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EP-4736920-A2 - FULL-FACE PATIENT INTERFACE

EP4736920A2EP 4736920 A2EP4736920 A2EP 4736920A2EP-4736920-A2

Abstract

The present invention relates to a patient interface comprising: a plenum chamber being formed entirely from a flexible material, the plenum chamber including: a cavity, an inlet port, and a groove formed on a surface of the plenum chamber outside the cavity and exposed to ambient pressure, the groove formed radially outside of the inlet port, and the groove forming an enclosed perimeter; a seal-forming structure; a positioning and stabilizing structure comprising: a frame coupled to the plenum chamber, the frame including, a central portion including an inner perimeter and an outer perimeter removably positionable within the groove, the inner perimeter configured to be spaced apart from the inlet port while positioned within the groove, a pair of upper arms, and a pair of lower arms; and headgear straps coupled to the pair of upper arms and the pair of lower arms of the frame.

Inventors

  • HARTONO, Marvin Sugi
  • MAUNG, KYI THU

Assignees

  • ResMed Pty Ltd

Dates

Publication Date
20260506
Application Date
20220309

Claims (15)

  1. A patient interface comprising: a plenum chamber being formed entirely from a flexible material, the plenum chamber including: a cavity that is pressurisable to a therapeutic pressure of at least 6 cmH 2 O above ambient air pressure, an inlet port configured to provide fluid communication between the cavity and ambient, and a groove formed on a surface of the plenum chamber outside the cavity and exposed to ambient pressure, the groove formed radially outside of the inlet port, and the groove forming an enclosed perimeter; a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the cavity of the plenum chamber throughout the patient's respiratory cycle in use; a positioning and stabilizing structure configured to maintain the seal-forming structure in a therapeutically effective position, the positioning and stabilizing structure comprising: a frame coupled to the plenum chamber, the frame including, a central portion including an inner perimeter and an outer perimeter removably positionable within the groove, the inner perimeter configured to be spaced apart from the inlet port while positioned within the groove, a pair of upper arms that extend away from the central portion in a posterior direction, the pair of upper arms being configured to, in use, extend over the patient's cheeks, and a pair of lower arms that extend away from the central portion; and headgear straps coupled to the pair of upper arms and the pair of lower arms of the frame and configured to provide a tensile force to the seal-forming structure into the patient's face via the frame.
  2. The patient interface of claim 2, wherein the upper arms are longer than the lower arms.
  3. The patient interface of any one of claims 1 and 2, wherein the pair of upper arms each include a first type of connector and the pair of lower arms each include a second type of connector that is different from the first type of connector.
  4. The patient interface of claim 3, wherein the first type of connector is selected from a group consisting of a loop, a ladder lock, and a cord stopper.
  5. The patient interface of any one of claims 3 and 4, wherein the second type of connector is a magnetic member.
  6. The patient interface of claim 5, wherein a housing is removably and magnetically connected to the magnetic member.
  7. The patient interface of claim 6, wherein the housing includes a strap connector for connecting to a strap of the headgear straps, the strap connector is selected from a group consisting of a loop, a ladder lock, and a cord stopper.
  8. The patient interface of any one of claims 1 to 7, wherein at least one strap of the headgear straps includes a first width and a second width that is greater than the first width.
  9. The patient interface of claim 8, wherein the first width is selectively receivable through the first type of connector, and wherein the second width is substantially blocked from passing through the first type of connector.
  10. The patient interface of any one of claims 1 to 9, wherein the pair of upper arms and the pair of lower arms are integrally formed with the central portion.
  11. The patient interface of any one of claims 1 to 10, wherein the plenum chamber includes at least one projection that extends from the groove, and wherein the central portion of the frame includes at least one slot configured to selectably receive the at least one projection.
  12. The patient interface of any one of claims 1 to 11, wherein the pair of lower arms is substantially flush with the central portion.
  13. The patient interface of any one of claims 1 to 12, wherein the seal-forming structure further includes: a first seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's mouth; a second seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's nares; wherein the groove is disposed on the plenum chamber inferior to the second seal-forming structure and opposite to the first seal-forming structure.
  14. The patient interface of any one of claims 1 to 13, wherein a textile sleeve is connected to each upper arm of the pair of upper arms.
  15. A system for providing pressurized air to a patient, the system comprising: the patient interface of any one of claims 1 to 14; a respiratory therapy system (RPT) device configured to provide a flow of air at the therapeutic pressure; and a conduit connecting the RPT device to the patient interface, the conduit configured to convey the flow of air to the patient interface; wherein the conduit is connected to the inlet port of the plenum chamber.

Description

1 CROSS-REFERENCE TO RELATED APPLICATION This application claims the benefit of S.G. Provisional Patent Application No. 10202105065S, filed May 14, 2021, and S.G. Provisional Patent Application No. 10202102386Q, filed March 9, 2021, each of which is incorporated herein by reference in its entirety. International Application No. PCT/AU2020/050953, filed September 9, 2020, which claims priority to U.S. Provisional Patent Application No. 63/058,001, filed July 29, 2020, are each incorporated herein by reference in their entirety. 2 BACKGROUND OF THE TECHNOLOGY 2.1 FIELD OF THE TECHNOLOGY The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory-related disorders. The present technology also relates to medical devices or apparatus, and their use. 2.2 DESCRIPTION OF THE RELATED ART 2.2.1 Human Respiratory System and its Disorders The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient. The airways include a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lung. The prime function of the lung is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and carbon dioxide to move in the opposite direction. The trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles. The bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli. The alveolated region of the lung is where the gas exchange takes place, and is referred to as the respiratory zone. See "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012. A range of respiratory disorders exist. Certain disorders may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas. Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and Chest wall disorders. Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing (SDB), is characterised by events including occlusion or obstruction of the upper air passage during sleep. It results from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes the affected patient to stop breathing for periods typically of 30 to 120 seconds in duration, sometimes 200 to 300 times per night. It often causes excessive daytime somnolence, and it may cause cardiovascular disease and brain damage. The syndrome is a common disorder, particularly in middle aged overweight males, although a person affected may have no awareness of the problem. See US Patent No. 4,944,310 (Sullivan). Cheyne-Stokes Respiration (CSR) is another form of sleep disordered breathing. CSR is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of waxing and waning ventilation known as CSR cycles. CSR is characterised by repetitive de-oxygenation and re-oxygenation of the arterial blood. It is possible that CSR is harmful because of the repetitive hypoxia. In some patients CSR is associated with repetitive arousal from sleep, which causes severe sleep disruption, increased sympathetic activity, and increased afterload. See US Patent No. 6,532,959 (Berthon-Jones). Respiratory failure is an umbrella term for respiratory disorders in which the lungs are unable to inspire sufficient oxygen or exhale sufficient CO2 to meet the patient's needs. Respiratory failure may encompass some or all of the following disorders. A patient with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath on exercise. Obesity Hyperventilation Syndrome (OHS) is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness. Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a group of lower airway diseases that have certain characteristics in common. These include increased resistance to air movement, extended expiratory phase of respiration, and loss of the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (primary risk factor), occupational exposures, air pollution and genetic factors. Symptoms include: dyspnea on exertion, chronic cough and sputum production. Neuromuscular Disease (NMD) is a broad term that encompasses many diseases and ailments that impair the functioning of