided, comprising:
[0099] A gas delivery patient interface with an integrated gas collector as described herein.
[0100] The kit may also include any one or more of the following:
[0101] At least one airflow duct,
[0102] Inhalation branch, and
[0103] Humidification room.
[0104] According to another aspect of the present invention, a gas collector for collecting gas from a patient is provided, the gas collector comprising:
[0105] A gas collection unit for collecting at least a portion of the gas exhaled by the patient through the patient's nose and / or mouth, and
[0106] A coupling mechanism is used to connect the gas collection unit to the gas delivery patient interface, which is adapted to deliver gas to the patient.
[0107] The gas collection section is configured to provide damping for external forces applied to it, so as to reduce force transmission between the gas collection section and the connecting mechanism.
[0108] The gas collection section may include an elastic material to dampen external forces applied thereto. The connection mechanism may include a rigid material to stabilize the gas delivery patient interface.
[0109] The coupling mechanism may include a coupling for engaging with a gas delivery patient interface.
[0110] The junction may include a U-shaped retainer for receiving a gas delivery patient interface therein.
[0111] Gas delivery patient interfaces may include nasal cannulas.
[0112] The gas collector may also include a gas collection inlet in fluid communication with the gas collection section, such that at least a portion of the gas collected by the gas collection section flows into the gas collection inlet.
[0113] The gas collection unit may include a nasal airflow guide configured to extend below the patient's nose during use to facilitate the collection of gas from the patient's nose toward the gas collection inlet.
[0114] The nasal airflow guide may include a neck for housing nasal forks on both sides of the neck for receiving gas delivery patient interfaces.
[0115] The gas collection unit may include a mouthpiece configured to extend below or near the patient's upper lip and / or upper teeth during use to facilitate the collection of gas from the patient's mouth toward the gas collection inlet.
[0116] The gas collection unit may also include an offset region near the mouth. The offset region may be configured to be located away from the patient's mouth during use to facilitate gas flow between the patient's mouth and the gas collection inlet.
[0117] The gas collector may also include a flow channel in fluid communication with the gas collection inlet to allow gas to flow from the patient’s nose and / or mouth toward the gas collection inlet.
[0118] The flow channel may include a rigid material.
[0119] The flow channel can be integrally formed with the connecting mechanism.
[0120] The gas collection section may define a narrow section adjacent to the mouthpiece. The narrow section may be provided with a hinge to allow the mouthpiece to move relative to the narrow section.
[0121] The gas collection unit may also include a pair of guide members that protrude from the edge of the gas collection inlet toward the mouth so as to guide at least a portion of the airflow from the patient’s mouth toward the gas collection inlet.
[0122] The mouthpiece may include a spoon-shaped portion between the guide members. The spoon-shaped portion may have an edge configured to extend below the patient's upper lip during use to facilitate gas flow from the patient's mouth toward the gas collection inlet.
[0123] The mouthpiece may include a pair of mouth airflow guiding protrusions. Each mouth airflow guiding protrusion may be configured to extend in use below or near the corners of the patient's upper lip to facilitate the collection of gas from the patient's mouth toward the gas collection inlet.
[0124] The gas collection unit may include a pair of nasal airflow guiding protrusions. Each nasal airflow guiding protrusion may be configured to extend laterally adjacent to the patient's nose during use to facilitate the collection of gas from the patient's nose toward the gas collection inlet.
[0125] According to another aspect of the present invention, a patient interface component is provided, comprising:
[0126] A gas delivery patient interface for delivering gas streams to a patient, and
[0127] Gas collector according to any embodiment described herein.
[0128] The patient interface component may also include a filter for filtering return gas from the patient. The filter may be installed upstream of the gas delivery patient interface.
[0129] The patient interface may also include a catheter for connecting the gas delivery patient interface and the filter.
[0130] According to another aspect of the present invention, a kit is provided, comprising:
[0131] A gas delivery patient interface for delivering gas streams to a patient, and
[0132] Gas collector according to any embodiment described herein.
[0133] The kit may also include any one or more of the following:
[0134] At least one airflow duct,
[0135] Inhalation branch, and
[0136] Humidification room.
[0137] According to another aspect of the present invention, a system is provided, comprising:
[0138] Gas delivery patient interface for delivering gas streams to patients
[0139] As described herein, the gas collector is installed at the gas delivery patient interface, and
[0140] A humidifier is used to humidify the gas stream delivered to the patient.
[0141] According to another aspect of the present invention, a system is provided, comprising:
[0142] Gas delivery patient interface for delivering gas streams to patients
[0143] As described herein, the gas collector is installed at the gas delivery patient interface, and
[0144] An airflow generator used to produce a gas flow for delivery to the patient.
[0145] The system may also include one or more gas analyzers connected to a gas collector for analyzing the gas from the gas collector.
[0146] According to another aspect of the present invention, a system is provided, comprising:
[0147] As described in this article, the gas delivery patient interface, and
[0148] A humidifier is used to humidify the gas stream delivered to the patient.
[0149] According to another aspect of the present invention, a system is provided, comprising:
[0150] As described in this article, the gas delivery patient interface, and
[0151] An airflow generator used to produce a gas flow for delivery to the patient.
[0152] The system may also include one or more gas analyzers connected to the gas delivery patient interface for analyzing gases from the gas sampling unit.
[0153] According to another aspect of the present invention, a gas delivery patient interface for delivering gas to a patient is provided, the gas delivery patient interface comprising:
[0154] The main body has an airflow manifold for receiving the gas flow delivered to the patient, and
[0155] A pair of nose forks, extending from the body, are used to deliver a flow of air to the patient through the patient's nostrils.
[0156] A gas sampling unit for sampling gas from a patient, the gas sampling unit having a nasal sampling section located between the nasal bifurcations, the nasal sampling section defining at least one inlet opening for sampling gas from the patient's nose, and
[0157] A sampling gas conduit is used to provide fluid communication between the gas sampling unit and the sensing device.
[0158] The sampling gas conduit extends along the airflow manifold.
[0159] Optionally, the gas sampling section and the sampling gas conduit are integrally formed with the airflow manifold.
[0160] In one embodiment, the gas sampling unit and the sampling gas conduit can be selectively attached to and detached from the body.
[0161] In one embodiment, the body may have: an inner surface facing the patient's face when the gas delivery patient interface is installed on the patient; and an outer surface opposite to the inner surface, facing away from the patient's face when the gas delivery patient interface is installed on the patient. The at least one inlet opening may be oriented to substantially cross the inner surface of the body.
[0162] The nasal sampling unit may define two inlet openings for sampling gas from the patient's nose. The body may have: an inner surface facing the patient's face when the gas delivery patient interface is installed; and an outer surface opposite to the inner surface, facing away from the patient's face when the gas delivery patient interface is installed. Each inlet opening may be oriented to approximately cross the inner surface of the body.
[0163] In one embodiment, the position of the at least one inlet opening of the nasal sampling unit may be fixed relative to the body.
[0164] In one embodiment, the nasal sampling portion may be substantially fixed relative to the body and / or the nasal fork.
[0165] In some embodiments, the position of the at least one inlet opening of the nasal sampling portion may be fixed relative to the body and / or the nasal fork.
[0166] Typically, the nasal sampling section is located adjacent to at least one nasal fork. The nasal sampling section may be centered relative to the body of the gas delivery patient interface.
[0167] In some embodiments, the airflow manifold may be collapsible.
[0168] In some embodiments, the sampling unit may further include a mouth sampling unit configured to extend below the body for placement adjacent to the patient's mouth during use. The mouth sampling unit may define at least one inlet hole for sampling gas at the patient's mouth.
[0169] In some embodiments, the mouth sampling portion may be movable relative to the body and / or the nose fork.
[0170] In some embodiments, the mouth sampling section may include a mouth sampling guide configured to extend below the body. The mouth sampling guide may have a mouth sampling end that defines at least one inlet orifice for sampling gas at the patient's mouth. The mouth sampling end may be located at one end of the mouth sampling guide.
[0171] In some embodiments, the mouth sampling guide may be flexible to allow selective repositioning of the mouth sampling end. In some embodiments, the mouth sampling guide may be selectively removable. Optionally, the mouth sampling guide may be offset from the central plane of the gas delivery patient interface. The central plane may extend between the nasal forks such that the nasal forks are spaced approximately equal relative to the central plane. The mouth sampling guide may be oriented at an angle relative to the central plane. In some embodiments, this angle may be a predetermined angle. More specifically, this angle may be approximately between -100° and 100°.
[0172] In some embodiments, the nasal sampling portion may define one or more nasal gas sampling channels, providing fluid communication between each of the at least one inlet opening of the nasal sampling portion and a sampling gas conduit. The mouth sampling portion may define one or more oral gas sampling channels, providing fluid communication between each of the at least one inlet opening of the mouth sampling portion and a sampling gas conduit. The flow resistance in the one or more nasal gas sampling channels may be lower than the flow resistance in the one or more oral gas sampling channels.
[0173] In another embodiment, the nasal sampling portion may define one or more nasal gas sampling channels, providing fluid communication between each of the at least one inlet opening of the nasal sampling portion and a sampling gas conduit. The mouth sampling portion may define one or more oral gas sampling channels, providing fluid communication between each of the at least one inlet opening of the mouth sampling portion and a sampling gas conduit. The flow resistance in the one or more nasal gas sampling channels may be higher than the flow resistance in the one or more oral gas sampling channels.
[0174] In some embodiments, the nasal sampling unit may be positioned above the main body of the patient interface.
[0175] In some embodiments, the surface covering at least a portion of the sampling gas conduit may be a curved surface. The curved surface may define a protrusion that accommodates a portion of the sampling gas conduit.
[0176] According to another aspect, a gas collector is provided for collecting gas at a patient's site, the gas collector comprising:
[0177] A gas sampling unit is used to sample the gas from the patient's area, and
[0178] A sampling gas conduit is used to provide fluid communication between the gas sampling unit and the sensing device.
[0179] The gas collector is configured to attach to a gas delivery patient interface, which has:
[0180] The main body has an airflow manifold for receiving the gas flow delivered to the patient, and
[0181] A pair of nose forks, extending from the body, are used to deliver a flow of air to the patient through the patient's nostrils.
[0182] The gas sampling unit has a nasal sampling unit positioned between the nasal forks of the gas delivery patient interface, and the nasal sampling unit defines at least one inlet opening for sampling gas from the patient's nose.
[0183] The sampling gas conduit extends along the airflow manifold.
[0184] In some embodiments, the gas collector may further include a coupling mechanism for connecting the gas sampling unit to the gas delivery patient interface. The gas sampling unit and the sampling gas conduit may be selectively attached to the body of the gas delivery patient interface and may be detached from the body of the gas delivery patient interface.
[0185] In some embodiments, the nasal sampling portion may be configured such that when the gas collector is attached to the gas delivery patient interface, the at least one inlet opening is oriented to substantially cross the inner surface of the body of the gas delivery patient interface. The inner surface may be the body surface facing the patient's face when the gas delivery patient interface is installed on the patient.
[0186] In some embodiments, the nasal sampling unit may define two inlet openings for sampling gas from the patient's nose. When the gas collector is attached to the gas delivery patient interface, each inlet opening may be oriented to substantially cross the inner surface of the body of the gas delivery patient interface. The inner surface may be the body surface facing the patient's face when the gas delivery patient interface is mounted on the patient.
[0187] In some embodiments, the sampling unit may further include a mouth sampling unit configured to extend below the body of the gas delivery patient interface for placement adjacent to the patient's mouth during use. The mouth sampling unit may define at least one inlet hole for sampling gas at the patient's mouth.
[0188] In some embodiments, the mouth sampling section may include a mouth sampling guide configured to extend below the body of the gas delivery patient interface. The mouth sampling guide may have a mouth sampling end defining at least one inlet aperture for sampling gas at the patient's mouth. The mouth sampling end may be located at one end of the mouth sampling guide.
[0189] The mouth sampling guide can be flexible to allow for selective repositioning of the mouth sampling tip. The mouth sampling guide can be selectively removable.
[0190] In some embodiments, the mouth sampling guide may be offset from the central plane of the nasal sampling portion. The central plane may extend between a pair of inlet openings of the nasal sampling portion, such that the pair of inlet openings are spaced apart by approximately equal distances relative to the central plane. The mouth sampling guide may be oriented at an angle relative to the central plane. This angle may be a predetermined angle. In some embodiments, this angle may be approximately between -100° and 100°.
[0191] A nasal sampling portion may define one or more nasal gas sampling channels, providing fluid communication between each of the at least one inlet opening of the nasal sampling portion and a sampling gas conduit. A mouth sampling portion may define one or more oral gas sampling channels, providing fluid communication between each of the at least one inlet opening of the mouth sampling portion and a sampling gas conduit. In some embodiments, the flow resistance in the one or more nasal gas sampling channels may be lower than the flow resistance in the one or more oral gas sampling channels. In other embodiments, the flow resistance in the one or more nasal gas sampling channels may be higher than the flow resistance in the one or more oral gas sampling channels.
[0192] In some embodiments, the nasal sampling unit may be configured to be positioned above the body and the airflow manifold.
[0193] In some embodiments, the surface covering at least a portion of the sampling gas conduit may be a curved surface.
[0194] To make this invention easier to understand and implement, one or more preferred embodiments of the invention will now be described by way of example only with reference to the accompanying drawings.
[0195] It should be understood that, for the sake of simplicity and clarity, reference numerals may be repeated in the figures where deemed appropriate to indicate corresponding or similar elements. Attached Figure Description
[0196] Figure 1 A respiratory support system for delivering airflow therapy to a patient is shown.
[0197] Figure 2 A gas collector installed to a gas delivery patient interface according to one embodiment is shown.
[0198] Figure 3 yes Figure 2 A three-dimensional diagram of a gas collector.
[0199] Figure 4 yes Figure 2 Another perspective view of the gas collector.
[0200] Figure 5 yes Figure 3 A partial AA cross-sectional view of the gas collector, in which one of the optional airflow guides is omitted.
[0201] Figure 6 A gas collector installed to a gas delivery patient interface according to another embodiment is shown.
[0202] Figure 7 yes Figure 6 A three-dimensional diagram of a gas collector.
[0203] Figure 8 yes Figure 7 BB cross-sectional view of the gas collector.
[0204] Figure 9 This is a perspective view of a gas collector according to another embodiment.
[0205] Figure 10 yes Figure 9 Another perspective view of the gas collector.
[0206] Figure 11 The installation onto the gas delivery patient interface is shown. Figure 9 and Figure 10 Gas collector.
[0207] Figure 12 A gas collector installed to a gas delivery patient interface according to another embodiment is shown.
[0208] Figure 13 This is a perspective view of a gas collector according to another embodiment.
[0209] Figure 14 yes Figure 13 CC cross-sectional view of the gas collector.
[0210] Figure 15A gas collector installed to a gas delivery patient interface according to another embodiment is shown.
[0211] Figure 16 yes Figure 15 A three-dimensional diagram of a gas collector.
[0212] Figure 17 yes Figure 16 DD cross-sectional view of the gas collector.
[0213] Figure 18 A gas collector installed to a gas delivery patient interface according to another embodiment is shown.
[0214] Figure 19 yes Figure 18 A three-dimensional diagram of a gas collector.
[0215] Figure 20 yes Figure 19 EE cross-sectional view of the gas collector.
[0216] Figure 21 This is a side view of a gas collector according to another embodiment.
[0217] Figure 22 yes Figure 21 Another side view of the gas collector.
[0218] Figure 23 yes Figure 21 and Figure 22 A three-dimensional diagram of a gas collector.
[0219] Figure 24 yes Figures 21 to 23 The inside of the gas collector is for facing the patient during use.
[0220] Figure 25 This is a perspective view of a gas collector according to another embodiment.
[0221] Figure 26 yes Figure 25 The inside of the gas collector is for facing the patient during use.
[0222] Figure 27 This is a perspective view of a gas collector according to another embodiment.
[0223] Figure 28 This is a schematic diagram showing a kit that includes a catheter, inhalation tube, patient interface, gas collector, and humidification chamber.
[0224] Figure 29 A patient wearing a respiratory support system is shown.
[0225] Figure 30A patient wearing a gas delivery patient interface and a face mask is shown as an example.
[0226] Figure 31 It shows Figure 30 A cross-section of a portion of the patient interface.
[0227] Figures 32 to 35 A nasal cannula including a collapsible section is shown, and a gas collector can be attached to or integrated with the nasal cannula.
[0228] Figures 36 to 38 Another embodiment of the gas delivery patient interface is shown.
[0229] Figure 39A This is a schematic diagram illustrating a gas delivery patient interface according to one embodiment.
[0230] Figure 39B It is shown Figure 39A A schematic top view of the gas delivery patient interface.
[0231] Figure 40 yes Figure 39A A partial cross-sectional view of the AA section of the gas delivery patient interface, showing the sampling gas catheter.
[0232] Figure 41A A gas delivery patient interface according to another embodiment is shown.
[0233] Figure 41B A gas delivery patient interface according to another embodiment is shown.
[0234] Figure 42 It shows Figure 39A A schematic diagram of a cross-sectional view of the BB section of the gas delivery patient interface.
[0235] Figure 43 A portion of the mouth sampling guide of the gas delivery interface shown in Figure 41 is illustrated.
[0236] Figures 44 to 47 The mouth sampling tip of the gas delivery patient interface shown in Figure 41 is illustrated.
[0237] Figure 48 and Figure 49 This is a detailed view of the mouth sampling unit, which includes... Figures 44 to 47 The mouth sampling tip, which is installed to, for example Figure 43 The mouth sampling guide shown.
[0238] Figure 50 This is a schematic diagram showing the nasal gas passage and oral gas passage of the gas sampling section of a gas delivery patient interface or gas collector according to one embodiment.
[0239] Figure 51 The patient's face is shown. Detailed Implementation
[0240] It is beneficial to monitor the patient's gas levels when receiving respiratory support. This monitoring provides useful feedback to clinicians. For example, monitoring exhaled gases during the pre-oxygenation phase can be used to determine whether the patient has reached the expected end-expiratory O2 level, indicating that pre-oxygenation is adequate and / or that the pre-oxygenation phase can be completed. Exhaled gas monitoring can be used to detect changes in the patient's condition, such as spontaneously breathing patients experiencing apnea after anesthesia or when experiencing airway obstruction. Clinicians can make decisions based on the patient's gas monitoring results to provide better care.
[0241] Unfortunately, monitoring the target gas at the patient's location while providing airflow can affect sampling results because the supplied airflow contaminates the actual value (e.g., concentration) of the target gas. For example, exhaled CO2 (carbon dioxide) can be diluted by the supplied gas, or end-tidal O2 can be enhanced by a higher concentration of O2 in the supplied airflow. NHF exacerbates this problem due to the high gas flow rates involved.
[0242] Monitoring exhaled gases can be challenging due to the variability of the exhalation pathway—that is, via the patient's nose, mouth, or both. Patients can alternate between these pathways during monitoring. How the patient breathes can affect gas sampling results, for example, when the patient primarily exhales through their mouth, the amount of exhaled gas collected from the nose will be insufficient.
[0243] It is desirable to provide a gas collector or patient interface for collecting gas at the nasal and oral passages of a patient, to improve upon or overcome one or more disadvantages or inconveniences of known gas collectors, particularly but not limited to NHF applications. Furthermore, it is desirable to provide a gas collector or patient interface capable of consistently sampling exhaled gas regardless of variability in the expiratory pathway.
[0244] Various embodiments are described with reference to the accompanying drawings. Throughout the drawings and description, the same reference numerals may be used to denote the same or similar components, and redundant descriptions may be omitted.
[0245] In this specification, "high flow rate" or other equivalent terms refer to, but are not limited to, any gas flow rate that is higher than the usual / normal flow rate. For example, higher than the normal inspiratory flow rate of a healthy patient. Alternatively or additionally, it may be higher than some other threshold flow rate, for example, situation-dependent, such as when an airflow is provided to the patient at a flow rate that meets or exceeds inspiratory needs; this flow rate can be considered "high flow rate" because it is higher than the nominal flow rate that might otherwise be provided. Therefore, "high flow rate" is situation-dependent, and what constitutes a "high flow rate" depends on many factors, such as the patient's health status, the type of procedure / treatment / support provided, the patient's nature (large, small, adult, child), etc. Those skilled in the art will know from the situation what constitutes a "high flow rate." It is a flow rate that exceeds and is higher than the flow rate that might otherwise be provided.
[0246] However, without limitation, some representative values for high flow rates can be as follows.
[0247] In some configurations, gas is delivered to the patient at a flow rate of about 5 or 10 liters per minute (5 or 10 LPM or L / min).
[0248] In some configurations, gas is delivered to the patient at a flow rate of about 5 LPM 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 the various embodiments and configurations described herein, the flow rate of gas supplied or provided via the system or supplied or provided to the interface from a gas flow source or flow regulator may include, but is not limited to, flow rates 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 as 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).
[0249] In the "high flow" configuration, the delivered gas will be selected based on the intended use, such as for treatment and / or respiratory support. The delivered gas may include a certain percentage of oxygen. In some configurations, the percentage of oxygen in the delivered gas may be about 15% to about 100%, about 20% to about 100%, or about 30% to about 100%, or about 40% to about 100%, or about 50% to about 100%, or about 60% to about 100%, or about 70% to about 100%, or about 80% to about 100%, or about 90% to about 100%, or about 100%, or 100%.
[0250] The flow rate for "high-flow" in premature infants / pediatricians (weighing approximately 1 to 30 kg) can vary. The flow rate can be set from 0.4 to 8 L / min / kg, with a minimum of approximately 0.5 L / min and a maximum of approximately 70 L / min. For patients weighing less than 2 kg, the maximum flow rate can be set to 8 L / min. For example, for a 2 kg patient, the flow rate would be approximately 0.8 LPM to 16 LPM.
[0251] High-flow rates have been found to be effective in meeting or exceeding a patient's normal true inspiratory flow rate, thereby enhancing oxygenation and / or reducing the work of breathing. Additionally, high-flow therapy and / or respiratory support can produce a flushing effect in the nasopharynx, flushing the anatomical dead space of the upper airway with high-flow air. This creates a reserve of fresh gas available for each breath while minimizing the re-inhalation of carbon dioxide, nitrogen, etc.
[0252] For example, see the following reference Figure 1 Describe a high-flow respiratory system 10. High flow can be used as a means of promoting gas exchange and / or respiratory support by delivering oxygen and / or other gases and facilitating the removal of CO2 from the patient's airway. High flow can be particularly useful before, during, or after medical and / or anesthesia procedures.
[0253] When used before a medical procedure, a high gas flow rate can preload the patient with oxygen (i.e., increase the oxygen reserve in the blood), resulting in a higher than normal blood oxygen saturation level and lung oxygen volume, thus providing an oxygen buffer. This can be useful in reducing the risk of oxygen saturation drop or preventing oxygen saturation drop, for example, when the patient is in the apnea phase during a medical procedure.
[0254] Continuous oxygen supply is important for maintaining healthy respiratory function during medical procedures where respiratory function may be impaired (e.g., reduced or stopped) (e.g., during anesthesia). When this supply is impaired, conditions such as hypoxia and / or hypercapnia can occur. During medical procedures such as anesthesia and / or sedation, patient breathing is monitored to detect whether spontaneous breathing is reduced or stopped. If oxygen supply and / or CO2 removal are impaired, the clinician stops the medical procedure and promotes oxygen supply and / or CO2 removal. This can be achieved, for example, by manually ventilating the patient through a bag-valve mask, or by using a high-flow-rate breathing system or by jet ventilation to deliver a high flow of gas to the patient's airway. Furthermore, it should be understood that masks used for sedation / ventilation (not necessarily limited to bag-valve masks) can also be used for pre-oxygenation and for monitoring patient parameters such as end-expiratory CO2.
[0255] Other advantages of high-flow bronchodilator (HF) can include: increased pressure in the patient's airway, providing pressure support to open the airway, trachea, lungs / alveoli, and bronchioles. This opening of the structures enhances oxygenation and, to some extent, helps remove CO2 and / or may help support patients with areas of lung collapse.
[0256] When humidified, the high-flow-rate gas can also prevent airway dryness, reduce damage to mucociliary mucosa, lower the risk of infection, reduce the risk of laryngospasm, and reduce risks associated with airway dryness, such as nosebleeds, aspiration (a consequence of nosebleeds), and airway obstruction, swelling, and bleeding.
[0257] Figure 1A respiratory support system 10 is shown. System 10 can be configured to provide high-flow respiratory support and / or high-flow therapy. The respiratory support system 10 includes an airflow generator 12. The airflow generator 12 is configured to generate an airflow through the respiratory support system 10. The airflow generator 12 is configured to generate an airflow to be provided to the patient at the flow rates described elsewhere in this specification. The airflow generator 12 delivers air to a humidifier 14. The humidifier 14 is configured to heat and humidify the airflow generated by the airflow generator 12 (heating and humidifying to the temperature and / or humidity as described elsewhere in this specification). In some configurations, the airflow generator 12 includes a blower adapted to receive gas from the environment outside the respiratory support system 10 and drive the gas through the respiratory therapy system 10. In some configurations, the airflow generator 12 may include other gas generating devices. For example, in some configurations, the airflow generator 12 may include one or more containers of a source (e.g., oxygen or air) available from a hospital gas outlet, or compressed air and / or other gases, and one or more valve devices adapted to control the flow rate of the gas leaving said one or more containers. As another example, in some configurations, the airflow generator 12 may include an oxygen concentrator. In some configurations, the airflow generator 12 may be adapted to deliver high-flow respiratory support and / or high-flow therapy. In some embodiments, the airflow source may include a compressed gas source, means for changing the flow rate from the compressed gas source, and / or an airflow generator for generating airflow.
[0258] The respiratory support system 10 includes a housing 16 that at least partially houses an airflow generator 12 and a humidifier 14 (e.g., the respiratory support system 10 may include an integrated airflow generator / humidifier unit). In other configurations, the airflow generator 12 and the humidifier 14 may each have their own housing and / or may be separate components. A hardware controller 18 is shown in electronic communication with the airflow generator 12 and the humidifier 14, but in some configurations, the hardware controller 18 may communicate only with the airflow generator 12 or the humidifier 14. In some configurations, the airflow generator 12 and the humidifier 14 may each have their own controller, which may or may not communicate with each other. The hardware controller 18 may include a microcontroller or other architecture configured to direct the operation of controllable components of the respiratory support system 10, including but not limited to the airflow generator 12 and / or the humidifier 14.
[0259] Input / output module 20 is shown in electronic communication with controller 18. Input / output module 20 may be configured to allow a user to interact with controller 18 to control controllable components of respiratory support system 10 (including, but not limited to, airflow generator 12 and / or humidifier 14) and / or view data regarding the operation of respiratory support system 10 and / or its components. Input / output module 20 may include, for example, one or more buttons, knobs, dials, switches, levers, touchscreens, speakers, displays, and / or other input or output peripherals that the user can use to view data and / or input commands to control components of respiratory support system 10.
[0260] like Figure 1 As further shown, the supplemental gas source 22 can be used to add one or more supplemental gases to the gas flowing through the respiratory support system 10. The one or more supplemental gases are added to the airflow generated by the airflow generator 12. The supplemental gas source 22 can be configured to deliver one or more supplemental gases, including but not limited to air, oxygen (O2), carbon dioxide (CO2), nitrogen (N2), nitrous oxide (NO), anesthetics, and / or a helium-oxygen mixture (a mixture of helium and oxygen). The supplemental gas source 22 can deliver the one or more supplemental gases to or to the airflow generator 12 via a first supplemental gas conduit 24, and / or deliver the one or more supplemental gases to a location in the airflow channel between the airflow generator 12 and the humidifier 14 via a second supplemental gas conduit 26. One or more supplemental airflow valves 28, 30 can be used to control the flow of the one or more supplemental gases from the supplemental gas source 22 and the flow rate through the first and / or second supplemental gas conduits 24, 26. One or more supplementary airflow valves 28, 30 can communicate electronically with controller 18 or a separate controller, which can control the operation and / or status of the one or more supplementary airflow valves 28, 30.
[0261] In some embodiments, supplementary airflow valves 28, 30 may be provided by and / or integrated with the airflow generator 12. At least one of the supplementary airflow valves 28, 30 may be a proportional valve. In one example, a user can set the flow rate and / or oxygen concentration via the input / output module 20. The airflow generator 12 and the supplementary airflow valves 28, 30 may work together to achieve the user-set flow rate and / or oxygen concentration.
[0262] In other configurations, supplemental gas source 22 may be configured to add one or more supplemental gases downstream of humidifier 14. In other configurations, supplemental gas source 22 may be configured to add one or more supplemental gases to humidifier 14, for example, to a humidification chamber containing water and capable of engaging with a heater base, the water being heated by a heating element to humidify the gas stream delivered to the patient.
[0263] like Figure 1 As shown, a conduit 32 extending from the humidifier 14 connects the humidifier 14 to a gas delivery patient interface 102 (also referred to herein as the patient interface). The conduit 32 may include a conduit heater 34 adapted to heat the gas passing through it. In other configurations, the conduit heater 34 may be absent. The conduit 32 and the conduit heater 34 form an intake branch 37 that delivers humidified gas from the humidifier 14 to the patient via the patient interface 102.
[0264] In some embodiments, an optional filter 36 is disposed between the catheter 32 and the patient interface 102. The filter 36 prevents backflow of gas from the patient into the catheter 32. In some cases, microorganisms may accompany gas from the patient when they exhale or cough. The filter 36 prevents any microorganisms accompanying any gas from the patient from entering the catheter 32. This serves to keep the respiratory support system 10 upstream of the filter 36 hygienic for reuse. An inspiratory branch 37 may be provided for coupling the filter 36 to the humidification chamber 14.
[0265] Figure 1 The gas delivery patient interface 102 is shown as a nasal cannula; however, it should be understood that other patient interfaces may be suitable in some configurations. For example, in some configurations, patient interface 102 may include a sealed or unsealed interface and may include a nasal mask, an oral mask, an oronasal mask, a full-face mask, a nasal pillow mask, a nasal cannula, an endotracheal tube, a tracheostomy tube, a combination of the above, or other gas delivery systems. In one embodiment, patient interface 102 is an unsealed interface, such as a nasal cannula, which allows gas exchange with the environment. For example, an unsealed cannula allows carbon dioxide to be removed and / or cleared from the patient's airway while the patient receives airflow from system 10. Furthermore, in some embodiments, patient interface 102 is in the form of a nasal interface, such that the system does not interfere with other oral airway devices and / or apparatuses, such as endotracheal tubes in intubation procedures.
[0266] Therefore, the patient can receive a continuous airflow throughout the intubation procedure. In other embodiments, the patient interface 102 is an oral interface, such as an oral interface received in the user's mouth. An oral interface may be preferred in cases involving nasal medical procedures, such that the interface does not interfere with nasal airway devices and / or apparatuses, such as endotracheal tubes used in nasal intubation procedures. In other embodiments, the interface may be adapted for both nasal and oral placement, or may be adjustable between nasal and oral configurations.
[0267] As shown in the figure, in some configurations, the patient interface 102 may further include a gas sensing module 38 adapted to measure the properties of gases passing through the patient interface 102. In some configurations, a gas collector 100 of this disclosure (e.g., any one of gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 as described herein) is mounted on the patient interface 102 to measure and monitor patient gases. In some configurations, a gas delivery patient interface 3000, 3500 providing gas sampling capability may be used as the patient interface 102. In some configurations, the patient interfaces 3000, 3500 and / or the gas collector 100 (or any one of 200, 300, 400, 500, 600, 700, 800, 900, 1000) may be integrated with the patient interface 102. Gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, and 1000 can be connected via sampling line 41 to one or more sensor units 39 to sense exhaled gases from the patient. Sensor units 39 can be independent units separate from the respiratory support system 16. The one or more sensor units 39 may include one or more gas analyzers. Furthermore, the one or more sensor units 39 may include sensors for determining gas concentration. More specifically, the one or more sensor units 39 may include a carbon dioxide monitor. Sampling line 41 can be a pneumatic line. Sampling line 41 facilitates fluid communication between the patient and the one or more sensor units 39.
[0268] The one or more gas analyzers (e.g., carbon dioxide monitors) may have an aspiration flow rate of less than 500 mL / min, or more specifically, between 50 mL / min and 300 mL / min. The aspiration flow rate of the one or more gas analyzers (e.g., carbon dioxide monitors) is generally lower than the flow rate of gas delivered to the patient via the nasal cannula 102.
[0269] The gas sensing module 38 may be located at other locations within the gas delivery system, such as at the breathing duct or humidifier. In some embodiments, one or more gas sensing modules 38 may be present. In other configurations, the gas sensing module 38 may be positioned and adapted to measure the characteristics of gases at or near other parts of the respiratory support system 10. The gas sensing module 38 may include one or more sensors adapted to detect the presence of a gas and / or measure various gas characteristics, including but not limited to pressure, flow rate, temperature, absolute humidity, relative humidity, enthalpy, gas composition, oxygen concentration, carbon dioxide concentration (e.g., for determining end-expiratory CO2), and / or nitrogen concentration. The gas characteristics determined by the gas sensing module 38 may be utilized in various ways, including but not limited to closed-loop control of gas parameters. For example, in some configurations, flow rate data acquired by the gas sensing module 38 may be used to determine instantaneous flow rate, which may then be used to determine the patient's respiratory cycle to facilitate airflow delivery synchronized with the portions of the respiratory cycle. The gas sensing module 38 may communicate with the controller 18 via a first transmission line 40. In some configurations, the first transmission line 40 may include a data communication connection adapted to transmit data signals. Data communication connections may include wired data communication connections (e.g., but not limited to data cables) or wireless data communication connections (e.g., but not limited to Wi-Fi or Bluetooth). In some configurations, both power and data can be transmitted over the same first transmission line 40. For example, the gas sensing module 38 may include a modulator that allows data signals to be “superimposed” on electrical signals. The data signals can be superimposed on the electrical signals, and the combined signals can be demodulated by the controller 18 before use. In other configurations, the first transmission line 40 may include a pneumatic communication connection adapted to transmit airflow for analysis at a portion of the respiratory support system 10. In other configurations, the transmission line 40 includes a pneumatic communication connection separate from the catheter 32, adapted to transmit airflow captured at or near the patient for analysis on a separate system or device, such as a carbon dioxide monitor.
[0270] Additionally, as shown in the figure, a physiological sensor module 42 may be present. The physiological sensor module 42 may be configured to detect various characteristics of the patient or patient health, including but not limited to heart rate, EEG signals, EKG / ECG signals, inertial sensors attached to the patient (e.g., attached to the chest) to detect motion, blood oxygen saturation (e.g., via a pulse oximeter), blood CO2 concentration, transcutaneous CO2 (TcCO2), and / or blood glucose. Similarly, the physiological sensor module 42 may communicate with the controller 18 via a second transmission line 44. Similar to the first transmission line 40, the second transmission line 44 may include a wired or wireless data communication connection and may similarly transmit power and data. The physiological sensor module 42 may be used, for example, to determine the patient's blood oxygen saturation. In some embodiments, the second transmission line 44 may include a pneumatic communication connection adapted to transmit fluid for analysis at a portion of the respiratory support system 10 or at a separate system or device.
[0271] Figure 29 A user or patient P wearing the patient interface 102 is shown, for example... Figure 1 The patient interface 102 of the respiratory system 10 is shown. The patient depicted is an adult; however, the patient could be an infant, newborn, or child. In the non-limiting configuration shown, the patient interface 102 is a nasal cannula 104. The patient interface 102 includes a first gas conduit 136. The first gas conduit 136 is adapted to receive gas from the respiratory support system 10 (e.g., via...). Figure 1 The first gas catheter 136 (as shown in catheter 32) guides gas to the patient P. The first gas catheter 136 may include a reinforcing element 138 adapted to strengthen and / or increase the rigidity of the first gas catheter to prevent deformation or collapse of the first gas catheter 136 due to forces applied to it. The reinforcing element 138 may include various structures, including but not limited to plastic or metal reinforcing ribs located in or on the wall of the lumen 136 of the first catheter.
[0272] A first gas conduit 136 is pneumatically connected to an airflow manifold 106. The airflow manifold 106 receives gas from the first gas conduit 136 and delivers the gas to one or more nasal delivery elements 108, 110 (e.g., nasal forks). The one or more nasal delivery elements 108, 110 extend outward from the airflow manifold 106. When positioned in one or more nostrils of a patient P, the one or more nasal delivery elements 108, 110 are adapted to be non-sealed (i.e., there is a gap between each nasal delivery element and the patient's nasal passage). As shown, the patient interface 102 includes two nasal forks 108, 110 adapted to be positioned in each of the patient's nostrils, respectively. Each nasal fork 108, 110 may be shaped or angled to extend inward toward the patient's nasal septum. Alternatively, the gas delivery patient interface 102 may be a sealed nasal interface.
[0273] exist Figure 29 In the illustrated embodiment, the airflow manifold 106 receives airflow from one lateral side (e.g., relative to an imaginary vertical plane bisecting the patient's face) and directs the airflow to the manifold and each nasal fork 108, 110. In some configurations, the airflow manifold 106 receives airflow from one side and directs the airflow to the manifold and each nasal fork 108, 110. This one side may be a single lateral side. In some embodiments, the catheter may extend from either the left-hand or right-hand side of the manifold. In some cases, providing the catheter on the left-hand side of the patient interface may be preferred for clinician access, such as for intubation. Alternatively, a catheter extending from the right-hand side may be preferred, for example in procedures such as endoscopy, where the patient typically lies with their left hand on their side. In other configurations, the patient interface 102 may include more (e.g., three or four) or fewer (e.g., one) nasal delivery elements 108, 110. In other configurations, each nasal delivery element 108, 110 may have different structures, sizes, shapes and / or characteristics. For example, one of a pair of nasal delivery elements 108, 110 may be relatively long, while the other nasal delivery element 108, 110 may be relatively short.
[0274] In some configurations, the airflow manifold 106 can be configured to receive air from both lateral sides of the airflow manifold 106 (e.g., from the "left" and "right" of the airflow manifold 106, rather than as shown in the image). Figure 29 The airflow is received only from the patient's right-hand side of the airflow manifold 106 (as seen in the illustration). In some such configurations, multiple gas conduits may be used to provide pneumatic communication between the airflow manifold 106 and the respiratory support system 10. For example, the patient interface 102 may include dual conduits, with a first gas conduit 136 extending from a first side of the interface (the patient's right-hand side in the illustrated example) and a second gas conduit extending from a second, opposite side of the interface. In some configurations, the airflow manifold 106 may be configured to receive airflow from a non-lateral side of the airflow manifold 106 (e.g., from the "bottom" or "top" of the airflow manifold 106). In some configurations, the airflow manifold 106 may receive airflow from one or more gas conduits from a single side (optionally a single lateral side) of the manifold 106. In some configurations, one fork may receive airflow from one gas conduit while another fork may receive airflow from another separate gas conduit.
[0275] The patient interface 102 may also include mounts and / or supports, such as cheek supports 140, for attaching and / or supporting the gas conduit 136 to and / or supporting the patient's face. Alternatively or additionally, the patient interface may be held in place via one or more headbands or caps.
[0276] The first gas conduit 136 may include a first portion 142 configured to transition from a first configuration to a second configuration, wherein in the first configuration a first level of gas can pass through the first portion 142, and in the second configuration a second level of gas can pass through the first portion 142.
[0277] Figure 30 The image shows the person wearing the face mask 144 component (second patient interface). Figure 29 A non-limiting exemplary embodiment of the patient P in the patient interface 102 (first patient interface) shown. Figure 30 The face mask 144 is schematically shown as a transparent structure to show the patient interface 102 beneath it. The first patient interface 102 can be used with a first respiratory support subsystem, and the second patient interface 144 can be used with a second respiratory support subsystem. In some embodiments, the first patient interface 102 and the second patient interface 144 can be used with the same respiratory support system.
[0278] The system can be beneficial for selectively delivering separate respiratory support and / or treatment to patients using different patient interfaces, and / or stopping or terminating the delivery of respiratory support and / or treatment from the interface, and / or allowing sampling of the gas supplied by the interface.
[0279] The systems and devices described are particularly suitable for emergency resuscitation, intubation of patients receiving high-flow respiratory support and / or treatment, ear, nose and throat (ENT) surgery, preoperative status before anesthetic administration, and assisting patient care after extubation and during recovery.
[0280] The face mask assembly 144 can be used as a second respiratory support subsystem and / or in conjunction with it, and / or to deliver one or more substances other than those delivered by the cannula 102 (e.g., anesthetics or oxygen) or the same substances but at different flow rates and / or pressure levels to the patient. Alternatively, the face mask assembly 144 can be used to stop the delivery of respiratory support and / or treatment from the first respiratory support subsystem. The face mask assembly 144 can also be adapted to measure respiratory gases, such as carbon dioxide exhaled by the patient, the measurement results of which may otherwise be affected by the airflow from the patient interface 144 of the first respiratory support subsystem.
[0281] therefore, Figure 30 The embodiment shown allows for alternation between two different respiratory support subsystems. Additionally, this configuration allows the patient interface 102 to remain on the patient throughout the surgical procedure and / or recovery (regardless of whether the patient continuously receives airflow through the patient interface 102 throughout the procedure) without interfering with other clinical practices.
[0282] In the illustrated embodiment, the face mask assembly 144 includes a full-face mask 146 configured to cover the patient's nose and mouth. In other configurations, the face mask 144 may be a nasal mask placed over the patient interface 102 to cover only the patient's nasal region. In such a configuration, a portion of the face mask 144 may be placed on a portion of the patient interface 102, such as a first portion 142.
[0283] As shown, the face mask 146 includes a sealing area 148 adapted to seal onto a patient's face. The face mask assembly 144 is connected, for example via a filter element 150 or a moisture exchanger (not shown), to a second gas source that supplies one or more other gases to the patient via the face mask. That is, the second gas source is preferably different from the source supplying gas to the patient interface 102 (e.g., supplemental gas source 22 / airflow generator 12). In other embodiments, the patient interface 102 and the face mask assembly 144 are connected to a common gas source.
[0284] In one embodiment, the face mask assembly 144 is connected to a separate gas source or a separate respiratory support device. For example, the respiratory support device may be a ventilator, CPAP, high-flow respiratory support and / or treatment device, or a manual resuscitator (e.g., a handheld face mask with an airbag). Alternatively or supplementally, the face mask assembly 144 may be connected to a device for measuring respiratory gas characteristics.
[0285] Alternatively, the mask assembly 144 can be connected to an anesthesia device, and an anesthetic gas, or air, or oxygen, or a combination of gases can be delivered via the mask 146.
[0286] Figure 30 The embodiments shown allow for the delivery of gas from multiple sources via at least two different respiratory support modes, and also allow physicians, clinicians, or medical personnel to quickly and easily change the type of respiratory support mode.
[0287] In one specific application, a patient preparing for anesthesia may be pre-oxygenated by delivering a high flow rate of oxygen or humidified gas, or a mixture of both, via a nasal cannula. In some cases, an anesthesiologist managing the patient's sedation and / or anesthesia may wish to switch between delivering airflow from one patient interface (e.g., nasal cannula 102) and from another patient interface (e.g., via face mask 144).
[0288] Anesthesiologists also use a bag-valve mask (“bag mask”) in fluid communication with the balloon to oxygenate the patient, and in some cases, using a bag mask is more beneficial if the patient’s vital signs begin to decline, for example, by delivering greater pressure or by having better control over changes in delivery pressure. In some situations, healthcare professionals may wish to switch between different respiratory systems or support modes. In a first mode, respiratory support may be provided by a first respiratory support system (e.g., via patient interface 102), and in a second mode, respiratory support may be provided by a second respiratory support system (e.g., via patient interface 144) and support from the first system may be reduced or stopped. For example, a high-flow-rate additional airflow from the nasal interface 102 may also alter the intended behavior of the anesthesia circuit provided by the face mask 144, so being able to reduce or stop the additional airflow from the first respiratory system can be advantageous.
[0289] In some configurations, the structure of a first gas conduit 136 can facilitate switching between two respiratory support modes or subsystems, the first gas conduit having a first portion 142 configured to transition from a first configuration to a second configuration, wherein in the first configuration a first level of gas can pass through the first portion 142 and in the second configuration a second level of gas can pass through the first portion 142.
[0290] In some configurations, the first portion 142 is configured to be more collapsible or otherwise better adapted to alter the gas flow through the first portion 142 (thus stopping or reducing the gas flow through the catheter and to the patient) than other portions of the catheter 136, and / or to allow a mask seal to be applied to the top of the catheter. In other configurations, the entire catheter may be configured to be collapsible. In some configurations, a venting device may be provided to release gas from the catheter to the atmosphere.
[0291] In some embodiments, the first configuration or first state is a substantially open configuration, and the second configuration or second state is a substantially closed configuration. That is, the conduit 136 is configured to be more collapsible, deformable, or otherwise adapted to completely cut off the airflow at the first portion 142 than at other portions of the conduit 136. In the second state, the flow of gas to the nasal delivery element 108 can be reduced or stopped.
[0292] Figure 31 An example of this configuration is shown, in which the conduit (e.g.) Figure 30The conduit 142 of the nasal cannula 104 is substantially closed at its first portion 142 by the seal 148 of the face mask 146. In this embodiment, the length of the first portion of the first gas conduit (i.e., the more collapsible or deformable portion) should be greater than or equal to the width of the portion of the face mask seal that supports the first portion of the first gas conduit. This allows the face mask seal to not support the non-collapsible portion of the first gas conduit. For example, the first portion may extend from a distance of 35 mm or less from a portion of the manifold 106 or the center of the user's nose to at least 50 mm from a portion of the manifold 106 or the center of the user's nose. The first portion 142 may have a length of at least about 5 mm, a length of about 1 mm to about 30 mm, a length of about 5 mm to about 15 mm, or a length of about 10 mm. In some embodiments, the length of the first portion 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 greater.
[0293] The first portion 142 may progress between a first configuration and a second configuration based on the relative levels of forces applied to the walls of the first portion 142. For example, as Figure 30 As shown, force can be applied by the seal 148 of the face mask 146. In this example, the first portion 142 is configured to be positioned below the seal 148 of the face mask 146.
[0294] Alternatively, force can be applied to the first portion 142 by other means (e.g., a clamp (not shown)); or, alternatively, medical personnel can compress the catheter by pressing the catheter wall with their fingers or thumb.
[0295] In some embodiments, the face mask seal acts on a first portion 142 of the gas conduit, such that the first portion 142 forms a seal or at least an obstruction between the nasal outlet of the first patient interface 102 and the airflow generator 12. Additionally, the face mask seal forms a seal or at least a partial seal on the first portion 142 of the gas conduit 136.
[0296] Therefore, switching between various respiratory support therapies is achieved simply by applying a mask to the patient's face such that the mask's seal causes a first portion of the gas conduit of the first interface 102 to collapse (partially or completely) to stop or "shut down" or reduce the respiratory support and / or therapy supplied by the first interface 102, and a seal is also provided between the face mask 144 and the outer surface of the first portion 142 of the conduit 136 so that respiratory support and / or therapy can be provided by the mask 144 if the respiratory support and / or therapy provided by the first interface 102 is stopped or reduced. As described above, the first portion 142 of the patient interface 102 is configured to collapse and will be referred to hereinafter as the collapseable portion 142.
[0297] A cannula with a collapsible catheter portion allows a user (e.g., an anesthesiologist, nurse, or clinician) to use a mask and prevents gas delivery from multiple sources (e.g., mask and cannula). A first interface 102 is configured to reduce or shut off high-flow delivery when the interface 102 is moved to a collapsible configuration and allows delivery of additional respiratory support and / or respiratory therapy or anesthetic gases via the mask. In some embodiments, removing the mask from the patient's face when the cannula returns from a collapsible configuration to an open configuration allows respiratory support and / or therapy supplied by the first interface to resume.
[0298] Figures 32 to 35 A patient interface 1400 is illustrated, which includes a nasal cannula and a gas delivery side component 1401 configured to deliver device gas (e.g., a gas flow from a gas flow source) to a patient via a manifold 1406 to a delivery outlet including a pair of nose forks 1408. The pair of nose forks 1408 extend from the manifold 1406. The gas delivery side component 1401 extends from a first side of the manifold 1406, and the interface 1400 also includes a non-delivery side component 1403 extending from a second side of the manifold 1406 opposite to the first side. The non-delivery side component 1403 includes an end portion 1409 configured for connection to a headband 1411.
[0299] Gas delivery side component 1401 includes a collapsible portion 1404 configured to... Figure 32 , Figure 34 and Figure 35 The normally open configuration shown moves to a collapsed configuration, in which the flow of device gas through the collapsed portion 1404 is reduced or stopped. The collapsed portion 1404 is configured to move to the collapsed configuration, for example, when a collapse force is applied from a patient mask placed on the patient's face, and wherein the mask's seal is pressed downward against the collapsed portion 1404. The gas delivery side component 1401 also includes a non-collapseable portion 1407 configured to remain open during the application of a collapse force to the collapsed portion 1404.
[0300] One end of the non-collapseable portion 1407 includes a delivery inlet 1407a for receiving device airflow. The patient interface 1400 also includes a gas connector 1413, which has a rigid structure and includes a delivery inlet 1413a and a delivery outlet 1413b. The gas connector delivery inlet 1413a can be connected to a device gas supply source via a conduit (not shown). The gas connector delivery outlet 1413b is connected to the delivery inlet 1407a of the non-collapseable portion 1407. The gas connector 1413 is also connected to a headband 1411. The headband 1411 is connected at its other end to the headband end 1409 of the non-delivery side component 1403.
[0301] Figure 33 A cross-section of the non-collapseable portion 1407, including a wall 1412 of uniform thickness, is shown. Figure 34 and Figure 35 A cross-section of a collapsible portion 1404, including a wall 1404a of uneven thickness, is shown. The collapsible portion 1404 has an elongated oval cross-section, particularly a stadium-shaped cross-section, and includes a pair of longitudinal sides 1404b extending between a pair of end portions 1404c. Figure 35 As shown, a thin-walled portion 1404 is provided at each end 1404c. The thin-walled portion 1404d is configured to provide a fold line at which the collapsible portion 1404 bends or folds when a collapsible force is applied.
[0302] In some embodiments, each of the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, and 1000 as described herein can be configured to be mounted to the corresponding nasal cannula 104, such that when the face mask assembly 144 is as described herein... Figure 31 When applied to the nasal cannula 104, as shown, the nasal cannula 104 and the corresponding gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, and 1000 are fitted under the face mask assembly 144. As described in further detail herein, the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, and 1000 can be generally configured to fit between the nasal forks 106 and 108 of the nasal cannula. In some configurations, the gas collectors 300, 500, 600, 700, 800, and 900 can be fitted around the nasal forks 106 and 108 of the nasal cannula 104. This configuration allows clinicians to seamlessly switch between two different respiratory support modes using either the nasal cannula 104 or the face mask assembly 144 as described herein, while simultaneously allowing the face mask assembly 144 to be used as described herein. Figure 31 As shown, when placed on the nasal cannula 104, it maintains uninterrupted sampling of the gas from the patient and / or the gas delivered to the patient.
[0303] Connect gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, and 1000 to the sampling line 41 of one or more gas analyzer / sensor units 39 (see...). Figure 1 It can be configured to remain open when the face mask assembly 144 is applied to the nasal cannula 104 and the first portion 142 of the gas conduit 136 collapses. See below for reference. Figures 39A to 40 The sampling gas conduit 3018 and gas delivery patient interface 3000 are shown to describe the example configuration in more detail. This allows the one or more gas analyzer / sensor units 39 (e.g., carbon dioxide monitors) to continuously sample gas from the patient while the face mask assembly 144 is applied. In some examples, the geometry of the sampling line 41 provides additional structural support to prevent the sampling line from collapsing when the face mask assembly 144 is applied to the nasal cannula 104. In some embodiments, the sampling line 41 may have a smaller cross-section than the gas conduit 136. In some embodiments, the sampling line 41 may have a thicker wall than the first portion 142 of the gas conduit 136.
[0304] In some embodiments, the one or more gas analyzer / sensor units 39 (e.g., carbon dioxide monitors) can be configured as follows: Figure 1 This is part of the respiratory support system shown. For example, the one or more gas analyzer / sensor units 39 may be disposed inside or outside the housing 16. In some embodiments, the one or more gas analyzer / sensor units 39 (e.g., a carbon dioxide monitor) may be configured to work with, for example, a respiratory support system. Figure 1 The respiratory support system shown is a separate system or device.
[0305] Figures 32 to 35 The patient interface 1400 shown here provides background for various embodiments of patient interfaces (or portions thereof) similar to those described herein as interfaces 2030 and 104.
[0306] Figures 36 to 38Another example of a patient interface is shown. The nasal cannula 2030 includes a face mount 2032, a pair of nose forks 2033, 2034, an airflow manifold 2035, and a gas conduit 2003. The face mount 2032 includes: an upper portion (first part) 2032a from which forks 2033, 2034 extend; and a face contact portion (second part) 2032b configured to contact the patient's upper lip in use. The upper portion 2032a and the face contact portion 2032b are angled to each other and optionally substantially perpendicular to each other. The face mount 2032 and the pair of nose forks 2033, 2034 are preferably integrally molded from a soft plastic material such as silicone or thermoplastic elastomer into a single unit, but in other forms the face mount and forks may be separate but can be attached together for use. In some configurations, the face mount 2032 and the nose forks 2033, 2034 may be formed from the same or different materials. The nose forks 2033 and 2034 may be tubular in shape and may have a uniform diameter, but may be shaped to fit the contours of a human nostril. The forks 2033 and 2034 may be angled relative to the central plane of the face mount 2032, which bisects the face mount 2032 between the forks. The forks 2033 and 2034 may be bent so that, in use, their outlets point towards the back of the patient's head. The forks 2033 and 2034 may include an internal and / or external cross-sectional shape that crosses the airflow direction of each fork during use; this shape may be elliptical, such as circular, or generally elliptical, such as oval. The shape and / or size of each fork 2033 and 2034 may be uniform, or may vary along the length of the fork. The forks 2033 and 2034 are configured not to form a seal with the patient's nostril during use, such that a gap exists between the fork and the patient's nostril. This allows for continuous airflow between the fork and the patient's nostril during use.
[0307] The face mount 2032 includes side arms 2031 extending laterally from the sides of the face mount 2032. The side arms 2031, together with a headband (not shown), help hold the nasal cannula 2030 in place on the patient's face. Each side arm 2031 includes one or more slits at its end to allow the end of the headband to pass through. This provides an adjustable connection between the headband and the side arm 2031. Other attachment mechanisms besides slits are also conceivable, such as buckles and clips.
[0308] The face mount 2032 also includes a third portion 2032c that extends from the upper portion 2032a and connects to the face contact portion 2032b to form a recess 2038 capable of receiving the airflow manifold 2035. In the illustrated embodiment, the recess 2038 provides a horizontal side entry for the airflow manifold 2035. Therefore, the airflow manifold 2035 can be laterally inserted into the recess 2038 via one lateral side of the face mount 2032 along the length of the transverse frustums 2033, 2034. Because the recess 2038 includes two lateral openings, the airflow manifold 3205 can be inserted into the recess 2038 via the left or right side of the face mount 2032. This allows the nasal cannula 2030 to be configured to allow gas to flow to the patient from either the left or right side of the nasal cannula. The airflow manifold 2035 can be attached to or integrally formed with the gas conduit 2003. Nose forks 2033 and 2034 include flow channels extending through face mount 2032 and into recess 2038. The assembly of face mount 2032 and airflow manifold 2035 includes a manifold. Airflow manifold 2035 is blocked at one end 2039 but attached to gas conduit 2003 at the other end. Airflow manifold 2035 has an opening 2037, which serves as an outlet for gas received from gas conduit 2003. Opening 2037 is shown as an elongated oval opening, but other shapes are conceivable. Airflow manifold 2035 may be more rigid than face mount 2032 or comprise a more rigid material. Due to the relative rigidity / flexibility of airflow manifold 2035 and face mount 2032, airflow manifold 2035 can be pushed through recess 2038 in face mount 2032, and opening 2037 in airflow manifold 2035 merges with the flow channels of forks 2033 and 2034. Therefore, in use, the gas flowing through the gas conduit 2003 and into the airflow manifold 2035 leaves through the opening 2037 and enters the tubular passage in the forks 2033 and 2034 and then enters the patient's nostrils.
[0309] To facilitate holding the airflow manifold 2035 within the recess 2038, the airflow manifold 2035 has a recess 2060 and lip regions 2058, 2059. Upon engagement with the face mount 2032, a third portion 2032c, forming part of the recess 2038, sits within the recess 2060, and the edge of the third portion 2032c abuts against the lips 2058, 2059 formed on the airflow manifold 2035. Additionally or alternatively, the airflow manifold 2035 includes one or more flanges 2035a configured to engage with a portion of the upper portion 2032a to hold the airflow manifold 2035 within the face mount 2032. The one or more flanges 2035a are located around the periphery of the opening 2037. In some configurations, the one or more flanges 2035a are a single flange extending around the entire periphery of the opening 2037.
[0310] The embodiments of the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, and 1000 described below can be attached to or integrated with nasal cannulas 2030, 104, and / or 1400. The embodiments of the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, and 1000 can be configured for installation into any suitable patient interface that includes a portion (such as a bridging section between nasal elements) for positioning in use below the patient's nasal septum (particularly the patient's columella).
[0311] Reference shows the patient's face Figure 51 The nasal septum 4000 (also referred to herein as the septum) is the structure separating the two nostrils 4002, 4004, and is generally vertically positioned between them. The columella 4006 is the anterior inferior part of the nasal septum 4000 and forms an external intermediate fleshy portion between the two nostrils 4002, 4004, which is visible at the lower end of the nose 4008. The columella 4006 is a midline structure composed of cartilage and covering skin, extending posteriorly from the tip of the nose 4008. As mentioned herein, the columella 4006 is the externally visible part of the nasal septum 4000. Throughout this instruction manual, the location 4010 below the patient's nasal septum 4000 or columella 4006 can be used interchangeably. Figure 51 The position 4010 shown refers to the location outside the patient's nose 4008, below the patient's nasal septum 4000 and columella 4006, roughly aligned with the philtrum 4012 extending along the midline sagittal plane between the patient's nostrils 4002 and 4004.
[0312] Below the columella 4006, the philtrum 4012 refers to the vertical groove located on the upper lip, extending from the base of the columella 4006 to the center point of the upper lip. These features are positioned relatively aligned along the midline of the patient's face (and the patient's midsagittal plane), with the columella 4006 forming the boundary between the upper nose 4008 and the lower philtrum 4012.
[0313] Figures 2 to 5 A gas collector 100 for collecting gas from a patient is shown according to one embodiment. In some embodiments, the gas collector 100 may be provided separately and releasably attached to a gas delivery patient interface 102. The gas delivery patient interface 102 may include an unsealed nasal cannula 104 for providing a flow of gas to the patient via the patient's nostrils.
[0314] In this specification, the gas sampled or collected at the patient by the gas collector 100 may include gas exhaled from the patient's lungs, gas diverted from gas delivered to the patient via the gas delivery patient interface 102, ambient gas near the patient, or any combination thereof. Sometimes, gas diverted from gas delivered to the patient via the gas delivery patient interface 102 may be referred to herein as a downwash stream. In some cases, the downwash stream may include gas diverted from gas delivered to the patient via the gas delivery patient interface 102 and / or other emissions from the patient (e.g., mucus).
[0315] Generally, the gas delivery patient interface 102 includes: a body 101 having an airflow manifold 106 for receiving a gas flow delivered to a patient; and a pair of nose forks 108, 110 extending from the body 101 and the airflow manifold 106 for delivering a gas flow to the patient through the patient's nostrils. In some embodiments, a suitable alternative gas delivery patient interface may include two separate airflow manifolds extending from both sides of the body 101, each airflow manifold delivering gas to a corresponding one of the nose forks 108, 110. In some embodiments of the patient interface 102, the body 101 includes a bridging portion 120 extending between the nose forks 108, 110.
[0316] It should be understood that the gas delivery patient interface 102 (e.g., nasal cannula 104) can be received and used in any suitable orientation. In the context of this disclosure, the first side 107 of the airflow manifold 106 (from which the nasal forks 108, 110 extend) (also referred to herein as the top side 107) and the area spanned from the first side 107 of the airflow manifold 106 away from the airflow manifold 106 may be referred to as the upper region 105 of the airflow manifold 106. The second side 109 of the airflow manifold 106 opposite to the first side 107 (also referred herein as the bottom side 109) and the area spanned from the second side 109 of the airflow manifold 106 away from the airflow manifold 106 may be referred to as the lower region 103 of the airflow manifold 106.
[0317] Any suitable gas delivery patient interface 102 can be used. For example, the gas delivery patient interface 102 may include the collapsible, non-sealed nasal cannula 1400 described above and in PCT application PCT / IB2023 / 058268 entitled “Gas Collector,” the entire contents of which are incorporated herein by reference. The non-sealed nasal cannula 104 can deliver high-flow-rate gas therapy to the patient. It may also use the same type of gas as referenced herein. Figures 36 to 38 The gas delivery patient interface 2030 is similar to the gas delivery patient interface.
[0318] The gas collector 100 may include a gas sampling section 111 for sampling gas from a patient. The gas sampling section 111 may include a nasal sampling section 112 defining at least one opening 114 for sampling gas from the patient's nose. Figures 2 to 5 In the specific embodiment shown, the nasal sampling portion 112 defines a pair of openings 114, 116 (see...) Figure 4 and Figure 5 Each inlet opening 114, 116 can be positioned on either side 122, 124 of the nasal sampling section 112 such that each inlet opening 114, 116 faces the corresponding nasal fork 108, 110 when the gas collector 100 is mounted to the gas delivery patient interface 102. In some embodiments, the nasal sampling section 112 may include a single opening 114 for sampling gas from the patient's nose. When the gas collector 100 is mounted to the gas delivery patient interface 102, the single opening 114 can be positioned to face either of the nasal forks 108, 110.
[0319] like Figure 2 As shown more clearly in the diagram, the one or more inlet openings 114 can be configured such that when the gas collector 100 is mounted to the patient interface 102, the one or more inlet openings 114 are positioned close to the base of the respective nose forks 108, 110. The base of each nose fork 108, 110 may be opposite to the opening of the respective nose fork 108, 110 and connected to the body 101 of the patient interface 102. More specifically, the one or more inlet openings 114 can be configured to be positioned adjacent to and close to the top side 107 of the body 101 and the airflow manifold 106 when the gas collector 100 is mounted to the patient interface 102.
[0320] Furthermore, the body 101 of the patient interface 102 may include an inner wall 113 for facing the patient's face during use and an outer wall opposite to the inner wall 113 (in Figure 2 (Hidden in the middle). When the patient interface 102 is installed on the patient, the outer wall faces away from the patient's face.
[0321] The one or more inlet openings 114 may be configured to be positioned adjacent to and close to the inner wall 113 of the body 101 when the gas collector 100 is mounted to the patient interface 102. Alternatively or in combination, the one or more inlet openings 114 may be configured to be positioned adjacent to and close to the central region between the inner wall 113 and the outer wall of the body 101, and / or adjacent to and close to the outer wall of the body 101, when the gas collector 100 is mounted to the patient interface 102.
[0322] The gas collector 100 also includes a coupling mechanism 118 for connecting the gas sampling unit 112 to the nasal cannula 104. Specifically, the coupling mechanism 118 can be configured for releasable attachment to the body 101 of the patient interface, for example, as... Figure 2 As shown in the diagram. In some embodiments, the coupling mechanism 118 may be configured for releasable attachment to the body 101. In a particular embodiment shown, the coupling mechanism 118 is an annular portion, ring, or hoop configured to assemble around the periphery of the body 101. More specifically, as previously described, the body 101 includes a bridging portion 120 extending between the nasal forks 108, 110. In other words, the bridging portion 120 is located between the nasal forks 108 and 110. The bridging portion 120 may be a wall portion of the body 101 and / or the airflow manifold 106. In some embodiments, a single airflow manifold 106 may extend across one side of the body 101 of the patient interface 102 and the bridging portion 120 to deliver gas to both nasal forks 108, 101. In these embodiments, the coupling mechanism 118 may be configured for releasable attachment to a portion of the airflow manifold 106 that coincides with the bridging portion 120. In some embodiments, the bridging portion 120 may include a recess in the wall of the body 101 to receive the nasal septum and columella. In some embodiments, the bridging portion 120 may include a flat surface located between the nose forks 108 and 110 and at the base of the nose forks 108 and 110.
[0323] The annular connecting mechanism 118 can be configured to assemble around or surround the bridging portion 120 of the body 101. In practice, the annular connecting mechanism 118 can be attached to the nasal cannula 104 by sliding the connecting mechanism 118 across the body 101 and either of the nose forks 108 or 110, such that the connecting mechanism 118 is positioned around the bridging portion 120 between the nose forks 108, as... Figure 2As shown. The coupling mechanism 118 allows connection to an extendable portion of the nasal cannula 104. At least a portion of the body 101 and / or the nose forks 108, 110 may be flexible to facilitate attachment of the coupling mechanism 118. In some embodiments, all components of the nasal cannula 102 may be flexible and extendable. For example, the nasal cannula 102 may be molded into a single piece using a soft plastic material. In some embodiments, the nose forks 108, 110 may be flexible and extendable, and the remaining features of the nasal cannula 102 may be relatively rigid and less flexible and extendable compared to the nose forks 108, 110. Thus, the body 101 of the nasal cannula 104, including the bridging portion 120 and / or the airflow manifold 106, may be flexible or collapsible to allow the annular coupling mechanism 118 to slide across the body 101 and at least one nose fork 108, 110. After the body 101 and at least one nose fork 108, 110 are inserted via the annular connecting mechanism 118, the body 101 returns to its original shape. Alternatively or in combination, the connecting mechanism 118 may be flexible and / or resilient, allowing it to extend to fit over the body 101 and nose forks 108, 110 for attachment to the bridging portion 120. In some embodiments, the gas collector 100 may be made of the same or similar material as the nasal cannula 104.
[0324] As will be understood, the terms stiffness, flexibility, or ductility of a component are intended to be relative terms, and these relative properties can be achieved by any one or more of the specific structure, geometry, and material used to describe the particular feature or associated with the particular feature described.
[0325] In some embodiments, the coupling mechanism 118 may be generally U-shaped or C-shaped, or have any suitable loop or partially closed / partially open loop cross-section, to facilitate the releasable mounting of the gas collector 100 to the bridging portion 120 of the patient interface 102.
[0326] When the gas collector 100 is installed into the nasal cannula 104, the nasal sampling section 112 can be positioned in the space between the patient's nasal septum / columella, the bridging portion 120 of the main body 101, and the nasal forks 108 and 110. Generally, in use, the nasal sampling section 112 is located below the patient's nasal septum / columella.
[0327] The at least one (e.g., a pair) inlet openings 114, 116 of the nasal sampling section 112 allows some exhaled air from the patient's nose to enter in the inlet airflow direction F. inlet Entering the nasal sampling section 112. Generally, the inlet airflow enters in the direction of F. inlet Unlike the direction of exhaled air from the patient's nose, F nose In some cases, the direction of exhaled air from the patient's nose is F. noseThis can change as the gas leaves the patient's nose. Thus, in the context of this disclosure, the direction F of the gas exhaled from the patient's nose... nose It can be defined by the initial direction of the gas exiting the patient's nostrils. Figures 2 to 5 In the embodiment shown, the inlet airflow direction F inlet Approximately perpendicular to the direction of the air exhaled from the patient's nose. nose .
[0328] In some embodiments, the inlet airflow direction F of each opening 114, 116 is... inlet The inlet openings 114 and 116 are generally perpendicular to the surfaces of the corresponding sides 122 and 124 of the nasal sampling portion 112. When the gas collector 100 is attached to the nasal cannula 104, each side 122 and 124 can face the corresponding nasal fork 108 and 110. Thus, when the gas collector 100 is attached to the nasal cannula 104, the one or more inlets 114 can face a corresponding nasal fork 108 or 110. Furthermore, when the gas collector is attached to the nasal cannula 104 and the nasal cannula 104 is applied to the patient, the one or more inlet openings 114 can be oriented in the patient's sagittal plane. Additionally, the inlet airflow in direction F... inlet This may differ from the flow direction of the gas delivered to the patient's nostrils via nasal forks 108 and 110. The inlet airflow direction F inlet It can be perpendicular to the central axis of each nose fork 108, 110.
[0329] It has been found that the orientation of inlet openings 114, 116 can affect the quality of sampling and gas monitoring. More specifically, when one or more inlet openings 114, 116 are oriented towards the nasal septum / columella, allowing exhaled air from the patient to enter directly into the inlet openings 114, 116 without changing direction, increased dilution of the exhaled air can be observed. Further detailing, when the inlet airflow direction F... inlet F is the direction of the air exhaled from the patient's nose. nose At the same time, the downwash stream from the nasal forks 108 and 110 (generally including gas diverted from the nasal cannula 102) will more easily enter the inlet openings 114 and 116. The downwash stream will undesirably dilute the sampled gas trace detected by the gas collector 100.
[0330] As previously mentioned, the suction flow rate of the carbon dioxide monitor connected to the gas collector 100 via sampling line 41 can be lower than the flow rate of gas supplied via nasal cannula 104. In some cases, when the inlet airflow enters direction F... inlet F is the direction of the air exhaled from the patient's nose. nose When they are roughly the same, this difference between the supply flow rate and the suction flow rate can exacerbate the dilution problem.
[0331] Thus, when the inlet airflow enters direction F inlet Unlike the direction of exhaled air from the patient's nose, F nose At that time, and specifically, when the inlet airflow enters in direction F inlet As described above, for example, F is approximately perpendicular to the direction of the gas exhaled from the patient's nose. nose This allows for improved quality sampling and gas monitoring. The positioning of the gas sampling unit 112 and the inlet openings 114, 116 allows exhaled gas from the patient to flow around the gas sampling unit 112 without creating unwanted cavitation and facilitates monitoring of the patient's cyclic breathing patterns. When in fluid communication with a carbon dioxide monitor, a portion of the gas in or near the patient's nose can be removed / sampled via suction through the inlet openings 114, 116.
[0332] The one or more inlet openings 114, 116 may have any suitable geometry and size. In some embodiments, the one or more inlet openings 114, 116 may be generally circular, having a diameter of about 0.5 mm to 1.5 mm, 0.6 mm to 1.5 mm, 0.7 mm to 1.5 mm, 0.7 mm to 1.4 mm, 0.7 mm to 1.3 mm, 0.7 mm to 1.2 mm, 0.7 mm to 1.1 mm, 0.7 mm to 1.0 mm, or 0.7 mm to 0.9 mm. In one embodiment, the one or more inlet openings 114, 116 may be generally circular with a diameter of about 0.8 mm.
[0333] In some cases where the gas collector samples gas from the patient's mouth, the inlet airflow is directed towards direction F. inlet Arranged in a direction different from the direction of the air exhaled from the patient's nose. nose This can also improve the gas collector's ability to sample from the nozzle, as shown in the reference below. Figure 14 Further detailed description.
[0334] In some procedures, gas can be supplied to the patient at a high flow rate via nasal cannula 104. Gas collector 100 can be coupled to a carbon dioxide monitor and can continuously collect / sample gas from the patient at a much lower suction flow rate than the gas delivered to the patient via nasal cannula 104. If the patient's breathing is flushed or substantially diluted by gas diverted from the gas supply from nasal cannula 104, it can sometimes be difficult to use a carbon dioxide monitor to capture a trace of the patient's breathing. The orientation and position of the one or more inlet openings 114, 116 on either side 122, 124 of the nasal sampling section 112 and facing the nasal forks 108, 110 cause F inlet Roughly perpendicular to F noseThis can further improve the ability of the nasal sampling unit 112 to sample at least some of the exhaled and diverted gases when a certain level of suction is applied via a carbon dioxide monitor. The orientation and positioning of the inlet openings 114 and 116 also minimize the downwash flow to avoid substantially blocking or occupying the inlet openings 114 and 116 and to avoid hindering the entry of sampled exhaled gas into the inlet openings 114 and 116. In other words, if the inlet openings 114 and 116 are positioned and oriented such that F inlet Roughly parallel to F nose (For example, if the inlet openings 114, 116 face the patient's nasal septum / columella during use), then the high flow rate and high pressure of the gas diverted from the nasal forks 108, 110 will prevent or block the entry of exhaled air from the patient into the inlet openings 114, 116. Furthermore, positioning the inlets 114, 116 on either side 122, 124 of the nasal sampling section 112 reduces changes in obstruction caused by discharges from the patient's nose (e.g., mucus and / or particles).
[0335] The compact configuration of the gas collector 100 and the positioning of the nasal sampling unit 112 below the patient's nasal septum / columella further provide improved gas sampling capabilities for more effective monitoring of patient respiration. Specifically, the nasal sampling unit 112 can be positioned directly below and adjacent to the patient's nasal septum / columella, where exhaled gas from the patient's nose has been found to temporarily accumulate. More specifically, positioning the nasal sampling unit 112 close to the patient's nasal septum / columella and above the bridging portion 120 provides improved sampling because exhaled gas from the patient's nose temporarily accumulates near the nasal septum / columella before dissipating. This positioning improves the exposure of the nasal sampling unit 112 to exhaled gas from the patient's nose, enabling better sampling and measurement. Positioning the nasal sampling unit 112 directly at the location where exhaled gas from the patient's nose most easily accumulates improves sampling results.
[0336] In some embodiments, for example Figures 2 to 5 The gas collector 100 shown includes at least a majority of the gas collector 100, including the connecting mechanism 118 and the nasal sampling section 112, which is substantially mounted between the nasal forks 108 and 110. More specifically, the nasal sampling section 112 is also above the bridging section 120.
[0337] Furthermore, by positioning the nasal sampling unit 112 directly below and close to the patient's nasal septum / columella, the gas collector 100 is further able to sample gas from either or both of the left and right nostrils.
[0338] The streamlined and low-profile design of the gas collector 100 provides low resistance to the flow of gas, which more effectively allows exhaled gas from the patient to enter the gas collector 100. Furthermore, the gas collector 100 can be seamlessly attached to the nasal cannula 104 without obstructing airflow to the patient or hindering medical personnel procedures. As previously described, secondary respiratory support can be provided via the face mask assembly 144 by placing the face mask assembly 144 on the nasal cannula 104 and collapsing a portion of the airflow manifold 106 while maintaining open fluid communication with the sampling lines 41 connecting the gas collector 100 to one or more gas sensors 39. More specifically, the gas collector 100 does not protrude beyond the existing framework and boundaries of the nasal cannula 104. In other words, when attached, the gas collector 100 is compact and does not significantly increase the size or volume of the nasal cannula 104 and the overall assembly of the gas collector 100. In practice, when the gas collector 100 is attached to the nasal cannula, the overall profile of the nasal cannula 104, particularly the patient-facing side, remains relatively unchanged, allowing the nasal cannula 104 to be positioned relatively flush with the patient's face. This minimizes patient discomfort and also minimizes the movement or displacement of the nasal forks 108, 110 away from the patient's face in the coronal plane, thereby minimizing interruptions to the gas supply to the patient via the nasal cannula 104.
[0339] In addition, the coupling mechanism 118 provides a secure and stable attachment of the gas collector 100 to the nasal cannula 106 to prevent unintentional movement of the gas collector 100 relative to the nasal cannula 106 during use.
[0340] The nasal sampling section 112 and thus the one or more inlets 114, 116 are generally fixed relative to the coupling mechanism 118. In some embodiments, the nasal sampling section 112 may be integrally formed with or rigidly attached to the coupling mechanism 118, such that the nasal sampling section 112 and the inlet openings 114, 116 have generally no movement relative to the coupling mechanism 118. The firm and stable positioning of the nasal sampling section 112 after being mounted to the nasal cannula 104 via the coupling mechanism 118 further facilitates improved measurement and patient monitoring results. The construction of the gas collector 100 also avoids the need for any readjustment of the positioning of the nasal sampling section 112 during medical procedures, which in some cases would lead to suboptimal positioning and reduced effectiveness of patient monitoring.
[0341] In some embodiments, in addition to the one or more inlet openings 114, 116, an additional inlet opening (e.g., similar to...) may be provided on the top surface of the nasal sampling portion 112. Figure 39BThe inlet opening 3015 is shown. In some cases, when the nasal cannula 104 and the gas collector 100 are in use, the additional inlet opening (e.g., 3015) on the top surface of the nasal sampling section 112 may be blocked by the patient's columella. Occasionally, the nasal cannula 104 and / or the gas collector 100 may be moved or positioned such that the additional inlet opening (e.g., 3015) is not completely blocked by the patient's columella (e.g., due to movement of the patient and / or clinician, or differences in the geometry of the patient's face). When the additional inlet opening (e.g., 3015) is not completely blocked by the patient's columella, the patient's gas sampling level can be achieved via the additional inlet opening (e.g., 3015). The patient's gas can be directed relative to the overall direction F of the gas exhaled from the patient's nose. nose Enter the additional inlet opening (e.g., 3015) at a certain angle.
[0342] In some embodiments, the gas collector 100 may be integrated with the nasal cannula 104. For example, the gas collectors 100, 200, 300, 400, 500, 600, 700, and 800 may be co-formed with the nasal cannula.
[0343] The gas collector 100 may also include a pair of airflow guides 126, 128 for guiding gas from the patient toward the gas sampling unit 112. Figure 3 and Figure 4 As shown more clearly, airflow guides 126, 128 are generally airfoil-shaped and positioned on either side of the nasal sampling portion 112. Airflow guides 126, 128 are configured to guide gas from the patient's nose to a pair of inlet openings 114, 116 of the nasal sampling portion 112. In some embodiments, airflow guides 126, 128 may be rigid members positioned adjacent to the inlet openings 114, 116, and may also be used to retain the adjacent inlet openings 114, 116, for example, by preventing the flexible portion of the nasal cannula 104 (e.g., the nasal fork 108, 110) or other medical devices from collapsing or moving into or covering the nasal sampling portion 112 and blocking the inlet openings 114, 116. As described above, the relative rigidity or flexibility of the features can be achieved by any one or more of the structure, geometry, and material of the associated features. In this example, the desired stiffness of the airflow guides 126, 128 can be achieved in any suitable manner, such as by using a more rigid material, or by providing an airflow guide thickness sufficient to provide the desired stiffness, or a combination of both. In some embodiments, the airflow guides 126, 128, any other part of the gas collector 100, and the patient interface 104 may be made of the same or similar materials.
[0344] like Figure 2As shown, a pair of airflow guides 126, 128 are configured to be positioned between nasal forks 108, 110 when the gas collector 100 is installed into the nasal cannula 104. Each airflow guide 126, 128 defines a curved surface for guiding airflow from the patient's nose to the inlet openings 114, 116 of the nasal sampling section 112. As described below with reference to the gas collector 200 excluding the airflow guides 126, 128, the inner walls of the nasal forks 108, 110 can serve as airflow guides to guide airflow from the patient's nose to the inlet openings of the nasal sampling section. More specifically, the inner walls of the nasal forks 108, 110 and the upper surface of the bridging portion 120 can form a generally U-shaped curved wall, which can serve as an airflow guide to guide airflow from the patient's nose to the inlet openings of the nasal sampling section.
[0345] like Figure 5 As shown more clearly in the cross-sectional view, the gas collector 100 also includes an outlet 130, which defines an outlet 132 in fluid communication with the inlet openings 114, 116. Gas collected via the inlet openings 114, 116 moves through the internal flow channel 134 of the gas collector 100 and exits the gas collector 100 via the outlet 132. The outlet 130 may be configured to connect to a conduit (also referred to herein as sampling line 41) for delivering gas collected by the gas sampling section to one or more sensor units 39 for analysis of the collected gas. The connection between the outlet 130 and the conduit 41 can be achieved in any suitable manner. For example, the outlet 130 may be threaded and include one or more tapered portions, protrusions, projections, notches, or grooves for secure attachment to the conduit.
[0346] The one or more sensor units 39 may include one or more gas analyzers for analyzing gases from the gas collector 100. Output from the sensor units 39 may be used to generate one or more traces to monitor patient respiration. In some embodiments, output from the sensor units 39 may be used to generate one or more visual / graphical representations of patient respiration. For example, one or more line graphs may represent one or more gas parameters plotted relative to time. For example, the output graphical representation may include a line graph (trace) representing the concentration or relative concentration of CO2 plotted relative to time. Thus, the visual representation can provide an indication of changes in CO2 concentration over time, providing effective monitoring of patient respiration.
[0347] Another embodiment of the gas collector 200 is in Figures 6 to 8 As shown in the diagram. In the gas collector 200, similar components refer to those previously associated with... Figures 2 to 5 The description of the components, as well as those described elsewhere in this specification.
[0348] Gas collector 200 with Figures 2 to 5 The gas collector 100 shown works in a similar manner. Figure 6 As shown, the gas collector 200 is configured for releasable attachment to the gas delivery patient interface 102, such as an unsealed nasal cannula 104.
[0349] The gas sampling unit 202 includes a nasal sampling unit 204, which includes one or more (e.g., a pair) inlet openings 214, 216 disposed on both sides of the nasal sampling unit 204 for sampling gas exhaled from the patient's nose. The gas collector 200 also includes a coupling mechanism 218 for releasably coupling the gas sampling unit 202 to a bridging portion 120 of the nasal cannula 104. As previously described, the gas collector 200 can be integrally disposed with the patient interface 102. Furthermore, the gas collector 200 can be manufactured from the same material, similar material, or different material as the patient interface 102.
[0350] exist Figures 6 to 8 In the specific embodiment shown, the gas collector 200 may not include any airflow guides. However, the sidewalls of the nasal forks 108, 110 adjacent to the nasal sampling portion 204 may serve as airflow guides to direct gas from the patient toward the one or more inlet openings 214, 216.
[0351] The gas sampling unit 202 may also include a mouth sampling unit 206, which is configured to extend below the body 101 and the airflow manifold 106 for placement adjacent to the patient's mouth during use. Figure 8 As shown more clearly in the cross-sectional view, the mouth sampling section 206 defines an inlet orifice 208 for sampling gas from the patient's mouth. In practice, some exhaled gas from the patient's nose can be captured via a pair of inlet openings 214, 216 defined by the nasal sampling section 204, and some exhaled gas from the patient's mouth can be captured via the inlet orifice 208 defined by the mouth sampling section 206. The gas captured via the inlet openings 214, 216 and the inlet orifice 208 moves through the internal flow channels 210, 212 of the gas collector 200 toward an outlet 232 defined by the outlet section 230 of the gas collector 200. The outlet section 230 may be threaded to facilitate attachment to a conduit that connects the gas collector 200 to one or more gas analyzers to analyze the captured gas from the patient.
[0352] The outlet section 230 may extend laterally relative to the patient and nasal cannula 104 in order to maintain the low profile of the gas collector 200, thereby avoiding obstruction of the operation of the patient and / or clinician.
[0353] Figures 9 to 11A gas collector 300 according to another embodiment is shown. The gas collector 300 includes a nasal sampling section 302 for sampling gas from a patient's nose. The nasal sampling section 302 defines a plurality of inlet openings 304. Any suitable number of inlet openings 304 can be provided in any suitable arrangement. Figures 9 to 11 In the specific embodiment shown, two rows of inlet openings 304 are provided. In some embodiments, only one row of inlet openings 304 may be provided. For example, a second row of inlet openings 306 may be provided, with the inlet airflow entering in the direction F. inlet Unlike the direction of exhaled air from the patient's nose, F nose The first row of inlet openings 304 can be omitted, and its inlet airflow direction is F. inlet F is the direction of the air exhaled from the patient's nose. nose same.
[0354] In various embodiments, for at least some inlet openings 306, the inlet airflow direction F inlet It may differ from the direction of air exhaled from the patient's nose. nose More specifically, for at least some of the inlet openings 304, the inlet airflow in direction F inlet It can be set relative to the direction of the air exhaled from the patient's nose F nose The angle is approximately 10° to 90°. The angle of the inlet opening 304 can be varied to change the amount of downwash entering the gas collector 300.
[0355] Similar to Figures 1 to 8 In the illustrated embodiment, the nasal sampling unit 302 is compact and configured to be positioned in the space between the patient's nasal septum / columella, the bridging portion 120 of the body 101, and the nasal forks 108, 110 when the gas collector 300 is inserted into the nasal cannula 104. The outlet 330 is located on the side of the nasal sampling unit facing away from the patient during use. A sampling line 41 can be connected to the nasal sampling unit 302 via the outlet 330, allowing gas captured by the nasal sampling unit 302 to move through the conduit for analysis by one or more gas analyzers.
[0356] The gas collector 100 also includes a coupling mechanism, which is in the form of two C-shaped or U-shaped clamping parts 308, 310, for mounting onto the nose forks 108, 110 of the nasal cannula 104, such as... Figure 11 As shown. Each clamping part 308, 310 is configured to be releasably attached to a corresponding nose fork 108, 110 via friction engagement.
[0357] The inlet opening, made of 304 or 306 stainless steel, can be any suitable shape. Figure 12In an alternative embodiment of the gas collector 400 shown, the two rows of inlet openings 304, 306 of the gas collector 300 are replaced by two parallel slits 402, 404. Similar features of the gas collector 400 are described in the previous reference. Figures 9 to 11 The features described in the gas collector 300.
[0358] Figure 13 and Figure 14 A collector 500 for collecting gas at a patient's site is shown according to yet another embodiment. The gas collector 500 may include a gas sampling section 502 for sampling the gas at the patient's site. The gas sampling section 502 includes a nasal sampling section 504 and a mouth sampling section 506. The nasal sampling section 504 defines one or more (e.g., a pair) openings 522. Figure 13 (Only one is shown in the image), which is disposed on one or both sides of the nasal sampling section 504 to sample gas exhaled from the patient's nose. The mouth sampling section 506 defines an orifice 510 for sampling gas exhaled from the patient's mouth. Similar to the aforementioned embodiments, in use, the nasal sampling section 504 is positioned close to and below the patient's nasal septum / columella, above the bridging portion 120 of the nasal cannula 104, and between the nasal forks 108 and 110. The mouth sampling section 506 extends downward below the bridging portion 120 and is configured for positioning adjacent to the patient's mouth. The mouth sampling section 506 defines a mouth sampling orifice 510 for sampling gas (including exhaled gas) from the patient's mouth. The sampled gas at the patient's mouth may include exhaled gas and / or ambient gas.
[0359] The coupling mechanism of the gas collector 500 includes a pair of rings 512, 514. Each ring 512, 514 is configured to attach to a corresponding nose fork 108, 110 of the nasal cannula 104. More specifically, each nose fork 108, 110 is inserted into a corresponding ring 512, 514 such that, in use, the nasal sampling portion 504 is positioned above the bridging portion 120 of the body 101 and between the nose forks 108, 110. In some embodiments, the rings 512, 514 may be replaced by C-shaped or U-shaped portions, or by any suitable partially open / partially closed loop portions for attachment to the nose forks 108, 110.
[0360] like Figure 14 As shown more clearly, the gas collector 500 includes an outlet section 518 defining an outlet 518. A sampling line 41 can be connected to the outlet section 518 to connect the outlet 518 to the one or more sensor units 39.
[0361] Although Figure 14The diagram shows that when the gas collector 500 is mounted on the nasal cannula, the outlet portion 518 extends in a direction away from the nasal cannula 104. However, it should be understood that the outlet portion 518 of the gas collector 500 (and any outlet portion of any gas collector embodiment) can extend in any suitable direction. For example, the outlet portion 518 can extend toward either side of the body 101 of the nasal cannula 104, such as toward the airflow manifold 106. Figure 6 and Figure 7 The outlet 232 of the gas collector 200 shown is illustrated. Advantageously, providing an outlet 232 extending toward one side of the body 101 allows the sampling line 41 and the outlet 232 to maintain a low profile more effectively. For example, arranging the sampling line 41 to extend along the airflow manifold 106 also allows for continuous sampling when the airflow manifold 106 collapses while the face mask assembly 144 is applied to the nasal cannula 104 (e.g., as shown in reference). Figures 39A to 40 (Described).
[0362] An additional port 520 may be provided adjacent to the mouth sampling port 510. The sampling gas at the patient's mouth may be received through any one or both of ports 510 and 520.
[0363] In some cases where the gas collector 500 samples gas from the patient's mouth, the inlet airflow at the inlet opening 522 of the nasal sampling section 504 is directed towards direction F. inlet Arranged in a direction different from the direction of exhaled air from the patient's nose F nose It can also improve the gas collector's ability to sample from the patient's mouth. By orienting the inlet opening 522 such that F inlet Roughly perpendicular to F nose Any diverted gas with a high flow rate from the nasal cannula 104 will not easily enter the inlet opening 522, pass through the internal flow channels 524 and 526 of the gas collector 500, and exit from the orifices 510 and 520 under high pressure. This flow of diverted gas (downwash flow) exiting from the orifices 510 and 520 will undesirably prevent gas from the mouth from entering the gas collector 500 via 510 and 520, thus hindering effective sampling and patient monitoring.
[0364] In such Figures 15 to 17 In an alternative embodiment of the gas collector 600 shown, the coupling mechanism includes a pair of rings 602, 604. Figure 13 and Figure 14 The illustrated embodiments are similar, with each ring 602, 604 configured to assemble around a corresponding nose fork 108, 110 for releasable attachment thereto. Figure 17 As shown more clearly in the cross-sectional view, each ring 602, 604 is hollow. In other words, each ring 602, 604 of the coupling mechanism includes a conduit or flow channel.
[0365] Each ring 602, 604 defines a plurality of radially spaced inlets 606, 608 surrounding its outer periphery. Each ring 602, 604 may also define a plurality of radially spaced inlet openings 610, 612 surrounding its inner periphery. In other embodiments, the inlet openings may be located anywhere on any one or both of the hollow rings 602, 604. A nasal sampling portion 616 is disposed between the rings 602, 604 and, in use, positioned between the nasal forks 108, 110 and above the bridging portion 120, as shown below. Figure 15 As shown. Similar to the aforementioned embodiments, the nasal sampling section 616 may provide a pair of inlet openings 622 on both sides of the nasal sampling section (partially hidden in the figure).
[0366] The outlet 618 of the defined outlet 620 can be located on the side of the gas collector away from the patient when the gas collector 600 is installed into the nasal cannula 104. The outlet 618 can be connected to the sampling line 41 and to one or more gas analyzers to analyze the patient gas collected via the gas collector 600. More specifically, the inlet openings 614, 622, 606, 608, 610, 612 provided by the nasal sampling section 616 and the connecting mechanisms 602, 604 pass through the internal flow path of the gas collector 600. Figure 17 It is connected to outlet 620. In this way, the gas collected through inlet openings 614, 622, 606, 608, 610, 612 leaves gas collector 600 through outlet 620 for analysis by one or more gas analyzers.
[0367] Optionally, the inlet openings 606, 608, 610, and 612 can vary in size to facilitate flow balance in the gas collector 600. For example, the inlet opening closer to the outlet 620 can be smaller than the inlet opening farther from the outlet 620.
[0368] It should be understood that the specific construction and orientation of the outlet 618 can vary in embodiments of gas collector 600. Similarly, the specific construction and orientation of the outlet 618 can vary in other embodiments of gas collectors 100, 200, 300, 400, 500, 700, 800, 900, and 1000 as described herein, or in embodiments having combinations of the gas collector features described herein. As previously mentioned, when mounted on a nasal cannula, the outlet 620 may protrude toward one side of the body 101 of the nasal cannula 104 to maintain a low profile.
[0369] In some embodiments, such as Figure 18 and Figure 19The mouth sampling section 702 is shown in the gas collector 700. The mouth sampling section 702 is configured to extend below the body 101 and bridging section 120 of the nasal cannula 104 during use, so as to be positioned adjacent to the patient's mouth. Similar features of the gas collector 700 are described in previous references. Figures 13 to 17 Those characteristics described. In Figure 18 and Figure 19 In the embodiment of the gas collector 700 shown, additional inlet openings may or may not be provided in the coupling mechanisms 704, 708. Furthermore, one or more mounting stabilizers 706 may be disposed on the inner side of each annular coupling mechanism 704, 708. Each mounting stabilizer 706 may be in the form of a protrusion for abutting against the corresponding nose fork 108, 110 to provide additional stability to the coupling mechanisms 704, 708.
[0370] Generally, in this article, refer to Figures 2 to 20 In the described embodiments, the gas sampling unit can be fixed relative to the coupling mechanism. More specifically, the nasal sampling unit can be fixed relative to the body of the gas collector such that its relative position to the body of the gas collector or the coupling mechanism is substantially fixed / stationary and does not change during operation. Thus, when the gas collector is installed to the patient interface 102, the positioning of the nasal sampling unit can be in a substantially stable position relative to the bridging portion 120 and the nasal forks 108, 110 of the nasal cannula 104, and does not require manual adjustment during medical procedures.
[0371] In some embodiments, the gas collector may have a degree of flexibility and elasticity. For example, the gas collector may be molded from a plastic material, which may be a soft or hard plastic. In some embodiments, the gas collector may be formed from a material similar to or the same as the material of the patient interface 102. In any case, the position of the nasal sampling section relative to the coupling mechanism is fixed. This facilitates precise positioning of the nasal sampling section below the patient's nasal septum / columella, above the bridging portion 120 of the nasal cannula 104, and between the nasal forks 108 and 110, thereby providing effective patient gas monitoring without relying on manual adjustment of the nasal sampling section's positioning by the clinician.
[0372] In some embodiments, the gas collector may be integrated with the nasal cannula. In particular, the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, and 1000 may be integrally formed with the nasal cannula 104.
[0373] Gas collector with rigid and flexible parts
[0374] Figures 21 to 24A gas collector 800 for collecting gas from a patient, according to another embodiment, is shown. The gas collector 800 includes a gas collecting section 802 for collecting at least a portion of the gas exhaled from the patient via the patient's nose and / or mouth. During operation, the gas collecting section 802 faces the patient and is generally positioned between and close to the patient's nose and mouth to collect exhaled gas from the patient's nose and / or mouth. Generally, the gas collector 800 is configured to extend from below the patient's nose to the top of the patient's mouth, upper lip, and / or teeth during use. The geometry of the gas collector 800 may generally follow the contour of the patient's face from near the nasal septum / columella to the patient's mouth.
[0375] The gas collector 800 also includes a coupling mechanism 804 for connecting the gas collection section 802 to the gas delivery patient interface 102 (such as the nasal cannula 104). In some embodiments, the coupling mechanism 802 includes an engagement portion in the form of a U-shaped retainer 806 for engaging with the nasal cannula 104. Specifically, the U-shaped retainer may receive the body 101 of the nasal cannula 104 therein. The body 101 of the nasal cannula may be flexible or collapsible to allow insertion into the U-shaped retainer. After insertion, the body 101 returns to its original shape. Advantageously, the U-shaped retainer may allow the gas collector 800 to be removed without removing the nasal forks 108, 110 from the patient's nostrils.
[0376] The gas collection section 802 can be configured to provide damping for external forces applied to it, thereby reducing force transmission between the gas collection section 802 and the coupling mechanism 804. More specifically, the gas collection section 802 may include an elastic material to dampen external forces, such as those applied to it by a patient. Further detailing, the gas collection section 802 may be made of an elastic material, and the damping properties of the elastic material can be used to insulate against forces applied to it. For example, forces are applied to the gas collection section 802 due to contact with a patient during use. These forces may be absorbed by the gas collection section 802 or may cause it to flex, bend, and / or deform. Insulation against these forces reduces the transmission of forces from the gas collection section 802 to the coupling mechanism 804, thereby reducing the risk of undesirable movement and / or displacement of the nasal cannula 104 during medical procedures.
[0377] The connection mechanism 804 may include a rigid material to further facilitate stability of the nasal cannula 104. Figures 21 to 23In the illustrated embodiment, the base of the coupling mechanism forms the central portion 808 of the gas collector 800. In use, a U-shaped retainer extends from the side of the central portion 808 away from the patient. The coupling mechanism 804 may be made of a rigid material. The rigidity of the coupling mechanism provides structural integrity and stability to both when the gas collector 800 and the nasal cannula 104 are attached to each other. It should be understood that terms such as rigidity, flexibility, and elasticity are relative terms when describing the physical properties of materials. Those skilled in the art will understand that, in the context of this embodiment, the coupling mechanism 804 is more rigid, less flexible, and less elastic than the gas collector 802, and vice versa.
[0378] The gas collector 800 also includes an outlet portion 810 defining an outlet 812 through which gas collected by the gas collector 800 exits the gas collector 800. The outlet portion 810 is configured for attachment to a conduit / sampling line 41, which provides a path for sampling gas to the one or more gas analyzers 39. The outlet portion 810 extends from and may be integral with the central portion 808. The outlet portion 810 may be made of the same rigid material as the central portion 808. The rigidity of the outlet portion 810 can further provide structural integrity to ensure a strong and stable attachment to the sampling line 41, which can also insulate against external forces applied to the gas collector 802 due to the damping effect of the gas collector 802.
[0379] like Figure 24 As shown more clearly, the gas collector 800 also includes a gas collection inlet 814, which is in fluid communication with the gas collection section 802, such that at least a portion of the gas collected by the gas collection section 802 flows into the gas collection inlet 814. The rigidity of the outlet 810 also ensures that the flow path between the inlet 814 and the outlet 812 remains open.
[0380] The gas collector 800 may further include a flow channel 816 in fluid communication with the gas collection inlet 814 to allow gas to flow from the patient's nose and / or mouth toward the gas collection inlet. The flow channel 816 may extend generally across the central portion 808 to the patient's side during use, such that the length of the flow channel 816 extends generally from near the patient's nasal septum / columella to the patient's mouth or upper lip. In other words, during use, the flow channel 816 may extend generally along the patient's philtrum to the patient's mouth or upper lip. The inlet 814 is in fluid communication with an outlet 812, such that gas collected by the gas collection portion 802 enters the inlet 814 and flows through the outlet 814 to the sampling line 41 for analysis by one or more gas analyzers 39. The flow channel 816 may comprise a rigid material. In some embodiments, the flow channel 816 may be integral with the central portion 808 and made of the same rigid material. The flow channel 816 may be integrally formed with the coupling mechanism 804. The rigidity of the flow channel 816 can prevent deformation of the flow channel 816 and help maintain fluid communication between the gas collection section 802, the flow channel 816 and the inlet 814.
[0381] The gas collection unit 802 may include a nasal airflow guide 818 configured to extend below the patient's nose during use to facilitate the collection of gas from the patient's nose into the gas collection inlet 814. The nasal airflow guide may take any suitable shape or form. Figures 21 to 24 In the specific embodiment shown, the nasal airflow guide 818 is shaped to generally follow the contour of the lower part of the patient's nose. Furthermore, the nasal airflow guide 818 may include a neck 820 for receiving nasal forks 108, 110 of the nasal cannula 104 on either side of the neck 820.
[0382] The gas collection unit 802 may also include a mouth portion 822 configured to extend in use below or near the patient's upper lip and / or upper teeth to facilitate gas collection from the patient's mouth toward the gas collection inlet 814. Figure 21 and Figure 22 As shown more clearly in the diagram, the gas collector 800 has a generally S-shaped profile. In other words, the generally S-shaped shape can be apparent when a vertical cross-section is taken through the centerline of the gas collector 800. More specifically, the gas collection section 802 also includes an offset region 824 near the mouth portion 822. The offset region 824 can be configured to be located away from the patient's mouth during use to facilitate gas flow between the patient's mouth and the gas collection inlet 814. The offset region 824 facilitates maintaining a distance between the gas collection section 802 and the patient during use to minimize the risk of the patient's upper lip obstructing part of the gas collection section and / or the inlet 814 during use.
[0383] Now see according to Figure 25 and Figure 26Another embodiment of the gas collector 900 is shown. Similar features in the gas collector 900 can be found in previous references. Figures 21 to 24 Those characteristics described.
[0384] The gas collector 900 includes a gas collection section 902 for collecting at least a portion of the gas exhaled from the patient via the patient's nose and / or mouth. The gas collector 900 also includes a coupling mechanism 904 having a U-shaped retainer 906 for receiving the airflow manifold 106 of the nasal cannula 104.
[0385] In some embodiments, the gas collection section 902 may be made of an elastic material to provide damping against external forces applied to the gas collection section 902, thereby reducing force transmission between the gas collection section 902 and the coupling mechanism 904. The coupling mechanism 904 may be made of a rigid material to further facilitate stability of the nasal cannula 104 and the sampling line during use.
[0386] like Figure 26 As shown more clearly in the diagram, the gas collector 800 may also include a flow channel 916 in fluid communication with the gas collection inlet 814 to allow gas to flow from the patient’s nose and / or mouth to the gas collection inlet 914.
[0387] The gas collection unit 902 includes a mouth portion 922 for placement adjacent to the patient's mouth. In some embodiments, the mouth portion 922 may extend partially into the patient's mouth, for example, below the patient's upper lip or below the patient's upper teeth. The gas collection unit 902 may define a narrowing portion 940 adjacent to the mouth portion 922. The narrowing portion 940 may be provided with a hinge to allow the mouth portion 922 to move relative to the narrowing portion 940. This additional flexibility of movement of the mouth portion 922 relative to the narrowing portion allows the gas collector 900 to better conform to the contours of the patient's mouth and facial features in use, resulting in a more streamlined and low-profile shape when the gas collector 900 is inserted into the nasal cannula 104 and placed on the patient's face.
[0388] like Figure 26 As shown more clearly in the diagram, the gas collection unit 902 may also include a pair of guide members 944, 946, each of which protrudes from the edge of the gas collection inlet 914 toward the mouth 946 in order to guide at least a portion of the airflow from the patient’s mouth toward the gas collection inlet 914.
[0389] The mouthpiece 922 may include a spoon-shaped portion 942 located between guide members 944 and 946. The spoon-shaped portion 942 may have an edge configured to extend below the patient's upper lip during use to facilitate gas flow from the patient's mouth toward the gas collection inlet. The spoon-shaped portion 942 prevents the patient's upper lip from obstructing the mouthpiece 922 from collecting gas from the patient's mouth.
[0390] Figure 27Another embodiment of the gas collector 1000 is shown. Similar features in the gas collector 1000 are described in the preceding reference. Figures 21 to 26 The features described. In the gas collector 1000, the mouthpiece includes a pair of mouth airflow guiding protrusions 1002, 1004. Each mouth airflow guiding protrusion 1002, 1004 is configured to extend in use below or near the opposite sides or corners of the patient's upper lip to facilitate the collection of gas from the patient's mouth toward the gas collection inlet (concealed).
[0391] The gas collection unit may also include a pair of nasal airflow guiding protrusions 1006, 1008. Each nasal airflow guiding protrusion 1006, 1008 is configured to extend adjacent to opposite sides of the patient's nose during use, facilitating access from the patient's nose toward the gas collection inlet (in...). Figure 27 (Hidden in the middle) collect gas.
[0392] like Figure 28 As shown, Figure 1 Various disposable components of the respiratory support system 10 shown can be included in the kit. For example, a gas delivery patient interface 102 (e.g., an unsealed patient interface, such as a nasal cannula 104) can be included in the kit, which includes a gas collector (e.g., such as a gas collector for attachment to the unsealed patient interface, such as the nasal cannula 104) for installation. Figure 13 and Figure 14 The gas collector 500 shown is included in the kit. The gas collector in the kit may be any one of the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, and 1000 as described herein, or may be an alternative gas collector having a combination of different features related to those described in the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, and 1000 disclosed herein.
[0393] In some embodiments, the kit may include a gas delivery patient interface 102, such as an unsealed patient interface, such as a nasal cannula 104, which is integrally formed with any of the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 as described herein, or integrally formed with an alternative gas collector having a combination of different features related to the different features described herein as for the gas collectors 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000.
[0394] In some embodiments, the kit may also include any one or more of the airflow duct 31, the intake branch 37, the filter 36, and the humidification chamber 14, such as... Figure 28 As shown. The gas flow duct 31 can be any supplemental gas duct, such as... Figure 1 The first supplemental gas conduit 24 or the second supplemental gas conduit 26 shown.
[0395] Figure 39A A schematic diagram of a gas delivery patient interface 3000 for delivering gas to a patient P according to another embodiment is shown. The gas delivery patient interface 3000 includes a body 3002 having an airflow manifold 3004 for receiving a gas flow for delivery to the patient P, similar to the previous reference. Figures 32 to 35 The patient interface 1400 is described. The gas delivery patient interface 3000 also includes a pair of nose forks 3006, 3008 extending from the body 3002 for delivering a gas flow to the patient P via the patient's nostrils. For simplicity, in Figure 39A Only a portion of the gas delivery patient interface 3000 is shown in the image. It should be understood that the gas delivery patient interface 3000 may include similar inlets, outlets, ports, connectors, straps, etc., for connection to a device gas supply source via any suitable conduit and for attaching the gas delivery patient interface 3000 to the patient P.
[0396] The gas delivery patient interface 3000 includes a gas sampling unit 3010 for sampling gas at the patient P. The gas sampling unit 3010 may be integral with the body of the patient interface 3000, or selectively attached to and removed from the body. Any suitable coupling mechanism can be provided to allow selective attachment of the gas sampling unit 3010 to the body of the patient interface 3000. For example, any coupling mechanism or similar mechanism as described in the various gas collector embodiments herein can be used.
[0397] The gas sampling unit 3010 includes a nasal sampling unit 3012 positioned between the nasal forks 3006 and 3008 to provide a low profile while effectively capturing exhaled gas from the patient's nose at or near the philtrum. The nasal sampling unit 3012 defines at least one opening. Figure 39A In the specific embodiment shown, the nasal sampling unit 3012 defines two inlet openings 3014, 3016 to sample gas at the philtrum. Similar to the previously described gas collector, for example... Figures 2 to 8 The gas collectors 100 and 200 shown herein have inlet openings 3014 and 3016 that can be oriented toward the corresponding nose fork 3006 and 3016. Furthermore, each inlet opening 3014 and 3016 can be oriented substantially transverse to (or perpendicular to) the inner surface 3025 or outer surface 3020 of the body 3002 (e.g., ...). Figure 42 (See more clearly in the image). The inlet openings 3014 and 3016 are also approximately perpendicular to the top surface 3021 of the nasal sampling section 3012 (see...). Figure 39BIn some embodiments, one or more alternative or additional inlet openings may be configured to be parallel to and aligned with, or parallel to and offset from, the inner surface 3025 and / or the outer surface 3020 (e.g., generally parallel to the patient's coronal plane in use). In some embodiments, one or more alternative or additional inlet openings 3015 may be oriented to be generally transverse to (or perpendicular to) the inner surface 3025 or the outer surface 3020 of the body 3002, for example as... Figure 39B As shown (e.g., approximately parallel to the patient's cross-section during use). For example... Figure 39B As shown, one or more inlet openings 3015 may be provided on the top surface 3021 of the nasal sampling section 3012. The one or more inlet openings 3015 may be positioned adjacent to the inner side 3023 of the nasal sampling section 3012 facing the patient during use. The inner surface 3025 of the body 3002 of the gas delivery patient interface 3000 may be the surface of the body 3002 facing the patient P during use. The outer surface 3020 of the body 3002 of the gas delivery patient interface 3000 may be the surface 3020 of the body 3002 opposite to the inner surface 3025 and facing away from the patient P during use.
[0398] like Figure 42 As shown in the BB cross-sectional view of the gas delivery patient interface 3000, one or more inlet openings 3014, 3016 (only one shown) are oriented substantially perpendicular to the inner surface 3025 and outer surface 3020 of the body 3002 of the patient interface 3000. The inlet openings 3014, 3016 are located on a plane parallel to the flow direction 3734, 3736 of the gas exiting the patient's nostrils during use (see also...). Figure 50 In this orientation, the inlet openings 3014 and 3016 are configured to indirectly pick up samples of gas 3734 and 3736 leaving the patient's nostrils.
[0399] Conversely, if the inlet openings 3014, 3016 are positioned in a plane perpendicular to the flow direction 3734, 3736 of the gas exiting the patient's nostrils (i.e., directly below the patient's nostrils and facing the nostril openings), gas will enter the inlet openings 3014, 3014 with high dynamic pressure. This dynamic pressure can be a result of the diverted high-flow-rate gas delivered to the patient via the nasal fork and / or the pressure generated by the patient during exhalation. Therefore, it has been found that, in some embodiments described further in detail below, positioning the inlet openings 3014, 3016 in a plane parallel to the overall gas flow direction indicated by 3734, 3736 allows for more efficient gas sampling at the patient's mouth.
[0400] Similar to the gas collector embodiments described above, the one or more inlet openings 3014, 3016 may be generally located above the body 3002 of the interface 3000. Specifically, the one or more inlet openings 3014, 3016 may be located above the bridging portion of the body 3002 of the interface 3000 between the nose forks 3006, 3008. In some embodiments, the one or more inlet openings 3014, 3016 may be located above the bridging portion of the body 3002 of the interface 3000 between the nose forks 3006 and laterally positioned adjacent to the outer surface 3020, the inner surface 3025, or generally centered between the inner surface 3020 and the outer surface 3025.
[0401] In some embodiments, the one or more inlet openings of the nasal sampling unit 3012 can be positioned and oriented on the nasal sampling unit 3012 in any suitable manner. For example, one or more inlet openings can be defined on an inclined surface converging at an angle to the body 3002 of the patient interface 3000, such as 30°, 45°, 50°, 70° angles or any suitable angle between 10° and 100°. Generally, one or more inlet openings of the nasal sampling unit 3012 are configured to be positioned generally below the nasal septum / columella region and oriented away from airflow 3734, 3736 exiting the patient's nostrils (see also...). Figure 50 In other words, the one or more inlet openings of the nasal sampling unit 3012 are positioned at an angle that is not approximately 90° relative to the direction of airflow 3734, 3736 leaving the patient's nostrils. It has been found that orienting the inlet openings 3014, 3016 away from the airflow leaving the patient's nose in this manner prevents excessive dynamic pressure of gas 3734, 3736 leaving the patient's nostrils from entering the nasal sampling unit 3012 (typically due to the high flow rate delivered from the gas delivery patient interface 3000) and passing through any oral sampling channel 3710 (see...). Figure 50 (For example, provided by the optional mouth sampling unit 3052 as described below with reference to FIG41). When the gas leaving the patient's nose flows through the oral sampling channel 3710, it is difficult to obtain a useful gas sample via the mouth sampling unit 3052. Therefore, it has been found that by providing inlet openings 3014, 3016 away from the airflow 3734, 3736 leaving the patient's nostrils in the manner described above, a useful amount of gas sampled from the nose can be obtained without adversely affecting the effectiveness of the mouth sampling unit 3052 in sampling gas from the patient's mouth. A top view of the gas delivery patient interface 3000 is shown in Figure 39BAs shown in the figure. As described above, in some embodiments of the gas delivery patient interface 3000, one or more inlet openings 3015 may optionally be provided on the top surface 3021 of the nasal sampling section 3012. In order to prevent gas with high dynamic pressure leaving the patient's nose from entering the inlet opening 3015, it is preferable to position the inlet opening 3015 on the top surface 3021 closer to the inner side 3023 of the nasal sampling section 3012 and below the patient's nasal septum / columella, such that the inlet opening 3015 is not directly aligned with the flow path of the gas 3734, 3736 leaving the patient's nostrils.
[0402] Now back Figure 39A The gas delivery patient interface 3000 also includes a sampling gas conduit 3018 for providing fluid communication between the gas sampling unit 3010 and a sensing device, such as a carbon dioxide monitor, a respiratory gas monitor, or other gas sensing device. It will be understood that, in practice, the sampling gas conduit 3018 may be connected to another conduit connected to the sensing device.
[0403] exist Figure 39A In the specific embodiment shown, the sampling gas conduit 3018 extends along the airflow manifold 3004. More specifically, the sampling gas conduit 3018 is positioned outside the airflow manifold 3004. Figure 40 As shown more clearly in the partial sectional view AA of the interface 3000, the sampling gas conduit 3018 protrudes from the outer surface 3020 of the body 3002 of the patient interface 3000. The surface 3022 covering at least a portion of the sampling gas conduit 3018 may be a curved surface. Specifically, the curved surface 3022 defines a protrusion 3024 that accommodates a portion of the sampling gas conduit 3018. The curved surface 3022 may have a gentle slope, such as... Figure 40 As shown. More specifically, the curved surface 3022 may have two inclined sides 3026, 3028 that meet at the circular peak 3030. In particular, the angle β at which each inclined side 3026, 3028 of the protrusion 3024 meets the outer surface 3020 of the body 3002 of the patient interface 3000 may be approximately between 0° and 89°.
[0404] In some embodiments, surface 3022 may include a central curve portion defining a circular peak 3030, with a curvature greater (smaller radius) than two adjacent side curve portions defining two inclined sides 3026, 3028. The direction of curvature of the central curve portion may be opposite to the curvature of the two side curve portions.
[0405] In some embodiments, the sampling conduit 3018 may be integrally formed with the body 3020 of the interface 3000. For example, the sampling conduit 3018 may be formed as a hole, channel, or any suitable recess in the wall of the body 3020. The sampling conduit 3018 may be formed by removing material from the body 3020 of the interface 3000.
[0406] In an embodiment where the airflow manifold 3004 is collapsible during the application of the face mask 144, the sampling gas conduit 3018 can remain open to allow continuous patient gas sampling. (See previously noted...) Figures 29 to 35 In some cases, it may be desirable to switch from a nasal cannula to a face mask 144 to deliver gas to the patient, and the airflow manifold 3004 can be collapsed by applying the face mask to the patient's face. By keeping the sampling gas tubing 3018 open, clinicians can continuously monitor patient parameters, even after the respiratory support mode has been changed (e.g., from a nasal cannula to a face mask). In some other cases, clinicians can manually collapse the airflow manifold 3004 to allow the patient to breathe from ambient air. In this case, the sampling gas tubing 3018 remains open to sample gas from the patient.
[0407] More specifically, the gentle gradient of the curved surface 3022, the structure of the protrusion 3024, and the geometry and / or rigidity of the sampling gas conduit 3018 wall can help maintain the structural integrity of the sampling gas conduit 3018 while allowing the seal 148 of the face mask 144 to collapse and seal the airflow manifold 3004 against the patient's face. In other words, the protrusion 3024 acts as a tunnel beneath the mask seal 148 to allow the sampling gas conduit 3018 to remain open when the airflow manifold 3004 collapses, thereby allowing continuous patient gas sampling while the face mask 144 is applied to the patient's face.
[0408] In particular, the gentle gradient of the curved surface 3022 (e.g., the angle β at which each inclined side 3026, 3028 of the protrusion 3024 meets the outer surface 3020 of the body 3002 of the patient interface 3000 can be approximately between 0° and 89°) effectively facilitates a proper seal of the face mask 144 over the sampling gas conduit 3018 and the protrusion 3024. The gentle gradient of the protrusion 3024 avoids any steep turns and / or sharp edges that would create gaps with the face mask 144 and hinder a proper seal between the face mask 144 and the sampling gas conduit 3018 and the protrusion 3024.
[0409] Furthermore, the gentle gradient of the curved surface 3002 and the inclined sides 3026, 3028 facilitates the distribution of loads from the applied face mask 144 to be evenly distributed across the entire curved surface 3002, thereby further reducing the likelihood of shutting off the sampling gas conduit 3018 when a force is applied to cause the airflow manifold 3004 to collapse (e.g., by the application of the face mask 144).
[0410] Furthermore, the geometry of the sampling gas conduit 3018 (smaller than the airflow manifold 3004 of the body 3002 of the interface 3000) also facilitates maintaining the sampling gas conduit 3018 in an open state when the airflow manifold 3004 collapses. In some embodiments, the materials used to form the airflow manifold 3004 and the sampling gas conduit 3018 can be the same or similar. In some embodiments, thicker walls or relatively rigid materials can be provided on the sampling gas conduit 3018 to facilitate maintaining the sampling gas conduit 3018 in an open state during use, especially when the airflow manifold 3004 collapses.
[0411] like Figure 40 As shown, the height 3029 of the material body 3027 in the protrusion 3024 covered by each inclined side 3026, 3028 can be approximately 80% of the height or diameter of the sampling gas conduit 3018, and the width 3031 is approximately 1.25 times the width or diameter of the sampling gas conduit 3018. The protrusion 3024 can be generally symmetrical with respect to the peak 3030 of the protrusion 3024. The material body 3027 below each inclined side 3026, 3028 can occupy approximately 80% to 99% of the total volume of the material below each inclined side 3026, 3018. The material body 3027 provides structural integrity and helps to keep the gas conduit open when a face mask is applied to the gas conduit 3018.
[0412] As referenced above Figures 32 to 35 As described above, when the face mask 144 is applied, the airflow manifold 3004 can move along the two ends of the airflow manifold 3004 (equivalent to...). Figure 34 and Figure 35 The fold line at end 1404c) shown collapses. The protrusion 3024 extends along the airflow manifold 3004 without interfering with the fold lines at both ends of the airflow manifold 3004, allowing the airflow manifold 3004 to collapse without obstruction by the protrusion 3024 or the sampling gas conduit 3018 when the face mask 144 is applied to the patient's face. Specifically, the sampling gas conduit 3018 extends along the outer surface 3020 of the airflow manifold 3004 and does not interfere with the fold lines of the airflow manifold 3004.
[0413] The size of the airflow passage provided by the sampling gas conduit 3018 is also much smaller than that provided by the airflow manifold 3004 (see also...) Figure 42This further facilitates maintaining the open position of the sampling gas conduit 3018 when the airflow manifold 3004 collapses.
[0414] Generally, the sampling gas conduit 3018 and / or the protrusion 3024 may be formed of a relatively rigid material (especially compared to the material of the airflow manifold 3004). The rigidity of the material helps maintain the structural integrity and open shape of the sampling gas conduit 3018 when force / face mask 144 is applied to cause the airflow manifold 3004 to collapse. The gas sampling conduit 3018 and / or the protrusion 3024 may be formed of the same material as the airflow manifold 3004.
[0415] In some embodiments, the sampling gas conduit 3018 may be located on the non-collapsed side of the body 3002 of the gas delivery patient interface 3000.
[0416] In some embodiments, the gas sampling unit 3010 and / or the sampling gas conduit 3018 may be integrally formed with the body 3002 and / or the airflow manifold 3004. In some embodiments, the gas sampling unit 3010 and / or the sampling gas conduit 3017 may be selectively attached to the body 3002 and / or the airflow manifold 3004 and may be detached therefrom.
[0417] In any case, when the gas sampling unit 3010 is disposed on the body 3002, the one or more (e.g., two) inlet openings 3014 and 3016 of the nasal sampling unit 3012 are fixed relative to the body 3002 and the nasal forks 3006, 3008. By providing a fixed gas sampling position for sampling in the patient, the reliability of patient gas sampling can be improved by preventing relative movement between the body 3002 of the patient interface 3000 and the nasal sampling unit 3012, especially when the patient and / or the patient interface 3000 moves during treatment. Furthermore, after the gas delivery patient interface 3000 is placed, the nasal sampling unit 3012 does not need to be individually adjusted to be properly positioned below the patient's nasal septum / columella for gas sampling in the patient's nasal cavity. Since the positions of the nasal sampling section 3012 and the inlet openings 3014, 3016 are fixed relative to the nasal forks 3006, 3008, proper placement of the gas delivery patient interface 3000, including the nasal forks 3006, 3008, provides proper positioning of the nasal sampling section 3012 and the inlet openings 3014, 3016.
[0418] In some embodiments, when the protrusion 3024 is applied over the sampling gas conduit 3018 and fastened to the outer surface 3020 of the body 3002 of the patient interface 3000 in any suitable manner (e.g., molding or adhesive or via one or more mechanical fastening mechanisms), the sampling gas conduit 3018 may be attached to the outer surface 3020 of the body 3002 of the patient interface 3000.
[0419] In some embodiments, a hollow sleeve may be formed in the protrusion 3024 to provide a portion of the sampling gas conduit 3018, and the protrusion 3024 may be fastened to the outer surface 3020 of the body 3002 of the patient interface 3000 in any suitable manner, such as molding or adhesive or via one or more mechanical fastening mechanisms.
[0420] In some embodiments, the protrusion 3024 may define a through-elongated groove. When the protrusion is secured to the outer surface 3020 of the body 3002 of the patient interface 3000 in any suitable manner as described above, the groove and the outer surface 3020 of the body 3002 of the patient interface 3000 may provide a portion of the sampling gas conduit 3018. In some embodiments, the groove in the protrusion 3024 may be aligned with a groove on the outer surface 3020 of the body 3002 of the patient interface 3000 to provide the sampling gas conduit 3018.
[0421] In some embodiments, at least a portion of the sampling gas conduit 3018 may be disposed within the wall of the body 3002. In particular, a portion of the sampling gas conduit 3018 may be disposed within the wall of the airflow manifold 3004. Thus, in some embodiments, the interface 3000 may not include the protrusion 3024 above the outer surface 3020 for receiving the sampling gas conduit 3018.
[0422] Turning now to Figure 41, a gas delivery patient interface 3500 according to another embodiment is shown. In the gas delivery patient interface 3500 of Figure 41, the same reference numerals denote the same references as previously mentioned. Figure 39A and Figure 40 The same features are described in the gas delivery patient interface 3000. Similar to the previous embodiments, the gas sampling unit 3010 can be integrally formed with the main body 3002 of the patient interface 3500 or be separately provided.
[0423] In addition to the nasal sampling section 3012, the gas sampling section 3010 of the gas delivery patient interface 3500 also includes a mouth sampling section 3052. The mouth sampling section 3052 is configured to extend below the body 3002 and airflow manifold 3004 of the patient interface 3500 for placement adjacent to the patient's mouth during use. Specifically, the mouth sampling section 3012 includes a mouth sampling guide 3054 extending from the body 3002 of the patient interface 3500. The mouth sampling guide 3054 may include a tube defining a through-oral sampling channel. Reference will be made below. Figure 43An example configuration of the mouth sampling guide 3054 is described in more detail. The mouth sampling guide 3054 can be inserted into and removed from the mounting portion 3056 of the gas sampling unit 3010. The mounting portion 3056 may include a sleeve, a protrusion, a recess or groove, or other suitable shaped configuration to allow selective installation and removal of the mouth sampling guide 3054. In some embodiments, the mounting portion 3056 may define a gas flow path having a check valve / one-way valve such that when the mouth sampling guide 3054 is attached to the mounting portion 3056, fluid communication with the mouth sampling guide 3054 can be established through the gas flow path. When the mouth sampling guide 3054 is not attached to the mounting portion 3056, the check valve / one-way valve prevents fluid communication between the gas flow path and the atmosphere. In some embodiments, a cap may be attached to the mounting portion 3056 when the mouth sampling guide 3054 is not attached to the mounting portion 3056. In some embodiments, the mouth sampling guide 3054 may be integrally formed with the gas sampling unit 3010.
[0424] The mouth sampling unit 3052 also includes a mouth sampling end 7050, which defines one or more inlet holes for sampling gas at the patient's mouth. The mouth sampling end 7050 is located at one end of the mouth sampling guide 3054. Generally, the mouth sampling guide can be flexible to allow selective repositioning of the mouth sampling end. Referring below... Figures 44 to 47 An exemplary embodiment of a mouth sampling end 7050 that defines three inlet holes 7230 is described in further detail. However, it should be understood that the mouth sampling end 7050 may define any suitable number of inlet holes. For example, the sampling end 7050 may define one, two, three, four, five or more inlet holes to sample gas at the patient's mouth.
[0425] Advantageously, the generally fixed and low-profile nasal sampling section 3012 provides stable nasal sampling at or near the patient's philtrum, increasing the accuracy and reliability of nasal sampling at the patient's site. As previously described, the nasal sampling section 3012 can remain in place during treatment without interfering with medical procedures such as the application of the face mask 144 as discussed and / or the use of various medical devices. Combined with the movable mouth sampling guide 3054, the interface 3500 can provide more comprehensive patient sampling than previously known solutions. During treatment, clinicians typically need to insert various medical devices into the patient's mouth (e.g., tracheostomy tubes). Thus, it is advantageous to provide a movable / selectively positioned mouth sampling guide 3054 so that clinicians can move the mouth sampling guide 3054 to and from the appropriate position as needed to perform medical procedures and sample the patient's gas at or near the mouth to supplement nasal sampling. Providing both nasal and mouth sampling options, as illustrated in the interface 3500, can further improve the accuracy and reliability of gas sampling at the patient's site. Therefore, this novel combination of fixed nasal sampling and adjustable oral sampling provides an improved ability to sample from both the patient's nose and mouth, thereby improving overall sampling accuracy, especially during high-flow respiratory support.
[0426] As shown in Figure 41, the mouth sampling guide 3054 is offset from the central plane 3058 of the gas delivery patient interface 3500. The central plane 3054 can be defined as an imaginary plane extending between the nose forks 3006, 3008 or a pair of inlet openings 3014, 3016, such that the nose forks 3006, 3008 and the inlet openings 3014, 3016 are spaced approximately equidistant from the central plane 3058. When the interface 3500 is placed on a patient, the central plane 3054 can be parallel to the patient's sagittal plane. In practice, the offset positioning of the mouth sampling guide 3054 can provide clinicians with improved access to the patient's mouth during medical procedures and / or better compatibility with the placement of the face mask 144 on the gas delivery patient interface 3500.
[0427] In some embodiments, the base of the mouth sampling guide 3054 may be oriented at an angle α relative to the central plane. This angular orientation of the mouth sampling guide 3054 may further provide clinicians with improved access to the patient's mouth during medical procedures and / or better compatibility with the placement of the face mask 144 on the gas delivery patient interface 3500.
[0428] Generally, angle α is a predetermined angle. For example, angle α can be approximately between 100° and -100°.
[0429] Inlet openings 3014 and 3016 are generally located on a plane parallel to and offset from the central plane 3058. In the aforementioned embodiments of the gas collectors 100, 200, 300, 400, 500, 700, 800, 900, and 1000 described herein, one or more corresponding inlet openings may be similarly positioned when inserted into the nasal cannula 104.
[0430] In some embodiments, the mouth sampling guide 3054 may be offset from the coronal plane 3057 of the gas delivery patient interface 3600, such as Figure 41B As shown. The coronal plane 3057 can be defined as an imaginary plane extending across the patient interface 3600 in a direction perpendicular to the central plane 3054. When the interface 3600 is placed on the patient, the coronal plane 3057 can be parallel to the patient's coronal plane.
[0431] like Figure 41B As shown, the base of the mouth sampling guide 3054 can be oriented at an angle β relative to the coronal plane 3057. This angular orientation of the mouth sampling guide 3054 can further provide clinicians with improved access to the patient's mouth during medical procedures and / or better compatibility with the placement of the face mask 144 on the gas delivery patient interface 3600.
[0432] Generally, angle β is a predetermined angle. For example, angle β can be approximately between 100° and -100°.
[0433] Now go to Figure 43 The illustration shows a detailed view of a portion of a mouth sampling guide 3054 according to an exemplary embodiment. In the particular exemplary embodiment shown, the mouth sampling guide 3054 includes a dual-lumen catheter 3201 (also referred to herein as a mouth sampling catheter 3201). The dual-lumen catheter 3201 has a catheter body 3203. The catheter body 3203 has a generally circular cross-section along its entire length. The catheter 3201 includes a flexible, resilient support structure that allows the catheter 3201 to be manipulated or bent into any desired shape, such that the mouth sampling end 7050 can be selectively positioned and repositioned in, around, or adjacent to any desired location in, the patient's mouth. In the specific embodiment of the gas delivery patient interface 3500 shown in FIG. 41, significant repositioning of the mouth sampling end 7050 may not be required due to the offset and / or angular positioning of the mounting portion 3056 as previously described. After the patient interface 3500 is mounted on the patient's face, the mouth sampling end 7050 can be positioned approximately in or near the desired location in the patient's mouth to be more compatible with the face mask 144 and / or differences in the patient's face geometry, and to allow clinicians sufficient space to access the patient's breathing path, including the mouth area.
[0434] The support structure can take many different forms. For example, the support structure may include a wire, rod, or strip made of a flexible, elastic material (such as a metallic or polymeric material) that extends along at least a portion of the conduit 3201 or along its entire length. In one form, the conduit 3201 includes a first support lumen in which the support structure, such as a wire, may be located. The wire may be inserted into the lumen or co-extruded with the conduit 3201, or a portion of the conduit 3201 may be overmolded around the wire. In other forms, the support structure may be formed around the outer wall of the conduit 3201, or the outer wall may be made of a suitable material providing the support structure (e.g., a flexible or bendable material).
[0435] exist Figure 43 In the illustrated embodiment, catheter 3201 includes a first support lumen 3204 for receiving a support structure in the form of a line 3210 within the first lumen. The first support lumen or line lumen 3204 has a generally circular cross-section along its entire length. A second gas lumen 3202 for receiving expiratory and / or exhaled gases has a generally crescent-shaped cross-section along its entire length. The first lumen 3204 is located within and on one side of the second lumen 3202, such that the crescent-shaped cross-section of the second gas lumen 3202 is formed by the shape of the open space surrounding the first line lumen 3204.
[0436] In an alternative embodiment, the outer wall of the gas lumen 3202 may include a flexible / bendable material, such as metal, thereby allowing the conduit 3201 to be flexible without requiring separate line lumens 3204 and lines 3210.
[0437] In some embodiments, the cross-sectional area of the gas lumen 3202 is greater than about 1.3 mm. 2 In some embodiments, the nominal cross-sectional area of the gas cavity 3202 may be 0.75 mm. 2 For example, it has a diameter of about 1 mm. In some embodiments, the cross-sectional area of the gas cavity 3202 may be greater than or equal to about 0.3 mm. 2 In some embodiments, the cross-sectional area of the gas cavity 3202 may be less than or equal to about 30 mm. 2 .
[0438] In some embodiments, the height of the gas lumen 3202 is greater than about 1.5 mm. In some embodiments, the width of the gas lumen 3202 is greater than about 1.5 mm. Generally, the height and width of the gas lumen 3202 refer to the diameter of the gas lumen 3202.
[0439] As described above, in one form, the flexible support structure may include a length of extendable thread, such as a cable or rod, located within the catheter 3201. The thread is preferably a metallic wire. The thread may extend along one or more portions of the catheter 3201, or it may extend along substantially the entire length of the catheter 3201. The distal or patient end of the thread may be coated with a soft material to prevent chafing or scratching the patient's face. Alternatively, the patient end of the thread may be positioned posteriorly sufficiently within the catheter 3201 such that it does not extend beyond the distal end of the catheter 3201. In another alternative, the end of the thread may be sealed within the catheter wall. In yet another alternative, the thread may be located within the support lumen / thread lumen 3204 of the double-lumen catheter 3201, and the patient end of the thread may be secured at one or more points along the inner wall of the thread lumen to hold the thread in place and prevent it from dislodging from the lumen.
[0440] In another form, catheter 3201 may include at least one lumen that serves as both a line lumen / support lumen and a gas lumen. In this form, the catheter may include a line with a diameter smaller than the inner diameter of the lumen. The line may be held within the lumen at one or more locations. In this arrangement, the catheter may bend around the line, but one or more gaps are provided between the line and the inner wall of the lumen, allowing gas to pass along the lumen for sampling by a breathing gas monitor. The lumen is not completely sealed around the incompressible line, thus preventing complete blockage.
[0441] A stretchable line may occupy at least a portion of the conduit 3201, or the line may extend along substantially the entire length of the conduit 3201. For example, in Figure 43 In the illustrated dual-lumen catheter, the line 3210 may occupy one or more portions of the first lumen 3204 of the dual-lumen catheter 3201, or the line may extend substantially along the entire length of the first lumen 3204. The presence of the line 3210 provides rigidity to the catheter 3201 and the mouth sampling portion 3052. The line 3210 is also flexible to allow for adjustment of the first support catheter 3204 and thus to allow for further customization of the positioning of the mouth sampling end 7050 based on the geometry of the patient's face, breathing behavior, and the requirements of a specific medical procedure.
[0442] The wire may include stainless steel wire capable of being bent / reshaped multiple times without breaking. The wire diameter may be between about 0.4 mm and 1.0 mm, and optionally about 0.6 mm or 0.7 mm. Optionally, the wire is 304 grade. These properties provide suitable ductility to allow the user to easily reshape / bend the conduit by hand. In another form, the wire includes aluminum wire. In yet another form, the wire includes nickel-titanium wire.
[0443] In one configuration, when catheter 3201 is bent, line 3210 is positioned on the inner curve of catheter 3201. This reduces the risk of kinking of the nozzle sampling catheter 3201 when bent. Alternatively, line 3210 may be positioned on the outer curve of the bent catheter 3201 or along one side or at any other orientation or location relative to the length of catheter 3201.
[0444] The use of a flexible mouth sampling catheter 3201 with a support structure (e.g., a thread) as described above allows the mouth sampling portion 3052 to be selectively positioned (elastically bendable / deformable) to be placed in or near any suitable location in or near the patient's mouth. In practice, the mouth sampling tip 7050 may be placed in the mouth approximately at or near the teeth.
[0445] Figures 44 to 47 An exemplary embodiment of a mouth sampling tip 7050 is shown, which can be connected to a mouth sampling catheter 3201 to receive gas exiting from patient P. The mouth sampling tip 7050 can be integrally formed with the mouth sampling catheter 3201, or it can be separately formed and then attached to the free end / gas inlet end of the mouth sampling catheter 3201. The mouth sampling tip 7050 can be attached to the free end of the mouth sampling catheter 3201 using any suitable attachment method. For example, the mouth sampling tip 7050 can be welded to the mouth sampling catheter 3201; attached to the free end of the mouth sampling catheter 3201 by threaded engagement; glued or otherwise adhered to the free end of the mouth sampling catheter 3201; or the mouth sampling tip 7050 and the mouth sampling catheter 3201 can be attached together in a snap-fit arrangement, a friction-fit arrangement, or the like.
[0446] Optionally, the mouth sampling tip 7050 is formed of a soft or semi-soft compressible material. In some cases, it has been found that a mouth sampling tip 7050 formed of a rigid or hard material can cause injury to the patient or damage the patient's teeth, especially if the mouth sampling tip 7050 is placed between the teeth and the patient inadvertently bites on the mouth sampling tip 7050. By providing a sampling tip that may include a compressible material that is unlikely to cause injury or damage to the patient, these risks can be avoided or at least mitigated.
[0447] In one embodiment, the mouth sampling end 7050 includes a body 7060, the body including a generally hollow internal region 7061 configured to be in fluid communication with an inlet 3206 of the mouth sampling conduit 3201 when the mouth sampling end 7050 is connected to the mouth sampling conduit 3201. The body 7060 includes one or more sidewalls forming an outer surface of the body, a proximal connection end 7062 for connecting to a free end (inlet 3206) of the mouth sampling conduit 3201 such that the hollow internal region is in fluid communication with the mouth sampling conduit 3201, and a distal end 7063 terminating at a distal end 7064 of the mouth sampling end 7050.
[0448] In one embodiment, the connecting end 7062 may be glued to the mouth sampling catheter 3201. In another embodiment, the connecting end 7062 may be threaded for connection to a corresponding threaded end of the mouth sampling catheter 3201, such that the mouth sampling end 7050 can be screwed onto and unscrewed from the free end of the mouth sampling catheter 3201. In yet another embodiment, the connecting end 7062 may include a lip configured to fit onto a collar at the inlet 3206 end of the mouth sampling catheter 3201 to connect the mouth sampling end 7050 and the catheter 3201 in a snap-fit arrangement. Alternatively, the inlet end 3206 of the mouth sampling catheter 3201 may include a lip fitted onto the collar of the connecting end 7062 of the mouth sampling end 7050.
[0449] The mouth sampling end 7050 includes at least one inlet / gas receiving port 7230. Gas exhaled or exhaled by the patient can be received through the inlet / gas receiving port 7230, which is in fluid communication with a generally hollow internal region 7061 of the body 7060, such that the received gas can pass through the body 7060 of the mouth sampling end 7050 and enter the inlet 3206 of the mouth sampling conduit 3201. Figures 44 to 47 In the illustrated embodiment, three inlet holes 7230 are provided in the nozzle sampling end 7050. Each inlet hole / gas receiving hole 7230 forms an opening leading to the hollow interior region 7061 of the body 7060 of the nozzle sampling end 7050.
[0450] In one embodiment, the inlet hole 7230 may extend from the distal end 7064 of the mouth sampling end 7050 along the side of the body 7060. Alternatively, the inlet hole 7230 may form an elongated opening in the distal end 7063 of the mouth sampling end 7050.
[0451] In one embodiment, the sampling end 7050 includes an end wall at its distal end 7064 and one or more inlet holes 7230 located on one or more sidewalls of the sampling end 7050. In one embodiment, the inlet hole 7230 may extend substantially around the entire outer periphery of the sampling end 7050, such as extending substantially around the entire outer periphery of an outer surface. When the sampling end 7050 has a substantially rounded / circular cross-section, the inlet hole 7230 may extend around the circumferential outer surface of the sampling end 7050 to form an annular hole. In another embodiment, the inlet hole 7230 may extend around the circumferential outer surface of the sampling end 7050 in a substantially helical arrangement, similar to the helical thread of a bottle stopper drill.
[0452] In some embodiments, the sampling end 7050 may include a plurality of inlet holes / gas receiving holes 7230. For example, the sampling end 7050 may include a pair of gas receiving holes 7230 extending from the distal end of the sampling end along both sides of the distal end 7063 of the body 7060. The holes 7230 may be evenly spaced from each other or unevenly spaced from each other. For example, the holes 7230 may be located on substantially opposite sides of the body 7060, or the holes 7230 may be positioned closer to each other in at least one direction. In other embodiments, the sampling end 7050 may include two, three, four or more gas receiving holes 7230. The holes 7230 may be evenly spaced from each other or unevenly spaced from each other.
[0453] exist Figures 44 to 47 In the specific embodiment shown, the sampling end 7050 includes three inlet holes 7230, which are evenly spaced around the distal end and side of the sampling end 7050. The spacing of the holes 7230 can be... Figure 46 It can be seen more clearly in the middle.
[0454] Each portion of the body 7060 located between the inlet orifices 7230 forms an elongated portion 7240 terminating at the distal end of the sampling end 7050. A central support 7250 may be located at the distal end of the sampling end 7050 and may be connected to the elongated portion 7240. The central support 7250 provides additional strength and positional integrity to the elongated portion 7240 to prevent it from squeezing together and at least partially obstructing the inlet orifice 7230. The central support 7250 of the sampling end 7050, the elongated portion 7240, and the body 7060 together define the edge of the inlet orifice 7230.
[0455] The body 7060 of the sampling end 7050 may have a generally cylindrical shape, and the elongated portions 7240 may be spaced approximately evenly around the circumference of the distal end 7063 of the sampling end 7050. In one embodiment, the inner portion of each elongated portion may include a cut-off region to form an enlarged opening within the sampling end 7050.
[0456] exist Figure 44 In the illustrated embodiment, the distal end 7064 of the sampling end 7050 (including the central support and the distal ends of each elongated portion) is bent outwards or protrudes to form a protruding shield that prevents the end opening of the inlet hole 7230 from being sucked onto the patient's face, mouth, or lips. The side surface of the elongated portion 7240 at the distal end of the sampling end 7050 may also be bent outwards to form a generally bulbous distal end.
[0457] Figure 48 and Figure 49A detailed view of a mouth sampling unit 3052 according to one embodiment is further shown. As described above, the mouth sampling unit 3052 includes a mouth sampling guide 3054, which may be provided by a flexible mouth sampling conduit 3201 and a sampling end 7050 coupled to its inlet 3206 end. The opposite end 3060 of the mouth sampling guide 3054 can be selectively attached to and removed from the mounting portion 3056 of the gas sampling unit 3010.
[0458] Returning to the embodiment of the gas delivery patient interface 3500 shown in FIG. 41, the nasal sampling section 3012 defines nasal gas sampling channels 3706, 3708 to provide fluid communication between each inlet opening 3014, 3016 of the nasal sampling section 3012 and the sampling gas conduit 3018. The mouth sampling section 3052 defines an oral gas sampling channel 3710 to provide fluid communication between each of the at least one inlet orifice 7230 of the mouth sampling section 3052 and the sampling gas conduit 3018.
[0459] Figure 50 The schematic diagram is a simplified illustration of the nasal gas sampling channel and the oral gas sampling channels 3706, 3708, and 3710 (not shown, connected to the outlet of the gas sensing device). Gas leaving the patient's nostrils can flow in the direction of arrows 3734 and 3736. The inlet openings 3014 and 3016 of the nasal sampling section 3012 are oriented approximately perpendicular to the direction of airflow 3734 and 3736 leaving the patient's nostrils.
[0460] During medical procedures, patients can switch between oral and nasal breathing. Furthermore, to accommodate the effects of high-flow-rate treatments, differences in patient anatomy, breathing habits and behaviors, and the requirements of different procedures, the characteristics of the nasal and oral gas sampling channels of the gas sampling unit 3010 can be modified or fine-tuned to provide the desired gas sampling results.
[0461] Specifically, the one or more nasal gas sampling channels and oral gas sampling channels can be configured such that the flow rate in the one or more nasal gas sampling channels is a percentage of the total flow rate in the one or more nasal gas sampling channels and oral gas sampling channels, wherein the percentage is within a predetermined range. This total flow rate includes a calculated total flow rate of the flow rates in the one or more nasal gas sampling channels and oral gas sampling channels (i.e., mathematically adding their respective flow rates), or the flow rate of a combined flow when the airflow in the one or more nasal gas sampling channels and the airflow in the oral gas sampling channels combine (e.g., at a confluence).
[0462] In some configurations with multiple nasal gas sampling channels, the multiple nasal gas sampling channels and oral gas sampling channels are configured such that the combined flow rate in the multiple nasal gas sampling channels is a percentage of the total flow rate in the multiple nasal gas sampling channels and oral gas sampling channels, wherein the percentage is within a predetermined range. In some configurations, multiple oral gas sampling channels are present. In this configuration, the one or more nasal gas sampling channels and the multiple oral gas sampling channels are configured such that the flow rate in the one or more nasal gas sampling channels is a percentage of the total flow rate in the one or more nasal gas sampling channels and the multiple oral gas sampling channels, wherein the percentage is within a predetermined range. The predetermined range may be from about 1% to about 99% (e.g., the flow rate in one or more nasal gas sampling channels is 1% of the total flow rate in the one or more nasal gas sampling channels and oral gas sampling channels), preferably from about 5% to about 95%, and even more preferably from about 20% to about 80%. In some embodiments, the predetermined range is from about 45% to about 55%. In some embodiments, the ratio may be about 50%, such that the flow rates in the one or more nasal gas sampling channels and the flow rates in the one or more oral gas sampling channels are substantially balanced.
[0463] In some embodiments, the relative positions of the nasal air inlet openings and / or oral air inlet openings (e.g., inlet openings 3014, 3016 of the nasal sampling section 3012 and inlet orifice 7230 of the mouth sampling section 3052) can be configured to achieve the aforementioned percentages within a predetermined range. For example, as shown in FIG41, the inlet openings 3014, 3016 of the nasal sampling section 3012 are positioned perpendicular to the flow direction from the patient's nasal region to the patient's oral region, while the inlet orifice 7230 of the mouth sampling section 3052 is positioned substantially facing the patient's oral region. In practice, the position and orientation of the mouth sampling end 7050 can be moved and repositioned as needed. Moving and repositioning the mouth sampling end 7050 can further allow adjustment of the aforementioned relative flow rate percentages.
[0464] In some embodiments, to achieve the aforementioned percentages within a predetermined range, nasal gas sampling channels 3708 and 3706 and oral gas sampling channel 3710 may be configured such that the ratio of the flow resistance (RTF) in one or more nasal gas sampling catheters and oral gas sampling catheters is within a predetermined range. In some embodiments, nasal gas sampling channels 3708 and 3706 and oral gas sampling channel 3710 may be configured such that the ratio of the combined RTF in the one or more nasal gas sampling channels 3706, 3708 to the RTF in the oral gas sampling channel 3710 is within a predetermined range.
[0465] In one or more embodiments, the nasal gas sampling channel and the oral gas sampling channel can be configured such that the RTF in these respective channels is approximately equal (i.e., approximately the same). Having approximately equal RTF in the respective channels can produce a approximately balanced flow rate in the nasal gas sampling channel and the oral gas sampling channel.
[0466] In other cases, having approximately equal RTFs in each channel does not necessarily result in approximately balanced flow rates in the nasal and oral gas sampling channels. For example, blockages in either the nasal or oral gas sampling channel can cause an imbalance in flow rates through the corresponding channel. In another instance, a mouth sampling unit attached to the oral gas sampling channel can increase the RTF of the oral gas sampling channel, which can lead to an imbalance in flow rates through the corresponding channel.
[0467] In one or more embodiments, the RTF (or combined RTF of the one or more nasal gas sampling channels) may be larger than the RTF of the oral gas sampling channels by a predetermined amount. This predetermined amount may be based on the percentage of the flow rate in the one or more nasal gas sampling channels relative to the total flow rate in the one or more nasal gas sampling channels and the oral gas sampling channels within a predetermined range. For example, the RTF (or combined RTF of the one or more nasal gas sampling channels) may be about 1%, about 2%, about 3%, about 4%, about 5%, about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, about 100%, or greater than about 100% of the RTF of the oral gas sampling channels. In some embodiments, the RTF (or combined RTF of the one or more nasal gas sampling channels) may be about 200%, about 300%, about 400%, or greater than about 400% of the RTF of the oral gas sampling channels. This is beneficial when the patient is primarily supplied with high-flow nasal gas from the nasal forks 3006 and 3008 of the patient interface 3500 and the patient is primarily breathing through their mouth.
[0468] In other embodiments, the RTF in the nasal gas sampling channel may be smaller than the RTF in the oral gas sampling channel. In other words, the RTF in the oral gas sampling channel may be a predetermined amount larger than the RTF in the one or more nasal gas sampling channels (or the combined RTF in the one or more nasal gas sampling channels). For example, the RTF in the oral gas sampling channel may be about 1%, about 2%, about 3%, about 4%, about 5%, about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, about 100%, or greater than about 100% larger than the RTF in the one or more nasal gas sampling channels (or the combined RTF in the one or more nasal gas sampling channels). In some embodiments, if the nasal gas sampling trace is expected to be weaker compared to the oral gas sampling trace (e.g., if the proportion of CO2 relative to exhaled gas in the nasal gas sampling trace is lower due to dilution of exhaled gas caused by the diversion of airflow delivered to the patient via the nasal fork), it is desirable for the RTF in the oral gas sampling channel to be larger than the RTF in the nasal gas sampling channel. Generally, the gas sampled via the oral gas sampling channel is not diluted by the airflow delivered via the nasal fork. Thus, when a lower RTF is provided for the nasal gas sampling channel compared to the oral gas sampling channel, the gas sampling unit 3010 can sample with approximately the same absolute volume of exhaled gas in both the nasal and oral gas sampling channels.
[0469] The pressure required to generate a predetermined gas flow rate in the nasal and oral gas sampling channels can be related to the RTF (Reactive Power Factor). Specifically, the higher the RTF in the channel, the greater the pressure required to generate the same gas flow rate through the channel. As described above, various characteristics of the nasal and oral gas sampling channels can be varied to achieve any target pressure ratio between the nasal and oral gas sampling channels. In some embodiments, the pressure ratio between the oral gas sampling channel 3710 and the combination of the two nasal gas sampling channels 3014, 3016 can be 2:1, or any value between 1:10 and 10:1, in order to generate the predetermined gas flow rate (e.g., 200 mL / min). For embodiments providing a single nasal gas sampling channel, the pressure ratio between the oral gas sampling channel and the single nasal gas sampling channel can be 2:1, or any value between 1:10 and 10:1, or any value between 1:100 and 100:1, in order to generate the predetermined gas flow rate (e.g., 200 mL / min).
[0470] The configuration of the nasal and oral gas sampling channels required to achieve the desired RTF ratio between them can be achieved by configuring one or more parameters of the channels or flow paths within them (e.g., cross-sectional area, shape, length, surface roughness, etc.). In some embodiments, the oral gas sampling channel includes a more tortuous flow path and / or a longer flow path to the confluence (e.g., where the flow paths in the respective catheters combine) compared to the one or more nasal gas sampling channels. In some embodiments, the cross-sectional shape and / or area of the flow path in one nasal gas sampling channel differs from the cross-sectional shape and / or area of the flow path in another nasal gas sampling channel and / or oral gas sampling channel. Furthermore, introducing bends / knots into the nasal and / or oral gas sampling channels can also increase the RTF in the respective channels.
[0471] In some embodiments, the inner surface of the one or more nasal sampling channels exposed to the airflow differs from the inner surface of the oral gas sampling channels exposed to the airflow; for example, the inner surface of the one or more nasal sampling channels has a greater surface roughness than the inner surface of the oral gas sampling channels (thus giving the one or more nasal sampling channels a higher RTF than the oral sampling channels). In some embodiments, the RTF in the one or more nasal gas sampling channels and / or oral gas sampling channels may be variable. In some embodiments, this variable RTF is adjustable. In some embodiments, the cross-sectional area and / or shape of a portion of one or more sampling catheters may be adjustable, for example, by providing a valve whose parameters can be controlled to change the flow path through that portion. The valve may be controlled automatically or manually (e.g., by rotating a dial).
[0472] In such Figure 42 In one example shown, the flow obstruction 3037 may extend from the inner wall of the oral gas sampling channel 3710 to increase the RTF in the oral gas sampling channel. In other examples, the RTF may be increased by making the flow path of the oral gas sampling channel 3710 tortuous or by reducing the opening area of the flow path.
[0473] Although Figure 39AWhile not specifically shown in Figure 41, but in some embodiments, the gas sampling unit 3010, the sampling gas conduit 3018, and the optional nozzle sampling unit 3052 may be configured as separate gas collectors for selective attachment to any suitable gas delivery patient interface, such as patient interfaces 102, 1400, and 2030 as described earlier herein. This separate gas collector may be configured to attach to gas delivery patient interfaces 102, 1400, and 2030 via any suitable means, such as by adhesive or any suitable mechanical attachment mechanism. The mechanical attachment mechanism may include rings, clips, clamps, mating parts, or any combination thereof.
[0474] The gas delivery patient interfaces 3000, 3500 (or a separate gas collector that can be attached to the gas delivery patient interfaces 102, 1400, and 2030) combine the reliability of philtrum sampling at the patient's nose with the flexibility of a selectively repositionable mouth sampling section 3052 for sampling gas at the mouth, provided between the nose forks 3006, 3008 and above the body 3002 and the airflow manifold 3004. The placement of the gas sampling catheter 3018 above the airflow manifold 3004 also provides reliable and continuous gas sampling when switching between different patient interfaces (e.g., between a nasal cannula and a face mask).
[0475] explain
[0476] This specification, including the claims, is intended to be interpreted as follows:
[0477] The embodiments or examples described in this specification are intended to illustrate the present invention and are not intended to limit its scope. The present invention can be implemented with various modifications and additions readily apparent to those skilled in the art. Therefore, it should be understood that the scope of the present invention is not limited to the precise construction and operation described or shown, but is defined only by the appended claims.
[0478] Furthermore, where deemed appropriate and suitable by those skilled in the art, any feature or element described in one embodiment may be combined with any feature or element described for any other embodiment as detailed herein.
[0479] The method steps or product elements simply disclosed in the specification should not be construed as necessary for the utility model claimed herein, unless expressly stated or explicitly stated in the claims.
[0480] The terms in the claims have the widest range of meaning as given by a person skilled in the art up to the relevant date.
[0481] Unless otherwise explicitly stated, the term "one" means "one or more".
[0482] The title and abstract of this application should not be considered as limiting the scope of the claimed utility model in any way.
[0483] Where the preamble of a claim describes the purpose, benefit, or possible use of the claimed utility model, it does not limit the claimed utility model to having only that purpose, benefit, or possible use.
[0484] It should be noted that the degree terms used in this article, such as “generally,” “roughly,” “about,” and “approximately,” refer to a reasonable amount of deviation from the term being modified, such that the final result is not significantly altered. If the deviation does not negate the meaning of the term being modified, these degree terms should be interpreted as including the deviation of the term being modified.
[0485] In the specification, including the claims, the term “comprising” and variations thereof (e.g., “including” or “containing”) are used to mean “including but not limited to”, unless otherwise expressly stated or unless an exclusive interpretation of the term is required in the context or use.
[0486] Furthermore, any range of values expressed by endpoints in this document includes all values and decimals included within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, and 5). It should also be understood that all values and decimals are assumed to be modified by the term “about,” meaning that a change of up to a certain amount of the value mentioned will be made if the final result does not change significantly.
[0487] As used herein, the term “and / or” is intended to indicate an inclusive “or”. That is, “X and / or Y” means, for example, X or Y or both. As another example, “X, Y and / or Z” means X or Y or Z or any combination thereof.
[0488] Throughout this specification, the same reference numerals denote the same features described herein. Therefore, any instance where the same reference numerals denote a feature or component implies a direct relation to a similar or identical feature or component previously described in this specification.
[0489] The disclosure of any document cited herein is incorporated by reference into this patent application as part of this disclosure, but should in no way be used to limit, define, or otherwise interpret any terminology in this application for purposes of written description and practicability, in which the application would not be able to provide a definite meaning without its incorporated reference. Any incorporated reference in itself does not constitute any endorsement or approval of any statement, opinion, or argument contained in any of the incorporated documents.
Claims
1. A gas collector for collecting gas from a patient, characterized in that, The gas collector includes: A gas sampling unit is used to sample the gas from the patient's area, and A coupling mechanism is used to connect the gas sampling unit to the gas delivery patient interface, the gas delivery patient interface having: The main body has an airflow manifold for receiving the gas flow delivered to the patient, and A pair of nose forks, extending from the body, are used to deliver a flow of air to the patient through the patient's nostrils. The gas sampling unit has a nasal sampling unit configured to be positioned above the main body of the gas delivery patient interface and between the nasal forks. The nasal sampling unit defines at least one inlet opening for sampling gas from the patient's nose. The position of the at least one inlet opening is fixed relative to the connecting mechanism.
2. The gas collector according to claim 1, characterized in that, The nasal sampling unit is configured to be positioned above the airflow manifold between the nasal forks of the gas delivery patient interface.
3. The gas collector according to claim 1 or 2, characterized in that, The at least one inlet opening of the nasal sampling unit allows sampling gas exhaled from the patient's nose to enter the nasal sampling unit in an inlet airflow direction that is substantially different from the direction of the exhaled gas from the patient's nose.
4. The gas collector according to claim 3, characterized in that, The surface of the at least one inlet is defined by the airflow direction entering the inlet, which is approximately perpendicular to the nasal sampling section.
5. The gas collector according to claim 3, characterized in that, The direction of the airflow entering the inlet is roughly perpendicular to the direction of the air exhaled from the patient's nose.
6. The gas collector according to claim 3, characterized in that, The direction of airflow entering the inlet is different from the direction of airflow delivered to the patient's nostrils via the nasal fork.
7. The gas collector according to claim 1 or 2, characterized in that, The nasal sampling unit defines at least two inlet openings, each located on one side of the nasal sampling unit.
8. The gas collector according to claim 1 or 2, characterized in that, The nasal sampling section has multiple inlet openings.
9. The gas collector according to claim 1 or 2, characterized in that, The nasal sampling unit is configured to be positioned below the patient's nasal septum during use.
10. The gas collector according to claim 1 or 2, characterized in that, The nasal sampling unit is configured to be positioned in the space between the gas delivery patient interface and the patient's nasal columella during use.
11. The gas collector according to claim 1 or 2, characterized in that, The main body of the patient interface has a bridging portion extending between the nasal forks; wherein the nasal sampling portion is configured to be positioned on the bridging portion of the patient interface.
12. The gas collector according to claim 11, characterized in that, The nasal sampling unit is configured to be positioned in the space between the patient's nasal septum, bridging portion, and nasal fork.
13. The gas collector according to claim 1 or 2, characterized in that, The nasal sampling section is configured such that when the gas collector is installed on the patient interface, the at least one inlet opening is close to the base of the nasal fork adjacent to the body of the patient interface.
14. The gas collector according to claim 1 or 2, characterized in that, The patient interface body has an inner wall facing the patient during use and an outer wall opposite to the inner wall, the outer wall being away from the patient during use; wherein, the nasal sampling section is configured such that the at least one inlet opening is close to any one of the following: Inner wall; outer wall; The central area between the inner and outer walls of the main body.
15. The gas collector according to claim 1 or 2, characterized in that, The nose forks have inner sidewalls facing each other, and the at least one inlet opening is located on the surface of the nose sampling portion facing the inner sidewall of the corresponding nose fork and offset from the inner sidewall of the corresponding nose fork.
16. The gas collector according to claim 1 or 2, characterized in that, The at least one inlet opening is offset from the central plane of the gas delivery patient interface; wherein the central plane extends between the nasal forks such that the nasal forks are spaced apart by approximately equal distances relative to the central plane.
17. The gas collector according to claim 1 or 2, characterized in that, The coupling mechanism is configured for releasable attachment to the body of the gas delivery patient interface.
18. The gas collector according to claim 17, characterized in that, The connection mechanism includes a ring configured for attachment to a bridging portion surrounding the gas delivery patient interface.
19. The gas collector according to claim 1 or 2, characterized in that, The coupling mechanism is configured to attach to one or both of the nose forks of the gas delivery patient interface.
20. The gas collector according to claim 1 or 2, characterized in that, The coupling mechanism includes one or more rings configured for attachment to one or both of the nose forks of the gas delivery patient interface.
21. The gas collector according to claim 20, characterized in that, The coupling mechanism includes a pair of rings, each ring configured to attach to a corresponding nose fork in a pair of nose forks.
22. The gas collector according to claim 1 or 2, characterized in that, The connecting mechanism defines one or more additional inlet openings thereon to sample the gas from the patient's nose.
23. The gas collector according to claim 20, characterized in that, Each of the one or more rings includes a conduit.
24. The gas collector according to claim 23, characterized in that, Each catheter defines one or more additional inlet openings to sample the gas exhaled from the patient's nose.
25. The gas collector according to claim 1 or 2, characterized in that, The coupling mechanism includes one or more C-shaped or U-shaped portions for mounting to the body and / or nose fork of the gas delivery patient interface.
26. The gas collector according to claim 1 or 2, characterized in that, The gas collector also includes an outlet section that defines an outlet; wherein the gas collected by the gas sampling section leaves the gas collector via the outlet.
27. The gas collector according to claim 26, characterized in that, The outlet is configured to be connected to a conduit for delivering the gas collected by the gas sampling unit to one or more sensor units.
28. The gas collector according to claim 1 or 2, characterized in that, The gas collector also includes one or more airflow guides for directing gas from the patient toward the gas sampling unit.
29. The gas collector according to claim 28, characterized in that, The airflow guide is configured to guide gas from the patient’s nose toward at least one inlet opening of the nasal sampling section.
30. The gas collector according to claim 28, characterized in that, The gas collector includes a pair of airflow guides, each extending from the opposite side of the nasal sampling section.
31. The gas collector according to claim 30, characterized in that, A pair of airflow guides are configured to be positioned between the nose forks during use.
32. The gas collector according to claim 28, characterized in that, Each airflow guide defines a curved surface for guiding airflow from the patient's nose to the at least one inlet opening of the nasal sampling section.
33. The gas collector according to claim 1 or 2, characterized in that, The gas sampling section is rigid.
34. The gas collector according to claim 1 or 2, characterized in that, The gas sampling section is roughly fixed relative to the connecting mechanism.
35. The gas collector according to claim 1 or 2, wherein, The coupling mechanism allows for connection to an extendable section of the gas delivery patient interface.
36. A gas delivery patient interface for delivering gas to a patient, characterized in that, The gas delivery patient interface includes: The main body has an airflow manifold for receiving the gas flow delivered to the patient, and A pair of nose forks, extending from the body, are used to deliver a flow of air to the patient through the patient's nostrils. A gas sampling unit for sampling gas from a patient, the gas sampling unit having a nasal sampling section disposed above the main body of the gas delivery patient interface and between the nasal forks, the nasal sampling section defining at least one inlet opening for sampling gas from the patient's nose.
37. The gas delivery patient interface according to claim 36, characterized in that, The nasal sampling unit is configured to be positioned above the airflow manifold between the nasal forks of the gas delivery patient interface.
38. The gas delivery patient interface according to claim 36 or 37, characterized in that, The gas sampling unit is integrated with the main body and / or the nose fork.
39. The gas delivery patient interface according to claim 36 or 37, characterized in that, The at least one inlet opening of the nasal sampling unit allows sampling gas from the patient to enter the nasal sampling unit in an inlet airflow direction different from the direction of the gas exhaled from the patient's nose.
40. The gas delivery patient interface according to claim 39, characterized in that, The inlet airflow direction is approximately perpendicular to the surface defining at least one inlet of the nasal sampling section.
41. The gas delivery patient interface according to claim 39, characterized in that, The direction of the airflow entering the inlet is roughly perpendicular to the direction of the air exhaled from the patient's nose.
42. The gas delivery patient interface according to claim 39, characterized in that, The direction of airflow entering the inlet is different from the direction of airflow delivered to the patient's nostrils via the nasal fork.
43. The gas delivery patient interface according to claim 36 or 37, characterized in that, The nasal sampling unit defines at least two inlet openings, each located on one side of the nasal sampling unit.
44. The gas delivery patient interface according to claim 36 or 37, characterized in that, The nasal sampling section has multiple inlet openings.
45. The gas delivery patient interface according to claim 36 or 37, characterized in that, The nasal sampling unit is configured to be positioned below the patient's nasal septum during use.
46. The gas delivery patient interface according to claim 36 or 37, characterized in that, The main body has a bridging portion extending between the nasal forks; wherein, the nasal sampling portion protrudes from the bridging portion of the main body and is positioned in the space between the patient's nasal septum, the bridging portion of the main body, and the nasal forks during use.
47. The gas delivery patient interface according to claim 36 or 37, characterized in that, The gas delivery patient interface also includes an outlet section that defines the exit; wherein the gas collected by the gas sampling section exits the gas collector via the outlet.
48. The gas delivery patient interface according to claim 47, characterized in that, The outlet is configured to connect to a conduit to deliver the gas collected by the gas sampling unit to one or more sensor units.
49. The gas delivery patient interface according to claim 36 or 37, characterized in that, The gas delivery patient interface also includes one or more airflow guides for directing the gas exhaled by the patient toward the gas sampling unit.
50. The gas delivery patient interface according to claim 49, characterized in that, The airflow guide is configured to guide gas from the patient’s nose toward at least one inlet opening of the nasal sampling section.
51. The gas delivery patient interface according to claim 49, characterized in that, The gas collector includes a pair of airflow guides, each extending from the opposite side of the nasal sampling section.
52. The gas delivery patient interface according to claim 51, characterized in that, A pair of airflow guides are configured for positioning between the nose forks.
53. The gas delivery patient interface according to claim 49, characterized in that, Each airflow guide defines a curved surface for guiding airflow from the patient's nose to the at least one inlet opening of the nasal sampling section.
54. The gas delivery patient interface according to claim 36 or 37, characterized in that, The gas sampling section is rigid.
55. A patient interface component, characterized in that, The patient interface components include: A gas delivery patient interface for delivering a gas stream to a patient, and The gas collector according to claim 1 or 2.
56. The patient interface component according to claim 55, characterized in that, The patient interface component also includes a filter for filtering return gas from the patient; wherein the filter is installed upstream of the gas delivery patient interface.
57. A patient interface component, characterized in that, The patient interface component includes the gas delivery patient interface as described in claim 36 or 37.
58. The patient interface component according to claim 57, characterized in that, The patient interface component also includes a catheter for connecting the gas delivery patient interface and the filter.
59. A kit, characterized in that, The kit includes: A gas delivery patient interface for delivering gas streams to a patient, and The gas collector according to claim 1 or 2.
60. The kit according to claim 59, characterized in that, The kit also includes any one or more of the following: At least one airflow duct, Inhalation branch, and Humidification room.
61. A kit, characterized in that, The kit includes: The gas delivery patient interface according to claim 36 or 37.
62. A system, characterized in that, The system includes: Gas delivery patient interface for delivering gas streams to patients The gas collector according to claim 1 or 2, wherein the gas collector is mounted to the gas delivery patient interface, and A humidifier is used to humidify the gas stream delivered to the patient.
63. The system according to claim 62, characterized in that, The system also includes one or more gas analyzers connected to the gas collector for analyzing the gas from the gas collector.
64. A system, characterized in that, The system includes: Gas delivery patient interface for delivering gas streams to patients The gas collector according to claim 1 or 2, wherein the gas collector is mounted to the gas delivery patient interface, and An airflow generator used to produce a gas flow for delivery to the patient.
65. A system, characterized in that the system include: The gas delivery patient interface according to claim 36 or 37, and A humidifier is used to humidify the gas stream delivered to the patient.
66. The system according to claim 65, characterized in that, The system also includes one or more gas analyzers connected to the gas delivery patient interface for analyzing gases from the gas sampling unit.
67. A system, characterized in that the system include: The gas delivery patient interface according to claim 36 or 37, and An airflow generator used to produce a gas flow for delivery to the patient.