EP-4736916-A2 - PATIENT INTERFACE

EP4736916A2EP 4736916 A2EP4736916 A2EP 4736916A2EP-4736916-A2

Abstract

The present invention disclodses a patient interface for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to a patient's airways including at least entrance of a patient's nares, wherein the patient interface is configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure in use, throughout a patient's respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing; said patient interface comprising: a cushion assembly including a shell and a seal-forming structure provided to the shell and structured to form a seal with a patient's nose and/or mouth, the shell and the seal-forming structure cooperating to form a plenum chamber, the seal-forming structure being constructed of a relatively flexible or pliable material, and the shell being constructed of a relatively rigid material; a shroud formed of a relatively rigid material, the cushion assembly being repeatedly engageable with and removably disengageable from the shroud via a snap-fit connection; and a headgear having a pair of straps; a headgear connector including a shroud connecting portion and a pair of headgear connector arms structured to connect to respective headgear straps of the headgear, the headgear connector comprising flexible portions.

Inventors

AMARASINGHE, AMAL SHIRLEY
EDWARDS, CRAIG DAVID
GILL, Christopher Andrew Wakeley
GOLDSPINK, LACHLAN RICHARD
KIRBY, THOMAS
MARKAPURAM CHENGALVARAYAN, Kishore
MILLER, Holly Elizabeth
NGA, LEMMY
TAN, Chia Ik
WELLS, Matthew Robin
BALUCHAGI, Ravikumar
BARLOW, ADAM FRANCIS
BATE, ANDREW JAMES
BLANCH, Emily Elizabeth
BRAUND, David James
CULLEN, Christopher Samuel
D'SOUZA, Errrol Savio Alex
DAVIES, BRUCE RICHARD

Assignees

ResMed Pty Ltd

Dates

Publication Date: 20260506
Application Date: 20160923

Claims (13)

A patient interface for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to a patient's airways including at least entrance of a patient's nares, wherein the patient interface is configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure in use, throughout a patient's respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing; said patient interface comprising: a cushion assembly including a shell and a seal-forming structure provided to the shell and structured to form a seal with a patient's nose and/or mouth, the shell and the seal-forming structure cooperating to form a plenum chamber, the seal-forming structure being constructed of a relatively flexible or pliable material, and the shell being constructed of a relatively rigid material; a shroud formed of a relatively rigid material, the cushion assembly being repeatedly engageable with and removably disengageable from the shroud via a snap-fit connection; and a headgear having a pair of straps; a headgear connector including a shroud connecting portion and a pair of headgear connector arms structured to connect to respective headgear straps of the headgear, the headgear connector comprising flexible portions.
The patient interface of claim 1, wherein the headgear connector is configured to allow bending into and away from the face to adapt varying facial widths; and/or wherein the headgear connector is configured to resist bending vertically up and down alongside the face.
The patient interface of claim 1 or 2, wherein the shroud connection portion is connected to the shroud by a plurality of pins received in respective openings provided to the shroud.
The patient interface of claim 1 or 2, wherein the shroud connection portion is connected to the shroud via a snap joint including pegs structured to engage within respective openings with a snap fit.
The patient interface of any one of the preceding claims, wherein the headgear connector arms curve in an upwards direction.
The patient interface of any one of the preceding claims, wherein each headgear connector arm includes an upper headgear connection point in the form of a slot structured to receive a respective headgear strap.
The patient interface of any one of the preceding claims, wherein the shroud includes a groove structured to receive the shroud connection portion of the headgear connector.
The patient interface of claim 7, wherein the groove is an upper groove.
The patient interface of any one of the preceding claims, wherein the headgear further includes: a pair of lower straps operatively connectable to the shroud, wherein the pair of straps is a pair of upper straps.
The patient interface of claim 9, wherein each of the lower straps includes a lower headgear clip having a protrusion and the shroud further includes lower headgear connectors having a receptacle, at least one of the lower straps is operatively connectable to the shroud by inserting one of said protrusions within one of said receptacles.
The patient interface of claim 9, wherein the headgear connector further includes: the headgear connector comprising lower headgear connector arms structured to connect to respective lower straps; and intermediate portions interconnecting the headgear connector arms and the lower headgear connector arms with the shroud connection portion.
The patient interface of claim 11, wherein each of the lower headgear connector arms includes a magnetic connector, and at least one of the lower straps includes a lower headgear clip, the magnetic connector being structured to locate and connect to the lower headgear clip.
The patient interface of any one of the preceding claims, wherein the snap-fit connection includes a plurality of spring arms or tabs spaced around an opening of the shroud.

Description

1 CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 62/222,593, filed September 23, 2015, and U.S. Provisional Application No. 62/376,961, filed August 19, 2016, each of which is incorporated herein by reference in its entirety. 2 BACKGROUND OF THE TECHNOLOGY 2.1 FIELD OF THE TECHNOLOGY The present technology relates to one or more of the detection, diagnosis, 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 air into the venous blood and carbon dioxide to move out. 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 2011. A range of respiratory disorders exist. Certain disorders may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas. Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing (SDB), is characterized 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 the muscles either directly via intrinsic muscle pathology, or indirectly via nerve pathology. Some NMD patients are characterised by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, swallowing difficulties, respiratory muscle weakness and, eventually, death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: Characterised by muscle impairment that worsens over months and results in death within a few years (e.g. Amyot