WO2023122333A1 - Medical gas delivery - Google Patents

Medical gas delivery Download PDF

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Publication number
WO2023122333A1
WO2023122333A1 PCT/US2022/053953 US2022053953W WO2023122333A1 WO 2023122333 A1 WO2023122333 A1 WO 2023122333A1 US 2022053953 W US2022053953 W US 2022053953W WO 2023122333 A1 WO2023122333 A1 WO 2023122333A1
Authority
WO
WIPO (PCT)
Prior art keywords
diffuser
subject
positioner
face
head
Prior art date
Application number
PCT/US2022/053953
Other languages
French (fr)
Inventor
Anthony Esplin
Larry Mastrovich
Vermon Sims Esplin
Richard Ashbaugh
Original Assignee
Sleep Easy Technology Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US17/741,406 external-priority patent/US20220339377A1/en
Application filed by Sleep Easy Technology Inc. filed Critical Sleep Easy Technology Inc.
Publication of WO2023122333A1 publication Critical patent/WO2023122333A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816Joints or connectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/02Gases
    • A61M2202/0208Oxygen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2206/00Characteristics of a physical parameter; associated device therefor
    • A61M2206/10Flow characteristics
    • A61M2206/14Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00Ancillary equipment
    • A61M2209/08Supports for equipment
    • A61M2209/084Supporting bases, stands for equipment

Definitions

  • This disclosure relates to systems for delivering medical gases, such as supplemental oxygen, to a subject. More specifically, this disclosure relates to systems that employ pillows to deliver medical gases, including pillows and systems that are designed to be assembled with a surface of a pillow or another surface on which a subject may rest their head. Such a system includes a positioner that positions the head and face of the subject in a desired orientation and a diffuser that delivers medical gas to the face of the subject. Methods for delivering medical gases are also disclosed.
  • supplemental oxygen helps subjects who suffer from sleep apnea, acute bronchitis, asthma, heart conditions, chronic obstructive pulmonary disease (COPD), dementia, Alzheimer’s disease, and other disorders achieve more stable, restful states of sleep than those subjects typically experience without supplemental oxygen.
  • COPD chronic obstructive pulmonary disease
  • a variety of apparatuses, including conventional oxygen delivery systems, may be used to provide hypoxic patients with supplemental oxygen as they sleep.
  • a conventional oxygen delivery system typically includes an oxygen source (e.g., an oxygen concentrator, an oxygen tank, liquid oxygen, etc.), tubing, and a nasal cannula that delivers oxygen from the oxygen concentrator to a subject’s nose.
  • An oxygen concentrator concentrates oxygen from the air, providing air with an above-ambient concentration of oxygen, which is also referred to herein as “supplemental oxygen” for the sake of simplicity.
  • the oxygen source delivers the supplemental oxygen to and through tubing to the nasal cannula.
  • the nasal cannula has a configuration that enables it to be secured beneath a subject’s nose in an orientation that directs the pressurized, supplemental oxygen into the subject’s nose. It is up to the patient to breathe in to access that oxygen from the nasal cannula.
  • Nasal cannulas may also be ineffective for delivering supplemental oxygen to subjects who suffer from upper respiratory tract infections (e.g., a common cold, influenza, sinus infections, etc.) and to subjects who suffer from nasal abnormalities (e.g., a deviated septum, etc.).
  • upper respiratory tract infections e.g., a common cold, influenza, sinus infections, etc.
  • nasal abnormalities e.g., a deviated septum, etc.
  • a nasal cannula can be uncomfortable and irritating.
  • the presence of the nasal cannula beneath the subject’s nose may be bothersome (e.g., it may lead to nose bleeds when the air is dry, such as during wintertime, etc.).
  • the delivery of supplemental oxygen into a subject’s nose has a tendency to dry out the subject’s nasal membranes, which may make the nasal cannula even more bothersome.
  • the discomfort a subject experiences while wearing a nasal cannula and while the nasal cannula delivers regulated, supplemental oxygen to the subject’s nose may lead to removal of the nasal cannula — either intentionally or unintentionally — as the subject tries to sleep.
  • the nasal cannula When the nasal cannula is removed or the subject breathes through their mouth, however, the subject no longer receives supplemental oxygen, which may cause the same problem the supplemental oxygen is intended to address (e.g., fitful, interrupted sleep for hypoxia patients, etc.).
  • An embodiment of a medical gas delivery system of this disclosure may include a diffuser and a positioner.
  • the diffuser may include a base that supports the diffuser on a surface (e.g., a surface on which a subject rests their head, such as a pillow, etc.), walls that define a recess, an inlet at one end of the receptacle, and a delivery face at an opposite end of the recess.
  • a gas delivery tube may couple to the diffuser adjacent to the inlet.
  • the walls of the diffuser may taper outwardly from the side of the diffuser on which the inlet is located to the side of the diffuser on which the delivery face is located.
  • the walls of the diffuser may impart the diffuser with a size and a shape that enable gas to be delivered efficiently and effectively to the face of a subject.
  • Use of the diffuser includes providing gas flow from a source, through the gas delivery tube, through the inlet, into the recess, and out of the delivery face.
  • an inlet of the diffuser may increase turbulence in gases that are delivered by the diffuser, which may facilitate the creation of a “gas cloud” for inhalation by a subject.
  • Such an inlet may include a baffle located within the recess of the diffuser, over a channel and/or an aperture the inlet. More specifically, the baffle may be positioned within a flow path defined by the inlet. A configuration (e.g., a shape, dimensions, etc.) and a position of the baffle may cause gas that flows into the recess to flow around the baffle and then toward and through the delivery face, albeit less forcefully and more diffuse than if the gas were to flow unimpeded through the recess.
  • the baffle may be removable from the recess and replaceable within the recess.
  • the positioner may include a base that supports the head positioner on the surface, as well as an orienting surface that receives a back of a subject’s head in a manner that orients the subject’s head on the surface and positions the subject’s face toward the delivery face of the diffuser.
  • One or both of the diffuser and the positioner may include a coupler.
  • a coupler may hold the base of its respective component (i.e., the diffuser or the positioner) in place on the surface that supports the component.
  • the coupler may comprise a strap that extends around the pillow or other cushion to secure the component to it.
  • the coupler may comprise a so-called “touch fastener” (e.g., the hook elements of Velcro, etc.) that engages another touch fastener, elastic, or a fabric (e.g., a soft, fuzzy fabric that comprises the loop elements of Velcro, etc.) on the surface (e.g., a pillowcase on a pillow, etc.).
  • the coupler may comprise a pocket associated with (e.g., on, in, etc.) the surface.
  • the medical gas delivery system may also include a cover.
  • the cover may comprise a pillowcase.
  • the cover may include a vent therethrough, which may be positionable over or adjacent to the delivery face of the diffuser to accommodate gas that flows from the delivery face of the diffuser.
  • a shape of the vent may enable it to accommodate a plurality of different positions of the diffuser on the surface.
  • a medical gas may be delivered to a subject with such a medical gas delivery system by arranging the medical gas delivery system on a surface (e.g., a pillow, another cushion, etc.) where the subject will rest their head.
  • the positioner is positioned at a first location on the surface, adjacent to a second location on the surface, where the subject’s head will rest.
  • the orienting surface of the positioner which may have a shape that will receive a back of the head of the subject, may face the second location, enabling the orienting surface to orient the head of the subject sideways over the second location on the surface.
  • the diffuser may be positioned at a third location on the surface, adjacent to the second location and on an opposite side of the second location from the first location.
  • the delivery face of the diffuser may be oriented toward the second location.
  • the delivery face may be oriented at an angle to the surface (e.g., an acute angle, etc.), which may enable the gas to be more effectively and/or efficiently delivered to the face of the subject.
  • One or both of the positioner and the diffuser may be secured in place relative to the surface (e.g., over the surface, to the surface, within a pocket associated with the surface, etc.).
  • a cover may be positioned over the positioner, the diffuser, and the surface. Positioning the cover may include positioning a vent through the cover over or adjacent to the delivery face of the diffuser to enable gas to flow freely from the delivery face of the diffuser to a face of the subject.
  • a subject’s head may be placed on the second location of the surface, with the back of the head placed against the orienting surface of the positioner, a side of the head placed against the second location, and a face of the subject oriented toward the delivery face of the diffuser.
  • the delivery face of the diffuser may tilt downward in a manner that deceases a distance between the delivery face and the second location on the surface, as well as a distance between the subject’s face and the delivery face.
  • the position of one or both of the positioner and the diffuser may be adjusted (e.g., moved laterally, etc.) to increase the subject’s comfort, optimize the efficiency with which the medical gas delivery systems delivers the gas to the subject, or the like.
  • the gas may be delivered through the delivery face of the diffuser to the face of the subject.
  • FIG. 1 is a perspective view of an embodiment of medical gas delivery system according to this disclosure
  • FIG. 2 is a front perspective view of an embodiment of a diffuser of the medical gas delivery system of FIG. 1;
  • FIG. 3 is a side view of the embodiment of diffuser shown in FIG. 2;
  • FIG. 4 is a top perspective view of the embodiment of diffuser shown in FIG. 2;
  • FIG. 5 is an isometric view of another embodiment of diffuser that may be used in a medical gas delivery system
  • FIG. 6 is a top, or distal side, plan view of the embodiment of the diffuser shown in FIG. 5;
  • FIG. 7 is a bottom, or proximal side, perspective view of the embodiment of the diffuser shown in FIG. 5;
  • FIG. 8 is a cross-sectional representation of the embodiment of the diffuser shown in FIG. 5;
  • FIG. 9 provides a representation of flow simulation through the embodiment of the diffuser shown in FIGs. 5-8;
  • FIG. 10 is a top, or distal side, isometric view of yet another embodiment of a diffuser that may be used in a medical gas delivery system;
  • FIG. 11 is a top, or distal side, isometric view of an embodiment of a baffle that may be assembled over an inlet of the embodiment of the diffuser shown in FIG. 10;
  • FIG. 12 is a side view of the embodiment of the diffuser shown in FIG. 10;
  • FIG. 13 is a cutaway view of the embodiment of the diffuser shown in FIG. 10;
  • FIGs. 14 and 15 are isometric views of an embodiment of a positioner that carries a diffuser, such as the embodiment of the diffuser shown in FIGs. 5-8 or the embodiment of the diffuser shown in FIGs. 10-13;
  • FIG. 16 is a side view of the embodiment of the positioner shown in FIGs. 14 and 15;
  • FIG. 17 illustrates use of the embodiment of the positioner shown in FIGs. 14-16 to supply supplemental gas to a subject
  • FIG. 18 provides a representation of an embodiment of a medical gas delivery system that includes two positioners that carry diffusers, such as the embodiment of the positioner shown in FIGs. 14-16;
  • FIG. 19 depicts an embodiment of use of an embodiment of the embodiment of the medical gas delivery system shown in FIGs. 1-4;
  • FIG. 20 is a graph showing the blood oxygen saturation (SpCh) of a subject receiving supplemental oxygen through a nasal cannula at a flow rate of 3 L/min; and FIGs. 21-23 are graphs showing the blood oxygen saturation of the same subject on three successive nights, with the embodiment of the medical gas delivery system depicted by FIG. 19 delivering the supplemental oxygen at a flow rate of 3 L/min.
  • SpCh blood oxygen saturation
  • FIG. 1 illustrates an embodiment of a medical gas delivery system 10 according to this disclosure.
  • the medical gas delivery system 10 is configured to be placed upon a surface 22 upon which a subject’s head will rest, such as a surface 22 of a pillow 20 of another cushion.
  • the medical gas delivery system 10 includes a diffuser 30 and a positioner 40.
  • the diffuser 30 may be positioned over the surface 22 at a location and in an orientation that will enable it to direct one or more medical gases (e.g., supplemental oxygen, air, etc.) to a desired location over the surface 22, such as a location where a subject’s face will be positioned.
  • the positioner 40 may be positioned over the surface 22 at a location and in an orientation that will enable it to orient the subject’s head and face toward the diffuser 30. As illustrated, the positioner 40 may be spaced apart from the diffuser 30 by a sufficient distance to accommodate the subject’s head.
  • a diffuser anchor 60 may secure the diffuser 30 in place over the surface 22 in a desired location and in a desired orientation.
  • a positioner anchor 70 may secure the positioner 40 in place over the surface 22 in a desired location and in a desired orientation.
  • the diffuser anchor 60 and/or the positioner anchor 70 may comprise a strap, as depicted.
  • the diffuser anchor 60 and/or the positioner anchor 70 may comprise a so-called touch fastener (e.g., a hook portion of a Velcro fastener, which may engage loops of a fabric that defines the surface 22, etc.), an adhesive material, or any other suitable anchor.
  • a medical gas delivery system 10 may include a cover (not shown), such as a pillowcase, that holds, or anchors, the diffuser 30 and the positioner 40 in place over the surface 22.
  • a cover may include pockets that are at least partially defined by vents (e.g., openings through the fabric of the cover, a mesh panel in the fabric, another type of panel that allows air to flow therethrough without restricting airflow, etc.).
  • a cover such as a pillowcase, may be used in conjunction with other anchors to accommodate a variety of different placements of the diffuser 30 and positioner 40 while increasing comfort for the subject and providing for unrestricted flow of the medical gas to the subject’s face.
  • the medical gas delivery system 10 may include a conduit, which may be referred to as a “gas delivery tube 50,” that transports a medical gas from a source (not shown) to the diffuser 30.
  • the medical gas delivery system 10 may also include a spacer (not shown), which facilitates positioning of the diffuser 30 and the positioner 40 relative to each other.
  • the diffuser 30 may comprise a block of a cushioning foam through which the gas delivery tube 50 may extend.
  • the diffuser 30 may have the shape of a rectangular prism, or it may be shaped as an oblique triangle with a delivery face 37 that creates a tent-like well over the surface 22 to trap and, thus, obstruct the dissipation of the medical gas and, thus, improve the efficiency with which the medical gas may be delivered to a subject’s face.
  • the diffuser 30 includes a body 32, a recess 36, a delivery face 37, and an inlet 38.
  • the body 32 includes a base 33, a rear wall 34 that extends upward from a rear of the base 33, and front edges 35 that extend upward from a front of the base 33.
  • the body 32 defines the recess 36.
  • the recess 36 opens to the delivery face 37, which is defined by the front edges 35 of the body 32.
  • the inlet 38 may be positioned on the rear wall 34 of the body 32.
  • the inlet 38 may have a configuration that enables it to couple with and receive a medical gas from the gas delivery tube 50.
  • a channel 39 extends through the inlet 38, the rear wall 34, and into the recess 36 of the diffuser 30, enabling the transport of medical gas into the recess 36.
  • the medical gas may flow out of the recess 36 through the delivery face 37.
  • the delivery face 37 of the diffuser 30 may be oriented at an obtuse angle to the base 33 of the body 32 of the diffuser 30. The angle at which the delivery face 37 is oriented may define an acute angle with the surface 22 on which the diffuser 30 is placed.
  • the angle between the surface 22 and the delivery face 37 may at least partially accommodate a subject’s face when the subject’s head is placed on the surface 22, toward the delivery face 37 of the diffuser, which may cause a portion of the diffuser 30 to extend over the surface 22 or even over a portion the subject’s face in a manner that (further) traps air and any medical gas mixed therewith and, thus, (further) limits the rate at which the air and any medical gas mixed therewith can diffuse upwardly, which may (further) improve the efficiency with which the diffuser 30 delivers medical gas to the subject’s face.
  • the surface 22 on which the diffuser 30 is placed gives way (e.g., concavely bows, is indented, etc.) when the subject’s head is placed thereon, the extent to which the portion of the diffuser extends over the surface 22 may increase, which may further improve the efficiency with which medical gas is delivered to the subject’s face.
  • the diffuser 30' includes a body 32', a recess 36', a delivery face 37', an inlet 38', and a baffle 39'.
  • the inlet 38' is located at a proximal side of the diffuser 30'.
  • the body 32' includes walls 34' that extend outward distally from the inlet 38' to define the recess 36', with outer edges 35' of the walls 34' defining delivery face 37' at a distal side of the diffuser 30'.
  • the recess 36' opens to the delivery face 37'.
  • the inlet 38' may have a configuration that enables it to couple with and receive a medical gas from the gas delivery tube 50 (FIG. 1).
  • the inlet 38' may include a channel 38c' that extends through a proximal side of the inlet 38'.
  • the inlet 38' may also include an aperture 38a', which may be located at a distal end of the channel 38c'.
  • the channel 38c' may have a configuration that enables it to receive and, optionally, couple to a distal end of the gas delivery tube 50 (FIG. 1).
  • the baffle 39' may be positionable (e.g., in embodiments where the baffle 39' is removable and/or replaceable, etc.) or positioned over a distal side of the aperture 38a' of the inlet 38.
  • the baffle 39' includes a body 39b' and may include a post 39p', which may extend from a proximal side of the body 39b'.
  • the post 39p' may hold the body 39b' of the baffle 39' in place over the aperture 38a' of the inlet 38'; more specifically, the post 39p' may extend partially into the aperture 38a', with a lateral extension 391' from the post 39p' securing the post 39p' in place relative to a wall 38w' of the aperture 38a'.
  • a distance across the body 39b' e.g., an outer diameter of the body 39b', etc.
  • Gas entering the inlet 38' may be able to flow into the aperture 38a', around the post 39p', and into the recess 36', where the body 39b' of the baffle 39' disrupts flow of the gas.
  • a shape of the body 39b' may be tailored to disrupt the flow of gas into the recess 36' in a desired manner.
  • the body 39b' has a configuration with a mushroom-like appearance, in which its distal side is larger than its proximal side and its proximally facing surfaces taper, or even curve, to its proximal side.
  • FIG. 9 is a diagram that provides a representation of the manner in which the baffle 38b' of the inlet 38' disrupts and diffuses gas flow delivered to a subject S through a gas delivery tube 50 to and through the embodiment of diffuser 30' shown in FIGs. 5-8, with the dots representing gas molecules (e.g., O2, etc.).
  • gas molecules e.g., O2, etc.
  • the diffuser 30 includes a body 32", a recess 36", a delivery face 37", an inlet 38", and a baffle 39".
  • the inlet 38" is located at a proximal side of the diffuser 30".
  • the body 32" includes a wall 34" that extends outward distally from the inlet 38" to define the recess 36", with an outer edge 35" of the wall 34" defining the delivery face 37" at a distal side of the diffuser 30".
  • the recess 36" opens to the delivery face 37".
  • the inlet 38" may include a channel 38c" that extends through a proximal side of the inlet 38'.
  • the channel 38c" may have a configuration that enables it to receive and, optionally, couple to a distal end of the gas delivery tube 50 (FIG. 1).
  • the inlet 38" may also include an aperture 38a" at a distal end of the channel 38c".
  • a baffle engagement slot 38s" may be formed in the inlet 38".
  • the baffle engagement slot 38s" may be continuous with and, thus, open to a side of the aperture 38a".
  • a configuration of the baffle engagement slot 38s" may enable it to receive and engage a corresponding diffuser engager 39e" of the baffle 39".
  • the configuration of the baffle engagement slot 38s" may enable it to receive the diffuser engager 39e” in a manner that ensures the baffle 39" is properly positioned within the recess 36" of the diffuser 30".
  • the baffle 39" may be removably positioned over a distal side of the aperture 38a" of the inlet 38" of the diffuser 30".
  • the baffle 39" includes a body 39b".
  • a post 39p" extends from a proximal side of the body 39b" of the baffle 39".
  • a lateral extension 391" from the post 39p” connects the diffuser engager 39e" to the post 39p".
  • the diffuser engager 39e" is receivable by the baffle engagement slot 38s" of the inlet 38" and, thus, holds the baffle 39" in place relative to a wall 38w" of the aperture 38a" of the inlet 38", with body 39b" of the baffle 39" being located over the aperture 38a".
  • a distance across the body 39b" (e.g., an outer diameter of the body 39b", etc.) may exceed a distance across the aperture 38a" (e.g., an inner diameter of the aperture 38a", etc.).
  • the post 39p" may extend partially into the aperture 38a".
  • Gas entering the inlet 38" may be able to flow into the aperture 38a", around the post 39p", and into the recess 36", where the body 39b" of the baffle 39" disrupts flow of the gas.
  • a shape of the body 39b" may be tailored to disrupt the flow of gas into the recess 36" in a desired manner.
  • the body 39b" has a configuration with a mushroom-like appearance, in which its distal side is larger than its proximal side and its proximally facing surfaces taper, or even curve, to its proximal side.
  • the positioner 40 may include a base 42 and an orienting surface 44.
  • the base 42 may face the surface 22 over which the positioner 40 is positioned.
  • the orienting surface 44 which extends upwardly from the base 42, may be oriented on the surface 22 such that the orienting surface 44 faces the diffuser 30.
  • the orienting surface 44 has a shape that enables it to receives the back of the subject’s head and to stably orient the subject’s head such that the subject’s face will face the delivery face 37 (FIGs. 2-4) of the diffuser 30.
  • the positioner 40 may comprise a shaped block of foam or another cushioning material with sufficient density to support and stably hold the subject’s head in a desired orientation.
  • the positioner 40'" may be configured similarly to the positioner 40 shown in and described in reference to FIG. 1.
  • the positioner 40'" may include a base 42'" and a lateral surface 44'" with configurations that enable them to perform the same functions as the base 42 and orienting surface 44 of the embodiment of the positioner 40 shown in FIG. 1.
  • the lateral surface 44'" may include a receptacle 46'" for the diffuser 30'".
  • a configuration of the receptacle 46'" may enable it to orient the diffuser 30'" in a manner that causes gas to flow laterally or at a somewhat downward angle, from the diffuser 30'" through a side, or the lateral surface 44'", of the positioner 40'".
  • the receptacle 46'" may carry the diffuser 30'", which may comprise a diffuser according to this disclosure, which may in turn receive a medical gas from a medical gas source 52 through a gas delivery tube 50.
  • the positioner 40"' may include a cushion flap 45"' protruding from an upper portion of the lateral surface 44'" and extending over the lateral surface 44'".
  • the cushion flap 45'" may extend over, or overhang, the receptacle 46'" and any diffuser 30'" therein.
  • the cushion flap 45'" may have a configuration that enables it to collapse (e.g., over the delivery face 37'" of the diffuser 30'", etc.) to comfortably support a subject’s head while minimizing any discomfort that might otherwise be caused as the subject’s head rests on the diffuser 30'".
  • the cushion flap 45'" may automatically return to its overhanging orientation when the subject’s head is removed from it, exposing the diffuser 30'" and its delivery face 37'" so the flow of gas therefrom is unobstructed.
  • the cushion flap 45'" of the positioner 40'" may also be positioned over a portion of a face of a subject S (e.g., the subject S’s mouth and/or nose, etc.) when the diffuser 30'" carried by the positioner 40'" is used to supply a medical gas to the individual, as shown in FIG. 17.
  • An orientation (e.g., slightly raised, etc.) and/or a shape (e.g., concavely bowed of the cushion flap 45'" may provide a pocket 47'" that can comfortably receive a portion of the face of a subject S.
  • an outer edge of the cushion flap 45'" may be slightly raised.
  • the cushion flap 45'" may be bowed.
  • a lower surface 45b'" of the cushion flap 45'" may be concavely bowed.
  • a thickness of the cushion flap 45'" may gradually decrease from the location where it extends from the orienting surface 44'" to its outer edge 45e'".
  • the pocket 47'" created by the cushion flap 45'" may trap air and any medical gas mixed therewith, which may prevent the air and any medical gas mixed therewith from diffusing before the subject S can inhale it, which may enhance the efficiency with which the diffuser 30'" delivers medical gas to the face of the subject S.
  • FIG. 18 illustrates an embodiment of a medical gas delivery system 10'" that includes two positioners 40'" that carry diffusers 30'".
  • Gas delivery tubes 50 extend between a medical gas source 52 and the diffusers 30'" to enable medical gas to flow from the medical gas source 52 to and through the diffusers 30'".
  • the positioners 40'" may be positioned at spaced apart locations on a surface 22. As illustrated, the positioners 40'" may be spaced apart from each other by a sufficient distance to accommodate a subject’s head.
  • a location and an orientation of each positioner 40'" may enable the diffuser 30'" carried by each positioner 40'" to direct one or more medical gases (e.g., supplemental oxygen, air, etc.) to a desired location over the surface 22 between the positioners 40"', such as a location where the subject’s face may be positioned.
  • a location and an orientation of each positioner 40"' may enable it to orient the subject’s head and face toward the diffuser 30'" carried by the opposite positioner 40'".
  • the flow of medical gas may be the same or about the same as the flow if the medical gas were to be delivered through a nasal cannula (e.g., about 2 L/min., about 1-4 L/min., about 1-6 L/min, any value within the aforementioned ranges, etc.), but split between the diffusers 30'" (e.g., about 1 L/min per diffuser 30'", about 0.5-2 L/min., about 0.5-3 L/min, any value within the aforementioned ranges, etc.).
  • a nasal cannula e.g., about 2 L/min., about 1-4 L/min., about 1-6 L/min, any value within the aforementioned ranges, etc.
  • split between the diffusers 30' e.g., about 1 L/min per diffuser 30'", about 0.5-2 L/min., about 0.5-3 L/min, any value within the aforementioned ranges, etc.
  • each diffuser 30' e.g., the presence of a baffle 39', 39" in diffuser 30', 30", respectively, etc.
  • the fixed inspired (FI) content of the gas e.g., FIO2, etc.
  • FIO2 content may be about 24% to about 44%, by volume, etc.
  • the subject may receive approximately the same concentration of the medical gas as they would have if they instead used a much less comfortable nasal cannula.
  • FIG. 19 an embodiment of use of a medical gas delivery system 10 is depicted.
  • the method is also applicable to any other embodiment of medical gas delivery system according to this disclosure, including the medical gas delivery system 10'" shown in FIG. 18.
  • a diffuser 30 and a positioner 40 have been positioned over the surface 22 of a pillow 20.
  • the back HB of a subject S’s head H rests against the orienting surface 44 of the positioner 40, while the delivery face 37 of the diffuser 30 faces the subject S’s face F.
  • the subject S’s blood oxygen saturation (SpO 2 ) was measured while the subject S received supplemental oxygen at a flow rate of 3 L/min. over a first night, as depicted by the graph of FIG. 20.
  • the subject’s blood oxygen saturation was again measured while the subject S slept using the system shown in FIG. 19, which also delivered supplemental oxygen at a flow rate of 3 L/min, as depicted by the graphs of FIGs. 21-23.
  • the medical gas delivery system 10 delivered the supplemental oxygen with an efficiency equivalent to that of a nasal cannula.

Abstract

A system for delivering medical gases, such as supplemental oxygen, to a subject includes a positioner and a diffuser positionable on opposite sides of a location on a surface where the subject will rest their head. The positioner may position a head and face of the subject in a desired orientation, while the diffuser may direct at least one medical gas to be delivered to the subject toward the subject's face. Methods for delivering medical gas(es) are also disclosed.

Description

MEDICAL GAS DELIVERY
CROSS-REFERENCE TO RELATED APPLICATION
Claims for priority to the December 23, 2022 filing date of U.S. Provisional Patent Application No. 63/293,517, titled MEDICAL GAS DELIVERY (“the ’517 Provisional Application”) and the May 10, 2022 filing date of U.S. Patent Application
No. 17/741,406, titled MEDICAL GAS DELIVERY (“the ’406 Application”) are hereby made. The entire disclosures of the ’785 Provisional Application and ’406 Application are hereby incorporated herein.
TECHNICAL FIELD
This disclosure relates to systems for delivering medical gases, such as supplemental oxygen, to a subject. More specifically, this disclosure relates to systems that employ pillows to deliver medical gases, including pillows and systems that are designed to be assembled with a surface of a pillow or another surface on which a subject may rest their head. Such a system includes a positioner that positions the head and face of the subject in a desired orientation and a diffuser that delivers medical gas to the face of the subject. Methods for delivering medical gases are also disclosed.
RELATED ART
A variety of health conditions may lead to the need for the delivery of medical gases, such as supplemental oxygen. Among other conditions, supplemental oxygen helps subjects who suffer from sleep apnea, acute bronchitis, asthma, heart conditions, chronic obstructive pulmonary disease (COPD), dementia, Alzheimer’s disease, and other disorders achieve more stable, restful states of sleep than those subjects typically experience without supplemental oxygen. A variety of apparatuses, including conventional oxygen delivery systems, may be used to provide hypoxic patients with supplemental oxygen as they sleep.
A conventional oxygen delivery system typically includes an oxygen source (e.g., an oxygen concentrator, an oxygen tank, liquid oxygen, etc.), tubing, and a nasal cannula that delivers oxygen from the oxygen concentrator to a subject’s nose. An oxygen concentrator concentrates oxygen from the air, providing air with an above-ambient concentration of oxygen, which is also referred to herein as “supplemental oxygen” for the sake of simplicity. The oxygen source delivers the supplemental oxygen to and through tubing to the nasal cannula. The nasal cannula has a configuration that enables it to be secured beneath a subject’s nose in an orientation that directs the pressurized, supplemental oxygen into the subject’s nose. It is up to the patient to breathe in to access that oxygen from the nasal cannula. If the patient is a mouth breather, as over 70% of people are when they sleep, the concentrated oxygen is not inhaled. Nasal cannulas may also be ineffective for delivering supplemental oxygen to subjects who suffer from upper respiratory tract infections (e.g., a common cold, influenza, sinus infections, etc.) and to subjects who suffer from nasal abnormalities (e.g., a deviated septum, etc.).
The use of a nasal cannula can be uncomfortable and irritating. The presence of the nasal cannula beneath the subject’s nose may be bothersome (e.g., it may lead to nose bleeds when the air is dry, such as during wintertime, etc.). In addition, the delivery of supplemental oxygen into a subject’s nose has a tendency to dry out the subject’s nasal membranes, which may make the nasal cannula even more bothersome. The discomfort a subject experiences while wearing a nasal cannula and while the nasal cannula delivers regulated, supplemental oxygen to the subject’s nose may lead to removal of the nasal cannula — either intentionally or unintentionally — as the subject tries to sleep. When the nasal cannula is removed or the subject breathes through their mouth, however, the subject no longer receives supplemental oxygen, which may cause the same problem the supplemental oxygen is intended to address (e.g., fitful, interrupted sleep for hypoxia patients, etc.).
SUMMARY
An embodiment of a medical gas delivery system of this disclosure may include a diffuser and a positioner.
The diffuser may include a base that supports the diffuser on a surface (e.g., a surface on which a subject rests their head, such as a pillow, etc.), walls that define a recess, an inlet at one end of the receptacle, and a delivery face at an opposite end of the recess. A gas delivery tube may couple to the diffuser adjacent to the inlet. The walls of the diffuser may taper outwardly from the side of the diffuser on which the inlet is located to the side of the diffuser on which the delivery face is located. The walls of the diffuser may impart the diffuser with a size and a shape that enable gas to be delivered efficiently and effectively to the face of a subject. Use of the diffuser includes providing gas flow from a source, through the gas delivery tube, through the inlet, into the recess, and out of the delivery face.
Optionally, an inlet of the diffuser may increase turbulence in gases that are delivered by the diffuser, which may facilitate the creation of a “gas cloud” for inhalation by a subject. Such an inlet may include a baffle located within the recess of the diffuser, over a channel and/or an aperture the inlet. More specifically, the baffle may be positioned within a flow path defined by the inlet. A configuration (e.g., a shape, dimensions, etc.) and a position of the baffle may cause gas that flows into the recess to flow around the baffle and then toward and through the delivery face, albeit less forcefully and more diffuse than if the gas were to flow unimpeded through the recess. In some embodiments, the baffle may be removable from the recess and replaceable within the recess.
The positioner may include a base that supports the head positioner on the surface, as well as an orienting surface that receives a back of a subject’s head in a manner that orients the subject’s head on the surface and positions the subject’s face toward the delivery face of the diffuser.
One or both of the diffuser and the positioner may include a coupler. A coupler may hold the base of its respective component (i.e., the diffuser or the positioner) in place on the surface that supports the component. In embodiments where the surface comprises a surface of a pillow or another cushion, the coupler may comprise a strap that extends around the pillow or other cushion to secure the component to it. Alternatively, the coupler may comprise a so-called “touch fastener” (e.g., the hook elements of Velcro, etc.) that engages another touch fastener, elastic, or a fabric (e.g., a soft, fuzzy fabric that comprises the loop elements of Velcro, etc.) on the surface (e.g., a pillowcase on a pillow, etc.). As another alternative, the coupler may comprise a pocket associated with (e.g., on, in, etc.) the surface.
The medical gas delivery system may also include a cover. In some embodiments, including those where surface comprises a surface of a pillow or another cushion, the cover may comprise a pillowcase. The cover may include a vent therethrough, which may be positionable over or adjacent to the delivery face of the diffuser to accommodate gas that flows from the delivery face of the diffuser. A shape of the vent may enable it to accommodate a plurality of different positions of the diffuser on the surface. A medical gas may be delivered to a subject with such a medical gas delivery system by arranging the medical gas delivery system on a surface (e.g., a pillow, another cushion, etc.) where the subject will rest their head. The positioner is positioned at a first location on the surface, adjacent to a second location on the surface, where the subject’s head will rest. The orienting surface of the positioner, which may have a shape that will receive a back of the head of the subject, may face the second location, enabling the orienting surface to orient the head of the subject sideways over the second location on the surface. The diffuser may be positioned at a third location on the surface, adjacent to the second location and on an opposite side of the second location from the first location. The delivery face of the diffuser may be oriented toward the second location. The delivery face may be oriented at an angle to the surface (e.g., an acute angle, etc.), which may enable the gas to be more effectively and/or efficiently delivered to the face of the subject. One or both of the positioner and the diffuser may be secured in place relative to the surface (e.g., over the surface, to the surface, within a pocket associated with the surface, etc.).
In some embodiments, a cover may be positioned over the positioner, the diffuser, and the surface. Positioning the cover may include positioning a vent through the cover over or adjacent to the delivery face of the diffuser to enable gas to flow freely from the delivery face of the diffuser to a face of the subject.
A subject’s head may be placed on the second location of the surface, with the back of the head placed against the orienting surface of the positioner, a side of the head placed against the second location, and a face of the subject oriented toward the delivery face of the diffuser. As the subject’s head is placed on the second location of the surface, the delivery face of the diffuser may tilt downward in a manner that deceases a distance between the delivery face and the second location on the surface, as well as a distance between the subject’s face and the delivery face. If desired, the position of one or both of the positioner and the diffuser may be adjusted (e.g., moved laterally, etc.) to increase the subject’s comfort, optimize the efficiency with which the medical gas delivery systems delivers the gas to the subject, or the like.
With the subject’s head positioned on the surface, the gas may be delivered through the delivery face of the diffuser to the face of the subject.
Other aspects of the disclosed subject matter, as well as features and advantages of various aspects of the disclosed subject matter, should be apparent to those of ordinary skill in the art through consideration of the ensuing description, the accompanying drawings, and the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of an embodiment of medical gas delivery system according to this disclosure;
FIG. 2 is a front perspective view of an embodiment of a diffuser of the medical gas delivery system of FIG. 1;
FIG. 3 is a side view of the embodiment of diffuser shown in FIG. 2;
FIG. 4 is a top perspective view of the embodiment of diffuser shown in FIG. 2;
FIG. 5 is an isometric view of another embodiment of diffuser that may be used in a medical gas delivery system;
FIG. 6 is a top, or distal side, plan view of the embodiment of the diffuser shown in FIG. 5;
FIG. 7 is a bottom, or proximal side, perspective view of the embodiment of the diffuser shown in FIG. 5;
FIG. 8 is a cross-sectional representation of the embodiment of the diffuser shown in FIG. 5;
FIG. 9 provides a representation of flow simulation through the embodiment of the diffuser shown in FIGs. 5-8;
FIG. 10 is a top, or distal side, isometric view of yet another embodiment of a diffuser that may be used in a medical gas delivery system;
FIG. 11 is a top, or distal side, isometric view of an embodiment of a baffle that may be assembled over an inlet of the embodiment of the diffuser shown in FIG. 10;
FIG. 12 is a side view of the embodiment of the diffuser shown in FIG. 10;
FIG. 13 is a cutaway view of the embodiment of the diffuser shown in FIG. 10;
FIGs. 14 and 15 are isometric views of an embodiment of a positioner that carries a diffuser, such as the embodiment of the diffuser shown in FIGs. 5-8 or the embodiment of the diffuser shown in FIGs. 10-13;
FIG. 16 is a side view of the embodiment of the positioner shown in FIGs. 14 and 15;
FIG. 17 illustrates use of the embodiment of the positioner shown in FIGs. 14-16 to supply supplemental gas to a subject; FIG. 18 provides a representation of an embodiment of a medical gas delivery system that includes two positioners that carry diffusers, such as the embodiment of the positioner shown in FIGs. 14-16;
FIG. 19 depicts an embodiment of use of an embodiment of the embodiment of the medical gas delivery system shown in FIGs. 1-4;
FIG. 20 is a graph showing the blood oxygen saturation (SpCh) of a subject receiving supplemental oxygen through a nasal cannula at a flow rate of 3 L/min; and FIGs. 21-23 are graphs showing the blood oxygen saturation of the same subject on three successive nights, with the embodiment of the medical gas delivery system depicted by FIG. 19 delivering the supplemental oxygen at a flow rate of 3 L/min.
DETAILED DESCRIPTION
FIG. 1 illustrates an embodiment of a medical gas delivery system 10 according to this disclosure. The medical gas delivery system 10 is configured to be placed upon a surface 22 upon which a subject’s head will rest, such as a surface 22 of a pillow 20 of another cushion.
The medical gas delivery system 10 includes a diffuser 30 and a positioner 40. The diffuser 30 may be positioned over the surface 22 at a location and in an orientation that will enable it to direct one or more medical gases (e.g., supplemental oxygen, air, etc.) to a desired location over the surface 22, such as a location where a subject’s face will be positioned. The positioner 40 may be positioned over the surface 22 at a location and in an orientation that will enable it to orient the subject’s head and face toward the diffuser 30. As illustrated, the positioner 40 may be spaced apart from the diffuser 30 by a sufficient distance to accommodate the subject’s head.
A diffuser anchor 60 may secure the diffuser 30 in place over the surface 22 in a desired location and in a desired orientation. A positioner anchor 70 may secure the positioner 40 in place over the surface 22 in a desired location and in a desired orientation. Without limitation, the diffuser anchor 60 and/or the positioner anchor 70 may comprise a strap, as depicted. Alternatively, the diffuser anchor 60 and/or the positioner anchor 70 may comprise a so-called touch fastener (e.g., a hook portion of a Velcro fastener, which may engage loops of a fabric that defines the surface 22, etc.), an adhesive material, or any other suitable anchor. As an alternative to the aforementioned diffuser coupler 60 and positioner coupler 70, a medical gas delivery system 10 according to this disclosure may include a cover (not shown), such as a pillowcase, that holds, or anchors, the diffuser 30 and the positioner 40 in place over the surface 22. Such a cover may include pockets that are at least partially defined by vents (e.g., openings through the fabric of the cover, a mesh panel in the fabric, another type of panel that allows air to flow therethrough without restricting airflow, etc.). As another option, a cover, such as a pillowcase, may be used in conjunction with other anchors to accommodate a variety of different placements of the diffuser 30 and positioner 40 while increasing comfort for the subject and providing for unrestricted flow of the medical gas to the subject’s face.
In addition to the diffuser 30 and the positioner 40, the medical gas delivery system 10 may include a conduit, which may be referred to as a “gas delivery tube 50,” that transports a medical gas from a source (not shown) to the diffuser 30.
In some embodiments, the medical gas delivery system 10 may also include a spacer (not shown), which facilitates positioning of the diffuser 30 and the positioner 40 relative to each other.
In some embodiments, the diffuser 30 may comprise a block of a cushioning foam through which the gas delivery tube 50 may extend. The diffuser 30 may have the shape of a rectangular prism, or it may be shaped as an oblique triangle with a delivery face 37 that creates a tent-like well over the surface 22 to trap and, thus, obstruct the dissipation of the medical gas and, thus, improve the efficiency with which the medical gas may be delivered to a subject’s face.
With reference to FIGs. 2-4, another specific embodiment of a diffuser 30 is depicted. The diffuser 30 includes a body 32, a recess 36, a delivery face 37, and an inlet 38. The body 32 includes a base 33, a rear wall 34 that extends upward from a rear of the base 33, and front edges 35 that extend upward from a front of the base 33. The body 32 defines the recess 36. The recess 36 opens to the delivery face 37, which is defined by the front edges 35 of the body 32. The inlet 38 may be positioned on the rear wall 34 of the body 32. The inlet 38 may have a configuration that enables it to couple with and receive a medical gas from the gas delivery tube 50. A channel 39 extends through the inlet 38, the rear wall 34, and into the recess 36 of the diffuser 30, enabling the transport of medical gas into the recess 36. The medical gas may flow out of the recess 36 through the delivery face 37. In some embodiments, the delivery face 37 of the diffuser 30 may be oriented at an obtuse angle to the base 33 of the body 32 of the diffuser 30. The angle at which the delivery face 37 is oriented may define an acute angle with the surface 22 on which the diffuser 30 is placed. The angle between the surface 22 and the delivery face 37 may at least partially accommodate a subject’s face when the subject’s head is placed on the surface 22, toward the delivery face 37 of the diffuser, which may cause a portion of the diffuser 30 to extend over the surface 22 or even over a portion the subject’s face in a manner that (further) traps air and any medical gas mixed therewith and, thus, (further) limits the rate at which the air and any medical gas mixed therewith can diffuse upwardly, which may (further) improve the efficiency with which the diffuser 30 delivers medical gas to the subject’s face. In embodiments where the surface 22 on which the diffuser 30 is placed gives way (e.g., concavely bows, is indented, etc.) when the subject’s head is placed thereon, the extent to which the portion of the diffuser extends over the surface 22 may increase, which may further improve the efficiency with which medical gas is delivered to the subject’s face.
As seen in FIGs. 5-8, another embodiment of diffuser 30' is depicted. The diffuser 30' includes a body 32', a recess 36', a delivery face 37', an inlet 38', and a baffle 39'. The inlet 38' is located at a proximal side of the diffuser 30'. The body 32' includes walls 34' that extend outward distally from the inlet 38' to define the recess 36', with outer edges 35' of the walls 34' defining delivery face 37' at a distal side of the diffuser 30'. The recess 36' opens to the delivery face 37'.
The inlet 38' may have a configuration that enables it to couple with and receive a medical gas from the gas delivery tube 50 (FIG. 1). The inlet 38' may include a channel 38c' that extends through a proximal side of the inlet 38'. The inlet 38' may also include an aperture 38a', which may be located at a distal end of the channel 38c'. The channel 38c' may have a configuration that enables it to receive and, optionally, couple to a distal end of the gas delivery tube 50 (FIG. 1).
The baffle 39' may be positionable (e.g., in embodiments where the baffle 39' is removable and/or replaceable, etc.) or positioned over a distal side of the aperture 38a' of the inlet 38. The baffle 39' includes a body 39b' and may include a post 39p', which may extend from a proximal side of the body 39b'. The post 39p' may hold the body 39b' of the baffle 39' in place over the aperture 38a' of the inlet 38'; more specifically, the post 39p' may extend partially into the aperture 38a', with a lateral extension 391' from the post 39p' securing the post 39p' in place relative to a wall 38w' of the aperture 38a'. A distance across the body 39b' (e.g., an outer diameter of the body 39b', etc.) may exceed a distance across the aperture 38a' (e.g., an inner diameter of the aperture 38a', etc.).
Gas entering the inlet 38' may be able to flow into the aperture 38a', around the post 39p', and into the recess 36', where the body 39b' of the baffle 39' disrupts flow of the gas. A shape of the body 39b' may be tailored to disrupt the flow of gas into the recess 36' in a desired manner. In the depicted embodiment, the body 39b' has a configuration with a mushroom-like appearance, in which its distal side is larger than its proximal side and its proximally facing surfaces taper, or even curve, to its proximal side.
FIG. 9 is a diagram that provides a representation of the manner in which the baffle 38b' of the inlet 38' disrupts and diffuses gas flow delivered to a subject S through a gas delivery tube 50 to and through the embodiment of diffuser 30' shown in FIGs. 5-8, with the dots representing gas molecules (e.g., O2, etc.).
Another embodiment of diffuser 30" is shown in FIGs. 10-13. The diffuser 30" includes a body 32", a recess 36", a delivery face 37", an inlet 38", and a baffle 39". The inlet 38" is located at a proximal side of the diffuser 30". The body 32" includes a wall 34" that extends outward distally from the inlet 38" to define the recess 36", with an outer edge 35" of the wall 34" defining the delivery face 37" at a distal side of the diffuser 30". The recess 36" opens to the delivery face 37".
The inlet 38" may include a channel 38c" that extends through a proximal side of the inlet 38'. The channel 38c" may have a configuration that enables it to receive and, optionally, couple to a distal end of the gas delivery tube 50 (FIG. 1). The inlet 38" may also include an aperture 38a" at a distal end of the channel 38c".
A baffle engagement slot 38s" may be formed in the inlet 38". The baffle engagement slot 38s" may be continuous with and, thus, open to a side of the aperture 38a". A configuration of the baffle engagement slot 38s" may enable it to receive and engage a corresponding diffuser engager 39e" of the baffle 39". The configuration of the baffle engagement slot 38s" may enable it to receive the diffuser engager 39e" in a manner that ensures the baffle 39" is properly positioned within the recess 36" of the diffuser 30".
The baffle 39" may be removably positioned over a distal side of the aperture 38a" of the inlet 38" of the diffuser 30". The baffle 39" includes a body 39b". A post 39p" extends from a proximal side of the body 39b" of the baffle 39". A lateral extension 391" from the post 39p" connects the diffuser engager 39e" to the post 39p". The diffuser engager 39e" is receivable by the baffle engagement slot 38s" of the inlet 38" and, thus, holds the baffle 39" in place relative to a wall 38w" of the aperture 38a" of the inlet 38", with body 39b" of the baffle 39" being located over the aperture 38a". A distance across the body 39b" (e.g., an outer diameter of the body 39b", etc.) may exceed a distance across the aperture 38a" (e.g., an inner diameter of the aperture 38a", etc.). The post 39p" may extend partially into the aperture 38a".
Gas entering the inlet 38" may be able to flow into the aperture 38a", around the post 39p", and into the recess 36", where the body 39b" of the baffle 39" disrupts flow of the gas. A shape of the body 39b" may be tailored to disrupt the flow of gas into the recess 36" in a desired manner. In the depicted embodiment, the body 39b" has a configuration with a mushroom-like appearance, in which its distal side is larger than its proximal side and its proximally facing surfaces taper, or even curve, to its proximal side.
With returned reference to FIG. 1, the positioner 40 may include a base 42 and an orienting surface 44. The base 42 may face the surface 22 over which the positioner 40 is positioned. The orienting surface 44, which extends upwardly from the base 42, may be oriented on the surface 22 such that the orienting surface 44 faces the diffuser 30. The orienting surface 44 has a shape that enables it to receives the back of the subject’s head and to stably orient the subject’s head such that the subject’s face will face the delivery face 37 (FIGs. 2-4) of the diffuser 30. With limitation, the positioner 40 may comprise a shaped block of foam or another cushioning material with sufficient density to support and stably hold the subject’s head in a desired orientation.
Referring now to FIGs. 14-16, an embodiment of a positioner 40"' that carries a diffuser 30"' is depicted. The positioner 40'" may be configured similarly to the positioner 40 shown in and described in reference to FIG. 1. The positioner 40'" may include a base 42'" and a lateral surface 44'" with configurations that enable them to perform the same functions as the base 42 and orienting surface 44 of the embodiment of the positioner 40 shown in FIG. 1. In addition, the lateral surface 44'" may include a receptacle 46'" for the diffuser 30'". A configuration of the receptacle 46'" may enable it to orient the diffuser 30'" in a manner that causes gas to flow laterally or at a somewhat downward angle, from the diffuser 30'" through a side, or the lateral surface 44'", of the positioner 40'". As illustrated, the receptacle 46'" may carry the diffuser 30'", which may comprise a diffuser according to this disclosure, which may in turn receive a medical gas from a medical gas source 52 through a gas delivery tube 50.
The positioner 40"' may include a cushion flap 45"' protruding from an upper portion of the lateral surface 44'" and extending over the lateral surface 44'". Thus, the cushion flap 45'" may extend over, or overhang, the receptacle 46'" and any diffuser 30'" therein. The cushion flap 45'" may have a configuration that enables it to collapse (e.g., over the delivery face 37'" of the diffuser 30'", etc.) to comfortably support a subject’s head while minimizing any discomfort that might otherwise be caused as the subject’s head rests on the diffuser 30'". In addition, the cushion flap 45'" may automatically return to its overhanging orientation when the subject’s head is removed from it, exposing the diffuser 30'" and its delivery face 37'" so the flow of gas therefrom is unobstructed.
The cushion flap 45'" of the positioner 40'" may also be positioned over a portion of a face of a subject S (e.g., the subject S’s mouth and/or nose, etc.) when the diffuser 30'" carried by the positioner 40'" is used to supply a medical gas to the individual, as shown in FIG. 17. An orientation (e.g., slightly raised, etc.) and/or a shape (e.g., concavely bowed of the cushion flap 45'" may provide a pocket 47'" that can comfortably receive a portion of the face of a subject S. For example, an outer edge of the cushion flap 45'" may be slightly raised. As another example, the cushion flap 45'" may be bowed. As yet another example, a lower surface 45b'" of the cushion flap 45'" may be concavely bowed. In still another example, a thickness of the cushion flap 45'" may gradually decrease from the location where it extends from the orienting surface 44'" to its outer edge 45e'". The pocket 47'" created by the cushion flap 45'" may trap air and any medical gas mixed therewith, which may prevent the air and any medical gas mixed therewith from diffusing before the subject S can inhale it, which may enhance the efficiency with which the diffuser 30'" delivers medical gas to the face of the subject S.
FIG. 18 illustrates an embodiment of a medical gas delivery system 10'" that includes two positioners 40'" that carry diffusers 30'". Gas delivery tubes 50 extend between a medical gas source 52 and the diffusers 30'" to enable medical gas to flow from the medical gas source 52 to and through the diffusers 30'". The positioners 40'" may be positioned at spaced apart locations on a surface 22. As illustrated, the positioners 40'" may be spaced apart from each other by a sufficient distance to accommodate a subject’s head. A location and an orientation of each positioner 40'" may enable the diffuser 30'" carried by each positioner 40'" to direct one or more medical gases (e.g., supplemental oxygen, air, etc.) to a desired location over the surface 22 between the positioners 40"', such as a location where the subject’s face may be positioned. In addition, a location and an orientation of each positioner 40"' may enable it to orient the subject’s head and face toward the diffuser 30'" carried by the opposite positioner 40'".
In such a medical gas delivery system 10'", the flow of medical gas may be the same or about the same as the flow if the medical gas were to be delivered through a nasal cannula (e.g., about 2 L/min., about 1-4 L/min., about 1-6 L/min, any value within the aforementioned ranges, etc.), but split between the diffusers 30'" (e.g., about 1 L/min per diffuser 30'", about 0.5-2 L/min., about 0.5-3 L/min, any value within the aforementioned ranges, etc.). Despite the split flow of medical gas, a configuration of each diffuser 30'" (e.g., the presence of a baffle 39', 39" in diffuser 30', 30", respectively, etc.) may insure that the fixed inspired (FI) content of the gas (e.g., FIO2, etc.) is comparable to if the medical gas were delivered through a nasal cannula (e.g., FIO2 content may be about 24% to about 44%, by volume, etc.). Thus, regardless of which side, or diffuser 30'" a subject’s face faces, the subject may receive approximately the same concentration of the medical gas as they would have if they instead used a much less comfortable nasal cannula.
Turning now to FIG. 19, an embodiment of use of a medical gas delivery system 10 is depicted. The method is also applicable to any other embodiment of medical gas delivery system according to this disclosure, including the medical gas delivery system 10'" shown in FIG. 18. As illustrated, a diffuser 30 and a positioner 40 have been positioned over the surface 22 of a pillow 20. The back HB of a subject S’s head H rests against the orienting surface 44 of the positioner 40, while the delivery face 37 of the diffuser 30 faces the subject S’s face F. To provide a baseline, the subject S’s blood oxygen saturation (SpO2) was measured while the subject S received supplemental oxygen at a flow rate of 3 L/min. over a first night, as depicted by the graph of FIG. 20. On three subsequent nights, the subject’s blood oxygen saturation was again measured while the subject S slept using the system shown in FIG. 19, which also delivered supplemental oxygen at a flow rate of 3 L/min, as depicted by the graphs of FIGs. 21-23. As can be seen by comparing the graphs of FIGs. 21-23 (i.e., average SpO2 of greater than 94% each night) to the graph of FIG. 19 (i.e., average SpO2 of about 94.5%), the medical gas delivery system 10 delivered the supplemental oxygen with an efficiency equivalent to that of a nasal cannula. Although this disclosure and the accompanying drawings provide many specifics, they should not be construed as limiting the scopes of any of the appended claims, but merely as providing information pertinent to some specific embodiments that may fall within the scopes of the appended claims. Features from different embodiments may be employed in combination. In addition, the scopes of the appended claims may encompass other embodiments. All additions to, deletions from, and modifications of the disclosed subject matter that fall within the scopes of the claims are to be embraced by the claims.

Claims

CLAIMS What is claimed:
1. A medical gas delivery system, comprising: a diffuser including: a base that supports the diffuser on a surface; a delivery face; a recess the opens to the delivery face; and an inlet through which a gas is delivered in communication with the recess; and a positioner including: a base that supports the head positioner on the surface; an orienting surface that receives a back of a subject’s head in a manner that orients the subject’s head on the surface and positions the subject’s face toward the delivery face of the diffuser.
2. The medical gas delivery system of claim 1, wherein the delivery face is oriented at an acute angle to the surface
3. The medical gas delivery system of claim 1 or claim 2, wherein the diffuser further includes: a coupler that holds the base of the diffuser in place on the surface.
4. The medical gas delivery system of claim 3, wherein the coupler of the diffuser includes a strap.
5. The medical gas delivery system of claim 3, wherein the coupler of the diffuser comprises a touch fastener.
6. The medical gas delivery system of claim 1 or claim 2, wherein the positioner further includes: a coupler that holds the base of the positioner in place on the surface.
7. The medical gas delivery system of claim 6, wherein the coupler of the positioner includes a strap.
8. The medical gas delivery system of claim 6, wherein the coupler of the positioner comprises a touch fastener.
9. The medical gas delivery system of claim 1 or claim 2, further comprising: a pillow over which the diffuser and the positioner are positionable.
10. A system for delivering a gas, comprising: a positioner at a first location on a surface on which a head of the subject will be placed, adjacent to a second location on which the head of the subject will be placed, with an orienting surface of the positioner facing the second location and having a shape that will receive a back of the head of the subject and orient the head of the subject sideways over the second location on the surface; and a diffuser at a third location on the surface on which the head of the subject will be placed, adjacent to the second location and on an opposite side of the second location from the first location, with a delivery face of the diffuser oriented toward the second location.
11. The system of claim 10, wherein: the orienting surface of the positioner receives a back of the head and the second location receives a side of the head, with a face of the subject being oriented toward the delivery face of the diffuser.
12. The system of claim 11, wherein the delivery face of the diffuser delivers the gas to the face of the subject.
13. The system of claim 12, wherein the positioner and the diffuser are positioned over a surface of a pillow. -16-
14. The system of claim 11, wherein the delivery face of the diffuser tilts downward in a manner that traps air between the diffuser and the second location on the surface upon placing the head of the subject on the second location.
15. The system of claim 11, where a lateral position of the diffuser on the surface is adjustable.
16. The system of claim 10, wherein at least one of the positioner and the diffuser is secured in place over the surface.
17. The system of claim 16, wherein a base of the positioner and/or a base of the diffuser is secured to the surface.
18. The system of claim 16, wherein a positioner pocket that receives the positioner and/or a diffuser pocket that receives the diffuser is associated with the surface.
19. The system of claim 16, further comprising: a cover over the positioner, the diffuser, and the surface, a vent through the cover being positioned over or adjacent to the delivery face of the diffuser to enable gas to flow freely from the delivery face of the diffuser to a face of the subject.
20. The system of claim 19, wherein the vent of the cover accommodates a plurality of different positions of the diffuser on the surface.
PCT/US2022/053953 2021-12-23 2022-12-23 Medical gas delivery WO2023122333A1 (en)

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US202163293517P 2021-12-23 2021-12-23
US63/293,517 2021-12-23
US17/741,406 2022-05-10
US17/741,406 US20220339377A1 (en) 2020-03-05 2022-05-10 Medical gas delivery

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