Respiratory sampling interface

Abstract

A respiratory gas delivery and sampling system, a gas sampling system, a gas sampling interface, and a gas sampling tip are provided that can be used to sample exhaled and / or exhaled gases from patients, particularly patients with apnea and / or patients receiving high-flow respiratory therapy. [Solution] The gas sampling system comprises a respiratory gas monitor in fluid communication with a gas sampling interface, the gas sampling interface comprising the gas sampling tip of the present invention. The gas sampling interface comprises a gas sampling conduit, the gas sampling tip located at the free end of the conduit. The gas sampling interface can be configured to allow selective positioning of the gas sampling tip in or within the nostrils of the mouth or nose of a patient.

Description

Technical Field

[0001]

[0001] This disclosure generally relates to respiratory gas therapy. More particularly, this disclosure relates to an interface for capturing exhaled and / or expiratory gases, such as CO2, near a patient's nose or mouth while respiratory gas is being supplied to the patient by a respiratory device. In use, the interface includes or is typically fluidly connected to a gas sampling conduit that is fluidly connected to a respiratory gas monitor. This interface can be particularly useful when measuring exhaled and / or expiratory gases from a patient receiving high flow respiratory gas.

Background Art

[0002]

[0002] In a medical environment, it is common practice to monitor the concentration of gases exhaled and / or breathed by a patient using a gas sampling system comprising a respiratory gas monitor connected to a gas sampling interface comprising a gas sampling conduit for transmitting exhaled and / or expiratory gases from the patient to the respiratory gas monitor. Respiratory gas monitors are well known in the art and range from more comprehensive monitors capable of monitoring several different types of gases (nitrogen, O2, CO2, anesthetic gases, etc.) to more specialized monitors capable of monitoring only a single type of gas. An example of a more specialized respiratory gas monitor is a capnogram / capnograph that monitors CO2 by drawing exhaled and / or expiratory gases from the patient into a gas sampling interface connected to the capnogram / capnograph. Anesthesia machines can also provide a respiratory gas monitor. The respiratory gas monitor can be fully or partially incorporated into the anesthesia machine or can be independent of the anesthesia machine. The respiratory gas monitor can provide a small amount of suction to draw gas into the sampling conduit.

[0003]

[0003] The respiratory gas monitor receives exhaled and / or exhaled gases through a sampling conduit of the gas sampling interface. For example, the inlet of the sampling conduit can be positioned near the patient's nose or mouth so that the sampling conduit captures the exhaled and / or exhaled gases passing through it, and the exhaled and / or exhaled gases then enter the conduit through the inlet. In some examples, the inlet can be fluidly connected to or form part of a respiratory device such as a mask or cannula. In some examples, the sampling conduit is independent of the patient interface, and the end of the sampling conduit can be held in place on the patient's face or secured with tape.

[0004]

[0004] Gas sampling is generally used in patients under anesthesia, but known gas sampling interfaces, gas sampling conduits, and processes for gas sampling are fraught with difficulties.

[0005]

[0005] For example, the process of taping a sampling conduit to the patient's face requires some preparation time and skills related to the roles of an anesthesiologist, anesthetic technician, nurse, or other healthcare professional. Also, correct placement of the sampling conduit is required to ensure that the conduit / tube is positioned to reliably capture exhaled and / or exhaled gases.

[0006]

[0006] The gas sampling interface or sampling conduit may also become detached if the patient moves their head, or if an instrument is used near or must operate around the sampling interface or conduit.

[0007]

[0007] Some gas sampling interfaces may also interfere with instruments or equipment such as bite blocks, endoscopes, or laryngoscopes. Furthermore, if a portion of the sampling conduit is positioned inside the patient's mouth, the end of the sampling conduit may become blocked by saliva or blood, or may aspirate the inside of the patient's cheek or the patient's tongue.

[0008]

[0008] With the current method, it is not possible to easily change the position of the sampling interface when necessary. For example, reliable CO2 sampling may be difficult when it is unknown before the procedure whether the patient primarily breathes through the nose or mouth. For example, if the sampling conduit is taped in place in the patient's nose, and it is later discovered that the patient primarily breathes through the mouth, it would be necessary to remove the conduit and then tape it in place in the patient's mouth. Changing the position of the sampling conduit in this way requires repeating the sampling conduit installation procedure, which is time-consuming.

[0009]

[0009] Therefore, it is desirable to provide a sampling interface that facilitates engagement of the sampling conduit to the patient so that engagement is performed rapidly and the conduit arrangement ensures that CO2 is captured during exhaled and / or exhaled respiration.

[0010]

[0010] When a patient is apnea, gas sampling becomes particularly difficult because the amount of gas released or exhaled from the lungs of an apnea patient is very small. Patient ventilation cannot substantially remove the gas from the lungs to that extent, and any gas released from the nose or mouth is greatly diluted, making it impossible to accurately detect exhaled CO2 (which can easily diffuse from the airway of an apnea patient) in the nose or mouth. It may be possible to somehow sample the released gas in the trachea where the released gas is not so diluted (i.e., from the back of the throat to the keel). However, sampling from the back of the throat becomes difficult during procedures that require access to the patient's airway, such as during oral procedures where the sampling interface may interfere with the surgeon's instruments. Also, intubation is difficult, and sometimes impossible, for patients undergoing oral surgery. For this reason, high-flow respiratory therapy may be used in some cases to supply respiratory gas to patients undergoing oral surgery or surgery on sites accessed through the mouth, although high-flow therapy can also be used in many other medical procedures. High-flow therapy refers to supplying breathing gas to adult patients at a high flow rate (typically about 15 L / min to 150 L / min, preferably about 30 L / min to 120 L / min) through a respiratory device. However, the flow rate defined as high-flow can vary depending on the patient. For example, in high-flow therapy for neonates, breathing gas is typically supplied at a flow rate of about 2 L / min / kg. Low-flow cannulas typically cannot supply breathing gas at a flow rate exceeding 15 L / min.

[0011]

[0011] The nature of high-flow therapy results in considerable dilution of exhaled gases from the patient, making it difficult to accurately measure CO2 and other exhaled gases.

[0012]

[0012] More specifically, the anatomical dead space is the total volume of the patient's guided airways from the nose and mouth to the terminal bronchioles. During normal exhalation, this dead space is uniformly filled with a gas containing a large amount of CO2 from the lungs. At the transition point from exhalation to inhalation, the gas containing a large amount of CO2 remaining in the dead space is re-inhaled into the lungs as part of the inhalation. When CO2 monitoring is used in this state (i.e., normal spontaneous breathing by the patient), the gas containing a large amount of CO2 filling the dead space during exhalation is measured by the gas sampling system. Because the gas distribution is uniform, sampling can be performed nasally or orally by the CO2 sampling interface, and sample measurements that are approximately equivalent to the CO2 levels found in the lungs can be obtained, making it possible to make inferences about the measurement. However, it is difficult to provide high-flow therapy (supplying respiratory gases to the patient at high flow rates through a respiratory device) while monitoring CO2 or other exhaled and / or exhaled gases. This is because the flushing mechanism provided by high-flow therapy alters the flow pattern within the anatomical dead space, resulting in a non-uniform distribution of exhaled gases. The CO2-rich gas flow from the lungs is displaced or "pushed" out of the dead space by fresh gas from the respiratory apparatus and (to a much smaller extent) cardiac pulses. As a result, high-flow therapy leads to a turbulent gas motion pattern with recirculation characteristics, resulting in less CO2 being reinhaled. When a non-uniform gas distribution is sampled from the nose and / or mouth, quantitative measurements performed by standard respiratory gas monitors in gas sampling systems become invalid. Provided sufficient CO2 is sampled, compensation algorithms can be implemented to help offset inaccurate measurements, while still allowing for qualitative interpretation of the gas samples.

[0013]

[0013] U.S. Patent No. 7,337,780 discloses a combined gas delivery and gas sampling interface. The interface comprises a nasal cannula having a mouth trunk, where gas is delivered through one of the nasal prongs of the cannula and sampled through the other prong and mouth trunk. The mouth trunk includes a wire projection that allows the mouth trunk to be bent to a desired position to sample gas exhaled from the patient's mouth. However, this cannula is not suitable for delivering high-flow therapy, delivering therapy through both nostrils of the patient's nose, or enabling selective gas sampling from the nose or mouth.

[0014]

[0014] Therefore, it would be useful to provide a gas sampling interface that can be used to selectively sample exhaled and / or exhaled gas from the mouth or nose, even when gas is being supplied to a sleep-apnea patient receiving high-flow therapy.

[0015]

[0015] Following the use of the sampling conduit, it is typically necessary to dispose of and replace or disinfect the sampling conduit before the next patient in order to prevent contamination.

[0016]

[0016] Therefore, it is also desirable to facilitate the easy disposal or disinfection of the sampling conduit or associated components. [Overview of the project]

[0017]

[0017] According to a first embodiment, a gas sampling interface is provided comprising a conduit having a body with a hook portion for engaging with a part of a patient's face, the body defining a lumen having an inlet for receiving gas exhaled and / or exhaled by the patient and an outlet for delivering the exhaled and / or exhaled gas to a gas measuring device.

[0018]

[0018] In one embodiment, the hook portion is configured to engage with the patient's face at or near the mouth. Preferably, the hook portion is configured to engage with the patient's mouth or a part of the patient's mouth. The hook portion can be configured to engage with the patient's nose or a part of the patient's nose. Preferably, the shape of the hook portion is adjustable. In one embodiment, the hook portion has a substantially convex portion. Preferably, the main body further has a substantially concave portion that fits into the substantially convex hook portion, and the substantially convex hook portion fits into another substantially concave portion.

[0019]

[0019] The interface is preferably disposable.

[0020]

[0020] In one embodiment, the conduit is a double-lumen conduit. In one embodiment, the gas sampling interface further comprises a malleable wire occupying one of the lumens.

[0021]

[0021] In another form, the conduit is a single-lumen conduit.

[0022]

[0022] The conduit is preferably made of a polymer material or contains a polymer material.

[0023]

[0023] The conduit can be connected to the sampling tube via a lure.

[0024]

[0024] The inlet preferably has an opening with a cross-sectional area larger than the cross-sectional area of ​​the conduit or lumen.

[0025]

[0025] In one embodiment, the conduit has tips that have alternating or variable depths when viewed in cross-section.

[0026]

[0026] Optionally, the conduit may be provided with a plurality of gas receiving apertures or openings located around the tip and / or along the distance from the tip of the conduit. Preferably, the conduit may be provided with one or more non-circular openings located around the tip and / or along the distance from the tip of the conduit.

[0027]

[0027] Preferably, the tip of the interface comprises a filter or a tip structure configured to substantially suppress the intrusion of liquid. The tip structure can comprise an absorbent porous sponge or foam that at least partially surrounds the tip of the interface.

[0028]

[0028] Preferably, the tip structure comprises a shield, cage, drum, or spacer that surrounds the tip of the interface. In one form, the shield comprises a substantially cylindrical component. In another form, the shield comprises an elongate component having a generally C-shaped cross-section. In yet another form, the shield comprises an elongate component having a generally square cross-section. Optionally, the shield has one or more openings or cutouts. For example, the shield can comprise a toothed component. Alternatively, the shield can comprise a wavy component. In one form, the shield comprises a generally V-shaped component. In another form, the shield comprises a planar component.

[0029]

[0029] According to a second aspect, there is provided a gas sampling interface comprising a hook for engaging a portion of a patient's face and an attachment member for securing a gas sampling conduit to the hook such that the inlet receives gas exhaled or breathed out by the patient.

[0030]

[0030] Preferably, the hook is rigid. Alternatively, the hook is flexible. In one form, the position of the gas sampling conduit is adjustable relative to the hook.

[0031]

[0031] The mounting member is preferably removablely attached to the gas sampling conduit. In one embodiment, the mounting member consists of or comprises a channel. In another embodiment, the mounting member consists of one clip or a pair of clips, or comprises one clip or a pair of clips. In one embodiment, the mounting member consists of or comprises an elastomer material. The mounting member can optionally be integrated with a hook. Alternatively, the mounting member is a separate component from the hook.

[0032]

[0032] According to a third aspect, a gas sampling interface is provided comprising a manifold and a nasal cannula having at least one nasal prong or outlet extending from the manifold and being received into the patient's nostril, and a mounting member for securing a gas sampling conduit to the nasal cannula such that the inlet receives gas exhaled or inhaled by the patient.

[0033]

[0033] The mounting member is preferably removablely attached to the gas sampling conduit. In one embodiment, the mounting member consists of one clip or a pair of clips, or comprises one clip or a pair of clips. In another embodiment, the mounting member consists of a band or sleeve, or comprises a band or sleeve. Optionally, the mounting member consists of an elastomer material, or comprises an elastomer material. In one embodiment, the mounting member is integrated with the manifold and / or at least one nasal prong or outlet. In another embodiment, the mounting member is a separate component from the manifold and / or at least one nasal prong or outlet. The position of the gas sampling conduit is preferably adjustable with respect to the mounting member.

[0034]

[0034] According to a fourth embodiment, an assembly is provided comprising a gas sampling conduit and a mounting member for fixing the gas sampling conduit to a nasal cannula, the mounting member being attachable to the nasal cannula and comprising at least two offset clips attachable to the gas sampling conduit, the gas sampling conduit following a meandering path when attached.

[0035]

[0035] The mounting members are preferably removablely attached to the gas sampling conduit. In one embodiment, each clip has a tube receiving area that can hold a portion of the gas sampling conduit within the tube receiving area.

[0036]

[0036] In one embodiment, the mounting member comprises a sleeve having a body and a pair of spaced arms projecting from the body, the sleeve further comprising an internal region located between the arms and an opening to the internal region, the opening being formed along the length of the sleeve and defined by the side edges of the arms, and the internal region being configured to receive a portion of the breathing apparatus. Optionally, the body of the mounting member comprises a sleeve having an internal region and an opening to the internal region, the opening being formed along the length of the sleeve and defined by the side edges of the sleeve, and the internal region being configured to receive a portion of the breathing apparatus. The internal region preferably includes a substantially arcuate inner surface. For example, the sleeve may include a substantially C-shaped cross-section. In another embodiment, the sleeve includes a substantially U-shaped cross-section. Optionally, the substantially arcuate inner surface is formed from a plurality of substantially planar surfaces continuously connected to form a substantially arcuate shape. In this embodiment, the sleeve may include a substantially C-shaped cross-section. Alternatively, the sleeve may include a substantially U-shaped cross-section. The sleeve is preferably formed from a substantially flexible elastic material. For example, the sleeve may include a polymer material. The internal region of the sleeve is substantially curved and dimensionally set to receive a portion of the gas delivery tube of the nasal cannula, and the width of the opening between the side edges is preferably smaller than the diameter of the portion of the gas delivery tube held by the attachment member. In one embodiment, the arms of the sleeve are biased toward each other. Each clip may form a hook with a curved arm extending from the body and ending at the distal end, the arm may include an inner surface that forms a substantially concave receiving region. The diameter of the substantially concave receiving region is preferably at least the same as the diameter of the gas sampling lumen. In one embodiment, the distance between the distal end portion of the hook and the body is smaller than the diameter of the gas sampling conduit.

[0037]

[0037] The mounting member is preferably configured to be attached to the side arm of a cannula, such as a nasal cannula. Optionally, the recessed receiving area of ​​the clip is sized or molded to conform to the shape of the cannula side arm. In one embodiment, the recessed receiving area of ​​the clip includes a plurality of planar surfaces molded to accommodate the cannula side arm.

[0038]

[0038] According to a fifth aspect, a gas sampling tip is provided which is detachably connected to the inlet of a gas sampling conduit, the sampling tip comprising a body having a substantially hollow internal region configured to be in fluid communication with the inlet of the gas sampling conduit when connected to the gas sampling conduit, the body also comprising a distal end portion including a distal end face and an outer surface, the gas sampling tip further comprising at least one gas receiving aperture for receiving gas exhaled or inhaled by a patient, the gas receiving aperture being in fluid communication with the substantially hollow internal region of the body.

[0039]

[0039] Preferably, at least one gas receiving aperture is formed on both the distal end face and the outer peripheral side surface, and the gas receiving aperture extends from the distal end face along the outer surface. In one embodiment, at least one gas receiving aperture forms an elongated opening at the distal end portion of the gas sampling tip. The distal end of the gas sampling tip can be curved outward. For example, the distal end portion of the gas sampling tip can be substantially spherical.

[0040]

[0040] The gas sampling tip preferably comprises three gas receiving apertures uniformly spaced around the distal end of the sampling tip. The distal end of the gas receiving aperture(s) is preferably narrower than the opposite end of the gas receiving aperture(s).

[0041]

[0041] In one embodiment, the gas sampling tip has a substantially cylindrical shape and forms substantially circumferential outer surfaces. Preferably, each part of the main body located between the gas receiving apertures forms longitudinal folds, and these longitudinal folds are substantially uniformly spaced around the periphery of the distal end portion of the gas sampling tip.

[0042]

[0042] According to a sixth aspect, a gas sampling interface is provided comprising a gas sampling conduit having an inlet for receiving gas exhaled or inhaled by a patient and an outlet connected to a respiratory gas monitor, and a removable sampling tip located at the inlet of the conduit, the sampling tip comprising a body having a substantially hollow internal region configured to be in fluid communication with the inlet of the gas sampling conduit when connected to the gas sampling conduit, the body also comprising a distal end portion including a distal end face and an outer surface, the gas sampling tip further comprising at least one gas receiving aperture for receiving gas exhaled or inhaled by a patient, the gas receiving aperture being in fluid communication with the substantially hollow internal region of the body.

[0043]

[0043] At least one gas receiving aperture is formed on both the distal end face and the outer surface, and it is preferable that the gas receiving aperture extends from the distal end face along the side surface. The gas receiving aperture can form an elongated opening at the distal end of the gas sampling tip. In one embodiment, the distal end of the gas sampling tip is curved outward. For example, the distal end of the gas sampling tip can be substantially spherical.

[0044]

[0044] The gas sampling tip preferably comprises three gas receiving apertures uniformly spaced around the distal end of the sampling tip. The distal end of the gas receiving aperture(s) can be narrower than the opposite end of the gas receiving aperture(s). In one embodiment, the gas sampling tip has a substantially cylindrical shape. The gas sampling tip may comprises three gas receiving apertures uniformly spaced around the distal end of the sampling tip. Each portion of the body located between the gas receiving apertures preferably forms longitudinal folds, which are preferably uniformly spaced around the periphery of the distal end portion of the gas sampling tip.

[0045]

[0045] The gas sampling conduit may comprise a first lumen through which gas can flow, and a second lumen in which a flexible elastic structural support member is positioned to allow the gas sampling conduit to be bent into a desired shape and substantially maintain that desired shape. Alternatively, the gas sampling conduit may comprise a tube wall in which the flexible elastic structural member is positioned. The gas sampling conduit may be co-extruded with a structural member so that the structural member is embedded in the wall of the conduit. The structural support member may comprise a metal filament. For example, the structural support member may comprise a wire. The wire may be at least partially formed from stainless steel, aluminum, or nickel-titanium.

[0046]

[0046] According to a seventh aspect, a gas sampling interface is provided comprising a gas sampling conduit having a gas inlet, a gas outlet, and a malleable projection that allows the gas sampling tube to be bent into a desired shape, the gas sampling interface further comprising a removable gas sampling tip having at least one gas receiving aperture in fluid communication with the gas inlet of the gas sampling conduit.

[0047]

[0047] The malleable projection is preferably semi-rigid so as to allow the gas sampling conduit to be bent into a desired shape and substantially retain that shape. In one embodiment, the malleable projection comprises a wire. The wire can be formed at least partially from stainless steel, aluminum, or nickel-titanium.

[0048]

[0048] The gas sampling tip comprises a body having a substantially circular cross-section, and further comprises at least three gas receiving apertures formed within the body, each gas receiving aperture extending from the distal end of the body along the side of the body, and preferably the gas receiving apertures are uniformly spaced circumferentially around the body such that they form longitudinal folds between adjacent gas receiving apertures.

[0049]

[0049] According to an eighth aspect of the present invention, the present invention provides a gas sampling tip connected to the inlet of a gas sampling conduit, the sampling tip comprising a body having a substantially hollow internal region configured to be in fluid communication with the inlet of the gas sampling conduit when connected to the gas sampling conduit, the body also comprising a distal end portion including a distal end wall and an outer surface, the gas sampling tip further comprising a gas receiving aperture connected to the internal region, the gas receiving aperture configured to receive gas exhaled or inhaled by a patient, and the gas receiving aperture extends substantially along the entire outer circumference of the outer surface.

[0050]

[0050] The wall of the gas sampling tip is supported by a centrally located support member connected to at least one inner wall of the main body, and the gas receiving aperture preferably extends over the entire outer circumference of the outer surface. The main body of the sampling tip can be substantially cylindrical, and the gas receiving aperture forms a ring-shaped aperture around the outer surface of the main body. In one embodiment, the main body of the sampling tip is substantially cylindrical, and the gas receiving aperture forms a spiral aperture around the outer surface of the main body.

[0051]

[0051] According to a ninth aspect, the present invention provides a gas sampling tip comprising a body having a substantially hollow internal region, the body comprising one or more side walls forming an outer surface of the body, a proximal end configured to connect to a gas sampling conduit such that the hollow internal region is in fluid communication with the gas sampling conduit, and a distal end defined by an end wall, the body further comprising a gas receiving aperture forming an opening to the hollow internal region of the body, the gas receiving aperture extending substantially over the entire outer periphery of the outer surface of the body.

[0052]

[0052] In one embodiment, the end wall is substantially lateral to the gas receiving aperture and offset from the gas receiving aperture. Optionally, the end wall is integrally formed with the main body. The cross-section of the wall can be the same as or larger than the cross-section of the gas receiving aperture. In one embodiment, the end wall is offset longitudinally by a distance greater than the width of the gas receiving aperture. Optionally, the end wall cantilevered from a portion of the main body by a support member, which can constitute a column, pole, arm, or elongated extension. In one embodiment, the main body is substantially cylindrical, and the gas receiving aperture forms an annular ring around the main body. Alternatively, the main body is substantially cylindrical, and the gas receiving aperture forms a spiral arrangement around the main body.

[0053]

[0053] According to a tenth aspect, the present invention provides a respiratory therapy system for providing high-flow respiratory therapy to a patient and sampling exhaled or exhaled gas from the patient, the system comprising a respiratory device comprising a patient interface and a respiratory gas delivery tube, wherein the respiratory gas delivery tube is connected to a gas source and is configured to deliver high-flow respiratory gas from the gas source through the respiratory gas delivery tube to the patient via the patient interface; and a gas sampling interface comprising a conduit, wherein the conduit includes a first end that is in fluid communication with a respiratory gas monitor and a second distal end having at least one inlet for receiving respiratory gas exhaled or exhaled from the patient. In some embodiments, the respiratory device supplies respiratory gas to the patient at a flow rate of about 15 to about 150 L / min. Optionally, the respiratory device delivers respiratory gas to the patient at flow rates of approximately 30–120 L / min, 60–110 L / min, 50–150 L / min, or 60–100 L / min. In some configurations, the respiratory device delivers high-flow respiratory gas to the patient at flow rates greater than approximately 30 L / min, greater than approximately 40 L / min, greater than approximately 50 L / min, greater than approximately 60 L / min, or greater than approximately 70 L / min. Optionally, the system is configured to deliver respiratory gas to neonatal patients at a flow rate of approximately 2 L / min / kg.

[0054]

[0054] In one embodiment, the conduit comprises a flexible elastic support structure that allows the distal end portion to be manipulated into a desired shape for selective guidance toward the patient's nose or mouth. The flexible elastic support structure may comprise a wire located within the conduit, which allows at least a portion of the conduit to bend to form a hook shape. Optionally, the diameter of the wire is smaller than the inner diameter of the conduit, and a gap is formed between the wire and the inner wall of the conduit, allowing gas to flow along the conduit. In one embodiment, the conduit comprises a first gas receiving lumen and a second support lumen. In this embodiment, the wire is located in at least a portion of the support lumen. Optionally, the wire is co-extruded with the gas sampling conduit. In one embodiment, the wire is located in the distal end portion of the conduit so as to allow the distal end portion to bend to form a hook shape.

[0055]

[0055] In one embodiment, the system also includes a mounting member for attaching the gas sampling interface to a breathing apparatus. Optionally, the mounting member is integrated with or attached to the breathing gas delivery tube and comprises a sleeve that at least partially encloses a portion of the breathing gas delivery tube, the sleeve comprising at least one clip located on the outer surface of the sleeve for receiving a portion of the conduit and attaching the conduit to the breathing apparatus. In one embodiment, the sleeve comprises a pair of clips offset from each other. Each clip may comprise a hook including a tube receiving area, and a portion of the conduit may be positioned within the tube receiving area to follow a meandering path. Preferably, the hooks face in opposite directions from each other.

[0056]

[0056] In one embodiment, the gas sampling interface further comprises an endpiece located at the distal end of a conduit, the endpiece comprising a substantially hollow body having at least one gas receiving aperture for receiving gas exhaled or exhaled by a patient, the gas receiving aperture being in fluid communication with at least one inlet of the conduit, and the body of the endpiece further comprises a distal end portion including a distal end face and an outer surface. At least one gas receiving aperture can be formed on both the distal end face and the outer surface, and the gas receiving aperture extends from the distal end face along the outer surface. In one embodiment, at least one gas receiving aperture forms an elongated opening in the distal end portion of the gas sampling endpiece.

[0057]

[0057] In one embodiment, the body of the tip includes a substantially cylindrical shape. Optionally, the distal end of the gas sampling tip is curved outward. Preferably, the distal end portion of the gas sampling tip is substantially spherical.

[0058]

[0058] In one embodiment, the gas sampling tip comprises at least three gas receiving apertures uniformly spaced around the distal end of the sampling tip. Optionally, each portion of the body located between the gas receiving apertures forms longitudinal folds, which are substantially uniformly spaced around the periphery of the distal end portion of the gas sampling tip.

[0059]

[0059] The respiratory device is preferably a nasal cannula.

[0060]

[0060] Patients who are optionally receiving treatment with a respiratory device are experiencing apnea.

[0061]

[0061] According to an eleventh aspect, the present invention provides a gas sampling interface for use with a high-flow respiratory gas delivery system, the gas sampling interface comprising a conduit, the conduit comprising a first end having fluid communication with a respiratory gas monitor and a second distal end having at least one inlet for receiving respiratory gases exhaled or exhaled by a patient, the gas sampling tip comprising a substantially hollow body located at the distal end of the conduit and comprising at least one gas receiving aperture for receiving gases exhaled or exhaled by a patient, the gas receiving aperture having fluid communication with at least one inlet of the conduit, and the body of the tip further comprising a distal end portion including a distal end face and an outer surface. Preferably, at least one gas receiving aperture is formed on both the distal end face and the outer surface, and the gas receiving aperture extends from the distal end face along the outer surface to form an elongated opening in the distal end portion of the gas sampling tip.

[0062]

[0062] Optionally, the distal end portion of the gas sampling tip is substantially spherical.

[0063]

[0063] In one embodiment, the gas sampling tip comprises three gas receiving apertures uniformly spaced around the distal end of the sampling tip. Optionally, each portion of the body located between the gas receiving apertures forms longitudinal folds, which are substantially uniformly spaced around the periphery of the distal end portion of the gas sampling tip.

[0064]

[0064] In one embodiment, the gas sampling conduit is connected to the gas sampling tube of the respiratory gas monitor via a Luer connector.

[0065]

[0065] In another configuration, the gas sampling conduit is connected directly to the inlet of the respiratory gas monitor.

[0066]

[0066] In one embodiment, the gas sampling interface is configured to receive exhaled or exhaled gas from a patient receiving respiratory gas from a respiratory device at a flow rate of approximately 15 to approximately 150 L / min. Optionally, the gas sampling interface is configured to receive exhaled or exhaled gas from a patient receiving respiratory gas from a respiratory device at a flow rate of approximately 30 to approximately 120 L / min, or approximately 60 to approximately 110 L / min, or approximately 50 to approximately 150 L / min, or approximately 60 to approximately 100 L / min. In some embodiments, the gas sampling interface is configured to receive exhaled or exhaled gas from a patient receiving high-flow respiratory gas from a respiratory device at a flow rate greater than approximately 30 L / min, greater than approximately 40 L / min, greater than approximately 50 L / min, greater than approximately 60 L / min, or greater than approximately 70 L / min.

[0067]

[0067] Optionally, the gas sampling interface is configured to receive respiratory gas from a neonatal patient receiving respiratory gas from a respiratory device at a flow rate of approximately 2 L / min / kg.

[0068]

[0068] According to a twelfth aspect, the present invention provides a breathing apparatus comprising: a nasal cannula having a manifold, the manifold being for supporting at least one nasal prong or outlet extending from the manifold and being received into the nostril of a user; a gas delivery tube having fluid communication with at least one nasal prong or outlet and supplying breathing gas through at least one nasal prong or outlet; and a mounting member for attaching a gas sampling interface to the nasal cannula, the mounting member being integrated with or attached to the breathing gas delivery tube or manifold, the mounting member comprising a sleeve at least partially enclosing a portion of the breathing gas delivery tube or manifold, the sleeve comprising at least one clip for receiving a portion of a gas sampling conduit and attaching the conduit to the breathing apparatus. Optionally, the sleeve includes a substantially arcuate inner surface enclosing a portion of the breathing gas delivery tube. The clip may be located on the outer surface of the sleeve. Preferably, the sleeve comprises a pair of clips offset from each other. Each clip optionally includes a hook containing a receiving area, within which a portion of the conduit can be positioned to follow a meandering path. Preferably, the hooks face in opposite directions. In one embodiment, the conduit is held substantially loosely within each clip, and by removing the conduit from one clip, the conduit can be slid through the other clip, thereby adjusting the length of the free end portion of the conduit extending between the distal end of the conduit and the sleeve. Optionally, the sleeve includes a substantially C-shaped cross-section.

[0069]

[0069] In one embodiment, the gas delivery tube supplies breathing gas to the patient at a flow rate of approximately 15 to 150 L / min. Optionally, the gas delivery tube supplies breathing gas to the patient at a flow rate of approximately 30 to 120 L / min, or approximately 60 to 110 L / min, or approximately 50 to 150 L / min, or approximately 60 to 100 L / min. In some embodiments, the gas delivery tube supplies high-flow breathing gas to the patient at a flow rate greater than approximately 30 L / min, greater than approximately 40 L / min, greater than approximately 50 L / min, greater than approximately 60 L / min, or greater than approximately 70 L / min.

[0070]

[0070] Optionally, the gas delivery tube supplies respiratory gas to the neonatal patient at a flow rate of approximately 2 L / min / kg.

[0071]

[0071] According to a thirteenth aspect, the present invention provides a gas sampling tip that is detachably connected to the distal end of a gas sampling conduit, the sampling tip comprising a body having a substantially hollow internal region configured to be in fluid communication with the inlet of the gas sampling conduit when connected to the gas sampling conduit, the body also comprising a distal end portion including a distal end face and an outer surface, the gas sampling tip further comprising at least one gas receiving aperture connected to the hollow internal region to receive gas exhaled or inhaled by a patient, the gas receiving aperture being in fluid communication with the substantially hollow internal region of the body. At least one gas receiving aperture can be formed on both the distal end face and the outer surface, the gas receiving aperture extending from the distal end face along the outer surface. Optionally, at least one gas receiving aperture forms an elongated opening in the distal end portion of the gas sampling tip.

[0072]

[0072] In one embodiment, the distal end of the gas sampling tip is curved outward. Optionally, the distal end portion of the gas sampling tip is substantially spherical. In one embodiment, the gas sampling tip has a substantially cylindrical shape. In one embodiment, the gas sampling tip comprises a body having a substantially cylindrical shape and a substantially spherical distal end.

[0073]

[0073] In one embodiment, the gas sampling tip comprises three gas receiving apertures uniformly spaced around the distal end of the sampling tip. 50. The gas sampling tip according to claim 49, wherein each portion of the body located between the gas receiving apertures forms longitudinal folds, which are substantially uniformly spaced around the periphery of the distal end portion of the gas sampling tip.

[0074]

[0074] Optionally, the gas sampling tip is configured to receive exhaled or exhaled gas from a patient supplied with respiratory gas by a respiratory device at a flow rate of approximately 15 to 150 L / min. Optionally, the gas sampling tip is configured to receive exhaled or exhaled gas from a patient supplied with respiratory gas by a respiratory device at a flow rate of approximately 30 to 120 L / min, or approximately 60 to 110 L / min, or approximately 50 to 150 L / min, or approximately 60 to 100 L / min. In some embodiments, the respiratory device supplies the patient with a high flow rate of respiratory gas at a flow rate greater than approximately 30 L / min, greater than approximately 40 L / min, greater than approximately 50 L / min, greater than approximately 60 L / min, or greater than approximately 70 L / min.

[0075]

[0075] Optionally, the gas sampling tip is configured to receive exhaled or exhaled gas from a neonatal patient to whom breathing gas is supplied by a respiratory device at a flow rate of approximately 2 L / min / kg.

[0076]

[0076] According to a thirteenth aspect of the present invention, the present invention provides a method for manufacturing a double-lubricated gas sampling conduit comprising a body having a gas lumen and a wire lumen, wherein the conduit is manufactured by co-extruding a wire with the conduit body such that the wire is placed inside the wire conduit.

[0077]

[0077] According to a fourteenth aspect of the present invention, the present invention provides a method for manufacturing a double-lubricated gas sampling conduit comprising a body having a gas lumen and a wire lumen, the conduit being manufactured by overmolding the conduit around a wire such that the wire is placed inside the wire conduit.

[0078]

[0078] According to a 15th aspect of the present invention, the present invention provides a method for sampling respiratory gases from an apnea patient receiving high-flow respiratory therapy using a respiratory therapy system of a 10th aspect of the present invention, the method comprising the steps of: positioning an inlet of a gas sampling interface near the patient's airway; receiving a sample of respiratory gases through the inlet; and determining whether the patient's airway(s) are open using a respiratory gas monitor.

[0079]

[0079] Optionally, the respiratory gas monitor can also measure the volume of respiratory gas or one or more components.

[0080]

[0080] The present invention consists of the above, and also assumes structures given below only as examples.

[0081]

[0081] Specific embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein with reference to the following figures. [Brief explanation of the drawing]

[0082] [Figure 1] This figure shows one embodiment of a gas sampling interface. [Figure 2] This figure shows an alternative embodiment of the gas sampling interface. [Figure 3] This figure shows splines representing a series of curved sections applied to the conduit of the interface. [Figure 4] This figure shows an alternative embodiment of the gas sampling interface. [Figure 5] This figure shows an alternative embodiment of the gas sampling interface. [Figure 6] This figure shows an alternative embodiment of the gas sampling interface. [Figure 7] This figure shows an alternative embodiment of the gas sampling interface. [Figure 8]This figure shows an alternative embodiment of the gas sampling interface. [Figure 9] This figure shows an alternative embodiment of the gas sampling interface. [Figure 10] This figure shows splines representing a series of curves applied to a conduit in an alternative embodiment of a gas sampling interface. [Figure 11] This figure shows splines representing a series of curves applied to a conduit in an alternative embodiment of a gas sampling interface. [Figure 12] This figure shows a vertical cross-section of an alternative embodiment of the gas sampling interface. [Figure 13] This figure shows a horizontal cross-section of an alternative embodiment of the gas sampling interface. [Figure 14] This figure shows an alternative embodiment of the gas sampling interface. [Figure 15] This figure shows an alternative embodiment of the gas sampling interface. [Figure 16] This figure shows an alternative embodiment of the gas sampling interface. [Figure 17] This figure shows an alternative embodiment of the gas sampling interface. [Figure 18] This figure shows an alternative embodiment of the gas sampling interface. [Figure 19] This figure shows an alternative embodiment of the gas sampling interface. [Figure 20] This figure shows an alternative embodiment of the gas sampling interface. [Figure 21] This figure shows an alternative embodiment of the gas sampling interface. [Figure 22] This figure shows an alternative embodiment of the gas sampling interface. [Figure 23] This figure shows an alternative embodiment of the gas sampling interface. [Figure 24]This figure shows an alternative embodiment of the gas sampling interface. [Figure 25] This figure shows an alternative embodiment of the gas sampling interface. [Figure 26] This figure shows an alternative embodiment of the gas sampling interface. [Figure 27] This figure shows one embodiment of a mounting member for a gas sampling interface. [Figure 28] Figure 27 shows the mounting components along with details of the relative positions of the cannula and gas sampling conduit. [Figure 29] This figure shows an alternative embodiment of the mounting member for the gas sampling interface. [Figure 30] Figure 29 shows the mounting components along with details of the relative positions of the cannula and gas sampling conduit. [Figure 31] This figure shows an alternative embodiment of the mounting member for the gas sampling interface. [Figure 32] Figure 31 shows the mounting components along with details of their relative positions to the cannula and gas sampling conduit. [Figure 33] This figure shows an alternative embodiment of the mounting member for the gas sampling interface. [Figure 34] Figure 33 shows the mounting components along with details of their relative positions to the cannula and gas sampling conduit. [Figure 35] This diagram shows the connector for the gas sampling interface. [Figure 36] This diagram shows the connector for the gas sampling interface. [Figure 37] This figure shows an alternative embodiment of the gas sampling interface, including the connectors shown in Figure 35 and Figure 36. [Figure 38] This is a side view of an alternative embodiment of the hook for the gas sampling interface. [Figure 39] Figure 38 is a perspective view of the hook. [Figure 40]Figure 38 is a side view showing the gas sampling interface along with the gas sampling conduit. [Figure 41] This is a perspective view from one side of an alternative embodiment of the gas sampling interface. [Figure 42] Figure 41 is a perspective view of the gas sampling interface from the other side. [Figure 43] This is a perspective view of an alternative embodiment of the hook for the gas sampling interface. [Figure 44] This figure shows an alternative embodiment of the gas sampling interface incorporating the rigid hook shown in Figure 43. [Figure 45] This is a side view of an alternative embodiment of the gas sampling interface. [Figure 46] Figure 45 is a perspective view of the gas sampling interface. [Figure 47] This figure shows an alternative embodiment of the hook for the gas sampling interface in the configuration before use. [Figure 48] Figure 47 shows the hook in the configuration in use, along with the gas sampling conduit. [Figure 49] This figure shows one embodiment of a clip for a gas sampling interface. [Figure 50] This figure shows an alternative embodiment of a clip for a gas sampling interface. [Figure 51] This figure shows an alternative embodiment of a clip for a gas sampling interface. [Figure 52] This figure shows an alternative embodiment of a clip for a gas sampling interface. [Figure 53] This figure shows an alternative embodiment of a clip for a gas sampling interface. [Figure 54] This is an end view of an alternative embodiment of the clip for the gas sampling interface. [Figure 55]This is a schematic diagram of another embodiment of a gas sampling interface attached to a nasal cannula. [Figure 56] This is a perspective view of one type of mounting component for attaching a gas sampling conduit to a breathing apparatus. [Figure 57] Figure 56 is an end view of the mounting member. [Figure 58] This is a perspective view of one embodiment of a gas sampling tip. [Figure 59] Figure 58 is an end view of the distal end of the gas sampling tip. [Figure 60] Figure 58 is an end view of the connecting end of the gas sampling tip. [Figure 61] This is a perspective view of another embodiment of the gas sampling tip. [Figure 62] Figure 61 is a side view of the gas sampling tip. [Figure 63] Figure 61 is an end view of the distal end of the gas sampling tip. [Figure 64] Figure 61 is an end view of the connecting end of the gas sampling tip. [Figure 65] This is a perspective view of one form of gas sampling assembly, comprising a gas sampling tip connected to a gas sampling tube connected to a connector in the form of a lure. [Figure 66] Figure 65 is a side view of the assembly. [Figure 67] This is a perspective view of one type of connector (in this case, a Luer connector) that can be used to connect a gas sampling conduit to a respiratory gas monitor. [Figure 68A] This is a side view of a different form of gas sampling tip. [Figure 68B] This is a side view of a different form of gas sampling tip. [Figure 68C] Figures 68A and 68B are side cross-sectional views of the gas sampling tip. [Figure 69A] This is a side view of a different form of gas sampling tip. [Figure 69B]This is a side view of a different form of gas sampling tip. [Figure 69C] Figures 69A and 69B are side cross-sectional views of the gas sampling tip. [Figure 70] This is a schematic diagram of a patient wearing one form of gas delivery system and one form of gas sampling interface, in which the tip of the gas sampling interface is positioned near the patient's mouth to sample gases exhaled and / or exhaled from the mouth. [Figure 71] Figure 70 shows a schematic diagram of a patient wearing another form of gas delivery system, in which the tip of the gas sampling interface is positioned near the nostrils of the patient's nose to sample exhaled and / or exhaled gases. [Modes for carrying out the invention]

[0083]

[0154] Generally, the present invention relates to a respiratory gas delivery and sampling system, a gas sampling system, a gas sampling interface, and a gas sampling tip that can be used to sample exhaled and / or exhaled gases from a patient. The gas sampling system comprises a respiratory gas monitor in fluid communication with a gas sampling interface, and the gas sampling interface comprises the gas sampling tip of the present invention. The gas sampling interface comprises a gas sampling conduit, and the gas sampling tip is located at the free end of the conduit. The gas sampling interface may be configured to allow selective positioning of the gas sampling tip in or within the nostrils of the mouth or nose of a patient. The sampling tip comprises at least one inlet for receiving exhaled or exhaled gases from a patient. The sampling tip may also be configured to include a shield or structure that helps prevent fluids, such as moisture or body fluids, from entering the sampling tip. Additionally or alternatively, the sampling tip may be configured to prevent or reduce the possibility of the tip aspirating the patient, such as from the patient's tongue or cheek. In some embodiments, the shield or structure of the sampling tip may help prevent the ingress of fluids and aspiration of the patient. The gas sampling interface may include a filter positioned at the tip or at any other location along the gas sampling lumen of the sampling interface to prevent fluids such as moisture or body fluids from entering the gas sampling lumen or entering the respiratory gas monitor along the gas sampling lumen.

[0084]

[0155] The following describes various gas sampling interfaces / respiratory sampling interfaces for use with respiratory gas monitors in gas sampling systems. It should be understood that any of these interfaces can be used in combination with (or attached to) a respiratory gas delivery and sampling system that includes a respiratory device for delivering respiratory gases to a patient. Each gas sampling interface can sample exhaled and / or exhaled gases from a patient. Each interface can be used to sample nitrogen, O2, anesthetic gases, and / or CO2. Alternatively, two sampling interfaces can be used, one for sampling nitrogen and the other for sampling CO2. These interfaces sample exhaled and / or exhaled gases and can also be fluidly connected to a separate gas analyzer for identifying CO2 and nitrogen in the exhaled and / or exhaled gases. Exhaled gases are understood to be the gases that leave a patient's lungs for gas exchange within the lungs. Exhaled gases are gases that leave the lungs when the patient is not breathing spontaneously, such as when the patient is apnea (e.g., gases diffusing from the lungs). Exhaled gas is the gas that is pushed up from the patient's lungs due to the patient's spontaneous breathing.

[0085]

[0156] The gas sampling interface of the present invention disclosed herein may be disposable or reusable. A filter may be fitted at the end of the sampling interface between the inlet to the interface and the sampling conduit to allow the sampling conduit to be reused. The gas sampling interface 100 and / or filter may be replaced for each patient. The disclosed gas sampling interface and gas sampling conduit may be used alone to engage with a portion of a patient's face, or may be attached to a respiratory device such as a nasal cannula, nasal mask, mouth mask, or other form of patient interface that delivers respiratory gas to the patient.

[0086]

[0157] The gas sampling interface of the present invention can be used in conjunction with a respiratory device that supplies a patient with a high flow rate of respiratory gas. Typically, the respiratory device supplies a high flow rate of respiratory gas to a patient experiencing apnea, such as during anesthesia, but the device and interface can also be used to measure the respiratory gas of a patient who is breathing spontaneously. To supply a high flow rate of respiratory gas, the gas can typically flow at about 15 L / min to about 150 L / min for an adult patient. Illustrative flow rates of respiratory gas supplied to a patient by the patient interface include about 15 to about 150 L / min, about 30 to about 120 L / min, about 40 to about 100 L / min, about 50 to about 80 L / min, about 60 to about 100 L / min, and about 35 to about 75 L / min. In other examples, a patient can be supplied with a high flow rate of respiratory gas at flow rates of about 30 to about 120 L / min, or about 60 to about 110 L / min, or about 50 to about 150 L / min, or about 60 to about 100 L / min. In some configurations, high-flow respiratory gas can be supplied to patients at flow rates greater than approximately 30 L / min, 40 L / min, 50 L / min, 60 L / min, or 70 L / min. The flow rate considered "high-flow" may vary slightly depending on the patient's size. For example, neonatal patients can be supplied with high-flow respiratory gas at a flow rate of approximately 2 L / min / kg. In some configurations, the gas sampling interface is configured to have a shape and / or position that can be adapted to the respiratory apparatus. Providing an adaptable shape for the interface allows for manipulation to best engage with the patient, such as by hooking it onto the patient's lips, cheeks, or nostrils. It is also possible to adjust the direction and position of the interface to face the vicinity of the patient's mouth or nose by manipulating it. This allows clinicians to select the best position for the interface and easily change its position if necessary.By providing an adjustable position for the interface relative to the respiratory device, as described above, the interface can be directed toward the patient's mouth or nose, and the length of the free end portion of the interface relative to the respiratory device can be easily adjusted. An interface with a free end portion of easily adjustable length makes it possible to use the interface on patients with different face sizes. For example, the gas sampling interface of the present invention should require a shorter free end portion when used on a smaller child than when used on a larger adult. If the sampling interface of the present invention is adjustable in terms of shape and / or position, the interface is particularly versatile and useful for a wide range of patients and medical procedures. For example, the sampling interface provides a selectively positionable device that can be moved between the mouth and nostrils depending on whether the patient's mouth is open and the type of medical procedure being received.

[0087]

[0158] Figure 1 shows one embodiment of a gas sampling interface 100. The gas sampling interface 100 comprises a gas sampling conduit 101 having a body 103, and as shown in Figure 1, the body 103 is preferably formed partially or entirely from a substantially cylindrical wall so as to provide the body 103 with a substantially circular cross-section along its length. The conduit shown in Figure 1 has a single lumen extending along the length of the conduit and is therefore referred to herein as a single-lumen conduit. However, a gas sampling conduit may have one, two, or more lumens within the conduit. A gas sampling conduit having two lumens within the conduit is referred to herein as a double-lumen conduit. Both lumens of a double-lumen conduit may extend substantially along the entire length of the conduit, or the first supporting lumen may extend only partially along the length of the conduit, as will be described in more detail later herein, and the second gas lumen may extend substantially along the entire length of the conduit.

[0088]

[0159] The size of the conduit and its lumen(s) are important for its operability. It will be understood that the outer diameter of the conduit is determined by the required inner diameter or inner diameter of the lumen(s) and the material from which the conduit is made. It is important that the inner diameter(s) of the lumen(s) is not so large that the conduit becomes too large for the patient to use comfortably and easily manipulate to the desired shape and position. It is also important that the inner diameter(s) of the lumen(s) is not so small relative to the outer diameter of the conduit that the gas flow through the conduit is excessively obstructed, or that the conduit walls become so thick that it becomes difficult to manipulate the conduit to the desired shape and substantially hold it in that shape.

[0089]

[0160] The outer diameter (or outer diameter) of the main body of the gas sampling conduit 101 is preferably about 2.5 mm to about 5.0 mm. This diameter can be about 3.5 mm to about 4 mm, or about 3.0 mm to about 3.5 mm, or about 3.1 mm to about 3.4 mm, or about 3.2 mm to about 3.3 mm. The outer diameter of the main body of the gas sampling conduit is preferably about 3.8 mm. The inner diameter of the gas sampling conduit (the conduit having a single lumen) is preferably about 0.5 mm to about 2 mm, corresponding to the inner diameter of the main sampling line or gas sampling tube of the respiratory gas monitor, without introducing additional flow resistance. For example, the inner diameter of the conduit can be about 1.2 mm to 1.4 mm. The inner diameter is preferably about 1.4 mm.

[0090]

[0161] In one embodiment, the wall thickness of the tubular body of the gas sampling conduit 101 is approximately 0.9 mm. In this embodiment, the outer diameter of the conduit body 103 can be approximately 3.0 mm, and the inner diameter can be approximately 1.2 mm. In this embodiment, it is preferable that the gas sampling conduit has a single gas lumen inside the conduit.

[0091]

[0162] In one embodiment, the outer diameter of the double-lumen conduit is approximately 2.5 mm to 5.0 mm. In another embodiment, the outer diameter can be approximately 3.2 mm. The diameter can be approximately 3.5 mm to 4 mm, or approximately 3.0 mm to 3.5 mm, or approximately 3.1 mm to 3.4 mm, or approximately 3.2 mm to 3.3 mm. The outer diameter of the main body of the gas sampling conduit is preferably approximately 3.8 mm. In another embodiment, the outer diameter is approximately 4.0 mm. The diameters of the lumens within the conduit may be the same or different. For example, the inner diameters of the lumens can each be approximately 1.2 mm. In one embodiment, the outer diameter of the double-lumen conduit is approximately 3.8 mm, and the inner diameter of each lumen is approximately 1.4 mm. Alternatively, for example, the diameter of the first lumen can be approximately 1.0 mm, and the diameter of the second lumen can be approximately 1.3 mm. In yet another form of the double-lumen conduit, the outer diameter of the conduit can be approximately 3.8 mm. In this form, the inner diameter of the first lumen can be approximately 0.6 mm, and the inner diameter of the second lumen can be approximately 1.4 mm.

[0092]

[0163] The outer diameter of the conduit should preferably be relatively small so that it occupies a smaller space in the patient's mouth.

[0093]

[0164] In one embodiment, as shown in Figure 2, the gas sampling interface comprises a double-lumen conduit 201. This conduit is similar to the conduit shown in Figure 1, and similar numbering is used, with 100 added to indicate similar parts. In the embodiment shown in Figure 2, the conduit body 203 has a circular cross-section along its entire length. The conduit comprises a flexible elastic support structure that allows the conduit to be manipulated into a desired shape, such as a hook shape. The support structure can take different forms. For example, the support structure may comprise a wire, rod, or strip of a flexible elastic material (such as a metallic material) extending along at least a portion of the conduit, preferably from the free end portion of the conduit. In one embodiment, the conduit comprises a first support lumen in which the support structure, such as a wire, can be positioned. The wire may be inserted into the lumen, co-extruded with the conduit, or a portion of the conduit may be overmolded around the wire. In other embodiments, the support structure may be formed around the outer wall of the conduit, or the outer wall may be made of a suitable material to provide the support structure.

[0094]

[0165] In the embodiment shown in Figure 2, the conduit comprises a first support lumen 210, which houses a support structure in the form of a wire within the first lumen. The first support lumen or wire lumen has a substantially circular cross-section along its entire length. A second gas lumen 202 for receiving exhaled and / or exhaled gases has a substantially crescent cross-section along its entire length. The first lumen 210 is located within the second lumen 202 on one side of the second lumen 202, and therefore the crescent cross-section of the second gas lumen is formed by the shape of the open space around the first wire lumen 210. In an alternative embodiment of the double-lumen conduit, each lumen may have a substantially D-shaped cross-section (shown in Figure 9), or a substantially semicircular or substantially circular cross-section along its entire length. The cross-sectional area of ​​the gas lumen is approximately 1.3 mm². 2 Larger is preferable. The height of the gas lumen is preferably greater than about 1.5 mm. The width of the gas lumen is preferably greater than about 1.5 mm. Figure 13 shows a double-lumen conduit in which each lumen contains a substantially circular cross-section along its length.

[0095]

[0166] The gas sampling conduit 101 may be made of or contain a polymer material. The material may be any suitable medical material such as PVC, TPU, or silicone. The hardness of the material is preferably about 30 to about 85 on the Shore A hardness scale. The material is preferably transparent so that the inside of the conduit can be seen to check, for example, whether saliva, blood, or other bodily fluids that may be present have been drawn into the conduit. The sampling conduit material may contain a hardness of less than 90 on the Shore A hardness scale. This reduces the torque of the conduit on the patient end of the interface (compared to a harder conduit), and therefore reduces the probability of the sampling conduit falling out of the patient's mouth or nostril. Also, a softer material is more comfortable when in contact with the patient's face. The material may contain polyurethane or silicone. Alternatively, the material may contain PVC.

[0096]

[0167] The gas sampling conduit 101 has at least one inlet or gas receiving aperture or opening 107 for receiving gas exhaled and / or exhaled by the patient. The inlet 107 may be formed in the distal end portion of the conduit, such as the outer wall of the conduit or the distal end of the conduit. In the embodiment shown in Figure 1, the inlet is located at the distal end 108 of the conduit body 103. The conduit also has an outlet 109 for delivering the exhaled and / or exhaled gas to a respiratory gas monitor, which may be a capnogram / capnograph or other form of gas monitor for monitoring CO2 levels and / or other respiratory gas levels. The outlet 109 may be in fluid communication with a gas sampling tube or gas sampling line fluidly connected to the respiratory gas monitor. In another embodiment, the outlet of the gas sampling conduit may be directly attached to the respiratory gas monitor.

[0097]

[0168] The conduit should preferably be at least 30 cm in length. This means that when the patient is lying on the conduit, none of the connectors / luers connecting the conduit to the gas sampling tube of the respiratory gas monitor should be located under the patient's head. Having the connectors / luers under the patient's head can be uncomfortable.

[0098]

[0169] The conduit 101 can be configured to take a desired shape to engage with the patient's face, allowing for easy attachment / engagement and removal / disconnection of the conduit to the patient's face. In a preferred embodiment, the conduit can be shaped like a hook so as to hook onto the patient's lips or teeth or around the patient's cheek or nostril. In this embodiment, it is not necessary to tape the conduit to the patient's face, and therefore the conduit can be quickly and easily positioned in the desired location and then quickly and easily removed after use.

[0099]

[0170] In one embodiment, as shown in Figures 1 and 3-6, 10-12, 14-26, 37-46, 48, 52, 55, 70, and 71, the conduit 101 includes a hook portion 105. The hook portion 105 is preferably located at the distal end of the conduit. In one embodiment, the tubular structure of the conduit may include a flexible elastic support structure that allows a portion of the conduit to be formed into a hook shape and substantially maintain its position. In another embodiment, the tubular structure of the conduit may be attached to a rigid or semi-rigid hook to form a conduit having a hook portion. In yet another embodiment, the conduit may be manufactured to include a hook portion, such as an end portion formed into a hook shape. The hook portion 105 forms a hook shape for engaging with a portion of the patient's face.

[0100]

[0171] The hook portion 105 of the conduit 101 is configured to engage with the patient's face at or near the patient's mouth. In one embodiment, the hook portion 105 is configured to engage with the patient's mouth or a portion of the patient's mouth. When in use, the hook portion 105 passes around the patient's cheek and enters the patient's mouth. The hook portion 105 allows the tip 108 and entrance 107 of the conduit 101 to be suspended inside the patient's mouth, if desired. In another embodiment, the hook portion 105 is configured to engage with the patient's nose or a portion of the patient's nose, such as the nostrils or alae. In this embodiment, the tip 108 or entrance end of the conduit can be suspended or positioned at least partially inside or near the nostrils or alae of the patient.

[0101]

[0172] The hook portion of the conduit may include a semi-rigid or rigid material that forms a flexible elastic support structure or projection that allows the conduit to be bent or manipulated into a desired shape. In some embodiments, the conduit may be configured to substantially maintain its desired shape indefinitely. In other embodiments, the conduit may be configured to substantially maintain its desired shape until manipulated by the user to form a different shape.

[0102]

[0173] In one embodiment, the flexible elastic support structure may comprise a single malleable wire, such as a cable or rod, located within the conduit. The wire is preferably a metallic wire. The wire may extend along one or more portions of the conduit, or substantially along the entire length of the conduit. The distal end or patient end of the wire may be covered with a soft material to prevent abrasion or scratching of the patient's face. Alternatively, the patient end of the wire may be positioned sufficiently posteriorly within the conduit so as not to extend beyond the distal end of the conduit. In a further alternative embodiment, the end of the wire may be sealed inside the conduit wall. In a further alternative embodiment, the wire may be located within the support lumen / wire lumen of a double-lumen conduit, and the patient end of the wire may be fixed at one or more points along the inner wall of the wire lumen to hold the wire in place and prevent the wire from protruding from the lumen.

[0103]

[0174] In another embodiment, the conduit may comprise at least one lumen that acts as both a wire / support lumen and a gas lumen. In this embodiment, the conduit may comprise a wire having a diameter smaller than the inner diameter of the lumen. The wire may be held in one or more positions within the lumen. In this arrangement, the conduit may bend around the wire, but one or more gaps are provided between the wire and the inner wall of the lumen so that the gas can travel along the lumen to be sampled by the respiratory gas monitor. The lumen is not capable of completely sealing around the incompressible wire, thereby preventing complete blockage.

[0104]

[0175] A single malleable wire can occupy at least the hook portion of the conduit, or the wire can extend substantially along the entire length of the conduit. For example, in the double-lumen conduit shown in Figure 2, the wire 210 may occupy one or more portions of the first lumen 204 of the double-lumen conduit 201, or it may extend substantially along the entire length of the first lumen 204. The presence of the wire 210 provides rigidity to the conduit 201 and the gas sampling interface 200. The wire 210 is also flexible so as to give the first support conduit 201, and therefore the conduit 201, some degree of adjustment to further customize the shape of the interface to fit the patient's face. In particular, the shape of the hook portion is adjustable by bending the wire 210 to form a desired hook shape for engagement with the patient's face.

[0105]

[0176] The wire can be made of stainless steel wire that can be bent / deformed several times without breaking. The wire can have a diameter of approximately 0.4 mm to 1.0 mm, preferably approximately 0.6 mm or 0.7 mm. The wire is preferably Grade 304. These properties result in suitable malleability, which allows the user to easily deform / bend the conduit by hand. In another form, the wire can be made of aluminum wire. In another form, the wire can be made of nickel-titanium wire.

[0106]

[0177] In one embodiment, the wire 210 is positioned on the inner curve of the hook portion. This is to reduce the risk of the gas sampling conduit twisting when bent. Alternatively, the wire 210 may be positioned along the outer curve or side of the hook portion, or in any other orientation or position with respect to a single conduit.

[0107]

[0178] Figures 12 and 13 show another configuration of a double-lumen conduit 1200. A first wire / support lumen 1211 houses a wire that gives the conduit a malleable shape. A second gas lumen 1213 can be connected to a gas sampling tube that is in fluid communication with a respiratory gas monitor, or can be connected to a respiratory gas monitor directly (if the sampling system does not include a sampling tube between the monitor and the sampling conduit). In this double-lumen conduit, the conduit is preferably bent or formed such that one conduit is located inside the curve of the hook portion and the other conduit is located outside the curve. This arrangement results in lower flow resistance than if the lumens were positioned in parallel around the curve. The wire is fed through the first lumen 1211 located inside the curve of the hook portion of the conduit. This reduces the risk of the wire perforating the conduit wall and the risk of the wire twisting the conduit when the conduit is bent.

[0108]

[0179] Figure 13 shows a cross-sectional view of a double-lubricated conduit comprising a first wire lumen 1211 and a second gas lumen 1213. In one embodiment, the inner diameter of the gas lumen 1213 can be approximately 1.2 mm to match the inner diameter of a gas sampling tube from an anesthesia machine or other form of respiratory gas monitor, or the inlet of a respiratory gas monitor. In another embodiment, the inner diameter of the gas lumen 1213 can be approximately 1.4 mm, and the inner diameter of the wire lumen can be approximately 0.6 mm. Smaller inner diameters may increase flow resistance and increase the probability of blockage occurring in the gas sampling conduit, leading to an alarm. It will be understood that the inner diameters can be optionally selected or designed to match the inner diameter of a gas sampling tube from an anesthesia machine or respiratory gas monitor, or the inlet of a respiratory gas monitor. However, as mentioned above, the inner diameter of the lumen and the outer diameter of the conduit can vary.

[0109]

[0180] The inner diameter of the wire lumen 1211 can be approximately 1.0 mm. This diameter is suitable for a 0.7 mm wire. It will be understood that the inner diameter is selected or designed to accommodate the wire.

[0110]

[0181] The outer diameter of the conduit can be approximately 3.1 mm. This diameter is selected so that, as mentioned above, it is possible to construct conduits with inner diameters of 1.2 mm and 1.0 mm with sufficient wall thickness. Smaller outer diameter conduits are desirable to reduce the size of the interface in the patient's mouth in order to improve patient comfort and give clinicians greater access to the inside of the mouth. Smaller diameter conduits also allow the interface to fit under a bite block.

[0111]

[0182] As shown in Figure 13, the lumen of the conduit can preferably be round or circular, but this is not required. A circular lumen has greater torsional resistance. In one embodiment, the wall thickness WT1 between the lumens can be greater than the outer wall thicknesses WT2, WT3 (wall thickness of the conduit). This wall structure also reduces the risk of twist formation within the conduit when the conduit is bent, for example, when a user deforms the conduit to create a tighter bend in the hook-shaped portion. In a preferred embodiment, the gas sampling interface and gas sampling conduit constitute a double-lumen conduit with an outer diameter of approximately 3.8 mm. The conduit includes a first wire lumen with an inner diameter of approximately 0.6 mm (to receive a wire with an outer diameter of approximately 0.6 mm) and a second gas lumen with an inner diameter of approximately 1.4 mm. Both lumens have a substantially circular cross-section.

[0112]

[0183] In a double-lumen conduit, the wire preferably extends into the conduit through the first wire lumen. In one embodiment, the wire terminates midway along the lumen or conduit. For example, the wire may extend approximately 60 mm from the free end of the conduit. In another embodiment, the wire may extend substantially along the entire length of the conduit. Optionally, the wire is co-extruded with the tubular material of the conduit. When the conduit is bent, the free end of the wire can be substantially aligned with the free end of the conduit (or slightly retracted from the free end of the conduit). Optionally, the free end of the wire in a bent conduit can also be substantially aligned with the other end of the wire. This makes it possible to maximize the clamping force of the hook-shaped portion of the conduit that rests on the cheek. This design also minimizes the rigid length extending beyond the clamping point and thus reduces the torque acting on the clamping point that could potentially disengage the interface.

[0113]

[0184] In one embodiment, the conduit is manufactured to include a hook portion. For example, during manufacturing, the conduit can start in a straight state and then bend or form into a hook shape using a jig. Alternatively, the conduit can be heated over a period of time to harden it in shape. In another embodiment, the conduit can be a thermoplastic tube. During manufacturing, the conduit can be formed into a hook shape by starting in a straight state and then bending or forming into a permanently modified hook shape using a jig and a short period of heat to harden the conduit in shape.

[0114]

[0185] In the embodiment shown in Figure 1, the gas sampling interface 100 consists of a gas sampling conduit 101 that constitutes a single tube, and the interface end of the sampling conduit is formed in the hook shape shown in Figure 1. This embodiment may be a single-lumen conduit interface or a double-lumen conduit interface. In other embodiments, the gas sampling conduit 101 may be equipped with a sampling tip as described later in this specification, and the conduit and tip are combined to form the gas sampling interface.

[0115]

[0186] Figure 3 shows a spline representing a series of curves applied to one embodiment of the interface conduit. The conduit may include additional curved portions immediately adjacent to the hook, these curved portions curving inward from the hook curve. That is, viewed from the outside, a substantially concave portion 317 of the conduit connects to a substantially convex hook portion 315, and the substantially convex hook portion 315 connects to another substantially concave portion 319. The curvature of the concave portions 317 and 319 may be the same or different. The resulting combined shape provides a central pinch area. A narrow pinch point can improve patient comfort by minimizing the pinch area. When in use, the pinch area can contact the inside and outside of the patient's cheek or nostril to help hold the interface. The additional curved and hook portions provide further deformation resistance of the conduit, thereby helping to hold the interface by applying a slight reaction force to the inside and outside of the patient's cheek.

[0116]

[0187] In one embodiment, a gas sampling interface or conduit can be hooked around the cannula prong to sample exhaled and / or exhaled gas from the patient's nostrils.

[0117]

[0188] The embodiments shown in Figures 7 and 8 should be advantageous in this configuration because the opening captures exhaled and / or exhaled gas from the patient's nostrils.

[0118]

[0189] One of the additional concave sections 319 may extend between the convex section 315 and the distal end of the conduit. When in use, this additional concave curve can displace the sampling conduit from contact with the patient's face. Optionally, a convex curve 321 may be provided between the additional concave curve and the distal end of the conduit. This further convex curve 321 can orient the distal end of the conduit so that, when in use, the sampling conduit extends offset from the patient's cheek, nearly parallel to the patient's cheek. This reduces the torque on the sampling conduit on the hook at the patient's face, thereby reducing or preventing the risk of detachment.

[0119]

[0190] The other additional concave curved portion 317 may extend between the hook curved portion 315 and the conduit opening. This additional curved portion 317 can displace the conduit opening away from contact with the inside of the patient's cheek. It is desirable to displace the conduit opening away from the inside of the patient's cheek in order to avoid, or at least substantially prevent, complete or partial occlusion of the conduit and / or sampling conduit by other bodily fluids that may be present, such as saliva or blood.

[0120]

[0191] The hook shape may include a series of curved sections in a substantially two-dimensional plane, and may include at least one curved or bent section that curves substantially inward to form a hook. The hook shape may include a conduit in the shape of a "J," "L," "U," "V," "Ω," or "hairpin," or any combination thereof. That is, the hook section may have one or more curved sections, one or more straight sections extending inclined relative to adjacent curved sections, or a combination of straight and curved sections to form a hook. In one embodiment, the hook may include two substantially parallel sections, with a curved or inclined section positioned between the parallel sections to form a hook. This can increase the surface area of ​​the narrow pinch point that contacts the cheek, thereby increasing stability on the face.

[0121]

[0192] To avoid blocking or obstructing the inlet 107, several embodiments of the tip are envisioned, as will be described later. It should be understood that the conduit may be equipped with any suitable tip for receiving exhaled and / or exhaled gases.

[0122]

[0193] In one embodiment shown in Figures 4-6, the inlet 408 may have a mouth 407, the cross-sectional area of ​​which is larger than the adjacent portion of the conduit body. This interface is similar to the interface shown in Figure 1, and similar numbering is used with 300 added to indicate similar parts (i.e., 103 to 403). The mouth 407 preferably has a shape that widens outward from the lumen. Thus, the outer shape of the tip 408 widens outward from the body 403. The mouth 407 can be frustoconical, pyramidal, flared, bell-shaped, etc. Such shapes increase the opening area that the salivary meniscus can form. As a result, the surface tension of the saliva is reduced, and the likelihood of forming an obstruction within the conduit is decreased.

[0123]

[0194] In one embodiment shown in Figure 6, the tip 608 may have alternating or variable depths when viewed in cross-section. This interface is similar to the interface shown in Figure 1, and similar numbering is used, with units of 500 added to indicate similar parts. For example, when viewed in cross-section, a wavy or cutout shape may be seen around the tip. Such a shape disrupts the area where saliva or other bodily fluid meniscus may form. As a result, the stability of the meniscus can be reduced, and the possibility of saliva blocking the duct can also be reduced. Such a shape also prevents complete blockage by the internal tissues of the mouth (or nose). The tips illustrated and described in relation to Figure 6 can be used with single or double lumen duct interfaces.

[0124]

[0195] For example, in another embodiment shown in Figure 7, the conduit 701 may have multiple inlets / openings 723 along the periphery of the tip and / or along the distance of the conduit from the tip. This interface is similar to the interface shown in Figure 1, and similar numbering is used with 600 units added to indicate similar parts. If one opening 723 is blocked, the multiple openings 723 provide alternative inlet points for receiving discharge and / or exhaled gas. The multiple openings 723 may be substantially the same size or vary in size. The multiple openings 723 may be arranged along a particular side, or the distribution of openings 723 on a particular side of the tip 708 may be greater than on another side. The shape of the openings 723 can vary. The distribution, size, and / or shape of the openings 723 can vary in combination. Figure 7 shows a portion of this alternative embodiment having diamond-shaped openings. Liquids tend to be drawn to the corners. Diamond-shaped openings help draw other fluids, such as saliva or blood, out of the center of the blocked opening, thus breaking the meniscus. Figure 8 shows a portion of a similar embodiment. Figure 8 has a circular opening 823. It will be understood that the tips shown in Figure 7 and Figure 8 may be substantially straight as shown in these figures, or they may be curved according to the splines illustrated and described in relation to Figure 3. The tips illustrated and described in relation to Figure 7 can be used with a single or double lumen interface.

[0125]

[0196] The diameter or width of the opening can be larger than the inner diameter of the gas lumen. This means that the flow resistance of each opening is not as great as the flow resistance of the gas lumen. Therefore, if only one opening is exposed, a respiratory gas monitor such as an anesthesia machine does not need to fight against a greater flow resistance that could lead to obstruction and alarm. Any suitable inlet / opening will work as long as the pressure drop at that opening is greater than or equal to the pressure drop at the gas lumen itself (i.e., the same or less flow resistance).

[0126]

[0197] In one embodiment, the inlets / openings 723, 823 perforate only the outer wall of the gas lumen within the conduit, while the wire remains completely enclosed within the wire conduit / support lumen of the conduit. These openings are preferably not located on the side of the conduit that comes into contact with the patient's cheek to prevent the conduit from sucking the cheek.

[0127]

[0198] These openings can be located in the portion of the conduit that extends from the distal end to the length of the conduit indicating the maximum insertion depth. This ensures that the openings enclose only air from inside the opening and not any ambient air that could dilute the gas reading.

[0128]

[0199] These openings can be increased in size towards the end of the conduit. The opening sizes are selected so that the flow resistance through each opening is equal.

[0129]

[0200] The tip of the interface may, by alternative means and / or additional means, be equipped with a tip structure that further avoids the intrusion of other bodily fluids that may be present, such as saliva or blood, as described later.

[0130]

[0201] In another embodiment, the tip structure may include a filter that at least partially surrounds the tip of the interface, or can be positioned inside the conduit at the distal end of the conduit, or inside the tip. The filter may be substantially porous to allow exhaled and / or exhaled gases to pass through the filter into the tip of the interface. Additionally and / or alternatively, the filter may include an opening (in addition to the porous opening) to allow the passage of exhaled and / or exhaled gases. The filter may also absorb moisture, saliva, or other bodily fluids that may be present, such as blood, to prevent or at least substantially prevent blockage or obstruction of the conduit. In one embodiment, the filter may include a substantially absorbent porous sponge, foam, or other suitably porous material. In another embodiment, the filter may include a substantially hydrophobic material, such as a hydrophobic foam that repels fluid / moisture while allowing exhaled or exhaled gases to pass through the filter into the sampling tip. Suitable hydrophobic foams for use in such filters include, but are not limited to, open-cell polyurethane foams with a hydrophobic coating (which can have a variable density) and microporous calcined polytetrafluoroethylene. Another suitable material for use as a hydrophobic filter is a hydrophobic fiber such as WrapPel, made by coating 100% filament polyester with hydrophobic fluorocarbon. Other possible materials for hydrophobic filters include WrapPel and Gore-Tex. In one embodiment, the filter can form a sampling tip, and thus the sampling tip consists of the filter. In another embodiment, the filter can substantially or partially surround the sampling tip. In yet another embodiment, the filter can be placed inside the sampling tip or inside the sampling conduit to prevent moisture from exhaled or exhaled gas or fluids such as body fluids from entering the gas sampling conduit, or from moving through the gas sampling conduit after the fluid has entered the conduit.

[0131]

[0202] Alternatively or additionally, to help protect the breathing gas monitor by preventing fluid from moving along the sampling conduit into the breathing gas monitor, filters can be placed at any position along the length of the gas sampling conduit to separate the fluid from the gas.

[0132]

[0203] In another embodiment, the tip structure may include a shield, cage, drum, or spacer surrounding the tip of the interface. During use, the shield, cage, drum, or spacer abuts against the inside of the patient's cheek, displacing the tip of the interface away from the inside of the patient's cheek to reduce the possibility of saliva or other bodily fluids reaching the tip that receives the exhaled and / or exhaled gas. The cage, drum, or spacer may be formed integrally with the conduit or separately from the conduit.

[0133]

[0204] Further examples of conduits and gas sampling interfaces are described below, with reference to Figures 10-13.

[0134]

[0205] Figure 10 shows a spline for an example of a hook shape. The shape of the interface on the outside of the patient's cheek is preferably curved to follow the shape of the patient's cheek. This reduces the distance from the patient's face to the interface, reduces torque, and improves stability. This shape also reduces or eliminates the probability of the ends of the interface poking the patient's face, improving comfort. Figures 10 and 11 show exemplary splines or shapes. The lines shown are the centerlines of any conduit cross-sectional profile. The hook shape is a smooth curve to prevent twisting of the conduit, which could interfere with the gas flow and cause blockage.

[0135]

[0206] The insertion depth of the conduit into the patient's mouth or nose is selectable by the clinician. Typically, the insertion depth is greater than 10 mm, preferably greater than 20 mm. If the insertion depth is less than 10 mm, the interface may roll out of the patient's mouth, especially when the patient is sitting upright or nearly upright. The gap formed at the end of the hook (i.e., the space between the distal end of the conduit and the substantially straight portion of the body of the conduit) is preferably about 5 mm to provide a tight fit against the patient's cheek. Also, if the insertion depth is longer, the conduit may extend beyond where the tip of the patient's tongue would naturally rest. This means that the patient is less likely to block the end with their tongue or push the interface out of their mouth. This can be problematic when the patient is not accustomed to a foreign object in their mouth and may try to remove it with their tongue.

[0136]

[0207] Referring to Figures 14-25, alternative embodiments of conduits with shields are described below. As described above, the conduit may have several smaller inlets / openings or one larger inlet / opening near the tip of the conduit to provide an alternative gas pathway in case the inlet at the distal end of the conduit is blocked. The shields illustrated and described in relation to Figures 14-25 prevent, or at least substantially prevent, the opening(s) from being blocked. The shield may have a curved extension around the hook portion to prevent, or at least substantially prevent, the outlet of the shield from being inserted into the mouth beyond the patient's lips. The shield may be non-circular to prevent, or at least substantially prevent, the patient's cheek from completely sealing and / or sealing around the shield. The shield may include cutouts that allow gas to enter. The shield may include one or more projections that prevent the patient's cheek or lips from sealing the opening(s). One or more projections allow saliva / blood to flow out of the tube opening(s). In one embodiment, the shield can form a separate component attached to the conduit. Optionally, the shield can have a triangular shape. In one embodiment, the shield can only partially cover the inlet / opening(s), and therefore the shield does not completely cover the opening(s). In one embodiment, the shield can cover only some of the inlets / openings of the conduit.

[0137]

[0208] The inlet(s) / opening(s) of a conduit with multiple openings can be sized to provide flow resistance similar to that of a single inlet formed at the distal end of the conduit, so that gas is drawn uniformly through the opening(s). The opening(s) can also be sized to minimize the maximum velocity through the conduit to reduce the risk of other bodily fluids, such as saliva or blood, being drawn into the conduit. For example, in the case of a conduit with a single lumen of 1.2 mm inner diameter, the oval opening could be 1 mm × 5 mm. Figure 14 shows an oval opening without a shield. Figure 15 shows an embodiment with a shield.

[0138]

[0209] Figure 15 shows a gas sampling interface or conduit having a shield 1529 around the conduit to cover the opening in the conduit and prevent the opening from being partially or completely blocked. The shield in Figure 15 is in the form of a substantially cylindrical component.

[0139]

[0210] The shield may have non-flat areas to increase the surface area and angle that must be sealed to cause occlusion on the inside of the patient's cheek.

[0140]

[0211] Figure 16 shows a shield having internal ribs 1630 to separate the shield 1629 from the outside of the conduit and from the opening protected by the shield.

[0141]

[0212] In one embodiment, as shown in Figure 17, the shield 1729 may extend beyond the patient's lips during use to prevent partial or complete occlusion and subsequent mechanical alarms, even if the patient's lips seal around the interface, allowing gas to still be entrained from the outside air.

[0142]

[0213] Alternatively, the conduit may be equipped with a barrier 1830 (shown in Figure 18) located on the curved portion of the hook to prevent the distal end of the shield 1829 from being inserted beyond the lip into the patient's mouth or too deeply into the nostril. In other words, the barrier can form a depth limit to prevent the gas sampling conduit from being inserted too deeply into the patient's mouth or nostril.

[0143]

[0214] The shield can be opened along its entire length on one side, allowing gas from the mouth to still enter the gas sampling conduit through the opening if the patient's lips are closed.

[0144]

[0215] Figure 19 shows the shield 1929 in the form of an elongated component having a roughly C-shaped cross-section.

[0145]

[0216] The shield may be non-circular so as to prevent the patient's cheek from completely sealing and / or sealing around the shield, at least substantially. For example, Figures 20 and 21 show square shields 2029 / 2129 with a substantially square cross-section. These shields may have cutouts 2032 / 2132 or openings to allow gas to enter the sampling conduit through the shield when the patient's lips are closed.

[0146]

[0217] Figures 22 and 23 show the configuration of a shield having protrusions to prevent the patient's cheek or lip from sealing the entrance to the gas sampling conduit. Figure 22 shows a shield having multiple protrusions in the form of prongs to form a dentate component 2229. Figure 23 shows a shield having pleated protrusions to form a wavy component 2329. Each arrangement of protrusions forms a shield that allows saliva and / or other bodily fluids, such as blood, to flow out of the conduit entrance, reducing the risk of the entrance becoming blocked.

[0147]

[0218] The shield may be integrated with the conduit or attached to the conduit as a separate component. Alternatively, to reduce the risk of a portion of the shield breaking off inside the patient's airway, the shield may be attached to or delivered through a portion of the conduit that extends from and is attached to the patient's mouth.

[0148]

[0219] Figure 24 shows an example of a shield 2429 having an alternative projection with outward-extending arms that form substantially triangular or V-shaped components around the conduit inlet. Figure 25 shows a shield in the form of a planar component with arms projecting from the side of the conduit.

[0149]

[0220] In one embodiment, the gas sampling interface can be attached to the breathing apparatus via a mounting member that is a separate component that can be attached to both the breathing apparatus and the sampling interface, or via a mounting member that forms part of the breathing apparatus (integrated), or via a mounting member that forms part of the sampling interface (integrated).

[0150]

[0221] The sampling interface can be attached to the respiratory apparatus at any suitable location. For example, if the respiratory apparatus is a nasal cannula, the sampling interface can be attached to the cannula manifold, the headgear strap, or the respiratory gas delivery tube. If the respiratory apparatus is a mask, the sampling interface can be attached to the mask frame, the mask seal, the mask headgear strap, or the respiratory gas delivery tube.

[0151]

[0222] Figure 26 shows one embodiment of a respiratory apparatus comprising a gas sampling interface of one embodiment of the present invention, attached to or integrated with the respiratory apparatus. The respiratory apparatus comprises a nasal cannula to which the gas sampling interface is attached. The nasal cannula comprises a manifold and at least one nasal prong or outlet extending from the manifold and received into the user's nostril. The nasal cannula also comprises mounting members for securing the gas sampling conduit to the nasal cannula so that the inlet(s) of the gas sampling conduit receive gas exhaled and / or exhaled by the patient. In alternative embodiments, the respiratory apparatus may comprise a different form of patient interface, such as a mask, nasal interface, or full-face mask, and mounting members for securing the gas sampling conduit to the patient interface so that the inlet(s) of the conduit receive gas exhaled and / or exhaled by the patient. The respiratory apparatus can supply the patient with a high flow rate of respiratory gas.

[0152]

[0223] The mounting member may comprise any suitable mounting system for attaching the gas sampling conduit to a nasal cannula or other form of patient interface. For example, the mounting member may comprise a single clip, a pair of clips, or a band. The mounting member may include an elastomer material.

[0153]

[0224] If the patient interface is a nasal cannula, the mounting component can be integrated with the cannula's manifold and / or at least one nasal prong or outlet. Alternatively, the mounting component may be a separate component that can be attached to the manifold and / or at least one nasal prong or outlet, or to another suitable part of the respiratory device, such as a respiratory gas delivery tube.

[0154]

[0225] Figures 27–34 show various embodiments of mounting members configured to attach the conduit of the respiratory sampling interface 100 to a cannula manifold or a respiratory device headgear strap (both shown as 4000 in Figures 28, 30, 32, and 34).

[0155]

[0226] The position of the gas sampling conduit can be adjusted relative to the mounting member. For example, Figure 35 shows a mounting member / connector for the patient interface, the mounting member comprising a headgear clip 3550 with a clip 3551 suitable for securing the conduit to a respiratory device such as a nasal cannula. The headgear clip connects a headgear strap to the side arm of the nasal cannula. The side arm of the nasal cannula includes a complementary clip receiver.

[0156]

[0227] Figure 36 shows another form of mounting member / connector for a nasal cannula. The connector is in the form of a manifold portion 3650 that can be inserted into the nasal cannula. The manifold portion is connected to a gas supply tube with a threaded end. The opposite end is inserted into a complementary aperture within the nasal cannula to supply gas to the prongs of the nasal cannula. The manifold portion includes a clip 3651 for securing the gas sampling conduit.

[0157]

[0228] Figure 37 shows a respiratory device incorporating the connectors / mounting components shown in Figures 35 and 36 connected to a nasal cannula, and also shows the relative position of the respiratory device on the patient's face. A gas sampling conduit is attached to the cannula by a clip similar to those in Figures 35 and 36.

[0158]

[0229] A breathing apparatus incorporating one or both of the connectors / mounting members shown in Figures 35 and 36 enables a holding method in which the gas sampling conduit is attached to the breathing apparatus independently of the shape and / or size of the patient's face.

[0159]

[0230] The gas sampling conduit is typically held lightly in place inside or near the patient's mouth, or just inside or near one of the patient's nostrils, to reduce the probability of obstruction occurring from fluid being drawn into the conduit or the conduit aspirating the patient through the patient's cheek or lips. Positioning the conduit in this manner is less invasive and less intrusive than known sampling systems that require the gas sampling interface entrance to be positioned behind the patient's mouth. Positioning the conduit just inside or near the oral or nasal cavity reduces the risk of the sampling conduit causing pressure points or movement in the patient.

[0160]

[0231] In one embodiment, the gas sampling interface or conduit can be integrated with the cannula and molded or extruded to produce a single portion having two gas lumens, one gas lumen for fluid communication with the respiratory gas monitor and the other gas lumen / tube for fluid communication with the gas source of the cannula. For example, the gas sampling interface or conduit can be partially co-extruded or simultaneously molded along the gas delivery tube of the cannula.

[0161]

[0232] In one embodiment, the gas sampling conduit can be clipped to a respiratory device such as a nasal cannula. The sampling conduit can be clipped to the cannula during manufacturing or by the end user to provide flexibility in use. In one embodiment, the sampling conduit can be attached using only one clip. Alternatively, multiple clips can be used over at least a portion of the length of the cannula to provide further stability and positional control of the sampling conduit relative to the cannula. The clips can be positioned on one side of the patient's face so that there is no device on the other side of the face. Alternatively, the clips can be positioned on either side of the nasal prongs of the cannula.

[0162]

[0233] In one embodiment, the nasal cannula and gas sampling conduit can be configured to connect the gas sampling conduit to the gas sampling tube of a respiratory gas monitor and simultaneously connect the cannula to the gas delivery source by a single coupling and / or coupling movement with two connectors.

[0163]

[0234] As described above, the sampling conduit may be a single-lumen conduit. Alternatively, the sampling conduit may be a double-lumen conduit having a wire located in at least one of the lumens to provide positional control of the sampling conduit so that the conduit can be selectively positioned in or near one of the patient's mouth or nostrils.

[0164]

[0235] Other forms of mounting members can also be used to attach the gas sampling conduit to the respiratory apparatus. For example, Figures 27 and 28 show one embodiment of a mounting member in the form of a band or loop 2740. The band or loop may include an elastic or elastomer material such as TPE or silicone. The band or loop 2740 can stretch and slide over the cannula and the gas sampling conduit. The position of the cannula is indicated by 2741, and the position of the gas sampling conduit is indicated by 2743. The cannula side of the band 2740 may have a thinner wall (e.g., 0.5–1 mm) to ensure a low profile on the patient's face and sufficient stretch. The conduit side of the band 2740 may have a thicker wall (e.g., 1.5–2 mm) to ensure that the conduit does not stick to the band when pulled through and / or repositioned, and that the clip does not move with the conduit. The cross-section of the band can be circular, triangular, or irregular in shape, and / or in shape corresponding to the cross-section of the cannula.

[0165]

[0236] Figures 29–34 show embodiments of mounting members in the form of clips 2940, 3140, and 3340, which allow a cannula to slide. The positions of the cannula are indicated by 2941 / 3141 / 3341, and the positions of the gas sampling conduit are indicated by 2943 / 3143 / 3343. Figures 29 and 30 show clips with overlapping portions 2945. Figures 31–34 show clips having tongues 3145 / 3340 / 3341 extending from the body of the clip to provide space for inserting and holding a cannula. The tongues can be bent or curved to allow for insertion. The clips in Figures 33 and 34 also show a curved tongue 3345 that provides space for inserting and holding a gas sampling conduit. Each tongue can be bent or curved to allow for insertion. For example, the gap between the tongue and the body of the clip can, in some cases, be smaller than the outer diameter of the gas sampling conduit or a portion of the cannula attached to the clip. In this configuration, the flexibility of the tongue allows the cannula or conduit to be pushed into the gap, moving the tongue away from the clip body, allowing the cannula or conduit to be positioned between the clip body and the tongue. After the cannula or conduit is positioned within the clip, the pressure on the tongue can be relieved, and as a result, the tongue returns to its natural resting position, and the cannula or conduit cannot be removed from the clip unless sufficient force is applied to pull the tongue away from the clip body again. The tongue can be biased toward the clip body. In some embodiments, the gap between the tongue and the clip body can be made slightly smaller than the outer diameter of the portion of the cannula held by the clip or the conduit, so that the cannula or conduit is lightly compressed between the tongue and the clip body. These embodiments may include polymer materials such as polypropylene. In one embodiment, the clip may have a notched cross section that provides space for the cannula to pass through. The clip may have a separate portion for securing the gas sampling conduit, which may be a clip such as a partial cylinder or cylinder. This cross-sectional design can depend on the cross-section of the cannula.

[0166]

[0237] In one embodiment, the gas sampling interface comprises a hook for engaging with a portion of the patient's face and a mounting system for securing a gas sampling conduit to the hook so that the conduit's inlet receives gas exhaled and / or exhaled by the patient. The hook can be inserted into the patient's nostril or mouth. For example, the hook can be inserted into the edge of the patient's mouth. The hook provides a system for attaching the conduit to the patient and positioning the conduit near the mouth or nose.

[0167]

[0238] The hook can be rigid. Alternatively, the hook can be flexible. In further alternative forms, the hook can be a combination of rigid and flexible materials or features. Rigid or flexible hooks can be made of molded polymer materials.

[0168]

[0239] The hook may be equipped with any suitable mounting system for securing the gas sampling conduit to the hook, comprising at least one mounting member such as a channel, a single clip, a pair of clips, or a band. The mounting member may include an elastomer material.

[0169]

[0240] The mounting component may be integrated with the hook or may be a separate component from the hook. The position of the gas sampling conduit can be adjusted relative to the hook.

[0170]

[0241] The following alternative embodiments of the gas sampling interface are equipped with a rigid hook, which can be supplied in a variable size based on considerations regarding patient anthropometry.

[0171]

[0242] Referring to the embodiment shown in Figure 38, the gas sampling interface comprises a rigid hook 3860 for supporting the gas sampling conduit. Figure 38 shows one embodiment of the hook having a narrow area. This hook has a shape similar to the spline shape illustrated and described in relation to Figure 3. The narrow area is advantageous in that it provides some compression of the patient's cheek to fix the hook in place. In the embodiment of Figure 38, the narrow area is approximately 8 mm.

[0172]

[0243] The radius at the end of the hook defines the minimum radius of curvature of the gas sampling conduit, thereby preventing twisting of the conduit and providing a gap around the thicker area of ​​the patient's cheek near the mouth (lip axis).

[0173]

[0244] The outside of the mouth is provided with a sloping or curved section that keeps the hook away from the cheek, allowing for easy attachment and removal of the hook.

[0174]

[0245] The following embodiments of the gas sampling interface incorporate a gas sampling conduit that includes a flexible elastic support structure such as a wire. The wire may be a metal wire or rod, positioned within the lumen of the gas sampling conduit, integrated with the material of the gas sampling conduit (overmolded or co-molded), or otherwise attached to or joined to the outside of the gas sampling conduit. This allows for adjustment of the position of the free end of the conduit. Alternatively, the hook may be malleable yet semi-rigid, and therefore a wire is not required.

[0175]

[0246] In some embodiments, the gas sampling conduit can slide along the hook to vary the length of the free end of the conduit, which can extend beyond the free end of the hook. In other embodiments, the conduit can be attached to the hook so that the free end portion of the conduit is of a desired length. When combined with the ability to move the gas sampling conduit relative to the hook, the end position of the gas sampling conduit is limited only by the length of the conduit material, the length of the wire within the conduit, and physical constraints imposed by the patient or the necessary surgical or procedural equipment.

[0176]

[0247] Figures 38-46 show embodiments of rigid and semi-rigid hooks having different features and / or methods for attaching gas sampling conduits to rigid or semi-rigid hooks.

[0177]

[0248] Embodiments shown in Figures 38-40 include a mounting member comprising a clip 3861 integrated with the outside of a rigid hook. The clip 3861 allows the sampling conduit 3863 to be pushed into the clip by bending the clip, the gas sampling conduit, or both. The clip also allows the sampling conduit to be pulled or pushed axially through the clip to adjust the length of the free end portion of the gas sampling conduit. After adjustment, the clip holds the sampling conduit in place relative to the hook.

[0178]

[0249] Figures 41 and 42 show a hook having a conduit mounting system that includes a mounting member comprising a clip 4167 integrated with an internal channel 4165 of the hook 4160. This embodiment allows the gas sampling conduit 4163 to be pushed into the clip by bending the clip or the gas sampling conduit. This embodiment also allows the gas sampling conduit 4163 to be pulled or pushed axially through the clip 4167 and channel 4165 so that the free length of the tube can be adjusted. Furthermore, this embodiment holds the gas sampling conduit 4163 in a fixed position relative to the hook 4160.

[0179]

[0250] Figure 43 shows a perspective view of an alternative embodiment of the rigid hook of the gas sampling interface 4360. This embodiment incorporates a rigid endstop for the arrangement and restraint of a flexible component that attaches the sampling tube to the rigid hook.

[0180]

[0251] Figure 44 shows one embodiment having the rigid hook of Figure 43 and a flexible component 4469 forming a sleeve, the flexible component 4469 being used to allow adjustment of the length of the free end portion of the gas sampling conduit 4463 while holding it. The sleeve may be ribbed to provide further grip against the outside of the patient's cheek.

[0181]

[0252] Figures 45 and 46 show embodiments of a hook having an overmolded mounting system. These embodiments include a rigid polymer hook 4560 and one or more overmolded sleeves, each forming a mounting member. To attach a gas sampling conduit 4563 to the hook, the gas sampling conduit is threaded through the sleeve(s) or more. The length of the free end portion of the gas sampling conduit can be adjusted by pulling the conduit through the sleeve / overmolded material until the desired length extends beyond the sleeve. That is, the sleeve / overmolded portion or component is secured to the rigid hook by mechanical and / or chemical lock, but not to the gas sampling conduit. These embodiments may incorporate bending relief and other features, such as a soft grip handle.

[0182]

[0253] As mentioned above, the hook can be flexible. A pre-formed flexible hook is inserted into the edge of the patient's mouth, providing an attachment for securing the gas sampling conduit near the patient's mouth or nose. One advantage of the flexible hook is that its shape can be modified, for example, by bending, to fit the size of the patient's mouth.

[0183]

[0254] Embodiments shown in Figures 47 and 48 incorporate a wire in the form of a flexible wire, rod, or strip (metal or polymer), which is overmolded or co-molded (in a flat position) with a suitable flexible polymer such as TPE or silicone, and then formed into a hook before being shipped to the customer. This embodiment includes a mounting member with a clip 4761 for attaching a gas sampling conduit 4763 from the outside. In this embodiment, the overmolded material is bonded to the internal flexible wire, rod, or strip (metal or polymer) to allow for easy modification of the hook size and shape to suit individual patients. The overmolded design includes one or more mounting members (clips) for attachment to the gas sampling conduit. The overmolded design may include features for bending relief at suitable positions to allow the overmolded wire to bend into a hook shape. In this embodiment, the bending relief features may be located within the molding tool for wire placement. The hook can be pre-formed before shipping.

[0184]

[0255] Referring to Figures 49-53, alternative embodiments of mounting members having a double flexible tube or sleeve for attachment to two tubular members are shown. For example, the tubular members may comprise a gas delivery conduit and a gas sampling conduit, or the tube may comprise a gas sampling lumen and a support lumen, or the tube may comprise a pair of gas sampling lumens. In these embodiments, the gas sampling interface may incorporate a gas sampling conduit having a wire, such as a metal wire or rod or strip, the wire being located in the wire lumen and integrated with the tubular material of the conduit (by overmolding or co-molding, etc.), or attached to or joined to the outside of the conduit. The gas sampling conduit is preferably formed in a hook shape for attachment to the patient's mouth. These embodiments also incorporate a gas sampling conduit having a wire, such as a metal wire or rod or strip, located in one of two or more lumens within the gas sampling conduit. The wire can be integrated with the conduit material (by overmolding or co-molding, etc.) or attached to or joined to the outside of the conduit material to allow for adjustment of the conduit's position by providing the conduit with a semi-flexible and elastic end that can be bent into a desired shape to engage with the patient's mouth or nostril during gas sampling.

[0185]

[0256] The two conduits can be attached via one or more mounting members equipped with clips (4973 / 5073 / 5173) that restrict or prohibit movement relative to the hook-shaped conduit (4973 / 5073 / 5173), while allowing the sampling conduit to move axially through the clips (4971 / 5071 / 5171) to adjust the free length of the conduit. Multiple clips may be required. Figures 49–51 show various embodiments of the clips 4970 / 5070 / 5170. These clips can be molded or extruded components. Figure 52 shows a gas sampling conduit 5263 attached to a hook 5260 by a clip 5270.

[0186]

[0257] Figure 53 shows clips 5270 molded around a pair of lumens of a double-lumen conduit. The clips 5270 may be overmolded on top of the lumens or co-molded with the lumens. This form of clip holds the lumens substantially equidistant from each other, but allows the lumens of the conduit to be pulled or pushed axially through the overmolded or co-molded material of the clip, so that the free length of the conduit can be adjusted. Multiple overmolded or co-molded clips can be used along the length of the conduit.

[0187]

[0258] Figure 54 shows a cross-sectional view of a zip cord conduit, where a first cord is for gas sampling and a second cord is configured to form a hook shape. These cords in the conduit can be opened and cut, and the second zip cord can be shaped to form a hook substantially shorter than the first zip cord used for gas sampling. The gas sampling cord can also be shaped into a hook shape suitable for best sampling of exhaled or exhaled gas from a patient. Figure 54 shows a gas sampling conduit comprising a first zip cord having a gas sampling lumen 5481 and a wire lumen 5483, and a second zip cord having a second wire lumen 5485 for forming a hook shape.

[0188]

[0259] In one embodiment, as shown in Figure 55, the gas sampling interface comprises a gas sampling conduit 6163 and a mounting member 6140 for securing the gas sampling conduit to a respiratory device 1000 that delivers respiratory gas to a patient, such as a mask or nasal cannula 8040. In one embodiment, the gas sampling conduit is detachably attached to the mounting member. The mounting member may be configured to be detachably attached to the respiratory device, or it may be integrated with (form part of) the respiratory device. For example, the mounting member can be incorporated into the design of a nasal cannula, mask, or other respiratory device so as to detachably attach the gas sampling conduit to the respiratory device.

[0189]

[0260] In one embodiment, as shown in Figures 55-57, the mounting member 6140 comprises a main body 6141 that can be attached to the breathing apparatus 1000. The main body 6141 can be fastened to a portion of the breathing apparatus. In one embodiment, the main body 6141 of the mounting member 6140 can form a substantially or partially enclosed sleeve that wraps around a portion of the breathing apparatus 1000.

[0190]

[0261] As shown in Figures 55-57, when the sleeve is partially enclosed, the body / sleeve 6141 comprises a pair of spaced-apart projecting elastic arms 6150. Each projecting arm terminates at a side edge 6144. The sleeve 6141 comprises an internal region 6142 and an opening 6143 to the internal region 6142. The arms 6150 can bend toward each other, so that the area between the body 6141 and the projecting arms 6150 forms the internal region 6142 of the sleeve. The opening 6143 is defined by the arms and the side edges 6144 of the sleeve and extends along the length of the sleeve. The internal region 6142 is defined by the inner surface of the mounting member and is molded and dimensioned to receive a portion of a respiratory device 1000, such as a portion of a nasal cannula. The arms 6150 can be configured to be biased toward each other, but can also be flexible enough to be pushed apart, for example, by pushing a portion of the respiratory device 1000 between the arms 6150. The material and dimensions of the sleeve-shaped body 6141 can be such that at least a portion of the respiratory apparatus is held in the internal region 6142 of the sleeve 6141, for example, by the arm 6150 tightening the respiratory apparatus. Other forms of attachments may also be suitable. Typically, the attachment member 6140 is configured to attach to the air delivery tube 8060 of the respiratory apparatus 1000, but it is also conceivable that the attachment member may be configured to attach to another part of the respiratory apparatus, such as the head strap of the respiratory apparatus. For example, if the respiratory apparatus constitutes a nasal cannula 8040, the attachment member may be configured to attach to the air delivery tube 8060, the cannula manifold 8070, the cannula side arm 8080, or the cannula head strap 8090.

[0191]

[0262] In the embodiments shown in Figures 55-57, the body 6141 of the mounting member 6140 is configured to be attached to a substantially curved portion of a respiratory device, such as a respiratory gas delivery tube 8060. In this embodiment, the mounting member 6140 comprises a substantially curved sleeve having a curved arm 6150 or an arm having at least a curved inner surface, and the arm is configured to be tightened to or at least partially wrapped around the curved outer surface of the respiratory gas delivery tube, as shown in the figure. In other words, the internal region 6142 is shaped to substantially match the external profile of the gas delivery tube 8060 of the nasal cannula. For example, the internal region 6142 of the sleeve can be substantially curved to provide a substantially arc-shaped inner surface to the internal region, and the sleeve can be given a substantially C-shaped cross-section, as a result the sleeve can at least partially wrap around a portion of the gas delivery tube 8060 or another suitable curved portion of the respiratory device, such as a curved portion of the manifold of the nasal cannula. In another embodiment, the sleeve may have a substantially U-shaped cross-section so as to wrap at least partially around a portion of the gas delivery tube 8060 or another suitable curved portion of the respiratory apparatus, such as a curved manifold. In yet another embodiment, at least the substantially arcuate inner surface of the sleeve may be formed from a plurality of substantially planar regions / surfaces arranged in a continuous manner to form a substantially or completely enclosed sleeve. If the sleeve is substantially enclosed, the substantially planar surfaces may be arranged to form a sleeve having a substantially C-shaped cross-section or a substantially U-shaped cross-section. In any embodiment, at least the inner surface of the sleeve may be shaped to substantially conform to the outer shape of the portion of the respiratory apparatus to which the sleeve is attached. For example, if the sleeve is attached to the side arm of a nasal cannula having a substantially thin rectangular profile, the inner surface of the sleeve may be formed from three substantially planar regions joined at right angles to provide the sleeve with a substantially angular U-shaped profile.

[0192]

[0263] The sleeve can be formed from a substantially flexible elastic material, such as metal or polymer, so as to bias the separated lateral edges 6144 or arms of the sleeve toward each other in the stationary position, move toward each other when the sleeve is pressed into a portion of the nasal cannula, and return substantially to its original stationary position. Typically, the width of the opening between the lateral edges 6144 is smaller than the diameter of the portion of the gas delivery tube 8060 that is held within the sleeve (or other parts of the breathing apparatus) so that the breathing apparatus is fixed and held within the sleeve.

[0193]

[0264] In one embodiment, the inner surface of the sleeve 6141 may be provided with a plurality of ribs to engage with or interlock with a rib-like configuration located on the outer surface of the pleated respiratory gas delivery tube 8060. In one embodiment, the mounting member 6140 can be detachably attached to one of the side arms 8080 of the nasal cannula 8040 (or a side arm of the mask) by any preferred form of attachment. For example, the mounting member 6140 may comprise a pair of spaced-apart projection arms 6150, the arms 6150 being biased toward each other and configured to fit onto both sides of the side arms of the cannula or mask in order to fasten the mounting member to the side arm. To fit the mounting member 6140 onto the side arm, the mounting member 6140 may be positioned such that the side edge of the side arm is located in the opening between the projection arms 6150 of the mounting member 6140. Next, by sliding the protruding arm 6150 of the sleeve 6141 across the front and rear surfaces opposite the side arm, the mounting member is pushed into the side arm, and the arm 6150 is spread open. Due to the biased nature of the arm 6150, the arm 6150 is tightened against the side arm.

[0194]

[0265] In another configuration, the mounting member may be equipped with a hinged fastener comprising a pair of arms attached together at a closing hinge end, and an opposite receiving end configured to open and close by moving the arms of the fastener toward and toward each other to open and close the hinge. The receiving end of the fastener may be equipped with a locking system configured to lock both arms of the fastener in a releaseable manner. Any suitable locking system is sufficient, such as one in which a hook or post located on one arm of the fastener is configured to engage with a hook or aperture located on the other arm of the fastener. To fit the mounting member onto the side arm, the receiving end of the fastener is opened, allowing one arm of the fastener to slide beneath the side arm of the nasal cannula or mask. The other arm is then positioned above the side arm and locked into the lower arm to tighten the side arm and hold the hinged fastener in place. When the mounting member forms a clamping portion, the arm or clamping member of the clamping portion can be shaped to substantially complement the shape of the side arm in order to maximize the clamping and holding force applied to the side arm, and preferably to maximize patient comfort.

[0195]

[0266] In one embodiment, the body or sleeve 6141 of the mounting member 6140 includes at least two offset clips 6167 (a first clip and a second clip) that can be attached to the gas sampling conduit 6163. These offset clips can be located on the outer surface of the mounting member. The offset arrangement of the clips 6167 causes the gas sampling conduit 6163 to follow a meandering path when attached. This helps to hold the sampling conduit 6163 in place and reduces the risk of the sampling conduit being accidentally pulled out of or pushed too far into the patient's oral or nasal cavity.

[0196]

[0267] Each clip 6167 is equipped with a tube receiving area 6170, which can hold a portion of the gas sampling conduit 6163 within the tube receiving area 6170.

[0197]

[0268] In one embodiment, each clip 6167 forms a hook comprising an arm 6168 extending from a clip body 6141 and ending at a distal end 6169, the distal end 6169 suspended at a distance from the outer surface of the mounting member body 6141. The space between the distal end 6169 of the clip and the outer surface of the mounting member 6140 forms a clip opening. The arm 6168 can be curved. For example, the arm 6168 may have an inner surface that forms a substantially curved or concave tube receiving area 6170. The curved profile of the tube receiving area 6170 can be sized to substantially match the curved outer profile of the gas sampling conduit 6163. In one embodiment, the diameter of the curved tube receiving area 6170 can be at least the same as the diameter of the gas sampling conduit 6163. In another embodiment, the diameter of the curved tube receiving area 6170 can be slightly smaller than the diameter of the gas sampling conduit to help press the gas sampling conduit against it and maintain its position within the clip 6167. In one embodiment, the hook-shaped clip can face in opposite directions. For example, the first hook can face one side of the gas delivery tube (when positioned on the tube), and the second hook can face the opposite side.

[0198]

[0269] To fit the gas sampling conduit 6163 into the mounting member 6140, the conduit 6163 is pushed through the opening of one clip 6167 and then through the opening of the other clip 6167, following a meandering path that holds the conduit in place within the clip. The length of the free end portion of the conduit can be easily adjusted by detaching / removing the conduit from the first clip and then pulling the conduit in the desired direction so that the conduit slides through the second clip until the free end portion reaches the desired length. The conduit can then be hooked back onto the first clip to secure it in place.

[0199]

[0270] The gas sampling conduit 6163 can be detachably installed within the clip 6167 of the mounting member 6140 so that the conduit can be replaced if necessary. Therefore, the gas sampling conduit can be removed from the mounting member by pulling it out of the clip opening. Alternatively, the gas sampling conduit can be permanently retained within the mounting member.

[0200]

[0271] Each clip 6167 is typically formed from a flexible elastic material that allows at least a portion of the hook to move away from the body 6141 when the gas sampling conduit 6163 is pushed into the tube receiving area 6170, and to substantially return to its original position after the gas sampling conduit 6163 has entered the tube receiving area 6170. In this embodiment, to help prevent the gas sampling conduit 6163 from accidentally detaching from the clip 6167, the distance between the distal end portion of each hook-shaped arm 6168 and the body 6141 (clip opening) can be smaller than the diameter of the gas sampling conduit 6163.

[0201]

[0272] Depending on the shape and dimensions of the tube receiving area 6170 and the gas sampling conduit 6163 within each clip 6167, the clip 6167 can be configured to loosely hold the gas sampling conduit 6163 in place within the clip 6167, or to firmly hold the conduit 6163 in place.

[0202]

[0273] In one embodiment, each clip 6167 can be configured to tighten at least a portion of the gas sampling conduit 6163 with sufficient force to attach the conduit 6163 to the clip 6167 without blocking the gas flow path within the sampling conduit 6163.

[0203]

[0274] As shown in Figures 65-67, a connecting or mounting member 8050, such as a Luer connector, can be provided at or near the outlet 109 of the gas sampling conduit 101 of the gas sampling interface 100 to fluidly connect the sampling conduit 101 and the interface 100 to the gas sampling tube of the respiratory gas monitor. Alternatively, it will be understood that any other connecting means can be used between the interface and the gas sampling tube. In another embodiment, the outlet of the gas sampling conduit can be directly connected to the inlet of the respiratory gas monitor.

[0204]

[0275] As described above, using a flexible and elastic sampling conduit with a support structure such as a wire, and attaching the conduit to the respiratory device using a mounting member that allows adjustment of the length of the free end portion of the conduit, as described above, is a particularly advantageous embodiment because, as shown in Figures 70 and 71, the conduit, and therefore the sampling interface, can be selectively positioned (elastically bendable / formable) to be located near the mouth or nostrils. The distal end of the sampling interface can be positioned roughly near the teeth in the patient's mouth, or near one of the nostrils or inside the nostril. When a nasal cannula is used as a respiratory device, it may be difficult to fit both the cannula prongs and the sampling interface into the patient's nostrils, but depending on the size of the end or tip of the sampling interface and how the patient is anesthetized, both the sampling interface and the cannula prongs can also be inserted into the nostrils. Alternatively, the sampling interface can be positioned just outside the nostrils. Therefore, the versatility of the sampling interface due to its positioning possibilities means that it can be used for patients who exhale and / or breathe gas through their mouth or nose (or patients with apnea, patients whose respiratory gases are primarily or exclusively released from their body through either their mouth or nose). The interface can be easily repositioned to suit the patient as needed. The interface can also be repositioned to suit the needs of the clinician and the constraints of the medical procedure. For example, during surgery, the patient's mouth is often held open by other medical devices or equipment, in which case good respiratory gas tracking of exhaled and / or exhaled breath is likely to be obtained at the patient's mouth by the gas sampling interface / device disclosed herein. Alternatively, when the patient's mouth is closed, the sampling interface can be easily moved to be positioned near the nostrils, or the distal end or tip of the sampling interface can be positioned between the patient's lips, such as against the patient's teeth.When a patient is receiving high-flow therapy via a nasal cannula, tracking the breath exhaled and / or exhaled from the patient's mouth has been found to be particularly effective. This is because the gas flow resistance entering the sampling interface is generally lower in the mouth than the resistance caused by the high-flow respiratory gas supplied to the nostrils, making it possible to find the tracking by placing the sampling interface in the mouth.

[0205]

[0276] Figures 58–64 show further embodiments of gas sampling tips 7050 that can be connected to a gas sampling conduit to receive gases released from a patient. The sampling tips 7050 may be integrally formed with the gas sampling conduit 6163, or they may be formed separately and then attached to the free end / gas inlet end of the sampling conduit 6163. Each sampling tip 7050 can be attached to the free end of the sampling conduit 6163 using any preferred form of attachment. For example, the sampling tip may be welded to the sampling conduit, screwed to the threaded free end of the sampling conduit, glued or otherwise attached to the free end of the sampling conduit, and the sampling tip and sampling conduit may be attached together in a snap-fit, friction-fit, or the like.

[0206]

[0277] In a preferred embodiment, the gas sampling tip 7050 is formed from a soft or semi-soft compressible material. Sampling tips formed from rigid or hard materials may injure the patient and damage their teeth, especially if the tip is positioned between teeth and the patient inadvertently bites the tip. These risks can be avoided or at least mitigated by providing a sampling tip that can include a compressible material that is less likely to cause injury or damage to the patient.

[0207]

[0278] In one embodiment, the sampling tip 7050 comprises a body 7060, the body 7060 comprising a substantially hollow internal region 7061 configured to fluidly communicate with the inlet of the gas sampling conduit 6163 when the sampling tip 7050 is connected to the sampling conduit 6163. The body 7060 comprises one or more side walls forming the outer surface of the body, a proximal connecting end 7062 for connecting to the free end of the gas sampling conduit so that the hollow internal region is in fluid communication with the gas sampling conduit, and a distal end portion 7063 ending at the distal end 7064 of the sampling tip 7050.

[0208]

[0279] In one embodiment, the connecting end 7062 can be bonded to the gas sampling conduit 6163. In another embodiment, the connecting end 7062 can be threaded to connect to the threaded end of the gas sampling conduit 6163, so that the sampling tip can be attached and detached from the free end of the sampling conduit by screw. In yet another embodiment, the connecting end may have a lip configured to fit onto a collar at the inlet end of the sampling conduit in order to connect the sampling tip and the conduit in a snap-fit ​​configuration. Alternatively, the inlet end of the sampling conduit may have a lip that fits onto the collar at the connecting end of the sampling tip.

[0209]

[0280] The sampling tip 7050 comprises at least one inlet / gas receiving aperture 7230. The inlet / gas receiving aperture 7230 can receive gas exhaled or exhaled by the patient, and the inlet / gas receiving aperture 7230 is in fluid communication with a substantially hollow internal region 7061 of the body 7060, so that the received gas can pass through the body 7060 of the sampling tip and enter the inlet of the gas sampling conduit. Each inlet / gas receiving aperture forms an opening to the hollow internal region of the body of the tip.

[0210]

[0281] In one embodiment, the gas receiving aperture 7230 can extend from the distal end 7064 of the sampling tip along the side surface of the sampling tip body 7060. Preferably, the gas receiving aperture 7230 forms an elongated opening at the distal end portion 7063 of the gas sampling tip.

[0211]

[0282] In one embodiment, the sampling tip 7050 comprises an end wall located at its distal end 7064 and one or more gas receiving apertures located on one or more side walls of the sampling tip. In one embodiment, the gas receiving aperture 7230 can extend substantially over the entire outer circumference of the sampling tip, such as the entire outer circumference of the outer surface. If the sampling tip has a substantially round / circular cross-section, the gas receiving aperture 7230 can extend over the outer circumference of the sampling tip to form an annular ring-shaped aperture, as shown in Figures 68A-68C. In another embodiment, the gas receiving aperture 7230 can extend over the outer circumference of the sampling tip in a substantially helical arrangement, similar to the spiral screw of a corkscrew.

[0212]

[0283] The end wall can be offset substantially laterally from the gas receiving aperture(s). In one configuration, the end wall can be offset longitudinally by a distance greater than the width of the gas inlet(s).

[0213]

[0284] The cross-sectional area of ​​the end wall may be smaller, substantially equal to, or larger than the cross-sectional area of ​​the hollow internal region of the sampling tip body.

[0214]

[0285] In one configuration, the cross-section of the end wall is greater than or equal to the cross-section of the gas receiving aperture(s) / inlet(s).

[0215]

[0286] In some embodiments, as shown in Figures 58-66, the gas sampling tip 7050 may be equipped with multiple inlet / gas receiving apertures 7230. For example, the sampling tip 7050 may be equipped with a pair of gas receiving apertures 7230 extending from the distal end of the sampling tip along the side of the distal end portion 7063 of the gas sampling tip body 7060. The apertures 7230 may or may not be uniformly spaced apart from each other. For example, the apertures 7230 may be located substantially on both sides of the body 7060, or the apertures 7230 may be located closer to each other in at least one direction. In other embodiments, the gas sampling tip 7050 may be equipped with two, three, four, or more gas receiving apertures 7230. The apertures 7230 may or may not be uniformly spaced apart from each other.

[0216]

[0287] In the embodiments shown in Figures 58-66, the gas sampling tip 7050 comprises three gas receiving apertures 7230 uniformly spaced around the distal end and sides of the sampling tip 7050. The spacing of the apertures 7230 can be best seen in Figures 58, 59, 61, and 63.

[0217]

[0288] Each portion of the sampling tip body 7060, positioned between the gas receiving apertures 7230, forms longitudinal folds 7240 that terminate at the distal end of the sampling tip 7050. A central support 7250 can be positioned at the distal end of the sampling tip 7050, and the central support 7250 can be connected to the longitudinal folds 7240. The central support 7250 provides additional strength and positional integrity to the longitudinal folds 7240, preventing them from collapsing together and at least partially sealing the gas receiving apertures 7230. The central support 7250, longitudinal folds 7240, and body 7060 of the sampling tip 7050 together define the edge of the gas receiving apertures 7230.

[0218]

[0289] The body 7060 of the gas sampling tip 7050 can have a substantially cylindrical shape, and the longitudinal folds 7240 can be substantially uniformly spaced around the periphery of the distal end portion 7063 of the gas sampling tip 7050. In one embodiment, the interior of each longitudinal fold may be provided with a cutout region for forming an enlarged opening within the tip.

[0219]

[0290] In one embodiment, as shown in Figures 68A-68C, the distal end 7064 of the sampling tip can be supported by a support member 7070 which constitutes a core / pillar / arm / elongated extension connected to the end wall and the main body 7060. The support member 7070 may be substantially centered along the longitudinal axis of the sampling tip, or substantially laterally offset from the center of the longitudinal axis of the sampling tip. For example, the support member 7070 can be connected to at least one inner wall of the main body or to the outer surface of the main body of the sampling tip. In one embodiment, as shown in Figure 68C, the main body 7060 of the sampling tip can form a plug having a protruding support member 7070 which constitutes a pillar connected to the distal end 7064 of the sampling tip. The plug-shaped main body 7060 can be configured to be located in the lumen or auxiliary channel within the gas sampling conduit 201 so as to attach the tip to the conduit without blocking the gas receiving inlet of the sampling conduit. For example, the auxiliary channel can be a first support lumen 211 of the gas sampling conduit 201, such as the conduit shown in Figure 2. The support member / support can be offset from the longitudinal centerline of the tip body 7060 and / or the gas sampling conduit 201, as shown in Figures 68A-68C. This arrangement is particularly advantageous when the tip body is configured to engage with an offset body receiving lumen or aperture located adjacent to one side of the inlet of the gas sampling conduit.

[0220]

[0291] In another embodiment, the sampling tip body 7060 may be configured to be received at an inlet located at the distal end of a gas sampling conduit. In this embodiment, the sampling tip comprises a body 7060 that is molded and sized to be received at the gas inlet of the sampling conduit. A support member 7070, which constitutes a core / column / arm / elongated extension, protrudes from the body 7060 and is connected to the distal end portion 7064 of the sampling tip 7050, holding the distal end portion 7064 at a distance from the body 7060. For example, the support member or column 7070 may protrude from the upper surface of the sampling tip body 7060. The support member / column 7070 may protrude substantially from the center of the upper surface of the body 7060 or it may be offset from the center of the body 7060. The support column 7070 and distal end portion 7064 of the sampling tip 7050 can be configured such that the distal end portion 7064 cantilever outwards from the support column 7070, or protrudes at least beyond the periphery of the support column 7070. The arrangement of the distal end portion and support members forms a shield covering the inlet(s) / gas receiving aperture(s) of the gas sampling tip. Since the sampling tip body 7060 is positioned in a plug-like configuration at the gas inlet of the gas sampling lumen, at least one gas receiving aperture(s) 7230 is formed within the sampling tip 7050 to allow gas to pass through the sampling tip 7050 by entering the gas sampling conduit through the gas receiving aperture(s) 7230 and the hollow body 7060 of the tip. In one embodiment, as shown in Figures 69A to 69C, at least one gas receiving aperture 7230 is formed on the upper surface of the main body 7060 and is in fluid communication with the substantially hollow interior 7061 of the main body, the hollow interior 7061 is open at its proximal end to form a fluid passage to the gas sampling conduit.In another form, at least one gas inlet aperture 7230 can be formed in the support member / strut 7070, which can comprise a substantially hollow body in fluid communication with the substantially hollow interior of the gas inlet aperture 7230 and the sampling tip body 7060, so that gas can flow through the gas inlet aperture(s) 7230 and the hollow body 7060 into the gas sampling conduit.

[0221]

[0292] In another form, the support member / strut 7070 can extend from at least one side wall of the gas sampling tip body 7060, such that the distal end 7064 projects cantilever - like from the strut 7070. For example, the support member / strut 7070 can extend from the body (such that the outer surface of the body extends along the outer surface of the strut), and the distal end can project cantilever - like from the strut. In one form, the end wall is integrally formed with the body 7060.

[0222]

[0293] In one form, as shown in FIGS. 68A - 69C, the distal end portion 7064 of the sampling tip can comprise a curved or domed end wall 7064a, which forms a shield for protecting the inlet(s) / gas inlet aperture(s) of the gas sampling tip from being aspirated against the patient's cheek, mouth, lip, or nostril. The end wall also advantageously prevents saliva from entering directly into the hollow interior region of the body, particularly longitudinally. This is important in preventing blockage of the sampling tip and the gas sampling conduit.

[0223]

[0294] In the embodiment shown in FIG. 61, the distal end 7064 (comprising the longitudinal fold central support and the distal end) of the gas sampling tip 7050 is curved outwardly or convex so as to form a projecting shield that prevents the end opening of the gas inlet aperture 7230 from aspirating against the patient's cheek, mouth, lip, or nostril. The sides of the longitudinal fold 7240 at the distal end portion of the sampling tip 7050 can also be curved outwardly to form a substantially spherical distal end.

[0224]

[0295] The sampling tip and / or sampling tube and / or mounting member can be a disposable product for single use by a patient, or can be configured to be reusable by making it from a material suitable for an autoclave for cleaning or reducing the risk of infection using a sterilization process.

[0225]

[0296] Any of the embodiments described herein can be used in combination with a breathing device such as a nasal cannula to place a sampling interface on a patient. The nasal cannula can supply a high flow of breathing gas through the nasal cannula to the patient's airway. The gas is generally oxygen or a mixture of air / oxygen. The gas is humidified by a humidifier before being delivered to the patient. The high flow gas causes turbulence and flushes the pharynx, and also pushes oxygen / breathing gas into the patient's airway. The cannula continuously provides gas to the upper airway of the patient. The gas sampling interface is used to sample the gas exhaled and / or excreted by the patient. Due to the versatility of the interface, the interface can optionally be placed away from the gas supply, and as a result, the gas sampling measurements are less diluted than when gas sampling and gas delivery are performed at the same physical location as the patient.

[0226]

[0297] The interface can be attached or engaged to a portion of the user's face such as the cheek, lip, or nostril. When the interface has a hook-shaped free end portion, or can be operated to provide a hook-shaped portion (such as the embodiments shown in FIGS. 1-6, FIGS. 9-26, FIGS. 37-48, FIGS. 52-55, FIG. 70, and FIG. 71), the interface can be hooked around a portion of the patient's face such as the mouth or nostril, engaged to the patient's face, and the interface can be placed in the vicinity of the patient's airway.

[0227]

[0298] The sampling interface can be attached to a portion of the cannula / respiratory device to hold the gas sampling interface in an operational position, for example, by clipping it in place. For example, the respiratory device or nasal cannula can optionally be used as a mounting element for attaching the sampling interface to the respiratory device, rather than taping the interface to the patient's face. Optionally, the interface can be attached to the respiratory device using any of the mounting member embodiments shown in Figures 26-37 and 49-57, which are suitably attached to the respiratory device.

[0228]

[0299] Combining the gas sampling interface with a nasal cannula-type respiratory device reduces the need for additional headgear or tape. Furthermore, attaching or clipping the gas sampling interface to the nasal cannula reduces the pressure on the user's cheeks or nostrils.

[0229]

[0300] It will be further understood that any combination of the embodiments of the tip structure can be used in any of the embodiments described herein. For example, the gas sampling interface may comprise any of the embodiments of the gas sampling tip shown in Figures 4-8, 14-25, 55, 58-66, and 68A-71.

[0230]

[0301] Nasal cannulas and exhalation and / or exhalation gas sampling interfaces can be used in patients with apnea as well as patients who are breathing spontaneously. Since patients with apnea do not have active exhalation, the amount of CO2 released from the patient, if any, is not very large. Furthermore, low-flow respiratory gas delivery systems cannot establish the turbulent flow model necessary to push CO2 out of the physical dead space in the lungs of patients with apnea. Again, this means that patients with apnea do not release much CO2. Moreover, the small amount of CO2 released is diluted by the gas flow from the respiratory device / gas delivery system. This dilution makes it even more difficult to identify whether or not CO2 is being released from the patient's lungs, or how much CO2 is being released. In cases of apnea, CO2 cannot usually be detected in the nose or mouth because there is no ventilation from the patient to push the CO2 out there. It has been found that the turbulence generated in the lungs by high-flow respiratory therapy pushes CO2 from the lungs to the nose and / or mouth, potentially enabling respiratory / gas sampling. Oscillating high-flow therapy can amplify this response, making it possible to increase the probability of detecting CO2 in the nose or mouth. It has been shown that combining cardiac oscillation with high-flow respiratory therapy can provide a certain level of ventilation because the respiratory gases move with the patient's heartbeat and are expelled by the cardiac pulse. The gas sampling interface of the present invention is particularly suitable for measuring the exhaled and / or exhaled gases of apnea patients, especially when used with a respiratory gas monitor having sufficiently low resolution and / or a specific algorithm that deals with very small amounts of CO2 (which can be as low as at least one-tenth of the normal range). As a result, the gas sampling interface of the present invention can be used to determine whether there is an open airway in an apnea patient and whether high-flow respiratory therapy is working, and to measure the level of CO2 exhaled and / or released by the patient.

[0231]

[0302] The above description of the present invention includes preferred embodiments of the present invention. Modifications to the present invention can be made without departing from the scope of the present invention.

[0232]

[0303] In this specification, the term “comprising” means “consisting at least in part of.” When interpreting any expression in this specification that contains the term “comprising,” other characteristics may also exist that do not begin with that term. Related terms such as “comprise” and “comprises” should be interpreted similarly.

[0233]

[0304] Wherever an integer or component having a well-known equivalent is referred to in the above description, those integers or components are also incorporated herein, as they are individually described.

[0234]

[0305] The methods, apparatus, and systems disclosed can also be broadly considered to include, individually or collectively, any combination of two or more of the parts, elements, and features referenced or described in this disclosure.

[0235]

[0306] The scope descriptions herein are intended solely as a concise way of referring individually to each distinct sub-scope or value that falls within that scope, unless otherwise indicated herein, and each distinct sub-scope or value is incorporated herein as if it were individually described herein.

[0236]

[0307] References to prior art in this specification do not constitute an affirmation or any suggestion that such prior art forms part of common knowledge in any field of effort in any country in the world, and should not be interpreted as such.

[0237]

[0308] Some specific features, embodiments, and advantages of certain configurations of this disclosure have been described with reference to the use of a gas humidification system in conjunction with a respiratory therapy system. However, it is advantageous that the specific features, embodiments, and advantages of using the gas humidification system described herein can also be used in conjunction with other therapeutic or non-therapeutic systems that require gas humidification. The specific features, embodiments, and advantages of the methods and apparatuses of this disclosure can be equally applied to their use in other systems.

[0238]

[0309] While specific embodiments have been described in this disclosure, other embodiments that would be obvious to those skilled in the art are also within the scope of this disclosure. Therefore, various changes and modifications can be made without departing from the spirit and scope of this disclosure. For example, the positions of various components can be changed as desired. Furthermore, not all of these features, embodiments, and advantages are necessarily required to implement this disclosure. Accordingly, the scope of this disclosure is intended to be defined solely by the following claims.

Claims

[Claim 1] The invention described in the specification.

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