TW201841666A - Breath sampling interface - Google Patents

Abstract

There is provided a respiratory gas delivery and sampling system, a gas sampling system, a gas sampling interface and a gas sampling tip that may be used to sample exhaled and/or expired gases from a patient, particularly from a patient who is apnoeic and/or who is receiving high flow respiratory therapy. The gas sampling system comprises a respiratory gas monitor in fluid communication with the gas sampling interface, which comprises the gas sampling tip of the invention. The gas sampling interface comprises a gas sampling conduit and the gas sampling tip is located at a free end of the conduit. The gas sampling interface may be configured to allow the gas sampling tip to be selectively positioned at or in the mouth or a nare of the patient's nose.

Description

Breath sampling interface

This application is generally directed to respiratory gas therapy. More particularly, the present application relates to a system for simultaneously breathing gas supplied by the breathing apparatus to the patient, and capturing expiratory gas (e.g., CO ₂₎ or outgoing / near the nose or mouth of the patient interface . In use, the interface includes or is typically fluidly coupled to a gas sampling conduit that is fluidly coupled to the respiratory gas monitor. The interface can be particularly useful when measuring the exhaled and/or exhaled gases of a patient receiving a high flow of breathing gas.

In a medical setting, it is common practice to monitor the patient's exhaled and/or exhaled gas concentration using a gas sampling system including a respiratory gas monitor that is coupled to a gas sampling interface including a gas sampling tube to deliver the disease. Exhaled and/or exhaled gas to the respiratory gas monitor. Respiratory gas monitor is well known in the art, and can range from to monitor a plurality of different types of gases (e.g. nitrogen, O _2, CO ₂ and anesthetic gases, etc.) of a more comprehensive monitoring is to only monitor a single type of gas More specialized monitors. An example of a more specialized respiratory gas monitor is a carbon dioxide graph/carbon dioxide monitor that draws a patient's exhaled and/or exhaled gas into a gas sampling interface that is connected to a carbon dioxide graph/carbon dioxide monitor. Monitor carbon dioxide. An anesthesia machine 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 Breathing Gas Monitor provides a small amount of suction to draw gas into the sampling conduit.

The respiratory gas monitor receives exhaled and/or exhaled gases via a sampling conduit of the gas sampling interface. For example, the inlet of the sampling catheter can be positioned adjacent the patient's nose or mouth such that the sampling catheter captures the exhaled and/or exhaled gases that pass through the inlet and then enters the catheter. In some cases, the inlet may be fluidly connected to or form part of a respiratory device, such as a mask or catheter. In some cases, the sampling catheter is independent of the patient interface, and the end of the sampling catheter can be held or adhered to the appropriate location on the patient's face.

Although gas sampling is commonly used in anesthesia patients, known gas sampling interfaces, gas sampling catheters, and gas sampling processes are still difficult.

For example, the process of attaching a sampling catheter to a patient's face requires some preparation time and skill from a part of an anesthesiologist, anesthesiologist, caregiver, or other medical professional. The sampling catheter must also be placed correctly to place the catheter/tube so that the catheter/tube reliably captures the exhaled and/or exhaled gases.

The gas sampling interface or sampling catheter can also be removed if the patient moves his or her head, or if the instrument is used close, or has to be manipulated around the sampling interface or catheter.

Some gas sampling interfaces may also interfere with instruments or equipment such as mouthpieces, endoscopes, or laryngoscopes. Alternatively, if a portion of the sampling catheter is located within the patient's mouth, the end of the sampling catheter may be blocked by saliva or blood, or may be inhaled into the patient's cheek or on the patient's tongue.

Current methods do not allow for simple repositioning of the sampling interface when needed. For example, when a patient is mainly clear from the nose or mouth breathing before the program, reliable sampling of CO ₂ may be difficult. For example, if the sampling catheter is glued to the appropriate location on the patient's nose, and then it is apparent that the patient is primarily breathing from the mouth, the catheter will need to be removed and the catheter then adhered to the patient's mouth. position. Repositioning the sampling catheter in this manner requires a repetitive sampling catheter attachment procedure that is quite time consuming.

Accordingly, it is desirable to provide a sampling interface, the sample interface facilitates engagement sampling conduit such that the engagement of the patient is rapid, and the catheter is placed in the exhalation reliably capture and / or in the exhaled CO _2.

Sampling of the gas is particularly difficult when the patient has an apnea (the amount of gas exhaled or exhaled by the apnea patient is very low). Because there is no patient ventilation to effectively expel gas away from the lungs, and any gas coming out of the nose or mouth is significantly thin, it is impossible to accurately detect exhaled CO ₂ in the nose or mouth (its It may simply spread from the airway of patients with apnea). It is possible to sample the exhaust gas from anywhere in the exhausted gas pipe (ie, from the back of the throat to the tracheal carina). However, sampling in the posterior portion of the throat can be difficult in the process of requiring access to the patient's airway (as in the oral process where the sampling interface can interfere with the surgeon's tools). It is also difficult (and sometimes impossible) to intubate patients undergoing oral surgery. For this reason, high-flow respiratory therapy can sometimes be used to provide breathing gas to patients undergoing oral surgery or undergoing surgery through the mouth, but high-flow therapy can also be used in numerous other medical procedures. High flow therapy refers to the supply of respiration to an adult patient via a respiratory device at a high flow rate (typically between about 15 L/min and about 150 L/min, preferably between about 30 L/min and about 120 L/min). gas. However, traffic defined as high flow rates can vary from patient to patient. For example, in high flow treatment of newborn babies, breathing gas is typically supplied at a flow rate of about 2 L/min/kg. Low flow catheters typically do not provide breathing gas at flow rates above 15 L/min.

The nature of high flow therapy results in significant dilution of exhaled gases from patients, making it difficult to accurately measure CO ₂ and other exhaled gases.

More specifically, the anatomical void is the total volume of the airway leading to the patient from the nose and mouth to the terminal bronchioles. During normal exhalation, this dead space is filled with gas from the CO ₂ -rich the lungs. Again sucked into the lungs at the transition point from exhalation to inhalation, the gas remaining in the CO ₂ -rich ineffective chamber as part of inhalation. When a CO ₂ monitor (i.e., no normal patient assisted breathing) In this state, the dead space is filled during exhalation gas enriched in CO ₂ by a gas sampling system, the system measured gas. Due to the uniform gas distribution, the CO ₂ sampling interface can be used for nasal or oral sampling to perform a sampling measurement roughly equivalent to the CO ₂ concentration in the lung, so that the measurement can be inferred. However, monitoring CO ₂ or other exhaled and/or exhaled gases while providing high flow therapy (supplying breathing gas to the patient via a respiratory device at high flow rates) is difficult. This is due to the irrigation mechanism provided by the high flow therapy, which alters the flow pattern within the anatomical void, resulting in an uneven distribution of exhaled gases. Qieyi by fresh gas from the breathing apparatus by psychogenic pulse (to a small extent) removed from the dead space or "flushed" from the CO ₂ -rich gas stream to the lungs. As a result, high flow mode with treating a vortex gas recirculation characteristics of motion, resulting in less CO ₂ is sucked again. When a non-uniform gas distribution is sampled from the nose and/or mouth, an ineffective quantitative measurement is performed by a standard respiratory gas monitor in the gas sampling system. A compensation algorithm can be implemented to help explain incorrect measurements, and if sufficient CO ₂ is sampled, a qualitative interpretation of the gas sample is still possible.

U.S. Patent No. 7,337,780 discloses a combined gas delivery and gas sampling interface. The interface includes a nasal cannula having a mouth passage in which gas is delivered through one of the nasal cannula of the catheter and the gas is sampled through both the cannula and the mouth channel. The mouth channel includes a wire spine that bends the mouth channel to a desired location to sample exhaled gas from the patient's mouth. However, catheters are not suitable for providing high flow therapy, delivery therapy through the two nostrils of the patient's nose, or allowing selective gas sampling from the nose or mouth.

Accordingly, it would be useful to provide a gas sampling interface that can be used to selectively sample exhaled and/or exhaled gases from the mouth or nose, even when supplying gas to an apnea patient under high flow therapy.

After the use of the sampling catheter, in order to prevent contamination, the sampling catheter is typically disposed, replaced or sanitized prior to the next patient.

Therefore, it is also advantageous to facilitate the disposal or sanitization of the sampling catheter or related components.

According to a first aspect, a gas sampling interface is provided, comprising: a catheter having a body having a hook portion for engaging a portion of a patient's face, the body defining a cavity for receiving a patient call An inlet for gas and/or exhaled gas and an outlet for delivering exhaled and/or exhaled gases to the gas measuring device.

In one form, the hook portion is adapted to engage the patient's face at or near an orifice of the patient's face. Preferably, the hook portion is adapted to engage a patient's mouth or a portion of the patient's mouth. The hook portion can be adapted to engage a patient's nose or a portion of the patient's nose. Preferably, the shape of the hook portion is adjustable. In one form, the hook portion includes a substantially convex portion. Preferably, the body further includes a substantially concave portion that leads to the substantially convex hook portion that leads to the other substantially concave portion.

Preferably, the interface is disposable.

In one form, the catheter is a dual catheter lumen. In one form, the gas sampling interface further includes a length of ductile wire occupying one of the cavities.

In another form, the catheter is a single lumen catheter.

Preferably, the conduit is a polymeric material or comprises a polymeric material.

The catheter can be connected to the sampling tube via a luer connector.

Preferably, the inlet has a mouth having a cross-sectional area that is greater than the cross-sectional area of the conduit or cavity.

In one form, the catheter has alternating or varying depth heads when viewed in cross section.

Optionally, the catheter includes a plurality of gas receiving apertures or openings around the perimeter of the head and/or along the distance of the catheter from the tip. Preferably, the catheter includes one or more non-circular openings around the perimeter of the head and/or along the distance of the catheter from the tip.

Preferably, the interface head includes a filter or head structure adapted to substantially inhibit liquid ingress. The head structure can include an absorbent porous sponge or foam material that at least partially surrounds the tip of the interface.

Preferably, the head structure includes a cover, cage, roller or spacer surrounding the interface head. In one form, the cover includes a substantially cylindrical member. In another form, the shield includes an elongate member having a substantially C-shaped cross section. In yet another form, the cover includes an elongate member having a substantially square cross section. Optionally, the cover has one or more openings or slits. For example, the cover can include a toothed member. Alternatively, the cover may comprise a curved element. In one form, the cover includes a substantially V-shaped element. In another form, the cover includes a planar element.

According to a second aspect, a gas sampling interface is provided, the gas sampling interface including a hook for engaging a portion of a patient's face and an expiration for securing the gas sampling catheter relative to the hook such that the inlet receives the patient Or an exhalation attachment member of the gas.

Preferably, the hook is rigid. Or, the hook is flexible. In one form, the position of the gas sampling conduit relative to the hook is adjustable.

Preferably, the attachment member is detachably attached to the gas sampling conduit. In one form, the attachment member is comprised of or includes a channel. In another form, the attachment member is comprised of a clip or a pair of clips or includes a clip or a pair of clips. In one form, the attachment member is constructed of or comprises an elastomeric material. The attachment member can optionally be integrally formed with the hook. Alternatively, the attachment member is an element that is separate from the hook.

According to a third aspect, a gas sampling interface is provided, comprising: a nasal cannula having a manifold and at least one nasal cannula or outlet extending from the manifold to be received by a patient In the nostrils; and an attachment member that secures the gas sampling catheter relative to the nasal cannula such that the inlet receives exhaled or exhaled gas from the patient.

Preferably, the attachment member is detachably attached to the gas sampling conduit. In one form, the attachment member is comprised of a clip or a pair of clips or includes a clip or a pair of clips. In another form, the attachment member is comprised of or includes a strap or sleeve. Optionally, the attachment member is comprised of or comprises an elastomeric material. In one form, the attachment member is integral with the manifold and/or the at least one nasal cannula or outlet. In another form, the attachment member is an element that is separate from the manifold and/or at least one nasal cannula or outlet. Preferably, the position of the gas sampling conduit is adjustable relative to the attachment member.

According to a fourth aspect, an assembly is provided, the assembly comprising a gas sampling conduit and an attachment member for securing the gas sampling conduit to the nasal conduit, wherein the attachment member is attachable to the nasal conduit, the attachment member comprising at least two An offset clip attachable to the gas sampling conduit to allow the gas sampling conduit to follow a tortuous path when connected.

Preferably, the attachment member is detachably attached to the gas sampling conduit. In one form, each clip includes a tube receiving area in which a portion of the gas sampling conduit can be retained.

In one form, the attachment member includes a sleeve including a body and a pair of spaced apart arms projecting from the body, wherein the sleeve further includes an interior region between the arms and an opening to the interior region, Wherein the opening is formed along the length of the sleeve and is defined by a side edge of the arm, and wherein the inner region is configured to receive a portion of the respiratory device. Optionally, the body of the attachment member includes a sleeve including an inner region and an opening to the inner region, wherein the opening is formed along the length of the sleeve and is defined by the side edges of the sleeve, and wherein the inner region is Configured to receive a portion of the respiratory device. Preferably, the inner region comprises a substantially arcuate inner surface. For example, the sleeve can include a substantially C-shaped cross section. In another form, the sleeve includes a substantially U-shaped cross section. Optionally, the substantially arcuate inner surface is formed by a plurality of substantially flat surfaces joined in series to form a substantially arcuate shape. In this form, the sleeve can include a substantially C-shaped cross section. Alternatively, the sleeve may comprise a substantially U-shaped cross section. Preferably, the sleeve is formed from a substantially flexible elastomeric material. For example, the sleeve can comprise a polymeric material. Preferably, the inner region of the sleeve is substantially curved, and the inner region of the sleeve is sized to receive a portion of the gas delivery tube of the nasal conduit, and the width of the opening between the side edges is less than attached The diameter of the portion of the gas delivery tube that the member holds. In one form, the arms of the sleeve are offset from one another. Each clip can form a hook that includes a curved arm that extends from the body and terminates at a distal end, wherein the arm can include an inner surface that forms a substantially concave receiving area. Preferably, the substantially concave receiving area has a diameter at least as large as the diameter of the gas sampling lumen. In one form, the distance between the distal portion of the hook and the body is less than the diameter of the gas sampling conduit.

Preferably, the attachment member is configured to be attached to a side arm of a catheter such as a nasal cannula. Optionally, the concave receiving area of the clip is sized or shaped to match the shape of the side arm of the catheter. In one form, the concave receiving area of the clip includes a plurality of flat surfaces shaped to receive the side arms of the catheter.

According to a fifth aspect, there is provided a gas sampling head removably coupled to an inlet of a gas sampling conduit, wherein the sampling head includes a body including a substantially hollow interior region, the hollow The inner region is configured to be in fluid communication with the inlet of the gas sampling conduit when coupled to the gas sampling conduit, and wherein the body also includes a distal portion including a distal surface and an outer surface, wherein the gas sampling head Further comprising at least one gas receiving aperture to receive a patient exhalation or exhalation gas, and wherein the gas receiving aperture is in fluid communication with the substantially hollow interior region of the body.

Preferably, at least one gas receiving hole is formed in both the distal end surface and the outer circumferential side surface such that the gas receiving hole extends from the distal end surface and along the outer side surface. In one form, the at least one gas receiving aperture forms an elongated opening in the distal end portion of the gas sampling head. The distal end of the gas sampling head can be bent outward. For example, the distal end portion of the gas sampling head can be substantially spherical.

Preferably, the gas sampling head includes three gas receiving apertures evenly spaced around the distal end of the sampling head. Preferably, the distal end of the gas receiving aperture(s) is narrower than the opposite end of the gas receiving aperture(s).

In one form, the gas sampling head has a substantially cylindrical shape and forms a substantially circumferential outer side surface. Preferably, each portion of the body between the gas receiving apertures defines a recess wherein the recesses are substantially evenly spaced around the circumference of the distal end portion of the gas sampling head.

According to a sixth aspect, a gas sampling interface is provided, the gas sampling interface comprising: a gas sampling conduit including an inlet for receiving a patient's exhaled or exhaled gas and an outlet connected to the respiratory gas monitor; And a removable sampling head at the inlet of the conduit, wherein the sampling head includes a body including a substantially hollow interior region configured to be coupled to the gas sampling conduit An inlet of the gas sampling conduit is in fluid communication, and wherein the body further includes a distal end portion including a distal end surface and an outer side surface, wherein the gas sampling head further includes at least one gas receiving aperture to receive a patient exhalation or exhalation The gas, and the gas receiving aperture therein, is in fluid communication with a substantially hollow interior region of the body.

Preferably, at least one gas receiving aperture is formed in both the distal end surface and the outer side surface such that the gas receiving aperture extends from the distal end surface and along the side surface. The gas receiving aperture can form an elongated opening in the distal end portion of the gas sampling head. In one form, the distal end of the gas sampling head is outwardly curved. For example, the distal end portion of the gas sampling head can be substantially spherical.

Preferably, the gas sampling head comprises three gas receiving apertures evenly spaced around the distal end of the sampling head. The distal end of the gas receiving aperture(s) may be narrower than the opposite end of the gas receiving aperture(s). In one form, the gas sampling head has a substantially cylindrical shape. The gas sampling head can include three gas receiving holes that are evenly spaced around the distal end of the sampling head. Preferably, each portion of the body between the gas receiving apertures defines a recess wherein the recesses are substantially evenly spaced around the circumference of the distal end portion of the gas sampling head.

The gas sampling conduit can include a first chamber and a second chamber through which gas can flow, wherein the flexible resilient structural support member is positioned in the second chamber to allow the gas sampling conduit to be bent into a desired shape and substantially maintained as desired shape. Alternatively, the gas sampling conduit includes a tube wall in which the flexible resilient structural member is located. A gas sampling conduit can be coextruded with the structural member to enclose the structural member within the wall of the conduit. The structural support member can comprise metal filaments. For example, the structural support member can include a wire. The wire can be formed at least in part from stainless steel, aluminum or nickel titanium.

According to a seventh aspect, a gas sampling interface is provided, the gas sampling interface comprising a gas sampling conduit including a gas inlet, a gas outlet, and a malleable spine that allows the gas sampling tube to be bent into a desired shape; wherein the gas sampling The interface further includes a removable gas sampling head including at least one gas receiving aperture in fluid communication with the gas inlet of the gas sampling conduit.

Preferably, the malleable spine is semi-rigid to allow the gas sampling conduit to be bent into a desired shape and substantially maintain the shape. In one form, the extensible spine includes a wire. The wire can be formed at least in part from stainless steel, aluminum or nickel titanium.

Preferably, the gas sampling head comprises a body having a substantially circular cross section, and further comprising at least three gas receiving holes formed in the body, wherein each gas receiving hole extends from the distal end of the body and along the side of the body And the gas receiving holes therein are evenly spaced circumferentially around the body to form a groove between adjacent gas receiving holes.

According to an eighth aspect, the present invention provides a gas sampling head for connection to an inlet of a gas sampling conduit, wherein the sampling head includes a body including a substantially hollow interior region, the substantially hollow interior region being configured The fluid sampling conduit is in fluid communication with the inlet of the gas sampling conduit, and the central body also includes a distal portion having a distal wall and an outer surface, wherein the gas sampling head further includes a gas receiving aperture, the gas receiving aperture being connected To the interior region and configured to receive exhaled or exhaled gas from the patient, and wherein the gas receiving aperture extends substantially around the entire outer periphery of the outer surface.

Preferably, the gas sampling head end wall is supported by a centrally disposed support member coupled to at least one inner wall of the body, and wherein the gas receiving aperture extends around the entire outer periphery of the outer side surface. The body of the sampling head can be substantially cylindrical, and the gas receiving aperture forms an annular aperture around the outer side surface of the body. In one form, the body of the sampling head is substantially cylindrical and the gas receiving aperture forms a helical aperture around the outer side surface of the body.

According to a ninth aspect, the present invention provides a gas sampling head comprising a body having a substantially hollow interior region, wherein the body comprises one or more side walls forming an outer side surface of the body, configured to interact with a gas The sampling conduit is coupled such that the hollow interior region is in fluid communication with the gas sampling conduit, the proximal end, the distal end defined by the end wall, and the intermediate body further comprising a gas receiving aperture that defines an opening into the hollow interior region of the body, Wherein the gas receiving aperture extends substantially around the entire outer periphery of the outer side surface of the body.

In one form, the end walls are substantially transverse to and offset from the gas receiving aperture. Optionally, the end wall is formed integrally with the body. The cross section of the wall may be the same as or larger than the cross section of the gas receiving hole. In one form, the end wall is longitudinally offset by a distance equal to or greater than the width of the gas receiving aperture. Optionally, the end wall overhangs from a portion of the body by a support member, which may include a strut, a rod, an arm or an elongated extension. In one form, the body is substantially cylindrical and the gas receiving aperture forms an annular ring around the body. Alternatively, the body is substantially cylindrical and the gas receiving apertures are helically disposed about the body.

According to a tenth aspect, the present invention provides a respiratory therapy system for delivering a high-flow respiratory therapy to a patient and sampling an exhaled or exhaled gas of the patient, wherein the system includes: a respiratory device including the patient An interface and a respiratory gas delivery tube connected to the gas source to deliver high-flow breathing gas from the gas source to the patient via the respiratory gas delivery tube via the patient interface; and a gas sampling interface, The gas sampling interface includes a catheter including a first end in fluid communication with the respiratory gas monitor and a second distal end including at least one inlet for receiving exhaled or exhaled breathing gas from the patient, wherein the catheter is at least A portion is flexible to allow the inlet to be selectively positioned at the patient's mouth or nose. In some forms, the respiratory device provides breathing gas to the patient at a flow rate between about 15 and about 150 L/min. Optionally, the respiratory device provides breathing gas to the patient at a flow rate between 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 forms, the respiratory device provides a high flow of breathing gas to the patient at a flow rate greater than about 30 L/min, greater than about 40 L/min, greater than about 50 L/min, greater than about 60 L/min, or greater than about 70 L/min. Optionally, the system is configured to deliver respiratory gas to a neonatal infant patient at a flow rate of about 2 L/min/kg.

In one form, the catheter includes a flexible, resilient support structure that allows the distal portion to be manipulated into a desired shape and selectively directed to the patient's nose or mouth. The flexible resilient support structure can include a wire positioned within the catheter that allows at least a portion of the catheter to be bent to form a hook shape. Optionally, the wire has a smaller diameter than the inner diameter of the conduit, and wherein a gap is formed between the wire and the inner wall of the conduit to allow gas to flow along the conduit. In one form, the conduit includes a first gas receiving chamber and a second support chamber. In this form, the wire is located in at least a portion of the support cavity. Optionally, the wire is coextruded with the gas sampling conduit. In one form, the lead is located in the distal portion of the catheter to allow the distal portion to flex to form a hook shape.

In one form, the system also includes an attachment member that attaches the gas sampling interface to the respiratory device. Optionally, the attachment member is integral with or attached to the respiratory gas delivery tube, and the attachment member comprises: a sleeve at least partially surrounding a portion of the respiratory gas delivery tube; wherein the sleeve The cartridge includes at least one clip on an outer surface of the sleeve for receiving a portion of the catheter to attach the catheter to the respiratory device. In one form, the sleeve includes a pair of clips that are offset from one another. Each clip can include a hook that includes a tube receiving area in which a portion of the catheter can be located to follow a tortuous path. Preferably, the hooks face in opposite directions to each other.

In one form, the gas sampling interface further includes a head at the distal end of the catheter, wherein the head includes a substantially hollow body including at least one gas receiving aperture to receive exhaled or exhaled gas from the patient, Wherein the gas receiving aperture is in fluid communication with at least one inlet of the catheter, and wherein the body of the head further comprises a distal portion comprising a distal surface and an outer surface. At least one gas receiving hole may be formed in both the distal end surface and the outer circumferential side surface such that the gas receiving hole extends from the distal end surface and along the outer side surface. In one form, the at least one gas receiving aperture forms an elongated opening in the distal end portion of the gas sampling head.

In one form, the body of the head includes a substantially cylindrical shape. Optionally, the distal end of the gas sampling head is outwardly curved. Preferably, the distal end portion of the gas sampling head is substantially spherical.

In one form, the gas sampling head includes at least three gas receiving apertures evenly spaced around the distal end of the sampling head. Optionally, each portion of the body between the gas receiving apertures defines a recess, wherein the recesses are substantially evenly spaced around the circumference of the distal end portion of the gas sampling head.

Preferably, the respiratory device is a nasal cannula.

Preferably, the patient receiving the treatment from the respiratory device is apneaed.

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 catheter comprising: a first end in fluid communication with a respiratory gas monitor and a second distal end, the second distal end including at least one inlet for receiving exhaled or exhaled breathing gas from the patient; a gas sampling head located at the distal end of the catheter and including a substantially hollow body The substantially hollow body includes at least one gas receiving aperture to receive a patient exhalation or exhalation gas, wherein the gas receiving aperture is in fluid communication with at least one inlet of the catheter, and wherein the body of the head further includes a distal surface and an outer surface The distal part. Preferably, at least one gas receiving aperture is formed in both the distal end surface and the outer circumferential side surface such that the gas receiving aperture extends from the distal surface and along the outer side surface to form an elongated opening in the distal end portion of the gas sampling head.

Optionally, the distal end portion of the gas sampling head is substantially spherical.

In one form, the gas sampling head includes three gas receiving apertures that are evenly spaced around the distal end of the sampling head. Optionally, each portion of the body between the gas receiving apertures defines a recess, wherein the recesses are substantially evenly spaced around the circumference of the distal end portion of the gas sampling head.

In one form, the gas sampling conduit is connected to the gas sampling tube of the respiratory gas monitor via a Luer connector.

In another form, the gas sampling conduit is directly connected to the inlet of the respiratory gas monitor.

In one form, the gas sampling interface is configured to receive exhalation or exhaled gas from a respiratory device at a flow rate between about 15 and about 150 L/min from a patient receiving respiratory gas. Optionally, the gas sampling interface is configured to be between about 30 to about 120 L/min, or between about 60 to about 110, or between about 50 to about 150 L/min or between about 60 to about 100 L/min The flow comes from the breathing device receiving exhaled or exhaled gases from the patient receiving the breathing gas. In some forms, the gas sampling interface is configured to receive from the respiratory device at a flow rate greater than about 30 L/min, greater than about 40 L/min, greater than about 50 L/min, greater than about 60 L/min, or greater than about 70 L/min. Exhaled or exhaled gas from a patient with a flow of breathing gas.

Optionally, the gas sampling interface is configured to receive breathing gas from a neonatal infant patient receiving respiratory gas from a respiratory device at a flow rate of about 2 L/min/kg.

In one form, at least a portion of the catheter is flexible to allow the inlet to be selectively positioned at the mouth or nose of the patient.

According to a twelfth aspect, the present invention provides a respiratory apparatus comprising: a nasal cannula having at least one nasal cannula for supporting a self-manifold extension and to be received in a nostril of a user or a manifold of the outlet; a gas delivery tube in fluid communication with the at least one nasal cannula or outlet for supplying respiratory gas via the at least one nasal cannula or outlet; and an attachment member for A gas sampling interface is attached to the nasal cannula, wherein the gas sampling interface includes a catheter including a first end and a second distal end in fluid communication with the respiratory gas monitor, the second distal end including at least one for receiving a disease An inlet of exhaled or exhaled breathing gas, wherein at least a portion of the catheter is flexible to allow the inlet to be selectively positioned at the mouth or nose of the patient, and the attachment member thereof and the respiratory gas delivery tube or manifold The tube is integral or attached to the respiratory gas delivery tube or manifold, and the attachment member includes a sleeve that at least partially surrounds a portion of the respiratory gas delivery tube or manifold; The sleeve includes a means for receiving the gas sampling portion of the catheter to the catheter attached to the respiratory device at least one clip. Optionally, the sleeve includes a substantially arcuate inner surface to enclose a portion of the respiratory gas delivery tube. The clip can be located on the outer surface of the sleeve. Preferably, the sleeve includes a pair of clips that are offset from one another. Each clip optionally includes a hook that includes a receiving area in which a portion of the catheter can be located to follow a tortuous path. Preferably, the hooks face in opposite directions to each other. In one form, the catheter is held substantially loosely within each clip such that disconnection of the catheter from one of the clips allows the catheter to slide past the other clip to adjust the free end of the catheter extending between the distal end of the catheter and the sleeve. The length of the part. Optionally, the sleeve includes a substantially C-shaped cross section.

In one form, the gas delivery tube supplies breathing gas to the patient at a flow rate between about 15 and about 150 L/min. Optionally, the gas delivery tube supplies the patient with a flow of between 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. gas. In some forms, the gas delivery tube provides a high flow of breathing gas to the patient at a flow rate greater than about 30 L/min, greater than about 40 L/min, greater than about 50 L/min, greater than about 60 L/min, or greater than about 70 L/min.

Optionally, the gas delivery tube supplies breathing gas to the newborn infant patient at a flow rate of about 2 L/min/kg.

According to a thirteenth aspect, the present invention provides a gas sampling head removably coupled to a distal end of a gas sampling conduit, wherein the sampling head includes a body including a substantially hollow interior region, The substantially hollow interior region is configured to be in fluid communication with the inlet of the gas sampling conduit when coupled to the gas sampling conduit, and wherein the body also includes a distal portion having a distal surface and an outer surface, wherein the gas sampling head further At least one gas receiving aperture is included, the at least one gas receiving aperture being coupled to the hollow interior region to receive an expiratory or exhaled gas of the patient, and wherein the gas receiving aperture is in fluid communication with the substantially hollow interior region of the body. At least one gas receiving hole may be formed in both the distal end surface and the outer circumferential side surface such that the gas receiving hole extends from the distal end surface and along the outer side surface. Optionally, the at least one gas receiving aperture forms an elongated opening in the distal end portion of the gas sampling head.

In one form, the distal end of the gas sampling head is outwardly curved. Optionally, the distal end portion of the gas sampling head is substantially spherical. In one form, the gas sampling head has a substantially cylindrical shape. In one form, the gas sampling head includes a body having a substantially cylindrical shape and a substantially spherical distal end.

In one form, the gas sampling head includes three gas receiving apertures evenly spaced around the distal end of the sampling head. 50. The gas sampling head of claim 49, wherein each portion of the body between the gas receiving apertures defines a groove, wherein the groove is substantially uniform around a circumference of the distal end portion of the gas sampling head Interspersed.

Optionally, the gas sampling head is configured to receive exhaled or exhaled gas from a patient to whom the breathing gas is supplied by a respiratory device at a flow rate between about 15 and about 150 L/min. Optionally, the gas sampling head is configured to be between about 30 to about 120 L/min, or between about 60 to about 110, or between about 50 to about 150 L/min, or from about 60 to about, by the breathing apparatus. The flow between 100 L/min receives exhaled or exhaled gases from the patient to whom the breathing gas is supplied. In some forms, the respiratory device provides a high flow of breathing gas to the patient at a flow rate greater than about 30 L/min, greater than about 40 L/min, greater than about 50 L/min, greater than about 60 L/min, or greater than about 70 L/min.

Optionally, the gas sampling head is configured to receive an exhaled or exhaled gas of a newborn infant patient being supplied with breathing gas by a respiratory device at a flow rate of about 2 L/min/kg.

In one form, the head can be attached to a gas sampling interface, the gas sampling interface including a catheter including a first end in fluid communication with the respiratory gas monitor and a second distal end attached to the head, and the second The distal end includes at least one inlet for receiving exhaled or exhaled breathing gas from the patient, wherein at least a portion of the catheter is flexible to allow the inlet to be selectively positioned at the patient's mouth or nose.

According to a thirteenth aspect, the present invention provides a breathing apparatus comprising: a nasal cannula including at least one nasal cannula or an outlet to be received in a nostril of a user; a gas delivery tube, a gas delivery tube in fluid communication with the at least one nasal cannula or outlet to supply respiratory gas via the at least one nasal cannula or outlet; and an attachment member for attaching a gas sampling interface to the nasal cannula, Wherein the attachment member is integral with or attached to the respiratory gas delivery tube, and the attachment member comprises: a sleeve at least partially surrounding a portion of the respiratory gas delivery tube; wherein the sleeve includes A portion of the gas sampling conduit is received to attach the catheter to at least one clip of the respiratory device. Optionally, the sleeve includes a substantially arcuate inner surface to enclose a portion of the respiratory gas delivery tube. In one form, the clip is located on the outer surface of the sleeve. Preferably, the sleeve includes a pair of clips that are offset from one another. Each clip may optionally include a hook that includes a receiving area in which a portion of the catheter may be located to follow a tortuous path. In one form, the hooks face in opposite directions to each other. Preferably, the catheter is held substantially loosely within each clip such that disconnection of the catheter from one of the clips allows the catheter to slide over the other clip to adjust the free end of the catheter extending between the distal end of the catheter and the sleeve. The length of the part. The sleeve can optionally include a substantially C-shaped cross section.

In one form, the gas delivery tube supplies breathing gas to the patient at a flow rate between about 15 and about 120 L/min.

In another form, the gas delivery tube supplies breathing gas to a newborn infant patient at a flow rate of about 2 L/min/kg.

According to a fourteenth aspect, the present invention provides a method of manufacturing a dual chamber gas sampling catheter comprising a body comprising an air chamber and a lead lumen, wherein the catheter is shared by the catheter body Squeeze out to position the wire within the wire guide.

According to a fifteenth aspect, the present invention provides a method of manufacturing a dual chamber gas sampling catheter comprising a body comprising an air chamber and a lead lumen, wherein the catheter is formed by overlying the catheter To position the wire within the wire guide.

According to a sixteenth aspect, the present invention provides a method of sampling respiratory gas from an apnea patient receiving high-flow respiratory therapy using a respiratory therapy system according to a tenth aspect of the present invention, wherein the method comprises the steps of: approaching a patient The airway locates the inlet of the gas sampling interface, receives a sample of breathing gas via the inlet, and uses a respiratory gas monitor to determine if the airway of the patient is open.

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

The present invention consists of the foregoing, and it is also contemplated that the following merely gives an example structure.

In summary, the present invention relates to a respiratory gas delivery and sampling system, a gas sampling system, a gas sampling interface, and a gas sampling head that can be used to sample exhaled and/or exhaled gases of a patient. The gas sampling system includes a respiratory gas monitor in fluid communication with the gas sampling interface, including the gas sampling head of the present invention. The gas sampling interface includes a gas sampling conduit, and the gas sampling head is located at the free end of the conduit. The gas sampling interface can be configured to allow the gas sampling head to be selectively positioned at the mouth (middle) or at the nostrils of the patient's nose (middle). The sampling head includes at least one inlet to receive exhaled or exhaled gases from the patient. The sampling head can also be configured to include a cover or structure that helps prevent fluids, such as moisture or body fluids, from entering the sampling head. Additionally or alternatively, the sampling head can be configured to prevent or reduce the likelihood that the head will adsorb to the patient, such as the patient's tongue or cheek. In some forms, the cap or structure of the sampling head can help prevent fluid ingress and can also help prevent patient aspiration. The gas sampling interface can include a filter at the head of the gas sampling chamber of the sampling interface or at any other location to prevent fluid (such as moisture or body fluids) from entering or moving along the gas sampling chamber into the respiratory gas monitor.

Various gas sampling interface/breath sampling interfaces for use with the respiratory gas monitor of the gas sampling system will now be described. It will be appreciated that any of these interfaces may be used (or connectable) in combination with a respiratory gas delivery and sampling system including a respiratory device for delivering respiratory gases to a patient. Each gas sampling interface can sample the patient's exhaled and/or exhaled gases. Each interface can be used to sample nitrogen, O ₂ , anesthetic gas, and/or CO ₂ . Alternatively, two samples interface for sampling a nitrogen and the other for sampling CO _2. The interface will sample exhaled and/or exhaled gases and may be fluidly coupled to a separate gas analyzer to identify CO ₂ and nitrogen in the exhaled and/or exhaled gases. It will be appreciated that the exhaled gas is the gas that leaves the patient's lungs due to gas exchange in the lungs. Exhaled gas is the gas that is expelled from the lungs (such as gases that diffuse from the lungs) when the patient does not breathe spontaneously (such as when the patient has difficulty breathing). The exhaled gas is a gas that is pushed out from the patient's lungs due to the patient's spontaneous breathing.

The gas sampling interface of the present invention as disclosed herein can be disposable or reusable. A filter can be connected between the end of the sampling interface, the interface inlet and the sampling conduit to allow the sampling conduit to be reused. The gas sampling interface 100 and/or filter can vary for each patient. The disclosed gas sampling interface and gas sampling catheter can be used alone to engage a portion of the patient's face, or the gas sampling interface and gas sampling catheter can be attached to a respiratory device (such as a nasal catheter) that delivers breathing gas to the patient. , nasal mask, mask or other form of patient interface).

The gas sampling interface of the present invention can be used with respiratory devices that provide a high flow of breathing gas to a patient. In general, respiratory devices provide high-flow breathing gas to patients with apnea (such as during anesthesia), but devices and interfaces can also be used to measure breathing gases in spontaneously breathing patients. In order to provide breathing gas at high flow rates, the gas can typically flow between about 15 L/min and about 150 L/min for adult patients. An exemplary flow rate of respiratory gas provided to the patient by the patient interface is between about 15 to about 150 L/min; between about 30 to about 120 L/min; between about 40 to about 100 L/min; about 50 to about Between 80 L/min; between about 60 and about 100 L/min; and between about 35 and about 75 L/min. In other examples, the high flow breathing gas may be supplied to the disease at a flow rate between 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. Suffering. In some forms, the patient may be supplied with a high flow of breathing gas at a flow rate greater than about 30 L/min, greater than about 40 L/min, greater than about 50 L/min, greater than about 60 L/min, or greater than about 70 L/min. Traffic that may be considered "high traffic" may vary, depending on the size of the patient. For example, a newborn infant patient can supply a high flow of breathing gas at a flow rate of about 2 L/min/kg. In some forms, the gas sampling interface is configured to have an adaptive shape and/or position relative to the respiratory device. By providing an interface with an adapted shape, the interface is manipulated to best interface with the patient, such as by hanging on the patient's lips, cheeks or nostrils. It is also possible to adjust the orientation and position of the interface by manipulating the interface to be close to the patient's mouth or nose. This allows the clinician to select the optimal location of the interface and can easily change the location if needed. By providing an interface having an adjustable position relative to the respiratory device, the interface can be oriented toward the patient's mouth or nose as described above, and the length of the free end portion of the interface associated with the respiratory device can be readily adjusted. An interface with a free end portion that can be easily adjusted in length allows the interface to be used for patients with different sized faces. For example, when used in a child, the gas sampling interface of the present invention requires a shorter free end portion than when used in an adult. Where the sampling interface of the present invention is adjustable in shape and/or position, the interface is particularly versatile and can be used in 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 nose depending on whether the patient's mouth is open and the type of medical procedure being performed.

FIG. 1 illustrates an embodiment of a gas sampling interface 100. The gas sampling interface 100 includes a gas sampling conduit 101 having a body 103 that is preferably formed partially or completely from a substantially cylindrical wall (as shown in Figure 1) to provide the body 103 along its length. A substantially circular cross section. The catheter shown in Figure 1 has a single lumen extending along the length of the catheter and is therefore referred to herein as a single lumen catheter. However, the gas sampling conduit can include one, two or more lumens within the conduit. A gas sampling catheter comprising two lumens within a catheter is referred to herein as a dual lumen catheter. Both lumens of the dual lumen catheter may extend only partially along the entire length of the catheter, or the first support lumen may extend only partially along the length of the catheter (as will be described in further detail later in this specification), and The second air chamber can extend substantially along the entire length of the catheter,

The size of the catheter and its lumen(s) is important for its operability. It will be appreciated that the outer diameter of the catheter will be determined by the desired inner diameter of the lumen(s) and the material from which the catheter is made. It is important that the inner diameter(s) of the cavity(s) are not so large that the catheter is too large to allow the patient to comfortably use and to easily operate to the desired shape and position. It is also important that the inner diameter(s) of the cavity(s) are not too small relative to the outer diameter of the conduit, such that the airflow through the conduit is improperly obstructed, or the walls of the conduit are so thick, making it difficult The catheter is operated to the desired shape and the catheter is held substantially in this shape.

Preferably, the body of the gas sampling conduit 101 has an outer (or outer) diameter of between about 2.5 mm and about 5.0 mm. The diameter can be from about 3.5 mm to about 4 mm, or from about 3.0 mm to about 3.5 mm, or from about 3.1 mm to about 3.4 mm, or from about 3.2 mm to about 3.3 mm. Preferably, the body of the gas sampling conduit has an outer diameter of about 3.8 mm. The inner diameter of the gas sampling conduit (with a single lumen of the conduit) is preferably between about 0.5 mm and about 2 mm to correspond to the inner diameter of the main sampling tube or gas sampling tube of the respiratory gas monitor without causing Additional resistance to fluidity. For example, the inner diameter of the catheter can be from about 1.2 mm to 1.4 mm. Preferably, the inner diameter is about 1.4 mm.

In one form, the tubular body of the gas sampling conduit 101 has a wall thickness of about 0.9 mm. In this form, the body 103 of the catheter can have an outer diameter of about 3.0 mm and an inner diameter of about 1.2 mm. This form of gas sampling conduit preferably includes a single air cavity within the conduit.

In one form, the dual lumen catheter has an outer diameter of between about 2.5 mm and about 5.0 mm. In one form, the outer diameter can be about 3.2 mm. The diameter can be from about 3.5 mm to about 4 mm, or from about 3.0 mm to about 3.5 mm, or from about 3.1 mm to about 3.4 mm, or from about 3.2 mm to about 3.3 mm. Preferably, the body of the gas sampling conduit has an outer diameter of about 3.8 mm. In another form, the outer diameter is about 4.0 mm. The lumens within the catheter can have the same diameter or different diameters. For example, the cavities can each have an inner diameter of about 1.2 mm. In one form, the dual lumen catheter has an outer diameter of about 3.8 mm and each lumen has an inner diameter of about 1.4 mm. Alternatively, for example, the first cavity can have a diameter of about 1.0 mm and the second cavity can have a diameter of about 1.3 mm. In another form of dual lumen catheter, the catheter can have an outer diameter of about 3.8 mm. In this form, the first chamber can have an inner diameter of about 0.6 mm and the second chamber can have an inner diameter of about 1.4 mm.

It is desirable that the outer diameter of the catheter be relatively small to take up less space in the patient's mouth.

In one embodiment, as shown in FIG. 2, the gas sampling interface includes a dual lumen catheter 201. This catheter is similar to the catheter shown in Figure 1 and uses similar numbers (plus 100) to indicate similar parts. In the embodiment shown in Figure 2, the catheter body 203 has a circular cross section along its entire length. The catheter includes a flexible resilient support structure that allows the catheter to be manipulated into a desired shape (e.g., a hook shape). The support structure can take many different forms. For example, the support structure can include a wire, rod or band of flexible elastomeric material (e.g., metallic material) extending along at least a portion of the catheter, preferably at the free end portion of the catheter. In one form, the catheter includes a first support cavity in which a support structure, such as a wire, can be located. The lead can be inserted into the cavity or coextruded with the catheter, or a portion of the catheter can be overlaid around the lead. In other forms, the support structure can be formed around the outer wall of the catheter, or the outer wall can be made of a suitable material that provides the support structure.

In the embodiment shown in Figure 2, the catheter includes a first support cavity 201 to house a support structure in the form of a wire in the first cavity. The first support cavity or wire cavity has a substantially circular cross section along its entire length. The second air chamber 202 for receiving exhalation and/or exhalation gas has a substantially crescent shaped cross section along its entire length. The first cavity 201 is located inside and on one side of the second cavity 202 such that the crescent-shaped cross section of the second air cavity is formed by the shape of the open space surrounding the first inner cavity 201. In an alternative embodiment of a dual lumen catheter, each lumen may have a substantially D-shaped cross section (as shown in Figure 9), or a substantially semi-circular cross section, or substantially circular along its entire length. Cross section. Preferably, the air chamber has a cross-sectional area greater than about 1.3 mm. Preferably, the height of the air chamber is greater than about 1.5 mm. Preferably, the width of the air cavity is greater than about 1.5 mm. Figure 13 shows a dual lumen catheter wherein each lumen includes a substantially circular cross section along its length.

The gas sampling conduit 101 can be comprised of or comprise a polymeric material. The material can be any suitable medical material such as PVC, TPU or silicone resin. The hardness of the material is preferably from about 30 to about 85 on a Shore A durometer. The material is preferably transparent such that the interior of the catheter is visible, for example to see if saliva, blood or other bodily fluids that may be present have been drawn into the catheter. The sampling conduit material can include a hardness of less than 90 on a Shore A durometer. This reduces the torque of the catheter on the patient's end of the interface (compared to a harder catheter) and thus reduces the chance of the sampling catheter falling out of the patient's mouth or nostrils. Softer materials are also more comfortable on the patient's face. The material may comprise polyurethane or tantalum resin. Alternatively, the material may comprise PVC.

The gas sampling conduit 101 has at least one inlet for receiving exhaled and/or exhaled gases from a patient, or a gas receiving aperture or opening 107. The inlet 107 can be formed in a distal portion of the catheter, such as in the outer wall of the catheter or at the distal end of the catheter. In the embodiment shown in Figure 1, the inlet is located at the distal end 108 of the body 103 of the catheter. Conduit also has an outlet for the exhalation and / or the exhalation gas to the respiratory gas monitor 109, monitor the respiratory gas may be carbon dioxide graph / carbon dioxide monitor, or other form of gas monitor to monitor the level of CO ₂ And/or other levels of breathing gas. The outlet 109 can be in fluid communication with a gas sampling tube or gas sampling line fluidly connected to the respiratory gas monitor. In another form, the outlet of the gas sampling conduit can be directly connected to the respiratory gas monitor.

The catheter is preferably at least 30 cm long. This means that if the patient is on the catheter, any connector/luer connector that connects the catheter to the gas sampling tube of the respiratory gas monitor will not be under the patient's head (which may be uncomfortable).

The catheter 101 can be configured to engage the patient's face in a desired shape such that the catheter can be easily attached to the patient's face/engaged to the patient's face and detached from the patient's face/ Separated from the patient's face. In a preferred form, the catheter can be shaped as a hook to hook the patient's lips or teeth or the patient's cheeks or nostrils. In this form, it may be unnecessary to adhere the catheter to the patient's face so that the catheter can be quickly and easily positioned at the desired location and quickly and easily removed after use.

In one form, for example, as shown in FIGS. 1 and 3 to 6 , 10 to 12 , 14 to 26 , 37 to 46 , 48 , 52 , 55 , 70 , and 71 As shown, the catheter 101 includes a hook portion 105 that is preferably located at a distal end portion of the catheter. In one form, the tubular structure of the catheter can include a flexible, resilient support structure that allows a portion of the catheter to be formed into a hook shape and substantially maintain the position. In another form, the tubular structure of the catheter can be attached to a rigid or semi-rigid hook to form a catheter having a hook portion. In another form, the catheter can be fabricated in a manner that includes a hook portion, such as an end formed in a hook shape. The hook portion 105 forms a hook shape for engaging a portion of the patient's face.

The hook portion 105 of the catheter 101 is adapted to engage the patient's face at the orifice of the patient's face or near the orifice of the patient's face. In one embodiment, the hook portion 105 is adapted to engage a portion of the patient's mouth or patient's mouth. In use, the hook portion 105 wraps around the patient's cheek and into the patient's mouth. The hook portion 105 allows the head 108 and inlet 107 of the catheter 101 to be suspended within the patient's mouth, if desired. In another embodiment, the hook portion 105 is adapted to engage a patient's nose or a portion of the patient's nose, such as the patient's nose or nostrils. In this embodiment, the head 108 or inlet end of the catheter can be at least partially suspended or positioned within the patient's nostril or in the nostril, or can be at least partially suspended or positioned adjacent the nostril/nostril.

The hook portion of the catheter can comprise a semi-rigid or rigid material that forms a flexible elastic support structure or spine that allows the catheter to be bent or manipulated into a desired shape. In some forms, the catheter can be configured to substantially maintain the desired shape indefinitely. In other forms, the catheter can be configured to substantially maintain the desired shape until manipulated by a user to form a different shape.

In one form, the flexible resilient support structure can include a length of extended wire, such as, for example, a cable or rod located within the conduit. The wire is preferably a metal wire. The wire may extend along one or more portions of the catheter, or the wire may extend substantially along the entire length of the catheter. The distal or patient end of the lead can be coated with a soft material so as not to scratch or scratch the patient's face. Alternatively, the patient end of the lead can be positioned far enough back into the catheter so that it does not extend beyond the distal end of the catheter. In a further alternative, the ends of the wires can be sealed within the walls of the conduit. In a further alternative, the lead can be located within the support lumen/line lumen of the dual lumen catheter, and the patient end of the cord can be secured along one or more points of the inner wall of the lumen to hold the wire in place And prevent the wires from moving out of the cavity.

In another form, the catheter can include at least one lumen that acts as both a lead/support lumen and an air lumen. In this form, the catheter can include a wire having a diameter that is smaller than the inner diameter of the lumen. The wires can be held within the cavity at one or more locations. In such an arrangement, the catheter can be bent around the wire, but one or more gaps are provided between the wire and the inner wall of the cavity such that gas can pass along the cavity for sampling by the respiratory gas monitor. The cavity does not completely seal the incompressible wires to prevent complete blockage.

A length of ductile wire may occupy at least the hook portion of the catheter, or the wire may extend substantially along the entire length of the catheter. For example, in the dual lumen catheter shown in FIG. 2, the lead 210 can occupy one or more portions of the first lumen 204 of the dual lumen catheter 201, or the lead can extend substantially along the entire length of the first lumen 204. The presence of wire 210 provides rigidity to conduit 201 and gas sampling interface 200. The lead 210 is also flexible to allow the first support catheter 201 (and thus the catheter 201) to be adjusted to a degree to further customize the shape of the patient's facial interface. In particular, the shape of the hook portion can be formed by bending the wire 210 to form a desired hook shape to engage the patient's face.

The wire may comprise a stainless steel wire that can be bent/reshaped multiple times without breaking. The diameter of the wire can be between about 0.4 mm and 1.0 mm, and preferably about 0.6 mm or 0.7 mm. Preferably, the wires are of the order of 304. These properties produce suitable ductility to allow the user to easily reshape/bend the catheter by hand. In another form, the wire comprises an aluminum wire. In another form, the wire comprises a nickel-titanium wire.

In one form, the line 210 is located on the inner curve of the hook portion. This is to reduce the risk of kinking the gas sampling conduit during bending. Alternatively, the wire 210 can be positioned on the outer curve of the hook portion, or along the side, or at any other orientation or location around the length of the catheter.

Another form of dual lumen catheter 1200 is shown in FIGS. 12 and 13. The first lead/support cavity 1211 includes a wire that forms a plastic shape. The second air chamber 1213 can be coupled in fluid communication with the gas sampling tube (the gas sampling tube is in fluid communication with the respiratory gas monitor) or in direct fluid communication with the respiratory gas monitor (wherein the sampling system does not include the monitor and the sampling conduit) Sampling tube). In this dual lumen catheter, the catheter is preferably curved or formed by a catheter located inside the curved portion of the hook portion and a catheter located outside the curve. This arrangement produces lower flow resistance than if the cavities are positioned side by side around the bend. The wire is fed through a first cavity 1211 located on the inner curve of the hook portion of the catheter. This reduces the risk of the wire piercing the catheter wall and reduces the risk of the wire tying the catheter when the wire is bent.

Figure 13 shows a cross section of a dual lumen catheter including a first lead lumen 1211 and a second lumen 12.13. In one form, the air cavity 1213 can include an inner diameter of about 1.2 mm to correspond to the inner diameter of the gas sampling tube of the anesthesia machine or other form of respiratory gas monitor or to the inlet of the respiratory gas monitor. In another form, the air cavity 1213 can have an inner diameter of about 1.4 mm, and the wire cavity can have an inner diameter of about 0.6 mm. A smaller inner diameter will increase the resistance to flow and may increase the chance of clogging in the gas sampling conduit and cause an alarm. It will be appreciated that the inner diameter may alternatively be selected or designed to correspond to the inner diameter of the gas sampling tube of the anesthesia machine or respiratory gas monitor, or to the inlet of the respiratory gas monitor. However, as noted above, the inner and outer diameters of the lumen of the catheter can vary.

The wire cavity 1211 can include an inner diameter of about 1.0 mm. This diameter is to accommodate a 0.7mm wire. It will be appreciated that the inner diameter will be selected or designed to accommodate the wires.

The outer diameter of the catheter can be about 3.1 mm. This diameter was chosen because it allows the catheter to include a catheter having an inner diameter of 1.2 mm and 1.0 mm and having sufficient wall thickness (as described above). A catheter that includes a small outer diameter is advantageous for reducing the size of the interface in the patient's mouth to improve patient comfort and to allow the clinician to have greater accessibility in the mouth. The smaller diameter conduit also allows the interface to be adapted to fit under the bite block.

As shown in Figure 13, the lumen of the catheter may preferably be (but not necessarily) circular (circular or circular). The circular cavity and cavity are more resistant to kinks. In one form, the wall thickness WT1 between the cavities can be greater than the outer wall thickness WT2 and WT3 (the wall thickness of the conduit) of the cavity. Such a wall structure also reduces the risk of kinking in the catheter when the catheter is bent; for example, if the user reshapes the catheter to create a tighter bend in the hook portion. In a preferred form, the gas sampling interface and gas sampling conduit comprise a dual lumen catheter having an outer diameter of about 3.8 mm. The catheter includes a first lead lumen having an inner diameter of about 0.6 mm (to receive a lead having an outer diameter of about 0.6 mm) and a second air pocket having an inner diameter of about 1.4 mm. Both chambers have a substantially circular cross section.

In a dual lumen catheter, the lead preferably extends down the first lead lumen within the catheter. In one form, the wire terminates along a portion of the lumen or conduit. For example, the wire can extend from the free end of the catheter to approximately 60 mm. In another form, the wire can extend substantially the entire length of the catheter. Optionally, the wire is coextruded with the tubular material of the catheter. When the catheter is bent, the free end of the wire can be substantially aligned with the free end of the catheter (or can be slightly retracted from the free end of the catheter). Alternatively, the free end of the wire in the curved conduit may also be substantially aligned with the other end of the wire. This allows for the maximum clamping force of the hook portion of the catheter on the cheek. This design also minimizes the length of the extension through the clamping point, thereby reducing the torque acting on the clamping point that causes the interface to disengage.

In one embodiment, the catheter is fabricated to include a hook portion. For example, during manufacture, the catheter can be started in a straight state, which can then be bent or formed into a hook shape using a jig. It is also possible to apply a heat to the catheter for a period of time to shape the catheter. In another form, the conduit can be a thermoplastic tube. During manufacture, the catheter can be formed into a hook shape by starting in a straight state and prior to setting the catheter to a desired shape to bend it or form a permanently changing hook shape using a clamp and short heating.

In the embodiment shown in FIG. 1, the gas sampling interface 100 is comprised of a gas sampling conduit 101 that includes a length of tubing in which the interface ends of the sampling tubing form a hook shape as shown in FIG. This embodiment can be a single lumen catheter 1 interface or a dual lumen catheter interface. In other forms, the gas sampling conduit 101 can include a sampling head (such as those described later in this specification) such that the catheter and head combination form a gas sampling interface.

Figure 3 shows a spline curve representing a series of curves for an embodiment of a catheter applied to the interface. The catheter can include an additional curved portion directly adjacent the hook that curves toward the interior of the hook curve. That is, when viewed from the outside, the conduit has a generally concave portion 317 that enters a generally convex hook portion 315 that enters another substantially concave portion. Part 319. The recessed portions 317 and 319 can have the same or different curvatures. The resulting combined shape provides a central pinch zone. A narrow pinch point improves patient comfort by minimizing the pinch area. In use, the gripping area can contact the inside and outside of the patient's cheeks or nostrils and help maintain the interface. The additional curved portion and the hook portion additionally provide some resistance to deformation of the catheter, which can exert a small reaction force on the inside and outside of the patient's cheek to help maintain the interface.

In one embodiment, a gas sampling interface or catheter can be hooked around the catheterization to sample exhaled and/or exhaled gases from the patient's nostrils.

The embodiment shown in Figures 7 and 8 would be advantageous in this configuration because the opening will capture gas that is exhaled and/or exhaled from the nostrils of the patient.

One of the additional recessed portions 319 can extend between the raised portion 315 and the distal end of the catheter. In use, this additional concave curved portion can move the sampling catheter away from contact with the patient's face. A further convex curved portion 321 can optionally be disposed between the additional concave curved portion and the distal end of the catheter. This further convex curve 321 can position the distal end of the catheter such that (in use) the sampling catheter extends generally parallel to the patient's cheek and off the patient's cheek. This reduces the torque of the sampling catheter on the hook on the patient's face, thereby reducing or preventing the risk of displacement.

Additional concave curved portions 317 can extend between the hook curved portion 315 and the inlet of the conduit. This additional curved portion 317 can move the entrance of the catheter away from contact with the interior of the patient's cheek. In order to avoid or at least substantially inhibit complete or partial occlusion of the catheter and/or sampling catheter having saliva or other body fluids (e.g., blood) that may be present, it is desirable to move the inlet of the catheter away from the inside of the patient's cheek.

The hook shape can include a series of curves in a generally two-dimensional plane and include at least one curve or bend that curves substantially inwardly to form a hook. The hook shape may comprise a "J", "L", "U", "V", "Omega" or "hairpin" shaped catheter, or any combination thereof. That is, the hook portion may have one or more curved portions, one or more straight portions extending at an angle with respect to the adjacent curved portions, or a combination of the straight portions and the curved portions to form the hooks. In one embodiment, the hook can include two generally parallel portions with curved or angled portions between the parallel portions to form a hook. This increases the surface area of the narrow pinch point in contact with the cheek and increases the stability of the face.

To avoid clogging or clogging the inlet 107, various embodiments of the head are contemplated (as will be described below). It should be understood that the catheter can include any suitable head for receiving exhaled and/or exhaled gases.

In one embodiment, as shown in Figures 4-6, the inlet 408 can have a mouth 407 having a cross-sectional area that is greater than an adjacent portion of the catheter body. This interface is similar to the interface shown in Figure 1, and like numbers are used to indicate similar parts plus 300 units (i.e., 103 and 403). The mouth 407 preferably has a shape that is spaced outwardly from the cavity. Thus, the inlet 408 has an outer shape that is outwardly separated from the body 403. The mouth 407 can be frustoconical, tapered, flared, bell shaped or the like. This shape increases the open area on which the liquid saliva meniscus can be formed. Therefore, the surface tension in the liquid saliva is lowered, so that it is less likely to form a blockage in the catheter.

In one embodiment, as shown in Figure 6, the head 608 can have alternating or varying depths when viewed in cross section. This interface is similar to the interface shown in Figure 1, and like numbers are used to indicate that a similar portion of 500 units is added. For example, the undulating waveform 607 or the incision around the periphery of the head may be apparent when viewed in cross section. This shape destroys areas where liquid saliva or other body fluid meniscus can be formed. Therefore, the stability of the meniscus can be reduced, and the possibility of salivation in the catheter can be reduced. This shape also prevents complete obstruction caused by the internal tissues of the mouth (or nose). The head shown and described with respect to Figure 6 can be used with a single lumen catheter interface or a dual lumen catheter interface.

In another embodiment, such as shown in Figure 7, the conduit 701 can include a plurality of inlets/openings 723 around the perimeter of the head and/or the distance from the beginning of the conduit. This interface is similar to the interface shown in Figure 1, and uses similar numbers to indicate the addition of 600 units of similarity. In the event that one of the openings 723 is blocked, the plurality of openings 723 provide an alternate entry point for receiving exhaled and/or exhaled gases. The plurality of openings 723 can have substantially the same size or varying dimensions. The plurality of openings 723 can be disposed along a particular side or have a larger (as compared to the other) distribution of the opening 723 toward a particular side of the head 708. The shape of the opening 723 can vary. The distribution, size and/or shape of the openings 723 can be varied in combination. Figure 7 shows a portion of this alternative embodiment with a diamond shaped opening. Liquids have a tendency to inhale corners. A diamond shaped opening will help to absorb saliva or other fluids (such as blood) from the center of the blocked hole and also help to break the meniscus. Figure 8 shows a portion of a similar embodiment. Figure 8 has a circular opening 823. It will be appreciated that the head shown in Figure 7 and the head shown in Figure 8 can be substantially straight (as shown in the figures) or can follow the curvature of the spine (as shown in Figure 3 and related). Said). The head shown and described with respect to Figure 7 can be used with a single or double cavity interface.

The diameter or width of the opening may be greater than the inner diameter of the air chamber. This means that the flow resistance of each opening is not greater than the flow resistance of the air chamber. Therefore, if only one opening is exposed, the breathing gas monitor such as the anesthesia machine will not need to absorb against the larger resistance (this may cause blockage and cause an alarm). Any suitable inlet/opening is successful as long as the opening has the same or greater pressure drop (i.e., the same or less flow resistance) as the air chamber itself.

In one form, the inlets/openings 723 and 823 pierce only the outer wall of the air cavity within the conduit to completely enclose the wire within the conduit/support cavity of the catheter. The opening is preferably not located on one side of the catheter contacting the inside of the patient's cheek to prevent the catheter from sucking onto the cheek.

The opening can be located in a portion of the catheter that extends from the distal end of the catheter to the length of the catheter that marks the maximum insertion depth. This ensures that the opening only draws in air from the mouth and does not entrain any ambient air that may dilute the gas reading.

The opening may increase in size toward the end of the catheter. The opening size is chosen such that the resistance to flow through each opening is equal.

The head of the interface may optionally and/or additionally include a head structure that further avoids the entry of saliva or other bodily fluids (such as blood) that may be present (as will be described below).

In another embodiment, the head structure can include a filter that at least partially surrounds the head of the interface, or the filter can be positioned inside the catheter at the distal end of the catheter, or can be positioned within the head. The filter can be substantially porous to allow exhalation and/or exhalation of gas through the filter and into the head of the interface. Additionally and/or alternatively, the filter may include an opening (in addition to the porous opening) to allow passage of exhaled and/or exhaled gases. The filter may also absorb moisture, saliva or other bodily fluids (such as blood) that may be present to prevent or at least substantially inhibit clogging or clogging of the catheter. In one form, the filter can comprise a substantially absorbent porous sponge, foam or other suitable porous material. In another form, the filter can comprise a substantially hydrophobic material (eg, such as a hydrophobic foam material) that dislodges fluid/moisture while allowing exhaled or exhaled gases to pass through the filter and into sampling. head. Suitable hydrophobic foam materials for use in such filters include, but are not limited to, open cell polyurethane foams having hydrophobic coatings (which may be of different densities) and microporous sintered polytetrafluoroethylene. Another suitable material for use as a hydrophobic filter is a hydrophobic textile such as WrapPel made from 100% filament polyester coated in a hydrophobic fluorocarbon. Other possible materials for the hydrophobic filter can be WrapPel and Gore-Tex. In one form, the filter can form a sampling head such that the sampling head is comprised of a filter. In another form, the filter can substantially surround or partially surround the sampling head. In another form, the filter can be placed inside the sampling head or inside the sampling conduit to prevent fluid (such as moisture) from entering the gas sampling conduit from exhaled or exhaled gases or body fluids, or when the fluid has entered the gas sampling conduit. Move the gas sampling tube up.

Alternatively or additionally, a filter for separating the fluid from the gas may be placed at any location along the length of the gas sampling conduit to prevent fluid from moving up the sampling conduit and into the respiratory gas monitor. Help protect the respiratory gas monitor.

In another embodiment, the head structure can include a cover, cage, roller or spacer surrounding the head of the interface. In use, a cover, cage, roller or spacer abuts the patient's inner cheek to move the interface's head away from the patient's inner cheek to reduce saliva or other bodily fluids from expiring and/or exhaling the gas receiving head. possibility. The cover, roller or spacer may be formed integrally with the catheter or separately from the catheter.

Referring to Figures 10 through 13, a further example of a catheter and gas sampling interface will now be described.

Figure 10 shows a spine 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, reducing torque and increasing stability. The shape also reduces or eliminates the chance of the end of the interface being poked into the patient's face, improving comfort. Figures 10 and 11 depict an exemplary spine or shape. The line shown is the centerline of any conduit cross-sectional profile. The hook shape is a smooth curve to prevent kinking in the conduit that can interfere with the airflow and can cause blockage.

The depth of insertion of the catheter into the patient's mouth or into the nose can be selected by the clinician. Generally, the insertion depth is greater than 10 mm, preferably greater than 20 mm. An insertion depth of 10 mm (or less) allows the interface to roll out of the patient's mouth (especially when the patient is sitting upright or semi-erect). The gap formed at the end of the hook (i.e., the space between the distal end of the catheter and the substantially straight portion of the catheter body) is preferably about 5 mm to provide a clamp on the patient's cheek. A longer insertion depth also allows the catheter to extend beyond where the patient's tip is naturally located. This means that patients are less likely to use their tongues to block the ends or push the interface out of their mouths. When patients are not accustomed to foreign objects in their mouths, they may try to remove the foreign objects with their tongues; this may be a problem.

Referring to Figures 14 through 25, an alternative embodiment of a catheter with a cover will now be described. As noted above, if the inlet at the distal end of the catheter is blocked, the catheter can have several small inlets/openings or a larger inlet/opening 1427 near the tip of the catheter to provide an alternate gas path. The cover shown and described with respect to Figures 14-25 prevents or at least substantially prevents the opening(s) from being blocked. The cover may have an extension that is curved about the hook portion to prevent or at least substantially prevent the outlet of the cover from being inserted into the mouth through the patient's lips. The cover may be non-circular to prevent or at least substantially inhibit the patient's cheek from being fully encapsulated and/or sealed around the cover. The cover may include a slit to allow gas to enter. The cover may include one or more protrusions that prevent the patient's cheeks or lips from sealing over the opening(s). One or more protrusions allow saliva/blood to drain from the tube opening(s). In one form, the cover can form a separate component that is attached to the catheter. Alternatively, the cover may have a triangular shape. In one form, the cover may only partially cover the inlet(s)/(s) opening such that the cover does not completely cover the opening(s). In one form, the cover may cover only some of the inlets/openings of the catheter.

The inlet(s) of the conduit having the plurality of openings may be sized to provide a flow resistance similar to a single inlet formed in the distal end of the conduit such that the gas passes uniformly through the plurality(s) Opening. The size of the opening can also be set to minimize the maximum velocity through the catheter to reduce the risk of saliva or other bodily fluids (such as blood) that may be present being drawn into the catheter. For example, for a catheter comprising a single lumen having an inner diameter of 1.2 mm, the elliptical aperture can be 1 mm x 5 mm. Figure 14 shows an oval opening without a cover. Figure 15 illustrates an embodiment with a cover.

Figure 15 shows a gas sampling interface or conduit having a shroud 1529 surrounding the conduit to cover an opening in the conduit to prevent partial or complete clogging of the opening. The cover of Figure 15 is in the form of a substantially cylindrical element.

The cover may have a non-flat area to increase the surface area and angle over which the inside of the patient's cheek must be sealed to create a blockage.

Figure 16 shows the cover with internal ribs 1630 to keep the cover 1629 away from the exterior of the catheter and the opening protected by the cover.

In one form, as shown in Figure 17, the cover 1729 can extend through the patient's lips during use so that if the patient's lips are sealed around the interface, gas may still be entrained from the outside air to prevent partial or complete Occlusion and subsequent machine alarms.

Alternatively, the catheter can include a barrier 1830 (shown in Figure 18) at the curved portion of the hook portion to prevent the distal end of the cover 1829 from being inserted into the patient's mouth through the patient's lips or inserted into the nostrils too deep . In other words, the barrier can form a depth limit that prevents the gas sampling catheter from being inserted into the patient's mouth or too deep in the nostrils.

The cover can be open downwardly along the entire length of one side such that if the patient's lips are tight, gas from the patient's mouth can still enter the gas sampling conduit via the opening.

Figure 19 shows a cover 1929 in the form of an elongate member having a generally C-shaped cross section.

The cover may be non-circular to at least substantially inhibit the patient's cheeks from completely encasing and/or sealing around the cover. For example, Figures 20 and 21 show a square cover 2029/2129 having a generally square cross section. The cover has a slit 2032/2132 or opening to allow gas to enter the sampling conduit via the cover when the patient's lips are closed.

Figures 22 and 23 illustrate the form of a cover having protrusions that prevent the patient's cheeks or lips from sealing on the gas sampling catheter inlet. Figure 22 shows a cover having a plurality of protrusions in the form of sleeves to form a toothed member 2229. FIG. 23 shows a cover including a bell shaped protrusion to form a curved member 2329. Each arrangement of the protrusions forms a hood that allows saliva and/or other bodily fluids (such as blood) that may be present to be expelled from the catheter inlet, reducing the risk of clogging of the inlet.

The cover may be attached to the catheter either integrally with the catheter or as a separate component. Alternatively, the cover can be attached to or fed through a portion of the catheter that extends out of the patient's mouth and is attached to the patient's mouth to reduce the risk of the portion of the cover falling out of the patient's airway.

Figure 24 shows an example of a cover 2429 having an alternative projection including an outwardly extending arm that forms a generally triangular or V-shaped member around the catheter inlet. Figure 25 shows a cover in the form of a planar element having an arm projecting from the side of the catheter.

In one form, the gas sampling interface can be attached to the respiratory device via an attachment member, which can be a separate component that can be attached to both the respiratory device and the sampling interface, or can be part of forming a respiratory device (or An attachment member integral with the respiratory device, or may be an attachment member that forms part of the sampling interface (or integral with the sampling interface).

The sampling interface can be attached to the respiratory device at any suitable location. For example, where the respiratory device is a nasal cannula, the sampling interface can be attached to a manifold of the catheter, or a strip attached to the headgear, or to a respiratory gas delivery tube. Where the breathing apparatus is a mask, the sampling interface can be attached to the frame of the mask, the seal of the mask or the strip of the mask headband or the breathing gas delivery tube.

Figure 26 illustrates a form of breathing apparatus that includes a form of gas sampling interface of the present invention that is coupled to or integral with a respiratory device. The breathing apparatus includes a nasal cannula that is connected to a gas sampling interface. The nasal cannula includes a manifold and at least one nasal cannula or outlet extending from the manifold for receipt in a nostril of a user. The nasal cannula also includes an attachment member for securing the gas sampling catheter relative to the nasal cannula such that the inlet(s) of the gas sampling conduit receive exhalation and/or exhalation of gas from the patient. In an alternate embodiment, the respiratory device can include a different form of patient interface (such as a mask, nasal interface, or full face mask) and an attachment member for securing the gas sampling catheter relative to the patient interface such that the catheter The portal receives exhaled and/or exhaled gases from the patient. Breathing equipment provides high-flow breathing gas to patients.

The attachment member can include any suitable attachment system to attach the gas sampling catheter to a nasal cannula or other form of patient interface. For example, the attachment member can include a clamp, a pair of clamps or a strap. The attachment member can comprise an elastomeric material.

Where the patient interface is a nasal cannula, the attachment member can be integral with the cannula of the cannula and/or at least one nasal cannula or outlet. Alternatively, the attachment member can be a separate component that can be attached to the manifold and/or at least one nasal cannula or outlet or to another suitable portion of the respiratory device, such as a respiratory gas delivery tube.

27-34 illustrate various embodiments of attachment members configured to attach a catheter of a respiratory sampling interface 100 to a manifold or headgear strap of a cannula of a respiratory device (both in the figure) 28. Figures 30, 32, and 34 are all indicated by 4000).

The position of the gas sampling conduit can be adjusted relative to the attachment member. For example, Figure 35 illustrates an attachment member/connector for a patient interface, wherein the attachment member includes a headgear clip 3550 that includes a foot strap clamp 3550 that is adapted to secure the catheter to a respiratory device, such as a nasal cannula. Fixture 3551. A headband clip connects the headgear strap to the side arm of the nasal cannula. The side arms of the nasal cannula include complementary clamp receivers.

Figure 36 illustrates another form of attachment member/connector for a nasal cannula. A connector in the form of a manifold portion 3650 can be inserted into the nasal cannula. The manifold portion is connected to the gas supply tube at the threaded end. The opposite end is inserted into a complementary hole in the nasal cannula to supply gas to the cannula of the nasal cannula. The manifold portion includes a clamp 3651 for securing the gas sampling conduit.

Figure 37 illustrates a respiratory device incorporating the connector/attachment member of Figures 35 and 36 coupled to a nasal cannula, and also showing the relative position of the respiratory device on the patient's face. A gas sampling conduit is attached to the conduit using a clamp similar to that shown in Figures 35 and 36.

The method of holding the breathing apparatus that incorporates either or both of the connector/attachment members of Figures 35 and 36 allows the gas sampling catheter to be attached to the respiratory device independent of the patient's facial shape and/or size.

The gas sampling catheter is typically held slightly in or near the patient's mouth, or just inside or near a nostril of the patient, to reduce fluid inhalation into the catheter or from the catheter to the patient (eg, sucking the patient's cheek) Or a chance of clogging on the lips. Positioning the catheter in this manner is less invasive and less obstructive than known sampling systems that require the entrance of the gas sampling interface to be positioned at the back of the patient's mouth. By positioning the catheter in or near the oral cavity or nasal cavity, it is possible to reduce the risk of the sampling catheter creating a pressure point or agitating the patient.

In one form, the gas sampling interface or conduit can be integrated with the catheter and molded or extruded to form a portion having two gas chambers; an air chamber in fluid communication with the respiratory gas monitor and an air chamber/tube and conduit The gas flow source is in fluid communication. For example, the gas sampling interface or conduit can be partially coextruded or co-molded with the gas delivery tube of the conduit.

In one form, the gas sampling conduit can be clamped to a respiratory device, such as a nasal cannula. The sampling catheter can be clipped onto the catheter during manufacture or provided by the end user for flexibility of use. In one form, only one clamp can be used to connect the sampling conduit. Alternatively, multiple clamps can be used across at least a portion of the length of the catheter to impart additional stability and positioning control of the sampling catheter relative to the catheter. The fixture can be placed on one side of the patient's face so that there is no device on the other side of the face. Alternatively, the clamp can be placed on either side of the nasal cannula of the catheter.

In one form, the nasal cannula and the gas sampling conduit can be configured to connect the gas sampling conduit to the gas sampling tube of the respiratory gas monitor and simultaneously connect the conduit to the gas delivery source, and have a single connection comprising two connectors and / or have a single connection movement.

As noted above, the sampling catheter can be a single lumen catheter. Alternatively, the sampling catheter can be a dual lumen catheter having a lead within at least one lumen to provide positional control of the sampling catheter such that the catheter can be selectively positioned in the patient's mouth or in the patient's nose One (or nearby) nostril.

Other forms of attachment members can be used to attach the gas sampling catheter to the respiratory device. For example, Figures 27 and 28 illustrate an embodiment of an attachment member in the form of a strap or ring 2740. The belt or ring may comprise an elastic or elastomeric material such as TPE or silicone. The strap or ring 2740 can be stretched and slid over the catheter and gas sampling catheter. The position of the conduit is indicated by 2741 and the position of the gas sampling conduit is indicated by 2743. The catheter side of the strap 2740 can have a thinner wall portion (e.g., 0.5-1 mm) to ensure that it is compact and has sufficient stretch on the patient's face. The catheter side of the strap 2740 can have a thicker wall portion (eg, 1.5 mm - 2 mm) to ensure that the catheter does not stick to the strap when pulled and/or repositioned, and that the clamp does not move with the catheter. The cross-section of the belt may be circular, triangular or irregular, and/or depending on the cross-section of the conduit.

29-34 illustrate an embodiment of an attachment member in the form of a clamp 2940, a clamp 3140, and a clamp 3340 that can slide over the catheter. The position of the catheter is indicated by 2941/3141/3341, and the position of the gas sampling catheter is indicated by 2943/3143/3343. 29 and 30 show a clamp having an overlapping portion 2945. Figures 31 through 34 illustrate a clamp having a tongue 3145/3340/3341 extending from the clamp body to provide a space for insertion and retention of the catheter therein. The tongue can be bent or bent to allow for the insertion. The clamp of Figures 33 and 34 also shows a curved tongue 3345 that provides space for insertion of a gas sampling conduit and retention of the catheter therein. Each tongue can be bent or bent to allow for the insertion. For example, the gap between the tongue and the clamp body may be smaller than the outer diameter of the gas sampling conduit or a portion of the conduit to be attached to the clamp, as appropriate. In this arrangement, the flexible nature of the tongue allows the cannula or conduit to be pushed into the gap such that the tongue moves away from the clamp body to allow the cannula or catheter to be positioned between the clamp body and the tongue. Once the cannula or conduit is in the position within the clamp, the pressure on the tongue can be removed, causing the tongue to return to its natural rest position, and without sufficient force to force the tongue away from the fixture body again. The cannula or catheter cannot be removed from the fixture. The tongue may be offset towards the clamp body. In some forms, the gap between the tongue and the body of the clamp may be slightly smaller than the portion of the conduit held by the clamp or smaller than the outer diameter of the conduit such that the cannula or conduit is gently clamped between the tongue and the body of the clamp. between. Embodiments may include polymeric materials such as polypropylene. In one form, the clamp can have a broken cross section that allows the space through which the conduit passes. The clamp can have a fixed gas sampling conduit and can be a separate part of the clamp (such as a partial cylinder or cylinder). The cross-sectional design can depend on the cross-section of the conduit.

In one embodiment, the gas sampling interface includes a hook for engaging a portion of the patient's face and an attachment system for securing the gas sampling conduit relative to the hook such that the inlet of the catheter receives the patient's exhalation and/or exhaled gas . The hook can be inserted into the patient's nostrils or the patient's mouth. For example, the hook can be inserted into the corner of the patient's mouth. The hook provides a system by which the catheter is attached to the patient to position the catheter in the vicinity of the mouth or nose.

The hook can be rigid. Alternatively, the hooks can be flexible. In a further alternative, the hooks can be a combination of rigid and flexible materials or features. The rigid or flexible hook can be a molded polymeric material.

The hook can include any suitable attachment system including, for example, at least one attachment member (such as a channel, clamp, pair of clamps or straps) that secures the gas sampling conduit to the hook. The attachment member can comprise an elastomeric material.

The attachment member can be integral with the hook or with a separate element to the hook. The position of the gas sampling conduit can be adjusted relative to the hook.

The following alternative embodiments of the gas sampling interface include rigid hooks that can be supplied in different sizes based on patient body measurements.

Referring to the embodiment shown in Figure 38, the gas sampling interface includes a rigid hook 3860 for supporting a gas sampling conduit. Figure 38 shows an embodiment of a hook having a narrow area. The shape of the hook is similar to the shape of the spine shown and described in FIG. The narrow area advantageously provides some compression of the patient's cheek to secure the hook in place. In the embodiment of Figure 38, the narrow area is approximately 8 mm.

The radius of the end of the hook defines the minimum radius of curvature of the gas sampling catheter, thereby preventing kinking of the catheter and providing a gap around the thicker area of the patient's cheek (the face worm) near the patient's mouth.

An angled or curved portion is provided on the outside of the mouth, wherein the hook forms a shape away from the cheek to allow for easy hook attachment and removal.

The following embodiment of the gas sampling interface incorporates a gas sampling conduit that includes a flexible resilient support structure (such as a wire). The lead may be a wire or rod that is positioned (overmolded or co-molded) or otherwise attached or bonded to the exterior of the gas sampling conduit that is positioned in the cavity of the gas sampling conduit. This allows for positional adjustment of the free end of the catheter. Alternatively, the hooks can be semi-rigid, but still extendable so that no wires are needed.

In some forms, the gas sampling conduit can slide along the hook to change the length of the free end of the catheter that can extend beyond the free end of the hook. In another form, the catheter can be attached to the hook such that the free end portion of the catheter is at a desired length. When combined with the ability to move the gas sampling conduit relative to the hook, the gas sampling conduit end position is limited only by the length of the catheter tubing, the length of the lead within the catheter, and the physical limitations imposed by the patient or the necessary surgical or procedure equipment. .

38-46 illustrate an embodiment of a rigid and semi-rigid hook having different features and/or a method of attaching a gas sampling conduit to a rigid or semi-rigid hook.

The embodiment shown in Figures 38-40 includes a connecting member having a one-piece clamp 3861 on the outside of the rigid hook. The clamp 3861 allows the sampling conduit 3863 to be pressed into the fixture via a curved clamp or a curved gas sampling conduit or both. The clamp also allows the sampling conduit to be axially pulled or pushed through the clamp to adjust the length of the free end portion of the gas sampling conduit. Once adjusted, the clamp holds the sampling catheter in place relative to the hook.

41 and 42 illustrate a hook having a catheter attachment system having attachment members that include a clamp 4167 that is integral with the internal passage 4165 of the hook 4160. This embodiment allows the gas sampling conduit 4163 to be pressed into the fixture via a bending fixture or a curved gas sampling conduit. This embodiment also allows the gas sampling conduit 4163 to be axially pulled or pushed through the clamp 4167 and channel 4165 such that the free length of the tube can be adjusted. Furthermore, this embodiment maintains the gas sampling conduit 4163 in a fixed position relative to the hook 4160.

FIG. 43 shows a perspective view of an alternate embodiment of a rigid hook of gas sampling interface 4360. This embodiment incorporates a rigid end stop for positioning and constraining the flexible element for attaching the sampling tube to the rigid hook.

44 illustrates an embodiment of a rigid hook having the rigid hook of FIG. 43 and a sleeve forming member 4469 for holding the gas sampling conduit 4463 while allowing adjustment of the length of the free end portion of the gas sampling conduit. The sleeve can be ribbed to provide an additional grip on the outside of the patient's cheek.

Figures 45 and 46 illustrate an embodiment of a hook having an attachment system that has been overmolded on a hook. These embodiments include a rigid polymeric hook 4560 and one or more overmold sleeves each forming an attachment member. A gas sampling conduit is passed through the casing(s) to attach the gas sampling conduit 4563 to the hook. The length of the free end portion of the gas sampling conduit can be adjusted by pulling the conduit through the sleeve/overmold material until the desired length extends beyond the sleeve. That is, the sleeve/overmold portion or component is secured to the rigid hook by mechanical and/or chemical locking without being secured to the gas sampling conduit. These embodiments can incorporate curved ridges and other features such as a soft handle.

As mentioned above, the hook can be flexible. The flexible preformed hook is inserted into the corner of the patient's mouth and provides an attachment for securing the gas sampling catheter to the patient's mouth or nose. One advantage of the flexible hook is that the shape of the hook can be changed, for example, by bending to accommodate the size of the patient's mouth.

The embodiment shown in Figures 47 and 48 incorporates a flexible wire, rod or strip (metal or polymer) wire that is overmolded with a suitable flexible polymer (in a flat position). Or co-molding, then forming a hook prior to delivery to the customer; the suitable flexible polymer such as TPE or silicone. This embodiment includes attachment members that include a clamp 4761 for external attachment of the gas sampling conduit 4763. In this embodiment, the overmold material is bonded to a wire such as an internal flexible wire, rod or tape (metal or polymer) to allow the hook size and shape to be easily modified to accommodate individual patients. The overmold design includes one or more connecting members (clamps) for connection to a gas sampling conduit. The overmold design can include features for bending release at suitable locations to enable the overmold wire to be bent into a hook shape. In this embodiment, there may be a curved release feature for wire positioning in the mold. The hook can be pre-formed prior to delivery.

Referring to Figures 49-53, an alternate embodiment of an attachment member having a dual flexible tube or sleeve for attachment to two tubular members is illustrated. The tubular member can include a gas delivery conduit and a gas sampling conduit, or the tube can include a gas sampling chamber and a support chamber, or the tube can include, for example, a pair of gas sampling chambers. In such embodiments, the gas sampling interface may incorporate a gas sampling conduit with a wire, such as a wire, or rod or strip, located within the lumen of the wire, the wire being integrated (eg, by overmolding or co-molding) ) to the tube material of the catheter or adhered or bonded to the exterior of the catheter. The gas sampling catheter is preferably formed in a hook shape for attachment to a patient's mouth. Embodiments also include a gas sampling conduit having a wire (e.g., a metal wire, or rod or strip) located in one of two or more chambers within the gas sampling conduit. The wires can be integrated (eg, by overmolding or co-molding) into the tube material of the catheter or adhered or bonded to the outside of the tube to allow for the catheter to be provided by providing a semi-flexible and resilient end of the catheter Position adjustment is made, the semi-flexible and resilient end can be bent into a desired shape to engage the patient's mouth or nostril during gas sampling.

Engagement of the two conduits may be via one or more attachment members including a clamp having limited or no motion relative to the hook conduit (4973/5073/5173) while allowing axial movement of the sampling conduit Pass through the clamp (4971/5071 / 5171) so that the free length of the catheter can be adjusted. Multiple fixtures may be required. Figures 49 through 51 show various embodiments of the clamp 4970/5070/5170. The clamp can be a molded or extruded component. FIG. 52 shows the gas sampling conduit 5263 attached to the hook 5260 by the clamp 5270.

Figure 53 shows a clamp 5270 molded around a pair of lumens of a dual lumen catheter. The clamp 5270 can be overmolded on the cavity and co-molded with the cavity. This type of clamp maintains a cavity that is substantially equidistant from one another, but also allows the lumen of the catheter to be axially pulled or pushed over the overmolded or co-molded material through the clamp so that the free length of the catheter can be adjusted. A plurality of overmolded or co-molded clamps can be used along the length of the conduit.

Figure 54 shows a cross section of a drawstring catheter wherein the first tether is used for gas sampling and the second tether is configured to form a hook shape. The cord of the catheter can be unwrapped and cut such that the second drawstring shape can be designed to form a hook that is substantially shorter than the first drawstring for gas sampling. The gas sampling cord can also be formed into a suitable hook shape to best sample the patient's exhaled or exhaled gas. Figure 54 shows a gas sampling conduit comprising a first drawstring having a gas sampling chamber 5481 and a wire cavity 5843, and a second drawstring having a second wire cavity 5485 for forming a hook shape.

In one embodiment, as shown in Figure 55, the gas sampling interface includes a gas sampling conduit 6163 and an attachment member 6140 to secure the gas sampling conduit to a respiratory device 1000 (such as a mask or nasal cannula that delivers breathing gas to the patient) 8040). In one form, the gas sampling conduit is detachably attached to the attachment member. The attachment member can be configured to be detachably coupled to the respiratory device, or the attachment member can be integral with (and form part of) the respiratory device. For example, the attachment member can be constructed into the design of a nasal cannula, mask, or other respiratory device to removably attach the gas sampling catheter to the respiratory device.

In an embodiment, as shown in FIGS. 55-57, the attachment member 6140 includes a body 6141 that is attachable to the respiratory device 1000. The body 6141 can be clamped onto a portion of the respiratory device. In one form, the body 6141 of the attachment member 6140 can form a substantially or partially enclosed sleeve that encases a portion of the respiratory device 1000.

As shown in Figures 55-57, with the sleeve partially closed, the body/sleeve 6141 includes a pair of spaced apart protruding resilient arms 6150. Each protruding arm terminates at a side edge 6144. The sleeve 6141 includes an interior region 6142 and an opening 6143 leading to the interior region 6142. The arms 6150 can be curved toward each other such that the area between the body 6141 and the protruding arms 6150 forms an interior region 6142 of the sleeve. The opening 6143 is defined by the arms and side edges 6144 of the sleeve and extends along the length of the sleeve. The inner region 6142 is defined by the inner surface of the attachment member and is shaped and sized to receive a portion of the respiratory device 1000 (eg, a portion of a nasal cannula). The arms 6150 can be configured to be biased toward each other, but can have sufficient flexibility to be pushed away, for example, by pushing a portion of the respiratory device 1000 between the arms 6150. The sleeve-like body 6141 is of a material and size such that at least a portion of the respiratory device is retained within the interior region 6142 of the sleeve 6141 by, for example, an arm 6150 that is clamped to the respiratory device. Other forms of attachment may also be suitable. In general, the attachment member 6140 is configured to be attached to the air delivery tube 8060 of the respiratory device 1000, but it is contemplated that the attachment member can be configured to be attached to another portion of the respiratory device, such as a headband of a respiratory device . For example, if the breathing apparatus includes a nasal cannula 8040, the attachment member can be configured to be attached to the air delivery tube 8060, the manifold 8070 of the catheter, the side arm 8080 of the catheter, or the headband 8090 of the catheter.

In the embodiment illustrated in Figures 55-57, the body 6141 of the attachment member 6140 is configured to be attached to a substantially curved portion of a respiratory device, such as respiratory gas delivery tube 8060. In this form, the attachment member 6140 includes a substantially curved sleeve having a curved arm 6150 or an arm, the curved arms 6150 or arms including at least a curved inner surface (as shown) such that the arms are configured to be clipped The outer curved surface of the respiratory gas delivery tube is wrapped tightly or at least partially. In other words, the shape of the inner region 6142 is designed to substantially correspond to the outer contour of the gas delivery tube 8060 of the nasal cannula. For example, the inner region 6142 of the sleeve can be substantially curved to provide a substantially arcuate inner surface to the inner region and a substantially C-shaped cross section to the sleeve such that the sleeve can at least partially enclose the gas delivery tube A portion of the 8060 or other suitable curved portion of the respiratory device, such as a curved portion of the manifold of the nasal cannula. In another form, the sleeve can form a substantially U-shaped cross-section to at least partially encase a portion of the gas delivery tube 8060 or other suitable curved portion of the respiratory device, such as a curved manifold. In another form, the at least substantially arcuate inner surface of the sleeve can be formed from a plurality of substantially flat regions/surfaces disposed in series to form a substantially closed or fully enclosed sleeve. Where the sleeve is substantially closed, the substantially flat surface may be arranged to form a sleeve having a substantially C-shaped cross section or to form a sleeve having a substantially U-shaped cross section. In any form, at least the shape of the inner surface of the sleeve can be designed to substantially match the outer shape of the portion of the respiratory device to which the sleeve is to be attached. For example, if the sleeve is to be attached to a side arm of a nasal cannula having a substantially thin rectangular profile, the inner surface of the sleeve can be formed from three substantially flat regions that are joined at right angles to provide substantially A sleeve with a U-shaped profile.

The sleeve may be formed from a substantially flexible elastomeric material, such as a metal or polymeric material, that allows the sleeve to be pushed over a portion of the nasal cannula and substantially returned to the original resting position or toward the original resting position. The spaced apart side edges 6144 or arms are biased and spaced toward each other in the rest position. Generally, the width of the opening between the side edges 6144 is less than the diameter of the portion of the gas delivery tube 8060 (or other portion of the breathing apparatus) that is held within the cannula such that the breathing apparatus is securely retained within the sleeve.

In an embodiment, the inner surface of the sleeve 6141 can include a plurality of ribs to engage or interlock with the ribbed configuration on the outer surface of the corrugated breathing gas delivery tube 8060. In an embodiment, the attachment member 6140 is detachably coupled to one of the side arms 8080 of the nasal cannula 8040 (or the side arms of the mask) by any suitable connection. For example, the attachment member 6140 can include a pair of spaced apart protruding arms 6150 that are biased toward one another and configured to mate on opposite side surfaces of the side arms of the cannula or mask to attach the attachment members Clamp to the side arm. To match the attachment member 6140 to the side arms, the attachment member 6140 can be positioned such that the side edges of the side arms are located at the opening between the protruding arms 6150 of the attachment member 6140. The arms 6150 are then separated by sliding the projecting arms 6150 of the sleeve 6141 onto the opposite front and rear surfaces of the side arms to push the attachment members onto the side arms. The biasing nature of the arms 6150 is such that the arms 6150 clamp the side arms.

In another form, the attachment member can include a hinged clasp including a pair of arms attached together at a closed hinged end and including opposing receiving ends configured to lend The lids are opened or closed by the arms of the hooks facing away from each other to close and open the hinges. The receiving end of the clasp can include a locking system configured to releasably lock the two arms of the clasp together. Any suitable locking system may be sufficient, such as a hook or post on one arm of the clasp that is configured to engage a hook or aperture on the other arm of the clasp. To match the attachment member to the side arm, the receiving end of the clasp is opened to allow one arm of the clasp to slide under the side arm of the nasal cannula or mask. The other arm is then placed on top of the side arm and locked to the lower arm to clamp onto the side arm and hold the hinged clasp in place. Where the attachment member forms a clamp, the shape of the arms or clamping members of the clamp can be designed to substantially complement the shape of the side arms to maximize grip retention on the side arms (preferably, to maximize Patient comfort).

In an embodiment, the body or sleeve 6141 of the attachment member 6140 includes at least two biasing clamps 6167 (a first clamp and a second clamp) attachable to the gas sampling conduit 6163. The biasing clamp can be located on an outer surface of the attachment member. The offset arrangement of the clamps 6167 causes the gas sampling conduit 6163 to follow a tortuous path when attached. This helps to keep the sampling catheter 6163 in place and reduces the risk that the sampling catheter may be accidentally pulled out of the patient's mouth or nose or accidentally pushed into the patient's mouth or nasal cavity.

Each clamp 6167 includes a tube receiving region 6170 within which a portion of the gas sampling conduit 6163 can be retained.

In one embodiment, each clamp 6167 forms a hook that includes an arm 6168 that extends from the clamp body 6141 and terminates at a distal end 6169 at a distance from the outer surface of the attachment member body 6141. The space between the distal end 6169 of the clamp and the outer surface of the attachment member 6140 forms a clamp opening. The arm 6168 can be curved. For example, the arm 6168 can include an inner surface that forms a substantially curved or concave tube receiving region 6170. The curved profile of the tube receiving region 6170 can be sized substantially corresponding to the curved outer contour of the gas sampling conduit 6163. In one form, the diameter of the curved tube receiving region 6170 can be at least as large as the diameter of the gas sampling conduit 6163. In another form, the diameter of the curved tube receiving region 6170 can be slightly smaller than the diameter of the gas sampling conduit to press against the gas sampling conduit and to help maintain the position of the gas sampling conduit within the clamp 6167. In one form, the hook clamps can face in opposite directions. For example, the first hook can face one side of the gas delivery tube (when located on the tube) and the second hook can face the opposite side.

To assemble the gas sampling conduit 6163 to the attachment member 6140, the conduit 6163 is pushed through the opening of one clamp 6167 and then through the opening of the other clamp 6167 to follow a tortuous path that holds the conduit in place within the clamp. The length of the free end portion of the catheter can be easily adjusted by hooking/removing the catheter from the first clamp and then pulling the catheter in the desired direction such that the catheter slides over the second clamp until the free end portion is at the desired length. The catheter can then be hooked into the first clamp again to secure the catheter in place.

The gas sampling conduit 6163 can be removably mounted within the clamp 6167 of the attachment member 6140 such that the conduit can be replaced, if desired. Thus, the gas sampling conduit can be removed from the attachment member by pulling the sampling conduit out of the clamp opening. Alternatively, the gas sampling conduit can be permanently retained in the attachment member.

Each clamp 6167 is typically formed from a flexible elastomeric material that pushes the gas sampling conduit 6163 into the tube receiving region 6170 and substantially returns once the gas sampling conduit 6163 is positioned within the tube receiving region 6170. In the original state, at least a portion of the hook is allowed to move away from the body 6141. In this embodiment, the distance between the distal end portion of each hook arm 6168 and the body 6141 (clamp opening) can be less than the diameter of the gas sampling conduit 6163 to help prevent the gas sampling conduit 6163 from inadvertently detaching from the clamp 6167.

Depending on the shape and size of the tube receiving area 6170 and gas sampling conduit 6163 in each clamp 6167, the clamp 6167 can be configured to loosely hold the gas sampling conduit 6163 in place within the clamp 6167 or to securely hold the conduit 6163 securely The right place.

In an embodiment, each clamp 6167 can be configured to be clamped to at least a portion of the gas sampling conduit 6163 with sufficient force to attach the conduit 6163 to the clamp 6167 without clogging the flow of gas within the sampling conduit 6163 path.

A connection or attachment member 8050 (such as the luer connector shown in Figures 65-67) may be provided at or near the outlet 109 of the gas sampling conduit 101 of the gas sampling interface 100 to fluidize the sampling conduit 101 and interface 100 A gas sampling tube connected to the respiratory gas monitor. It will be appreciated that any other means of attachment may alternatively be employed between the interface and the gas sampling tube. In another form, the outlet of the gas sampling conduit can be directly connected to the inlet of the respiratory gas monitor.

As described above, the use of a flexible elastic sampling catheter having a support structure (such as a wire) and the use of an attachment member to attach the catheter to the respiratory device, which allows the length of the free end portion to be adjusted is a particularly advantageous embodiment, As shown in Figures 70 and 71, the catheter (and thus the sampling interface) is selectively positionable (elastically bendable/formable) for placement near the mouth or nose. The distal end of the sampling interface can be placed in the mouth at approximately the location of the teeth, near the mouth or near the nostrils or nostrils of the patient. If a nasal cannula is used as a breathing apparatus, it may be difficult to match both the cannula and the sampling interface of the catheter into the patient's nostrils, but depending on the size of the end portion or head of the sampling interface and how the patient is anesthetized, sampling Both the interface and the catheter cannula can be inserted into the nostrils. Alternatively, the sampling interface can be just outside the nostril. Therefore, due to the positioning capability of the sampling interface, the versatility of the sampling interface means that it can be used for patients who breathe and/or exhale gas via the mouth or nose (or, for patients with dyspnea, and for their respiratory gases) a patient who is discharged from his body or discharged only through his mouth or nose. The interface can be easily repositioned as needed to suit the patient. The interface can also be repositioned to accommodate the needs of the clinician and the limitations of the medical procedure. For example, during surgery, the patient's mouth may be kept open by other medical devices or devices multiple times, which may allow for a good breathing trace of the gas sampling interface/device exhaled and/or exhaled by the gas sampling device disclosed herein. The patient was picked up at the mouth. Alternatively, if the patient's mouth is closed, the sampling interface can be easily moved to near the nostrils, or the distal end or head of the sampling interface can be positioned between the patient's lips (eg, against their teeth). It has been found that when a patient receives a high flow of therapy via a nasal cannula, it is particularly effective to extract exhalation and/or exhaled breath from the patient's mouth. This is because placing the sampling interface at the mouth allows the trace to be found (since the resistance to gas flow through the mouth into the sampling interface is typically less than the resistance generated by the high flow breathing gas supplied to the nostril).

58-64 illustrate a further embodiment of a gas sampling head 7050 that can be coupled to a gas sampling conduit to receive gas vented from a patient. The sampling head 7050 can be formed integrally with the gas sampling conduit 6163 or separately, and then attached to the free end/gas inlet end of the sampling conduit 6163. The sampling heads 7050 can each be coupled to the free end 6163 of the sampling conduit using any suitable form of attachment. For example, the sampling tip can be welded to the sampling conduit; screwed onto the free end of the thread of the sampling conduit; glued or otherwise adhered to the free end of the sampling conduit; or the sampling head and sampling conduit can be hook-fitted and friction-matched Etc. etc. are attached together.

In the preferred embodiment, gas sampling head 7050 is formed from a soft or semi-soft compressible material. A sampling head made of rigid or hard material may cause harm to the patient or may damage the patient's teeth (especially if the head is placed between the teeth and the patient may inadvertently bite the head). These risks are avoided or at least mitigated by providing a sampling head that can contain compressible materials that are less likely to cause harm or harm to the patient.

In an embodiment, the sampling head 7050 includes a body 7060 that includes a substantially hollow interior region 7061 that is configured to be coupled to the gas sampling conduit when the sampling head 7050 is coupled to the sampling conduit 6163 The inlet of 6163 is in fluid communication. The body 7060 includes one or more side walls forming an outer side surface of the body, a proximal connection end 7062 for connecting to a free end of the gas sampling conduit such that the hollow interior region is in fluid communication with the gas sampling conduit, and a distal end of the sampling head 7050 The distal portion 7063 of the end 7064.

In one form, the connection end 7062 can be glued to the gas sampling conduit 6163. In another form, the connecting end 7062 can be threaded to the threaded end of the gas sampling conduit 6163 so that the sampling head can be tightened and loosened on the free end of the sampling conduit. In another form, the attachment end can include a lip configured to fit over the collar of the inlet end of the sampling conduit to connect the sampling head and conduit in a snap-fit arrangement. Alternatively, the inlet end of the sampling conduit may include a lip that fits over the collar of the connection end with the sampling head.

The sampling head 7050 includes at least one inlet/gas receiving aperture 7230. The patient's exhaled or exhaled gas may be received by an inlet/gas receiving aperture 7230 that is in fluid communication with the substantially hollow interior region 7061 of the body 7060 such that the received gas may pass through the body 7060 of the sampling head. And enter the inlet of the gas sampling conduit. Each inlet/gas receiving aperture forms an opening to the hollow interior region of the head body.

In one form, the gas receiving aperture 7230 can extend from the distal end 7064 of the sampling head and along one side of the sampling head body 7060. Preferably, the gas receiving aperture 7230 defines an elongated opening in the distal end portion 7063 of the gas sampling head.

In one form, the sampling head 7050 includes an end wall at its distal end 7064 and one or more gas receiving apertures on one or more side walls of the sampling head. In one form, the gas receiving aperture 7230 can extend substantially around the entire outer circumference of the sampling head (eg, around the entire outer circumference of the outer surface). Where the sampling head has a substantially circular/circular cross section, the gas receiving aperture 7230 can extend around the circumferential outer surface of the sampling head to form an annular annular aperture (as shown in Figures 68A-68C) . In another form, the gas receiving aperture 7230 can extend around the circumferential outer surface of the sampling head in a substantially helical arrangement (similar to the helical thread of the screw cone).

The end wall can be substantially transverse to the gas receiving aperture(s) and offset from the gas receiving aperture(s). In one form, the end wall can be longitudinally offset by a distance equal to or greater than the width of the gas inlet(s).

The cross-sectional area of the end wall may be less than, substantially equal to, or greater than the cross-sectional area of the hollow interior region of the sampling head body.

In one form, the cross-section of the end wall is the same as or greater than the cross-section of the gas receiving aperture(s)/inlet(s).

In some embodiments, as shown in FIGS. 58-66, the gas sampling head 7050 can include a plurality of inlet/gas receiving apertures 7230. For example, the sampling head 7050 can include a pair of gas receiving apertures 7230 that extend from the distal end of the sampling head and along the sides of the distal end portion 7063 of the gas sampling head body 7060. The apertures 7230 can be evenly spaced from each other or can be unevenly spaced from one another. For example, the apertures 7230 can be located on substantially opposite sides of the body 7060, or the apertures 7230 can be closer to each other in at least one direction. In other embodiments, the gas sampling head 7050 can include two, three, four or more gas receiving holes 7230. The apertures 7230 can be evenly spaced from each other or can be spaced apart from each other evenly.

In the embodiment illustrated in FIGS. 58-66, the gas sampling head 7050 includes three gas receiving apertures 7230 that are evenly spaced around the distal end and sides of the sampling head 7050. The pitch of the holes 7230 can best be seen in Figures 58, 59, 61 and 63.

Each portion of the sampling head body 7060 located between the gas receiving apertures 7230 forms a recess 7240 that terminates at the distal end of the sampling head 7050. Central support 7250 can be located at the distal end of sampling head 7050 and can be coupled to recess 7240. The central support 7250 provides additional strength and positional integrity to the recess 6240 to prevent the grooves 7240 from pressing together and at least partially blocking the gas receiving apertures 7230. The central support 7250, the recess 7240, and the body 7060 of the sampling head 7050 together define an edge of the gas receiving aperture 7230.

The body 7060 of the gas sampling head 7050 can have a substantially cylindrical form, and the grooves 7240 can be substantially evenly spaced around the circumference of the distal end portion 7063 of the gas sampling head 7050. In one form, the interior of each groove can include a cut out region to form an enlarged opening in the head.

In one form, as shown in Figures 68A-68C, the distal end 7064 of the sampling head can be supported by a support member that includes a stem/strut/arm/elongate extension 7070 that is coupled to the end wall and body 7060. The support member 7070 can be positioned substantially centrally along the longitudinal axis of the sampling head, or the support member can be generally laterally offset from the center of the longitudinal axis of the sampling head. For example, the support member 7070 can be coupled to at least one inner wall of the body or an outer side surface of the body of the sampling head. In one form, as shown in Figure 68C, the body 7060 of the sampling head can form a plug having a protruding support member 7070 that includes a post that is coupled to the distal end 7064 of the sampling head. The plug body 7060 can be configured to be positioned within a cavity or auxiliary passage in the gas sampling conduit 201 to attach the head to the conduit without blocking the gas receiving inlet of the sampling conduit. For example, the auxiliary channel can be the first support cavity 211 of the gas sampling conduit 201 (such as the conduit shown in Figure 2). The support member/strut can be offset from the body of the head 7060 and/or offset from the longitudinal centerline of the gas sampling conduit 201 (as shown in Figures 68A-68C). Such an arrangement is particularly advantageous where the body of the head is configured to engage a biasing body that receives a cavity or aperture located adjacent and on one side of the inlet of the gas sampling conduit.

In another form, the sampling head body 7060 can be configured to be received within an inlet at a distal end of the gas sampling conduit. In this form, the sampling head includes a body 7060 that is shaped and sized to be received within the gas inlet of the sampling conduit. A support member 7070 including a stem/strut/arm/elongated extension or the like protrudes from the body 7060 and is coupled to the distal end portion 7064 of the sampling head 7050 to maintain the distal end portion 7046 at a distance from the body 7060. For example, a support member or post 7070 can protrude from the upper surface of the sampling head body 7060. The support member/strut 7070 can protrude substantially centrally from the upper surface of the body 7060, or the post 7070 can be offset from the center of the body 7060. The struts 7070 and the distal end portion 7604 of the sampling head 7050 can be configured such that the distal portion 7064 can overhang from the struts 7070 or at least extend beyond the struts 7070. The arrangement of the distal portion and the support member forms a cover over the inlet(s)/gas receiving aperture(s) of the gas sampling head. Since the sampling head body 7060 is placed in the gas inlet of the gas sampling chamber, in the plug arrangement, at least one gas receiving hole 7230 is formed in the sampling head 7050 to allow passage through the gas receiving hole 7230 and through the head. The hollow body 7060 enters the gas sampling conduit to pass gas through the sampling head 7050. In one form, at least one gas receiving aperture 7230 is formed in the upper surface of the body 7060 and in fluid communication with the substantially hollow interior 7061 of the body that opens at its proximal end to form a fluid flow having a gas sampling conduit Path (as shown in Figures 69A-69C). In another form, at least one gas receiving aperture 7230 can be formed in the support member/strut 7070, and the support member/strut 7070 can comprise a substantially hollow body in fluid communication with the gas receiving aperture 7230 and the basics of the sampling head body 7060. The hollow interior allows gas to flow through the gas receiving aperture(s) 7230, through the hollow body 7060, and into the gas sampling conduit.

In another form, the support member/strut 7070 can extend from at least one sidewall of the gas sampling conduit 7060 such that the distal end 7064 is overhanging 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 from the strut. In one form, the end wall is integrally formed with the body 7060.

In one form, as shown in Figures 68A-69C, the distal end portion 7604 of the sampling head can include a curved or dome shaped end wall 7064a that forms a cover to protect the inlet(s) of the gas sampling head. The gas receiving hole(s) is sucked by the patient's cheeks, mouth, lips or nostrils. The end wall also advantageously prevents saliva from directly entering the hollow interior of the body (especially from the longitudinal direction). This is very important to prevent blockage of the sampling head and gas sampling conduit.

In the embodiment illustrated in FIG. 61, the distal end 7064 of the gas sampling head 7050 (including the central support and the distal end of the recess) is outwardly curved or raised to form a protruding cover that prevents gas receiving aperture 7230. The end opening is drawn from the patient's cheeks, mouth, lips or nostrils. The side surface of the recess 7240 at the distal end portion of the sampling head 7050 can also be bent outward to form a substantially spherical distal end.

The sampling head and/or sampling tube and/or attachment member can be a single use product for a single patient single occasion, or can be configured to reduce any infection risk by being suitable for use in a sterilization process or autoclave cleaning The material is made to be used again.

Any of the embodiments described herein can be used in combination with a respiratory device (eg, a nasal cannula) to position the sampling interface on a patient. The nasal cannula provides a high flow of breathing gas to the patient's airway via the nasal cannula. The gas is generally oxygen or an air/oxygen mixture. The gas is humidified by a humidifier before being delivered to the patient. The high flow of gas causes turbulence and washes the pharynx and pushes oxygen/breathing gas into the patient's airway. The catheter constantly supplies gas to the upper respiratory tract of the patient. The gas sampling interface is used to sample the patient's exhaled and/or exhaled gases. The versatility of the interface allows the interface to be selectively remote from the gas supply so that gas sampling measurements are not as much diluted as gas sampling and gas delivery occurs at the same physical location in/on the patient.

The interface can be mounted to a portion of the user's face, such as a cheek, lip or nostril, or with a portion of the user's face, such as the cheeks, lips or nostrils. The interface includes a hooked free end portion or can be manipulated to provide a hooked portion (as in Figures 1-6, 9-26, 37-48, 52-55, 70, and 71) In the case of the illustrated embodiment, the interface can be hooked around a portion of the patient's face (such as around the mouth or nostril) to engage the patient's face and position the interface near the patient's airway.

A sampling interface can be attached (e.g., clipped) to a portion of the catheter/breathing device to maintain the gas sampling interface in the operative position. For example, a breathing apparatus or nasal cannula can optionally be used as a mounting component for attaching the sampling interface to the respiratory device rather than adhering the interface to the patient's face. Alternatively, the interface can be attached to the respiratory device using any of the embodiments of the attachment member shown in Figures 26-37 and 49-57 that are suitable for attachment to a respiratory device.

Combining the gas sampling interface with a breathing device in the form of a nasal cannula reduces the need for additional headbands or straps. In addition, attaching or clamping the gas sampling interface to the nasal cannula reduces the force on the user's cheeks or nostrils.

It will be further understood that any combination of embodiments of the head structure can also be used in any of the embodiments described herein. For example, the gas sampling interface can include any of the embodiments of the gas sampling heads illustrated in Figures 4-8, 14-25, 55, 58-66, and 68A-71.

Nasal catheters and exhalation and/or exhaled gas sampling interfaces can be used with patients with dyspnea and spontaneous breathing. Since patients with dyspnea do not actively exhale, there is not much CO ₂ excreted from the patient (if any). In addition, low-flow respiratory gas delivery system is not required to establish turbulent flow model out of the lungs in patients with dyspnea from a physiological dead space in the CO _2, this means that there is not much CO ₂ is discharged from the patient again. In addition, a small amount of CO ₂ discharged from the breathing apparatus will be / diluent gas flow rate of the gas delivery system. This was diluted so that the identification whether the CO ₂ from the patient leaving the lungs or how much CO ₂ is discharged more difficult. In the case of dyspnea, CO ₂ is not detected in the nose or mouth because there is no patient ventilation to expel distant CO ₂ . It has been found by eddy currents high flow of respiratory therapy in the lung can be rushed to the CO ₂ from the nose and lungs / or mouth, to potentially allow breaths / gas sampling. Oscillating high-flow therapy amplifies this response, making it more likely to detect CO _{2 in the} nose or mouth. It has been discovered that the combination of psychogenic oscillations and high flow breathing therapy allows a certain amount of ventilation of the breathing gas to move with the heartbeat of the patient and is expelled by the psychogenic pulse. The gas sampling interface of the present invention is particularly useful for measuring exhaled and/or exhaled gases in dyspnea patients, particularly when used with respiratory gas monitors of sufficiently low resolution and/or using specific algorithms. Handle very low amounts of CO ₂ (possibly at least as low as one tenth or less of the normal range). Accordingly, the present invention may be used to determine the gas sampling interface dyspnea whether the patient airway open, high flow respiratory therapy whether it is operational, and (Exhale or expell) level measurement of CO ₂ exhaled by patients.

The foregoing description of the invention includes its preferred forms. Modifications can be made without departing from the scope of the invention.

The term "comprising" as used in this specification means "consisting at least in part of". In the explanation of each statement including the term "comprising" in this specification, there may also be a feature in addition to or in addition to the term. Terms such as "include" should be interpreted in the same way.

Wherein, in the foregoing description, reference has been made to the whole or elements of their known equivalents, which are incorporated herein by reference.

The disclosed methods, devices, and systems may also broadly comprise two or more of the parts, elements and features in any or all combinations of the elements, elements or features referred to or indicated in the application. Individually or collectively).

Recitation of ranges within the scope of the individual sub-ranges or values that fall within the scope, and each individual sub-range or value is incorporated into the specification. As if it were described separately in this article).

The reference to any prior art in this specification is not, and should not be construed as an admission (or any form of suggestion) that the prior art constitutes a part of the common general knowledge in the field of the power of any country in the world.

Certain features, aspects, and advantages of some of the configurations of the present application have been described with reference to the use of a gas humidification system having a respiratory therapy system. However, certain features, aspects, and advantages of the use of the described gas humidification system can be advantageously used with other therapeutic or non-therapeutic systems that require gas humidification. Certain features, aspects, and advantages of the methods and apparatus of the present application are equally applicable to other systems.

Although the present application has been described in terms of certain embodiments, other embodiments that are obvious to those of ordinary skill in the art are also within the scope of the present application. Accordingly, various changes and modifications may be made without departing from the spirit and scope of the application. For example, the various components can be repositioned as needed. In addition, not all features, aspects, and advantages are required to practice the application. Accordingly, the scope of the present application is limited only by the scope of the appended claims.

100‧‧‧ gas sampling interface

101‧‧‧ gas sampling catheter

103‧‧‧ Subject

105‧‧‧ hook part

107‧‧‧ Entrance

108‧‧‧ distal

109‧‧‧Export

200‧‧‧ gas sampling interface

201‧‧‧ catheter

202‧‧‧Second air cavity

203‧‧‧ catheter body

204‧‧‧First cavity

210‧‧‧Wire

315‧‧‧ protruding hook section

317‧‧‧ substantially concave part

319‧‧‧ substantially concave part

321‧‧‧ protruding curved part

403‧‧‧ Subject

407‧‧‧ mouth

408‧‧‧ entrance

607‧‧‧ undulating waveform

608‧‧‧ head

701‧‧‧ catheter

708‧‧ head

723‧‧‧ entrance/opening

823‧‧‧round opening

1000‧‧‧Respiratory equipment

1200‧‧‧Double lumen catheter

1211‧‧‧First lead/support cavity

1213‧‧‧Second air cavity

1427‧‧‧ entrance/opening

1529‧‧ hood

1629‧‧ hood

1630‧‧‧Interior ribs

1729‧‧ hood

1829‧‧ hood

1830‧‧‧blocking parts

1929‧‧ hood

2029‧‧‧square cover

2032‧‧‧ incision

2129‧‧‧square cover

2132‧‧‧Incision

2229‧‧‧Toothed components

2329‧‧‧Bending parts

2429‧‧ hood

2740‧‧‧With or ring

2741‧‧‧ Position of the catheter

2743‧‧‧ Location of gas sampling conduit

2940‧‧‧Clamp

2941‧‧‧ Position of the catheter

2943‧‧‧ Location of the catheter

2945‧‧‧ overlap

3140‧‧‧ fixture

3141‧‧‧ Position of the catheter

3143‧‧‧ Location of the catheter

3145‧‧ ‧Tongue

3340‧‧‧Clamp

3341‧‧‧ Position of the catheter

3343‧‧‧ Position of the catheter

3345‧‧ ‧Tongue

3550‧‧‧ headband clip

3551‧‧‧ fixture

3650‧‧‧Management section

3651‧‧‧Clamp

3860‧‧‧Rigid hook

3861‧‧‧ fixture

3863‧‧‧Sampling catheter

4000‧‧‧Management or headgear strap

4160‧‧‧ hook

4163‧‧‧ gas sampling catheter

4165‧‧‧Internal passage

4167‧‧‧Clamp

4360‧‧‧ gas sampling interface

4463‧‧‧ gas sampling catheter

4469‧‧‧Flexible components

4560‧‧‧Rigid polymer hook

4563‧‧‧ gas sampling catheter

4761‧‧‧ fixture

4763‧‧‧ gas sampling catheter

4970‧‧‧Clamp

4971‧‧‧Clamp

4973‧‧‧Hook catheter

5070‧‧‧ fixture

5071‧‧‧ fixture

5073‧‧‧Hook catheter

5170‧‧‧ fixture

5171‧‧‧Clamp

5173‧‧‧ hooked catheter

5260‧‧‧ hook

5263‧‧‧ gas sampling catheter

5270‧‧‧ fixture

5481‧‧‧ gas sampling chamber

5483‧‧‧Line cavity

5485‧‧‧Second line cavity

6140‧‧‧ Attachment members

6141‧‧‧ Subject

6142‧‧‧Internal area

6143‧‧‧ openings

6144‧‧‧ side edge

6150‧‧‧ Arm

6163‧‧‧ gas sampling catheter

6167‧‧‧ fixture

6168‧‧‧ Arm

6169‧‧‧Remote

6170‧‧‧ tube receiving area

7050‧‧‧Sampling head

7060‧‧‧ Subject

7061‧‧‧Internal area

7062‧‧‧Connected end

7063‧‧‧ distal part

7064‧‧‧Remote

7064a‧‧‧End wall

7070‧‧‧Support members

7230‧‧‧Inlet/Gas Receiving Hole

7240‧‧‧ Groove

8040‧‧‧ nasal catheter

8050‧‧‧ Attachment components

8060‧‧‧Air duct

8070‧‧‧Management

8080‧‧‧ side arm

8090‧‧‧ headband

The specific embodiments of the present invention and modifications thereof will become apparent to those of ordinary skill in the art in the <RTIgt;

Figure 1 shows an embodiment of a gas sampling interface.

Figure 2 shows an alternate embodiment of a gas sampling interface.

Figure 3 shows a spline curve representing a series of curves applied to a catheter of the interface.

Figure 4 shows an alternate embodiment of a gas sampling interface.

Figure 5 shows an alternate embodiment of a gas sampling interface.

Figure 6 shows an alternate embodiment of a gas sampling interface.

Figure 7 shows an alternate embodiment of a gas sampling interface.

Figure 8 shows an alternate embodiment of a gas sampling interface.

Figure 9 shows an alternate embodiment of a gas sampling interface.

Figure 10 shows a spline curve representing a series of catheters applied to an alternate embodiment of a gas sampling interface.

Figure 11 shows a spline curve representing a series of catheters applied to an alternate embodiment of a gas sampling interface.

Figure 12 shows a vertical cross section of an alternate embodiment of a gas sampling interface.

Figure 13 shows a horizontal cross section of an alternate embodiment of a gas sampling interface.

Figure 14 shows an alternate embodiment of a gas sampling interface.

Figure 15 shows an alternate embodiment of a gas sampling interface.

Figure 16 shows an alternate embodiment of a gas sampling interface.

Figure 17 shows an alternate embodiment of a gas sampling interface.

Figure 18 shows an alternate embodiment of a gas sampling interface.

Figure 19 shows an alternate embodiment of a gas sampling interface.

Figure 20 shows an alternate embodiment of a gas sampling interface.

Figure 21 shows an alternate embodiment of a gas sampling interface.

Figure 22 shows an alternate embodiment of a gas sampling interface.

Figure 23 shows an alternate embodiment of a gas sampling interface.

Figure 24 shows an alternate embodiment of a gas sampling interface.

Figure 25 shows an alternate embodiment of a gas sampling interface.

Figure 26 shows an alternate embodiment of a gas sampling interface.

Figure 27 shows an embodiment of an attachment member for a gas sampling interface.

Figure 28 shows the attachment member of Figure 27 with details of the relative positions of the catheter and gas sampling catheter.

Figure 29 illustrates an alternate embodiment of an attachment member for a gas sampling interface.

Figure 30 shows the attachment member of Figure 29 with details of the relative positions of the catheter and the gas sampling catheter.

Figure 31 illustrates an alternate embodiment of an attachment member for a gas sampling interface.

Figure 32 shows the attachment member of Figure 31 with details of the relative positions of the catheter and gas sampling catheter.

Figure 33 shows an alternate embodiment of an attachment member for a gas sampling interface.

Figure 34 shows the attachment member of Figure 33 with details of the relative positions of the cannula and the gas sampling catheter.

Figure 35 shows the connector of the gas sampling interface.

Figure 36 shows the connector of the gas sampling interface.

37 shows an alternate embodiment of a gas sampling interface including the connector of FIG. 35 and the connector of FIG.

Figure 38 shows a side view of an alternate embodiment of a hook for a gas sampling interface.

Figure 39 shows a perspective view of the hook of Figure 38.

Figure 40 shows a side view of the gas sampling interface and gas sampling conduit of Figure 38.

Figure 41 shows a perspective view of one side of an alternate embodiment of a gas sampling interface.

Figure 42 shows a perspective view of the other side of the gas sampling interface of Figure 41.

Figure 43 shows a perspective view of an alternate embodiment of a hook for a gas sampling interface.

Figure 44 illustrates an alternate embodiment of a gas sampling interface incorporating the rigid hook of Figure 43.

Figure 45 shows a side view of an alternate embodiment of a gas sampling interface.

Figure 46 shows a perspective view of the gas sampling interface of Figure 45.

Figure 47 shows an alternate embodiment of a hook for a gas sampling interface configured prior to use.

Figure 48 shows the hook and gas sampling conduit of Figure 47 in use configuration.

Figure 49 shows an embodiment of a clip for a gas sampling interface.

Figure 50 shows an alternate embodiment of a clip for a gas sampling interface.

Figure 51 shows an alternate embodiment of a clip for a gas sampling interface.

Figure 53 shows an alternate embodiment of a clip for a gas sampling interface.

Figure 54 shows an end view of an alternate embodiment of a clip for a gas sampling interface.

Figure 55 shows a schematic view of another embodiment of a gas sampling interface attached to a nasal cannula.

Figure 56 shows a perspective view of one form of attachment member for attaching a gas sampling catheter to a respiratory device.

Figure 57 shows an end view of the attachment member shown in Figure 56.

Figure 58 shows a perspective view of one embodiment of a gas sampling head.

Figure 59 shows an end view of the distal end of the gas sampling head of Figure 58.

Figure 60 shows an end view of the connecting end of the gas sampling head of Figure 58.

Figure 61 shows a perspective view of another embodiment of a gas sampling head.

Figure 62 shows a side view of the gas sampling head of Figure 61.

Figure 63 shows an end view of the distal end of the gas sampling head of Figure 61.

Figure 64 shows an end view of the connecting end of the gas sampling head of Figure 61.

Figure 65 shows a perspective view of one form of gas sampling assembly including a gas sampling head coupled to a gas sampling tube that is coupled to a connector in the form of a Luer.

Figure 66 shows a side view of the assembly of Figure 65.

Figure 67 shows a perspective view of a connector (in this case a Luer form) that can be used to connect a gas sampling conduit to a respiratory gas monitor.

Figures 68A and 68B are side views of another form of gas sampling head.

Figure 68C is a cross-sectional side view of the gas sampling head of Figures 68A and 68B.

Figures 69A and 69B are side views of another form of gas sampling head.

Figure 69C is a cross-sectional side view of the gas sampling head of Figures 69A and 69B.

Figure 70 is a schematic illustration of a patient wearing a form of gas delivery system and a form of gas sampling interface in which the head of the gas sampling interface is positioned adjacent to the patient's mouth for exhalation and/or exhaled gases from the mouth. sampling.

Figure 71 is a schematic illustration of a patient wearing another form of gas delivery system and also wearing the gas sampling interface of Figure 70, wherein the head of the gas sampling interface is positioned near the nostril of the patient's nose to exhale from the nose and / Or exhaled gas for sampling.

Domestic deposit information (please note according to the registration authority, date, number order) None Foreign deposit information (please note according to the country, organization, date, number order)

Claims (64)

A respiratory therapy system for delivering a high-flow respiratory therapy to a patient and exhaled or expired gas from the patient, wherein the system includes: a respiratory device including a patient An interface and a respiratory gas delivery tube coupled to a gas source for delivering high flow breathing gas from the gas source to the patient via the respiratory gas delivery via the patient interface; and a gas sampling interface The gas sampling interface includes a conduit including a first end in fluid communication with a respiratory gas monitor and a second distal end including at least one inlet for receiving exhaled or exhaled breathing gas from the patient Where at least a portion of the catheter is flexible to allow the inlet to be selectively positioned at the mouth or nose of the patient. The respiratory therapy system of claim 1, wherein the respiratory device provides breathing gas to the patient at a flow rate between about 15 and about 150 L/min. The respiratory therapy system of claim 1, wherein the system is configured to deliver respiratory gas to a neonatal infant at a flow rate of about 2 L/min/kg. The respiratory treatment system of any of claims 1 to 3, wherein the catheter comprises a flexible elastic support structure that allows the distal portion to be manipulated into a desired shape and selectively Lead to the patient's nose or mouth. The respiratory treatment system of claim 4, wherein the flexible, resilient support structure comprises a wire within the catheter, the wire allowing at least a portion of the catheter to be bent to form a hook shape. The respiratory treatment system of claim 5, wherein the wire has a smaller diameter than an inner diameter of the catheter, and wherein a gap is formed between the wire and an inner wall of the catheter to allow gas Flow along the conduit. The respiratory therapy system of claim 5, wherein the catheter comprises a first gas receiving chamber and a second support chamber, and wherein the lead is located in at least a portion of the support chamber. The respiratory treatment system of any one of claims 5 to 7, wherein the wire is co-extruded with the gas sampling conduit. The respiratory treatment system of any of claims 5 to 7, wherein the lead is located in the distal portion of the catheter to allow the distal portion to flex to form a hook shape. The respiratory treatment system of any of the preceding claims further comprising an attachment member to attach the gas sampling interface to the respiratory device. The respiratory treatment system of claim 10, wherein the attachment member is integral with or attached to the respiratory gas delivery tube and comprises: a sleeve that at least partially surrounds the respiratory gas A portion of the delivery tube; wherein the sleeve includes at least one clip on an outer surface of the sleeve for receiving a portion of the catheter to attach the catheter to the respiratory device. The respiratory treatment system of claim 11, wherein the sleeve includes a pair of clips that are offset from one another. The respiratory treatment system of claim 11, wherein each of the clips includes a hook, the hook including a tube receiving area, a portion of the tube being positionable within the receiving area to follow a tortuous path. The respiratory treatment system of claim 13, wherein the hooks face in opposite directions from each other. A respiratory treatment system according to any of the preceding claims, wherein the gas sampling interface further comprises a head at the distal end of the catheter, wherein the head comprises a substantially hollow body, the substantially hollow body Included in at least one gas receiving aperture for receiving a patient expiratory or exhaled gas, wherein the gas receiving aperture is in fluid communication with the at least one inlet of the catheter, and wherein the body of the head further includes a distal portion, the distal end The portion includes a distal surface and an outer surface. The respiratory treatment system of claim 15, wherein the at least one gas receiving aperture is formed in both the distal end surface and the outer circumferential side surface such that the gas receiving aperture is from the distal surface and along the lateral surface extend. The respiratory treatment system of claim 15 or 16, wherein the at least one gas receiving aperture forms an elongated opening in the distal end portion of the gas sampling head. The respiratory treatment system of any of claims 15 to 17, wherein the body comprises a substantially cylindrical shape. The respiratory treatment system of any one of claims 15 to 18, wherein the distal end of the gas sampling head is outwardly curved. The respiratory treatment system of any of claims 15 to 19, wherein the distal portion of the gas sampling head is substantially spherical. The respiratory treatment system of any of claims 15 to 20, wherein the gas sampling head comprises at least three gas receiving apertures evenly spaced around the distal end of the sampling head. The respiratory treatment system of claim 21, wherein each portion of the body between the gas receiving apertures defines a recess, wherein the recess surrounds a circumference of the distal end portion of the gas sampling head. Evenly spaced apart. A respiratory therapy system according to any of the preceding claims, wherein the respiratory device is a nasal cannula. A respiratory therapy system according to any of the preceding claims, wherein the patient receiving treatment from the respiratory device is apnea. A gas sampling interface for use with a high flow respiratory gas delivery system, the gas sampling interface comprising: a catheter comprising: a first end, the first end in fluid communication with a respiratory gas monitor; and a first a second distal end, the second distal end including at least one inlet for receiving exhaled or exhaled breathing gas from the patient; a gas sampling head located at the distal end of the catheter and including a basic An upper hollow body comprising at least one gas receiving aperture for receiving a patient's exhaled or exhaled gas, wherein the gas receiving aperture is in fluid communication with the at least one inlet of the catheter, and wherein the head The body further includes a distal portion having a distal surface and an outer surface. The gas sampling interface of claim 25, wherein the at least one gas receiving hole is formed in the distal end surface and formed in both of the outer circumferential side surfaces such that the gas receiving hole is from the distal surface and along The outer side surface extends to form an elongated opening in the distal end portion of the gas sampling head. The gas sampling interface of claim 25 or 26, wherein the distal end portion of the gas sampling head is substantially spherical. The gas sampling interface of any one of claims 25 to 27, wherein the gas sampling head comprises three gas receiving holes evenly spaced around the distal end of the sampling head. The gas sampling interface of claim 28, wherein each portion of the body between the gas receiving apertures defines a recess, wherein the recesses substantially surround a circumference of the distal end portion of the gas sampling head Evenly spaced apart. The gas sampling interface of any one of claims 25 to 29, wherein the gas sampling conduit is connected to a gas sampling tube of the respiratory gas monitor via a Luer connector. The gas sampling interface of any one of claims 25 to 30, wherein the gas sampling interface is configured to receive a disease receiving respiratory gas from a respiratory device at a flow rate between about 15 and about 150 L/min Exhaled or exhaled gas. The gas sampling interface of any one of claims 25 to 30, wherein the gas sampling interface is configured to receive a newborn infant patient receiving respiratory gas from a respiratory device at a flow rate of about 2 L / min / kg Breathing gas. The gas sampling interface of any one of claims 25 to 32, wherein at least a portion of the catheter is flexible to allow the inlet to be selectively positioned at the mouth or nose of the patient. A breathing apparatus comprising: a nasal cannula having a manifold for supporting at least one nasal cannula or outlet, the at least one nasal cannula or outlet extending from the manifold and being received in a user In the nostril; a gas delivery tube in fluid communication with the at least one nasal cannula or outlet for supplying respiratory gas via the at least one nasal cannula or outlet; and an attachment member, the attachment member For attaching a gas sampling interface to the nasal cannula; wherein the gas sampling interface includes a catheter including a first end in fluid communication with a respiratory gas monitor and including at least one for receiving from the patient a second distal end of the inlet of the exhaled or exhaled breathing gas, wherein at least a portion of the catheter is flexible to allow the inlet to be selectively positioned at the mouth or nose of the patient, and wherein the attachment A member is integral with or attached to the respiratory gas delivery tube or manifold, and the attachment member includes: a sleeve that at least partially encloses the respiratory gas delivery A portion of the delivery tube or manifold; wherein the sleeve includes at least one clip for receiving a portion of a gas sampling conduit to attach the catheter to the respiratory device. The breathing apparatus of claim 34, wherein the sleeve includes a substantially arcuate inner surface to enclose a portion of the respiratory gas delivery tube. A breathing apparatus according to claim 34 or 35, wherein the clip is located on an outer surface of the sleeve. The breathing apparatus of claim 36, wherein the sleeve includes a pair of clips that are offset from one another. The breathing apparatus of claim 37, wherein each of the clips includes a hook, the hook including a receiving area, a portion of the catheter being positionable within the receiving area to follow a tortuous path. A breathing apparatus as claimed in claim 38, wherein the hooks face in opposite directions to each other. The breathing apparatus of any one of claims 37 to 39, wherein the catheter is substantially loosely retained within each clip such that disconnection of the catheter from a clip allows the catheter to slide over another clip to adjust The length of the free end portion of the catheter that extends between the distal end of the catheter and the sleeve. The breathing apparatus of any one of claims 34 to 340, wherein the sleeve comprises a substantially C-shaped cross section. The breathing apparatus of any one of claims 34 to 41, wherein the gas delivery tube supplies a patient with breathing gas at a flow rate between about 15 and about 120 L/min. The breathing apparatus of any one of claims 34 to 41, wherein the gas delivery tube supplies a breathing gas to a newborn infant patient at a flow rate of about 2 L / min / kg. A gas sampling head detachably coupled to a distal end of a gas sampling conduit, wherein the sampling head includes a body including a substantially hollow interior region, the substantially hollow interior region configured Formed in fluid communication with the inlet of the gas sampling conduit, and wherein the body also includes a distal portion including a distal surface and an outer surface, wherein the gas is sampled The head further includes at least one gas receiving aperture connected to the hollow interior region to receive a patient's exhaled or exhaled gas, and wherein the gas receiving aperture is substantially hollow to the body The internal area is in fluid communication. The gas sampling head according to claim 44, wherein the at least one gas receiving hole is formed in both the distal end surface and the outer circumferential side surface such that the gas receiving hole is from the distal end surface and along the outer side surface extend. The gas sampling head of claim 44 or 45, wherein the at least one gas receiving aperture forms an elongated opening in the distal end portion of the gas sampling head. The gas sampling head of any one of claims 44 to 46, wherein the distal end of the gas sampling head is outwardly curved. The gas sampling head of claim 47, wherein the distal end portion of the gas sampling head is substantially spherical. The gas sampling head of any one of claims 44 to 48, wherein the gas sampling head has a substantially cylindrical shape. The gas sampling head of any one of claims 44 to 49, wherein the gas sampling head comprises three gas receiving holes evenly spaced around the distal end of the sampling head. A gas sampling head according to claim 50, wherein each portion of the body between the gas receiving holes forms a groove, wherein the groove surrounds the circumference of the distal end portion of the gas sampling head substantially Evenly spaced apart. The gas sampling head of any one of claims 44 to 51, wherein the gas sampling head is configured to receive a supply of breathing gas from a supply of between 15 and about 150 L/min by a breathing apparatus. Exhaled or exhaled gas from a patient. The gas sampling head of any one of claims 44 to 51, wherein the gas sampling head is configured to receive a newborn baby from the supplied breathing gas by a breathing apparatus at a flow rate of about 2 L / min / kg The patient's exhaled or exhaled gas. The gas sampling head of any one of claims 44 to 53, wherein the head is connectable to a gas sampling interface, the gas sampling interface comprising a conduit, the conduit including a first fluid in fluid communication with a respiratory gas monitor One end and a second distal end attached to the head, the second distal end including at least one inlet for receiving exhaled or exhaled breathing gas from the patient, wherein at least a portion of the catheter is flexible To allow the inlet to be selectively positioned at the mouth or nose of the patient. A breathing apparatus comprising: a nasal cannula comprising at least one nasal cannula or an outlet to be received in a nostril of a user; a gas delivery tube, the gas delivery tube and the at least one nasal cannula or The outlet is in fluid communication to supply breathing gas via the at least one nasal cannula or outlet; and an attachment member for attaching a gas sampling interface to the nasal catheter, wherein the attachment member and the breathing a gas delivery tube integral or attached to the respiratory gas delivery tube, and the attachment member comprises: a sleeve at least partially surrounding a portion of the respiratory gas delivery tube; wherein the sleeve includes a receiving A portion of the gas sampling conduit is attached to the at least one clip of the respiratory device. The breathing apparatus of claim 55, wherein the sleeve includes a substantially arcuate inner surface to enclose a portion of the respiratory gas delivery tube. A breathing apparatus according to claim 55 or 56, wherein the clip is located on an outer surface of the sleeve. The breathing apparatus of claim 57, wherein the sleeve includes a pair of clips that are offset from one another. The breathing apparatus of claim 58, wherein each of the clips includes a hook, the hook including a receiving area, a portion of the catheter being positionable within the receiving area to follow a tortuous path. A breathing apparatus as claimed in claim 59, wherein the hooks face in opposite directions to each other. The breathing apparatus of any one of claims 55 to 60, wherein the catheter is substantially loosely retained within each of the clips such that disconnection of the catheter from a clip allows the catheter to slide over the other clip to adjust The length of the free end portion of the catheter that extends between the distal end of the catheter and the sleeve. A breathing apparatus according to any one of claims 55 to 61, wherein the sleeve comprises a substantially C-shaped cross section. The breathing apparatus of any one of claims 55 to 62, wherein the gas delivery tube supplies a breathing gas to a patient at a flow rate between about 15 and about 120 L/min. A breathing apparatus according to any one of claims 55 to 62, wherein the gas delivery tube supplies breathing gas to a newborn infant patient at a flow rate of about 2 L / min / kg.