Oxygen mask with oral / nasal capnography sampling

The hybrid mask integrates oxygen and exhalation conduits within a single cannula to address the challenge of high-flow oxygen delivery and accurate CO2 sampling, improving measurement accuracy and patient comfort.

WO2025196753A1PCT designated stage Publication Date: 2025-09-25ORIDION MEDICAL 1987
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Patent Information

Application Number
PCT/IL2025/050250
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-03-20
Filing Date
2025-03-18
Publication Date
2025-09-25

AI Technical Summary

Technical Problem

Existing oxygen delivery systems, such as cannulas and masks, face challenges in delivering high oxygen flow rates while accurately sampling exhaled carbon dioxide, leading to turbulence and reduced capnography measurement accuracy, and are often uncomfortable for patients.

Method used

A hybrid mask design that integrates an oxygen delivery conduit and an exhalation conduit within a single cannula, with nasal and oral prongs or scoops, to separate oxygen delivery from exhaled breath sampling, reducing turbulence and improving measurement accuracy.

Benefits of technology

The hybrid mask enables accurate capnometric measurements at higher oxygen flow rates, enhancing patient comfort by minimizing mixing between delivered oxygen and exhaled gases, and allowing for efficient oxygen delivery and CO2 sampling.

✦ Generated by Eureka AI based on patent content.

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Abstract

A hybrid mask for oxygen delivery and exhaled gas monitoring may include a mask body defining an interior space of the hybrid mask and a cannula coupled to the mask body. The cannula may include an oxygen delivery conduit configured to deliver oxygen to the interior space, an exhalation conduit configured to deliver exhaled breath to a sampling line, and first and second nasal prongs each comprising a channel directing exhaled nasal breath into the exhalation conduit. In an embodiment, the cannula may also include an oral scoop configured to deliver exhaled oral breath into the exhalation conduit in the first configuration.
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Description

OXYGEN MASK WITH ORAL / NASAL CAPNOGRAPHY SAMPLINGTECHNICAL FIELD

[0001] The present disclosure generally relates to a hybrid mask that delivers oxygen and that permits sampling of exhaled carbon dioxide (CO2).BACKGROUND

[0002] Different types of nasal or oral-nasal cannulas are used to deliver oxygen to patients who require assistance to breathe properly, to collect carbon dioxide samples from patients to monitor respiration, or to perform both functions. Such cannulas may be used when direct ventilation is not provided. A nasal cannula provides oxygen supply to the nasal cavity. For example, the cannula may deliver oxygen to patients at a rate of 6 liters per minute (L / min). If a higher rate if oxygen is needed, an oxygen mask may be used to supply oxygen to the patient and a cannula may be used to collect carbon dioxide samples. For example, a general oxygen mask may deliver oxygen to the patient at a rate up to 15 L / min. Sometimes, even higher oxygen rates are needed. However, delivering oxygen at such high rates may cause turbulence within the oxygen mask, which may disturb the carbon dioxide sample collection.SUMMARY

[0003] Certain embodiments commensurate in scope with the originally claimed subject matter are summarized below. These embodiments are not intended to limit the scope of the disclosure. Indeed, the present disclosure may encompass a variety of forms that may be similar to or different from the embodiments set forth below.

[0004] In one embodiment, a hybrid mask for oxygen delivery and exhaled gas monitoring may include a mask body defining an interior space of the hybrid mask and a cannula coupled to a wall of the mask body in the interior space. The cannula may include an oxygen delivery conduit delivering oxygen to the interior space via one or more oxygen delivery ports of the cannula, an exhalation conduit delivering exhaled breath to a sampling line, and first and second nasal prongs each comprising a channel directing exhaled nasal breath into the exhalation conduit.

[0005] In another embodiment, a capnography system may include a hybrid mask including a mask body defining an interior space of the hybrid mask, a cannula coupled to the mask bodyand positioned in the interior space, and an oxygen source coupled to the oxygen delivery conduit to provide oxygen via the oxygen delivery conduit. The cannula may include an oxygen delivery conduit delivering oxygen to the interior space, an exhalation conduit collecting an exhaled breath comprising a nasal exhaled breath and an oral exhaled breath, first and second nasal prongs coupled to the exhalation conduit, and an oral scoop fluidly coupled to the exhalation conduit.

[0006] Various refinements and features noted above may exist in relation to various aspects of the present disclosure. Further features may also be incorporated in these various aspects as well. These refinements and additional features may exist individually or in any combination. For instance, various features discussed below in relation to one or more of the illustrated embodiments may be incorporated into any of the above-described aspects of the present disclosure alone or in any combination. The brief summary presented above is intended only to familiarize the reader with certain aspects and context of embodiments of the present disclosure without limitation to the claimed subject matter.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Advantages of the disclosed techniques may become apparent upon reading the following detailed description and upon reference to the drawings in which:

[0008] FIG. 1 is a schematic view of an embodiment of a capnography system, in accordance with an aspect of the present disclosure;

[0009] FIG. 2 is a side perspective view of an embodiment of a hybrid mask which may be employed in the capnography system of FIG. 1, in accordance with an aspect of the present disclosure;

[0010] FIG. 3 is a front view of the hybrid mask of FIG. 2, in accordance with an aspect of the present disclosure;

[0011] FIG. 4 is a back perspective view of the hybrid mask of FIG. 2, in accordance with an aspect of the present disclosure;

[0012] FIG. 5 is side perspective view of an embodiment of the hybrid mask of FIG. 2 which may be employed in the capnography system of FIG. 1, in accordance with an aspect of the present disclosure;

[0013] FIG. 6 is a cross-sectional view of an embodiment of a cannula within the hybrid mask of FIG. 2; and

[0014] FIG. 7 is a flowchart of an example method for delivering oxygen and collecting breath samples to and from a patient using the capnography system of FIG. 1, in accordance with an aspect of the present disclosure.DETAILED DESCRIPTION

[0015] One or more specific embodiments of the present techniques will be described below. In an effort to provide a concise description of these embodiments, not all features of an actual implementation are described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers’ specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.

[0016] When introducing elements of various embodiments of the present disclosure, the articles “a,” “an,” and “the” are intended to mean that there are one or more of the elements. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. Additionally, it should be understood that references to “one embodiment” or “an embodiment” of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features.

[0017] During oxygen delivery using a cannula, the cannula may provide a nasal breath sample via collected exhaled gases that are collected through prongs inserted into nasal cavities and / or the mouth breath sample via collected gases that are collected through an oral prong. The use of dedicated prongs separates the collection of exhaled nasal gases from actively delivered oxygen, such that the delivered oxygen from the cannula does not significantly mix with the sampled exhaled nasal gases to permit more accurate measurements. However, typical oxygen delivery arrangements using the cannula are at relatively low flow rates (e.g., 2-5 liters perminute (L / min)) and may not be suitable for situations in which higher levels of oxygen delivery are needed and / or when nasal breathing is obstructed. As such, an oxygen mask may be used to deliver oxygen to the patient when higher oxygen flow rates are desired. When an oxygen mask is used to deliver the oxygen, collection of exhaled gases for capnography may be challenging, and the resulting capnography readings may be less accurate relative to those from a cannula. In certain instances, the oxygen mask may be used to deliver oxygen to the patient while a separate cannula may be used to collect exhaled gases for capnography. However, it can be challenging to both actively deliver oxygen at increased rates via the oxygen mask and also accurately measure CO2 exhaled from the nose and / or the mouth through the cannula. For example, when oxygen is continuously directed towards the nose or the mouth during oxygen delivery, any delivered oxygen may mix with the exhaled breath from the nose or the mouth, thus diluting the gas composition and preventing accurate measurements. In another example, an increased rate of oxygen delivery may cause turbulence within the oxygen mask, which may disrupt the collection of exhaled breath by the cannula and reduce accuracy of the capnography. Moreover, wearing both the cannula and the oxygen mask may be uncomfortable for the patient and may limit the activities of the patient. Accordingly, it is now recognized that improved systems and methods that enable capnometric measurement of exhaled CO2 while simultaneously providing adequate oxygenation are desired.

[0018] The present disclosure generally relates to the field of breath monitoring, and more particularly, to CO2 sampling alongside oxygen delivery using the hybrid mask disclosed herein. Present embodiments are directed to hybrid masks that deliver an adequate flow of oxygen and comfortable for patient use, while simultaneously permitting sampling of exhaled carbon dioxide from a nasal and / or oral cavity of the patient. The hybrid mask may include mask body that defines an interior space of the hybrid mask and a cannula integrated with and / or coupled to the mask body configured to deliver oxygen and receive an exhaled breath sample (e.g., nasal breath sample, mouth breath sample) for capnography. The mask may be a small form factor mask that may be configured to be placed over a nasal cavity and an oral cavity of the patient during use. As described in greater detail below, the size and shape of the mask may reduce turbulence caused by high rates of oxygen delivery, which may improve accuracy of capnometric measurements. The hybrid mask disclosed herein may include an intake inlet configured to couple to an oxygen source. The intake inlet may be configured to fluidly couple to an oxygen delivery conduit and direct oxygen from the oxygen source to one or more oxygen delivery ports positioned away from the patient’s face. The one or more oxygen delivery portsmay be configured to deliver oxygen to the interior space of the hybrid mask to provide adequate oxygenation to the patient.

[0019] Additionally, the hybrid mask discussed herein may include one or more nasal prongs configured to be inserted into a nasal cavity of the patient and an oral scoop configured to be position proximate an oral cavity of the patient in one configuration. In another configuration, the cannulas discussed herein may include one or more nasal prongs without the oral scoop. The nasal prongs and / or the oral scoop may be configured to be fluidly coupled to an exhalation conduit that may be configured to receive exhaled breath samples from the patient and deliver the exhaled breath samples to a capnograph for analysis. To this end, the exhalation conduit may be coupled to a sampling outlet, which in turn may be coupled to the capnograph via a sampling line. Similar to a cannula, the hybrid mask may be secured to the patient’s face via the oxygen delivery conduit and the sampling line, which may improve the patient’s comfort when using the hybrid mask. Thus, the hybrid masks discussed herein may deliver oxygen at increased rates while still permitting adequate breath sampling and / or capnometric analysis of the patient’s exhaled breath.

[0020] Turning now to FIG. 1, a capnography system 10 is illustrated that may be used in conjunction with the disclosed hybrid mask provided herein. The capnography system 10 may be utilized to sample exhaled breath from a patient 12, while providing adequate oxygenation to the patient 12. For example, the capnography system 10 may include a hybrid mask 14 that provides oxygen to the patient 12 during inhalation. In certain embodiments, oxygen provided to the patient 12 via the hybrid mask 14 may be received from an oxygen source 16. The oxygen source 16 may be coupled to an oxygen line 17, and the oxygen line 17 may be coupled to the hybrid mask 14, thereby enabling delivery of oxygen into the hybrid mask 14. The hybrid mask 14 may include an oxygen delivery conduit (e.g., first conduit system) configured to receive the oxygen from the oxygen source 16 and deliver the oxygen to the patient 12 via oxygen delivery ports, as described in greater detail below.

[0021] As the patient exhales, CO2 may be captured by the hybrid mask 14 and delivered to a gas analyzer 20 for analysis via a sampling line 18. In particular, the hybrid mask 14 may include nasal cannula configured to receive an exhaled breath from the patient 12 and deliver the exhaled breath to the gas analyzer 20, as will be described in greater detail herein. For example, the cannula may include one or more nasal prongs configured to be inserted into a nasal cavity of the patient 12 and an oral scoop positioned proximate an oral cavity of a patient.In certain instances, the cannula may only include the one or more nasal prongs. The one or more nasal prongs and / or the oral scoop may be fluidly coupled to an exhalation conduit (e.g., second conduit system) of the hybrid mask 14, thereby enabling capture and delivery of exhaled CO2 to the gas analyzer 20 via the sampling line 18. The gas analyzer 20 (e.g., capnograph) may provide an indication of the patient’s state based on measurement of the CO2 in sampled gas received from the hybrid mask 14. In certain embodiments, the gas analyzer 20 may be communicatively coupled to a computer 22 (e.g., a desktop computer, a tablet, a mobile device) or a separate display device to facilitate the display of information related to the patient’s condition, which may include displayed CO2 measurements from the gas analyzer.

[0022] The capnography system 10 may include additional or fewer components than those illustrated. In certain embodiments, the gas analyzer 20 and the computer 22 may be integrated into a single unit. Further, the illustrated oxygen line 17 and / or the sampling line 18 may include one or more gas transfer conduits. For example, the oxygen line 17 may include one or more fluidically connected conduits, and / or the sampling line 18 may include one or more fluidically connected conduits.

[0023] FIG. 2 is a side perspective view of an embodiment of the hybrid mask 14 which may be employed by the capnography system 10. The hybrid mask 14 permits oral oxygen and nasal oxygen delivery (e.g., continuous or intermittent oxygen delivery) and sampling of exhaled nasal gases and / or exhaled mouth gases via the hybrid mask 14. The hybrid mask 14 may be a small form factor mask configured to be placed proximate to a nasal cavity and an oral cavity of the patient 12. The hybrid mask 14 may not be hermetically sealed to the patient’s face, rather the hybrid mask 14 may fit comfortably to the patient’s face.

[0024] As illustrated, the hybrid mask 14 may include a mask body 50 defining an interior space 52 of the hybrid mask 14. The mask body 50 may include a rounded portion coupled to a first side piece and a second side piece. The rounded portion may include a concave portion with respect to the patient’s face and include a convex portion 53 at an end (e.g., bottom end) of the hybrid mask 14. That is, the rounded portion may curve away (e.g., outwards) from the patient’s face to form the interior space 52 and the convex portion 53 may curve towards the patient’s face. The convex portion 53 may visually appear as a curve in the mask body 50. The convex portion 53 may create one or more gaps between the patient 12 and the mask body 50, which may facilitate fluid flow to and from the interior space 52 and / or the hybrid mask 14. The first side piece may extend from a first end of the rounded portion and be configured tocontact with the patient’s face and the second side piece may extend from a second end of the rounded portion and be configured to contact with the patient’s face.

[0025] The hybrid mask 14 may include a cannula 54 (e.g., cannula device, oral / nasal cannula) positioned within the interior space 52 of the hybrid mask 14. The cannula 54 may be integrated with and / or coupled to the mask body 50. That is, the cannula body 56 may be integrated with the mask body 50 such that the cannula 54 is not easily separable or removable by hand from the mask body 50. For example, the cannula 54 may be part of a unitary assembly with the mask body 50 such that a cannula body 56 extends from an interior wall of the mask body 50. In an embodiment, the cannula 54 and the mask body 50 are formed from a unitary molded piece. In an embodiment, the cannula 54 is adhered to the mask body 50. The cannula body 56 may define an interior space of the cannula 54 and extend in a direction along a lateral axis 200 of the hybrid mask 14. For example, the cannula body 56 may include a first end coupled to a first end of the hybrid mask 14 defined by the first side piece and a second end coupled to a second end of the hybrid mask 14 defined by the second side piece (see FIG. 4).

[0026] The cannula body 56 may be positioned such that a gap 55 is formed between the cannula body 56 and an interior surface 57 of the mask body. As discussed herein, oxygen delivery from oxygen delivery ports may be generally directed towards and / or into the gap 55. In operation, at least a portion of the cannula body 56 may rest on or come into contact with the mouth or patient ’ s face (e.g., upper lip or above the lip) . In contrast to a conventional standalone cannula, the cannula body 56 may be relatively flatter.

[0027] The first end of the cannula body 56 and / or the first end of the hybrid mask 14 may include an intake inlet 58 that extends through or is accessible through a corresponding passage in the mask body 50 and is fluidly coupled to the oxygen source 16 via the oxygen line, as will be described in greater detail below. The cannula body 56 may include an interior oxygen delivery conduit (e.g., first conduit system) configured to direct oxygen from the oxygen source 16 toward one or more oral oxygen delivery ports. In an embodiment, the one or more oxygen delivery ports may be positioned on a side of the cannula body 56 that faces the mask body 50, such as in a direction along a longitudinal axis 202 of the hybrid mask 14. As such, the oxygen may enter the hybrid mask 14 via a conduit of the cannula body 56 and exit through one of the oxygen delivery ports towards the mask body 50 to deliver oxygen to the patient. That is, the oxygen delivery ports may be configured to direct the oxygen in a direction away from the nasal cavity and / or the oral cavity and towards the mask body 50. By delivering the oxygen awayfrom the nasal cavity and / or the oral cavity of the patient 12, the oxygen within the hybrid mask 14 may be less turbulent and more homogenous in comparison to delivering the oxygen towards the patient. That is, the oxygen may be dispersed within the interior space 52 of the hybrid mask 14 via the oxygen delivery ports. The patient 12 may inhale through their nasal cavity and / or oral cavity to receive the delivered oxygen.

[0028] The second end of the cannula body 56 and / or the second end of the hybrid mask 14 may include a sampling outlet fluidly coupled to the gas analyzer 20 via the sampling line 18 to measure CO2 exhaled by the patient 12. In certain instances, the cannula 54 may also include one or more nasal prongs 60 extending from the second side of the cannula body 56 in a direction (e.g., upward direction) along a vertical axis 204 of the hybrid mask 14. For example, the cannula 54 may include a pair of nasal prongs 60 that may be respectively inserted into a nasal cavity of the patient 12 when the hybrid mask 14 is in use with the patient 12. The exhaled breath received by the nasal prongs 60 may include CO2, which may be measured as part of capnography monitoring. In other instances, the cannula 54 may also include an oral scoop 62 positioned below the cannula body 56 (e.g., relative to a direction of gravity when in use with the patient 12) such that the cannula body 56 is positioned between the oral scoop 62 and the nasal prongs 60. The oral scoop 62 may be placed proximate to an oral cavity of the patient 12 when the hybrid mask 14 is in use with the patient and be configured to capture exhaled breath for capnometric measurements.

[0029] FIG. 3 is a front view of the hybrid mask 14 of FIG. 2 which may be employed by the capnography system 10. The hybrid mask 14 may include a cannula 54 disposed within and / or integrated with the hybrid mask 14 and facilitates both delivery of oxygen and sampling of exhaled nasal gases and / or mouth gases. The cannula 54 may include a cannula body 56 that forms an interior conduit of the cannula 54. As illustrated, the cannula body 56 extends from a first end 90 to a second end 92 of the hybrid mask 14 along a direction of a lateral axis 200 of the hybrid mask 14. That is, a first end of the cannula body 56 may be positioned at the first end 90 of the hybrid mask 14 and a second end of the cannula body 56 may be positioned at the second end 92 of the hybrid mask 14. At the first end 90 of the hybrid mask 14 and / or a first end of the cannula body 56, the hybrid mask 14 may include an intake inlet 58 fluidly coupled to the oxygen source 16 via the oxygen line 17. The second end 92 of the hybrid mask 14 and / or a second end of the cannula body 56 may include a sampling outlet 94 fluidly coupled to the gas analyzer 20 via the sampling line 18.

[0030] The intake inlet 58 and the sampling outlet 94 may be fluidly coupled to respective conduit systems disposed within the cannula body 56. For example, the intake inlet 58 may be configured to fluidly couple to an oxygen delivery conduit 96 (e.g., first conduit system) that directs oxygen from the oxygen source 16 towards one or more oxygen delivery ports 98 for delivering the oxygen to the interior space of the hybrid mask 14. In an embodiment, the one or more oxygen delivery ports 98 are located near or adjacent to respective ends of the cannula body 56. As illustrated, the oxygen delivery ports 98 may be spaced in a direction along a lateral axis 200 of the hybrid mask 14. In an embodiment, the oxygen delivery ports 98 are disposed on a side of the cannula body 56 facing the mask body 50 along a longitudinal axis 202 of the hybrid mask 14. In an embodiment, the oxygen delivery ports 98 direct oxygen to the gap (e.g., gap 55, see FIG. 2) formed between a wall 99 of the mask body 50 and the cannula 54. That is, the oxygen delivery ports 98 may direct the delivered oxygen away from a nasal cavity and / or an oral cavity of the patient. By directing the delivered oxygen away from the nasal cavity and the oral cavity, disturbance to the exhaled gas from the patient may be reduced, turbulence of gases in the interior space of the hybrid mask 14 may be reduced, and the accuracy of the analysis performed by the gas analyzer 20 may be improved. The oxygen may be redirected by the mask body 50 towards the nasal cavity and / or oral cavity of the patient. The redirection may reduce flow rate of the oxygen, which may reduce turbulence caused by oxygen delivery. As such, accuracy of capnometric measurements may be improved.

[0031] It should be understood that the hybrid mask 14 may include one or more oxygen delivery ports 98. For example, the hybrid mask 14 may include two or more oxygen delivery ports 98, three or more oxygen delivery ports 98, four or more oxygen delivery ports 98, five or more oxygen delivery ports 98, and so on. Since the oxygen is being delivered away from the nasal cavity and / or the oral cavity of the patient, the oxygen may be delivered at higher rates, including, but not limited to rates up to 60 liters of oxygen per minute (L / min). In certain instances, the oxygen may be delivered at rates greater than 60 L / min by the hybrid mask 14. Additionally or alternatively, the concentration of oxygen delivered may be up to 100%.

[0032] The cannula body 56 may also include an exhalation conduit 100 (e.g., second conduit system) that may receive exhaled breath from the nasal cavity and / or the oral cavity of the patient. The exhaled breath may include carbon dioxide. The exhalation conduit 100 may include one or more different conduits extending in different directions to facilitate collection of exhaled breath from the patient’s oral and / or nasal cavities. For example, the exhalationconduit 100 may include a primary conduit extending in a direction (e.g., horizontal direction) along the lateral axis 200 of the hybrid mask 14, a pair of secondary conduits extending in a direction (e.g., upward direction) along the vertical axis 204 of the hybrid mask 14, and an additional secondary conduit extending a direction (e.g., downward direction) along the vertical axis 204 of the hybrid mask 14. The first set of secondary conduits may be configured to extend through channels of the nasal prongs 60, and thus, may be configured to receive nasal exhaled breath from the patient and deliver the nasal exhaled breath to the primary conduit of the exhalation conduit 100. The additional secondary conduit may be configured to extend from the primary conduit through a portion of the oral scoop 62. In certain embodiments, the additional secondary conduit may include a port in fluid communication with a cavity of the oral scoop, thereby permitting the additional secondary conduit to receive exhaled oral breath from the patient and deliver the exhaled oral breath to the primary conduit of the exhalation conduit 100. The additional secondary conduit may extend from a central position of the cannula body 56. In other instances, the additional secondary conduit may extend from a position proximate the first end of the cannula body 56, in other embodiments, the additional secondary conduit may extend from the primary conduit at a position proximate the second end of the cannula body 56. Further, the intake inlet 58 and the sampling outlet 94 may include suitable couplings or connectors to permit reversible attachment of conduits (e.g., tubing) to permit transfer of gases from the oxygen source 16 and to the gas analyzer 20.

[0033] Each of the oxygen delivery conduit 96 and the exhalation conduit 100 may be fluidly isolated from one another within the cannula body 56, thereby limiting an amount of mixing between the oxygen delivered to the patient and the exhaled carbon dioxide received from the patient. For example, the oxygen delivery conduit 96 may extend from a first end of the cannula body 56 towards the second end of the cannula body 56, but may not be coupled to the second end. In contrast, the exhalation conduit 100 may extend from the second end of the cannula body 56 towards the first end of the cannula body 56 but may not be coupled to the first end of the cannula body 56. That is, the oxygen delivery conduit 96 may be coupled to the intake inlet 58 and the exhalation conduit 100 may be coupled to the sampling outlet 94. By fluidly isolating the oxygen delivery conduit 96 and the exhalation conduit 100, the accuracy of the analysis performed by the gas analyzer 20 may be improved. Additionally, in certain embodiments, the sampling line 18 may be coupled to a suction source (e.g., pump) configured to entrain exhaled breath into the sampling line 18. For example, the suction source may be apump configured to draw exhaled breath through the exhalation conduit 100, out of the sampling outlet 94, and toward the gas analyzer 20.

[0034] FIG. 4 is a back perspective view of the hybrid mask 14 of FIG. 2 which may be employed by the capnography system 10. As illustrated, the hybrid mask 14 may include a mask body 50 defining an interior space 52 of the hybrid mask 14 and a cannula 54 within the interior space 52. The mask body 50 includes a rounded portion 130 coupled to both a first side piece 132 and a second side piece 134. The rounded portion 130 may include a convex curve 53 at an end (e.g., bottom end) of the hybrid mask 14 proximate to an oral cavity. The convex curve 53 is configured to create one or more holes that facilitate fluid flow to and from the hybrid mask 14. In an embodiment, the hybrid mask 14 may not be sealed to the patient’s face when in use delivering oxygen and sampling exhaled breath. Nonetheless, even when not sealed, the hybrid mask 14 is capable of delivering oxygen at sufficient flow rates and accurate sampling of exhaled breath.

[0035] The mask body 50 also includes the first side piece 132 positioned at a first end 90 of the hybrid mask 14 and the second side piece 134 positioned at a second end 92 of the hybrid mask 14, and a portion of the first side piece 132 and a portion of the second side piece 134 may contact with the patient’s face when the hybrid mask 14 is in use by the patient. The first side piece 132 may include an intake inlet 58 formed in the mask body 50 that couples with the oxygen line 17 and the second side piece 134 may include a sampling outlet 94 that couples with the sampling line 18.

[0036] The hybrid mask 14 may also include the cannula 54 with a cannula body 56 extending in a direction (e.g., horizontal direction) along a lateral axis 200 of the hybrid mask 14. The cannula body 56 may include a first end 136 coupled to the first side piece 132 and a second end 138 coupled to the second side piece 134. As illustrated, the cannula body is affixed or coupled at a cannula first end 141 to the first end 136 of the mask body 50 and at a cannula second end 143 to the second end 138 of the mask body 50. In an embodiment, the cannula body 56 is only affixed to the mask body 50 at respective ends 141,143.

[0037] The cannula 54 may also include a pair of nasal prongs 60 extending from a side of the cannula body 56 in a direction (e.g., upward direction) along a vertical axis 204 of the hybrid mask 14. As discussed herein, the nasal prongs 60 may be respectively inserted into a nasal cavity of the patient when the hybrid mask 14 is in use by the patient. Each nasal prong 60 maydefine a channel 140 configured to receive exhaled nasal breath from the nasal cavity of the patient when in use. The cannula 54 may also include an oral scoop 62 positioned below the cannula body 56 (e.g., relative to a direction of gravity when in use with the patient) such that the cannula body 56 is positioned between the oral scoop 62 and the nasal prongs 60. It should be noted that while the oral scoop 62 is illustrated as having a square shape, the oral scoop 62 may take on other shapes including oval, rectangular, triangular, or any other suitable shape without departing from the scoop of this disclosure. The oral scoop 62 may also include a funnel 142 configured to facilitate collection of oral exhaled breath from the patient for collection and delivery of exhaled breath to the gas analyzer for analysis.

[0038] FIG. 5 is side perspective view of an embodiment of the hybrid mask 14 which may be employed by the capnography system 10. The hybrid mask 14 positioned over a nasal cavity and an oral cavity of a patient 12 to deliver oxygen and / or collect breath samples of the patient 12. As illustrated, the hybrid mask 14 may be attached to the patient 12 by oxygen line 17 and sampling line 18 without the use of additional straps. For example, the oxygen line 17 may be placed behind a first ear of the patient 12 and the sampling line 18 may be placed behind a second ear of the patient 12. Since the hybrid mask 14 may be small and loosely fit to the patient’s face, the hybrid mask 14 may be comfortable to wear. That is, the hybrid mask 14 may not be hermetically sealed (e.g., airtight seal) to the patient’s face. As such, the hybrid mask 14 may be comfortably worn by the patient 12.

[0039] By way of example, using the hybrid mask 14, oxygen delivery to the patient 12 may be up to 60 L / min or more. Additionally or alternatively, the hybrid mask 14 may be used in conjunction with low flow oxygen delivery or high flow oxygen delivery. In an embodiment, a low flow oxygen delivery may be between 2-6 L / min, while a high flow oxygen delivery may deliver oxygen at a rate above 6 L / min. However, it should be understood that flow rates outside of this range are also encompassed by the disclosure. The oxygen delivery may be continuous flow or intermittent flow.

[0040] In an embodiment, the hybrid mask 14 is a unitary structure. For example, the cannula 54 may be integrated with the mask body 50. In another example, the hybrid mask 14 may be a molded or formed piece. In other embodiments, the hybrid mask 14 may be assembled from component parts. For example, the cannula 54 may be coupled to the mask body 50. That is, the hybrid mask 14 may be assembled from two parts. The mask body 50 and the cannula 54may be formed from the same or different materials. The hybrid mask 14 may be silicon, rubber, plastic, other polymeric material, metal, or any other suitable material(s).

[0041] FIG. 6 is a cross-sectional view of the cannula 54 used within the hybrid mask 14 of FIG. 2 which may be used within the capnography system 10. The cannula 54 may include a cannula body 56 and an interior space 180, the first end 136, the second end 138, the nasal prongs 60, the channels 140, the intake inlet 58 disposed at the first end 136 of the cannula body 56, and the sampling outlet 94 disposed at the second end 138 of the cannula body 56. Additionally, the cannula 54 may include the oxygen delivery conduit 96 (e.g., first conduit system) configured to receive oxygen from the oxygen source 16 and one or more oxygen delivery ports 98 configured to deliverto the interior space ofthe hybrid mask 14. For example, the oxygen delivery conduit 96 may extend in a direction (e.g., horizontal direction) along a lateral axis 200 of the cannula 54, the oxygen delivery ports 98 may extend in a direction (e.g., forward direction) along a longitudinal axis 202 of the cannula 54 towards a mask body of the hybrid mask 14. That is, the oxygen delivery ports 98 may direct the oxygen away from the nasal cavity and / or the oral cavity of the patient. In this way, turbulence within the hybrid mask 14 may be reduced and accuracy of the analysis performed by the gas analyzer 20 may be improved, as described in greater detail below.

[0042] In the illustrated embodiment, the cannula 54 includes an oral scoop 62 positioned below the cannula body 56 relative to gravity. In certain embodiments, the oral scoop 62 may include a neck 182 (e.g., neck portion) extending from the cannula body 56 in a direction (e.g., downward direction) along the vertical axis 204 of the cannula 54 and a body portion 184 which may define a cavity 186 configured to receive exhaled oral breath from the oral cavity of the patient. The exhaled oral breath may include carbon dioxide. It should be noted that while the body portion 184 of the oral scoop 62 is illustrated as having an oval shape, the body portion 184 of the oral scoop 62 may take on other shapes including square, triangular, rectangular, or any other suitable shape without departing from the scope of this disclosure. In an embodiment, the oral scoop 62 is configured to at least in part contact the patient when the cannula 54 is in use, as described in greater detail below.

[0043] In certain embodiments, the cannula 54 may also include an exhalation conduit 100 configured to receive exhaled breath from the patient’s oral and nasal cavities and direct the exhaled breath to a gas analyzer 20 via a sampling line 18. To this end, the exhalation conduit 100 may include one or more different conduits extending in different directions to facilitatecollection of exhaled breath from the patient’s oral and / or nasal cavities. For example, the exhalation conduit 100 may include a primary conduit 188 extending in a direction (e.g., horizontal direction) along the lateral axis 200 of the cannula 54, a pair of secondary conduits 190 extending in a direction (e.g., upward direction) along the vertical axis 204 of the cannula 54, and an additional secondary conduit 192 extending in a direction (e.g., downward direction) along the vertical axis 204 of the cannula 54. The first set of secondary conduits 190 may be configured to extend through the channels 140 of the nasal prongs 60, and thus, may be configured to receive nasal exhaled breath from the patient and deliver the nasal exhaled breath to the primary conduit 188 of the exhalation conduit 100. The additional secondary conduit 192 may be configured to extend from the primary conduit 188 at a position proximate to a middle region of the cannula 54 and may be configured to extend through the oral scoop 62 such that the additional secondary conduit 192 may receive oral exhaled breath collected via the oral scoop 62. That is, the additional secondary conduit 192 may be in fluid communication with the cavity 186 of the oral scoop 62, thereby permitting the additional secondary conduit 192 to receive exhaled oral breath when the oral scoop 62 is in the first configuration. In certain embodiments, the additional secondary conduit 192 may be fluidly coupled to a funnel 142 disposed within the oral scoop 62. The funnel 142 may be configured to facilitate collection of oral exhaled breath from the patient for collection and delivery of exhaled breath to the gas analyzer 20 for analysis. Additionally, the sampling line 18 of the cannula 54 may be coupled to the suction source (e.g., pump) configured to entrain exhaled breath into the sampling line 18. For example, the suction source may be a pump configured to draw exhaled breath through the exhalation conduit 100, out of the sampling outlet 94, and toward the gas analyzer 20.

[0044] Further, each of the oxygen delivery conduit 96 and the exhalation conduit 100 may be fluidly isolated from one another, thereby limiting an amount of mixing between the oxygen delivered to the patient and the exhaled carbon dioxide received from the patient. As described above, the exhaled breath may be captured by the pair of secondary conduits 190 and the additional secondary conduits 192 as the patient exhales, while the patient may breathe in oxygen dispersed within the interior space of the hybrid mask. The oxygen may be delivered via the oxygen delivery ports 98 that direct the oxygen away from the nasal cavity and / or the oral cavity of the patient. As such, mixing between the exhaled breath and the oxygen may be limited, which may improve accuracy of capnometric measurements. Accordingly, the hybrid mask may improve accuracy of capnometric measurements under increased rates of oxygen delivery.

[0045] FIG. 7 is a flowchart of an example method 220 for delivering oxygen and collecting breath samples to and from a patient using the capnography system of FIG. 1. The hybrid mask may include a mask body defining an interior space of the hybrid mask and a cannula potion disposed within the interior space. The cannula portion may receive oxygen from an oxygen source and disperse the oxygen within the interior space of the hybrid mask. The cannula portion may also include nasal prongs and / or an oral scoop configured to collect breath samples from a patient. Since the breath sample may flow into the nasal prongs and / or oral scoop upon exhalation by the patient and the oxygen may be directed away from the patient, the amount of mixing between the oxygen and the breath samples may be limited, thereby improving accuracy of capnometric measurements while the hybrid mask delivers oxygen at an increased rate.

[0046] At block 222, a hybrid mask may be applied to a patient. For example, the hybrid mask may be placed on the patient to facilitate oxygen delivery and / or breath sample collection for capnometric measurements. Prior to placing the hybrid mask on the patient, the hybrid mask may be coupled to an oxygen source via an oxygen line and an intake inlet as well as a gas analyzer via a sampling line and a sampling outlet. As such, the hybrid mask may be coupled to two lines at opposite ends. The hybrid mask may be placed proximate to a nasal cavity and an oral cavity of the patient, the oxygen line may be placed over a first ear of the patient, and the sampling line may be placed over a second ear of the patient. The hybrid mask may not form a seal with the patient’s face, which may improve the comfort level of the hybrid mask.

[0047] At block 224, oxygen may be provided to the hybrid mask at a flow rate. The oxygen source may deliver oxygen to the hybrid mask at any suitable flow rate. By way of example, the hybrid mask may deliver oxygen at a rate of between 2 L / min to 60 L / min. It may be understood that flow rates outside of this range are also encompassed by this disclosure. For example, the hybrid mask may deliver oxygen at a rate greater than 60 L / min or less than 2 L / min. The oxygen may flow from the oxygen line to the oxygen delivery conduit and into the hybrid mask via oxygen delivery ports. The oxygen delivery ports may be positioned in a direction along a longitudinal axis of the hybrid mask and direct the oxygen away from the oral cavity and / or the nasal cavity of the patient. For example, the oxygen delivery ports may direct the oxygen towards a mask body of the hybrid mask, which may reduce mixing between the delivered oxygen and an exhaled breath sample.

[0048] At block 226, a breath sample may be collected for capnometric measurements. As the patient exhales, the breath sample may be collected by nasal prongs of a cannula portion of thehybrid mask and / or an oral scoop of the cannula portion. To this end, the nasal prongs may each include a channel configured to receive exhaled nasal breath from the nasal cavity of the patient and the oral scoop may include a funnel configured to receive exhaled oral breath from the oral cavity of the patient. The exhaled breath may flow to the sampling line via the exhalation conduit coupled to the respective channels and the funnel. In certain instances, the sampling line may be coupled to a suction source to draw the exhaled breath through the exhalation conduit and towards a gas analyzer for capnometric measurements.

[0049] The method may return to block 224 and block 226 when the hybrid mask may be in use by the patient. For example, the oxygen delivery may be continuously or intermittently delivered while the hybrid mask is in use by the patient. Additionally or alternatively, the breath sample measurements may be continuously or intermittently taken while the hybrid mask is in use by the patient.

[0050] At block 228, the hybrid mask may be removed from the patient. After a period of time, the hybrid mask may be removed by taking the oxygen line and / or the sampling line off the ears of the patient.

[0051] The method discussed herein includes various steps represented by blocks in flow diagrams. It should be noted that at least some steps may be performed as an automated procedure by one or more components of a system. Although the flow diagrams may illustrate the steps in a certain sequence, it should be understood that the steps may be performed in any suitable order and certain steps may be carried out simultaneously, where appropriate. Additionally, steps may be added to or omitted from the methods. While the disclosure may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the embodiments provided herein are not intended to be limited to the particular forms disclosed. Rather, the various embodiments may cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the following appended claims.

[0052] The following examples are illustrative of the techniques described herein.

[0053] Example 1. A hybrid mask for oxygen delivery and exhaled gas monitoring, comprising: a mask body defining an interior space of the hybrid mask; and a cannula coupledto a wall of the mask body in the interior space, the cannula comprising: an oxygen delivery conduit delivering oxygen to the interior space via one or more oxygen delivery ports of the cannula; an exhalation conduit delivering exhaled breath of a patient to a sampling line, wherein the oxygen delivery conduit and the exhalation conduit are configured to couple the hybrid mask to the patient; and first and second nasal prongs each comprising a channel directing exhaled nasal breath into the exhalation conduit.

[0054] Example 2. The hybrid mask of Example 1, wherein the cannula comprises an oral scoop extending from the cannula and comprising an inlet delivering exhaled oral breath into the exhalation conduit.

[0055] Example 3. The hybrid mask of Example 1, wherein the mask body forms a cover for the cannula.

[0056] Example 4. The hybrid mask of Example 1, wherein the oxygen delivery conduit comprises: a primary conduit extending in a first direction along a lateral axis of the cannula; and one or more oxygen delivery ports positioned along the first direction and delivering air, oxygen, oxygen-enriched air, or any combination thereof in a second direction along a longitudinal axis of the cannula.

[0057] Example 5. The hybrid mask of Example 1, wherein the mask body comprises a curve creating one or more holes in the hybrid mask to facilitate fluid flow to and from the hybrid mask.

[0058] Example 6. The hybrid mask of Example 1, wherein the cannula comprises a cannula body coupled to the wall of the mask body at a first end and a second end of the cannula body.

[0059] Example 7. A capnography system comprising: a hybrid mask comprising: a mask body defining an interior space of the hybrid mask; a cannula coupled to the mask body and positioned in the interior space, the cannula comprising: an oxygen delivery conduit delivering oxygen to the interior space; an exhalation conduit collecting an exhaled breath comprising a nasal exhaled breath and an oral exhaled breath; first and second nasal prongs coupled to the exhalation conduit; and an oral scoop fluidly coupled to the exhalation conduit; and an oxygen source coupled to the oxygen delivery conduit to provide oxygen via the oxygen delivery conduit.

[0060] Example 8. The capnography system of Example 7, comprising a monitor fluidly coupled to the exhalation conduit to analyze exhaled carbon dioxide received via the exhalation conduit.

[0061] Example 9. The capnography system of Example 7, wherein the hybrid mask is coupled to a patient via the oxygen delivery conduit and the exhalation conduit.

[0062] Example 10. The capnography system of Example 7, wherein the oral scoop is positioned proximate an oral cavity of a patient when the hybrid mask in in operation and collects an oral breath sample of the patient.

[0063] Example 11. The capnography system of Example 10, wherein the mask body comprises a curve proximate to the oral scoop, wherein the curve creates one or more holes within the mask body to facilitate fluid flow to and from the interior space.

[0064] Example 12. The capnography system of Example 7, comprising a gap is formed between a wall of the mask body and the cannula.

[0065] Example 13. The capnography system of Example 7, wherein the oxygen delivery conduit comprises one or more oxygen delivery ports positioned along a first direction along a lateral axis of the cannula, wherein the one or more oxygen delivery ports deliver the oxygen in a second direction along a longitudinal axis of the cannula.

[0066] Example 14. The capnography system of Example 7, wherein the exhalation conduit comprises a secondary conduit extending in a first direction along a vertical axis of the cannula and an additional secondary conduit extending in a second direction along the vertical axis of the cannula.

[0067] Example 15. The capnography system of Example 7, wherein the mask body forms a cover for the cannula.

Claims

CLAIMS1. A hybrid mask (14) for oxygen delivery and exhaled gas monitoring, comprising: a mask body (50) defining an interior space (180) of the hybrid mask (14); and a cannula (54) coupled to a wall (99) of the mask body (50) in the interior space (180), the cannula (54) comprising: an oxygen delivery conduit (96) delivering oxygen to the interior space (180) via one or more oxygen delivery ports of (98) the cannula (54); an exhalation conduit (100) delivering exhaled breath of a patient to a sampling line (18), wherein the oxygen delivery conduit (96) and the exhalation conduit (100) are configured to couple the hybrid mask (14) to the patient; and first and second nasal prongs (60) each comprising a channel (140) directing exhaled nasal breath into the exhalation conduit (100).

2. The hybrid mask (14) according to claim 1, wherein the cannula (54) comprises an oral scoop (62) extending from the cannula (54) and comprising an inlet delivering exhaled oral breath into the exhalation conduit (100).

3. The hybrid mask (14) according to any of claims 1 or 2, wherein the mask body (50) forms a cover for the cannula (54).

4. The hybrid mask (14) according to any of claims 1 to 3, wherein the oxygen delivery conduit (96) comprises: a primary conduit (188) extending in a first direction along a lateral axis (200) of the cannula (54); and one or more oxygen delivery ports (98) positioned along the first direction and delivering air, oxygen, oxygen-enriched air, or any combination thereof in a second direction along a longitudinal axis (202) of the cannula (54).

5. The hybrid mask (14) according to any of claims 1 to 4, wherein the mask body (50) comprises a curve (53) creating one or more holes in the hybrid mask (14) to facilitate fluid flow to and from the hybrid mask (14).

6. The hybrid mask (14) according to any of claims 1 to 5, wherein the cannula (54) comprises a cannula body (56) coupled to the wall (99) of the mask body (50) at a first end (90) and a second end (92) of the cannula body (56).

7. A capnography system (10) comprising: a hybrid mask (14) comprising: a mask body (50) defining an interior space (180) of the hybrid mask (14); a cannula (54) coupled to the mask body (50) and positioned in the interior space (180), the cannula (54) comprising: an oxygen delivery conduit (96) delivering oxygen to the interior space (180); an exhalation conduit (100) collecting an exhaled breath comprising a nasal exhaled breath and an oral exhaled breath; first and second nasal prongs (60) coupled to the exhalation conduit (100); and an oral scoop (62) fluidly coupled to the exhalation conduit (100); and an oxygen source (16) coupled to the oxygen delivery conduit (96) to provide oxygen via the oxygen delivery conduit (96).

8. The capnography system (10) according to claim 7, comprising a monitor (20) fluidly coupled to the exhalation conduit (100) to analyze exhaled carbon dioxide received via the exhalation conduit (100).

9. The capnography system (10) according to any of claims 7 or 8, wherein the hybrid mask ( 14) is coupled to a patient via the oxygen delivery conduit (96) and the exhalation conduit (100).

10. The capnography system (10) according to any of claims 7 to 9, wherein the oral scoop (62) is positioned proximate an oral cavity of a patient when the hybrid mask ( 14) in in operation and collects an oral breath sample of the patient.

11. The capnography system (10) according to any of claims 7 to 10, wherein the mask body (50) comprises a curve (53) proximate to the oral scoop (62), wherein the curve (53)creates one or more holes within the mask body (50) to facilitate fluid flow to and from the interior space (180).

12. The capnography system (10) according to any of claims 7 to 11, comprising a gap (55) is formed between a wall (99) of the mask body (50) and the cannula (54).

13. The capnography system (10) according to claim any of claims 7 to 12, wherein the oxygen delivery conduit (96) comprises one or more oxygen delivery ports (98) positioned along a first direction along a lateral axis (200) of the cannula (54), wherein the one or more oxygen delivery ports (98) deliver the oxygen in a second direction along a longitudinal axis (202) of the cannula (54).

14. The capnography system (10) according to any of claims 7 to 13 , wherein the exhalation conduit (100) comprises a secondary conduit (190) extending in a first direction along a vertical axis (204) of the cannula (54) and an additional secondary conduit (192) extending in a second direction along the vertical axis (204) of the cannula (54).

15. The capnography system (10) according to any of claims 7 to 14, wherein the mask body (50) forms a cover for the cannula (54).

Citation Information

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