EP-4740986-A2 - POSITIONING AND STABILISING STRUCTURE WITH TEXTILE SLEEVE

EP4740986A2EP 4740986 A2EP4740986 A2EP 4740986A2EP-4740986-A2

Abstract

A positioning and stabilising structure is provided for holding a seal-forming structure of a patient interface on a patient's head. The structure comprises a gas delivery tube arranged to pass over the top of the patient's head to deliver a flow of air to the patient's airways. An elongate textile sleeve is provided around the gas delivery tube and is arranged to contact the patient's face in use. The textile sleeve is characterized in that it comprises a single-piece knitted and/or woven structure that is resiliently flexible in both a circumferential direction and an axial direction. This construction provides a comfortable and secure fit while accommodating patient movement.

Inventors

The designation of the inventor has not yet been filed

Assignees

ResMed Asia Pte. Ltd.

Dates

Publication Date: 20260513
Application Date: 20210917

Claims (15)

A positioning and stabilising structure to provide a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the 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 for sealed delivery of a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure to at least the patient's nares throughout the patient's respiratory cycle in use, the positioning and stabilising structure comprising: a gas delivery tube to receive the flow of air from a connection port on top of the patient's head and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure, the gas delivery tube being constructed and arranged to contact, in use, at least a region of the patient's head superior to an otobasion superior of the patient's head, the positioning and stabilising structure further comprising an elongate textile sleeve provided around the gas delivery tube and arranged to be in contact, in use, with the patient's face, wherein the sleeve comprises a single-piece knitted and/or woven structure that is resiliently flexible in both a circumferential direction and an axial direction.
The positioning and stabilising structure according to claim 1, wherein the textile sleeve comprises a main structure and one or more functional zones knitted and/or woven into the main structure, each said functional zone having one or more textile properties that are different than those of the main structure.
The positioning and stabilising structure according to claim 2, wherein at least one of said functional zones is a transparent or translucent zone through which at least a portion of the gas delivery tube is visible.
The positioning and stabilising structure according to claim 2 or 3, wherein the one or more textile properties comprise one or more of: knitting density; weaving density; a number of loops in a knit pattern; a pattern of the knit or weave; yarn density; yarn type; and fibre cross-section.
The positioning and stabilising structure according to any one of claims 1 to 4, wherein at least part of the textile sleeve is coated or impregnated with at least one material conferring functional and/or aesthetic properties.
The positioning and stabilising structure according to claim 5, wherein the at least one material is one or more of: a phosphorescent material, a luminescent material, or an anti-microbial composition.
The positioning and stabilising structure according to any one of claims 1 to 6, wherein the textile sleeve has a greater flexibility in the axial direction than the circumferential direction.
The positioning and stabilising structure according to any one of claims 1 to 7, wherein the gas delivery tube comprises a strap engaging portion, and the textile sleeve has a first opening through which at least part of the strap engaging portion is accessible for engaging a strap.
The positioning and stabilising structure according to claim 8, wherein the first opening comprises an edge reinforcement structure to reduce or eliminate fraying of the textile, wherein the edge reinforcement structure comprises one or more of: seam tape; stitching; a heat bonded section; and a thickened region.
The positioning and stabilising structure according to any one of claims 1 to 9, wherein the elongate textile sleeve is secured relative to the gas delivery tube at a position proximal to an end of the gas delivery tube proximal to the seal-forming structure.
The positioning and stabilising structure according to claim 10, wherein the textile sleeve is secured to the gas delivery tube by an adhesive.
The positioning and stabilising structure according to claim 10, wherein the elongate textile sleeve is secured relative to the gas delivery tube by an end cap.
The positioning and stabilising structure according to claim 12, wherein the end cap extends from an outer surface of the elongate textile sleeve, over an end of the elongate textile sleeve, and over at least a portion of a rim of the gas delivery tube.
The positioning and stabilising structure according to claim 12 or 13, wherein the end cap comprises at least one visual indicator indicating one or more of: alignment of the gas delivery tube to a connection to the seal-forming structure, and size of the positioning and stabilising structure.
The positioning and stabilising structure of any one of claims 1 to 14, wherein the textile sleeve is secured relative to the gas delivery tube by an overmoulded end portion.

Description

1 BACKGROUND OF THE TECHNOLOGY 1.1 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. 1.2 DESCRIPTION OF THE RELATED ART 1.2.1 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 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 withi