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WO2024229353A9 - Interface patient oronasale conçue pour une utilisation dans une distribution de pression positive dans les voies respiratoires - Google Patents

Interface patient oronasale conçue pour une utilisation dans une distribution de pression positive dans les voies respiratoires

Info

Publication number
WO2024229353A9
WO2024229353A9 PCT/US2024/027676 US2024027676W WO2024229353A9 WO 2024229353 A9 WO2024229353 A9 WO 2024229353A9 US 2024027676 W US2024027676 W US 2024027676W WO 2024229353 A9 WO2024229353 A9 WO 2024229353A9
Authority
WO
WIPO (PCT)
Prior art keywords
individual
interface system
nasal
oronasal
chamber body
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/US2024/027676
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English (en)
Other versions
WO2024229353A2 (fr
WO2024229353A3 (fr
Inventor
Leslie Hoffman
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Individual
Original Assignee
Individual
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Publication date
Application filed by Individual filed Critical Individual
Publication of WO2024229353A2 publication Critical patent/WO2024229353A2/fr
Publication of WO2024229353A3 publication Critical patent/WO2024229353A3/fr
Publication of WO2024229353A9 publication Critical patent/WO2024229353A9/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A61M16/0616—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • A61M16/0066—Blowers or centrifugal pumps
    • A—HUMAN NECESSITIES
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
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    • A61M16/0666—Nasal cannulas or tubing
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    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
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    • A61M16/0683—Holding devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
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    • A—HUMAN NECESSITIES
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    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1045—Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
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    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0225—Carbon oxides, e.g. Carbon dioxide
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    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
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    • A61M2205/3306—Optical measuring means
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES 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
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    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3375—Acoustical, e.g. ultrasonic, measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7527—General characteristics of the apparatus with filters liquophilic, hydrophilic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/08—Supports for equipment
    • A61M2209/088—Supports for equipment on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0618—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0625—Mouth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/205—Blood composition characteristics partial oxygen pressure (P-O2)
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/62—Posture

Definitions

  • the present invention relates to devices and methods for the treatment of airway disorders using positive airway pressure.
  • Positive airway pressure (PAP) therapy is a generic term applied to treatments using a stream of air at greater than atmospheric pressure to support airway and pulmonary patency.
  • Typical PAP therapy involves a portable machine that directs pressurized room air into the airway through a tube connected to a face mask. This positive airflow helps keep the airway open.
  • the most familiar application of PAP therapy is preventing the collapse that occurs during sleep apnea, thus allowing normal breathing.
  • CPAP Continuous positive airway pressure
  • CPAP is a type of PAP therapy in which the air flow is introduced into the airways to maintain a continuous pressure to constantly stent the airways open, in people who are breathing spontaneously.
  • BiPAP bilevel positive airway pressure
  • the air pressure cycles between two levels of pressure based on whether the patient is inhaling or exhaling, but positive pressure is delivered continuously at some level.
  • These pressures are known as inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP).
  • the pressures involved are typically recited in terms of centimeters of water pressure (cm H2O) because lung pressure is often expressed in those units.
  • 1 cm H2O is the amount of pressure required to raise a column of water 1 cm in height. This is equal to 98.07 Pascals.
  • the pressures utilized in PAP therapy are generally between 2 and 30 cm H2O.
  • Various interfaces are available for the delivery of PAP and most can be divided into 3 categories: nasal masks which cover the nose and leave the mouth free; nasal pillows which insert directly into the nostrils; and oronasal (i.e., full face) masks, which cover the nose and the mouth. These interfaces are collectively referred to herein as “face masks.”
  • Patient interfaces such as a mask assembly, for use with blowers and flow generators in the treatment of sleep disordered breathing (SDB) typically include a soft patient-contacting portion, such as a cushion, and a rigid shell or frame.
  • a soft patient-contacting portion such as a cushion
  • a rigid shell or frame In use, the patient interface is held in a sealing position by headgear so as to enable a supply of air at positive pressure to be delivered to the patient's airways.
  • the cushion and frame are manufactured from different materials, they need to be held together in some way. It is also generally desirable that the patient interface be cleanable, for example, allowing a person to wash a mask between uses. While some semi -permanent assembly methods are available, they generally leave small gaps and crevices that can accumulate dirt and be difficult to clean.
  • the frame and cushion include a mechanism that enables both assembly and disassembly. It is also desirable that there be a seal between the frame and cushion to reduce or eliminate leaks from the assembly in use. Since many patients lack dexterity, a good design is simple and easy to use for patients.
  • a number of cushion-to-frame assembly mechanisms are known. For example, see U.S. Pat. No. 6,412,487 to Gunaratnam, et al. and U.S. Pat. No. 6,823,869 to Raje et al. Also see ResMed's MIRAGE®, ULTRA MIRAGE®, ACTIVA®, and VISTA® masks.
  • Mouth leak can occur if respiratory therapy is delivered to the patient's nasal cavity with a nasal patient interface but the mouth of the patient is open or opens during delivery of the therapy.
  • the patient's open mouth may provide a pathway for the pressurized gases to bypass the patient's lungs.
  • the presence of a mouth leak may effectively render the respiratory support system unsealed due to gases being able to leave the patient's mouth to atmosphere.
  • the sub-optimal pressure level may compromise the efficacy of the respiratory support.
  • Headgear such as a chin restraint
  • chin restraints may be fitted to a patient and can be used to urge the mouth of the patient closed to reduce mouth leak and ensure that gases are delivered at to the patient at the desired pressure level.
  • chin restraints may be uncomfortable for the patient, inconvenient to don, and/or inconvenient to adjust, for example.
  • Oronasal masks have been described, such as the Philips Respironics DreamWear full face mask, in an attempt to deal with such issues common to nasal masks. These oronasal masks, however, suffer from issues with comfort, a requirement for higher therapeutic pressures, and poorer acceptance by patients. In studies comparing nasal versus oronasal CPAP, nasal interfaces resulted in better patient compliance, reduced sleepiness, and lower residual apnea-hyp opnea index. Mortimore et al., Thorax. 1998;53:290-292; Ebben et al., Sleep Med. 2014;15:619-624.
  • SDB sleep disordered breathing
  • OSA obstructive sleep apnea
  • the invention relates to an oronasal patient interface adapted for the delivery of positive air pressure to an individual, comprising: a nasal interface portion comprising a first resilient elastomeric hollow chamber body defining a first space-filled interior chamber, the first hollow chamber body comprising a concave, bowl-shaped, skin contact surface configured to receive the nose of the individual, wherein the skin contact surface comprises a superior margin configured to contact the individual’s skin at the supratip lobule and terminate contact of the unitary chamber with the individual’s skin at or inferior to the supratip break, and an inferior margin configured to contact the individual’s skin inferior to the coumella and superior to the upper vermillion border, a surface recess in the skin contact surface positioned inferior to the superior margin and configured to receive the individual’s tip lobule, a pair of nasal interfaces, each nasal interface comprising an opening at an upper surface thereof in fluid communication with the space-filled interior chamber, and first and second elastomeric side members, each side member configured to
  • plenum space refers to a chamber configured to contain a pressurized gas for delivery to the airway of an individual via an oral route.
  • an oral mask forms a seal on the face of the wearer, thereby defining an enclosed air-filled volume within the mask - the “plenum space” - overlying the patient’s mouth.
  • this plenum space is in fluid communication with the hollow chamber body of the nasal interface portion such that the pressurized gas is administered by both the oral and nasal route.
  • the oral interface portion extends around and under the mental protuberance of the mandible in an intimate fashion such that the plenum space formed by the oral interface portion ends below the mental protuberance. This allows the oral interface portion to include an anchor under the mandible which also acts as a gentle chin restraint to discourage mouth leaks.
  • each nasal interface is formed as a hollow, approximately conical frustra extending from the skin contact surface and configured to insert into a nostril, wherein each nasal interface.
  • each nasal interface is an opening in the surface of the hollow chamber body configured to abut the wearer’s nose at the location of each nostril.
  • a headgear is configured to firmly hold the oral interface portion around and under the mental protuberance of the mandible so that the oral interface portion is pulled upward against the underside of the mandible.
  • this upward force from the headgear secures the anchor of the oral interface portion under the mandible, making the oronasal patient interface less prone to dislodge from its seated position on the face of the individual.
  • this upward force acts to secure the nasal interface portion against the underside of the nose, reducing the possibility of air leakage and further limiting the ability of the oronasal patient interface to be dislodged from the face of the wearer.
  • the nasal interface and the oral interface portions of the oronasal patient interface of the present invention are formed as a combined single, unitary piece, typically of a suitable elastomeric material as described hereinafter.
  • unitary as used herein with reference to an element of the oronasal interface system refers to the element as being formed of a single discrete piece.
  • integral which, as used herein, refers to the element as being “composed of integrated parts.”
  • the nasal interface and the oral interface portions may be constructed as a unitary piece, but that unitary piece may subsequently mate to a separately constructed substantially rigid housing (also referred to herein as a “base” or “frame”) to form an integral unit.
  • the fluid connection between the nasal interface portion and the oral interface portion comprises one or more openings below the lower boundary of nasal interface portion. Examples of such a fluid connection are shown in Figs. 3 and 9B.
  • the portion of the unitary elastomeric device comprises a region of regional stiffness between the two openings to maintain the stiffness of the nasal interface portion
  • one or more of the exhaust apertures comprise a flow path length of from about 3 mm to about 7 mm.
  • these apertures are in the form of elongate hollow tubes.
  • the term “flow path” as used in connection with the tubular exhaust apertures refers to the distance from one open end of the tube to the other open end.
  • Such apertures may be in the chamber body, but are preferably in the substantially rigid housing.
  • these tubular exhaust apertures comprise an open bore diameter of between about 0.7 mm to about 2.5 mm, and are preferably not tapered (meaning the open bore diameter of a tubular exhaust aperture does not vary along its length).
  • the flow path through a tubular exhaust aperture is substantially linear (meaning the tubular exhaust aperture does not comprise a substantial change in angle along its length).
  • the open bore diameter of a tubular exhaust aperture is about 0.8 mm, about 1.0 mm, about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, or about 2 mm.
  • the one or more exhaust apertures provide a total aperture area of between about 15 mm 2 to about 30 mm 2 .
  • total aperture area is meant the sum of the surface area of all exhaust apertures in the oronasal interface system, measured at the exterior opening of each exhaust aperture.
  • unitary as used herein with reference to an element of the nasal interface system refers to the element as being formed of a single discrete piece. This contrasts with “integral” which, as used herein, refers to the element as being “composed of integrated parts.”
  • the unitary nasal interface system may be integral with regard to a substantially rigid housing, wherein the unitary chamber is configured to mate to the substantially rigid housing to form a single integral unit.
  • resilient refers to the material of which the unitary chamber is composed being able to substantially retain its shape at ambient air pressure and in the absence of a pressure differential within the chamber versus outside the chamber, but being able to be easily deformable by an applied pressure such as a pinch between two fingers that applies a pressure of 4 N to the surface of the unitary chamber.
  • certain portions of the oronasal interface may be more or less resilient than other portions.
  • those parts of the oral interface portion lying under the mandible may be made of a thicker or more dense material than those parts forming the peripheral seal around the mouth or forming the nasal interface portion.
  • the portion of the chamber body forming the space-filled interior chamber may be made both softer and thinner than the gas ingress port, so that the space-filled interior chamber provides comfort to the wearer and the gas ingress port provides a more positive mating surface to the unitary substantially rigid housing.
  • the portion of the chamber body forming the spacefilled interior chamber of the nasal interface portion has a Shore A durometer of between 10 and 80.
  • the portion of the chamber body forming the spacefilled interior chamber may have a Shore A durometer of between 30 and 60 and a wall thickness of between 0.5 mm and 2.0 mm.
  • elastomeric refers to an amorphous polymeric material that is maintained above their glass transition temperature, so that considerable molecular reconformation is feasible without breaking of covalent bonds. At ambient temperatures, such elastomeric materials are thus relatively compliant (E ⁇ 3 MPa) and deformable.
  • elastomeric materials include, but are not limited to, silicone elastomers, polyurethane elastomers, and polyurethane siloxane copolymer elastomers.
  • substantially rigid refers to a material that having the character of being able to self-maintain a stiff, three-dimensional shape in the absence of any external force being applied, but which may bend to some degree without breaking when a sufficient external force is applied. That is, a “substantially rigid” material may be rigid enough to provide its own structural support without being brittle. For example, thick glass may be a rigid material, whereas some types of plastic may be substantially rigid materials. This contrasts with the term “flexible” which, as used herein, refers to materials that are pliable and capable of easily bending without breaking when lesser amounts of external forces are applied, and rely on an external support to maintain a three-dimensional structure.
  • the oronasal interface system may further comprise a hygroscopic condenser humidifier element, which may preferably be positioned within the unitary substantially rigid housing, configured to maintain a level of the humidity of the inhaled gas as it traverses the fluidly connected pathway between the gas source and the user.
  • a hygroscopic condenser humidifier element may preferably be positioned within the unitary substantially rigid housing upstream of the gas ingress port.
  • Such a hygroscopic condenser humidifier can act to retain moisture in gases exhaled by the wearer and return this moisture to the inhaled gas stream.
  • the choice of material for the hollow chamber body can act to limit this expansion so that the unitary chamber doesn’t shift on the face during normal movement of the wearer.
  • the opening at the upper surface of each nasal interface through which pressurized air is administered to the wearer is oval, stadium, pyriform, spherical, or elliptical in shape.
  • the oronasal interface system is configured such that the skin contact surface of the unitary chamber is configured to terminate proximal to or upon the infraorbital portion of the face of the individual between the superior and inferior margins. In this manner, the side edges of the chamber body rest upon, or within 1-5 mm of, the cheeks of the wearer.
  • the present invention relates to methods of treating sleep apnea, snoring, or another breathing disorder in an individual, comprising: positioning the oronasal interface system over the mouth and nose of the individual such that the nasal interfaces, each formed as a hollow, approximately conical, frustra extending from the skin contact surface, insert into the nostrils of an individual and the lower portion of the oral interface portion envelopes the mental protuberance; and energizing a flow generator operably connected to the oronasal interface system to administer airflow produced by the flow generator into the individual’s mouth nostrils via the oronasal interface system.
  • the invention relates to nasal interface systems for delivery of positive air pressure to an individual, comprising: a resilient elastomeric hollow chamber body defining a space-filled interior chamber, the hollow chamber body comprising (i) a first surface region forming a concave, bowl-shaped, skin contact surface configured to receive the nose of the individual, and (ii) a second surface region of the chamber body comprising a gas ingress port configured to receive a gas under positive pressure for delivery to the individual, wherein the gas ingress port is in fluid communication with the space-filled interior chamber, wherein the first surface region comprises a superior margin configured to contact the individual’s skin at the supratip lobule and terminate contact of the unitary chamber with the individual’s skin at or inferior to the supratip break, an inferior margin configured to contact the individual’s skin inferior to the coumella and terminate contact of the unitary chamber with the individual’s skin at or superior to the upper vermillion border, a pair of nasal interfaces, each nasal interface formed as a hollow, approximately conical
  • the invention relates to nasal interface systems for delivery of positive air pressure to an individual, comprising: a unitary chamber comprising: a resilient elastomeric hollow chamber body defining a space-filled interior chamber, the hollow chamber body comprising (i) a first surface region forming a concave, bowl-shaped, skin contact surface configured to receive the nose of the individual, and (ii) a second surface region of the chamber body comprising a gas ingress port configured to receive a gas under positive pressure for delivery to the individual, wherein the gas ingress port is in fluid communication with the space-filled interior chamber, wherein the first surface region comprises a superior margin configured to contact the individual’s skin at the supratip lobule and terminate contact of the unitary chamber with the individual’s skin at or inferior to the supratip break, an inferior margin configured to contact the individual’s skin inferior to the coumella and terminate contact of the unitary chamber with the individual’s skin at or superior to the upper vermillion border, a pair of nasal interfaces, each nasal
  • first and second solid elastomeric side members each further comprise an interior surface recess in the second surface region configured to receive the individual’s alar rim.
  • the nasal interface system further comprises a unitary substantially rigid housing comprising: a first surface configured to mate to the gas ingress port and a second surface configured to operably connect to a gas source, thereby providing a fluidly connected pathway between the gas source and the gas ingress port.
  • the unitary substantially rigid housing further comprises shielding portions extending across a portion of the external surface of the chamber body distal to the skin contact surface.
  • the fourth surface region is configured to provide a region of increased flexibility in the portion of the side member overlying the maxilla by introducing a recessed area in the fourth surface region that results in thinning of the material forming the solid elastomeric side member.
  • the transition between the thicker areas and the thinned area provides a hinging action at the transition point. This can enhance comfort for the wearer while still maintaining the position and stability of the nasal interface system on the face.
  • the nasal interface systems comprise (i) one or more exhaust apertures through the chamber body that fluidly connect the space-filled interior chamber to ambient external atmosphere; (ii) one or more exhaust apertures through the substantially rigid housing that fluidly connect the space-filled interior chamber to ambient external atmosphere; or (iii) both (i) or (ii).
  • exhaust aperture refer to discrete openings engineered into the nasal interface systems to permit gas from the interface system to escape during exhaling. This is not meant to indicate that such apertures only operate to remove exhaled air.
  • inspiration the oxygen- enriched air that has accumulated in the mask, along with some room air entrained through the exhaust apertures, is inhaled.
  • exhaled gas is deposited in the mask, with the rest exiting through the vent holes. The continuous flow of air from the air source then partially washes out the mask before the next inspiration.
  • one or more of the exhaust apertures comprise a flow path length of from about 3 mm to about 7 mm.
  • these apertures are in the form of elongate hollow tubes.
  • the term “flow path” as used in connection with the tubular exhaust apertures refers to the distance from one open end of the tube to the other open end.
  • Such apertures may be in the chamber body, but are preferably in the substantially rigid housing.
  • these tubular exhaust apertures comprise an open bore diameter of between about 0.7 mm to about 2.5 mm, and are preferably not tapered (meaning the open bore diameter of a tubular exhaust aperture does not vary along its length).
  • the flow path through a tubular exhaust aperture is substantially linear (meaning the tubular exhaust aperture does not comprise a substantial change in angle along its length).
  • the open bore diameter of a tubular exhaust aperture is about 0.8 mm, about 1.0 mm, about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, or about 2 mm.
  • the one or more exhaust apertures provide a total aperture area of between about 15 mm 2 to about 30 mm 2 .
  • total aperture area is meant the sum of the surface area of all exhaust apertures in the nasal interface system, measured at the exterior opening of each exhaust aperture.
  • the nasal interface system may further comprise a hygroscopic condenser humidifier element positioned within the unitary substantially rigid housing or within the unitary chamber and configured to maintain a level of the humidity of the inhaled gas as it traverses the fluidly connected pathway between the gas source and the user.
  • the hygroscopic condenser humidifier element may preferably be positioned within the unitary substantially rigid housing upstream of the gas ingress port. Such a hygroscopic condenser humidifier can act to retain moisture in gases exhaled by the wearer and return this moisture to the inhaled gas stream.
  • the portion of the chamber body forming the spacefilled interior chamber may be made both softer and thinner than the posterior surface of the chamber body that comprises the gas ingress port, so that the space-filled interior chamber provides comfort to the wearer and the posterior surface provides a more positive mating surface to the unitary substantially rigid housing.
  • the portion of the chamber body forming the space-filled interior chamber has a Shore A durometer of between 10 and 80.
  • the portion of the chamber body forming the space-filled interior chamber may have a Shore A durometer of between 30 and 60 and a wall thickness of between 0.5 mm and 2.0 mm in the sealing regions.
  • introduction of positive air pressure in the range of 4-20 cm H2O into the hollow chamber body can cause the hollow chamber body to inflate slightly to enhance sealing in the thinned regions or to provide an air-cushioning effect in use.
  • This tendency to expand can serve to improve sealing of the nasal interface system to the wearer’s airway by causing each nasal interface to adapt to the wearer’s anatomy and firmly support the conical frustral shape within the nostril.
  • introduction of positive air pressure in the range of 4-20 cm H2O into the hollow chamber body can increase the seal of each nasal interface within the nostril.
  • the pliability of the inflated chamber spreads the load evenly on the user’s skin contact area minimizing pressure points and enhancing comfort.
  • the choice of material for the hollow chamber body can act to limit this expansion so that the unitary chamber doesn’t shift on the face during normal movement of the wearer and this resistance to movement is enhanced by regionally thicker, stiffer regions of the interface.
  • the opening at the upper surface of each nasal interface through which pressurized air is administered to the wearer is oval, stadium, pyriform, spherical, or elliptical in shape.
  • the nasal interface system is configured such that the skin contact surface of the unitary chamber is configured to terminate proximal to or upon the infraorbital portion of the face of the individual between the superior and inferior margins. In this manner, the side edges of the chamber body rest upon, or within 1-5 mm of, the cheeks of the wearer.
  • the present invention relates to methods of treating sleep apnea, snoring, or another breathing disorder in an individual, comprising: positioning the nasal interface system over the nose of the individual such that the nasal interfaces, each formed as a hollow, approximately conical, frustra extending from the skin contact surface, insert into the nostrils of an individual; and energizing a flow generator operably connected to the nasal interface system to administer airflow produced by the flow generator into the individual’s nostrils via the nasal interface system.
  • the present invention provides patient interfaces comprising: a mask configured to cover the nose and/or mouth of a user in use, the mask comprising a resilient user contact surface, a gas ingress port for receiving the gas from a gas source, and one or more administration apertures in the resilient user contact surface for gas administration to the user; a substantially rigid housing comprising a first surface in fluid communication with the gas ingress port and a second surface in fluid communication with the gas source, thereby providing a fluidly connected pathway at a location between the gas source and the gas ingress port; and one or more exhaust apertures within the substantially rigid housing that fluidly connect the fluidly connected pathway to ambient external atmosphere, wherein one or more of the exhaust apertures in the substantially rigid housing comprise a flow path length of from about 3 mm to about 7 mm.
  • tubular exhaust apertures there may be any number of such tubular exhaust apertures, with preferred numbers being between 4 and 60, more preferably between 10 and 30, still more preferably between 15 and 25, and in certain embodiments 15, 16, 17, 18, 19, or 20.
  • these tubular exhaust apertures comprise an open bore diameter of between about 0.7 mm to about 2.5 mm, and are preferably not tapered (meaning the open bore diameter of a tubular exhaust aperture does not vary along its length).
  • the flow path through a tubular exhaust aperture is substantially linear (meaning the tubular exhaust aperture does not comprise a substantial change in angle along its length).
  • the open bore diameter of a tubular exhaust aperture is about 0.8 mm, about 1.0 mm, about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, or about 2 mm.
  • the one or more exhaust apertures provide a total aperture area of between about 15 mm 2 to about 30 mm 2 .
  • “about X” includes a range of values that are ⁇ 20%, ⁇ 10%, ⁇ 5%, ⁇ 2%, ⁇ 1%, ⁇ 0.5%, ⁇ 0.2%, or ⁇ 0.1% of X, where X is a numerical value.
  • the term “about” refers to a range of values which are 10% more or less than the specified value.
  • the term “about” refers to a range of values which are 5% more or less than the specified value.
  • the term “about” refers to a range of values which are 1% more or less than the specified value.
  • ranges of values are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein.
  • a range used herein, unless otherwise specified, includes the two limits of the range. For example, the terms “between X and Y” and “range from X to Y, are inclusive of X and Y and the integers there between.
  • any range including any of the two individual values as the two end points is also conceived in this disclosure.
  • Fig. 1 depicts facial landmarks referred to in the present specification.
  • Fig. 2 depicts facial landmarks referred to in the present specification.
  • FIG. 3 depicts a 3-D rendering of an elastomeric oronasal interface of the present invention.
  • Fig. 4 depicts an oronasal interface system of the present invention positioned on an individual.
  • FIG. 5 depicts an exploded and a side elevation view of an elastomeric oronasal interface of the present invention.
  • Fig. 6 depicts a unitary substantially rigid housing (or “frame”) of the present invention as an elevation view and a sectional view.
  • Fig. 7 depicts an oronasal interface system of the present invention as two elevation views and a sectional view.
  • Fig. 8 depicts an oronasal interface system of the present invention assembled with a frame as an elevation view and a sectional view.
  • Fig. 9A depicts a 3-D rendering of an alternative oronasal interface system of the present invention.
  • Fig. 9B depicts a 3-D rendering of an alternative oronasal interface system of the present invention.
  • Fig. 10 depicts an elevation view of an oronasal interface system of the present invention showing the skin contacting aspect of the interface.
  • Fig. 11 depicts an elevation view of an oronasal interface system of the present invention showing the upper (relative to the face of the wearer) aspect of the interface and a sectional view.
  • Fig. 12 depicts a cross sectional view of an oronasal interface system of the present invention and two details of the oronasal interface system.
  • FIG. 13 an exploded view of of an oronasal interface system of the present invention and its associated frame and headgear.
  • FIG. 14 depicts a 3-D rendering and various elevation views of a frame adapted for use with an oronasal interface system of the present invention.
  • FIG. 15 depicts sectional and detail views of a frame adapted for use with an oronasal interface system of the present invention.
  • Fig. 16 depicts side elevation and detail views of a frame adapted for use with an oronasal interface system of the present invention.
  • Fig. 17 depicts two elevation and two detail views of an alternative frame adapted for use with an oronasal interface system of the present invention.
  • Fig. 18 depicts an oronasal interface system of the present invention assembled with a PAP blower as described in PCT/US2022/043556 assembled as an integral unit.
  • Fig. 19 depicts a nasal interface system of the present invention in assembled and exploded views.
  • Fig. 20 depicts alternative views of a nasal interface system of the present invention.
  • Fig. 21 depicts views of a resilient elastomeric chamber body component of a nasal interface system of the present invention with exemplary features shown as angles (in degrees), diameters (
  • Fig. 22 depicts views of a resilient elastomeric chamber body component of a nasal interface system of the present invention with exemplary wall thicknesses (in millimeters).
  • Fig. 23 depicts a nasal interface system of the present invention as a component of a positive airway pressure device as described in PCT/US2022/043556.
  • Fig. 24 depicts a nasal interface system of the present invention as a component of a positive airway pressure device configured to connect to a PAP blower by a flexible supply conduit in exploded form.
  • Fig. 25 depicts a nasal interface system of the present invention as a component of a positive airway pressure device configured to connect to a PAP blower by a flexible supply conduit in assembled form.
  • Fig. 26 depicts a resilient elastomeric chamber body component of a nasal interface system of the present invention.
  • Fig. 27 depicts a housing of the present invention providing an intermediate coupling means between a resilient elastomeric chamber body of the present invention and a gas supply hose.
  • Fig. 28 depicts a housing for coupling to a nasal interface system of the present invention configured for a 4-point retaining harness.
  • Fig. 29 depicts a exemplary embodiment in which exhaust apertures are provided in the substantially rigid housing instead of in the resilient elastomeric chamber body.
  • Fig. 30 depicts the substantially rigid housing of Fig. 28 in detail.
  • Fig. 31 depicts a chin-mounted CPAP device comprising dovetail rail system.
  • Fig. 32 depicts wall thicknesses (in mm) at various points on an exemplary resilient elastomeric nasal interface chamber body. These measurements apply to both the nasal interface as a standalone device and as a component of an oronasal interface.
  • the present invention provides an oronasal interface system for use with PAP systems for providing positive air pressure, particularly for use in Continuous Positive Airway Pressure (CPAP) devices, bilevel pressure support devices (BiPAP) devices and related respiratory support devices.
  • CPAP Continuous Positive Airway Pressure
  • BiPAP bilevel pressure support devices
  • FIGs. 3, 4 and 5 depict an exemplary oronasal interface system 100.
  • a nasal interface portion 101 is formed as a single unitary piece with an oral interface portion 102 of a resilient biocompatible elastomeric material such as a silicone elastomer, polyurethane elastomer, or polyurethane siloxane copolymer elastomer which defined an external surface and a hollow interior.
  • a gas ingress port 103 is positioned in the rear aspect of oronasal interface system 100 and is in fluid communication with both the pair of nasal interfaces 104 and the plenum space 113 provided by the approximately bowlshaped oral interface portion 102.
  • the pair of nasal interfaces 104 are molded into the unitary device in the form of hollow, approximately conical, frustra that terminate in an opening fluidly connected with the hollow interior of nasal interface portion 101.
  • the nasal interfaces 104 e.g., prongs having an approximately frustroconical shape
  • the lower portion of oral interface portion 102 provides a chin cup 107 that embraces the mental protuberance of the wearer.
  • a peripheral seal around the wearer’s mouth is provided by the lower boundary 105 of nasal interface portion 101 which is continuous with a sealing rim 106 of oral interface portion 102.
  • nasal interface portion 101 wrap around the nose of the wearer, contacting the sides of the nose at the skin contact surface of the nasal interface portion 101 chamber body.
  • This contact surface presents with a concave, bowl-shaped profile.
  • This provides a skin contact surface that embraces the nose on either side, with the rhinal columella of the wearer positioned at approximately the bottom of the “bowl” lying superior to lower boundary 105 of nasal interface portion 101.
  • the dorsum nasi is substantially external of the nasal interface portion 101. This results in the superior margin of the skin contact surface terminating at, or inferior to, the supratip break, and the inferior margin of the skin contact surface terminating at or superior to the upper vermillion border.
  • the concave chamber body continues laterally from the nose with two side members, or “wings”, the inner surface of which form part of the skin contact surface of nasal interface portion 101, with an exterior surface that lies distal to that contact surface.
  • the stiffer wings in conjunction with the immediately adjacent conical frustra gently grips the sides of the nostrils for an immediate and secure “fit” of the interface on the user’s nose.
  • Fig. 4 shows the exemplary oronasal interface system 100 on the face of a wearer.
  • the gas ingress port 103 in Fig. 5 is connected to base 200 which permits fluid communication of a source of pressurized gas to the nasal and oral interface portions.
  • Base 200 is provided as substantially rigid housing having upper surface 206 that mates and seals with gas ingress port 103 and lower surface configured to operably connect to a pressurized gas source (i.e., a PAP blower), thereby providing a fluidly connected pathway for delivery of pressurized gas to the wearer.
  • the air pathway may optionally incorporate a hygroscopic condenser humidifier element that inserts into the base 200.
  • the humidifier element retains moisture when the user exhales, and this moisture is in turn returned as humidified pressurized air on inspiration.
  • a headgear 300 having four points of attachment 301 to the substantially rigid housing 200 is depicted. This headgear attaches with rotating “buttons” that “clip” into and out of mating recessed holes on the substantially rigid housing 200. It will be understood that the oronasal interface system and headgear can be larger or smaller as required to fit different facial features (e.g., nose sizes/shapes), and with different attachment means.
  • Gas ingress port 103 mates to the upper opening 206 of frame 200, and resilient pin 108 of the oronasal interface system 100 inserts into opening 202 of frame 200 to stabilize the frame on the oronasal interface system.
  • Opening 202 may be located at different or multiple points on the frame and can be a groove rather than a hole to allow additional flexibility of the elastomeric cushion in the frame.
  • Lateral arms 205 wrap around the exterior of oronasal interface system 100 and terminate in the recessed holes 201 that reversibly receive the connectors 301 on headgear 300.
  • Coupling 204 is configured to receive an air hose or other conduit from the pressurized air supply (e.g., a CPAP blower unit).
  • Exhaust apertures 203 in the frame each having a diameter of about 1.19 mm and a flow path length about of 5mm, provides comparable high exhaust flows when compared to the range observed for a commercially available BREVIDATM (Fisher and Paykel) CPAP mask at pressures between 5 and 16 cm H2O.
  • this arrangement of tubular exhaust apertures is about 3 dBA quieter than the BREVIDATM mask at 10 cm H2O pressure.
  • the use of tubular exhaust apertures is believed to smooth what is a noisy turbulent airflow to a quieter, more laminar, flow.
  • the immediate contacting surface in one embodiment is flat under the nose, with one or two outlet holes directing the airflow into the nares. While depicted as hollow, approximately conical frustra configured to insert into a nostril in these figures, the nasal interface in the nasal interface portion may be openings that do not insert into the nostril bur rather abut the nostril. Correct positioning and fit is enhanced by the addition of frustoconical nasal prongs above the outlet holes of the interface. Stability of the nasal interface is further enhanced by having a cup like structure surrounding the nasal prongs/outlet holes to envelop the base of the nose.
  • the interface also has relatively stiffer/thicker elastomeric side members to stop sideways movement of the interface relative to the nares and cause misalignment of the outlet holes with the nares.
  • the height of these elastomeric side members relative to the flat area under the nares is a minimum of 10 mm and a maximum extending to 10 mm above the bottom of the nasal bone.
  • the elastomeric side members are configured to be appropriately compliant to be comfortable, but stiff enough to firmly secure the nose and not distort so as to impede movement of the interface on the wearer.
  • the cutout on top of the soft section of the interface stops the interface touching the bony bridge of the nose, which is often irritated and eroded by the skin pressure from conventional over-the-nose CPAP masks.
  • the air pathway may optionally incorporate a hygroscopic condenser humidifier element that inserts into the bore of the frame or the gas ingress port 103 or as part of an optional adapter may be provided that provides a first connection to the end of flexible supply conduit and a second connection to the coupling 204.
  • Different adapters may be produced to adapt the oronasal interface system of the present invention to a variety of manufacturer’s PAP blowers.
  • FIG. 101 A detailed view of an exemplary nasal interface portion 101 is described as a discrete unitary chamber in U.S. Provisional Patent Application 63/619,689, which is hereby incorporated by reference in its entirety and shown in Figs. 5-8.
  • the sides (“wings”) 109 of nasal interface portion 101 wrap around the nose of the wearer.
  • the skin contact surface of the nasal interface portion 101 presents with a concave, bowl-shaped profile.
  • This provides a skin contact surface that embraces the nose on either side, with the rhinal columella of the wearer positioned at approximately the bottom of the “bowl.”
  • a first “superior” margin 111 of the skin contact surface is positioned proximal to the subnasale, while a second “inferior” margin 110 of the skin contact surface is proximal to the rhinal apex.
  • the dorsum nasi is substantially external of the chamber body.
  • a slight depression or recess may be present at the rhinal apex location to reduce pressure on the tip of the nose without compromising the peripheral seal.
  • the shape of the skin contact surface causes the greatest pressure to overlie the bony structure of the maxilla at the position of the upper lip when the oronasal interface system 100 is properly supported on the wearer by the headgear 300.
  • the bowl-shaped surface continues into two side member “wings” 109, the inner surface of which form part of the skin contact surface, and comprise an exterior surface that lies distal to that contact surface.
  • the inner skin contact surface extends over the nasal ala towards a position overlying the maxilla, and terminates skin contact proximal to a location overlying the zygomaticomaxillary suture.
  • One or more vent holes may be positioned through this exterior surface at or near the base of wings. During expiration, exhaled gas is deposited in the hollow interior, which can exit through these pre-existing vent holes.
  • the distal portion of wings 109 need not be part of the hollow cavity of nasal interface portion 101, but rather the upper part of wings 109 may be solid features that remain a unitary part of nasal interface portion 101.
  • a recess or thinned section 112 may be present in the external surface of the solid wing structure at approximately a position where the wings overlie the portion of the maxilla that is proximal to the zygomaticomaxillary suture.
  • the location of transition between the soft lower portion of the wings and harder and relatively thicker upper portion of wings 109 creates a hinging feature, enhanced by the softer recess feature 112. This permits wings 109 to flex at a controlled location in order to allow a comfortable fit and seal on the cheeks.
  • the hollow cavity portion of nasal interface portion lOl is comfortably soft under the nose, relatively stiff at the thicker portion of the wings, and less stiff at the recesses.
  • making at least part of the wings 109 solid reduces dead space inside nasal interface portion 101, reduces air turbulence and the resulting noise, and improves cleanability of the chamber.
  • the thinner recessed portion also increases comfort where the wings contact the cheeks.
  • the shape of the hollow chamber stops the interface from contacting the bony bridge of the nose, which is often irritated and eroded by the skin pressure from conventional over-the-nose CPAP masks.
  • Tapered nasal prongs 104 provide a more secure nasal seal when gently pushed into the nares by the interface cushion contact surface under the nose and position air outlets into the nasal cavity. They also act as gentle nasal dilators to reduce nasal resistance and minimize CPAP pressure needs. Stability and seal of the nasal interface is further enhanced by having a cup like structure surrounding the nasal prongs to envelop the base of the nose nasal interface portion 101.
  • the cup-like structure of nasal interface portion 101 can have optional recesses molded into the contact surface at areas under the tip of the nose, over the upper lip and the sides of the nostrils to reduce “hot spot” high contact pressures at these points.
  • the soft nasal prongs coupled with the stiffer high wings allow easy fitment of the mask and provide improved stability of the mask on the nose (e.g., when the wearer of the mask or the attachment hose moves).
  • the chin cup of the oral interface portion 102 provides an anchor that further enhances stability of the oronasal interface system on the wearer when supported by the headgear 300.
  • FIGs. 9-17 depict a second exemplary oronasal interface system 400 and associated frame 500.
  • a nasal interface portion 401 is formed as a single unitary piece with an oral interface portion 402 of a resilient biocompatible elastomeric material such as a silicone elastomer, polyurethane elastomer, or polyurethane siloxane copolymer elastomer which defined an external surface and a hollow interior.
  • a gas ingress port 403 is positioned in the rear aspect of oronasal interface system 400 and is in fluid communication with both the pair of nasal interfaces 404 and the plenum space 413 provided by the approximately bowl-shaped oral interface portion 402.
  • the pair of nasal interfaces 404 are molded into the unitary device in the form of hollow, approximately conical, frustra that terminate in an opening fluidly connected with the hollow interior of nasal interface portion 401.
  • the nasal interfaces 404 e.g., approximately frustroconical prongs
  • the shape of these nasal interfaces may be altered according to a desired design, or may be omitted entirely in favor of simple openings in nasal interface portion 401 at the position of the nostrils.
  • the lower portion of oral interface portion 402 provides a chin cup 407 that embraces the mental protuberance of the wearer.
  • a peripheral seal around the wearer’s mouth is provided by the lower boundary 405 of nasal interface portion 401 which is continuous with a sealing rim 406 of oral interface portion 102.
  • Oronasal interface system 400 differs from oronasal interface system 100, in several aspects.
  • resilient ribs 415 are molded into the lower end of the chin cup. These ribs provide support for a sensor module 416 which inserts into the interior of the oral interface portion 402 at a position just under the wearer’s chin.
  • the sensor module is inserted under a flap that forms the skin contact surface of chin cup 407 by sliding over and past ribs 415, which then act to hold sensor module 416 by means of a friction or snap fit design under the skin contacting flap.
  • the material forming the skin contact surface of oral interface portion 402 can be made effectively transparent to the light wavelengths utilized by the pulse oximeter.
  • the term “effectively transparent” as used herein refers to sufficient transparency to the light wavelengths that the sensor is capable of producing a photoplethysmogram signal that is effective to measure pulse waves from the capillaries of the wearer’s chin. Reliable measurements obtained from sensors mounted on the neck or the chest can be superior to those obtained from sensors on a wrist.
  • a convenient and removable sensor module mounted on a CPAP mask allows the user to not need to wear an extra wearable device and is mounted in an optimum position for sleep quality actigraphy measurements.
  • an off the shelf pulse oximeter unit functioned through up to 4 mm thickness of silicone.
  • small openings in the material forming the skin contact surface of oral interface portion 402 can be provided over the light source(s) and photodetectors of the pulse oximeter.
  • other sensors can be added, such as an accelerometer for monitoring body position and sleep quality by actigraphy or a microphone for detecting breath/cardiac sounds.
  • oronasal interface system 400 differs from oronasal interface system 100 in that the gas ingress port 403 lies in a plane that is approximately in parallel with the long axis of oronasal interface system 400 as shown in Fig. 11, section B-B.
  • the gas ingress port 103 of oronasal interface system 100 lies in a plane that is approximately 45 degrees compared with the long axis of oronasal interface system 400 as shown in Fig. 5.
  • oronasal interface system 400 comprises a pair of resilient flaps 414 which extends down each side external to the plenum space and configured to lie on the cheeks (buccse) on the sides of the face to provide additional stability and improved seal when the oronasal interface system 400 is positioned on the wearer.
  • these resilient flaps 414 may extend a minimum of 50 mm, although this length will vary depending on the size of the oronasal interface.
  • nasal interface portion 401 wrap around the nose of the wearer, contacting the sides of the nose at the skin contact surface of the nasal interface portion 401 chamber body.
  • This contact surface presents with a concave, bowl-shaped profile.
  • This provides a skin contact surface that embraces the nose on either side, with the rhinal columella of the wearer positioned at approximately the bottom of the “bowl” lying superior to lower boundary 405 of nasal interface portion 401.
  • the dorsum nasi is substantially external of the nasal interface portion 401. This results in the superior margin of the skin contact surface terminating at, or inferior to, the supratip break, and the inferior margin of the skin contact surface terminating at or superior to the upper vermillion border.
  • the concave chamber body continues laterally from the nose with two side members, or “wings” 412, the inner surface of which form part of the skin contact surface of nasal interface portion 401, with an exterior surface that lies distal to that contact surface.
  • the relatively stiffer wings gently hold the sides of the nostrils between the wings and the approximately frustroconical prongs.
  • Base (or “frame”) 500 is shown in Figs 14-17.
  • the base is provided as a substantially rigid housing having upper surface 506 that mates and seals with gas ingress port 503 and lower surface configured to operably connect to a pressurized gas source (i.e., a PAP blower), thereby providing a fluidly connected pathway for delivery of pressurized gas to the wearer.
  • a pressurized gas source i.e., a PAP blower
  • the air pathway may optionally incorporate a hygroscopic condenser humidifier element 507 that inserts into the base 500.
  • the humidifier element retains moisture when the user exhales, and this moisture is in turn returned as humidified pressurized air on inspiration.
  • base 500 is more linear in profile as shown in Section F-F of Figs. 15-17. That is, the long axis of the air path from air hose coupling 504 to upper opening 506 is at approximately 90° to the long axis of frame 500. This is as compared to base 200 shown in Fig. 6, in which the long axis of the air path from air hose coupling 204 to upper opening 206 is at approximately 45° to the long axis of frame 200.
  • a headgear 600 having four points of attachment 601 to the substantially rigid frame 500 is depicted. This headgear attaches with rotating “buttons” 510 that “clip” into and out of mating recessed holes 501 on the substantially rigid frame 500. It will be understood that the oronasal interface system and headgear can be larger or smaller as required to fit different facial features (e.g., nose sizes/shapes), and with different attachment means.
  • Gas ingress port 403 mates to the upper opening 506 of frame 500, and resilient pin 408 of the oronasal interface system 400 inserts into opening 502 (Fig. 14) or slot 508 (Fig. 17) of frame 500 to stabilize the frame on the oronasal interface system.
  • Lateral arms 505 wrap around the exterior of oronasal interface system 400 and terminate in the recessed holes 501 that reversibly receive the connectors 601 on headgear 600 via the connecting button clips 510.
  • Coupling 504 is configured to receive an air hose or other conduit from the pressurized air supply (e.g., a CPAP blower unit).
  • Exhaust apertures 503 are provided in the frame, each having a diameter of about 1.19 mm and a flow path length about of 5mm.
  • Figs. 14-17 also depict a location in the frame for an anti -asphyxiation valve 509 that, by opening to atmosphere in a failsafe manner, reduces the risk of excessive CO2 rebreathing by a patient.
  • the immediate contacting surface in one embodiment is flat under the nose, with one or two outlet holes directing the airflow into the nares. While depicted as hollow, approximately conical frustra configured to insert into a nostril in these figures, the nasal interface in the nasal interface portion may be openings that do not insert into the nostril bur rather abut the nostril. Correct positioning and fit are enhanced by the addition of frustoconical nasal prongs above the outlet holes of the interface. Stability of the nasal interface is further enhanced by having a cup like structure surrounding the nasal prongs/outlet holes to envelop the base of the nose.
  • the interface also has elastomeric side members to stop sideways movement of the interface relative to the nares and cause misalignment of the outlet holes with the nares.
  • the height of these elastomeric side members relative to the flat area under the nares is a minimum of 10 mm and a maximum extending to 10 mm above the bottom of the nasal bone.
  • the elastomeric side members are configured to be appropriately compliant to be comfortable.
  • the cutout on top of the soft section of the interface stops the interface touching the bony bridge of the nose, which is often irritated and eroded by the skin pressure from conventional over-the-nose CPAP masks.
  • the air pathway may optionally incorporate a hygroscopic condenser humidifier element 507 that inserts into the bore of the frame or the gas ingress port 403 or as part of an optional adapter may be provided that provides a first connection to the end of flexible supply conduit and a second connection to the coupling 504.
  • a hygroscopic condenser humidifier element 507 that inserts into the bore of the frame or the gas ingress port 403 or as part of an optional adapter may be provided that provides a first connection to the end of flexible supply conduit and a second connection to the coupling 504.
  • Different adapters may be produced to adapt the oronasal interface system of the present invention to a variety of manufacturer’s PAP blowers.
  • nasal interface portion 401 A detailed view of an exemplary nasal interface portion 401 is described hereinafter.
  • the sides (“wings”) 409 of nasal interface portion 401 wrap around the nose of the wearer.
  • the skin contact surface of the nasal interface portion 401 presents with a concave, bowl-shaped profile. This provides a skin contact surface that embraces the nose on either side, with the rhinal columella of the wearer positioned at approximately the bottom of the “bowl.”
  • a first “superior” margin of the skin contact surface is positioned proximal to the subnasale, while a second “inferior” margin of the skin contact surface is proximal to the rhinal apex.
  • the dorsum nasi is substantially external of the chamber body.
  • a slight depression or recess may be present at the rhinal apex location to reduce pressure on the tip of the nose without compromising the peripheral seal.
  • the shape of the skin contact surface causes the greatest pressure to overlie the bony structure of the maxilla at the position of the upper lip when the oronasal interface system 400 is properly supported on the wearer by the headgear 600.
  • the inner skin contact surface extends over the nasal ala towards a position overlying the maxilla, and terminates skin contact proximal to a location overlying the zygomaticomaxillary suture.
  • One or more vent holes may be positioned through this exterior surface at or near the base of wings. During expiration, exhaled gas is deposited in the hollow interior, which can exit through these pre-existing vent holes.
  • the distal portion of wings 409 need not be part of the hollow cavity of nasal interface portion 401, but rather the upper part of wings 409 are solid features that remain a unitary part of nasal interface portion 401.
  • a recess or thinned section may be present in the external surface of the solid wing structure at approximately a position where the wings overlie the portion of the maxilla that is proximal to the zygomaticomaxillary suture.
  • the location of transition between the soft lower portion of the wings and harder and relatively thicker upper portion of wings 409 creates a hinging feature, enhanced by the softer recess feature. This permits wings 409 to flex at a controlled location in order to allow a comfortable fit and seal on the cheeks.
  • the hollow cavity portion of nasal interface portion 401 is comfortably soft under the nose, relatively stiff at the thicker portion of the wings, and less stiff at the recesses.
  • making at least part of the wings 409 solid reduces dead space inside nasal interface portion 401, reduces air turbulence and the resulting noise, and improves cleanability of the chamber.
  • the thinner recessed portion also increases comfort where the wings contact the cheeks.
  • the shape of the hollow chamber stops the interface from contacting the bony bridge of the nose, which is often irritated and eroded by the skin pressure from conventional over-the- nose CPAP masks.
  • Openings 417 fluidly connect the hollow cavity portion of nasal interface portion 401, the plenum space of oronasal interface system 400, and upper opening 506 of frame 500.
  • Tapered nasal prongs 404 provide a more secure nasal seal when gently pushed into the nares by the interface cushion contact surface under the nose and position air outlets into the nasal cavity. They also act as gentle nasal dilators to reduce nasal resistance and minimize CPAP pressure needs. Stability and seal of the nasal interface is further enhanced by having a cup like structure surrounding the nasal prongs to envelop the base of the nose nasal interface portion 401.
  • the cup-like structure of nasal interface portion 401 can have optional recesses molded into the contact surface at areas under the tip of the nose, over the upper lip and the sides of the nostrils to reduce “hot spot” high contact pressures at these points.
  • the soft nasal prongs coupled with the stiffer high wings gently embrace the sides of the nostrils allowing easy fitment of the mask and provide improved stability of the mask on the nose (e.g., when the wearer of the mask or the attachment hose moves).
  • the chin cup of the oral interface portion 402 provides an anchor that further enhances stability of the oronasal interface system on the wearer when supported by the headgear 600.
  • Fig. 18 depicts the use of an oronasal interface of the present invention in which the “frame” is provided in the form of an integrated PAP blower such as that described in PCT/US2022/043556, which is hereby incorporated by reference.
  • the present invention also provides a nasal interface system for use with PAP systems for providing positive air pressure, particularly for use in Continuous Positive Airway Pressure (CPAP) devices, bilevel pressure support devices (BiPAP) devices and related respiratory support devices.
  • CPAP Continuous Positive Airway Pressure
  • BiPAP bilevel pressure support devices
  • Fig. 19 depicts an exemplary nasal interface system 2100 assembled (left) and in exploded form (right). Fig.
  • a unitary chamber 2101 is formed as a single piece of a resilient biocompatible elastomeric material such as a silicone elastomer, polyurethane elastomer, or polyurethane siloxane copolymer elastomer which defined an external surface and a hollow interior.
  • a pair of nasal interfaces 2106 are molded into the unitary chamber in the form of hollow, approximately conical, frustra that terminate in an opening fluidly connected with the hollow interior.
  • the interfaces 2106 e.g., approximately frustroconical prongs
  • the sides of unitary chamber 2101 wrap around the nose of the wearer, contacting the sides of the nose at the skin contact surface 2105 of the chamber body.
  • This contact surface presents with a concave, bowl-shaped profile.
  • This provides a skin contact surface that embraces the nose on either side, with the rhinal columella of the wearer positioned at approximately the bottom of the “bowl” at location 2118.
  • a first “superior” margin 2114 of the skin contact surface is positioned proximal to the subnasale, while a second “inferior” margin 2113 of the skin contact surface is proximal to the rhinal apex.
  • the dorsum nasi is substantially external of the chamber body.
  • a surface recess 2117 in the first surface region is positioned inferior to the upper margin and configured to receive the individual’s tip lobule.
  • the concave chamber body continues laterally from the nose with two side members, or “wings,” 2115, the inner surface of which form part of the skin contact surface, with an exterior surface that lies distal to that contact surface.
  • wings the inner surface of which form part of the skin contact surface
  • these wings may alternatively be solid or partially solid at their upper region and so not a part of the chamber body.
  • One or more exhaust apertures (or “vent holes”) 2108 are positioned through this exterior surface at or near the base of wings 2115. During expiration, exhaled gas is deposited in the hollow interior, which can exit through these pre-existing vent holes.
  • the base surface 2107 of the chamber body that is distal to the skin contact surface provides an open gas ingress port, which provides access of pressurized gas to the hollow chamber interior.
  • a substantially rigid housing 2102 comprises an upper surface 2110 that mates and seals with gas ingress port to form the nasal interface system.
  • a lower surface 2109 of substantially rigid housing 2102 is configured to operably connect to a pressurized gas source (i.e., a PAP blower), thereby providing a fluidly connected pathway between the pressurized gas source and the interior of the hollow chamber body 2101.
  • O-rings 2116 can be provided on an interior or exterior surface of lower surface 2109 to provide an airtight friction fit to the pressurized gas source.
  • the wings 2115 of the chamber body 2101 are hollow, they may be collapsed if the wearer’s head applies pressure to the exterior as might occur during sleep, compromising the fit and seal of the nasal interface system and collapse the underlying nostril.
  • the unitary substantially rigid housing 2102 can provide optional shielding portions 2104 extending across at least a portion of the external surface of each wing structure 2115.
  • regional stiffening of the upper part of the wings can provide additional protection of the chamber body to prevent distortion and movement of the nasal interface or collapse.
  • the air pathway may optionally incorporate a hygroscopic condenser humidifier element 2103 that inserts into the substantially rigid housing 2102 or the base of the chamber body 2101.
  • the humidifier element 2103 retains moisture when the user exhales, and this moisture is in turn returned as humidified pressurized air on inspiration. Moisture retention by the element on exhalation is enhanced by providing the exhaust apertures 2108 on the outside of the chamber body 2101 pointing downwards and away from the user. As described hereinafter, these exhaust apertures may also be placed elsewhere within the air pathway, such as within the substantially rigid housing.
  • the immediate contacting surface in one embodiment is flat under the nose, with one or two outlet holes directing the airflow into the nares. Correct positioning and fit are enhanced by the addition of frustoconical nasal prongs above the outlet holes of the interface. Stability of the nasal interface is further enhanced by having a cup like structure surrounding the nasal prongs to envelop the base of the nose.
  • the interface also has elastomeric side members 2115 to stop sideways movement of the interface relative to the nares and cause misalignment of the outlet holes with the nares.
  • the height of these elastomeric side members relative to the flat area under the nares is a minimum of 10 mm and a maximum extending to 10 mm above the bottom of the nasal bone.
  • the elastomeric side members are configured to be appropriately compliant to be comfortable.
  • the elastomeric side members and the entire thin-walled soft upper section of the interface may be configured to inflate slightly under the applied CPAP pressure and essentially float on the nose without significant pressure points.
  • the hard plastic base of the interface unit may include hard plastic wings protruding upwards from the base connector to protect the outside of the side bolsters.
  • the cutout on top of the soft section of the interface stops the interface touching the bony bridge of the nose, which is often irritated and eroded by the skin pressure from conventional over-the-nose CPAP masks.
  • Fig. 21 depicts one example of a resilient elastomeric chamber body, showing the angles (in degrees), diameters (
  • the interface design can be larger or smaller as required to fit different nose sizes/shapes and accommodate different distances between the CPAP unit and a user’s nose.
  • the large bulbous noise absorbing chamber acts as a compliance buffer between the nose and the hard plastic base of the interface and to avoid the user’s nose contacting this hard surface.
  • the soft bulbous section of the interface is preferably made from a 30 to 70 durometer biocompatible silicone (ideally 40 to 60) but higher and lower durometers and different materials may also be substituted.
  • Exemplary wall thicknesses for various features of the resilient elastomeric chamber body are depicted in Fig. 22.
  • the portion of the chamber body forming the space-filled interior chamber may have a Shore A durometer of between 30 and 60 and a wall thickness of between 0.5 mm and 5.0 mm, with regional differences in wall thickness (and so stiffness) used to provide regional variations in deformability.
  • the nasal interface system of the present invention finds particularly advantageous use with the body -worn positive airway pressure devices as described in PCT/US2022/043556, in which the PAP blower unit is chin mounted and held in place by a head strap, and a face mask (e.g., nasal pillow) is positioned at the wearer’s nose as an integral component of the PAP device.
  • a face mask e.g., nasal pillow
  • This use is depicted in Figs. 23 and 29, in which unitary chamber 2101 is mounted to the unitary substantially rigid housing 2102, which is then directly coupled to the body -worn positive airway pressure device 2501.
  • the nasal interface system of the present invention may itself be held in position using a head strap.
  • the nasal interface system of the present invention finds use with more traditional positive airway pressure devices that are connected to a PAP blower by a flexible supply conduit (e.g., a hose).
  • a flexible supply conduit e.g., a hose
  • a flexible supply conduit e.g., a hose
  • the unitary chamber 2601 is in this case is formed as a single piece of a resilient biocompatible elastomeric material such as a silicone elastomer, polyurethane elastomer, or polyurethane siloxane copolymer elastomer which defined an external surface and a hollow interior.
  • a substantially rigid housing 2602 comprises an upper surface that mates and seals with a gas ingress port to of unitary chamber 2601, and a lower surface of substantially rigid housing 2602 is configured to operably connect to a pressurized gas source (i.e., a PAP blower) via flexible supply conduit 2604, thereby providing a fluidly connected pathway between the pressurized gas source and the interior of the hollow chamber body 2601.
  • a pressurized gas source i.e., a PAP blower
  • the air pathway may optionally incorporate a hygroscopic condenser humidifier element 2603 that inserts into the substantially rigid housing 602 or the base of the chamber body 2601.
  • An optional adapter 2605 may be provided that provides a first connection to the end of flexible supply conduit 2604 and a second connection that is adapted to connect the system to the ouput port of a particular PAP blower.
  • Different adapters 2605 may be produced to adapt the nasal interface system of the present invention to a variety of manufacturer’s PAP blowers.
  • a headgear having four points of attachment to the substantially rigid housing 2602 is depicted. This headgear attaches with rotating “buttons” 2606 that “clip” into and out of mating recessed holes on the substantially rigid housing 2602.
  • a detailed view of the substantially rigid housing 2602 is shown in Fig. 29, with the mating holes 21001 depicted as extensions from the generally circular body 21003.
  • a coupling 21002 is provided for attachment of the flexible supply conduit. It will be understood that the interface design and headgear can be larger or smaller as required to fit different facial features (e.g., nose sizes/ shapes).
  • the nasal and oronasal system headgear designs are similar in their approach - to provide a stable 4 point attachment which pulls slightly upwards to maintain a seal under the nose, and under the chin in the case of the oronasal system.
  • the headgear is preferably designed to sit above the ears and be adjusted for different size heads by a single strap adjustment at the top of the head.
  • the adjustable side straps allow a gentle stable pull on the sides of the masks.
  • the headgear may have stiffening elements, which can range from providing thicker material or sections, and/or plastic inserts in the headgear material. AN extended loop and hook closure on the top of the head can also provide a stiffer headgear. A stiffer headgear would maintain its head shape and so simplify fitting on a user.
  • FIG. 26 and 27 A detailed view of the unitary chamber 2601 is depicted in Figs. 26 and 27.
  • the sides 2808 of unitary chamber 2601 wrap around the nose of the wearer.
  • the skin contact surface 2803 of the chamber body presents with a concave, bowls-shaped profile. This provides a skin contact surface that embraces the nose on either side, with the rhinal columella of the wearer positioned at approximately the bottom of the “bowl.”
  • a first “superior” margin 2807 of the skin contact surface is positioned proximal to the subnasale, while a second “inferior” margin 2806 of the skin contact surface is proximal to the rhinal apex.
  • the dorsum nasi is substantially external of the chamber body.
  • a slight depression or recess may be present at the rhinal apex location 2803 to reduce pressure on the tip of the nose without compromising the peripheral seal.
  • the shape of the skin contact surface causes the greatest pressure to overlie the bony structure of the maxilla at the position of the upper lip when the unitary chamber 2601 is properly supported by the headgear 2607.
  • the bowl-shaped surface continues into two side member “wings” 2808, the inner surface of which form part of the skin contact surface, and comprise an exterior surface that lies distal to that contact surface.
  • the inner skin contact surface extends over the nasal ala towards a position overlying the maxilla, and terminates skin contact proximal to a location overlying the zygomaticomaxillary suture.
  • One or more vent holes 2810 are positioned through this exterior surface at or near the base of wings 2808. During expiration, exhaled gas is deposited in the hollow interior, which can exit through these pre-existing vent holes.
  • the base, or posterior surface, 2805 of the chamber body provides an open gas ingress port, which provides access of pressurized gas to the hollow chamber interior.
  • a substantially rigid housing 2602 comprises an upper surface that mates and seals with gas ingress port to form the nasal interface system.
  • wings 2808 are not part of the hollow cavity of unitary chamber 2601, but rather the upper part of wings 2808 are solid features that remain a unitary part of unitary chamber 2601. This can permit the deletion of shielding portions on rigid housing 2602 that were depicted in the embodiment of Fig. 18.
  • a recess or thinned section 2809 may be present in the external surface of the solid wing structure at approximately a position where the wings overlie the portion of the maxilla that is proximal to the zygomaticomaxillary suture.
  • the location of transition between the soft lower portion of the wings and harder and relatively thicker upper portion of wings 2808 creates a hinging feature, enhanced by the softer recess feature.
  • the hollow cavity portion of unitary chamber 2601 is comfortably soft under the nose, relatively stiff at the thicker portion of the wings, and less stiff at the recesses.
  • making at least part of the wings 2808 solid reduces dead space inside unitary chamber 2601, reduces air turbulence and the resulting noise, and improves cleanability of the chamber.
  • the thinner recessed portion also increases comfort where the wings contact the cheeks.
  • the shape of the hollow chamber reduces the propensity of the interface from contacting the bony bridge of the nose, which is often irritated and eroded by the skin pressure from conventional over-the-nose CPAP masks.
  • Tapered nasal prongs 2801 provide a secure nasal seal when gently pushed into the nares by the interface cushion contact surface under the nose and position air outlets 2802 into the nasal cavity. They also act as gentle nasal dilators to reduce nasal resistance and minimize CPAP pressure needs. Stability and seal of the nasal interface is further enhanced by having a cup like structure surrounding the nasal prongs to envelop the base of the nose. This cup-like structure can have optional recesses molded into the contact surface at areas under the tip of the nose, over the upper lip and the sides of the nostrils to reduce “hot spot” high contact pressures at these points.
  • the soft nasal prongs coupled with the stiffer high wings allow easy fitment of the mask and provide improved stability of the mask on the nose (e.g., when the wearer of the mask or the attachment hose moves).
  • Fig. 29 depicts another exemplary embodiment in which the resilient elastomeric chamber body 21201 is operably connected to substantially rigid housing 21202.
  • the exhaust apertures 21203 are provided in the substantially rigid housing 21202 instead of in the resilient elastomeric chamber body.
  • This array of exhaust apertures is tubular in nature, with an open bore diameter of each of the exhaust apertures being about 1.2 mm, and the flow path length of each of the exhaust apertures is about 5 mm.
  • a lower surface of substantially rigid housing 21202 is configured to operably connect to a pressurized gas source 21204 (i.e., a PAP blower) that is powered by a battery 21206.
  • a pressurized gas source 21204 i.e., a PAP blower
  • a headgear 21205 is used to position the device on the wearer, with the weight of the system applied to the wearer through chin cup 21207.
  • the exhaust holes can be oriented in a variety of different directions, e.g. so as not to direct the exhaust airflow onto the user or a bed partner.
  • Figs. 28 and 30 depict substantially rigid housing 21202 in more detail. Relocating the mask exhaust holes 21203 from the resilient elastomeric chamber body to the housing can reduce the noise level during use of the nasal interface to deliver positive pressure gases at therapeutic levels of airflow into the mask.
  • 17 exhaust apertures 21203 each having a diameter 21302 of 1.19 mm and a flow path length 21301 of 5mm, provides comparable high exhaust flows when compared to the range shown for a commercially available BREVIDATM (Fisher and Paykel) CPAP mask at pressures between 5 and 16 cm H2O.
  • this arrangement of tubular exhaust apertures is about 3 to 4 dBA quieter than the BREVIDATM mask at 10 cm H2O pressure.
  • the use of tubular exhaust apertures is believed to smooth what is a noisy turbulent airflow to a quieter, more laminar, flow.
  • the entire flow path length is accommodated by the wall thickness of the substantially rigid housing. If additional flow path length is desired or the wall thickness is reduced, these tubular exhaust apertures could be constructed to extend externally or internally from the wall in the form of actual tubular structures.
  • the chin cup 21207 is advantageously mounted via a dovetail rail system that allows adjustment of the chin cup along two axes as shown. That is, the chin cup 21207 may slide along the dovetail rail 21401 in a direction that runs up and down relative to the pressurized gas source 21204, and may slide fore and aft relative to the pressurized gas source 21204 by means of slot 21402. The dovetail rail system may then be fixed into a final position by tightening screw 21403. In this way, the chin cup can be adjusted to fit a number of different facial shapes and sizes and also may be removed and replaced.
  • aspects of the devices described herein may be formed using a number of methods known to those of skill in the art, including but not limited to injection molding, machining, etching, 3D printing, etc.
  • the elements of the oronasal interface system are injection molded, a process for forming thermoplastic and thermoset materials into molded products of intricate shapes, at high production rates and with good dimensional accuracy.
  • the resilient elastomeric portions of the devices described herein may be formed, molded, or fabricated from any suitable material or combination of materials.
  • suitable material or combination of materials include, but are not limited to, thermoplastic elastomers (TPEs), silicone, rubber, copolyesters, polycarbonates, or urethane.
  • TPE products include block copolymers such as Thermolast, Hipex, Copec, For Tec E, Santoprene, Termoton, Amitel, Solprene, Engage, Hytrel, Dryflex, Mediprene, Kraton, and Pibiflex; elasomeric alloys sucxh as Thermolast A, Thermolast V, Hipex, Forprene, Termoton-V and Vegaprene; styrenic block copolymers such as Thermolast K, Thermolast M, Sofprene, and Laprene; thermoplastic polyurethanes such as Copec; and thermoplastic olefins such as For-Tec E.
  • block copolymers such as Thermolast, Hipex, Copec, For Tec E, Santoprene, Termoton, Amitel, Solprene, Engage, Hytrel, Dryflex, Mediprene, Kraton, and Pibiflex
  • Portions of the devices may be made of a rigid or substantially rigid material.
  • a number of polymers may be used including thermoplastics, some thermosets, and elastomers.
  • Thermoplastic materials become flowing liquids when heated and solids when cooled, they are often capable of undergoing multiple heating/cooling cycles without losing mechanical properties.
  • Thermoset materials are made of prepolymers which upon reaction cure irreversibly into a solid polymer network.
  • Elastomers are viscoelastic materials which exhibit both elastic and viscous properties and can be either a thermoplastic or thermoset.
  • thermoplastics include PMMA, cyclic olefin copolymer, ethylene vinyl acetate, polyacrylate, polyaryletherketone, polybutadiene, polycarbonate, polyester, polyetherimide, polysulfone, nylon, polyethylene, and polystyrene.
  • Common thermosets include polyesters, polyurethanes, duroplast, epoxy resins, and polyimides. This list is not meant to be limiting. Functional filler materials such as talc and carbon fibers can be included for purposes of improving stiffness, working temperatures, and part shrinkage.
  • the devices of the present invention are preferably sufficiently stiff, and exhibit additional material thickness regionally, such that the devices reduce deformation in use as compared to various prior art masks that can deform/collapse/move and leak as the user moves during sleep.
  • Fig. 32 depicts wall thicknesses (in mm) at various points on the nasal interface. If all other parameters such as shape and material durometer remain roughly the same, a silicone rubber section twice as thick should be eight times as stiff, as stiffness is proportional to the cube of the thickness based on the following equation:
  • Exemplary regional wall thicknesses for a nasal interface are shown in Fig. 32.
  • the I and L stiffness regions are particularly relevant for stopping the overall deformation of the mask and collapse of the nasal prongs during use, and the N area regional stiffness in combination with the contained nasal prongs, is particularly relevant to stopping the mask moving during use and also allowing easy user fitment by instantly holding the nasal prongs firmly and correctly in the right position. These thicknesses are approximate and exemplary only.
  • An oronasal patient interface system adapted for the delivery of positive air pressure to an individual, comprising: a nasal interface portion comprising a first resilient elastomeric hollow chamber body defining a first space-filled interior chamber, the first hollow chamber body comprising a concave, bowl-shaped, skin contact surface configured to receive the nose of the individual, wherein the skin contact surface comprises a superior margin configured to contact the individual’s skin at the supratip lobule and terminate contact of the unitary chamber with the individual’s skin at or inferior to the supratip break, and an inferior margin configured to contact the individual’s skin inferior to the coumella and superior to the upper vermillion border, a surface recess in the skin contact surface positioned inferior to the superior margin and configured to receive the individual’s tip lobule, a pair of nasal interfaces, each nasal interface comprising an opening at an upper surface thereof in fluid communication with the space-filled interior chamber, and first and second elastomeric side members, each side member configured to extend laterally from the resilient elastomeric hollow chamber
  • each nasal interface is formed as a hollow, approximately conical frustra extending from the skin contact surface and configured to insert into a nostril.
  • An oronasal patient interface system according to one of embodiments 1-3, further comprising a unitary substantially rigid housing comprising a first surface configured to mate to the gas ingress port and a second surface configured to operably connect to a gas source, thereby providing a fluidly connected pathway at a location between the gas source and the gas ingress port.
  • An oronasal patient interface system wherein the unitary substantially rigid housing comprises one or more exhaust apertures that fluidly connect the plenum space and the hollow chamber body to ambient external atmosphere.
  • An oronasal patient interface system according to embodiment 5, wherein one or more of the exhaust apertures in the unitary substantially rigid housing comprise a flow path length of from about 3 mm to about 7 mm. 7. An oronasal patient interface system according to embodiment 6, wherein one or more of the exhaust apertures in the unitary substantially rigid housing comprise a flow path length of between about 3 mm to about 7 mm and an open bore diameter of between about 0.7 mm to about 2.5 mm.
  • an oronasal patient interface system according to one of embodiments 6-11, wherein the unitary substantially rigid housing further comprises a plurality of mount points configured to mate to a headgear configured to retain the oronasal interface system on the head of the user thereof.
  • An oronasal patient interface system according to one of embodiments 4-12, wherein the unitary substantially rigid housing further comprises four headgear mount points.
  • An oronasal patient interface system according to embodiment 13, further comprising the headgear, wherein the headgear comprises four fasteners configured to mate to the four mount points.
  • An oronasal patient interface system according to one of embodiments 1-14, further comprising a replaceable hygroscopic condenser humidifier element positioned within the unitary substantially rigid housing and configured to increase the humidity of the gas as it traverses the fluidly connected pathway between the gas source and the gas ingress port.
  • nasal interface portion and the oral interface portion are formed of a polyurethane elastomer.
  • nasal interface portion and the oral interface portion are formed of a polyurethane siloxane copolymer elastomer.
  • a method of treating sleep apnea, snoring, or another breathing disorder in an individual comprising: positioning the oronasal interface system according to one of embodiments 1-21 over the nose and mouth of the individual such that the nasal interfaces insert into or onto the nostrils of an individual and the oral interface portion defines a plenum space over the mouth of the individual and extends around and under the mental protuberance of the individual to envelop said mental protuberance such that the chin of the individual seats into a cup-shaped region formed by the lower portion of the oronasal interface system defining the plenum space; and energizing a flow generator operably connected to the oronasal interface system to administer airflow produced by the flow generator into the individual’s oral cavity and nostrils via the oronasal interface system.
  • a method of administering positive airway pressure to an individual comprising: positioning the oronasal interface system according to one of embodiments 1-21 over the nose and mouth of the individual such that the nasal interfaces insert into or onto the nostrils of an individual and the oral interface portion defines a plenum space over the mouth of the individual and extends around and under the mental protuberance of the individual to envelop said mental protuberance such that the chin of the individual seats into a cup-shaped region formed by the lower portion of the oronasal interface system defining the plenum space; and energizing a flow generator operably connected to the oronasal interface system to administer airflow produced by the flow generator into the individual’s oral cavity and nostrils via the oronasal interface system.
  • a nasal interface system for delivery of positive air pressure to an individual comprising: a resilient elastomeric hollow chamber body defining a space-filled interior chamber, the hollow chamber body comprising (i) a first surface region forming a concave, bowl-shaped, skin contact surface configured to receive the nose of the individual, and (ii) a second surface region of the chamber body comprising a gas ingress port configured to receive a gas under positive pressure for delivery to the individual, wherein the gas ingress port is in fluid communication with the space-filled interior chamber, wherein the first surface region comprises a superior margin configured to contact the individual’s skin at the supratip lobule and terminate contact of the unitary chamber with the individual’s skin at or inferior to the supratip break, an inferior margin configured to contact the individual’s skin inferior to the coumella and terminate contact of the unitary chamber with the individual’s skin at or superior to the upper vermillion border, a pair of nasal interfaces, each nasal interface formed as a hollow, approximately conical frustra extending from the first surface region and
  • a nasal interface system for delivery of positive air pressure to an individual comprising: a resilient elastomeric hollow chamber body defining a space-filled interior chamber, the hollow chamber body comprising (i) a first surface region forming a concave, bowl-shaped, skin contact surface configured to receive the nose of the individual, and (ii) a second surface region of the chamber body comprising a gas ingress port configured to receive a gas under positive pressure for delivery to the individual, wherein the gas ingress port is in fluid communication with the space-filled interior chamber, wherein the first surface region comprises a superior margin configured to contact the individual’s skin at the supratip lobule and terminate contact of the unitary chamber with the individual’s skin at or inferior to the supratip break, an inferior margin configured to contact the individual’s skin inferior to the coumella and terminate contact of the unitary chamber with the individual’s skin at or superior to the upper vermillion border, a pair of nasal interfaces, each nasal interface formed as a hollow, approximately conical frustra extending from the first surface region and
  • a nasal interface system according to embodiment 24 or 25, further comprising a unitary substantially rigid housing comprising a first surface configured to mate to the gas ingress port and a second surface configured to operably connect to a gas source, thereby providing a fluidly connected pathway between the gas source and the gas ingress port.
  • a nasal interface system according to embodiment 29, further comprising the headgear, wherein the headgear comprises four fasteners configured to mate to the four mount points.
  • a nasal interface system according to one of embodiments 24-30, further comprising a replaceable hygroscopic condenser humidifier element positioned within the unitary substantially rigid housing and configured to increase the humidity of the gas as it traverses the fluidly connected pathway between the gas source and the gas ingress port.
  • a nasal interface system according to one of embodiments 24-31 wherein the resilient elastomeric chamber body is configured such that introduction of positive air pressure in the range of 4-30 cm H2O into the space-filled interior chamber causes the space-filled interior chamber to increase in volume.
  • the chamber body is formed of a silicone elastomer.
  • a nasal interface system according to one of embodiments 24-32, wherein the chamber body is formed of a polyurethane elastomer.
  • a nasal interface system according to one of embodiments 24-32, wherein the chamber body is formed of a polyurethane siloxane copolymer elastomer.
  • a nasal interface system according to one of embodiments 24-35, wherein the portion of the chamber body forming the space-filled interior chamber has a Shore A durometer of between 10 and 80.
  • a nasal interface system according to embodiment 36 wherein the portion of the chamber body forming the space-filled interior chamber has a Shore A durometer of between 30 and 60 and a wall thickness of between 0.5 mm and 2.0 mm.
  • a nasal interface system according to one of embodiments 24-37, wherein the opening at the upper surface of each nasal interface is oval, stadium, pyriform, spherical, or elliptical in shape.
  • a nasal interface system according to one of embodiments 24-38, wherein the chamber body retains its shape, and a force of 4 N collapses, the portion of the chamber body forming the space-filled interior chamber when the space-filled interior chamber is at 1 atm of pressure.
  • a nasal interface system according to one of embodiments 24-39, wherein the skin contact surface of the chamber body is configured to terminate proximal to the infraorbital portion of the face of the individual between the first and second margins.
  • a nasal interface system according to one of embodiments 24-40, wherein introduction of positive air pressure in the range of 4-30 cm H2O into the space-filled interior chamber increases the seal of each nasal interface within the nostril.
  • a method of treating sleep apnea, snoring, or another breathing disorder in an individual comprising: positioning the nasal interface system according to one of embodiments 24-41 over the nose of the individual such that the nasal interfaces, each formed as a hollow, approximately conical, frustra extending from the skin contact surface, insert into or onto the nostrils of an individual; and energizing a flow generator operably connected to the nasal interface system to administer airflow produced by the flow generator into the individual’s nostrils via the nasal interface system.
  • a respiratory mask configured for the delivery of positive pressure gas to an individual, comprising: an interior surface defining a plenum space configured and arranged to position over the nose, mouth, or nose and mouth of the individual and to contact the face of the individual with portion of the respiratory mask providing a peripheral seal; and a sensor module comprising a photoplethysmogram (PPG) sensor comprising a light emitter and a light detector configured to generate PPG sensor data, wherein the sensor module is configured and arranged to be positioned separated from the skin surface of the individual by the peripheral seal and to collect PPG sensor data through the peripheral seal.
  • PPG photoplethysmogram
  • a respiratory mask configured for the delivery of positive pressure gas to an individual, comprising: a resilient oral or oronasal patient interface; and a frame comprising a first aperture configured to receive the positive pressure gas from a gas source and a second aperture configured to operably connect to the resilient oral or oronasal patient interface to administer the positive pressure gas to the individual, wherein the oral or oronasal patient interface system comprises one or more exhaust apertures in the form of elongate hollow tubes comprising a flow path length of from about 3 mm to about 7 mm and an open bore diameter of between about 0.7 mm to about 2.5 mm. 45.
  • a respiratory mask configured for the delivery of positive pressure gas to an individual, comprising: an elastomeric patient interface configured and arranged to position over the mouth of an individual and comprising interior surface defining a plenum space; and a pair of resilient flaps external to the plenum space and configured and arranged to lie on the cheeks (buccse) on the sides of the face or the individual, wherein the pair of resilient flaps are unitary with the elastomeric patient interface.

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Otolaryngology (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne un système d'interface oronasale pour l'administration d'une pression respiratoire positive dans les voies respiratoires, qui comprend une partie d'interface nasale et une partie d'interface orale, la partie d'interface orale entourant le menton de l'individu.
PCT/US2024/027676 2023-05-03 2024-05-03 Interface patient oronasale conçue pour une utilisation dans une distribution de pression positive dans les voies respiratoires Pending WO2024229353A2 (fr)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US202363499818P 2023-05-03 2023-05-03
US63/499,818 2023-05-03
US202363514775P 2023-07-20 2023-07-20
US63/514,775 2023-07-20
US202463619689P 2024-01-10 2024-01-10
US63/619,689 2024-01-10
US202463561126P 2024-03-04 2024-03-04
US63/561,126 2024-03-04

Publications (3)

Publication Number Publication Date
WO2024229353A2 WO2024229353A2 (fr) 2024-11-07
WO2024229353A3 WO2024229353A3 (fr) 2025-05-15
WO2024229353A9 true WO2024229353A9 (fr) 2025-10-16

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Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090151729A1 (en) * 2005-11-08 2009-06-18 Resmed Limited Nasal Assembly
NZ706053A (en) * 2007-11-05 2016-10-28 Resmed Ltd Patient interface
NZ713055A (en) * 2010-09-30 2017-04-28 Resmed Ltd Mask system
CN114191673B (zh) * 2012-05-18 2024-04-26 瑞思迈私人有限公司 鼻罩系统
TWI744906B (zh) * 2013-05-14 2021-11-01 澳大利亞商瑞思邁私人股份有限公司 口鼻患者介面
GB2615230B (en) * 2019-07-18 2024-04-17 Fisher & Paykel Healthcare Ltd Patient interface
EP4188497A4 (fr) * 2020-07-30 2024-08-28 ResMed Pty Ltd Structure formant un joint d'interface patient avec de multiples matériaux d'étanchéité
WO2022183116A1 (fr) * 2021-02-26 2022-09-01 Resmed Inc. Système et procédé de réglage continu de la forme d'un masque personnalisé

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WO2024229353A3 (fr) 2025-05-15

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