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EP-4740984-A2 - INFLATABLE HEADGEAR AND PATIENT INTERFACE

EP4740984A2EP 4740984 A2EP4740984 A2EP 4740984A2EP-4740984-A2

Abstract

The invention discloses headgear designed to hold a seal-forming structure in a therapeutically effective position on a patient's head. The seal-forming structure forms an airtight seal around the patient's airway entrance to deliver airflow at a therapeutic pressure of at least 6 cmH 2 O throughout the respiratory cycle. The headgear includes at least one air inlet, at least one air outlet in fluid communication with the seal, and headgear tubing extending between them. The tubing is made from a composite material comprising a double-walled film that defines an inner cavity and includes first and second air-holding materials, the first being more relaxed prior to use. The film is impervious to pressurized air and has first and second fabric layers attached to corresponding sides. The tubing has two transverse axes and is more expandable along the first axis. The first air-holding material expands more in this direction, while the second fabric layer limits expansion along the second axis.

Inventors

  • Valiyambath, Mohankumar Krishnan
  • LOWRY, Adrian Jeffrey
  • TAN, Bangzheng
  • SUPAOPASPHUN, Thontira
  • OZOLINS, ANGELENE MARIE
  • CHEN, JING
  • R, Nithya
  • Wijoyoseno, Maximilian Aji

Assignees

  • ResMed Asia Pte. Ltd.

Dates

Publication Date
20260513
Application Date
20210630

Claims (15)

  1. A headgear for providing 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 delivery of a flow of air at a therapeutic pressure of at least 6 cmH 2 O above ambient air pressure throughout the patient's respiratory cycle in use, the headgear comprising: at least one air inlet; at least one air outlet configured to be in fluid communication with the seal-forming structure when the headgear is in use; headgear tubing extending along a length between the air inlet and the air outlet, the headgear tubing being formed from a composite material; and a tensioning structure for providing a force to maintain the seal-forming structure in the as-used position; wherein the composite material comprises: a double walled film defining an inner cavity between respective walls thereof, the double walled film including a first air-holding material and a second air-holding material, the first air-holding material being in a more relaxed state than the second air-holding material prior to use; and an outer surface, the outer surface having a first side on the first air-holding material and a second side on the second air-holding material; wherein the double walled film is impervious to pressurised air; wherein a first fabric layer is connected to the first side and a second fabric layer is connected to the second side and at least partially overlaps the first fabric layer; wherein the headgear tubing has a first transverse axis extending generally transversely of the headgear tubing along the length, and a second transverse axis generally transverse to the first transverse axis and extending generally transversely of the headgear tubing along the length; and wherein the headgear tubing is more expandable in a first direction along the first transverse axis than in a second direction along the second transverse axis, wherein the first air-holding material is more expandable in the first direction than the second material, and wherein the second fabric layer limits expansion in the second direction.
  2. The headgear according to claim 1, wherein the composite material has a flexural modulus of less than 15 N/mm 2 , wherein the headgear tubing is made of a material that is stretchable, wherein the headgear tubing is more stretchable along at least part of its length than in the second transverse axis, and/or wherein the Young's modulus along the length of the tubing is about 15 N/mm 2 to about 150 N/mm 2 .
  3. The headgear according to claim 1, wherein a gap is formed in the first air-holding material and a fastening portion bridges the gap to form an air sealing layer.
  4. The headgear according to claim 3, wherein the fastening portion is openable to expose the double walled film, wherein the fastening portion is in contact with the headgear tubing along the length, and/or wherein the fastening portion extends from a first position proximate to the at least one air inlet to a second position proximate to the at least one air outlet.
  5. The headgear according to claim 1, wherein the headgear tubing is flat when in a collapsed state, wherein the headgear tubing further comprises an air vent near the at least one air outlet of the headgear, wherein the headgear tubing when in an inflated state is arranged to conform to a contour of a patient's head, and/or wherein the headgear tubing has a flexural modulus of less than 15 N/mm 2 .
  6. The headgear according to any one of claims 1 to 5, wherein the second fabric layer is annealed to the first fabric layer.
  7. The headgear according to any one of claims 1 to 6, wherein the double walled film has a total transmittance of more than 90%, and/or wherein the double walled film is selected from thermoplastic polyurethane.
  8. The headgear according to any one of claims 1 to 7, wherein the first fabric layer is laminated to the first side via thermal bonding or glue bonding, and/or wherein the second fabric layer is laminated to the second side via thermal bonding or glue bonding.
  9. The headgear according to any one of claims 1 to 8, wherein the first fabric layer is a mesh fabric layer, the mesh fabric layer has a knit structure selected from single jersey, rib, interlock, raschel, or jacquard, wherein the second fabric layer is selected from microfiber yarns, nylon 6,6, peach-skin finish, elastic knitted fabric, two-way stretch, non stretch, circular knit fabric, woven fabric, or warp knit fabric, and/or wherein the second fabric layer is surface treated with a hydrophobic coating.
  10. The headgear according to any one of claims 1 to 9, wherein the composite material further comprises a foam sandwiched between the second fabric layer and the second side of the double walled film, and/or wherein the composite material further comprises a foam sandwiched between the first fabric layer and the first side of the double walled film.
  11. The headgear according to any one of claims 1 to 10, wherein the headgear tubing is formed from at least two composite materials for providing different stiffness and/or flexibility.
  12. The headgear according to any one of claims 1 to 11, wherein the tensioning structure is positionable to overlie a posterior region of the patient's head, and/or wherein the tensioning structure is an elastic material.
  13. The headgear according to any one of claims 1 to 11, wherein the tensioning structure is formed from the composite material.
  14. The headgear according to any one of claims 1 to 13, wherein the air inlet is positionable to overlie a cranial region of the patient's head when in use.
  15. A patient interface, comprising: a headgear according to any one of claims 1 to 14; and a seal-forming structure that is integrated with or attachable to the headgear at the at least one air outlet thereof, the seal-forming structure constructed and arranged to form a seal with a region of a patient's face surrounding an entrance to the patient's airway for delivery of air flow at a pressure of at least 6 cmH 2 O above ambient air pressure.

Description

A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in Patent Office patent files or records, but otherwise reserves all copyright rights whatsoever. 1 CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Singapore Patent Application No. 10202006317V, filed June 30, 2020, and Singapore Patent Application No. 10202011064U, filed 6 November 2020, the contents of each of which are 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 prod