CN-121987912-A - Inflatable headgear and patient interface

Abstract

The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory related disorders. The present technology also relates to medical devices or apparatus and uses thereof. In particular, the present technology provides a headgear for supplying pressurized air to a patient, the headgear including a headgear tube inflatable from a collapsed state to an inflatable state to form a conduit for supplying pressurized air to the patient, and the headgear tube itself being elastically deformable and collapsible when the headgear tube is in the collapsed state. The headband may also include a stiffening member.

Inventors

• M. K. Valyambas
• A. J. Lorry
• B.Tan
• T. Supapaspen
• A. M. Ozolins
• J.CHEN
• N .rui
• M. A. Vihojoseno

Assignees

• 瑞思迈亚洲私人有限公司

Dates

Publication Date

20260508

Application Date

20210630

Priority Date

20200630

Claims (20)

1. 1. A headgear for providing a force to maintain 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 an area of the patient's face surrounding an entrance to an airway of the patient for delivering an air flow at a therapeutic pressure of at least 6 cmH 2 O above ambient air pressure throughout a respiratory cycle of the patient in use, the headgear comprising: at least one air inlet; At least one air outlet positionable in fluid communication with the seal-forming structure when the headband is in use; A headgear duct extending between the air inlet and the air outlet, the headgear duct comprising at least one fabric layer; At least one stiffening member disposed within the headgear duct, the at least one stiffening member including a spine extending at least partially along the headgear duct and located at a central region of the length of the headgear duct, and A tensioning structure for providing a force to hold the seal-forming structure in use; Wherein the headgear tube is inflatable in one direction from a collapsed state to an inflated state to form a channel for supplying pressurized air to the patient, and Wherein the headgear duct is collapsible upon itself when the headgear duct is in the collapsed state.
2. 2. The headgear of claim 1, wherein the headgear duct comprises a fastening portion that fluidly connects at least two sheets of material that at least partially form the headgear duct.
3. 3. The headgear of claim 2, wherein the fastening portion is movable between a first position in which an interior of the channel is exposed to the ambient environment and a second position in which the channel is configured to communicate an air flow between the at least one air inlet and the at least one air outlet.
4. 4. A headgear according to claim 3, wherein the fastening portion is a zipper, tape or hook and loop fastener.
5. 5. A headgear according to claim 3, wherein the fastening portion is formed as part of a double-wall film and is configured to expose an inner surface of the double-wall film in the first position.
6. 6. A headgear according to any one of claims 3-5, wherein the fastening portion extends at least partially between the at least one air inlet and the at least one air outlet.
7. 7. The headgear of any one of claims 3-5, wherein the fastening portion is in the first position proximate the at least one air outlet and in the second position proximate the at least one air inlet.
8. 8. A headgear according to any one of claims 3-5, wherein the fastening portions are provided on a non-patient contacting side of the headgear tube.
9. 9. A headgear for providing a force to maintain 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 an area of the patient's face surrounding an entrance to an airway of the patient for delivering an air flow at a therapeutic pressure of at least 6 cmH 2 O above ambient air pressure throughout a respiratory cycle of the patient in use, the headgear comprising: at least one air inlet; at least one air outlet in fluid communication with the seal-forming structure when the headband is in use; a headgear duct extending along a length between the air inlet and the air outlet, the headgear duct formed of a composite material; At least one stiffening member disposed within the headgear duct, the at least one stiffening member including a spine extending at least partially along the headgear duct and located at a central region of the length of the headgear duct, and A tensioning structure for providing a force to hold the seal-forming structure in a use position; Wherein the composite material comprises: a double-walled film comprising a first air-retaining material and a second air-retaining material defining an interior cavity therebetween, and Wherein the double-walled film comprises an outer surface having a first side on the first air-retaining material and a second side on the second air-retaining material; Wherein the double-walled film is impermeable to pressurized air; Wherein a first fabric layer is connected to the first side and a second fabric layer is connected to the second side via the at least one rigid member; Wherein the headgear duct has a first transverse axis extending generally transverse to the headgear duct along the length and a second transverse axis extending generally transverse to the first transverse axis, an Wherein the headgear duct is more expandable in a first direction along the first lateral axis than in a second direction along the second lateral axis.
10. 10. The headgear of claim 9 wherein the at least one stiffening member is bonded to the second side of the outer surface of the double-walled film.
11. 11. The headgear of claim 9, wherein the at least one stiffening member has a width that is about 1/3 to about 1/2 of the width of the headgear duct along the second lateral axis.
12. 12. The headgear of claim 9, wherein the at least one stiffening member has a thickness of about 200 μιη to about 2 mm.
13. 13. The headgear of claim 9, wherein the spine has a tapered profile.
14. 14. The headgear of claim 9, wherein the spine has an elongated structure, a zig-zag structure, a square wave structure, or a sinusoidal structure.
15. 15. The headgear of claim 9, wherein the at least one stiffening element comprises a plurality of projections extending from at least one side of the spine.
16. 16. The headgear of claim 15, wherein the plurality of projections are spaced apart from one another at intervals along the length of the spine.
17. 17. The headgear of claim 15, wherein the projections are formed on both lateral sides of the spine.
18. 18. The headgear of claim 15, wherein the projections on one lateral side of the spine have opposing projections on the other side.
19. 19. The headgear of claim 15, wherein the projections on one lateral side of the spine are laterally spaced apart relative to the opposing projections.
20. 20. The headgear of any one of claims 15-19, wherein the projections each have a contact angle of about 20 ° to about 60 ° relative to the spine.

Description

Inflatable headgear and patient interface The present application is a divisional application of patent application number 202180052399.6, application day 2021, 6/30, and entitled "inflatable headgear and patient interface". 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 the patent office document or the record, but otherwise reserves any copyright rights whatsoever. Cross reference to related application 1 The application claims the benefit of U.S. patent application number 10202006317V filed on month 6 and 30 of 2020 and U.S. patent application number 10202011064U filed on month 11 and 6 of 2020, each of which is incorporated herein by reference in its entirety. Background 2.1 Technical field The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory related disorders. The present technology also relates to medical devices or apparatus and uses thereof. 2.2 Description of related Art 2.2.1 Human respiratory system and disorders thereof The respiratory system of the human body promotes gas exchange. The nose and mouth form the entrance to the patient's airway. The airways include a series of branches that become narrower, shorter and more numerous as the branch airways penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter venous blood from the inhaled air and to expel carbon dioxide in the opposite direction. The trachea is divided into left and right main bronchi, which are ultimately subdivided into end bronchioles. The bronchi constitute the conducting airways, but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lung is the region where gas exchange occurs and is referred to as the respiratory region. See, 2012, respiratory physiology (Respiratory Physiology), 9 th edition, published by John b. West, lippincott Williams & Wilkins. There are a range of respiratory disorders. Certain conditions may be characterized by specific events such as apneas, hypopneas, and hyperbreaths. Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), tidal breathing (CSR), respiratory insufficiency, obese Hyperventilation Syndrome (OHS), chronic Obstructive Pulmonary Disease (COPD), neuromuscular disease (NMD), and chest wall disorders. Obstructive Sleep Apnea (OSA) is a form of Sleep Disordered Breathing (SDB) characterized by events that include occlusion or blockage of the upper airway during sleep. It results from the combination of abnormally small upper airway and normal loss of muscle tone in the tongue, soft palate, and area of the posterior oropharyngeal wall during sleep. The condition causes the affected patient to stop breathing, typically for a period of 30 seconds to 120 seconds, sometimes 200 to 300 times per night. This often results in excessive daytime sleepiness, and can lead to cardiovascular disease and brain damage. The complications are common disorders, especially in middle-aged overweight men, but the affected person may not be aware of the problem. See U.S. Pat. No. 4,944,310 (Sullivan). Tidal breathing (CSR) is another form of sleep disordered breathing. CSR is an obstacle to the respiratory controller of a patient in which there are alternating periods of rhythms of active and inactive ventilation called the CSR cycle. CSR is characterized by repeated hypoxia and reoxygenation of arterial blood. CSR may be detrimental due to insufficient repetitive oxygen. In some patients, CSR is associated with repeated arousals from sleep, which results in severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Pat. No. 6,532,959 (Berthon-Jones). Respiratory failure is a term for respiratory disorders in which the lungs cannot inhale enough oxygen or exhale enough CO2 to meet the needs of the patient. Respiratory failure may encompass some or all of the following disorders. Patients with respiratory insufficiency, a form of respiratory failure, may experience abnormal shortness of breath while exercising. Obesity hyper-ventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia upon waking, with no other known cause of hypoventilation. Symptoms include dyspnea, morning headaches, and excessive daytime sleepiness. Chronic Obstructive Pulmonary Disease (COPD) encompasses any one of a group of lower airway diseases that share some common features. These include increased airflow resistance, prolonged expiratory phases of respiration, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (major risk fac